Nationwide Consumer and Fuel Retailer Choice Act Recycling and Composting Accountability Act SUPPORT for Patients and Communities Reauthorization Act of 2025 American Music Tourism Act Deploying American Blockchains Act

I 119TH CONGRESS 1ST SESSION H. R. 1768 To provide for lower costs for everyday Americans, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 3, 2025 Mr. P ALLONE introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Budget, the Judiciary, and Education and Work- force, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for lower costs for everyday Americans, and for other purposes. Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Lower Costs for Every-4 day Americans Act’’. 5 SEC. 2. TABLE OF CONTENTS. 6 The table of contents for this Act is as follows: 7 Sec. 1. Short title. Sec. 2. Table of contents. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 2 •HR 1768 IH DIVISION A—RECYCLING, WATER, AND ENVIRONMENT RELATED PROVISIONS Sec. 101. Recycling and composting accountability. Sec. 102. Recycling Infrastructure and Accessibility Program. Sec. 103. Drinking water infrastructure risk and resilience. Sec. 104. Reauthorization of Diesel Emissions Reduction Act. Sec. 105. Nationwide Consumer and Fuel Retailer Choice Act. DIVISION B—COMMERCE TITLE I—YOUTH POISONING PREVENTION Sec. 101. Short title. Sec. 102. Banning of products containing a high concentration of sodium ni- trite. TITLE II—CONSUMER PRODUCT SAFETY STANDARD FOR CERTAIN BATTERIES Sec. 201. Consumer product safety standard for certain batteries. TITLE III—FOREIGN ADVERSARY COMMUNICATIONS TRANSPARENCY ACT Sec. 301. Short title. Sec. 302. List of entities holding FCC authorizations, licenses, or other grants of authority and having certain foreign ownership. TITLE IV—PROMOTING RESILIENT SUPPLY CHAINS Sec. 401. Short title. Sec. 402. Additional responsibilities of Assistant Secretary of Commerce for In- dustry and Analysis. Sec. 403. Critical supply chain resilience working group. Sec. 404. Department of Commerce capability assessment. Sec. 405. No additional funds. Sec. 406. Sunset. Sec. 407. Definitions. TITLE V—DEPLOYING AMERICAN BLOCKCHAINS Sec. 501. Short title. Sec. 502. Definitions. Sec. 503. Department of Commerce leadership on blockchain. Sec. 504. Reports to Congress. TITLE VI—FUTURE NETWORKS ACT Sec. 601. Short title. Sec. 602. 6G task force. Sec. 603. Termination of Task Force. TITLE VII—SECURE SPACE ACT Sec. 701. Short title. Sec. 702. Prohibition on grant of certain satellite licenses, United States mar- ket access, or earth station authorizations. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 3 •HR 1768 IH TITLE VIII—TAKE IT DOWN ACT Sec. 801. Short title. Sec. 802. Criminal prohibition on intentional disclosure of nonconsensual inti- mate visual depictions. Sec. 803. Notice and removal of nonconsensual intimate visual depictions. Sec. 804. Definitions. Sec. 805. Severability. TITLE IX—RURAL BROADBAND PROTECTION ACT Sec. 901. Short title. Sec. 902. Vetting process for prospective high-cost universal service fund appli- cants. TITLE X—AMERICAN MUSIC TOURISM Sec. 1001. Short title. Sec. 1002. Responsibilities of the Assistant Secretary of Commerce for Travel and Tourism. TITLE XI—INFORMING CONSUMERS ABOUT SMART DEVICES Sec. 1101. Short title. Sec. 1102. Required disclosure of a camera or recording capability in certain internet-connected devices. Sec. 1103. Enforcement by the Federal Trade Commission. Sec. 1104. Definition of covered device. Sec. 1105. Effective date. TITLE XII—SECURING SEMICONDUCTOR SUPPLY CHAINS ACT Sec. 1201. Short title. Sec. 1202. SelectUSA defined. Sec. 1203. Findings. Sec. 1204. Coordination with State-level economic development organizations. Sec. 1205. Report on increasing foreign direct investment in semiconductor-re- lated manufacturing and production. Sec. 1206. No additional funds. TITLE XIII—HOTEL FEES TRANSPARENCY ACT Sec. 1301. Short title. Sec. 1302. Prohibition on unfair and deceptive advertising of hotel rooms and other short-term rental prices. TITLE XIV—TRANSPARENCY IN CHARGES FOR KEY EVENTS TICKETING Sec. 1401. Short title. Sec. 1402. All inclusive ticket price disclosure. Sec. 1403. Speculative ticketing ban. Sec. 1404. Disclosures. Sec. 1405. Refund requirements. Sec. 1406. Report by the Federal Trade Commission on BOTS Act of 2016 en- forcement. Sec. 1407. Enforcement. Sec. 1408. Definitions. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 4 •HR 1768 IH TITLE XV—ROUTERS ACT Sec. 1501. Short title. Sec. 1502. Study of national security risks posed by certain routers and modems. TITLE XVI—NTIA REAUTHORIZATION Sec. 1601. Short title. Sec. 1602. Definitions. Subtitle A—Reauthorization Sec. 1611. Reauthorization of the National Telecommunications and Informa- tion Administration Organization Act. Sec. 1612. NTIA Consolidated Reporting Act. Subtitle B—Office of Spectrum Management Sec. 1621. Office of Spectrum Management. Subtitle C—Office of International Affairs Sec. 1631. Office of International Affairs. DIVISION C—HEALTH TITLE I—MEDICAID Sec. 101. Streamlined enrollment process for eligible out-of-state providers under Medicaid and CHIP. Sec. 102. Making certain adjustments to coverage of home or community-based services under Medicaid. Sec. 103. Removing certain age restrictions on Medicaid eligibility for working adults with disabilities. Sec. 104. Medicaid State plan requirement for determining residency and cov- erage for military families. Sec. 105. Ensuring the reliability of address information provided under the Medicaid program. Sec. 106. Codifying certain Medicaid provider screening requirements related to deceased providers. Sec. 107. Modifying certain State requirements for ensuring deceased individ- uals do not remain enrolled. Sec. 108. One-year delay of Medicaid and CHIP requirements for health screenings, referrals, and case management services for eligible juveniles in public institutions; State interim work plans. Sec. 109. State studies and HHS report on costs of providing maternity, labor, and delivery services. Sec. 110. Modifying certain disproportionate share hospital allotments. Sec. 111. Modifying certain limitations on disproportionate share hospital pay- ment adjustments under the Medicaid program. Sec. 112. Ensuring accurate payments to pharmacies under Medicaid. Sec. 113. Preventing the use of abusive spread pricing in Medicaid. TITLE II—MEDICARE Sec. 201. Extension of increased inpatient hospital payment adjustment for cer- tain low-volume hospitals. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 5 •HR 1768 IH Sec. 202. Extension of the Medicare-dependent hospital (MDH) program. Sec. 203. Extension of add-on payments for ambulance services. Sec. 204. Extending incentive payments for participation in eligible alternative payment models. Sec. 205. Temporary payment increase under the Medicare physician fee sched- ule to account for exceptional circumstances. Sec. 206. Extension of funding for quality measure endorsement, input, and se- lection. Sec. 207. Extension of funding outreach and assistance for low-income pro- grams. Sec. 208. Extension of the work geographic index floor. Sec. 209. Extension of certain telehealth flexibilities. Sec. 210. Requiring modifier for use of telehealth to conduct face-to-face en- counter prior to recertification of eligibility for hospice care. Sec. 211. Extending acute hospital care at home waiver flexibilities. Sec. 212. Enhancing certain program integrity requirements for DME under Medicare. Sec. 213. Guidance on furnishing services via telehealth to individuals with lim- ited English proficiency. Sec. 214. In-home cardiopulmonary rehabilitation flexibilities. Sec. 215. Inclusion of virtual diabetes prevention program suppliers in MDPP Expanded Model. Sec. 216. Medication-induced movement disorder outreach and education. Sec. 217. Report on wearable medical devices. Sec. 218. Extension of temporary inclusion of authorized oral antiviral drugs as covered part D drugs. Sec. 219. Extension of adjustment to calculation of hospice cap amount. Sec. 220. Multiyear contracting authority for MedPAC and MACPAC. Sec. 221. Contracting parity for MedPAC and MACPAC. Sec. 222. Adjustments to Medicare part D cost-sharing reductions for low-in- come individuals. Sec. 223. Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act. Sec. 224. Medicare coverage of multi-cancer early detection screening tests. Sec. 225. Medicare coverage of external infusion pumps and non-self-admin- istrable home infusion drugs. Sec. 226. Assuring pharmacy access and choice for Medicare beneficiaries. Sec. 227. Modernizing and Ensuring PBM Accountability. Sec. 228. Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider. Sec. 229. Medicare sequestration. TITLE III—OTHER MATTERS Sec. 301. Sexual risk avoidance education extension. Sec. 302. Personal responsibility education extension. Sec. 303. Extension of funding for family-to-family health information centers. TITLE IV—PUBLIC HEALTH EXTENDERS Subtitle A—Extensions Sec. 401. Extension for community health centers, National Health Service Corps, and teaching health centers that operate GME pro- grams. Sec. 402. Extension of special diabetes programs. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 6 •HR 1768 IH Subtitle B—World Trade Center Health Program Sec. 411. 9/11 responder and survivor health funding corrections. TITLE V—SUPPORT ACT REAUTHORIZATION Sec. 501. Short title. Subtitle A—Prevention Sec. 511. Prenatal and postnatal health. Sec. 512. Monitoring and education regarding infections associated with illicit drug use and other risk factors. Sec. 513. Preventing overdoses of controlled substances. Sec. 514. Support for individuals and families impacted by fetal alcohol spec- trum disorder. Sec. 515. Promoting state choice in PDMP systems. Sec. 516. First responder training program. Sec. 517. Donald J. Cohen National Child Traumatic Stress Initiative. Sec. 518. Protecting suicide prevention lifeline from cybersecurity incidents. Sec. 519. Bruce’s law. Sec. 520. Guidance on at-home drug disposal systems. Sec. 521. Assessment of opioid drugs and actions. Sec. 522. Grant program for State and Tribal response to opioid use disorders. Subtitle B—Treatment Sec. 531. Residential treatment program for pregnant and postpartum women. Sec. 532. Improving access to addiction medicine providers. Sec. 533. Mental and behavioral health education and training grants. Sec. 534. Loan repayment program for substance use disorder treatment work- force. Sec. 535. Development and dissemination of model training programs for sub- stance use disorder patient records. Sec. 536. Task force on best practices for trauma-informed identification, refer- ral, and support. Sec. 537. Grants to enhance access to substance use disorder treatment. Sec. 538. State guidance related to individuals with serious mental illness and children with serious emotional disturbance. Sec. 539. Reviewing the scheduling of approved products containing a combina- tion of buprenorphine and naloxone. Subtitle C—Recovery Sec. 541. Building communities of recovery. Sec. 542. Peer support technical assistance center. Sec. 543. Comprehensive opioid recovery centers. Sec. 544. Youth prevention and recovery. Sec. 545. CAREER Act. Sec. 546. Addressing economic and workforce impacts of the opioid crisis. Subtitle D—Miscellaneous Matters Sec. 551. Delivery of a controlled substance by a pharmacy to a prescribing practitioner. Sec. 552. Technical correction on controlled substances dispensing. Sec. 553. Required training for prescribers of controlled substances. Sec. 554. Extension of temporary order for fentanyl-related substances. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 7 •HR 1768 IH TITLE VI—PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND RESPONSE Sec. 601. Short title. Subtitle A—State and Local Readiness and Response Sec. 611. Temporary reassignment of State and local personnel during a public health emergency. Sec. 612. Public Health Emergency Preparedness program. Sec. 613. Hospital Preparedness Program. Sec. 614. Facilities and capacities of the Centers for Disease Control and Pre- vention to combat public health security threats. Sec. 615. Pilot program to support State medical stockpiles. Sec. 616. Enhancing domestic wastewater surveillance for pathogen detection. Sec. 617. Reauthorization of Mosquito Abatement for Safety and Health pro- gram. Subtitle B—Federal Planning and Coordination Sec. 621. All-Hazards Emergency Preparedness and Response. Sec. 622. National Health Security Strategy. Sec. 623. Improving development and distribution of diagnostic tests. Sec. 624. Combating antimicrobial resistance. Sec. 625. Strategic National Stockpile and material threats. Sec. 626. Medical countermeasures for viral threats with pandemic potential. Sec. 627. Public Health Emergency Medical Countermeasures Enterprise. Sec. 628. Fellowship and training programs. Sec. 629. Regional biocontainment research laboratories. Sec. 629A. Limitation related to countries of concern conducting certain re- search. Subtitle C—Addressing the Needs of All Individuals Sec. 631. Improving access to certain programs. Sec. 632. Supporting at-risk individuals during emergency responses. Sec. 633. National advisory committees. Sec. 634. National Academies study on prizes. Subtitle D—Additional Reauthorizations Sec. 641. Medical countermeasure priority review voucher. Sec. 642. Epidemic Intelligence Service. Sec. 643. Monitoring and distribution of certain medical countermeasures. Sec. 644. Regional health care emergency preparedness and response systems. Sec. 645. Emergency system for advance registration of volunteer health pro- fessionals. Sec. 646. Ensuring collaboration and coordination in medical countermeasure development. Sec. 647. Military and civilian partnership for trauma readiness. Sec. 648. National Disaster Medical System. Sec. 649. Volunteer Medical Reserve Corps. Sec. 650. Epidemiology-laboratory capacity. TITLE VII—PUBLIC HEALTH PROGRAMS Sec. 701. Action for dental health. Sec. 702. PREEMIE. VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6211 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 8 •HR 1768 IH Sec. 703. Preventing maternal deaths. Sec. 704. Sickle cell disease prevention and treatment. Sec. 705. Traumatic brain injuries. Sec. 706. Lifespan respite care. Sec. 707. Dr. Lorna Breen health care provider protection. Sec. 708. Conforming amendment to Internal Revenue Code of 1986. Sec. 709. SCREENS for Cancer. Sec. 710. DeOndra Dixon INCLUDE Project. Sec. 711. IMPROVE Initiative. Sec. 712. Organ Procurement and Transplantation Network. Sec. 713. Honor Our Living Donors. Sec. 714. Program for pediatric studies of drugs. TITLE VIII—FOOD AND DRUG ADMINISTRATION Subtitle A—Give Kids a Chance Sec. 801. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted can- cer drugs. Sec. 802. Ensuring completion of pediatric study requirements. Sec. 803. FDA report on PREA enforcement. Sec. 804. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases. Sec. 805. Limitations on exclusive approval or licensure of orphan drugs. Subtitle B—United States-Abraham Accords Cooperation and Security Sec. 811. Establishment of Abraham Accords Office within Food and Drug Ad- ministration. TITLE IX—LOWERING PRESCRIPTION DRUG COSTS Sec. 901. Oversight of pharmacy benefit management services. Sec. 902. Full rebate pass through to plan; exception for innocent plan fidu- ciaries. Sec. 903. Increasing transparency in generic drug applications. Sec. 904. Title 35 amendments. TITLE X—MISCELLANEOUS Sec. 1001. Two-year extension of safe harbor for absence of deductible for tele- health. DIVISION A—RECYCLING, 1 WATER, AND ENVIRONMENT 2 RELATED PROVISIONS 3 SEC. 101. RECYCLING AND COMPOSTING ACCOUNTABILITY. 4 (a) SHORT TITLE.—This section may be cited as the 5 ‘‘Recycling and Composting Accountability Act’’. 6 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 9 •HR 1768 IH (b) DEFINITIONS.— 1 (1) IN GENERAL .—In this section: 2 (A) A DMINISTRATOR.—The term ‘‘Admin-3 istrator’’ means the Administrator of the Envi-4 ronmental Protection Agency. 5 (B) C OMPOST.—The term ‘‘compost’’ 6 means a product that— 7 (i) is manufactured through the con-8 trolled aerobic, biological decomposition of 9 biodegradable materials; 10 (ii) has been subjected to medium and 11 high temperature organisms, which— 12 (I) significantly reduce the viabil-13 ity of pathogens and weed seeds; and 14 (II) stabilize carbon in the prod-15 uct such that the product is beneficial 16 to plant growth; and 17 (iii) is typically used as a soil amend-18 ment, but may also contribute plant nutri-19 ents. 20 (C) C OMPOSTABLE MATERIAL .—The term 21 ‘‘compostable material’’ means material that is 22 a feedstock for creating compost, including— 23 (i) wood; 24 (ii) agricultural crops; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 10 •HR 1768 IH (iii) paper, such as cardboard and 1 other paper products; 2 (iv) certified compostable products as-3 sociated with organic waste; 4 (v) other organic plant material; 5 (vi) organic waste, including food 6 waste and yard waste; and 7 (vii) such other material that is com-8 posed of biomass that can be continually 9 replenished or renewed, as determined by 10 the Administrator. 11 (D) I NDIAN TRIBE .—The term ‘‘Indian 12 Tribe’’ has the meaning given the term in sec-13 tion 4 of the Indian Self-Determination and 14 Education Assistance Act (25 U.S.C. 5304). 15 (E) R ECYCLABLE MATERIAL .—The term 16 ‘‘recyclable material’’ means a material that is 17 obsolete, previously used, off-specification, sur-18 plus, or incidentally produced for processing 19 into a specification-grade commodity for which 20 a reuse market currently exists or is being de-21 veloped. 22 (F) R ECYCLING.—The term ‘‘recycling’’ 23 means the series of activities— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 11 •HR 1768 IH (i) during which recyclable materials 1 are processed into specification-grade com-2 modities and consumed as raw-material 3 feedstock, in lieu of virgin materials, in the 4 manufacturing of new products; 5 (ii) that may, with regard to recycla-6 ble materials and prior to the activities de-7 scribed in clause (i), include sorting, collec-8 tion, processing, and brokering; and 9 (iii) that result, subsequent to proc-10 essing described in clause (i), in consump-11 tion by a materials manufacturer, includ-12 ing for the manufacturing of new products. 13 (G) S TATE.—The term ‘‘State’’ has the 14 meaning given the term in section 1004 of the 15 Solid Waste Disposal Act (42 U.S.C. 6903). 16 (2) D EFINITION OF PROCESSING .—In subpara-17 graphs (E) and (F) of paragraph (1), the term 18 ‘‘processing’’ means any mechanical, manual, or 19 other method that— 20 (A) transforms a recyclable material into a 21 specification-grade commodity; and 22 (B) may occur in multiple steps, with dif-23 ferent phases, including sorting, occurring at 24 different locations. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 12 •HR 1768 IH (c) R EPORTS ON COMPOSTING AND RECYCLING IN-1 FRASTRUCTURE CAPABILITIES.— 2 (1) I N GENERAL .—Subtitle D of the Solid 3 Waste Disposal Act (42 U.S.C. 6941 et seq.) is 4 amended by adding at the end the following: 5 ‘‘SEC. 4011. REPORTS ON COMPOSTING AND RECYCLING IN-6 FRASTRUCTURE CAPABILITIES. 7 ‘‘(a) DEFINITIONS.—In this section: 8 ‘‘(1) R ECYCLING AND COMPOSTING ACCOUNT -9 ABILITY ACT TERMS .—The terms ‘compost’, 10 ‘compostable material’, ‘recyclable material’, and ‘re-11 cycling’ have the meanings given the terms in sub-12 section (b) of the Recycling and Composting Ac-13 countability Act. 14 ‘‘(2) C OMPOSTING FACILITY .—The term 15 ‘composting facility’ means a location, structure, or 16 device that transforms compostable materials into 17 compost. 18 ‘‘(3) I NDIAN TRIBE .—The term ‘Indian Tribe’ 19 has the meaning given the term in section 4 of the 20 Indian Self-Determination and Education Assistance 21 Act (25 U.S.C. 5304). 22 ‘‘(4) MATERIALS RECOVERY FACILITY .— 23 ‘‘(A) I N GENERAL .—The term ‘materials 24 recovery facility’ means a dedicated facility 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 13 •HR 1768 IH where primarily residential recyclable materials, 1 which are diverted from disposal by the gener-2 ator and collected separately from municipal 3 solid waste, are mechanically or manually sort-4 ed into commodities for further processing into 5 specification-grade commodities for sale to end 6 users. 7 ‘‘(B) E XCLUSION.—The term ‘materials 8 recovery facility’ does not include a solid waste 9 management facility that may process munic-10 ipal solid waste to remove recyclable materials. 11 ‘‘(C) D EFINITION OF PROCESSING .—For 12 purposes of this paragraph, the term ‘proc-13 essing’ has the meaning given the term in sub-14 section (b)(2) of the Recycling and Composting 15 Accountability Act. 16 ‘‘(b) REPORT.— 17 ‘‘(1) IN GENERAL .—The Administrator shall re-18 quest information and data from, collaborate with, 19 or contract with, as necessary and appropriate, 20 States, units of local government, and Indian Tribes, 21 for the provision, preparation, and publication of a 22 report, or to expand work under the National Recy-23 cling Strategy to include information and data, on 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 14 •HR 1768 IH compostable materials and efforts to reduce contami-1 nation rates for recycling, including— 2 ‘‘(A) an evaluation of existing Federal, 3 State, and local laws that may present barriers 4 to implementation of composting strategies; 5 ‘‘(B) a description and evaluation of 6 composting infrastructure and programs within 7 States, units of local government, and Indian 8 Tribes; 9 ‘‘(C) an estimate of the costs and approxi-10 mate land needed to expand composting pro-11 grams; and 12 ‘‘(D) a review of the practices of manufac-13 turers and companies that are moving to using 14 compostable packaging and food service ware 15 for the purpose of making the composting proc-16 ess the end-of-life use of those products. 17 ‘‘(2) S UBMISSION.—Not later than 2 years 18 after the date of enactment of this section, the Ad-19 ministrator shall submit to Congress the report pre-20 pared under paragraph (1). 21 ‘‘(c) I NVENTORY OF MATERIALS RECOVERY FACILI-22 TIES.—Not later than 3 years after the date of enactment 23 of this section, and every 4 years thereafter, the Adminis-24 trator, in consultation with relevant Federal agencies and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 15 •HR 1768 IH States, units of local government, and Indian Tribes, 1 shall— 2 ‘‘(1) prepare an inventory or estimate of mate-3 rials recovery facilities in the United States, includ-4 ing— 5 ‘‘(A) the number of materials recovery fa-6 cilities in each State; and 7 ‘‘(B) a general description of the materials 8 that each of those materials recovery facilities 9 can process, including— 10 ‘‘(i) in the case of plastic, a descrip-11 tion of— 12 ‘‘(I) the types of accepted resin, 13 if applicable; and 14 ‘‘(II) the packaging or product 15 format, such as a jug, a carton, or 16 film; 17 ‘‘(ii) food packaging and service ware, 18 such as a bottle, cutlery, or a cup; 19 ‘‘(iii) paper; 20 ‘‘(iv) aluminum, such as an aluminum 21 beverage can, food can, aerosol can, or foil; 22 ‘‘(v) steel, such as a steel food or aer-23 osol can; 24 ‘‘(vi) other scrap metal; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 16 •HR 1768 IH ‘‘(vii) glass; or 1 ‘‘(viii) any other material not de-2 scribed in any of clauses (i) through (vii) 3 that a materials recovery facility processes; 4 and 5 ‘‘(2) submit to Congress the inventory or esti-6 mate prepared under paragraph (1). 7 ‘‘(d) INFORMATION ON RECYCLING AND COMPOSTING 8 SYSTEMS.—The Administrator shall, as necessary and ap-9 propriate, collaborate or contract with States, units of 10 local government, and Indian Tribes to estimate, with re-11 spect to the United States— 12 ‘‘(1) the number and types of recycling and 13 composting programs; 14 ‘‘(2) the types and forms of materials accepted 15 by recycling or composting programs; 16 ‘‘(3) the number of individuals— 17 ‘‘(A) with access to recycling and 18 composting services to at least the extent of ac-19 cess to disposal services; and 20 ‘‘(B) who use, on a percentage basis, the 21 recycling and composting services described in 22 subparagraph (A); 23 ‘‘(4) the number of individuals with barriers to 24 accessing recycling and composting services similar 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 17 •HR 1768 IH to their access to disposal services and the types of 1 those barriers experienced; 2 ‘‘(5) the inbound contamination and capture 3 rates of recycling and composting programs; 4 ‘‘(6) if applicable, other available recycling or 5 composting programs; and 6 ‘‘(7) the average costs and benefits to States, 7 units of local government, and Indian Tribes of recy-8 cling and composting programs. 9 ‘‘(e) RECYCLING REPORTING RATES.— 10 ‘‘(1) C OLLECTION OF DATA ; DEVELOPMENT OF 11 RATES.—The Administrator may use amounts made 12 available under subsection (f) of the Recycling and 13 Composting Accountability Act— 14 ‘‘(A) to biannually collect, in collaboration 15 with States, to the extent practicable, informa-16 tion supplied on a voluntary basis to develop 17 the estimated rates described in subparagraphs 18 (B) and (C); 19 ‘‘(B) to develop a standardized estimated 20 rate of recyclable materials in States that pro-21 vide information under subparagraph (A) that 22 have been successfully diverted from the waste 23 stream and brought to a materials recovery fa-24 cility or composting facility; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 18 •HR 1768 IH ‘‘(C) to develop an estimated national recy-1 cling rate based on the information described in 2 subparagraphs (A) and (B). 3 ‘‘(2) U SE.—Using amounts made available 4 under subsection (f) of the Recycling and 5 Composting Accountability Act, the Administrator 6 may use the information collected and rates devel-7 oped under paragraph (1) to provide requesting 8 States, units of local government, and Indian Tribes 9 data and technical assistance— 10 ‘‘(A) to reduce the overall waste produced 11 by the States, units of local government, and 12 Indian Tribes; 13 ‘‘(B) to assist the States, units of local 14 government, and Indian Tribes in under-15 standing the nuances of the information col-16 lected relating to diversion activities; and 17 ‘‘(C) to increase recycling and composting 18 rates of the States, units of local government, 19 and Indian Tribes. 20 ‘‘(f) R EPORT ON END MARKETS.—The Adminis-21 trator, in collaboration or contract with, as necessary and 22 appropriate, relevant Federal agencies, States, units of 23 local government, or Indian Tribes, shall— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 19 •HR 1768 IH ‘‘(1) provide an update to the report submitted 1 under section 306 of the Save Our Seas 2.0 Act 2 (Public Law 116–224; 134 Stat. 1096) to include an 3 addendum on the end-market sale of all recyclable 4 materials from materials recovery facilities that 5 process recyclable materials, including, to the extent 6 practicable— 7 ‘‘(A) the total, in dollars per ton, domestic 8 sales of bales of recyclable materials; and 9 ‘‘(B) the total, in dollars per ton, inter-10 national sales of bales of recyclable materials; 11 ‘‘(2) prepare a report on the end-market sale of 12 compost from, to the extent practicable, compostable 13 materials, including the total, in dollars per ton, of 14 domestic sales of compostable materials; and 15 ‘‘(3) not later than 3 years after the date of en-16 actment of this section, submit to Congress the up-17 date to the report prepared under paragraph (1) and 18 the report prepared under paragraph (2). 19 ‘‘(g) P RIVILEGED OR CONFIDENTIAL INFORMA-20 TION.— 21 ‘‘(1) IN GENERAL .—Information collected under 22 subsection (e)(1) or paragraph (1) or (2) of sub-23 section (f) shall not include any privileged or con-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 20 •HR 1768 IH fidential information described in section 552(b)(4) 1 of title 5, United States Code. 2 ‘‘(2) N ONDISCLOSURE.—Information collected 3 to carry out this section shall not be made public if 4 the information meets the requirements of section 5 552(b) of title 5, United States Code.’’. 6 (2) C LERICAL AMENDMENT .—The table of con-7 tents in section 1001 of the Solid Waste Disposal 8 Act (Public Law 89–272; 90 Stat. 2795; 98 Stat. 9 3268) is amended by inserting after the item relat-10 ing to section 4010 the following: 11 ‘‘Sec. 4011. Report on composting and recycling infrastructure capabilities.’’. (d) FEDERAL AGENCY ACTIVITIES RELATED TO RE-12 CYCLING.—Not later than 2 years after the date of enact-13 ment of this Act, and every 2 years thereafter until 2033, 14 the Comptroller General of the United States shall make 15 publicly available a report— 16 (1) detailing or, to the extent practicable, pro-17 viding an estimate of— 18 (A) the total annual recycling and 19 composting rates reported by all Federal agen-20 cies; and 21 (B) the total annual percentage of prod-22 ucts containing recyclable material, compostable 23 material, or recovered materials purchased by 24 all Federal agencies, including— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 21 •HR 1768 IH (i) the total quantity of procured 1 products containing recyclable material or 2 recovered materials listed in the com-3 prehensive procurement guidelines pub-4 lished under section 6002(e) of the Solid 5 Waste Disposal Act (42 U.S.C. 6962(e)); 6 and 7 (ii) the total quantity of compostable 8 material purchased by all Federal agencies; 9 (2) identifying the activities of each Federal 10 agency that promote recycling or composting; and 11 (3) identifying activities that Federal agencies 12 could carry out to further promote recycling or 13 composting. 14 (e) STUDY ON THE DIVERSION OF RECYCLABLE MA-15 TERIALS FROM A CIRCULAR MARKET.— 16 (1) I N GENERAL .—Not later than 1 year after 17 the date of enactment of this Act, the Administrator 18 shall develop a metric for determining the proportion 19 of recyclable materials in commercial and municipal 20 waste streams that are being diverted from a cir-21 cular market. 22 (2) S TUDY; REPORT.—Not later than 1 year 23 after the development of a metric under paragraph 24 (1), the Administrator shall conduct a study of, and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 22 •HR 1768 IH submit to Congress a report on, the proportion of re-1 cyclable materials in commercial and municipal 2 waste streams that, during each of the 10 calendar 3 years preceding the year of submission of the report, 4 were diverted from a circular market. 5 (3) D ATA.—The report under paragraph (2) 6 shall provide data on specific recyclable materials, 7 including aluminum, plastics, paper and paperboard, 8 textiles, and glass, that were prevented from remain-9 ing in a circular market through disposal or elimi-10 nation, and to what use those specific recyclable ma-11 terials were lost. 12 (4) EVALUATION.—The report under paragraph 13 (2) shall include an evaluation of whether the estab-14 lishment or improvement of recycling programs 15 would— 16 (A) improve recycling rates; 17 (B) reduce the quantity of recyclable mate-18 rials being unutilized in a circular market; and 19 (C) affect prices paid by consumers for 20 products using materials recycled in the circular 21 market. 22 (f) A UTHORIZATION OF APPROPRIATIONS.—There is 23 authorized to be appropriated to the Administrator to 24 carry out this section and the amendments made by this 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 23 •HR 1768 IH section $4,000,000 for each of fiscal years 2025 through 1 2029. 2 (g) ADMINISTRATION.— 3 (1) U NFUNDED MANDATES .—The Adminis-4 trator or the Secretary of Commerce may not exer-5 cise any authority under this section or any amend-6 ment made by this section if exercising that author-7 ity would require a State, a unit of local govern-8 ment, or an Indian Tribe to carry out a mandate for 9 which funding is not available. 10 (2) N ONDISCLOSURE.—Any information col-11 lected to carry out this section shall not be made 12 public if the information meets the requirements of 13 section 552(b) of title 5, United States Code. 14 SEC. 102. RECYCLING INFRASTRUCTURE AND ACCESSI-15 BILITY PROGRAM. 16 (a) DEFINITIONS.—In this section: 17 (1) A DMINISTRATOR.—The term ‘‘Adminis-18 trator’’ means the Administrator of the Environ-19 mental Protection Agency. 20 (2) C URBSIDE RECYCLING .—The term 21 ‘‘curbside recycling’’ means the process by which 22 residential recyclable materials are picked up 23 curbside. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 24 •HR 1768 IH (3) ELIGIBLE ENTITY .—The term ‘‘eligible enti-1 ty’’ means— 2 (A) a State (as defined in section 1004 of 3 the Solid Waste Disposal Act (42 U.S.C. 4 6903)); 5 (B) a unit of local government; 6 (C) an Indian Tribe; and 7 (D) a public-private partnership. 8 (4) I NDIAN TRIBE .—The term ‘‘Indian Tribe’’ 9 has the meaning given the term in section 4 of the 10 Indian Self-Determination and Education Assistance 11 Act (25 U.S.C. 5304). 12 (5) MATERIALS RECOVERY FACILITY .— 13 (A) I N GENERAL .—The term ‘‘materials 14 recovery facility’’ means a recycling facility 15 where primarily residential recyclables, which 16 are diverted from disposal by a generator and 17 collected separately from municipal solid waste, 18 are mechanically or manually sorted into com-19 modities for further processing into specifica-20 tion-grade commodities for sale to end users. 21 (B) EXCLUSION.—The term ‘‘materials re-22 covery facility’’ does not include a solid waste 23 management facility that may process munic-24 ipal solid waste to remove recyclable materials. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 25 •HR 1768 IH (6) P ILOT GRANT PROGRAM .—The term ‘‘pilot 1 grant program’’ means the Recycling Infrastructure 2 and Accessibility Program established under sub-3 section (b). 4 (7) R ECYCLABLE MATERIAL .—The term ‘‘recy-5 clable material’’ means obsolete, previously used, off- 6 specification, surplus, or incidentally produced mate-7 rial for processing into a specification-grade com-8 modity for which a market exists. 9 (8) T RANSFER STATION .—The term ‘‘transfer 10 station’’ means a facility that— 11 (A) receives and consolidates recyclable 12 material from curbside recycling or drop-off fa-13 cilities; and 14 (B) loads the recyclable material onto trac-15 tor trailers, railcars, or barges for transport to 16 a distant materials recovery facility or another 17 recycling-related facility. 18 (9) U NDERSERVED COMMUNITY .—The term 19 ‘‘underserved community’’ means a community, in-20 cluding an unincorporated area, without access to 21 full recycling services because— 22 (A) transportation, distance, or other rea-23 sons render utilization of available processing 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 26 •HR 1768 IH capacity at an existing materials recovery facil-1 ity cost prohibitive; or 2 (B) the processing capacity of an existing 3 materials recovery facility is insufficient to 4 manage the volume of recyclable materials pro-5 duced by that community. 6 (b) E STABLISHMENT.—Not later than 18 months 7 after the date of enactment of this Act, the Administrator 8 shall establish a pilot grant program, to be known as the 9 ‘‘Recycling Infrastructure and Accessibility Program’’, to 10 award grants, on a competitive basis, to eligible entities 11 to improve recycling accessibility in a community or com-12 munities within the same geographic area. 13 (c) G OAL.—The goal of the pilot grant program is 14 to fund eligible projects that will significantly improve ac-15 cessibility to recycling systems through investments in in-16 frastructure in underserved communities through the use 17 of a hub-and-spoke model for recycling infrastructure de-18 velopment. 19 (d) APPLICATIONS.—To be eligible to receive a grant 20 under the pilot grant program, an eligible entity shall sub-21 mit to the Administrator an application at such time, in 22 such manner, and containing such information as the Ad-23 ministrator may require. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 27 •HR 1768 IH (e) C ONSIDERATIONS.—In selecting eligible entities 1 to receive a grant under the pilot grant program, the Ad-2 ministrator shall consider— 3 (1) whether the community or communities in 4 which the eligible entity is seeking to carry out a 5 proposed project has curbside recycling; 6 (2) whether the proposed project of the eligible 7 entity will improve accessibility to recycling services 8 in a single underserved community or multiple un-9 derserved communities; and 10 (3) if the eligible entity is a public-private part-11 nership, the financial health of the private entity 12 seeking to enter into that public-private partnership. 13 (f) PRIORITY.—In selecting eligible entities to receive 14 a grant under the pilot grant program, the Administrator 15 shall give priority to eligible entities seeking to carry out 16 a proposed project in a community in which there is not 17 more than 1 materials recovery facility within a 75-mile 18 radius of that community. 19 (g) U SE OF FUNDS.—An eligible entity awarded a 20 grant under the pilot grant program may use the grant 21 funds for projects to improve recycling accessibility in 22 communities, including in underserved communities, by— 23 (1) increasing the number of transfer stations; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 28 •HR 1768 IH (2) expanding curbside recycling collection pro-1 grams where appropriate; and 2 (3) leveraging public-private partnerships to re-3 duce the costs associated with collecting and trans-4 porting recyclable materials in underserved commu-5 nities. 6 (h) P ROHIBITION ON USE OF FUNDS.—An eligible 7 entity awarded a grant under the pilot grant program may 8 not use the grant funds for projects relating to recycling 9 education programs. 10 (i) M INIMUM AND MAXIMUM GRANT AMOUNT.—A 11 grant awarded to an eligible entity under the pilot grant 12 program shall be in an amount— 13 (1) not less than $500,000; and 14 (2) not more than $15,000,000. 15 (j) S ET-ASIDE.—The Administrator shall set aside 16 not less than 70 percent of the amounts made available 17 to carry out the pilot grant program for each fiscal year 18 to award grants to eligible entities to carry out a proposed 19 project or program in a single underserved community or 20 multiple underserved communities. 21 (k) FEDERAL SHARE.—The Federal share of the cost 22 of a project or program carried out by an eligible entity 23 using grant funds shall be not more than 95 percent. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 29 •HR 1768 IH (l) R EPORT.—Not later than 2 years after the date 1 on which the first grant is awarded under the pilot grant 2 program, the Administrator shall submit to Congress a re-3 port describing the implementation of the pilot grant pro-4 gram, which shall include— 5 (1) a list of eligible entities that have received 6 a grant under the pilot grant program; 7 (2) the actions taken by each eligible entity that 8 received a grant under the pilot grant program to 9 improve recycling accessibility with grant funds; and 10 (3) to the extent information is available, a de-11 scription of how grant funds received under the pilot 12 grant program improved recycling rates in each com-13 munity in which a project or program was carried 14 out under the pilot grant program. 15 (m) AUTHORIZATION OF APPROPRIATIONS.— 16 (1) I N GENERAL .—There is authorized to be 17 appropriated to the Administrator to carry out the 18 pilot grant program $30,000,000 for each of fiscal 19 years 2025 through 2029, to remain available until 20 expended. 21 (2) A DMINISTRATIVE COSTS AND TECHNICAL 22 ASSISTANCE.—Of the amounts made available under 23 paragraph (1), the Administrator may use up to 5 24 percent— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 30 •HR 1768 IH (A) for administrative costs relating to car-1 rying out the pilot grant program; and 2 (B) to provide technical assistance to eligi-3 ble entities applying for a grant under the pilot 4 grant program. 5 SEC. 103. DRINKING WATER INFRASTRUCTURE RISK AND 6 RESILIENCE. 7 Section 1433(g) of the Safe Drinking Water Act (42 8 U.S.C. 300i–2(g)) is amended— 9 (1) in paragraph (1), by striking ‘‘2020 and 10 2021’’ and inserting ‘‘2026 and 2027’’; 11 (2) in paragraph (4), by striking ‘‘$5,000,000’’ 12 and inserting ‘‘$10,000,000’’; 13 (3) in paragraph (5), by striking 14 ‘‘$10,000,000’’ and inserting ‘‘$20,000,000’’; and 15 (4) in paragraph (6)— 16 (A) by striking ‘‘$25,000,000’’ and insert-17 ing ‘‘$50,000,000’’; and 18 (B) by striking ‘‘2020 and 2021’’ and in-19 serting ‘‘2026 and 2027’’. 20 SEC. 104. REAUTHORIZATION OF DIESEL EMISSIONS RE-21 DUCTION ACT. 22 Section 797(a) of the Energy Policy Act of 2005 (42 23 U.S.C. 16137(a)) is amended by striking ‘‘2024’’ and in-24 serting ‘‘2029’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 31 •HR 1768 IH SEC. 105. NATIONWIDE CONSUMER AND FUEL RETAILER 1 CHOICE ACT. 2 (a) SHORT TITLE.—This section may be cited as the 3 ‘‘Nationwide Consumer and Fuel Retailer Choice Act’’. 4 (b) ETHANOL WAIVER.— 5 (1) E XISTING WAIVERS .—Section 211(f)(4) of 6 the Clean Air Act (42 U.S.C. 7545(f)(4)) is amend-7 ed— 8 (A) by striking ‘‘(4) The Administrator, 9 upon’’ and inserting the following: 10 ‘‘(4) WAIVERS.— 11 ‘‘(A) I N GENERAL .—The Administrator, 12 on’’; 13 (B) in subparagraph (A) (as so des-14 ignated)— 15 (i) in the first sentence— 16 (I) by striking ‘‘of this sub-17 section’’ each place it appears; and 18 (II) by striking ‘‘if he deter-19 mines’’ and inserting ‘‘if the Adminis-20 trator determines’’; and 21 (ii) in the second sentence, by striking 22 ‘‘The Administrator’’ and inserting the fol-23 lowing: 24 ‘‘(B) F INAL ACTION .—The Adminis-25 trator’’; and 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 32 •HR 1768 IH (C) by adding at the end the following: 1 ‘‘(C) R EID VAPOR PRESSURE .—A fuel or 2 fuel additive may be introduced into commerce 3 if— 4 ‘‘(i)(I) the Administrator determines 5 that the fuel or fuel additive is substan-6 tially similar to a fuel or fuel additive uti-7 lized in the certification of any model year 8 vehicle pursuant to paragraph (1)(A); or 9 ‘‘(II) the fuel or fuel additive has been 10 granted a waiver under subparagraph (A) 11 and meets all of the conditions of that 12 waiver other than any limitation of the 13 waiver with respect to the Reid Vapor 14 Pressure of the fuel or fuel additive; and 15 ‘‘(ii) the fuel or fuel additive meets all 16 other applicable Reid Vapor Pressure re-17 quirements under subsection (h).’’. 18 (2) R EID VAPOR PRESSURE LIMITATION .—Sec-19 tion 211(h) of the Clean Air Act (42 U.S.C. 20 7545(h)) is amended— 21 (A) by striking ‘‘vapor pressure’’ each 22 place it appears and inserting ‘‘Vapor Pres-23 sure’’; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 33 •HR 1768 IH (B) in paragraph (4), in the matter pre-1 ceding subparagraph (A), by striking ‘‘10 per-2 cent’’ and inserting ‘‘10 to 15 percent’’; and 3 (C) in paragraph (5)(A)— 4 (i) by striking ‘‘Upon notification, ac-5 companied by’’ and inserting ‘‘On receipt 6 of a notification that is submitted after the 7 date of enactment of the Nationwide Con-8 sumer and Fuel Retailer Choice Act, and is 9 accompanied by appropriate’’; 10 (ii) by striking ‘‘10 percent’’ and in-11 serting ‘‘10 to 15 percent’’; and 12 (iii) by adding at the end the fol-13 lowing: ‘‘Upon the enactment of the Na-14 tionwide Consumer and Fuel Retailer 15 Choice Act, any State for which the notifi-16 cation from the Governor of a State was 17 submitted before the date of enactment of 18 the Nationwide Consumer and Fuel Re-19 tailer Choice Act and to which the Admin-20 istrator applied the Reid Vapor Pressure 21 limitation established by paragraph (1) 22 shall instead have the Reid Vapor Pressure 23 limitation established by paragraph (4) 24 apply to all fuel blends containing gasoline 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 34 •HR 1768 IH and 10 to 15 percent denatured anhydrous 1 ethanol that are sold, offered for sale, dis-2 pensed, supplied, offered for supply, trans-3 ported, or introduced into commerce in the 4 area during the high ozone season.’’. 5 (c) G ENERATION OF CREDITS BY SMALL REFIN-6 ERIES UNDER THE RENEWABLE FUEL PROGRAM.—Sec-7 tion 211(o)(9) of the Clean Air Act (42 U.S.C. 8 7545(o)(9)) is amended by adding at the end the fol-9 lowing: 10 ‘‘(E) C REDITS GENERATED FOR 2016 –2018 11 COMPLIANCE YEARS .— 12 ‘‘(i) R ULE.—For any small refinery 13 described in clause (ii) or (iii), the credits 14 described in the respective clause shall 15 be— 16 ‘‘(I) returned to the small refin-17 ery and, notwithstanding paragraph 18 (5)(C), deemed eligible for future 19 compliance years; or 20 ‘‘(II) applied as a credit in the 21 EPA Moderated Transaction System 22 (EMTS) account of the small refinery. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 35 •HR 1768 IH ‘‘(ii) C OMPLIANCE YEARS 2016 AND 1 2017.—Clause (i) applies with respect to 2 any small refinery that— 3 ‘‘(I) retired credits generated for 4 compliance years 2016 or 2017; and 5 ‘‘(II) submitted a petition under 6 subparagraph (B)(i) for that compli-7 ance year that remained outstanding 8 as of December 1, 2022. 9 ‘‘(iii) C OMPLIANCE YEAR 2018 .—In 10 addition to small refineries described in 11 clause (ii), clause (i) applies with respect 12 to any small refinery— 13 ‘‘(I) that submitted a petition 14 under subparagraph (B)(i) for compli-15 ance year 2018 by September 1, 16 2019; 17 ‘‘(II) that retired credits gen-18 erated for compliance year 2018 as 19 part of the compliance demonstration 20 of the small refinery for compliance 21 year 2018 by March 31, 2019; and 22 ‘‘(III) for which— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 36 •HR 1768 IH ‘‘(aa) the petition remained 1 outstanding as of December 1, 2 2022; or 3 ‘‘(bb) the Administrator de-4 nied the petition as of July 1, 5 2022, and has not returned the 6 retired credits as of December 1, 7 2022.’’. 8 (d) A DDRESSING RENEWABLE FUEL MARKET MA-9 NIPULATION AND TRANSPARENCY.—Not later than 90 10 days after the date of enactment of this Act, the Adminis-11 trator of the Environmental Protection Agency, in collabo-12 ration with the Commodity Futures Trading Commission, 13 shall— 14 (1) review all applicable Renewable Identifica-15 tion Number (as described in section 80.1425 of title 16 40, Code of Federal Regulations (or successor regu-17 lations)) data collected for the EPA Moderated 18 Transaction System (as defined in section 80.2 of 19 title 40, Code of Federal Regulations (or successor 20 regulations)); and 21 (2) submit to Congress a report that identifies 22 any additional data that should be collected to re-23 duce renewable fuel market manipulation. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 37 •HR 1768 IH DIVISION B—COMMERCE 1 TITLE I—YOUTH POISONING 2 PREVENTION 3 SEC. 101. SHORT TITLE. 4 This title may be cited as the ‘‘Youth Poisoning Pro-5 tection Act’’. 6 SEC. 102. BANNING OF PRODUCTS CONTAINING A HIGH 7 CONCENTRATION OF SODIUM NITRITE. 8 (a) IN GENERAL.—Any consumer product containing 9 a high concentration of sodium nitrite shall be considered 10 to be a banned hazardous product under section 8 of the 11 Consumer Product Safety Act (15 U.S.C. 2057). 12 (b) R ULE OF CONSTRUCTION.—Nothing in this sec-13 tion shall be construed to— 14 (1) prohibit any commercial or industrial pur-15 pose in which high concentration sodium nitrite is 16 not customarily produced or distributed for sale to, 17 or use or consumption by, or enjoyment of, a con-18 sumer; and 19 (2) apply to high concentration sodium nitrite 20 that meets the definition of a drug, device, or cos-21 metic (as such terms are defined in sections 201(g), 22 (h), and (i) of the Federal Food, Drug, and Cos-23 metic Act (21 U.S.C. 321(g), (h), and (i))), or food 24 (as defined in section 201(f) of such Act (21 U.S.C. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 38 •HR 1768 IH 321(f))), including poultry and poultry products (as 1 such terms are defined in sections 4(e) and (f) of 2 the Poultry Products Inspection Act (21 U.S.C. 3 453(e) and (f))), meat and meat food products (as 4 such terms are defined in section 1(j) of the Federal 5 Meat Inspection Act (21 U.S.C. 601(j))), and eggs 6 and egg products (as such terms are defined in sec-7 tion 4 of the Egg Products Inspection Act (21 8 U.S.C. 1033)). 9 (c) DEFINITIONS.—For purposes of this section: 10 (1) C ONSUMER PRODUCT .—The term consumer 11 product has the meaning given that term under sec-12 tion 3(a)(5) of the Consumer Product Safety Act 13 (15 U.S.C. 2052(a)(5)). 14 (2) H IGH CONCENTRATION OF SODIUM NI -15 TRITE.—The term high concentration of sodium ni-16 trite means a concentration of 10 or more percent 17 by weight of sodium nitrite. 18 (d) EFFECTIVE DATE.—This section shall take effect 19 90 days after the date of enactment of this Act. 20 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 39 •HR 1768 IH TITLE II—CONSUMER PRODUCT 1 SAFETY STANDARD FOR CER-2 TAIN BATTERIES 3 SEC. 201. CONSUMER PRODUCT SAFETY STANDARD FOR 4 CERTAIN BATTERIES. 5 (a) C ONSUMER PRODUCT SAFETY STANDARD RE-6 QUIRED.—Not later than 180 days after the date of the 7 enactment of this Act, the Consumer Product Safety Com-8 mission (referred to in this section as the ‘‘Commission’’) 9 shall promulgate, under section 553 of title 5, United 10 States Code, the provisions of ANSI/CAN/UL 2271– 11 Standard for Batteries for Use in Light Electric Vehicle 12 Applications, ANSI/CAN/UL 2849–Standard for Safety 13 for Electrical Systems for eBikes, and ANSI/CAN/UL 14 2272–Standard for Electrical Systems for Personal E– 15 Mobility Devices, as in effect on the date of enactment 16 of this Act, as final consumer product safety standards. 17 (b) C ONSUMER PRODUCT SAFETY COMMISSION DE-18 TERMINATION OF SCOPE.—In adopting the standards 19 under subsection (a), the Commission shall limit the appli-20 cation of such standards to consumer products as defined 21 in section 3(a)(5) of the Consumer Product Safety Act (15 22 U.S.C. 2052(a)(5)). 23 (c) REVISION OF VOLUNTARY STANDARDS.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 40 •HR 1768 IH (1) N OTICE TO COMMISSION .—If the provisions 1 of ANSI/CAN/UL 2271–Standard for Batteries for 2 Use in Light Electric Vehicle Applications, ANSI/ 3 CAN/UL 2849–Standard for Safety for Electrical 4 Systems for eBikes, or ANSI/CAN/UL 2272–Stand-5 ard for Electrical Systems for Personal E–Mobility 6 Devices, are revised following the enactment of this 7 Act, the organization that revised the requirements 8 of such standard shall notify the Commission after 9 the final approval of the revision. 10 (2) T REATMENT OF REVISION .—The revised 11 voluntary standard shall be considered to be a con-12 sumer product safety standard issued by the Com-13 mission under section 9 of the Consumer Product 14 Safety Act (15 U.S.C. 2058), effective 180 days 15 after the date on which the organization notifies the 16 Commission (or such later date specified by the 17 Commission in the Federal Register) unless, within 18 90 days after receiving that notice, the Commission 19 notifies the organization that it has determined that 20 the proposed revision, in whole or in part, does not 21 improve the safety of the consumer product covered 22 by the standard and that the Commission is retain-23 ing the existing consumer product safety standard. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 41 •HR 1768 IH (d) T REATMENT OF STANDARD.—A standard pro-1 mulgated under this section, including a revision of such 2 standard adopted by the Commission, shall be treated as 3 a consumer product safety rule promulgated under section 4 9 of the Consumer Product Safety Act (15 U.S.C. 2058). 5 (e) REPORT TO CONGRESS.— 6 (1) I N GENERAL .—Not later than 5 years after 7 the date of enactment of this Act, the Commission 8 shall submit to the Committee on Commerce, 9 Science, and Transportation of the Senate and the 10 Committee on Energy and Commerce of the House 11 of Representatives, a report regarding fires, explo-12 sions, and other hazards relating to lithium-ion bat-13 teries used in micromobility products during the pe-14 riod beginning on the date of enactment of this Act 15 and ending on the report date. 16 (2) C ONTENT.—The report required by para-17 graph (1) shall describe, at a minimum— 18 (A) the source of the information that was 19 provided to the Commission regarding the fire, 20 explosion, or other hazard; 21 (B) the make and model of the lithium-ion 22 battery and micromobility product that resulted 23 in a fire, explosion, or other hazard, if known; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 42 •HR 1768 IH (C) whether a lithium-ion battery involved 1 in a fire, explosion, or other hazard complied 2 with the standard required by this section, if 3 known; and 4 (D) if known, the manufacturer and coun-5 try of manufacture of a lithium-ion battery that 6 resulted in a fire, explosion, or other hazard. 7 TITLE III—FOREIGN ADVERSARY 8 COMMUNICATIONS TRANS-9 PARENCY ACT 10 SEC. 301. SHORT TITLE. 11 This title may be cited as the ‘‘Foreign Adversary 12 Communications Transparency Act’’. 13 SEC. 302. LIST OF ENTITIES HOLDING FCC AUTHORIZA-14 TIONS, LICENSES, OR OTHER GRANTS OF AU-15 THORITY AND HAVING CERTAIN FOREIGN 16 OWNERSHIP. 17 (a) IN GENERAL.—Not later than 120 days after the 18 date of the enactment of this Act, the Commission shall 19 publish on the internet website of the Commission a list 20 of each entity— 21 (1) that holds a license issued by the Commis-22 sion pursuant to— 23 (A) section 309(j) of the Communications 24 Act of 1934 (47 U.S.C. 309(j)); or 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 43 •HR 1768 IH (B) the Act of May 27, 1921 (47 U.S.C. 1 34 et seq.; commonly known as the ‘‘Cable 2 Landing Licensing Act’’) and Executive Order 3 10530 (3 U.S.C. 301 note; relating to the per-4 formance of certain functions vested in or sub-5 ject to the approval of the President); and 6 (2) with respect to which— 7 (A) a covered entity holds an equity or vot-8 ing interest that is required to be reported to 9 the Commission under the ownership rules of 10 the Commission; or 11 (B) an appropriate national security agen-12 cy has determined that a covered entity exerts 13 control, regardless of whether such covered enti-14 ty holds an equity or voting interest as de-15 scribed in subparagraph (A). 16 (b) RULEMAKING.— 17 (1) I N GENERAL .—Not later than 18 months 18 after the date of the enactment of this Act, the 19 Commission shall issue rules to obtain information 20 to identify each entity— 21 (A) that holds any authorization, license, 22 or other grant of authority issued by the Com-23 mission (other than a license described in sub-24 section (a)(1)); and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00043 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 44 •HR 1768 IH (B) with respect to which a covered entity 1 holds an equity or voting interest that is re-2 quired to be reported to the Commission under 3 the ownership rules of the Commission. 4 (2) P LACEMENT ON LIST .—Not later than 1 5 year after the Commission issues the rules required 6 by paragraph (1), the Commission shall place each 7 entity described in such paragraph on the list pub-8 lished under subsection (a). 9 (c) P APERWORK REDUCTION ACT EXEMPTION.—A 10 collection of information conducted or sponsored by the 11 Commission to implement this section does not constitute 12 a collection of information for the purposes of subchapter 13 I of chapter 35 of title 44, United States Code (commonly 14 referred to as the ‘‘Paperwork Reduction Act’’). 15 (d) A NNUAL UPDATES.—The Commission shall, not 16 less frequently than annually, update the list published 17 under subsection (a), including with respect to any entity 18 required to be placed on such list by subsection (b)(2). 19 (e) DEFINITIONS.—In this section: 20 (1) A PPROPRIATE NATIONAL SECURITY AGEN -21 CY.—The term ‘‘appropriate national security agen-22 cy’’ has the meaning given such term in section 9 23 of the Secure and Trusted Communications Net-24 works Act of 2019 (47 U.S.C. 1608). 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 45 •HR 1768 IH (2) C OMMISSION.—The term ‘‘Commission’’ 1 means the Federal Communications Commission. 2 (3) C OVERED COUNTRY .—The term ‘‘covered 3 country’’ means a country specified in section 4 4872(f)(2) of title 10, United States Code. 5 (4) C OVERED ENTITY .—The term ‘‘covered en-6 tity’’ means— 7 (A) the government of a covered country; 8 (B) an entity organized under the laws of 9 a covered country; and 10 (C) a subsidiary of an entity described in 11 subparagraph (B), regardless of whether the 12 subsidiary is organized under the laws of a cov-13 ered country. 14 TITLE IV—PROMOTING 15 RESILIENT SUPPLY CHAINS 16 SEC. 401. SHORT TITLE. 17 This title may be cited as the ‘‘Promoting Resilient 18 Supply Chains Act’’. 19 SEC. 402. ADDITIONAL RESPONSIBILITIES OF ASSISTANT 20 SECRETARY OF COMMERCE FOR INDUSTRY 21 AND ANALYSIS. 22 In addition to the responsibilities of the Assistant 23 Secretary on the day before the date of the enactment of 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 46 •HR 1768 IH this Act, the Assistant Secretary shall have the following 1 responsibilities: 2 (1) Promote the stability and resilience of crit-3 ical supply chains and critical and emerging tech-4 nologies that strengthen the national security of the 5 United States. 6 (2) Lead the Working Group established pursu-7 ant to section 403 and consult covered nongovern-8 mental representatives, industry, institutions of 9 higher education, and State and local governments 10 in order to— 11 (A) promote resilient critical supply chains; 12 and 13 (B) identify, prepare for, and respond to 14 supply chain shocks to— 15 (i) critical industries; 16 (ii) critical supply chains; and 17 (iii) critical and emerging tech-18 nologies. 19 (3) Encourage the growth and competitiveness 20 of United States production and manufacturing in 21 the United States of emerging technologies. 22 (4) Assess the resilience, diversity, and strength 23 of critical supply chains and critical and emerging 24 technologies. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 47 •HR 1768 IH (5) In consultation with the Secretary of State 1 and the United States Trade Representative, sup-2 port the availability of critical goods from domestic 3 manufacturers, domestic enterprises, and manufac-4 turing operations in countries that are allies or key 5 international partner nations. 6 (6) Assist the Federal Government in preparing 7 for and responding to supply chain shocks to critical 8 supply chains, including by improving flexible manu-9 facturing capacities and capabilities in the United 10 States. 11 (7) Consistent with United States obligations 12 under international agreements, encourage and 13 incentivize the reduced reliance of domestic enter-14 prises and domestic manufacturers on critical goods 15 from countries that are described in section 16 407(2)(B). 17 (8) Encourage the relocation of manufacturing 18 facilities that manufacture critical goods from coun-19 tries that are described in section 407(2)(B) to the 20 United States and countries that are allies or key 21 international partner nations to strengthen the resil-22 ience, diversity, and strength of critical supply 23 chains. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 48 •HR 1768 IH SEC. 403. CRITICAL SUPPLY CHAIN RESILIENCE WORKING 1 GROUP. 2 (a) ESTABLISHMENT.—Not later than 120 days after 3 the date of the enactment of this Act, the Assistant Sec-4 retary shall establish a working group to be known as the 5 ‘‘Supply Chain Resilience Working Group’’ (in this title 6 referred to as the ‘‘Working Group’’) composed of the 7 Federal agencies that rely upon the Industry and Analysis 8 Business unit analysis, including agencies enumerated in 9 subsection (c). 10 (b) ACTIVITIES.—Not later than 1 year after the date 11 of the enactment of this Act, the Assistant Secretary shall 12 carry out the following activities: 13 (1) In consultation with the Working Group— 14 (A) assessing, mapping, and modeling crit-15 ical supply chains, including for critical and 16 emerging technologies, which may include— 17 (i) modeling the impact of supply 18 chain shocks on critical industries (includ-19 ing for critical and emerging technologies), 20 and critical supply chains; 21 (ii) assessing the demand for and sup-22 ply of critical goods, production equipment, 23 and manufacturing technology needed for 24 critical supply chains, including critical 25 goods, production equipment, and manu-26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 49 •HR 1768 IH facturing technology obtained by or pur-1 chased from a person outside of the United 2 States or imported into the United States; 3 and 4 (iii) assessing manufacturing, 5 warehousing, transportation, and distribu-6 tion related to critical supply chains; 7 (B) identifying high priority gaps and 8 vulnerabilities in critical supply chains and crit-9 ical industries (including critical industries for 10 critical and emerging technologies) that— 11 (i) exist as of the date of the enact-12 ment of this Act; or 13 (ii) are anticipated to occur after the 14 date of the enactment of this Act; 15 (C) identifying potential supply chain 16 shocks to a critical supply chain that may dis-17 rupt, strain, or eliminate the critical supply 18 chain; 19 (D) evaluating the capability and capacity 20 of domestic manufacturers or manufacturers lo-21 cated in countries that are allies or key inter-22 national partner nations to serve as sources for 23 critical goods, production equipment, or manu-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 50 •HR 1768 IH facturing technology needed in critical supply 1 chains; 2 (E) evaluating the effect on market sta-3 bility that may result from the disruption, 4 strain, or elimination of a critical supply chain; 5 (F) evaluating the state of the manufac-6 turing workforce, including by— 7 (i) identifying the needs of domestic 8 manufacturers; and 9 (ii) identifying opportunities to create 10 high-quality manufacturing jobs; and 11 (G) identifying and describing necessary 12 tools, including commercially available risk as-13 sessment tools, that leverage data and industry 14 expertise to provide insights into critical supply 15 chain vulnerabilities, including how such tools 16 fulfill the requirements described in subpara-17 graphs (A) through (F). 18 (2) In consultation with State and local govern-19 ments, the Working Group, and (as appropriate) 20 countries that are allies or key international partner 21 nations— 22 (A) identifying opportunities to reduce 23 gaps and vulnerabilities in critical supply chains 24 and critical industries; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 51 •HR 1768 IH (B) encouraging consultation between the 1 Federal Government, industry, covered non-2 governmental representatives, institutions of 3 higher education, and State and local govern-4 ments to— 5 (i) better respond to supply chain 6 shocks to critical supply chains and critical 7 industries (including critical industries for 8 emerging technologies); and 9 (ii) coordinate response efforts to sup-10 ply chain shocks; 11 (C) encouraging consultation between the 12 Federal Government and the governments of 13 countries that are allies or key international 14 partner nations; 15 (D) identifying opportunities to build the 16 capacity of the United States in critical supply 17 chains, critical industries, and emerging tech-18 nologies; 19 (E) identifying opportunities to build the 20 capacity of countries that are allies or key 21 international partner nations in critical indus-22 tries (including critical industries for emerging 23 technologies) and critical supply chains; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 52 •HR 1768 IH (F) developing and assessing contingency 1 plans and coordination mechanisms to improve 2 the response of critical supply chains and crit-3 ical industries to supply chain shocks. 4 (c) W ORKING GROUP MEMBERSHIP.—The Working 5 Group shall include a representative from each Federal 6 agency that relies on the analysis of the Industry and 7 Analysis business unit, including— 8 (1) the Department of State; 9 (2) the Department of Defense; 10 (3) the Department of Homeland Security; 11 (4) the Department of Transportation; 12 (5) the Department of Energy; 13 (6) the Department of Agriculture; 14 (7) the Department of the Interior; 15 (8) the Department of Health and Human 16 Services; 17 (9) the Office of the Director of National Intel-18 ligence; and 19 (10) the Small Business Administration. 20 (d) DESIGNATIONS.—The Assistant Secretary shall— 21 (1) not later than 120 days after the date of 22 the enactment of this Act, designate— 23 (A) critical industries; 24 (B) critical supply chains; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 53 •HR 1768 IH (C) critical goods; 1 (2) provide for a period of public comment and 2 review in carrying out paragraph (1); and 3 (3) update the designations made pursuant to 4 paragraph (1) not less frequently than once every 4 5 years, including designations for technologies that 6 are not described in section 407(12)(B) that the As-7 sistant Secretary considers necessary. 8 (e) I MPLEMENTATION REPORT.—Not later than 1 9 year after the date of the enactment of this Act, the As-10 sistant Secretary shall submit to the relevant committees 11 of Congress a report that— 12 (1) details supply chain activities, including ap-13 plicable activities described in subsection (b) and re-14 sponsibilities described in section 402, that the As-15 sistant Secretary has conducted over the past year; 16 (2) describes supply chain data collected, re-17 tained, and analyzed by the Assistant Secretary over 18 the past year; 19 (3) identifies and describes necessary tools, in-20 cluding commercially available risk assessment tools, 21 that leverage data and industry expertise to provide 22 insights into critical supply chain vulnerabilities, in-23 cluding how such tools fulfill each responsibility de-24 scribed in subsection (b); 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 54 •HR 1768 IH (4) identifies and describes all Federal agencies 1 with authorities or responsibilities described in sub-2 section (b); and 3 (5) identifies Federal agencies, programs, and 4 bureaus with duplicative purposes to fulfill any of 5 the authorities or responsibilities described in sub-6 section (b). 7 (f) NATIONAL STRATEGY AND REVIEW ON CRITICAL 8 SUPPLY CHAIN RESILIENCY AND MANUFACTURING IN 9 THE UNITED STATES.— 10 (1) I N GENERAL .—Not later than 18 months 11 after the date of the enactment of this Act, and an-12 nually thereafter, the Assistant Secretary, in con-13 sultation with the Working Group, covered non-14 governmental representatives, industries, institutions 15 of higher education, and State and local govern-16 ments, shall submit to the relevant committees of 17 Congress a report that— 18 (A) identifies— 19 (i) critical infrastructure that may as-20 sist in fulfilling the responsibilities de-21 scribed in section 402; 22 (ii) critical and emerging technologies 23 that may assist in fulfilling the responsibil-24 ities described in section 402, including 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 55 •HR 1768 IH such technologies that may be critical to 1 addressing preparedness, weaknesses, and 2 vulnerabilities relating to critical supply 3 chains; 4 (iii) critical industries, critical supply 5 chains, and critical goods designated pur-6 suant to subsection (d); 7 (iv) other supplies and services that 8 are critical to the crisis preparedness of 9 the United States; 10 (v) substitutes for critical goods, pro-11 duction equipment, and manufacturing 12 technology; 13 (vi) methods and technologies, includ-14 ing blockchain technology, distributed ledg-15 er technology, and other critical and 16 emerging technologies, as appropriate, for 17 the authentication and traceability of crit-18 ical goods; and 19 (vii) countries that are allies or key 20 international partner nations; 21 (B) describes the matters identified and 22 evaluated under subsection (b)(1), including— 23 (i) the manufacturing base, critical 24 supply chains, and emerging technologies 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 56 •HR 1768 IH in the United States, including the manu-1 facturing base and critical supply chains 2 for— 3 (I) critical goods; 4 (II) production equipment; and 5 (III) manufacturing technology; 6 and 7 (ii) the ability of the United States 8 to— 9 (I) maintain readiness with re-10 spect to preparing for and responding 11 to supply chain shocks; and 12 (II) in response to a supply chain 13 shock— 14 (aa) surge production in 15 critical industries; 16 (bb) surge production of 17 critical goods and production 18 equipment; and 19 (cc) maintain access to crit-20 ical goods, production equipment, 21 and manufacturing technology; 22 (C) assesses and describes— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 57 •HR 1768 IH (i) the demand and supply of critical 1 goods, production equipment, and manu-2 facturing technology; 3 (ii) the production of critical goods, 4 production equipment, and manufacturing 5 technology by domestic manufacturers; 6 (iii) the capability and capacity of do-7 mestic manufacturers and manufacturers 8 in countries that are allies or key inter-9 national partner nations to manufacture 10 critical goods, production equipment, and 11 manufacturing technology; and 12 (iv) how supply chain shocks could af-13 fect rural, Tribal, and underserved commu-14 nities; 15 (D) identifies threats and supply chain 16 shocks that may disrupt, strain, or eliminate 17 critical supply chains, critical goods, and critical 18 industries (including critical industries for 19 emerging technologies); 20 (E) with regard to any threat identified 21 under subparagraph (D), lists any threat or 22 supply chain shock that may originate from a 23 country, or a company or individual from a 24 country, that is described in section 407(2)(B); 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00057 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 58 •HR 1768 IH (F) assesses— 1 (i) the resilience and capacity of the 2 manufacturing base, critical supply chains, 3 and workforce of the United States and 4 countries that are allies or key inter-5 national partner nations that can sustain 6 critical industries (including critical indus-7 tries for emerging technologies) through a 8 supply chain shock; and 9 (ii) the effect innovation has on do-10 mestic manufacturers; 11 (G) assesses the flexible manufacturing ca-12 pacity and capability available in the United 13 States in the case of a supply chain shock; and 14 (H) develops a strategy for the Depart-15 ment of Commerce to support the resilience, di-16 versity, and strength of critical supply chains 17 and critical and emerging technologies to— 18 (i) support sufficient access to critical 19 goods by mitigating vulnerabilities in crit-20 ical supply chains, including critical supply 21 chains concentrated in countries that are 22 described in section 407(2)(B); 23 (ii) consult with other relevant agen-24 cies to assist countries that are allies or 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 59 •HR 1768 IH key international partner nations in build-1 ing capacity for manufacturing critical 2 goods; 3 (iii) recover from supply chain shocks; 4 (iv) identify, in consultation with the 5 Working Group and other relevant agen-6 cies, actions relating to critical supply 7 chains or emerging technologies that the 8 United States may take to improve re-9 sponses to supply chain shocks; 10 (v) protect against supply chain 11 shocks relating to critical supply chains 12 from countries that are described in sec-13 tion 407(2)(B); and 14 (vi) make specific recommendations to 15 implement the strategy under this section 16 and improve the security and resiliency of 17 manufacturing capacity and supply chains 18 for critical industries (including critical in-19 dustries for emerging technologies) by— 20 (I) developing long-term strate-21 gies; 22 (II) increasing visibility into the 23 networks and capabilities of domestic 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 60 •HR 1768 IH manufacturers and suppliers of do-1 mestic manufacturers; 2 (III) identifying and mitigating 3 risks, including— 4 (aa) significant 5 vulnerabilities to supply chain 6 shocks; and 7 (bb) exposure to gaps and 8 vulnerabilities in domestic capac-9 ity or capabilities and sources of 10 imports needed to sustain critical 11 industries (including critical in-12 dustries for emerging tech-13 nologies) or critical supply 14 chains; 15 (IV) identifying opportunities to 16 reuse and recycle critical goods, in-17 cluding raw materials, to increase re-18 silient critical supply chains; 19 (V) consulting with countries 20 that are allies or key international 21 partner nations on— 22 (aa) sourcing critical goods, 23 production equipment, and man-24 ufacturing technology; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00060 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 61 •HR 1768 IH (bb) developing, sustaining, 1 and expanding production and 2 availability of critical goods, pro-3 duction equipment, and manufac-4 turing technology during a supply 5 chain shock; and 6 (VI) providing guidance to other 7 relevant agencies with respect to crit-8 ical goods, supply chains, and critical 9 industries (including critical industries 10 for emerging technologies) that should 11 be prioritized to support United 12 States leadership in the deployment of 13 such technologies. 14 (2) P ROHIBITION.—The report submitted pur-15 suant to paragraph (1) may not include— 16 (A) critical supply chain information that 17 is not aggregated; 18 (B) confidential business information of a 19 private sector entity; or 20 (C) classified information. 21 (3) F ORM.—The report submitted pursuant to 22 paragraph (1), and any update submitted thereafter, 23 shall be submitted to the relevant committees of 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 62 •HR 1768 IH Congress in unclassified form and may include a 1 classified annex. 2 (4) P UBLIC COMMENT .—The Assistant Sec-3 retary shall provide for a period of public comment 4 and review in developing the report submitted pursu-5 ant to paragraph (1). 6 (g) CONSULTATION.—Not later than 1 year after the 7 date of the enactment of this Act, the Assistant Secretary 8 shall enter into an agreement with the head of any rel-9 evant agency to obtain any information, data, or assist-10 ance that the Assistant Secretary determines necessary to 11 conduct the activities described in subsection (b). 12 (h) R ULE OF CONSTRUCTION.—Nothing in this sec-13 tion may be construed to require any private entity— 14 (1) to share information with the Secretary or 15 Assistant Secretary; 16 (2) to request assistance from the Secretary or 17 Assistant Secretary; or 18 (3) to implement any measure or recommenda-19 tion suggested by the Secretary or Assistant Sec-20 retary in response to a request by the private entity. 21 (i) P ROTECTION OF VOLUNTARILY SHARED CRIT-22 ICAL SUPPLY CHAIN INFORMATION.— 23 (1) PROTECTION.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 63 •HR 1768 IH (A) I N GENERAL .—Notwithstanding any 1 other provision of law, critical supply chain in-2 formation (including the identity of the submit-3 ting person or entity) that is voluntarily sub-4 mitted under this section to the Department of 5 Commerce for use by the Department for pur-6 poses of this section, when accompanied by an 7 express statement described in subparagraph 8 (B)— 9 (i) shall be exempt from disclosure 10 under section 552(b)(3) of title 5, United 11 States Code (commonly referred to as the 12 ‘‘Freedom of Information Act’’); 13 (ii) is not subject to any agency rules 14 or judicial doctrine regarding ex parte 15 communications with a decision-making of-16 ficial; 17 (iii) may not, without the written con-18 sent of the person or entity submitting 19 such information, be used directly by the 20 Department of Commerce, any other Fed-21 eral, State, or local authority, or any third 22 party, in any civil action arising under 23 Federal or State law if such information is 24 submitted in good faith; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 64 •HR 1768 IH (iv) may not, without the written con-1 sent of the person or entity submitting 2 such information, be used or disclosed by 3 any officer or employee of the United 4 States for purposes other than the pur-5 poses of this section, except— 6 (I) in furtherance of an investiga-7 tion or the prosecution of a criminal 8 act; or 9 (II) when disclosure of the infor-10 mation would be— 11 (aa) to either House of Con-12 gress, or to the extent of matter 13 within its jurisdiction, any com-14 mittee or subcommittee thereof, 15 any joint committee thereof, or 16 any subcommittee of any such 17 joint committee; or 18 (bb) to the Comptroller Gen-19 eral of the United States, or any 20 authorized representative of the 21 Comptroller General, in the 22 course of the performance of the 23 duties of the Government Ac-24 countability Office; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 65 •HR 1768 IH (v) may not, if provided to a State or 1 local government or government agency— 2 (I) be made available pursuant to 3 any State or local law requiring dis-4 closure of information or records; 5 (II) otherwise be disclosed or dis-6 tributed to any party by such State or 7 local government or government agen-8 cy without the written consent of the 9 person or entity submitting such in-10 formation; or 11 (III) be used other than for the 12 purpose of carrying out this section, 13 or in furtherance of an investigation 14 or the prosecution of a criminal act; 15 and 16 (vi) does not constitute a waiver of 17 any applicable privilege or protection pro-18 vided under law, such as trade secret pro-19 tection. 20 (B) E XPRESS STATEMENT .—The express 21 statement described in this subparagraph, with 22 respect to information or records, is— 23 (i) in the case of written information 24 or records, a written marking on the infor-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 66 •HR 1768 IH mation or records substantially similar to 1 the following: ‘‘This information is volun-2 tarily submitted to the Federal Govern-3 ment in expectation of protection from dis-4 closure as provided by the provisions of the 5 Promoting Resilient Supply Chains Act.’’; 6 or 7 (ii) in the case of oral information, a 8 written statement similar to the statement 9 described in clause (i) submitted within a 10 reasonable period following the oral com-11 munication. 12 (2) LIMITATION.—No communication of critical 13 supply chain information to the Department of Com-14 merce made pursuant to this section may be consid-15 ered to be an action subject to the requirements of 16 chapter 10 of title 5, United States Code. 17 (3) I NDEPENDENTLY OBTAINED INFORMA -18 TION.—Nothing in this subsection may be construed 19 to limit or otherwise affect the ability of a State, 20 local, or Federal Government entity, agency, or au-21 thority, or any third party, under applicable law to 22 obtain critical supply chain information in a manner 23 not covered by paragraph (1), including any infor-24 mation lawfully and properly disclosed generally or 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 67 •HR 1768 IH broadly to the public and to use such information in 1 any manner permitted by law. For purposes of this 2 subsection, a permissible use of independently ob-3 tained information includes the disclosure of such in-4 formation under section 2302(b)(8) of title 5, 5 United States Code. 6 (4) TREATMENT OF VOLUNTARY SUBMITTAL OF 7 INFORMATION.—The voluntary submittal to the De-8 partment of Commerce of information or records 9 that are protected from disclosure by this section 10 may not be construed to constitute compliance with 11 any requirement to submit such information to an 12 agency under any other provision of law. 13 (5) I NAPPLICABILITY TO SEMICONDUCTOR IN -14 CENTIVE PROGRAM .—This subsection does not apply 15 to the voluntary submission of critical supply chain 16 information in an application for Federal financial 17 assistance under section 9902 of the William M. 18 (Mac) Thornberry National Defense Authorization 19 Act for Fiscal Year 2021 (Public Law 116–283). 20 SEC. 404. DEPARTMENT OF COMMERCE CAPABILITY AS-21 SESSMENT. 22 (a) R EPORT REQUIRED.—The Secretary shall 23 produce a report— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 68 •HR 1768 IH (1) identifying the duties, responsibilities, re-1 sources, programs, and expertise within the offices 2 and bureaus of the Department of Commerce rel-3 evant to critical supply chain resilience and manu-4 facturing innovation; 5 (2) identifying and assessing the purpose, legal 6 authority, effectiveness, efficiency, and limitations of 7 each office or bureau identified under paragraph (1); 8 and 9 (3) providing recommendations to enhance the 10 activities related to critical supply chain resilience 11 and manufacturing innovation of the Department of 12 Commerce, including— 13 (A) improving the effectiveness, efficiency, 14 and impact of the offices and bureaus identified 15 under paragraph (1); 16 (B) coordinating across offices and bu-17 reaus identified under paragraph (1); and 18 (C) consulting with agencies implementing 19 similar activities related to critical supply chain 20 resilience and manufacturing innovation. 21 (b) SUBMISSION OF REPORT.—Not later than 2 years 22 after the date of the enactment of this Act, the Secretary 23 shall submit to the relevant committees of Congress the 24 report required by subsection (a), along with a strategy 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 69 •HR 1768 IH to implement, as appropriate and as determined by the 1 Secretary, the recommendations contained in the report. 2 SEC. 405. NO ADDITIONAL FUNDS. 3 No additional funds are authorized to be appro-4 priated to carry out this title. 5 SEC. 406. SUNSET. 6 This title and all requirements, responsibilities, and 7 obligations under this title shall terminate on the date that 8 is 10 years after the date of the enactment of this Act. 9 SEC. 407. DEFINITIONS. 10 In this title: 11 (1) A GENCY.—The term ‘‘agency’’ has the 12 meaning given that term in section 551 of title 5, 13 United States Code. 14 (2) A LLY OR KEY INTERNATIONAL PARTNER 15 NATION.—The term ‘‘ally or key international part-16 ner nation’’— 17 (A) means a country that is critical to ad-18 dressing critical supply chain weaknesses and 19 vulnerabilities; and 20 (B) does not include— 21 (i) a country that poses a significant 22 risk to the national security or economic 23 security of the United States; or 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00069 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 70 •HR 1768 IH (ii) a country that is described in sec-1 tion 503(b) of the RANSOMWARE Act 2 (title V of division BB of the Consolidated 3 Appropriations Act, 2023; Public Law 4 117–328; 136 Stat. 5564). 5 (3) ASSISTANT SECRETARY .—The term ‘‘Assist-6 ant Secretary’’ means the Assistant Secretary of 7 Commerce assigned by the Secretary to direct the 8 office of Industry and Analysis. 9 (4) COVERED NONGOVERNMENTAL REPRESENT -10 ATIVE.—The term ‘‘covered nongovernmental rep-11 resentative’’ means a representative as specified in 12 the second sentence of section 135(b)(1) of the 13 Trade Act of 1974 (19 U.S.C. 2155(b)(1)), except 14 that such term does not include a representative of 15 a non-Federal government. 16 (5) C RITICAL GOOD .—The term ‘‘critical good’’ 17 means any raw, in process, or manufactured mate-18 rial (including any mineral, metal, or advanced proc-19 essed material), article, commodity, supply, product, 20 or item for which an absence of supply would have 21 a debilitating impact on— 22 (A) the national security or economic secu-23 rity of the United States; and 24 (B) either— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 71 •HR 1768 IH (i) critical infrastructure; or 1 (ii) an emerging technology. 2 (6) C RITICAL INDUSTRY .—The term ‘‘critical 3 industry’’ means an industry that— 4 (A) is critical for the national security or 5 economic security of the United States; and 6 (B) produces or procures a critical good. 7 (7) C RITICAL INFRASTRUCTURE .—The term 8 ‘‘critical infrastructure’’ has the meaning given that 9 term in section 1016 of the Critical Infrastructures 10 Protection Act of 2001 (42 U.S.C. 5195c). 11 (8) C RITICAL SUPPLY CHAIN .—The term ‘‘crit-12 ical supply chain’’ means a supply chain for a crit-13 ical good. 14 (9) C RITICAL SUPPLY CHAIN INFORMATION .— 15 The term ‘‘critical supply chain information’’ means 16 information that is not customarily in the public do-17 main and relates to— 18 (A) sustaining and adapting a critical sup-19 ply chain during a supply chain shock; 20 (B) critical supply chain risk mitigation 21 and recovery planning with respect to a supply 22 chain shock, including any planned or past as-23 sessment, projection, or estimate of a vulner-24 ability within the critical supply chain, includ-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 72 •HR 1768 IH ing testing, supplier network assessments, pro-1 duction flexibility, supply chain risk evaluations, 2 supply chain risk management planning, or risk 3 audits; or 4 (C) operational best practices, planning, 5 and supplier partnerships that enable enhanced 6 resilience of a critical supply chain during a 7 supply chain shock, including response, repair, 8 recovery, reconstruction, insurance, or con-9 tinuity. 10 (10) D OMESTIC ENTERPRISE .—The term ‘‘do-11 mestic enterprise’’ means an enterprise that con-12 ducts business in the United States and procures a 13 critical good. 14 (11) D OMESTIC MANUFACTURER .—The term 15 ‘‘domestic manufacturer’’ means a business that 16 conducts in the United States the research and de-17 velopment, engineering, or production activities nec-18 essary for manufacturing a critical good. 19 (12) E MERGING TECHNOLOGY .—The term 20 ‘‘emerging technology’’ means a technology that is 21 critical for the national security or economic security 22 of the United States, including the following: 23 (A) Technologies included in the American 24 COMPETE Act (title XV of division FF of the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00072 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 73 •HR 1768 IH Consolidated Appropriations Act, 2021; Public 1 Law 116–260; 134 Stat. 3276). 2 (B) The following technologies: 3 (i) Artificial intelligence. 4 (ii) Automated vehicles and unmanned 5 delivery systems. 6 (iii) Blockchain and other distributed 7 ledger, data storage, data management, 8 and cybersecurity technologies. 9 (iv) Quantum computing and quan-10 tum sensing. 11 (v) Additive manufacturing. 12 (vi) Advanced manufacturing and the 13 Internet of Things. 14 (vii) Nano technology. 15 (viii) Robotics. 16 (ix) Microelectronics, optical fiber ray, 17 and high performance and advanced com-18 puter hardware and software. 19 (x) Semiconductors. 20 (xi) Advanced materials science, in-21 cluding composition 2D, other next genera-22 tion materials, and related manufacturing 23 technologies. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 74 •HR 1768 IH (13) I NSTITUTION OF HIGHER EDUCATION .— 1 The term ‘‘institution of higher education’’ has the 2 meaning given that term in section 101 of the High-3 er Education Act of 1965 (20 U.S.C. 1001). 4 (14) M ANUFACTURE.—The term ‘‘manufac-5 ture’’— 6 (A) means any activity that is necessary 7 for the development, production, processing, 8 distribution, or delivery of any raw, in process, 9 or manufactured material (including any min-10 eral, metal, and advanced processed material), 11 article, commodity, supply, product, critical 12 good, or item of supply; and 13 (B) does not include software unrelated to 14 the manufacturing process. 15 (15) M ANUFACTURING TECHNOLOGY .—The 16 term ‘‘manufacturing technology’’ means a tech-17 nology that is necessary for the manufacturing of a 18 critical good. 19 (16) P RODUCTION EQUIPMENT .—The term 20 ‘‘production equipment’’ means any component, sub-21 system, system, equipment, tooling, accessory, part, 22 or assembly necessary for the manufacturing of a 23 critical good. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00074 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 75 •HR 1768 IH (17) R ELEVANT COMMITTEES OF CONGRESS .— 1 The term ‘‘relevant committees of Congress’’ means 2 the following: 3 (A) The Committee on Commerce, Science, 4 and Transportation of the Senate. 5 (B) The Committee on Energy and Com-6 merce of the House of Representatives. 7 (18) RESILIENT CRITICAL SUPPLY CHAIN .—The 8 term ‘‘resilient critical supply chain’’ means a crit-9 ical supply chain that— 10 (A) ensures that the United States can 11 sustain critical industry, including emerging 12 technologies, production, critical supply chains, 13 services, and access to critical goods, production 14 equipment, and manufacturing technology dur-15 ing a supply chain shock; and 16 (B) has key components of resilience that 17 include— 18 (i) effective private sector risk man-19 agement and mitigation planning to sus-20 tain critical supply chains and supplier 21 networks during a supply chain shock; and 22 (ii) minimized or managed exposure to 23 a supply chain shock. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 76 •HR 1768 IH (19) S ECRETARY.—The term ‘‘Secretary’’ 1 means the Secretary of Commerce. 2 (20) S TATE.—The term ‘‘State’’ means each of 3 the several States, the District of Columbia, each 4 commonwealth, territory, or possession of the United 5 States, and each federally recognized Indian Tribe. 6 (21) SUPPLY CHAIN SHOCK .—The term ‘‘supply 7 chain shock’’— 8 (A) means an event causing severe or seri-9 ous disruption to normal operations or capacity 10 in a supply chain; and 11 (B) includes— 12 (i) a natural disaster; 13 (ii) a pandemic; 14 (iii) a biological threat; 15 (iv) a cyber attack; 16 (v) a geopolitical conflict; 17 (vi) a terrorist or geopolitical attack; 18 (vii) a trade disruption caused by— 19 (I) a country described in para-20 graph (2)(B); or 21 (II) an entity or an individual 22 subject to the jurisdiction of such a 23 country; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 77 •HR 1768 IH (viii) an event for which the President 1 declares a major disaster or an emergency 2 under section 401 or 501, respectively, of 3 the Robert T. Stafford Disaster Relief and 4 Emergency Assistance Act (42 U.S.C. 5 5170; 42 U.S.C. 5191). 6 TITLE V—DEPLOYING AMERICAN 7 BLOCKCHAINS 8 SEC. 501. SHORT TITLE. 9 This title may be cited as the ‘‘Deploying American 10 Blockchains Act’’. 11 SEC. 502. DEFINITIONS. 12 In this title: 13 (1) A DVISORY COMMITTEE .—The term ‘‘Advi-14 sory Committee’’ means the National Blockchain 15 Deployment Advisory Committee established pursu-16 ant to section 503(c). 17 (2) B LOCKCHAIN TECHNOLOGY OR OTHER DIS -18 TRIBUTED LEDGER TECHNOLOGY .—The term 19 ‘‘blockchain technology or other distributed ledger 20 technology’’ means a distributed digital database 21 where data is— 22 (A) shared across a network of computers 23 to create a ledger of verified information among 24 network participants; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 78 •HR 1768 IH (B) linked using cryptography to maintain 1 the integrity of the ledger and to execute other 2 functions; and 3 (C) distributed among network partici-4 pants in an automated fashion to concurrently 5 update network participants on the state of the 6 ledger and other functions. 7 (3) COVERED NONGOVERNMENTAL REPRESENT -8 ATIVE.—The term ‘‘covered nongovernmental rep-9 resentative’’ means a representative as specified in 10 the second sentence of section 135(b)(1) of the 11 Trade Act of 1974 (19 U.S.C. 2155(b)(1)), except 12 that such term does not include a representative of 13 a non-Federal government. 14 (4) S ECRETARY.—The term ‘‘Secretary’’ means 15 the Secretary of Commerce. 16 (5) S TATE.—The term ‘‘State’’ means each of 17 the several States, the District of Columbia, each 18 commonwealth, territory, or possession of the United 19 States, and each federally recognized Indian Tribe. 20 (6) TOKEN.—The term ‘‘token’’ means a trans-21 ferable, digital representation of information re-22 corded on blockchain technology or other distributed 23 ledger technology. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 79 •HR 1768 IH (7) T OKENIZATION.—The term ‘‘tokenization’’ 1 means the process of creating a token. 2 SEC. 503. DEPARTMENT OF COMMERCE LEADERSHIP ON 3 BLOCKCHAIN. 4 (a) FUNCTION OF SECRETARY.—The Secretary shall 5 serve as a principal advisor to the President for policy per-6 taining to the deployment, use, application, and competi-7 tiveness of blockchain technology or other distributed ledg-8 er technology, applications built on blockchain technology 9 or other distributed ledger technology, tokens, and 10 tokenization. 11 (b) A CTIVITIES.—The Secretary shall support the 12 leadership of the United States with respect to the deploy-13 ment, use, application, and competitiveness of blockchain 14 technology or other distributed ledger technology, applica-15 tions built on blockchain technology or other distributed 16 ledger technology, tokens, and tokenization by organizing 17 the Advisory Committee— 18 (1) to examine and to provide recommendations 19 on issues and risks relating to the deployment, use, 20 application, and competitiveness of blockchain tech-21 nology or other distributed ledger technology, appli-22 cations built on blockchain technology or other dis-23 tributed ledger technology, tokens, and tokenization, 24 including the issues of decentralized identity, cyber-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00079 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 80 •HR 1768 IH security, key storage and security systems, artificial 1 intelligence, fraud reduction, regulatory compliance, 2 e-commerce, health care applications, and supply 3 chain resiliency; 4 (2) to support and to promote the improvement 5 and security of blockchain technology or other dis-6 tributed ledger technology, applications built on 7 blockchain technology or other distributed ledger 8 technology, tokens, and tokenization; 9 (3) to help to promote the leadership of the 10 United States with respect to the deployment, use, 11 application, and competitiveness of blockchain tech-12 nology or other distributed ledger technology, appli-13 cations built on blockchain technology or other dis-14 tributed ledger technology, tokens, and tokenization; 15 (4) to promote the national security of the 16 United States with respect to blockchain technology 17 or other distributed ledger technology, applications 18 built on blockchain technology or other distributed 19 ledger technology, tokens, and tokenization; 20 (5) to support engagement with the public to 21 develop a compendium of proposals for practices as 22 part of the work described in subsection (d); 23 (6) to consider policies to encourage coordina-24 tion among Federal agencies with respect to the de-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 81 •HR 1768 IH ployment of blockchain technology or other distrib-1 uted ledger technology, applications built on 2 blockchain technology or other distributed ledger 3 technology, tokens, and tokenization; 4 (7) to examine— 5 (A) how Federal agencies can benefit from 6 utilizing blockchain technology or other distrib-7 uted ledger technology, applications built on 8 blockchain technology or other distributed ledg-9 er technology, tokens, and tokenization; 10 (B) the current use by Federal agencies of 11 blockchain technology or other distributed ledg-12 er technology, applications built on blockchain 13 technology or other distributed ledger tech-14 nology, tokens, and tokenization; 15 (C) the current and future preparedness 16 and ability of Federal agencies to adopt 17 blockchain technology or other distributed ledg-18 er technology, applications built on blockchain 19 technology or other distributed ledger tech-20 nology, tokens, and tokenization; and 21 (D) additional security measures Federal 22 agencies may need to take— 23 (i) to securely use blockchain tech-24 nology or other distributed ledger tech-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 82 •HR 1768 IH nology, applications built on blockchain 1 technology or other distributed ledger tech-2 nology, tokens, and tokenization, including 3 to support the security of critical infra-4 structure; and 5 (ii) to enhance the resiliency of Fed-6 eral systems against cyber threats to 7 blockchain technology or other distributed 8 ledger technology, applications built on 9 blockchain technology or other distributed 10 ledger technology, tokens, and 11 tokenization; and 12 (8) to support coordination of the activities of 13 the Federal Government relating to the security of 14 blockchain technology and other distributed ledger 15 technology, applications built on blockchain tech-16 nology or other distributed ledger technology, to-17 kens, and tokenization. 18 (c) E STABLISHMENT OF NATIONAL BLOCKCHAIN 19 DEPLOYMENT ADVISORY COMMITTEE.— 20 (1) ESTABLISHMENT.— 21 (A) I N GENERAL .—Not later than 180 22 days after the date of the enactment of this 23 Act, the Secretary shall, in consultation with 24 the heads of relevant Federal agencies, establish 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00082 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 83 •HR 1768 IH an advisory committee to support the adoption 1 of blockchain technology or other distributed 2 ledger technology, applications built on 3 blockchain technology or other distributed ledg-4 er technology, tokens, and tokenization. 5 (B) D ESIGNATION.—The advisory com-6 mittee established pursuant to subparagraph 7 (A) shall be known as the ‘‘National Blockchain 8 Deployment Advisory Committee’’. 9 (2) MEMBERSHIP COMPOSITION .—The Advisory 10 Committee shall consist of members appointed by 11 the Secretary, which shall include— 12 (A) the Secretary; 13 (B) representatives of Federal agencies (as 14 determined necessary by the Secretary); and 15 (C) covered nongovernmental representa-16 tives with expertise related to blockchain tech-17 nology or other distributed ledger technology 18 (as determined necessary by the Secretary), 19 which may include— 20 (i) blockchain technology or other dis-21 tributed ledger technology infrastructure 22 operators, suppliers, service providers, and 23 vendors; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 84 •HR 1768 IH (ii) application developers building on 1 blockchain technology or other distributed 2 ledger technology; 3 (iii) developers and organizations sup-4 porting the advancement and deployment 5 of public blockchain technology or other 6 distributed ledger technology; 7 (iv) subject matter experts rep-8 resenting industrial sectors that can ben-9 efit from blockchain technology or other 10 distributed ledger technology; 11 (v) small, medium, and large busi-12 nesses; 13 (vi) think tanks and academia; 14 (vii) nonprofit organizations and con-15 sumer groups; 16 (viii) cybersecurity experts; 17 (ix) rural stakeholders; 18 (x) covered nongovernmental rep-19 resentatives; and 20 (xi) artists and the content creator 21 community. 22 (3) T ERMINATION OF ADVISORY COMMITTEE .— 23 The Advisory Committee shall terminate on the date 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 85 •HR 1768 IH that is 7 years after the date of the enactment of 1 this Act. 2 (d) B EST PRACTICES.—The Secretary shall, on an 3 ongoing basis, facilitate and support the development of 4 a compendium of identified or recommended guidelines or 5 best practices for the deployment of blockchain technology 6 or other distributed ledger technology, applications built 7 on blockchain technology or other distributed ledger tech-8 nology, tokens, and tokenization that— 9 (1) support the deployment of technologies 10 needed to advance the capabilities of blockchain 11 technology or other distributed ledger technology, 12 applications built on blockchain technology or other 13 distributed ledger technology, tokens, and 14 tokenization; 15 (2) support the interoperability of blockchain 16 technology or other distributed ledger technology, 17 applications built on blockchain technology or other 18 distributed ledger technology, tokens, and 19 tokenization; 20 (3) support operations, including hashing and 21 key storage and security systems, that form the 22 foundation of blockchain technology or other distrib-23 uted ledger technology, applications built on 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00085 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 86 •HR 1768 IH blockchain technology or other distributed ledger 1 technology, tokens, and tokenization; 2 (4) reduce cybersecurity risks that may com-3 promise blockchain technology or other distributed 4 ledger technology, applications built on blockchain 5 technology or other distributed ledger technology, to-6 kens, and tokenization; and 7 (5) quantify the value and potential cost sav-8 ings associated with adoption of blockchain tech-9 nology or other distributed ledger technology, appli-10 cations built on blockchain technology or other dis-11 tributed ledger technology, tokens, and tokenization, 12 including through comparative analyses of competing 13 and existing technologies within specific industry ap-14 plications. 15 (e) A DDITIONAL REQUIREMENTS.—In carrying out 16 this section, the Secretary shall— 17 (1) consult closely and regularly with stake-18 holders, including private sector individuals and enti-19 ties, and incorporate industry expertise; 20 (2) collaborate with private sector stakeholders 21 to identify prioritized, flexible, repeatable, perform-22 ance-based, and cost-effective approaches to the de-23 ployment of blockchain technology or other distrib-24 uted ledger technology, applications built on 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00086 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 87 •HR 1768 IH blockchain technology or other distributed ledger 1 technology, tokens, and tokenization; 2 (3) make public research and information per-3 taining to the use of, and marketplace for, 4 blockchain technology or other distributed ledger 5 technology, applications built on blockchain tech-6 nology or other distributed ledger technology, to-7 kens, and tokenization; 8 (4) develop standardized terminology for, and 9 promote common understanding of, blockchain tech-10 nology or other distributed ledger technology, appli-11 cations built on blockchain technology or other dis-12 tributed ledger technology, tokens, and tokenization; 13 (5) align the recommendations of the compen-14 dium described in subsection (d) with the goal of fa-15 cilitating the ease of use of blockchain technology or 16 other distributed ledger technology, applications 17 built on blockchain technology or other distributed 18 ledger technology, tokens, and tokenization; 19 (6) support open-source infrastructure, data 20 management, and authentication activities with re-21 spect to blockchain technology or other distributed 22 ledger technology, applications built on blockchain 23 technology or other distributed ledger technology, to-24 kens, and tokenization; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00087 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 88 •HR 1768 IH (7) consider the needs and interests of both the 1 private and public sector, including small businesses 2 and Federal, State, and local governments. 3 (f) RULES OF CONSTRUCTION.—Nothing in this sec-4 tion may be construed— 5 (1) to require a private entity to share informa-6 tion with the Secretary; 7 (2) to require a private entity to request assist-8 ance from the Secretary; 9 (3) to require a private entity to implement any 10 measure or recommendation suggested by the Sec-11 retary in response to a request by the private entity; 12 or 13 (4) to require the adoption of the best practices 14 described in subsection (d). 15 (g) C ONSULTATION.—In implementing this section, 16 the Secretary may, as appropriate, consult with the heads 17 of relevant Federal agencies. 18 SEC. 504. REPORTS TO CONGRESS. 19 (a) INTERIM REPORTS.—Not later than 2 years after 20 the date of the enactment of this Act, and annually there-21 after, the Secretary shall make public on the website of 22 the Department of Commerce and submit to the Com-23 mittee on Commerce, Science, and Transportation of the 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00088 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 89 •HR 1768 IH Senate and the Committee on Energy and Commerce of 1 the House of Representatives a report that includes— 2 (1) a description of the activities of the Sec-3 retary under this title during the preceding year; 4 (2) any recommendations by the Secretary for 5 additional legislation to strengthen the competitive-6 ness of the United States with respect to blockchain 7 technology or other distributed ledger technology, 8 applications built on blockchain technology or other 9 distributed ledger technology, tokens, and 10 tokenization; and 11 (3) a description of any emerging risks and 12 long-term trends with respect to blockchain tech-13 nology or other distributed ledger technology, appli-14 cations built on blockchain technology or other dis-15 tributed ledger technology, tokens, and tokenization. 16 (b) F INAL REPORT.—Not later than 18 months be-17 fore the termination of the Advisory Committee pursuant 18 to section 503(c)(3), the Secretary shall make available 19 to the public on the website of the Department of Com-20 merce and submit to the President, the Committee on 21 Commerce, Science, and Transportation of the Senate, 22 and the Committee on Energy and Commerce of the 23 House of Representatives a final report containing the 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00089 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 90 •HR 1768 IH findings, conclusions, and recommendations of the Advi-1 sory Committee. 2 TITLE VI—FUTURE NETWORKS 3 ACT 4 SEC. 601. SHORT TITLE. 5 This title may be cited as the ‘‘Future Uses of Tech-6 nology Upholding Reliable and Enhanced Networks Act’’ 7 or the ‘‘FUTURE Networks Act’’. 8 SEC. 602. 6G TASK FORCE. 9 (a) ESTABLISHMENT.—Not later than 120 days after 10 the date of the enactment of this Act, the Commission 11 shall establish a task force to be known as the ‘‘6G Task 12 Force’’. 13 (b) MEMBERSHIP.— 14 (1) A PPOINTMENT.—The members of the Task 15 Force shall be appointed by the Chair. 16 (2) C OMPOSITION.—To the extent practicable, 17 the membership of the Task Force shall be com-18 posed of the following: 19 (A) Representatives of companies in the 20 communications industry, except companies 21 that are determined by the Chair to be not 22 trusted. 23 (B) Representatives of public interest orga-24 nizations or academic institutions, except public 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00090 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 91 •HR 1768 IH interest organizations or academic institutions 1 that are determined by the Chair to be not 2 trusted. 3 (C) Representatives of the Federal Govern-4 ment, State governments, local governments, or 5 Tribal Governments, with at least one member 6 representing each such type of government. 7 (c) REPORT.— 8 (1) I N GENERAL .—Not later than 1 year after 9 the date on which the Task Force is established 10 under subsection (a), the Task Force shall publish 11 in the Federal Register and on the website of the 12 Commission, and submit to the Committee on En-13 ergy and Commerce of the House of Representatives 14 and the Committee on Commerce, Science, and 15 Transportation of the Senate, a report on sixth-gen-16 eration wireless technology, including— 17 (A) the status of industry-led standards- 18 setting bodies in setting standards for such 19 technology; 20 (B) possible uses of such technology identi-21 fied by industry-led standards-setting bodies 22 that are setting standards for such technology; 23 (C) any limitations of such technology (in-24 cluding any supply chain or cybersecurity limi-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00091 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 92 •HR 1768 IH tations) identified by industry-led standards-set-1 ting bodies that are setting standards for such 2 technology; 3 (D) workforce needs to build, maintain, 4 and utilize 6G and advanced wireless commu-5 nications technologies and networks, and strate-6 gies to conduct the necessary workforce train-7 ing; 8 (E) possible uses of emerging technologies 9 and Open RAN networks to bolster 6G and ad-10 vanced wireless networks; and 11 (F) how to best work with entities across 12 the Federal Government, State governments, 13 local governments, and Tribal Governments to 14 leverage such technology, including with regard 15 to siting, deployment, and adoption. 16 (2) D RAFT REPORT ; PUBLIC COMMENT .—The 17 Task Force shall— 18 (A) not later than 180 days after the date 19 on which the Task Force is established under 20 subsection (a), publish in the Federal Register 21 and on the website of the Commission a draft 22 of the report required by paragraph (1); and 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00092 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 93 •HR 1768 IH (B) accept public comments on such draft 1 and take such comments into consideration in 2 preparing the final version of such report. 3 (d) DEFINITIONS.—In this section: 4 (1) C HAIR.—The term ‘‘Chair’’ means the 5 Chair of the Commission. 6 (2) C OMMISSION.—The term ‘‘Commission’’ 7 means the Federal Communications Commission. 8 (3) NOT TRUSTED .— 9 (A) IN GENERAL .—The term ‘‘not trusted’’ 10 means, with respect to an entity, that— 11 (i) the Chair has made a public deter-12 mination that such entity is owned by, con-13 trolled by, or subject to the influence of a 14 foreign adversary; or 15 (ii) the Chair otherwise determines 16 that such entity poses a threat to the na-17 tional security of the United States. 18 (B) C RITERIA FOR DETERMINATION .—In 19 making a determination under subparagraph 20 (A)(ii), the Chair shall use the criteria de-21 scribed in paragraphs (1) through (4) of section 22 2(c) of the Secure and Trusted Communica-23 tions Networks Act of 2019 (47 U.S.C. 24 1601(c)), as appropriate. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00093 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 94 •HR 1768 IH (4) S TATE.—The term ‘‘State’’ has the mean-1 ing given such term in section 3 of the Communica-2 tions Act of 1934 (47 U.S.C. 153). 3 (5) T ASK FORCE .—The term ‘‘Task Force’’ 4 means the 6G Task Force established under sub-5 section (a). 6 SEC. 603. TERMINATION OF TASK FORCE. 7 The Task Force shall be terminated 30 days after 8 the date on which the Task Force submits the report re-9 quired under section 602(c). 10 TITLE VII—SECURE SPACE ACT 11 SEC. 701. SHORT TITLE. 12 This title may be cited as the ‘‘Secure Space Act’’. 13 SEC. 702. PROHIBITION ON GRANT OF CERTAIN SATELLITE 14 LICENSES, UNITED STATES MARKET ACCESS, 15 OR EARTH STATION AUTHORIZATIONS. 16 (a) IN GENERAL.—The Secure and Trusted Commu-17 nications Networks Act of 2019 (47 U.S.C. 1601 et seq.) 18 is amended— 19 (1) by redesignating sections 10 and 11 as sec-20 tions 11 and 12, respectively; and 21 (2) by inserting after section 9 the following: 22 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00094 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 95 •HR 1768 IH ‘‘SEC. 10. PROHIBITION ON GRANT OF CERTAIN SATELLITE 1 LICENSES, UNITED STATES MARKET ACCESS, 2 OR EARTH STATION AUTHORIZATIONS. 3 ‘‘(a) IN GENERAL.—The Commission may not grant 4 a license for, or a petition for a declaratory ruling to ac-5 cess the United States market using, a geostationary orbit 6 satellite system or a nongeostationary orbit satellite sys-7 tem, or an authorization to use an individually licensed 8 earth station or a blanket-licensed earth station, if such 9 license, grant of market access, or authorization would be 10 held or controlled by— 11 ‘‘(1) an entity that produces or provides any 12 covered communications equipment or service; or 13 ‘‘(2) an affiliate (as defined in section 3 of the 14 Communications Act of 1934 (47 U.S.C. 153)) of an 15 entity described in paragraph (1). 16 ‘‘(b) DEFINITIONS.—In this section: 17 ‘‘(1) B LANKET-LICENSED EARTH STATION .— 18 The term ‘blanket-licensed earth station’ means an 19 earth station that is licensed with a geostationary 20 orbit satellite system or a nongeostationary orbit 21 satellite system. 22 ‘‘(2) G ATEWAY STATION .—The term ‘gateway 23 station’ means an earth station or a group of earth 24 stations that— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00095 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 96 •HR 1768 IH ‘‘(A) supports the routing and switching 1 functions of a geostationary orbit satellite sys-2 tem or a nongeostationary orbit satellite sys-3 tem; 4 ‘‘(B) may also be used for telemetry, track-5 ing, and command transmissions; 6 ‘‘(C) does not originate or terminate com-7 munication traffic; and 8 ‘‘(D) is not for the exclusive use of any 9 customer. 10 ‘‘(3) I NDIVIDUALLY LICENSED EARTH STA -11 TION.—The term ‘individually licensed earth station’ 12 means— 13 ‘‘(A) an earth station (other than a blan-14 ket-licensed earth station) that sends a signal 15 to, and receives a signal from, a geostationary 16 orbit satellite system or a nongeostationary 17 orbit satellite system; or 18 ‘‘(B) a gateway station.’’. 19 (b) A PPLICABILITY.—Section 10 of the Secure and 20 Trusted Communications Networks Act of 2019, as added 21 by subsection (a), shall apply with respect to the grant 22 of a license, petition, or authorization on or after the date 23 of the enactment of this Act. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00096 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 97 •HR 1768 IH (c) RULES.—Not later than 1 year after the date of 1 the enactment of this Act, the Federal Communications 2 Commission shall issue rules to implement section 10 of 3 the Secure and Trusted Communications Networks Act of 4 2019, as added by subsection (a). 5 TITLE VIII—TAKE IT DOWN ACT 6 SEC. 801. SHORT TITLE. 7 This title may be cited as the ‘‘Tools to Address 8 Known Exploitation by Immobilizing Technological 9 Deepfakes on Websites and Networks Act’’ or the ‘‘TAKE 10 IT DOWN Act’’. 11 SEC. 802. CRIMINAL PROHIBITION ON INTENTIONAL DIS-12 CLOSURE OF NONCONSENSUAL INTIMATE 13 VISUAL DEPICTIONS. 14 (a) I N GENERAL.—Section 223 of the Communica-15 tions Act of 1934 (47 U.S.C. 223) is amended— 16 (1) by redesignating subsection (h) as sub-17 section (i); and 18 (2) by inserting after subsection (g) the fol-19 lowing: 20 ‘‘(h) I NTENTIONAL DISCLOSURE OF NONCONSEN-21 SUAL INTIMATE VISUAL DEPICTIONS.— 22 ‘‘(1) DEFINITIONS.—In this subsection: 23 ‘‘(A) C ONSENT.—The term ‘consent’ 24 means an affirmative, conscious, and voluntary 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00097 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 98 •HR 1768 IH authorization made by an individual free from 1 force, fraud, duress, misrepresentation, or coer-2 cion. 3 ‘‘(B) D IGITAL FORGERY .—The term ‘dig-4 ital forgery’ means any intimate visual depic-5 tion of an identifiable individual created 6 through the use of software, machine learning, 7 artificial intelligence, or any other computer- 8 generated or technological means, including by 9 adapting, modifying, manipulating, or altering 10 an authentic visual depiction, that, when viewed 11 as a whole by a reasonable person, is indistin-12 guishable from an authentic visual depiction of 13 the individual. 14 ‘‘(C) I DENTIFIABLE INDIVIDUAL .—The 15 term ‘identifiable individual’ means an indi-16 vidual— 17 ‘‘(i) who appears in whole or in part 18 in an intimate visual depiction; and 19 ‘‘(ii) whose face, likeness, or other dis-20 tinguishing characteristic (including a 21 unique birthmark or other recognizable 22 feature) is displayed in connection with 23 such intimate visual depiction. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00098 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 99 •HR 1768 IH ‘‘(D) I NTERACTIVE COMPUTER SERVICE .— 1 The term ‘interactive computer service’ has the 2 meaning given the term in section 230. 3 ‘‘(E) I NTIMATE VISUAL DEPICTION .—The 4 term ‘intimate visual depiction’ has the mean-5 ing given such term in section 1309 of the Con-6 solidated Appropriations Act, 2022 (15 U.S.C. 7 6851). 8 ‘‘(F) M INOR.—The term ‘minor’ means 9 any individual under the age of 18 years. 10 ‘‘(2) O FFENSE INVOLVING AUTHENTIC INTI -11 MATE VISUAL DEPICTIONS .— 12 ‘‘(A) I NVOLVING ADULTS .—Except as pro-13 vided in subparagraph (C), it shall be unlawful 14 for any person, in interstate or foreign com-15 merce, to use an interactive computer service to 16 knowingly publish an intimate visual depiction 17 of an identifiable individual who is not a minor 18 if— 19 ‘‘(i) the intimate visual depiction was 20 obtained or created under circumstances in 21 which the person knew or reasonably 22 should have known the identifiable indi-23 vidual had a reasonable expectation of pri-24 vacy; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00099 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 100 •HR 1768 IH ‘‘(ii) what is depicted was not volun-1 tarily exposed by the identifiable individual 2 in a public or commercial setting; 3 ‘‘(iii) what is depicted is not a matter 4 of public concern; and 5 ‘‘(iv) publication of the intimate visual 6 depiction— 7 ‘‘(I) is intended to cause harm; 8 or 9 ‘‘(II) causes harm, including psy-10 chological, financial, or reputational 11 harm, to the identifiable individual. 12 ‘‘(B) I NVOLVING MINORS .—Except as pro-13 vided in subparagraph (C), it shall be unlawful 14 for any person, in interstate or foreign com-15 merce, to use an interactive computer service to 16 knowingly publish an intimate visual depiction 17 of an identifiable individual who is a minor with 18 intent to— 19 ‘‘(i) abuse, humiliate, harass, or de-20 grade the minor; or 21 ‘‘(ii) arouse or gratify the sexual de-22 sire of any person. 23 ‘‘(C) E XCEPTIONS.—Subparagraphs (A) 24 and (B) shall not apply to— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00100 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 101 •HR 1768 IH ‘‘(i) a lawfully authorized investiga-1 tive, protective, or intelligence activity of— 2 ‘‘(I) a law enforcement agency of 3 the United States, a State, or a polit-4 ical subdivision of a State; or 5 ‘‘(II) an intelligence agency of 6 the United States; 7 ‘‘(ii) a disclosure made reasonably and 8 in good faith— 9 ‘‘(I) to a law enforcement officer 10 or agency; 11 ‘‘(II) as part of a document pro-12 duction or filing associated with a 13 legal proceeding; 14 ‘‘(III) as part of medical edu-15 cation, diagnosis, or treatment or for 16 a legitimate medical, scientific, or 17 education purpose; 18 ‘‘(IV) in the reporting of unlaw-19 ful content or unsolicited or unwel-20 come conduct or in pursuance of a 21 legal, professional, or other lawful ob-22 ligation; or 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00101 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 102 •HR 1768 IH ‘‘(V) to seek support or help with 1 respect to the receipt of an unsolicited 2 intimate visual depiction; 3 ‘‘(iii) a disclosure reasonably intended 4 to assist the identifiable individual; or 5 ‘‘(iv) a person who possesses or pub-6 lishes an intimate visual depiction of him-7 self or herself engaged in nudity or sexu-8 ally explicit conduct (as that term is de-9 fined in section 2256(2)(A) of title 18, 10 United States Code). 11 ‘‘(3) O FFENSE INVOLVING DIGITAL FOR -12 GERIES.— 13 ‘‘(A) I NVOLVING ADULTS .—Except as pro-14 vided in subparagraph (C), it shall be unlawful 15 for any person, in interstate or foreign com-16 merce, to use an interactive computer service to 17 knowingly publish a digital forgery of an identi-18 fiable individual who is not a minor if— 19 ‘‘(i) the digital forgery was published 20 without the consent of the identifiable indi-21 vidual; 22 ‘‘(ii) what is depicted was not volun-23 tarily exposed by the identifiable individual 24 in a public or commercial setting; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00102 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 103 •HR 1768 IH ‘‘(iii) what is depicted is not a matter 1 of public concern; and 2 ‘‘(iv) publication of the digital for-3 gery— 4 ‘‘(I) is intended to cause harm; 5 or 6 ‘‘(II) causes harm, including psy-7 chological, financial, or reputational 8 harm, to the identifiable individual. 9 ‘‘(B) I NVOLVING MINORS .—Except as pro-10 vided in subparagraph (C), it shall be unlawful 11 for any person, in interstate or foreign com-12 merce, to use an interactive computer service to 13 knowingly publish a digital forgery of an identi-14 fiable individual who is a minor with intent 15 to— 16 ‘‘(i) abuse, humiliate, harass, or de-17 grade the minor; or 18 ‘‘(ii) arouse or gratify the sexual de-19 sire of any person. 20 ‘‘(C) E XCEPTIONS.—Subparagraphs (A) 21 and (B) shall not apply to— 22 ‘‘(i) a lawfully authorized investiga-23 tive, protective, or intelligence activity of— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00103 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 104 •HR 1768 IH ‘‘(I) a law enforcement agency of 1 the United States, a State, or a polit-2 ical subdivision of a State; or 3 ‘‘(II) an intelligence agency of 4 the United States; 5 ‘‘(ii) a disclosure made reasonably and 6 in good faith— 7 ‘‘(I) to a law enforcement officer 8 or agency; 9 ‘‘(II) as part of a document pro-10 duction or filing associated with a 11 legal proceeding; 12 ‘‘(III) as part of medical edu-13 cation, diagnosis, or treatment or for 14 a legitimate medical, scientific, or 15 education purpose; 16 ‘‘(IV) in the reporting of unlaw-17 ful content or unsolicited or unwel-18 come conduct or in pursuance of a 19 legal, professional, or other lawful ob-20 ligation; or 21 ‘‘(V) to seek support or help with 22 respect to the receipt of an unsolicited 23 intimate visual depiction; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00104 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 105 •HR 1768 IH ‘‘(iii) a disclosure reasonably intended 1 to assist the identifiable individual; or 2 ‘‘(iv) a person who possesses or pub-3 lishes a digital forgery of himself or herself 4 engaged in nudity or sexually explicit con-5 duct (as that term is defined in section 6 2256(2)(A) of title 18, United States 7 Code). 8 ‘‘(4) PENALTIES.— 9 ‘‘(A) OFFENSES INVOLVING ADULTS .—Any 10 person who violates paragraph (2)(A) or (3)(A) 11 shall be fined under title 18, United States 12 Code, imprisoned not more than 2 years, or 13 both. 14 ‘‘(B) OFFENSES INVOLVING MINORS .—Any 15 person who violates paragraph (2)(B) or (3)(B) 16 shall be fined under title 18, United States 17 Code, imprisoned not more than 3 years, or 18 both. 19 ‘‘(5) R ULES OF CONSTRUCTION .—For purposes 20 of paragraphs (2) and (3)— 21 ‘‘(A) the fact that the identifiable indi-22 vidual provided consent for the creation of the 23 intimate visual depiction shall not establish that 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00105 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 106 •HR 1768 IH the individual provided consent for the publica-1 tion of the intimate visual depiction; and 2 ‘‘(B) the fact that the identifiable indi-3 vidual disclosed the intimate visual depiction to 4 another individual shall not establish that the 5 identifiable individual provided consent for the 6 publication of the intimate visual depiction by 7 the person alleged to have violated paragraph 8 (2) or (3), respectively. 9 ‘‘(6) THREATS.— 10 ‘‘(A) T HREATS INVOLVING AUTHENTIC IN -11 TIMATE VISUAL DEPICTIONS .—Any person who 12 intentionally threatens to commit an offense 13 under paragraph (2) for the purpose of intimi-14 dation, coercion, extortion, or to create mental 15 distress shall be punished as provided in para-16 graph (4). 17 ‘‘(B) T HREATS INVOLVING DIGITAL FOR -18 GERIES.— 19 ‘‘(i) T HREATS INVOLVING ADULTS .— 20 Any person who intentionally threatens to 21 commit an offense under paragraph (3)(A) 22 for the purpose of intimidation, coercion, 23 extortion, or to create mental distress shall 24 be fined under title 18, United States 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00106 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 107 •HR 1768 IH Code, imprisoned not more than 18 1 months, or both. 2 ‘‘(ii) T HREATS INVOLVING MINORS .— 3 Any person who intentionally threatens to 4 commit an offense under paragraph (3)(B) 5 for the purpose of intimidation, coercion, 6 extortion, or to create mental distress shall 7 be fined under title 18, United States 8 Code, imprisoned not more than 30 9 months, or both. 10 ‘‘(7) FORFEITURE.— 11 ‘‘(A) I N GENERAL .—The court, in impos-12 ing a sentence on any person convicted of a vio-13 lation of paragraph (2) or (3), shall order, in 14 addition to any other sentence imposed and ir-15 respective of any provision of State law, that 16 the person forfeit to the United States— 17 ‘‘(i) any material distributed in viola-18 tion of that paragraph; 19 ‘‘(ii) the person’s interest in property, 20 real or personal, constituting or derived 21 from any gross proceeds of the violation, or 22 any property traceable to such property, 23 obtained or retained directly or indirectly 24 as a result of the violation; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00107 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 108 •HR 1768 IH ‘‘(iii) any personal property of the 1 person used, or intended to be used, in any 2 manner or part, to commit or to facilitate 3 the commission of the violation. 4 ‘‘(B) P ROCEDURES.—Section 413 of the 5 Controlled Substances Act (21 U.S.C. 853), 6 with the exception of subsections (a) and (d), 7 shall apply to the criminal forfeiture of property 8 under subparagraph (A). 9 ‘‘(8) R ESTITUTION.—The court shall order res-10 titution for an offense under paragraph (2) or (3) in 11 the same manner as under section 2264 of title 18, 12 United States Code. 13 ‘‘(9) R ULE OF CONSTRUCTION .—Nothing in 14 this subsection shall be construed to limit the appli-15 cation of any other relevant law, including section 16 2252 of title 18, United States Code.’’. 17 (b) D EFENSES.—Section 223(e)(1) of the Commu-18 nications Act of 1934 (47 U.S.C. 223(e)(1)) is amended 19 by striking ‘‘or (d)’’ and inserting ‘‘, (d), or (h)’’. 20 (c) T ECHNICAL AND CONFORMING AMENDMENT.— 21 Subsection (i) of section 223 of the Communications Act 22 of 1934 (47 U.S.C. 223), as so redesignated by subsection 23 (a), is amended by inserting ‘‘D EFINITIONS.—’’ before 24 ‘‘For purposes of this section’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00108 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 109 •HR 1768 IH SEC. 803. NOTICE AND REMOVAL OF NONCONSENSUAL IN-1 TIMATE VISUAL DEPICTIONS. 2 (a) IN GENERAL.— 3 (1) NOTICE AND REMOVAL PROCESS .— 4 (A) E STABLISHMENT.—Not later than 1 5 year after the date of enactment of this Act, a 6 covered platform shall establish a process 7 whereby an identifiable individual (or an au-8 thorized person acting on behalf of such indi-9 vidual) may— 10 (i) notify the covered platform of an 11 intimate visual depiction published on the 12 covered platform that— 13 (I) includes a depiction of the 14 identifiable individual; and 15 (II) was published without the 16 consent of the identifiable individual; 17 and 18 (ii) submit a request for the covered 19 platform to remove such intimate visual 20 depiction. 21 (B) R EQUIREMENTS.—A notification and 22 request for removal of an intimate visual depic-23 tion submitted under the process established 24 under subparagraph (A) shall include, in writ-25 ing— 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00109 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 110 •HR 1768 IH (i) a physical or electronic signature 1 of the identifiable individual (or an author-2 ized person acting on behalf of such indi-3 vidual); 4 (ii) an identification of, and informa-5 tion reasonably sufficient for the covered 6 platform to locate, the intimate visual de-7 piction of the identifiable individual; 8 (iii) a brief statement that the identi-9 fiable individual has a good faith belief 10 that any intimate visual depiction identi-11 fied under clause (ii) is not consensual, in-12 cluding any relevant information for the 13 covered platform to determine the intimate 14 visual depiction was published without the 15 consent of the identifiable individual; and 16 (iv) information sufficient to enable 17 the covered platform to contact the identi-18 fiable individual (or an authorized person 19 acting on behalf of such individual). 20 (2) N OTICE OF PROCESS .—A covered platform 21 shall provide on the platform a clear and con-22 spicuous notice, which may be provided through a 23 clear and conspicuous link to another web page or 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00110 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 111 •HR 1768 IH disclosure, of the notice and removal process estab-1 lished under paragraph (1)(A) that— 2 (A) is easy to read and in plain language; 3 and 4 (B) provides information regarding the re-5 sponsibilities of the covered platform under this 6 section, including a description of how an indi-7 vidual can submit a notification and request for 8 removal. 9 (3) R EMOVAL OF NONCONSENSUAL INTIMATE 10 VISUAL DEPICTIONS .—Upon receiving a valid re-11 moval request from an identifiable individual (or an 12 authorized person acting on behalf of such indi-13 vidual) using the process described in paragraph 14 (1)(A)(ii), a covered platform shall, as soon as pos-15 sible, but not later than 48 hours after receiving 16 such request— 17 (A) remove the intimate visual depiction; 18 and 19 (B) make reasonable efforts to identify and 20 remove any known identical copies of such de-21 piction. 22 (4) LIMITATION ON LIABILITY .—A covered plat-23 form shall not be liable for any claim based on the 24 covered platform’s good faith disabling of access to, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00111 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 112 •HR 1768 IH or removal of, material claimed to be a nonconsen-1 sual intimate visual depiction based on facts or cir-2 cumstances from which the unlawful publishing of 3 an intimate visual depiction is apparent, regardless 4 of whether the intimate visual depiction is ultimately 5 determined to be unlawful or not. 6 (b) ENFORCEMENT BY THE COMMISSION.— 7 (1) U NFAIR OR DECEPTIVE ACTS OR PRAC -8 TICES.—A failure to reasonably comply with the no-9 tice and takedown obligations under subsection (a) 10 shall be treated as a violation of a rule defining an 11 unfair or a deceptive act or practice under section 12 18(a)(1)(B) of the Federal Trade Commission Act 13 (15 U.S.C. 57a(a)(1)(B)). 14 (2) POWERS OF THE COMMISSION .— 15 (A) I N GENERAL .—Except as provided in 16 subparagraph (D), the Commission shall en-17 force this section in the same manner, by the 18 same means, and with the same jurisdiction, 19 powers, and duties as though all applicable 20 terms and provisions of the Federal Trade 21 Commission Act (15 U.S.C. 41 et seq.) were in-22 corporated into and made a part of this section. 23 (B) P RIVILEGES AND IMMUNITIES .—Any 24 person who violates this section shall be subject 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00112 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 113 •HR 1768 IH to the penalties and entitled to the privileges 1 and immunities provided in the Federal Trade 2 Commission Act (15 U.S.C. 41 et seq.). 3 (C) A UTHORITY PRESERVED .—Nothing in 4 this title shall be construed to limit the author-5 ity of the Federal Trade Commission under any 6 other provision of law. 7 (D) S COPE OF JURISDICTION .—Notwith-8 standing sections 4, 5(a)(2), or 6 of the Federal 9 Trade Commission Act (15 U.S.C. 44; 45(a)(2); 10 46), or any jurisdictional limitation of the Com-11 mission, the Commission shall also enforce this 12 section in the same manner provided in sub-13 paragraph (A), with respect to organizations 14 that are not organized to carry on business for 15 their own profit or that of their members. 16 SEC. 804. DEFINITIONS. 17 In this title: 18 (1) C OMMISSION.—The term ‘‘Commission’’ 19 means the Federal Trade Commission. 20 (2) C ONSENT; DIGITAL FORGERY ; IDENTIFI-21 ABLE INDIVIDUAL ; INTIMATE VISUAL DEPICTION .— 22 The terms ‘‘consent’’, ‘‘digital forgery’’, ‘‘identifiable 23 individual’’, ‘‘intimate visual depiction’’, and 24 ‘‘minor’’ have the meaning given such terms in sec-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00113 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 114 •HR 1768 IH tion 223(h) of the Communications Act of 1934 (47 1 U.S.C. 223(h)), as added by section 802. 2 (3) COVERED PLATFORM .— 3 (A) I N GENERAL .—The term ‘‘covered 4 platform’’ means a website, online service, on-5 line application, or mobile application— 6 (i) that serves the public; and 7 (ii)(I) that primarily provides a forum 8 for user-generated content, including mes-9 sages, videos, images, games, and audio 10 files; or 11 (II) for which it is in the regular 12 course of trade or business of the website, 13 online service, online application, or mobile 14 application to publish, curate, host, or 15 make available content of nonconsensual 16 intimate visual depictions. 17 (B) E XCLUSIONS.—The term ‘‘covered 18 platform’’ shall not include the following: 19 (i) A provider of broadband internet 20 access service (as described in section 21 8.1(b) of title 47, Code of Federal Regula-22 tions, or successor regulation). 23 (ii) Electronic mail. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00114 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 115 •HR 1768 IH (iii) Except as provided in subpara-1 graph (A)(ii)(II), an online service, appli-2 cation, or website— 3 (I) that consists primarily of con-4 tent that is not user generated but is 5 preselected by the provider of such on-6 line service, application, or website; 7 and 8 (II) for which any chat, com-9 ment, or interactive functionality is 10 incidental to, directly related to, or 11 dependent on the provision of the con-12 tent described in subparagraph 13 (A)(ii)(I). 14 SEC. 805. SEVERABILITY. 15 If any provision of this title, or an amendment made 16 by this title, is determined to be unenforceable or invalid, 17 the remaining provisions of this title and the amendments 18 made by this title shall not be affected. 19 TITLE IX—RURAL BROADBAND 20 PROTECTION ACT 21 SEC. 901. SHORT TITLE. 22 This title may be cited as the ‘‘Rural Broadband Pro-23 tection Act’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00115 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 116 •HR 1768 IH SEC. 902. VETTING PROCESS FOR PROSPECTIVE HIGH-COST 1 UNIVERSAL SERVICE FUND APPLICANTS. 2 Section 254 of the Communications Act of 1934 (47 3 U.S.C. 254) is amended by adding at the end the fol-4 lowing: 5 ‘‘(m) VETTING OF HIGH-COST FUND RECIPIENTS.— 6 ‘‘(1) DEFINITIONS.—In this subsection— 7 ‘‘(A) the term ‘covered funding’ means any 8 new offer of high-cost universal service program 9 funding, including funding provided through a 10 reverse competitive bidding mechanism provided 11 under this section, for the deployment of a 12 broadband-capable network and the provision of 13 supported services over the network; and 14 ‘‘(B) the term ‘new covered funding award’ 15 means an award of covered funding that is 16 made based on an application submitted to the 17 Commission on or after the date on which rules 18 are promulgated under paragraph (2). 19 ‘‘(2) C OMMISSION RULEMAKING .—Not later 20 than 180 days after the date of enactment of this 21 subsection, the Commission shall initiate a rule-22 making proceeding to establish a vetting process for 23 applicants for, and other recipients of, a new covered 24 funding award. 25 ‘‘(3) CONTENTS.— 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00116 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 117 •HR 1768 IH ‘‘(A) I N GENERAL .—In promulgating rules 1 under paragraph (2), the Commission shall pro-2 vide that, consistent with principles of tech-3 nology neutrality, the Commission will only 4 award covered funding to applicants that can 5 demonstrate that they meet the qualifications in 6 subparagraph (B). 7 ‘‘(B) Q UALIFICATIONS DESCRIBED .—An 8 applicant for a new covered funding award shall 9 include in the initial application a proposal con-10 taining sufficient detail and documentation for 11 the Commission to ascertain that the applicant 12 possesses the technical, financial, and oper-13 ational capabilities, and has a reasonable busi-14 ness plan, to deploy the proposed network and 15 deliver services with the relevant performance 16 characteristics and requirements defined by the 17 Commission and as pledged by the applicant. 18 ‘‘(C) E VALUATION OF PROPOSAL .—The 19 Commission shall evaluate a proposal described 20 in subparagraph (B) against— 21 ‘‘(i) reasonable and well-established 22 technical, financial, and operational stand-23 ards, including the technical standards 24 adopted by the Commission in orders of 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00117 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 118 •HR 1768 IH the Commission relating to Establishing 1 the Digital Opportunity Data Collection 2 (WC Docket No. 19–195) (or orders of the 3 Commission relating to modernizing any 4 successor collection) for purposes of enti-5 ties that must report broadband avail-6 ability coverage; and 7 ‘‘(ii) the applicant’s history of com-8 plying with requirements in Commission 9 and other government broadband deploy-10 ment funding programs. 11 ‘‘(D) PENALTIES FOR PRE -AUTHORIZATION 12 DEFAULTS.—In adopting rules for any new cov-13 ered funding award, the Commission shall set a 14 penalty for pre-authorization defaults of at least 15 $9,000 per violation and may not limit the base 16 forfeiture to an amount less than 30 percent of 17 the applicant’s total support, unless the Com-18 mission demonstrates the need for lower pen-19 alties in a particular instance.’’. 20 TITLE X—AMERICAN MUSIC 21 TOURISM 22 SEC. 1001. SHORT TITLE. 23 This title may be cited as the ‘‘American Music Tour-24 ism Act’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00118 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 119 •HR 1768 IH SEC. 1002. RESPONSIBILITIES OF THE ASSISTANT SEC-1 RETARY OF COMMERCE FOR TRAVEL AND 2 TOURISM. 3 (a) D OMESTIC TRAVEL AND TOURISM.—Section 4 605(b) of the Visit America Act (15 U.S.C. 9803(b)) is 5 amended— 6 (1) in paragraph (2), by striking ‘‘; and’’ and 7 inserting a semicolon; 8 (2) in paragraph (3), by striking the period at 9 the end and inserting ‘‘; and’’; and 10 (3) by adding at the end the following: 11 ‘‘(4) identify locations and events in the United 12 States that are important to music tourism and fa-13 cilitate and promote domestic travel and tourism to 14 those locations and events.’’. 15 (b) F ACILITATION OF INTERNATIONAL BUSINESS 16 AND LEISURE TRAVEL.—Section 605 of the Visit America 17 Act (15 U.S.C. 9803) is amended by striking subsection 18 (d) and inserting the following: 19 ‘‘(d) F ACILITATION OF INTERNATIONAL BUSINESS 20 AND LEISURE TRAVEL.—The Assistant Secretary, in co-21 ordination with relevant Federal agencies, shall strive to 22 increase and facilitate international business and leisure 23 travel to the United States and ensure competitiveness 24 by— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00119 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 120 •HR 1768 IH ‘‘(1) facilitating large meetings, incentives, con-1 ferences, and exhibitions in the United States; 2 ‘‘(2) emphasizing rural and other destinations 3 in the United States that are rich in cultural herit-4 age or ecological tourism, among other uniquely 5 American destinations, as locations for hosting inter-6 national meetings, incentives, conferences, and exhi-7 bitions; 8 ‘‘(3) facilitating and promoting international 9 travel and tourism to sports and recreation events 10 and activities in the United States; and 11 ‘‘(4) identifying locations and events in the 12 United States that are important to music tourism 13 and facilitating and promoting international travel 14 and tourism to those locations and events.’’. 15 (c) R EPORTING REQUIREMENTS.—Section 605(f) of 16 the Visit America Act (15 U.S.C. 9803(f)) is amended by 17 adding at the end the following: 18 ‘‘(4) R EPORT ON GOALS RELATING TO DOMES -19 TIC AND INTERNATIONAL TRAVEL .—Not later than 20 1 year after the date of enactment of the American 21 Music Tourism Act, and every 2 years thereafter, 22 the Assistant Secretary shall submit to the Sub-23 committee on Tourism, Trade, and Export Pro-24 motion of the Committee on Commerce, Science, and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00120 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 121 •HR 1768 IH Transportation of the Senate and the Subcommittee 1 on Innovation, Data, and Commerce of the Com-2 mittee on Energy and Commerce of the House of 3 Representatives a report of activities, findings, 4 achievements, and vulnerabilities relating to the 5 goals described in subsections (a) through (d).’’. 6 (d) DEFINITION.—Section 600 of title VI of division 7 BB of the Consolidated Appropriations Act, 2023 (15 8 U.S.C. 9801) is amended— 9 (1) by redesignating paragraphs (1) and (2) as 10 subparagraphs (A) and (B), respectively, and adjust-11 ing the margins accordingly; and 12 (2) by striking ‘‘In this title, the term ‘COVID– 13 19 public health emergency’—’’ and inserting the 14 following: 15 ‘‘In this title: 16 ‘‘(1) COVID–19 PUBLIC HEALTH EMER -17 GENCY.—The term ‘COVID–19 public health emer-18 gency’—’’; and 19 (3) by adding at the end the following: 20 ‘‘(2) M USIC TOURISM .—The term ‘music tour-21 ism’ means— 22 ‘‘(A) the act of traveling to a State or lo-23 cality to visit historic or modern day music-re-24 lated attractions, including museums, studios, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00121 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 122 •HR 1768 IH venues of all sizes, and other sites related to 1 music; or 2 ‘‘(B) the act of traveling to a State or lo-3 cality to attend a music festival, a concert, or 4 other live musical performance or music-related 5 special event.’’. 6 TITLE XI—INFORMING CON-7 SUMERS ABOUT SMART DE-8 VICES 9 SEC. 1101. SHORT TITLE. 10 This title may be cited as the ‘‘Informing Consumers 11 about Smart Devices Act’’. 12 SEC. 1102. REQUIRED DISCLOSURE OF A CAMERA OR RE-13 CORDING CAPABILITY IN CERTAIN INTER-14 NET-CONNECTED DEVICES. 15 Each manufacturer of a covered device shall disclose, 16 clearly and conspicuously and prior to purchase, whether 17 the covered device manufactured by the manufacturer con-18 tains a camera or microphone as a component of the cov-19 ered device. 20 SEC. 1103. ENFORCEMENT BY THE FEDERAL TRADE COM-21 MISSION. 22 (a) U NFAIR OR DECEPTIVE ACTS OR PRACTICES.— 23 A violation of section 1102 shall be treated as a violation 24 of a rule defining an unfair or deceptive act or practice 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00122 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 123 •HR 1768 IH prescribed under section 18(a)(1)(B) of the Federal Trade 1 Commission Act (15 U.S.C. 57a(a)(1)(B)). 2 (b) ACTIONS BY THE COMMISSION.— 3 (1) IN GENERAL .—The Federal Trade Commis-4 sion (in this title referred to as the ‘‘Commission’’) 5 shall enforce this title in the same manner, by the 6 same means, and with the same jurisdiction, powers, 7 and duties as though all applicable terms and provi-8 sions of the Federal Trade Commission Act (15 9 U.S.C. 41 et seq.) were incorporated into and made 10 a part of this title. 11 (2) P ENALTIES AND PRIVILEGES .—Any person 12 who violates this title or a regulation promulgated 13 under this title shall be subject to the penalties and 14 entitled to the privileges and immunities provided in 15 the Federal Trade Commission Act (15 U.S.C. 41 et 16 seq.). 17 (3) S AVINGS CLAUSE .—Nothing in this title 18 shall be construed to limit the authority of the Com-19 mission under any other provision of law. 20 (c) C OMMISSION GUIDANCE.—Not later than 180 21 days after the date of enactment of this title, the Commis-22 sion, through outreach to relevant private entities, shall 23 issue guidance to assist manufacturers in complying with 24 the requirements of this title, including guidance about 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00123 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 124 •HR 1768 IH best practices for making the disclosure required by sec-1 tion 1102 as clear and conspicuous and age appropriate 2 as practicable and about best practices for the use of a 3 pictorial (as defined in section 2(a) of the Consumer Re-4 view Fairness Act of 2016 (15 U.S.C. 45b(a))) visual rep-5 resentation of the information to be disclosed. 6 (d) TAILORED GUIDANCE.—A manufacturer of a cov-7 ered device may petition the Commission for tailored guid-8 ance as to how to meet the requirements of section 1102 9 consistent with existing rules of practice or any successor 10 rules. 11 (e) L IMITATION ON COMMISSION GUIDANCE.—No 12 guidance issued by the Commission with respect to this 13 title shall confer any rights on any person, State, or local-14 ity, nor shall operate to bind the Commission or any per-15 son to the approach recommended in such guidance. In 16 any enforcement action brought pursuant to this title, the 17 Commission shall allege a specific violation of a provision 18 of this title. The Commission may not base an enforce-19 ment action on, or execute a consent order based on, prac-20 tices that are alleged to be inconsistent with any such 21 guidelines, unless the practices allegedly violate section 22 1102. 23 SEC. 1104. DEFINITION OF COVERED DEVICE. 24 As used in this title, the term ‘‘covered device’’— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00124 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 125 •HR 1768 IH (1) means a consumer product, as defined by 1 section 3(a) of the Consumer Product Safety Act 2 (15 U.S.C. 2052(a)) that is capable of connecting to 3 the internet, a component of which is a camera or 4 microphone; and 5 (2) does not include— 6 (A) a telephone (including a mobile phone), 7 a laptop, tablet, or any device that a consumer 8 would reasonably expect to have a microphone 9 or camera; 10 (B) any device that is specifically marketed 11 as a camera, telecommunications device, or 12 microphone; or 13 (C) any device or apparatus described in 14 sections 255, 716, and 718, and subsections 15 (aa) and (bb) of section 303 of the Communica-16 tions Act of 1934 (47 U.S.C. 255; 617; 619; 17 and 303(aa) and (bb)), and any regulations 18 promulgated thereunder. 19 SEC. 1105. EFFECTIVE DATE. 20 This title shall apply to all covered devices manufac-21 tured after the date that is 180 days after the date on 22 which guidance is issued by the Commission under section 23 1103(c), and shall not apply to covered devices manufac-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00125 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 126 •HR 1768 IH tured or sold before such date, or otherwise introduced 1 into interstate commerce before such date. 2 TITLE XII—SECURING SEMICON-3 DUCTOR SUPPLY CHAINS ACT 4 SEC. 1201. SHORT TITLE. 5 This title may be cited as the ‘‘Securing Semicon-6 ductor Supply Chains Act’’. 7 SEC. 1202. SELECTUSA DEFINED. 8 In this title, the term ‘‘SelectUSA’’ means the 9 SelectUSA program of the Department of Commerce es-10 tablished by Executive Order 13577 (76 Fed. Reg. 35715; 11 relating to establishment of the SelectUSA Initiative). 12 SEC. 1203. FINDINGS. 13 Congress makes the following findings: 14 (1) Semiconductors underpin the United States 15 and global economies, including manufacturing sec-16 tors. Semiconductors are also essential to the na-17 tional security of the United States. 18 (2) A shortage of semiconductors, brought 19 about by the COVID–19 pandemic and other com-20 plex factors impacting the overall supply chain, has 21 threatened the economic recovery of the United 22 States and industries that employ millions of United 23 States citizens. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00126 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 127 •HR 1768 IH (3) Addressing current challenges and building 1 resilience against future risks requires ensuring a se-2 cure and stable supply chain for semiconductors that 3 will support the economic and national security 4 needs of the United States and its allies. 5 (4) The supply chain for semiconductors is 6 complex and global. While the United States plays 7 a leading role in certain segments of the semicon-8 ductor industry, securing the supply chain requires 9 onshoring, reshoring, or diversifying vulnerable seg-10 ments, such as for— 11 (A) fabrication; 12 (B) advanced packaging; and 13 (C) materials and equipment used to man-14 ufacture semiconductor products. 15 (5) The Federal Government can leverage for-16 eign direct investment and private dollars to grow 17 the domestic manufacturing and production capacity 18 of the United States for vulnerable segments of the 19 semiconductor supply chain. 20 (6) The SelectUSA program of the Department 21 of Commerce, in coordination with other Federal 22 agencies and State-level economic development orga-23 nizations, is positioned to boost foreign direct invest-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00127 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 128 •HR 1768 IH ment in domestic manufacturing and to help secure 1 the semiconductor supply chain of the United States. 2 SEC. 1204. COORDINATION WITH STATE-LEVEL ECONOMIC 3 DEVELOPMENT ORGANIZATIONS. 4 Not later than 180 days after the date of the enact-5 ment of this Act, the Executive Director of SelectUSA 6 shall solicit comments from State-level economic develop-7 ment organizations— 8 (1) to review— 9 (A) what efforts the Federal Government 10 can take to support increased foreign direct in-11 vestment in any segment of semiconductor-re-12 lated production; 13 (B) what barriers to such investment may 14 exist and how to amplify State efforts to attract 15 such investment; 16 (C) public opportunities those organiza-17 tions have identified to attract foreign direct in-18 vestment to help increase investment described 19 in subparagraph (A); and 20 (D) resource gaps or other challenges that 21 prevent those organizations from increasing 22 such investment; and 23 (2) to develop recommendations for— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00128 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 129 •HR 1768 IH (A) how SelectUSA can increase such in-1 vestment independently or through partnership 2 with those organizations; and 3 (B) working with countries that are allies 4 or partners of the United States to ensure that 5 foreign adversaries (as defined in section 6 8(c)(2) of the Secure and Trusted Communica-7 tions Networks Act of 2019 (47 U.S.C. 8 1607(c)(2))) do not benefit from United States 9 efforts to increase such investment. 10 SEC. 1205. REPORT ON INCREASING FOREIGN DIRECT IN-11 VESTMENT IN SEMICONDUCTOR-RELATED 12 MANUFACTURING AND PRODUCTION. 13 Not later than 2 years after the date of the enact-14 ment of this Act, the Executive Director of SelectUSA, 15 in coordination with the Federal Interagency Investment 16 Working Group established by Executive Order 13577 (76 17 Fed. Reg. 35715; relating to establishment of the 18 SelectUSA Initiative), shall submit to the Committee on 19 Commerce, Science, and Transportation of the Senate and 20 the Committee on Energy and Commerce of the House 21 of Representatives a report that includes— 22 (1) a review of the comments SelectUSA re-23 ceived from State-level economic development organi-24 zations under section 1204; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00129 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 130 •HR 1768 IH (2) a description of activities SelectUSA is en-1 gaged in to increase foreign direct investment in 2 semiconductor-related manufacturing and produc-3 tion; and 4 (3) an assessment of strategies SelectUSA may 5 implement to achieve an increase in such investment 6 and to help secure the United States supply chain 7 for semiconductors, including by— 8 (A) working with other relevant Federal 9 agencies; and 10 (B) working with State-level economic de-11 velopment organizations and implementing any 12 strategies or recommendations SelectUSA re-13 ceived from those organizations. 14 SEC. 1206. NO ADDITIONAL FUNDS. 15 No additional funds are authorized to be appro-16 priated for the purpose of carrying out this title. The Ex-17 ecutive Director of SelectUSA shall carry out this title 18 using amounts otherwise available to the Executive Direc-19 tor for such purposes. 20 TITLE XIII—HOTEL FEES 21 TRANSPARENCY ACT 22 SEC. 1301. SHORT TITLE. 23 This title may be cited as the ‘‘Hotel Fees Trans-24 parency Act’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00130 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 131 •HR 1768 IH SEC. 1302. PROHIBITION ON UNFAIR AND DECEPTIVE AD-1 VERTISING OF HOTEL ROOMS AND OTHER 2 SHORT-TERM RENTAL PRICES. 3 (a) PROHIBITION.— 4 (1) I N GENERAL .—It shall be unlawful for a 5 covered entity to display, advertise, market, or offer 6 in interstate commerce, including through direct of-7 ferings, third-party distribution, or metasearch refer-8 rals, a price for covered services that does not clear-9 ly, conspicuously, and prominently— 10 (A) display the total services price, if a 11 price is displayed, in any advertisement, mar-12 keting, or price list wherever the covered serv-13 ices are displayed, advertised, marketed, or of-14 fered for sale; 15 (B) disclose to any individual who seeks to 16 purchase covered services the total services 17 price at the time the covered services are first 18 displayed to the individual and anytime there-19 after throughout the covered services pur-20 chasing process; and 21 (C) disclose, prior to the final purchase, 22 any tax, fee, or assessment imposed by any gov-23 ernment entity, quasi-government entity, or 24 government-created special district or program 25 on the sale of covered services. 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00131 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 132 •HR 1768 IH (2) I NDIVIDUAL COMPONENTS .—Provided that 1 such displays are less prominent than the total serv-2 ice price required in paragraph (1), nothing in this 3 Act shall be construed to prohibit the display of— 4 (A) individual components of the total 5 price; or 6 (B) details of other items not required by 7 paragraph (1). 8 (3) I NDEMNIFICATION PROVISIONS .—Nothing 9 in this section shall be construed to prohibit any cov-10 ered entity from entering into a contract with any 11 other covered entity that contains an indemnification 12 provision with respect to price or fee information 13 disclosed, exchanged, or shared between the covered 14 entities that are parties to the contract. 15 (b) ENFORCEMENT.— 16 (1) ENFORCEMENT BY THE COMMISSION .— 17 (A) UNFAIR OR DECEPTIVE ACTS OR PRAC -18 TICES.—A violation of subsection (a) shall be 19 treated as a violation of a rule defining an un-20 fair or deceptive act or practice prescribed 21 under section 18(a)(1)(B) of the Federal Trade 22 Commission Act (15 U.S.C. 57a(a)(1)(B)). 23 (B) POWERS OF THE COMMISSION .— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00132 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 133 •HR 1768 IH (i) I N GENERAL .—The Commission 1 shall enforce this section in the same man-2 ner, by the same means, and with the 3 same jurisdiction, powers, and duties as 4 though all applicable terms and provisions 5 of the Federal Trade Commission Act (15 6 U.S.C. 41 et seq.) were incorporated into 7 and made a part of this Act. 8 (ii) P RIVILEGES AND IMMUNITIES .— 9 Any person who violates this section shall 10 be subject to the penalties and entitled to 11 the privileges and immunities provided in 12 the Federal Trade Commission Act (15 13 U.S.C. 41 et seq.). 14 (iii) A UTHORITY PRESERVED .—Noth-15 ing in this section shall be construed to 16 limit the authority of the Commission 17 under any other provision of law. 18 (2) ENFORCEMENT BY STATES .— 19 (A) I N GENERAL .—If the attorney general 20 of a State has reason to believe that an interest 21 of the residents of the State has been or is 22 being threatened or adversely affected by a 23 practice that violates subsection (a), the attor-24 ney general of the State may, as parens patriae, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00133 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 134 •HR 1768 IH bring a civil action on behalf of the residents of 1 the State in an appropriate district court of the 2 United States to obtain appropriate relief. 3 (B) RIGHTS OF THE COMMISSION .— 4 (i) NOTICE TO THE COMMISSION .— 5 (I) IN GENERAL .—Except as pro-6 vided in subclause (III), the attorney 7 general of a State, before initiating a 8 civil action under subparagraph (A) 9 shall notify the Commission in writing 10 that the attorney general intends to 11 bring such civil action. 12 (II) C ONTENTS.—The notifica-13 tion required by subclause (I) shall in-14 clude a copy of the complaint to be 15 filed to initiate the civil action. 16 (III) E XCEPTION.—If it is not 17 feasible for the attorney general of a 18 State to provide the notification re-19 quired by subclause (I) before initi-20 ating a civil action under subpara-21 graph (A), the attorney general shall 22 notify the Commission immediately 23 upon instituting the civil action. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00134 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 135 •HR 1768 IH (ii) I NTERVENTION BY THE COMMIS -1 SION.—The Commission may— 2 (I) intervene in any civil action 3 brought by the attorney general of a 4 State under subparagraph (A); and 5 (II) upon intervening— 6 (aa) be heard on all matters 7 arising in the civil action; and 8 (bb) file petitions for appeal. 9 (C) I NVESTIGATORY POWERS .—Nothing in 10 this paragraph may be construed to prevent the 11 attorney general of a State from exercising the 12 powers conferred on the attorney general by the 13 laws of the State to conduct investigations, to 14 administer oaths or affirmations, or to compel 15 the attendance of witnesses or the production of 16 documentary or other evidence. 17 (D) A CTION BY THE COMMISSION .—When-18 ever a civil action has been instituted by or on 19 behalf of the Commission for violation of sub-20 section (a), no attorney general of a State may, 21 during the pendency of that action, institute an 22 action under subparagraph (A) against any de-23 fendant named in the complaint in that action 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00135 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 136 •HR 1768 IH for a violation of subsection (a) alleged in such 1 complaint. 2 (E) VENUE; SERVICE OF PROCESS .— 3 (i) V ENUE.—Any action brought 4 under subparagraph (A) may be brought 5 in— 6 (I) the district court of the 7 United States that meets applicable 8 requirements relating to venue under 9 section 1391 of title 28, United States 10 Code; or 11 (II) another court of competent 12 jurisdiction. 13 (ii) S ERVICE OF PROCESS .—In an ac-14 tion brought under subparagraph (A), 15 process may be served in any district in 16 which— 17 (I) the defendant is an inhab-18 itant, may be found, or transacts 19 business; or 20 (II) venue is proper under section 21 1391 of title 28, United States Code. 22 (F) A CTIONS BY OTHER STATE OFFI -23 CIALS.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00136 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 137 •HR 1768 IH (i) I N GENERAL .—In addition to civil 1 actions brought by an attorney general 2 under subparagraph (A), any other officer 3 of a State who is authorized by the State 4 to do so may bring a civil action under 5 subparagraph (A), subject to the same re-6 quirements and limitations that apply 7 under this paragraph to civil actions 8 brought by attorneys general. 9 (ii) S AVINGS PROVISION .—Nothing in 10 this paragraph may be construed to pro-11 hibit an authorized official of a State from 12 initiating or continuing any proceeding in 13 a court of the State for a violation of any 14 civil or criminal law of the State. 15 (3) A FFIRMATIVE DEFENSE .—In any action 16 pursuant to paragraph (1) or (2), an intermediary 17 or third-party online seller may assert an affirmative 18 defense if such intermediary or third-party online 19 seller— 20 (A) established procedures to receive up-to- 21 date price information from hotels or short- 22 term rentals, or agents acting on behalf of a 23 hotel or short-term rental; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00137 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 138 •HR 1768 IH (B) relied in good faith on information 1 provided to the intermediary or third-party on-2 line seller by a hotel or short-term rental, or 3 agent acting on behalf of such hotel or short- 4 term rental, and such information was inac-5 curate at the time it was provided to the inter-6 mediary or third-party online seller; and 7 (C) took prompt action to remove or cor-8 rect any false or inaccurate information about 9 the total services price after receiving notice 10 that such information was false or inaccurate. 11 (c) PREEMPTION.— 12 (1) IN GENERAL .—A State, or political subdivi-13 sion of a State, may not maintain, enforce, pre-14 scribe, or continue in effect any law, rule, regulation, 15 requirement, standard, or other provision having the 16 force and effect of law of the State, or political sub-17 division of the State, that prohibits a covered entity 18 from advertising, displaying, marketing, or otherwise 19 offering, or otherwise affects the manner in which a 20 covered entity may advertise, display, market, or 21 otherwise offer, for sale in interstate commerce, in-22 cluding through a direct offering, third-party dis-23 tribution, or metasearch referral, a price of a res-24 ervation for a covered service, and that requires fee 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00138 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 139 •HR 1768 IH disclosure, unless the law requires the total services 1 price to include each service fee, as defined in sub-2 section (d)(8), and in accordance with subsection 3 (a)(1). 4 (2) R ULE OF CONSTRUCTION .—This section 5 may not be construed to— 6 (A) preempt any law of a State or political 7 subdivision of a State relating to contracts or 8 torts; or 9 (B) preempt any law of a State or political 10 subdivision of a State to the extent that such 11 law relates to an act of fraud, unauthorized ac-12 cess to personal information, or notification of 13 unauthorized access to personal information. 14 (d) DEFINITIONS.—In this Act: 15 (1) B ASE SERVICES PRICE .—The term ‘‘base 16 services price’’ — 17 (A) means, with respect to the covered 18 services provided by a hotel or short-term rent-19 al, the price in order to obtain the covered serv-20 ices of the hotel or short-term rental; and 21 (B) does not include— 22 (i) any service fee; 23 (ii) any taxes or fees imposed by a 24 government or quasi-government entity; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00139 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 140 •HR 1768 IH (iii) assessment fees of a government- 1 created special district or program; or 2 (iv) any charges or fees for an op-3 tional product or service associated with 4 the covered services that may be selected 5 by a purchaser of covered services. 6 (2) C OMMISSION.—The term ‘‘Commission’’ 7 means the Federal Trade Commission. 8 (3) C OVERED ENTITY .—The term ‘‘covered en-9 tity’’ means a person, partnership, or corporation 10 with respect to whom the Commission has jurisdic-11 tion under section 5(a)(2) of the Federal Trade 12 Commission Act (15 U.S.C. 45(a)(2)), including— 13 (A) a hotel or short-term rental; 14 (B) a third-party online seller; or 15 (C) an intermediary. 16 (4) C OVERED SERVICES .—The term ‘‘covered 17 services’’— 18 (A) means the temporary provision of a 19 room, building, or other lodging facility; and 20 (B) does not include the provision of a 21 meeting room, banquet services, or catering 22 services. 23 (5) H OTEL.—The term ‘‘hotel’’ means an es-24 tablishment that is— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00140 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 141 •HR 1768 IH (A) primarily engaged in providing a cov-1 ered service to the general public; and 2 (B) promoted, advertised, or marketed in 3 interstate commerce or for which such estab-4 lishment’s services are sold in interstate com-5 merce. 6 (6) I NTERMEDIARY.—The term ‘‘intermediary’’ 7 means an entity that operates either as a business- 8 to-business platform, consumer-facing platform, or 9 both, that displays, including through direct offer-10 ings, third-party distribution, or metasearch referral, 11 a price for covered services or price comparison tools 12 for consumers seeking covered services. 13 (7) O PTIONAL PRODUCT OR SERVICE .—The 14 term ‘‘optional product or service’’ means a product 15 or service that an individual does not need to pur-16 chase to use or obtain covered services. 17 (8) SERVICE FEE .—The term ‘‘service fee’’— 18 (A) means a charge imposed by a covered 19 entity that must be paid in order to obtain cov-20 ered services; and 21 (B) does not include— 22 (i) any taxes or fees imposed by a 23 government or quasi-government entity; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00141 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 142 •HR 1768 IH (ii) any assessment fees of a govern-1 ment-created special district or program; 2 or 3 (iii) any charges or fees for an op-4 tional product or service associated with 5 the covered services that may be selected 6 by a purchaser of covered services. 7 (9) S HORT-TERM RENTAL .—The term ‘‘short- 8 term rental’’ means a property, including a single- 9 family dwelling or a unit in a condominium, coopera-10 tive, or time-share, that provides covered services 11 (either with respect to the entire property or a part 12 of the property) to the general public— 13 (A) in exchange for a fee; 14 (B) for periods shorter than 30 consecutive 15 days; and 16 (C) is promoted, advertised, or marketed in 17 interstate commerce or for which such prop-18 erty’s services are sold in interstate commerce. 19 (10) S TATE.—The term ‘‘State’’ means each of 20 the 50 States, the District of Columbia, and any ter-21 ritory or possession of the United States. 22 (11) THIRD-PARTY ONLINE SELLER .—The term 23 ‘‘third-party online seller’’ means any person other 24 than a hotel or short-term rental that sells covered 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00142 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 143 •HR 1768 IH services or offers for sale covered services with re-1 spect to a hotel or short-term rental in a transaction 2 facilitated on the internet. 3 (12) TOTAL SERVICES PRICE .—The term ‘‘total 4 services’’— 5 (A) means, with respect to covered serv-6 ices, the total cost of the covered services, in-7 cluding the base services price and any service 8 fees; and 9 (B) does not include— 10 (i) any taxes or fees imposed by a 11 government or quasi-government entity; 12 (ii) any assessment fees of a govern-13 ment-created special district or program; 14 or 15 (iii) any charges or fees for an op-16 tional product or service associated with 17 the covered services that may be selected 18 by a purchaser of covered services. 19 (e) E FFECTIVE DATE.—The prohibition under sub-20 section (a) shall take effect 450 days after the date of 21 the enactment of this Act and shall apply to advertise-22 ments, displays, marketing, and offers of covered services 23 of a covered entity made on or after such date. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00143 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 144 •HR 1768 IH TITLE XIV—TRANSPARENCY IN 1 CHARGES FOR KEY EVENTS 2 TICKETING 3 SEC. 1401. SHORT TITLE. 4 This title may be cited as the ‘‘Transparency In 5 Charges for Key Events Ticketing Act’’ or the ‘‘TICKET 6 Act’’. 7 SEC. 1402. ALL INCLUSIVE TICKET PRICE DISCLOSURE. 8 Beginning 180 days after the date of the enactment 9 of this Act, it shall be unlawful for a ticket issuer, sec-10 ondary market ticket issuer, or secondary market ticket 11 exchange to offer for sale an event ticket unless the ticket 12 issuer, secondary market ticket issuer, or secondary mar-13 ket ticket exchange— 14 (1) clearly and conspicuously displays the total 15 event ticket price, if a price is displayed, in any ad-16 vertisement, marketing, or price list wherever the 17 ticket is offered for sale; 18 (2) clearly and conspicuously discloses to any 19 individual who seeks to purchase an event ticket the 20 total event ticket price at the time the ticket is first 21 displayed to the individual and anytime thereafter 22 throughout the ticket purchasing process; and 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00144 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 145 •HR 1768 IH (3) provides an itemized list of the base event 1 ticket price and each event ticket fee prior to the 2 completion of the ticket purchasing process. 3 SEC. 1403. SPECULATIVE TICKETING BAN. 4 (a) P ROHIBITION.—Beginning 180 days after the 5 date of the enactment of this Act, a ticket issuer, sec-6 ondary market ticket issuer, or secondary market ticket 7 exchange that does not have actual or constructive posses-8 sion of an event ticket shall not sell, offer for sale, or ad-9 vertise for sale such event ticket. 10 (b) S ERVICES PERMITTED.—Notwithstanding sub-11 section (a), a secondary market ticket issuer or secondary 12 market ticket exchange may sell, offer for sale, or adver-13 tise for sale a service to an individual to obtain an event 14 ticket on behalf of such individual if the secondary market 15 ticket issuer or secondary market ticket exchange complies 16 with the following: 17 (1) Does not market or list the service as an 18 event ticket. 19 (2) Maintains a clear, distinct, and easily dis-20 cernible separation between the service and event 21 tickets that persists throughout the entire service se-22 lection and purchasing process. 23 (3) Clearly and conspicuously discloses before 24 selection of the service that the service is not an 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00145 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 146 •HR 1768 IH event ticket and that the purchase of the service 1 does not guarantee an event ticket. 2 SEC. 1404. DISCLOSURES. 3 A ticket issuer, secondary market ticket issuer, or 4 secondary market ticket exchange— 5 (1) if offering an event ticket for resale, shall 6 provide a clear and conspicuous statement, before a 7 consumer purchases the event ticket from the ticket 8 issuer, secondary market ticket issuer, or secondary 9 market ticket exchange, that the issuer or exchange 10 is engaged in the secondary sale of event tickets; and 11 (2) shall not state that the ticket issuer, sec-12 ondary market ticket issuer, or secondary market 13 ticket exchange is affiliated with or endorsed by a 14 venue, team, or artist, as applicable, including by 15 using words like ‘‘official’’ in promotional materials, 16 social media promotions, or paid advertising, unless 17 a partnership agreement has been executed or the 18 issuer or exchange has the express written consent 19 of the venue, team, or artist, as applicable. 20 SEC. 1405. REFUND REQUIREMENTS. 21 (a) C ANCELLATION.—Beginning 180 days after the 22 date of the enactment of this Act, if an event is canceled 23 or postponed (except for a case in which an event is can-24 celed or postponed due to a cause beyond the reasonable 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00146 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 147 •HR 1768 IH control of the issuer, including a natural disaster, civil dis-1 turbance, or otherwise unforeseeable impediment), a ticket 2 issuer, secondary market ticket issuer, or secondary mar-3 ket ticket exchange shall provide the purchaser of an event 4 ticket from the issuer or exchange for the canceled or post-5 poned event, at a minimum— 6 (1) if the event is cancelled, a full refund for 7 the total event ticket price; 8 (2) subject to availability, if the event is post-9 poned for not more than 6 months and the original 10 event ticket is no longer valid for entry to the re-11 scheduled event, a replacement event ticket for the 12 rescheduled event in the same or a comparable loca-13 tion once the event has been rescheduled; or 14 (3) if the event is postponed for more than 6 15 months, at the option of the purchaser— 16 (A) a full refund for the total event ticket 17 price; or 18 (B) if the original event ticket is no longer 19 valid for entry to the rescheduled event, a re-20 placement event ticket for the rescheduled event 21 in the same or a comparable location once the 22 event has been rescheduled. 23 (b) DISCLOSURE OF GUARANTEE AND REFUND POL-24 ICY REQUIRED.—Beginning 180 days after the date of the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00147 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 148 •HR 1768 IH enactment of this Act, a ticket issuer, secondary market 1 ticket issuer, or secondary market ticket exchange shall 2 disclose clearly and conspicuously to a purchaser before 3 the completion of an event ticket sale the guarantee or 4 refund policy of such ticket issuer, secondary market tick-5 et issuer, or secondary market ticket exchange, including 6 under what circumstances any refund issued will include 7 a refund of any event ticket fee. 8 (c) DISCLOSURE OF HOW TO OBTAIN A REFUND RE-9 QUIRED.—Beginning 180 days after the date of the enact-10 ment of this Act, a ticket issuer, secondary market ticket 11 issuer, or secondary market ticket exchange shall provide 12 a clear and conspicuous explanation of how to obtain a 13 refund of the total event ticket price. 14 SEC. 1406. REPORT BY THE FEDERAL TRADE COMMISSION 15 ON BOTS ACT OF 2016 ENFORCEMENT. 16 Not later than 6 months after the date of the enact-17 ment of this Act, the Commission shall submit to Congress 18 a report on enforcement of the Better Online Ticket Sales 19 Act of 2016 (Public Law 114–274; 15 U.S.C. 45c), includ-20 ing any enforcement action taken, challenges with enforce-21 ment and coordination with State Attorneys General, and 22 recommendations on how to improve enforcement and in-23 dustry compliance. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00148 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 149 •HR 1768 IH SEC. 1407. ENFORCEMENT. 1 (a) U NFAIR OR DECEPTIVE ACT OR PRACTICE.—A 2 violation of this title shall be treated as a violation of a 3 rule defining an unfair or deceptive act or practice under 4 section 18(a)(1)(B) of the Federal Trade Commission Act 5 (15 U.S.C. 57a(a)(1)(B)). 6 (b) POWERS OF COMMISSION.— 7 (1) I N GENERAL .—The Commission shall en-8 force this title in the same manner, by the same 9 means, and with the same jurisdiction, powers, and 10 duties as though all applicable terms and provisions 11 of the Federal Trade Commission Act (15 U.S.C. 41 12 et seq.) were incorporated into and made a part of 13 this title. 14 (2) PRIVILEGES AND IMMUNITIES .—Any person 15 who violates this title shall be subject to the pen-16 alties and entitled to the privileges and immunities 17 provided in the Federal Trade Commission Act (15 18 U.S.C. 41 et seq.). 19 (3) A UTHORITY PRESERVED .—Nothing in this 20 title shall be construed to limit the authority of the 21 Commission under any other provision of law. 22 SEC. 1408. DEFINITIONS. 23 In this title: 24 (1) ARTIST.—The term ‘‘artist’’ means any per-25 former, musician, comedian, producer, ensemble or 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00149 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 150 •HR 1768 IH production entity of a theatrical production, sports 1 team owner, or similar person. 2 (2) B ASE EVENT TICKET PRICE .—The term 3 ‘‘base event ticket price’’ means, with respect to an 4 event ticket, the price of the event ticket excluding 5 the cost of any event ticket fees. 6 (3) C OMMISSION.—The term ‘‘Commission’’ 7 means the Federal Trade Commission. 8 (4) E VENT.—The term ‘‘event’’ means any live 9 concert, theatrical performance, sporting event, 10 show, or similarly scheduled live activity, that is— 11 (A) taking place in a venue with a seating 12 or attendance capacity exceeding 200 persons; 13 (B) open to the general public; and 14 (C) promoted, advertised, or marketed in 15 interstate commerce, or for which event tickets 16 are generally sold or distributed in interstate 17 commerce. 18 (5) E VENT TICKET ; TICKET ISSUER .—The 19 terms ‘‘event ticket’’ and ‘‘ticket issuer’’ have the 20 meaning given those terms in section 3 of the Better 21 Online Ticket Sales Act of 2016 (15 U.S.C. 45c 22 note). 23 (6) E VENT TICKET FEE .—The term ‘‘event 24 ticket fee’’— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00150 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 151 •HR 1768 IH (A) means a charge for an event ticket 1 that must be paid in addition to the base event 2 ticket price in order to obtain an event ticket 3 from a ticket issuer, secondary market ticket 4 issuer, or secondary market ticket exchange, in-5 cluding any service fee, charge and order proc-6 essing fee, delivery fee, facility charge fee, tax, 7 and any other charge; and 8 (B) does not include any charge or fee for 9 an optional product or service associated with 10 the event that may be selected by a purchaser 11 of an event ticket. 12 (7) O PTIONAL PRODUCT OR SERVICE .—The 13 term ‘‘optional product or service’’ means a product 14 or service that an individual does not need to pur-15 chase to use or take possession of an event ticket. 16 (8) R ESALE; SECONDARY SALE .—The terms 17 ‘‘resale’’ and ‘‘secondary sale’’ mean any sale of an 18 event ticket that occurs after the initial sale of the 19 event ticket by a ticket issuer. 20 (9) S ECONDARY MARKET TICKET EXCHANGE .— 21 The term ‘‘secondary market ticket exchange’’ 22 means any person that in the regular course of trade 23 or business of that person operates a platform or ex-24 change for advertising, listing, or selling resale tick-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00151 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 152 •HR 1768 IH ets, on behalf of itself, vendors, or a secondary mar-1 ket ticket issuer. 2 (10) S ECONDARY MARKET TICKET ISSUER .— 3 The term ‘‘secondary market ticket issuer’’ means 4 any person, including a ticket issuer, that resells or 5 makes a secondary sale of an event ticket to the gen-6 eral public in the regular course of the trade or busi-7 ness of the person. 8 (11) T OTAL EVENT TICKET PRICE .—The term 9 ‘‘total event ticket price’’ means, with respect to an 10 event ticket, the total cost of the event ticket, includ-11 ing the base event ticket price and any event ticket 12 fee. 13 (12) V ENUE.—The term ‘‘venue’’ means a 14 physical space at which an event takes place. 15 TITLE XV—ROUTERS ACT 16 SEC. 1501. SHORT TITLE. 17 This title may be cited as the ‘‘Removing Our Unse-18 cure Technologies to Ensure Reliability and Security Act’’ 19 or the ‘‘ROUTERS Act’’. 20 SEC. 1502. STUDY OF NATIONAL SECURITY RISKS POSED BY 21 CERTAIN ROUTERS AND MODEMS. 22 (a) I N GENERAL.—The Secretary shall conduct a 23 study of the national security risks posed by consumer 24 routers, modems, and devices that combine a modem and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00152 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 153 •HR 1768 IH router that are designed, developed, manufactured, or sup-1 plied by persons owned by, controlled by, or subject to the 2 influence of a covered country. 3 (b) R EPORT TO CONGRESS.—Not later than 1 year 4 after the date of the enactment of this Act, the Secretary 5 shall submit to the Committee on Energy and Commerce 6 of the House of Representatives and the Committee on 7 Commerce, Science, and Transportation of the Senate a 8 report on the results of the study conducted under sub-9 section (a). 10 (c) DEFINITIONS.—In this section: 11 (1) C OVERED COUNTRY .—The term ‘‘covered 12 country’’ means a country specified in section 13 4872(f)(2) of title 10, United States Code. 14 (2) S ECRETARY.—The term ‘‘Secretary’’ means 15 the Secretary of Commerce, in consultation with the 16 Assistant Secretary of Commerce for Communica-17 tions and Information. 18 TITLE XVI—NTIA 19 REAUTHORIZATION 20 SEC. 1601. SHORT TITLE. 21 This title may be cited as the ‘‘National Tele-22 communications and Information Administration Reau-23 thorization Act’’ or the ‘‘NTIA Reauthorization Act’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00153 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 154 •HR 1768 IH SEC. 1602. DEFINITIONS. 1 In this title: 2 (1) C OMMISSION.—The term ‘‘Commission’’ 3 means the Federal Communications Commission. 4 (2) NTIA.—The term ‘‘NTIA’’ means the Na-5 tional Telecommunications and Information Admin-6 istration. 7 (3) U NDER SECRETARY .—The term ‘‘Under 8 Secretary’’ means the Under Secretary of Commerce 9 for Communications and Information. 10 Subtitle A—Reauthorization 11 SEC. 1611. REAUTHORIZATION OF THE NATIONAL TELE-12 COMMUNICATIONS AND INFORMATION AD-13 MINISTRATION ORGANIZATION ACT. 14 (a) A UTHORIZATION OF APPROPRIATIONS.—Section 15 151 of the National Telecommunications and Information 16 Administration Organization Act is amended by striking 17 ‘‘$17,600,000 for fiscal year 1992 and $17,900,000 for 18 fiscal year 1993’’ and inserting ‘‘$57,000,000 for fiscal 19 year 2025 and $57,000,000 for fiscal year 2026’’. 20 (b) UNDER SECRETARY OF COMMERCE FOR COMMU-21 NICATIONS AND INFORMATION.— 22 (1) U NDER SECRETARY ; DEPUTY UNDER SEC -23 RETARY.— 24 (A) U NDER SECRETARY .—The National 25 Telecommunications and Information Adminis-26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00154 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 155 •HR 1768 IH tration Organization Act (47 U.S.C. 901 et 1 seq.) is amended by striking ‘‘Assistant Sec-2 retary’’ each place it appears and inserting 3 ‘‘Under Secretary’’. 4 (B) D EPUTY UNDER SECRETARY .—Section 5 103(a) of the National Telecommunications and 6 Information Administration Organization Act 7 (47 U.S.C. 902(a)), as amended by this section, 8 is amended by adding at the end the following: 9 ‘‘(3) D EPUTY UNDER SECRETARY .—The Dep-10 uty Under Secretary of Commerce for Communica-11 tions and Information shall— 12 ‘‘(A) be the principal policy advisor of the 13 Under Secretary; 14 ‘‘(B) perform such other functions as the 15 Under Secretary shall from time to time assign 16 or delegate; and 17 ‘‘(C) act as Under Secretary during the 18 absence or disability of the Under Secretary or 19 in the event of a vacancy in the office of the 20 Under Secretary.’’. 21 (2) C ONTINUATION OF CIVIL ACTIONS .—This 22 subsection, and the amendments made by this sub-23 section, shall not abate any civil action commenced 24 by or against the Assistant Secretary of Commerce 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00155 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 156 •HR 1768 IH for Communications and Information before the date 1 of the enactment of this Act, except that the Under 2 Secretary shall be substituted as a party to the ac-3 tion on and after such date. 4 (3) C ONTINUATION IN OFFICE .—The individual 5 serving as the Assistant Secretary of Commerce for 6 Communications and Information and the individual 7 serving as the Deputy Assistant Secretary of Com-8 merce for Communications and Information on the 9 day before the date of the enactment of this Act may 10 serve as the Under Secretary and the Deputy Under 11 Secretary of Commerce for Communications and In-12 formation, respectively, on and after that date with-13 out the need for renomination or reappointment. 14 (4) REFERENCES.—Any reference in a law, reg-15 ulation, document, paper, or other record of the 16 United States to the Assistant Secretary of Com-17 merce for Communications and Information shall, on 18 and after the date of the enactment of this Act, be 19 deemed to be a reference to the Under Secretary. 20 (5) EXECUTIVE SCHEDULE .— 21 (A) I N GENERAL .—Subchapter II of chap-22 ter 53 of title 5, United States Code, is amend-23 ed— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00156 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 157 •HR 1768 IH (i) in section 5314, by adding at the 1 end the following: 2 ‘‘Under Secretary of Commerce for Commu-3 nications and Information.’’; and 4 (ii) in section 5315, in the item relat-5 ing to the Assistant Secretaries of Com-6 merce, by striking ‘‘(11)’’ and inserting 7 ‘‘(10)’’. 8 (B) E FFECTIVE DATE .—The amendment 9 made by subparagraph (A) (establishing the an-10 nual rate of the basic pay of the Under Sec-11 retary) shall take effect on the first day of the 12 first pay period beginning after the date of the 13 enactment of this Act. 14 (c) AUTHORITIES AND RESPONSIBILITIES.— 15 (1) C OORDINATION OF EXECUTIVE BRANCH 16 VIEWS ON MATTERS BEFORE THE FEDERAL COMMU -17 NICATIONS COMMISSION .—Section 105(a)(1) of the 18 National Telecommunications and Information Ad-19 ministration Organization Act (47 U.S.C. 904(a)(1)) 20 is amended— 21 (A) by striking ‘‘to ensure that the con-22 duct’’ and inserting the following: ‘‘to ensure 23 that— 24 ‘‘(A) the conduct’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00157 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 158 •HR 1768 IH (B) in subparagraph (A), as so designated, 1 by striking the period at the end and inserting 2 ‘‘; and’’; and 3 (C) by adding at the end the following: 4 ‘‘(B) the views of the executive branch on 5 matters presented to the Commission are, con-6 sistent with section 103(b)(2)(J)— 7 ‘‘(i) appropriately coordinated; and 8 ‘‘(ii) reflective of executive branch pol-9 icy.’’. 10 (2) A SSIGNED FUNCTIONS .—Section 103(b)(2) 11 of the National Telecommunications and Informa-12 tion Administration Organization Act (47 U.S.C. 13 902(b)(2)) is amended— 14 (A) in the matter preceding subparagraph 15 (A), by inserting ‘‘, some of which were’’ before 16 ‘‘transferred to the Secretary’’; and 17 (B) in subparagraph (M), by inserting ‘‘, 18 publish reports,’’ after ‘‘studies’’. 19 (3) R ULE OF CONSTRUCTION .—Nothing in the 20 amendments made by paragraphs (1) and (2) may 21 be construed to expand or contract the authority of 22 the Commission. 23 (d) TECHNICAL AND CONFORMING AMENDMENTS.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00158 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 159 •HR 1768 IH (1) P UBLIC TELECOMMUNICATIONS FINANCING 1 ACT OF 1978 .—Section 106(c) of the Public Tele-2 communications Financing Act of 1978 (5 U.S.C. 3 5316 note; Public Law 95–567) is amended by strik-4 ing ‘‘The position of Deputy Assistant Secretary of 5 Commerce for Communications and Information, es-6 tablished in Department of Commerce Organization 7 Order Numbered 10–10 (effective March 26, 8 1978),’’ and inserting ‘‘The position of Deputy 9 Under Secretary of Commerce for Communications 10 and Information, established under section 103(a) of 11 the National Telecommunications and Information 12 Administration Organization Act (47 U.S.C. 13 902(a)),’’. 14 (2) C OMMUNICATIONS ACT OF 1934 .—Section 15 344(d)(2) of the Communications Act of 1934 (47 16 U.S.C. 344(d)(2)) is amended by striking ‘‘Assistant 17 Secretary’’ and inserting ‘‘Under Secretary’’. 18 (3) H OMELAND SECURITY ACT OF 2002 .—Sec-19 tion 1805(d)(2) of the Homeland Security Act of 20 2002 (6 U.S.C. 575(d)(2)) is amended by striking 21 ‘‘Assistant Secretary for Communications and Infor-22 mation of the Department of Commerce’’ and insert-23 ing ‘‘Under Secretary of Commerce for Communica-24 tions and Information’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00159 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 160 •HR 1768 IH (4) A GRICULTURE IMPROVEMENT ACT OF 1 2018.—Section 6212 of the Agriculture Improvement 2 Act of 2018 (7 U.S.C. 950bb–6) is amended— 3 (A) in subsection (d)(1), in the heading, by 4 striking ‘‘ASSISTANT SECRETARY ’’ and inserting 5 ‘‘UNDER SECRETARY ’’; and 6 (B) by striking ‘‘Assistant Secretary’’ each 7 place the term appears and inserting ‘‘Under 8 Secretary’’. 9 (5) T ITLE 17 , UNITED STATES CODE .—Section 10 1201(a)(1)(C) of title 17, United States Code, is 11 amended by striking ‘‘Assistant Secretary for Com-12 munications and Information of the Department of 13 Commerce’’ and inserting ‘‘Under Secretary of Com-14 merce for Communications and Information’’. 15 (6) U NLOCKING CONSUMER CHOICE AND WIRE -16 LESS COMPETITION ACT .—Section 2(b) of the 17 Unlocking Consumer Choice and Wireless Competi-18 tion Act (17 U.S.C. 1201 note; Public Law 113– 19 144) is amended by striking ‘‘Assistant Secretary 20 for Communications and Information of the Depart-21 ment of Commerce’’ and inserting ‘‘Under Secretary 22 of Commerce for Communications and Information’’. 23 (7) C OMMUNICATIONS SATELLITE ACT OF 24 1962.—Section 625(a)(1) of the Communications 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00160 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 161 •HR 1768 IH Satellite Act of 1962 (47 U.S.C. 763d(a)(1)) is 1 amended, in the matter preceding subparagraph (A), 2 by striking ‘‘Assistant Secretary’’ and inserting 3 ‘‘Under Secretary of Commerce’’. 4 (8) S PECTRUM PIPELINE ACT OF 2015 .—The 5 Spectrum Pipeline Act of 2015 (47 U.S.C. 921 note; 6 title X of Public Law 114–74) is amended— 7 (A) in section 1002(1), in the heading, by 8 striking ‘‘ASSISTANT SECRETARY ’’ and inserting 9 ‘‘UNDER SECRETARY ’’; and 10 (B) by striking ‘‘Assistant Secretary’’ each 11 place the term appears and inserting ‘‘Under 12 Secretary’’. 13 (9) W ARNING, ALERT, AND RESPONSE NET -14 WORK ACT .—Section 606 of the Warning, Alert, and 15 Response Network Act (47 U.S.C. 1205) is amend-16 ed— 17 (A) by striking ‘‘Assistant Secretary’’ each 18 place the term appears and inserting ‘‘Under 19 Secretary’’; and 20 (B) in subsection (b), in the first sentence, 21 by striking ‘‘for7Communications’’ and insert-22 ing ‘‘for Communications’’. 23 (10) AMERICAN RECOVERY AND REINVESTMENT 24 ACT OF 2009 .—Section 6001 of the American Recov-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00161 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 162 •HR 1768 IH ery and Reinvestment Act of 2009 (47 U.S.C. 1305) 1 is amended by striking ‘‘Assistant Secretary’’ each 2 place the term appears and inserting ‘‘Under Sec-3 retary’’. 4 (11) MIDDLE CLASS TAX RELIEF AND JOB CRE -5 ATION ACT OF 2012 .—Title VI of the Middle Class 6 Tax Relief and Job Creation Act of 2012 (47 U.S.C. 7 1401 et seq.) is amended— 8 (A) in section 6001 (47 U.S.C. 1401)— 9 (i) by striking paragraph (4); 10 (ii) by redesignating paragraphs (5) 11 through (32) as paragraphs (4) through 12 (31), respectively; and 13 (iii) by inserting after paragraph (31), 14 as so redesignated, the following: 15 ‘‘(32) U NDER SECRETARY .—The term ‘Under 16 Secretary’ means the Under Secretary of Commerce 17 for Communications and Information.’’; and 18 (B) by striking ‘‘Assistant Secretary’’ each 19 place the term appears and inserting ‘‘Under 20 Secretary’’. 21 (12) R AY BAUM ’S ACT OF 2018 .—The RAY 22 BAUM’S Act of 2018 (division P of Public Law 23 115–141; 132 Stat. 348) is amended by striking 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00162 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 163 •HR 1768 IH ‘‘Assistant Secretary’’ each place the term appears 1 and inserting ‘‘Under Secretary’’. 2 (13) S ECURE AND TRUSTED COMMUNICATIONS 3 NETWORKS ACT OF 2019 .—Section 8 of the Secure 4 and Trusted Communications Networks Act of 2019 5 (47 U.S.C. 1607) is amended— 6 (A) in subsection (c)(1), in the heading, by 7 striking ‘‘ASSISTANT SECRETARY ’’ and inserting 8 ‘‘UNDER SECRETARY ’’; and 9 (B) by striking ‘‘Assistant Secretary’’ each 10 place the term appears and inserting ‘‘Under 11 Secretary’’. 12 (14) TITLE 51 , UNITED STATES CODE .—Section 13 50112(3) of title 51, United States Code, is amend-14 ed, in the matter preceding subparagraph (A), by 15 striking ‘‘Assistant Secretary’’ each place the term 16 appears and inserting ‘‘Under Secretary’’. 17 (15) C ONSOLIDATED APPROPRIATIONS ACT , 18 2021.—The Consolidated Appropriations Act, 2021 19 (Public Law 116–260) is amended— 20 (A) in title IX of division N— 21 (i) in section 902(a)(2), in the head-22 ing, by striking ‘‘A SSISTANT SECRETARY ’’ 23 and inserting ‘‘U NDER SECRETARY ’’; 24 (ii) in section 905— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00163 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 164 •HR 1768 IH (I) in subsection (a)(1), in the 1 heading, by striking ‘‘A SSISTANT SEC -2 RETARY’’ and inserting ‘‘U NDER SEC -3 RETARY’’; 4 (II) in subsection (c)(3)(B), in 5 the heading, by striking ‘‘ ASSISTANT 6 SECRETARY’’ and inserting ‘‘ UNDER 7 SECRETARY’’; 8 (III) in subsection (d)(2)(B), in 9 the heading, by striking ‘‘ ASSISTANT 10 SECRETARY’’ and inserting ‘‘ UNDER 11 SECRETARY’’; and 12 (iii) by striking ‘‘Assistant Secretary’’ 13 each place the term appears (except in sec-14 tion 905(a)(13)(E)) and inserting ‘‘Under 15 Secretary’’; and 16 (B) in title IX of division FF— 17 (i) in section 903(g)(2), in the head-18 ing, by striking ‘‘A SSISTANT SECRETARY ’’ 19 and inserting ‘‘U NDER SECRETARY ’’; and 20 (ii) by striking ‘‘Assistant Secretary’’ 21 each place the term appears and inserting 22 ‘‘Under Secretary’’. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00164 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 165 •HR 1768 IH (16) I NFRASTRUCTURE INVESTMENT AND JOBS 1 ACT.—The Infrastructure Investment and Jobs Act 2 (Public Law 117–58) is amended— 3 (A) in section 27003, by striking ‘‘Assist-4 ant Secretary’’ each place the term appears and 5 inserting ‘‘Under Secretary’’; 6 (B) in division F— 7 (i) in section 60102— 8 (I) in subsection (a)(2)(A), by 9 striking ‘‘A SSISTANT SECRETARY ’’ 10 and inserting ‘‘U NDER SECRETARY ’’; 11 (II) in subsection (d)(1), by 12 striking ‘‘A SSISTANT SECRETARY ’’ 13 and inserting ‘‘U NDER SECRETARY ’’; 14 and 15 (III) in subsection (h)— 16 (aa) in paragraph (1)(B), by 17 striking ‘‘ ASSISTANT SEC -18 RETARY’’ and inserting ‘‘ UNDER 19 SECRETARY’’; and 20 (bb) in paragraph 21 (5)(B)(iii), by striking ‘‘ ASSIST-22 ANT SECRETARY ’’ and inserting 23 ‘‘UNDER SECRETARY ’’; 24 (ii) in title III— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00165 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 166 •HR 1768 IH (I) in section 60302(5), by strik-1 ing ‘‘A SSISTANT SECRETARY ’’ and in-2 serting ‘‘UNDER SECRETARY ’’; and 3 (II) in section 4 60305(d)(2)(B)(ii), by striking ‘‘ AS-5 SISTANT SECRETARY ’’ and inserting 6 ‘‘UNDER SECRETARY ’’; 7 (iii) in section 60401(a)(2), by strik-8 ing ‘‘A SSISTANT SECRETARY ’’ and insert-9 ing ‘‘UNDER SECRETARY ’’; 10 (iv) by striking ‘‘Assistant Secretary’’ 11 each place the term appears and inserting 12 ‘‘Under Secretary’’; and 13 (C) in division J, in title I, in the matter 14 under the heading ‘‘distance learning, telemedi-15 cine, and broadband program’’ under the head-16 ing ‘‘Rural Utilities Service’’ under the heading 17 ‘‘RURAL DEVELOPMENT PROGRAMS’’, by 18 striking ‘‘Assistant Secretary’’ and inserting 19 ‘‘Under Secretary’’. 20 SEC. 1612. NTIA CONSOLIDATED REPORTING ACT. 21 (a) E LIMINATION OF CERTAIN OUTDATED OR COM-22 PLETED REPORTING REQUIREMENTS.— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00166 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 167 •HR 1768 IH (1) BTOP QUARTERLY REPORT .—Section 1 6001(d) of the American Recovery and Reinvestment 2 Act of 2009 (47 U.S.C. 1305(d)) is amended— 3 (A) in paragraph (2), by striking the semi-4 colon at the end and inserting ‘‘; and’’; 5 (B) in paragraph (3), by striking ‘‘; and’’ 6 and inserting a period; and 7 (C) by striking paragraph (4). 8 (2) CERTAIN REPORTS REQUIRED BY NATIONAL 9 TELECOMMUNICATIONS AND INFORMATION ADMINIS -10 TRATION ORGANIZATION ACT .—Sections 154, 155, 11 and 156 of the National Telecommunications and 12 Information Administration Organization Act are re-13 pealed. 14 (3) I NITIAL REPORT REQUIRED BY SECTION 15 9202(a)(1)(G) OF THE NDAA FOR FISCAL YEAR 16 2021.—Section 9202(a)(1)(G) of the William M. 17 (Mac) Thornberry National Defense Authorization 18 Act for Fiscal Year 2021 (47 U.S.C. 906(a)(1)(G)) 19 is amended— 20 (A) in clause (ii), by redesignating sub-21 clauses (I), (II), and (III) as clauses (i), (ii), 22 and (iii), respectively, and conforming the mar-23 gins of such clauses accordingly; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00167 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 168 •HR 1768 IH (B) by striking ‘‘R EPORTS TO CONGRESS ’’ 1 and all that follows through ‘‘For each fiscal 2 year’’ and inserting ‘‘A NNUAL REPORT TO CON -3 GRESS.—For each fiscal year’’. 4 (4) REPORT TO PRESIDENT .—Section 105(a) of 5 the National Telecommunications and Information 6 Administration Organization Act (47 U.S.C. 904(a)) 7 is amended— 8 (A) by striking paragraph (2); and 9 (B) by redesignating paragraph (3) as 10 paragraph (2). 11 (5) E FFECT ON AUTHORITY .—Nothing in this 12 subsection or the amendments made by this sub-13 section may be construed to expand or contract the 14 authority of the Secretary, the Under Secretary, the 15 NTIA, or the Commission. 16 (6) O THER REPORTS .—Nothing in this sub-17 section or the amendments made by this subsection 18 may be construed to prohibit or otherwise prevent 19 the Secretary, the Under Secretary, the NTIA, or 20 the Commission from producing any additional re-21 ports otherwise within the authority of the Sec-22 retary, the Under Secretary, the NTIA, or the Com-23 mission, respectively. 24 (b) CONSOLIDATED ANNUAL REPORT.— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00168 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 169 •HR 1768 IH (1) I N GENERAL .—In the first quarter of each 1 calendar year, the Under Secretary shall publish on 2 the website of the NTIA and submit to the Com-3 mittee on Energy and Commerce of the House of 4 Representatives and the Committee on Commerce, 5 Science, and Transportation of the Senate a report 6 that contains the reports described in paragraph (2) 7 for the fiscal year ending most recently before the 8 beginning of such quarter. 9 (2) R EPORTS DESCRIBED .—The reports de-10 scribed in this paragraph are the following: 11 (A) The report required by section 12 903(c)(2)(C) of division FF of the Consolidated 13 Appropriations Act, 2021 (47 U.S.C. 14 1307(c)(2)(C)). 15 (B) If amounts in the Public Wireless Sup-16 ply Chain Innovation Fund established by sec-17 tion 9202(a)(1)(A)(i) of the William M. (Mac) 18 Thornberry National Defense Authorization Act 19 for Fiscal Year 2021 (47 U.S.C. 20 906(a)(1)(A)(i)) were available for the fiscal 21 year described in paragraph (1) of this sub-22 section, the report required by section 23 9202(a)(1)(G) of such Act (47 U.S.C. 24 906(a)(1)(G)). 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00169 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 170 •HR 1768 IH (C) If the Under Secretary awarded grants 1 under section 60304(d)(1) of the Infrastructure 2 Investment and Jobs Act (47 U.S.C. 3 1723(d)(1)) in the fiscal year described in para-4 graph (1) of this subsection, the report required 5 by section 60306(a)(1)(A) of such Act (47 6 U.S.C. 1725(a)(1)(A)). 7 (3) T IMING OF UNDERLYING REPORTING RE -8 QUIREMENTS.— 9 (A) R EPORT OF OFFICE OF INTERNET 10 CONNECTIVITY AND GROWTH .—Section 11 903(c)(2)(C) of division FF of the Consolidated 12 Appropriations Act, 2021 (47 U.S.C. 13 1307(c)(2)(C)) is amended— 14 (i) in the matter preceding clause 15 (i)— 16 (I) by striking ‘‘Not later than 1 17 year after the date of the enactment 18 of this Act, and every year there-19 after,’’ and inserting ‘‘In the first 20 quarter of each calendar year,’’; 21 (II) by inserting ‘‘, for the fiscal 22 year ending most recently before the 23 beginning of such quarter,’’ after ‘‘a 24 report’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00170 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 171 •HR 1768 IH (ii) in clause (i), by striking ‘‘for the 1 previous year’’. 2 (B) R EPORT ON DIGITAL EQUITY GRANT 3 PROGRAMS.—Section 60306(a)(1) of the Infra-4 structure Investment and Jobs Act (47 U.S.C. 5 1725(a)(1)) is amended— 6 (i) in the matter preceding subpara-7 graph (A), by striking ‘‘Not later than 1 8 year’’ and all that follows through ‘‘shall— 9 ’’ and inserting the following: ‘‘For the 10 first fiscal year in which the Under Sec-11 retary awards grants under section 12 60304(d)(1), and each fiscal year there-13 after in which the Under Secretary awards 14 grants under such section, the Under Sec-15 retary shall—’’; and 16 (ii) in subparagraph (A)— 17 (I) by inserting ‘‘in the first 18 quarter of the first calendar year that 19 begins after the end of such fiscal 20 year,’’ before ‘‘submit’’; and 21 (II) by striking ‘‘, for the year 22 covered by the report’’. 23 (4) S ATISFACTION OF UNDERLYING REPORTING 24 REQUIREMENTS.— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00171 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 172 •HR 1768 IH (A) I N GENERAL .—Except as provided in 1 subparagraph (B), the publication and submis-2 sion of a report as required by paragraph (1) 3 in the first quarter of a calendar year shall be 4 treated as satisfying any requirement to publish 5 or otherwise make publicly available or to sub-6 mit to Congress or to a committee of Congress 7 a report described in paragraph (2) for the fis-8 cal year ending most recently before the begin-9 ning of such quarter. 10 (B) C ERTAIN SUBMISSION REQUIRE -11 MENTS.—At the time when the Under Secretary 12 submits a report required by paragraph (1) to 13 the committees described in such paragraph, 14 the Under Secretary shall submit any portion of 15 such report that relates to a report described in 16 paragraph (2)(C) to each committee of Con-17 gress not described in paragraph (1) to which 18 such report would (without regard to subpara-19 graph (A) of this paragraph) be required to be 20 submitted. 21 (5) A PPLICABILITY.—Paragraph (1), and the 22 amendments made by paragraph (3), shall apply be-23 ginning on January 1 of the first calendar year that 24 begins after the date of the enactment of this Act. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00172 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 173 •HR 1768 IH (c) EXTENSION OF CERTAIN AUDIT AND REPORTING 1 REQUIREMENTS.—Section 902(c)(4)(A) of division N of 2 the Consolidated Appropriations Act, 2021 (47 U.S.C. 3 1306(c)(4)(A)) is amended by striking ‘‘fiscal years 2021 4 and 2022’’ and inserting ‘‘fiscal years 2021, 2022, 2023, 5 and 2024’’. 6 (d) D EFINITION.—In this section, the term ‘‘Sec-7 retary’’ means the Secretary of Commerce. 8 Subtitle B—Office of Spectrum 9 Management 10 SEC. 1621. OFFICE OF SPECTRUM MANAGEMENT. 11 Part A of the National Telecommunications and In-12 formation Administration Organization Act (47 U.S.C. 13 901 et seq.) is amended by adding at the end the fol-14 lowing: 15 ‘‘SEC. 106. OFFICE OF SPECTRUM MANAGEMENT. 16 ‘‘(a) E STABLISHMENT.—There is established within 17 the NTIA an Office of Spectrum Management (in this sec-18 tion referred to as the ‘Office’). 19 ‘‘(b) HEAD OF OFFICE.— 20 ‘‘(1) I N GENERAL .—The head of the Office 21 shall be an Associate Administrator for Spectrum 22 Management (in this section referred to as the ‘As-23 sociate Administrator’). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00173 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 174 •HR 1768 IH ‘‘(2) R EQUIREMENT TO REPORT .—The Asso-1 ciate Administrator shall report to the Under Sec-2 retary (or a designee of the Under Secretary). 3 ‘‘(c) DUTIES.—The Associate Administrator shall, at 4 the direction of the Under Secretary— 5 ‘‘(1) carry out responsibilities under section 6 103(b)(2)(A) (relating to frequency assignments for 7 radio stations belonging to and operated by the 8 United States), make frequency allocations for fre-9 quencies that will be used by such stations, and de-10 velop and maintain techniques, databases, measure-11 ments, files, and procedures necessary for such allo-12 cations; 13 ‘‘(2) carry out responsibilities under section 14 103(b)(2)(K) (relating to establishing policies con-15 cerning spectrum assignments and use by radio sta-16 tions belonging to and operated by the United 17 States) and provide Federal agencies with guidance 18 to ensure that the conduct of telecommunications ac-19 tivities by such agencies is consistent with such poli-20 cies; 21 ‘‘(3) represent the interests of Federal agencies 22 in the process through which the Commission and 23 the NTIA jointly determine the National Table of 24 Frequency Allocations, and coordinate with the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00174 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 175 •HR 1768 IH Commission in the development of a comprehensive 1 long-range plan for improved management of all 2 electromagnetic spectrum resources; 3 ‘‘(4) appoint the chairpersons of and provide 4 secretariat functions for the Interdepartmental 5 Radio Advisory Committee and the Interagency 6 Spectrum Advisory Council; 7 ‘‘(5) carry out responsibilities under section 8 103(b)(2)(B) (relating to authorizing a foreign gov-9 ernment to construct and operate a radio station at 10 the seat of Government of the United States) and 11 assign frequencies for use by such stations; 12 ‘‘(6) provide advice and assistance to the Under 13 Secretary and coordinate with the Associate Admin-14 istrator for International Affairs in carrying out 15 spectrum management aspects of the international 16 policy responsibilities of the NTIA, including spec-17 trum-related responsibilities under section 18 103(b)(2)(G); 19 ‘‘(7) carry out spectrum-related responsibilities 20 under section 103(b)(2)(H) (relating to coordination 21 of the telecommunications activities of the executive 22 branch and assistance in the formulation of policies 23 and standards for such activities); 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00175 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 176 •HR 1768 IH ‘‘(8) carry out spectrum-related responsibilities 1 under section 103(b)(2)(Q) (relating to certain ac-2 tivities with respect to telecommunications re-3 sources); and 4 ‘‘(9) carry out any other duties of the NTIA 5 with respect to spectrum policy that the Under Sec-6 retary may designate.’’. 7 Subtitle C—Office of International 8 Affairs 9 SEC. 1631. OFFICE OF INTERNATIONAL AFFAIRS. 10 Part A of the National Telecommunications and In-11 formation Administration Organization Act (47 U.S.C. 12 901 et seq.), as amended by the preceding provisions of 13 this title, is further amended by adding at the end the 14 following: 15 ‘‘SEC. 107. OFFICE OF INTERNATIONAL AFFAIRS. 16 ‘‘(a) E STABLISHMENT.—There is established within 17 the NTIA an Office of International Affairs (in this sec-18 tion referred to as the ‘Office’). 19 ‘‘(b) HEAD OF OFFICE.— 20 ‘‘(1) I N GENERAL .—The head of the Office 21 shall be an Associate Administrator for International 22 Affairs (in this section referred to as the ‘Associate 23 Administrator’). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00176 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 177 •HR 1768 IH ‘‘(2) R EQUIREMENT TO REPORT .—The Asso-1 ciate Administrator shall report to the Under Sec-2 retary (or a designee of the Under Secretary). 3 ‘‘(c) DUTIES.—The Associate Administrator shall, at 4 the direction of the Under Secretary— 5 ‘‘(1) in coordination with the Secretary of 6 State, conduct analysis of, review, and formulate 7 international telecommunications and information 8 policy; 9 ‘‘(2) present on international telecommuni-10 cations and information policy— 11 ‘‘(A) before the Commission, Congress, 12 and others; and 13 ‘‘(B) in coordination with the Secretary of 14 State, before international telecommunications 15 bodies, including the International Tele-16 communication Union; 17 ‘‘(3) conduct or obtain analysis on economic 18 and other aspects of international telecommuni-19 cations and information policy; 20 ‘‘(4) formulate, and recommend to the Under 21 Secretary, polices and plans with respect to prepara-22 tion for and participation in international tele-23 communications and information policy activities; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00177 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 178 •HR 1768 IH ‘‘(5) in coordination with the Secretary of 1 State, coordinate NTIA and interdepartmental eco-2 nomic, technical, operational, and other preparations 3 related to participation by the United States in 4 international telecommunications and information 5 policy conferences and negotiations; 6 ‘‘(6) ensure NTIA representation with respect 7 to international telecommunications and information 8 policy meetings and the activities related to prepara-9 tion for such meetings; 10 ‘‘(7) in coordination with the Secretary of 11 State, coordinate with Federal agencies and private 12 organizations engaged in activities involving inter-13 national telecommunications and information policy 14 matters and maintain cognizance of the activities of 15 United States signatories with respect to related 16 treaties, agreements, and other instruments; 17 ‘‘(8) provide advice and assistance related to 18 international telecommunications and information 19 policy to other Federal agencies charged with re-20 sponsibility for international negotiations, to 21 strengthen the position and serve the best interests 22 of the United States in the conduct of negotiations 23 with foreign nations; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00178 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 179 •HR 1768 IH ‘‘(9) provide advice and assistance to the Under 1 Secretary with respect to evaluating the inter-2 national impact of matters pending before the Com-3 mission, other Federal agencies, and Congress; 4 ‘‘(10) carry out, at the request of the Secretary, 5 the responsibilities of the Secretary under the Com-6 munications Satellite Act of 1962 (47 U.S.C. 701 et 7 seq.) and other Federal laws related to international 8 telecommunications and information policy; and 9 ‘‘(11) carry out any other duties of the NTIA 10 with respect to international telecommunications and 11 information policy that the Under Secretary may 12 designate.’’. 13 DIVISION C—HEALTH 14 TITLE I—MEDICAID 15 SEC. 101. STREAMLINED ENROLLMENT PROCESS FOR ELI-16 GIBLE OUT-OF-STATE PROVIDERS UNDER 17 MEDICAID AND CHIP. 18 (a) IN GENERAL.—Section 1902(kk) of the Social Se-19 curity Act (42 U.S.C. 1396a(kk)) is amended by adding 20 at the end the following new paragraph: 21 ‘‘(10) S TREAMLINED ENROLLMENT PROCESS 22 FOR ELIGIBLE OUT -OF-STATE PROVIDERS .— 23 ‘‘(A) IN GENERAL .—The State— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00179 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 180 •HR 1768 IH ‘‘(i) adopts and implements a process 1 to allow an eligible out-of-State provider to 2 enroll under the State plan (or a waiver of 3 such plan) to furnish items and services to, 4 or order, prescribe, refer, or certify eligi-5 bility for items and services for, qualifying 6 individuals without the imposition of 7 screening or enrollment requirements by 8 such State that exceed the minimum nec-9 essary for such State to provide payment 10 to an eligible out-of-State provider under 11 such State plan (or a waiver of such plan), 12 such as the provider’s name and National 13 Provider Identifier (and such other infor-14 mation specified by the Secretary); and 15 ‘‘(ii) provides that an eligible out-of- 16 State provider that enrolls as a partici-17 pating provider in the State plan (or a 18 waiver of such plan) through such process 19 shall be so enrolled for a 5-year period, un-20 less the provider is terminated or excluded 21 from participation during such period. 22 ‘‘(B) DEFINITIONS.—In this paragraph: 23 ‘‘(i) E LIGIBLE OUT -OF-STATE PRO -24 VIDER.—The term ‘eligible out-of-State 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00180 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 181 •HR 1768 IH provider’ means, with respect to a State, a 1 provider— 2 ‘‘(I) that is located in any other 3 State; 4 ‘‘(II) that— 5 ‘‘(aa) was determined by the 6 Secretary to have a limited risk 7 of fraud, waste, and abuse for 8 purposes of determining the level 9 of screening to be conducted 10 under section 1866(j)(2), has 11 been so screened under such sec-12 tion 1866(j)(2), and is enrolled in 13 the Medicare program under title 14 XVIII; or 15 ‘‘(bb) was determined by the 16 State agency administering or su-17 pervising the administration of 18 the State plan (or a waiver of 19 such plan) of such other State to 20 have a limited risk of fraud, 21 waste, and abuse for purposes of 22 determining the level of screening 23 to be conducted under paragraph 24 (1) of this subsection, has been 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00181 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 182 •HR 1768 IH so screened under such para-1 graph (1), and is enrolled under 2 such State plan (or a waiver of 3 such plan); and 4 ‘‘(III) that has not been— 5 ‘‘(aa) excluded from partici-6 pation in any Federal health care 7 program pursuant to section 8 1128 or 1128A; 9 ‘‘(bb) excluded from partici-10 pation in the State plan (or a 11 waiver of such plan) pursuant to 12 part 1002 of title 42, Code of 13 Federal Regulations (or any suc-14 cessor regulation), or State law; 15 or 16 ‘‘(cc) terminated from par-17 ticipating in a Federal health 18 care program or the State plan 19 (or a waiver of such plan) for a 20 reason described in paragraph 21 (8)(A). 22 ‘‘(ii) Q UALIFYING INDIVIDUAL .—The 23 term ‘qualifying individual’ means an indi-24 vidual under 21 years of age who is en-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00182 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 183 •HR 1768 IH rolled under the State plan (or waiver of 1 such plan). 2 ‘‘(iii) S TATE.—The term ‘State’ 3 means 1 of the 50 States or the District 4 of Columbia.’’. 5 (b) CONFORMING AMENDMENTS.— 6 (1) Section 1902(a)(77) of the Social Security 7 Act (42 U.S.C. 1396a(a)(77)) is amended by insert-8 ing ‘‘enrollment,’’ after ‘‘screening,’’. 9 (2) The subsection heading for section 10 1902(kk) of such Act (42 U.S.C. 1396a(kk)) is 11 amended by inserting ‘‘enrollment,’’ after ‘‘screen-12 ing,’’. 13 (3) Section 2107(e)(1)(G) of such Act (42 14 U.S.C. 1397gg(e)(1)(G)) is amended by inserting 15 ‘‘enrollment,’’ after ‘‘screening,’’. 16 (c) E FFECTIVE DATE.—The amendments made by 17 this section shall take effect on the date that is 3 years 18 after the date of enactment of this Act. 19 SEC. 102. MAKING CERTAIN ADJUSTMENTS TO COVERAGE 20 OF HOME OR COMMUNITY-BASED SERVICES 21 UNDER MEDICAID. 22 (a) I NCREASING TRANSPARENCY OF HCBS C OV-23 ERAGE UNDER MEDICAID.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00183 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 184 •HR 1768 IH (1) I N GENERAL .—Section 1915(c) of the So-1 cial Security Act (42 U.S.C. 1396n(c)) is amend-2 ed— 3 (A) in paragraph (2)— 4 (i) in subparagraph (E)— 5 (I) by inserting ‘‘, not less fre-6 quently than’’ before ‘‘annually’’; and 7 (II) by inserting ‘‘(including, 8 with respect to such information pro-9 vided on or after July 9, 2027, the in-10 formation specified in paragraph 11 (11))’’ before the period at the end; 12 and 13 (ii) by adding at the end the following 14 flush sentence: 15 ‘‘The Secretary shall make all information provided 16 under subparagraph (E) on or after the date of the 17 enactment of this sentence publicly available on the 18 website of the Centers for Medicare & Medicaid 19 Services.’’; and 20 (B) by adding at the end the following new 21 paragraph: 22 ‘‘(11) For purposes of paragraph (2)(E), the 23 information specified in this paragraph is the fol-24 lowing: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00184 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 185 •HR 1768 IH ‘‘(A) In the case of a State that limits the 1 number of individuals who may be provided 2 home or community-based services under a 3 waiver granted under this subsection and main-4 tains a list of individuals waiting to enroll in 5 such waiver, a description of how the State 6 maintains such list, including— 7 ‘‘(i) information on whether the State 8 screens individuals on such list to deter-9 mine whether such individuals are eligible 10 to receive such services under such waiver; 11 ‘‘(ii) information on whether (and, if 12 applicable, how often) the State periodi-13 cally re-screens individuals on such list for 14 eligibility; 15 ‘‘(iii) the number of people on such 16 list of individuals waiting to enroll in such 17 waiver; and 18 ‘‘(iv) the average amount of time that 19 individuals newly enrolled in such waiver 20 within the past 12 months were on such 21 list of individuals waiting to enroll in such 22 waiver. 23 ‘‘(B) With respect to homemaker services, 24 home health aide services, personal care serv-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00185 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 186 •HR 1768 IH ices, and habilitation services furnished under 1 waivers under this subsection, by each such 2 service type— 3 ‘‘(i) for individuals newly receiving 4 such services within the past 12 months, 5 the average amount of time (which may be 6 determined using statistically valid random 7 sampling of such individuals) from when 8 such services are initially approved for 9 such an individual to when such individual 10 begins receiving such services; and 11 ‘‘(ii) the percentage of authorized 12 hours (which may be determined using sta-13 tistically valid random sampling of individ-14 uals authorized to receive such services) 15 that are provided within the past 12 16 months.’’. 17 (2) CONFORMING AMENDMENTS .—Section 1915 18 of the Social Security Act (42 U.S.C. 1396n) is 19 amended— 20 (A) in subsection (i) by adding at the end 21 the following new paragraph: 22 ‘‘(8) R EPORTING REQUIREMENT .—With respect 23 to homemaker services, home health aide services, 24 personal care services, and habilitation services pro-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00186 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 187 •HR 1768 IH vided under this subsection on or after July 9, 2027, 1 the State, not less frequently than annually, shall 2 provide to the Secretary the same information re-3 garding such services as the State is required to pro-4 vide under subsection (c)(11)(B).’’; 5 (B) in subsection (j)(2)(E), by inserting 6 after the second sentence the following: ‘‘With 7 respect to any homemaker services, home health 8 aide services, personal care services, and habili-9 tation services provided under this subsection 10 on or after July 9, 2027, the State, not less fre-11 quently than annually, shall provide to the Sec-12 retary the same information regarding such 13 services as the State is required to provide 14 under subsection (c)(11)(B).’’; and 15 (C) in subsection (k)(3)(E)— 16 (i) by striking ‘‘and’’ after ‘‘the cost 17 of such services and supports,’’; and 18 (ii) by inserting before the period, the 19 following: ‘‘, and with respect to home-20 maker services, home health aide services, 21 personal care services, and habilitation 22 services provided under this subsection on 23 or after July 9, 2027, not less frequently 24 than annually, the same information re-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00187 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 188 •HR 1768 IH garding such services as the State is re-1 quired to provide under subsection 2 (c)(11)(B)’’. 3 (b) D EMONSTRATION PROGRAM TO EXPAND HCBS 4 COVERAGE UNDER SECTION 1915(C) WAIVERS.—Section 5 1915(c) of the Social Security Act (42 U.S.C. 1396n(c)), 6 as amended by subsection (a), is further amended— 7 (1) in paragraph (2)(E), by inserting ‘‘, and the 8 information specified in paragraph (12)(C)(v), when 9 applicable’’ after ‘‘paragraph (11)’’; and 10 (2) by adding at the end the following new 11 paragraph: 12 ‘‘(12) D EMONSTRATION PROGRAM TO EXPAND 13 COVERAGE FOR HOME OR COMMUNITY -BASED SERV -14 ICES.— 15 ‘‘(A) IN GENERAL .— 16 ‘‘(i) A PPROVAL.—Not later than 24 17 months after the date on which the plan-18 ning grants under subparagraph (B) are 19 awarded, notwithstanding paragraph (1), 20 the Secretary may approve a waiver that is 21 standalone from any other waiver approved 22 under this subsection for not more than 5 23 States, selected in accordance with clause 24 (ii), to include as medical assistance under 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00188 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 189 •HR 1768 IH the State plan of such State, for the 3-year 1 period beginning on the date of such ap-2 proval, payment for part or all of the cost 3 of home or community-based services 4 (other than room and board (as described 5 in paragraph (1))) approved by the Sec-6 retary which are provided pursuant to a 7 written plan of care to individuals de-8 scribed in subparagraph (C)(iii). 9 ‘‘(ii) S ELECTION CRITERIA .—In se-10 lecting States for purposes of clause (i), 11 the Secretary shall— 12 ‘‘(I) only select States that re-13 ceived a planning grant under sub-14 paragraph (B); 15 ‘‘(II) only select States that meet 16 the requirements specified in subpara-17 graph (C) and such other require-18 ments as the Secretary may determine 19 appropriate; 20 ‘‘(III) select States in a manner 21 that ensures geographic diversity; 22 ‘‘(IV) give preference to States 23 with a higher percentage (relative to 24 other States that apply to be selected 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00189 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 190 •HR 1768 IH for purposes of clause (i)) of the total 1 State population residing in rural 2 areas (as determined by the Sec-3 retary); 4 ‘‘(V) give preference to States 5 that have demonstrated more progress 6 in rebalancing long-term services and 7 supports systems under this title, as 8 determined based on the relative share 9 of individuals who use home or com-10 munity-based services (as defined by 11 the Secretary) under this title as a 12 percentage of total individuals who 13 use long-term services and supports 14 (as defined by the Secretary) under 15 this title (in the most recent year for 16 which such data is available); and 17 ‘‘(VI) give preference to States 18 that pursue a waiver under this para-19 graph that incorporates the provision 20 of mental health services for adults 21 with serious mental illness, children 22 with serious emotional disturbances, 23 or individuals with substance use dis-24 order. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00190 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 191 •HR 1768 IH ‘‘(B) PLANNING GRANTS .— 1 ‘‘(i) IN GENERAL .— 2 ‘‘(I) A PPROVAL.—Not later than 3 18 months after the date of the enact-4 ment of this paragraph, the Secretary 5 shall award planning grants of not 6 more than $5,000,000 each to not 7 more than 10 States for purposes of 8 preparing to submit a request for a 9 waiver under this subsection (includ-10 ing for costs to implement the waiver 11 or other activities to expand the provi-12 sion of home or community-based 13 services under this section) to provide 14 home or community-based services to 15 individuals described in subparagraph 16 (C)(iii). 17 ‘‘(II) S ELECTION CRITERIA .—In 18 awarding planning grants under sub-19 clause (I), the Secretary shall use the 20 selection criteria specified in sub-21 clauses (III) through (VI) of subpara-22 graph (A)(ii). 23 ‘‘(ii) CONSULTATION.—A State that is 24 awarded a planning grant under clause (i) 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00191 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 192 •HR 1768 IH shall, in preparing to submit a request for 1 a waiver described in such clause, consult 2 with— 3 ‘‘(I) individuals in need of (and 4 not receiving) home or community- 5 based services, individuals receiving 6 home or community-based services, 7 and the caregivers of such individuals; 8 ‘‘(II) providers furnishing home 9 or community-based services; and 10 ‘‘(III) such other stakeholders, as 11 the Secretary may specify. 12 ‘‘(C) S TATE REQUIREMENTS .—In addition 13 to the requirements specified under this sub-14 section (except for the requirements described 15 in subparagraphs (C) and (D) of paragraph (2) 16 and any other requirement the Secretary deter-17 mines to be inapplicable in the context of a 18 waiver relation to individuals who do not re-19 quire the level of care described in paragraph 20 (1)), the requirements specified in this para-21 graph are, with respect to a State, the fol-22 lowing: 23 ‘‘(i) As of the date that such State re-24 quests a waiver under this subsection to 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00192 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 193 •HR 1768 IH provide home or community-based services 1 to individuals described in clause (iii), all 2 other waivers (if any) granted under this 3 subsection to such State meet the require-4 ments of this subsection. 5 ‘‘(ii) The State demonstrates to the 6 Secretary that approval of a waiver under 7 this subsection with respect to individuals 8 described in clause (iii) will not result in a 9 material increase of the average amount of 10 time that individuals with respect to whom 11 a determination described in paragraph (1) 12 has been made will need to wait to receive 13 home or community-based services under 14 any waiver granted under this subsection, 15 as determined by the Secretary. 16 ‘‘(iii) The State establishes needs- 17 based criteria, subject to the approval of 18 the Secretary, to identify individuals for 19 whom a determination described in para-20 graph (1) is not applicable, who will be eli-21 gible for home or community-based serv-22 ices under a waiver approved under this 23 paragraph, and specifies the home or com-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00193 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 194 •HR 1768 IH munity-based services such individuals so 1 eligible will receive. 2 ‘‘(iv) The State established needs- 3 based criteria for determining whether an 4 individual described in clause (iii) requires 5 the level of care provided in a hospital, 6 nursing facility, or an intermediate care fa-7 cility for individuals with developmental 8 disabilities under the State plan or under 9 any waiver of such plan that are more 10 stringent than the needs-based criteria es-11 tablished under clause (iii) for determining 12 eligibility for home or community-based 13 services. 14 ‘‘(v) The State attests that the State’s 15 average per capita expenditure for medical 16 assistance under the State plan (or waiver 17 of such plan) provided with respect to such 18 individuals enrolled in a waiver under this 19 paragraph will not exceed the State’s aver-20 age per capita expenditures for medical as-21 sistance for individuals receiving institu-22 tional care under the State plan (or waiver 23 of such plan) for the duration that the 24 waiver under this paragraph is in effect. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00194 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 195 •HR 1768 IH ‘‘(vi) The State provides to the Sec-1 retary data (in such form and manner as 2 the Secretary may specify) regarding the 3 number of individuals described in clause 4 (i) with respect to a State seeking approval 5 of a waiver under this subsection, to whom 6 the State will make such services available 7 under such waiver. 8 ‘‘(vii) The State agrees to provide to 9 the Secretary, not less frequently than an-10 nually, data for purposes of paragraph 11 (2)(E) (in such form and manner as the 12 Secretary may specify) regarding, with re-13 spect to each preceding year in which a 14 waiver under this subsection to provide 15 home and community-based services to in-16 dividuals described in clause (iii) was in ef-17 fect— 18 ‘‘(I) the cost (as such term is de-19 fined by the Secretary) of such serv-20 ices furnished to individuals described 21 in clause (iii), broken down by type of 22 service; 23 ‘‘(II) with respect to each type of 24 home and community-based service 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00195 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 196 •HR 1768 IH provided under the waiver, the length 1 of time that such individuals have re-2 ceived such service; 3 ‘‘(III) a comparison between the 4 data described in subclause (I) and 5 any comparable data available with 6 respect to individuals with respect to 7 whom a determination described in 8 paragraph (1) has been made and 9 with respect to individuals receiving 10 institutional care under this title; and 11 ‘‘(IV) the number of individuals 12 who have received home and commu-13 nity-based services under the waiver 14 during the preceding year.’’. 15 (c) NON-APPLICATION OF THE PAPERWORK REDUC-16 TION ACT.—Chapter 35 of title 44, United States Code 17 (commonly referred to as the ‘‘Paperwork Reduction Act 18 of 1995’’), shall not apply to the implementation of the 19 amendments made by subsections (a) and (b). 20 (d) CMS G UIDANCE TO STATES ON INTERIM COV-21 ERAGE UNDER SECTION 1915 H OME AND COMMUNITY- 22 BASED SERVICES AUTHORITIES.—Not later than January 23 1, 2027, the Secretary of Health and Human Services 24 shall issue guidance to the States to clarify how a State 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00196 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 197 •HR 1768 IH may provide, with respect to an individual who is eligible 1 for home and community-based services under section 2 1915 of the Social Security Act (42 U.S.C. 1396n), cov-3 erage of such services pursuant to a provisional written 4 plan of care, pending finalization, with respect to such in-5 dividual. 6 (e) FUNDING.— 7 (1) I N GENERAL .—There are appropriated, out 8 of any funds in the Treasury not otherwise obli-9 gated, $71,000,000 for fiscal year 2025, to remain 10 available until expended, to the Secretary of Health 11 and Human Services for purposes of carrying out 12 subsection (d) and the amendments made by sub-13 section (b). 14 (2) RESERVATION FOR PLANNING GRANTS .—Of 15 the amount appropriated under paragraph (1), the 16 Secretary of Health and Human Services shall re-17 serve $50,000,000 of such amount to award plan-18 ning grants under the demonstration program estab-19 lished by the amendments made by subsection (b). 20 SEC. 103. REMOVING CERTAIN AGE RESTRICTIONS ON MED-21 ICAID ELIGIBILITY FOR WORKING ADULTS 22 WITH DISABILITIES. 23 (a) MODIFICATION OF OPTIONAL BUY-IN GROUPS.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00197 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 198 •HR 1768 IH (1) I N GENERAL .—Section 1 1902(a)(10)(A)(ii)(XV) of the Social Security Act 2 (42 U.S.C. 1396a(a)(10)(A)(ii)(XV)) is amended by 3 striking ‘‘but less than 65,’’. 4 (2) D EFINITION MODIFICATION .—Section 5 1905(v)(1)(A) of the Social Security Act (42 U.S.C. 6 1396d(v)(1)(A)) is amended by striking ‘‘, but less 7 than 65,’’. 8 (b) A PPLICATION TO CERTAIN STATES.—A State 9 that, as of the date of enactment of this Act, provides for 10 making medical assistance available to individuals de-11 scribed in subclause (XV) or (XVI) of section 12 1902(a)(10)(A)(ii) of the Social Security Act (42 U.S.C. 13 1396a(a)(10)(A)(ii)) shall not be regarded as failing to 14 comply with the requirements of either such subclause (as 15 amended by subsection (a)(1)) or with section 16 1905(v)(1)(A) of the Social Security Act (42 U.S.C. 17 1396d(v)(1)(A)) (as amended by subsection (a)(2)) before 18 January 1, 2027. 19 SEC. 104. MEDICAID STATE PLAN REQUIREMENT FOR DE-20 TERMINING RESIDENCY AND COVERAGE FOR 21 MILITARY FAMILIES. 22 (a) I N GENERAL.—Section 1902 of the Social Secu-23 rity Act (42 U.S.C. 1396a) is amended— 24 (1) in subsection (a)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00198 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 199 •HR 1768 IH (A) in paragraph (86), by striking ‘‘and’’ 1 at the end; 2 (B) in paragraph (87), by striking the pe-3 riod at the end and inserting ‘‘; and’’; and 4 (C) by inserting after paragraph (87), the 5 following new paragraph: 6 ‘‘(88) beginning January 1, 2028, provide, with 7 respect to an active duty relocated individual (as de-8 fined in subsection (uu)(1))— 9 ‘‘(A) that, for purposes of determining eli-10 gibility for medical assistance under the State 11 plan (or waiver of such plan), such active duty 12 relocated individual is treated as a resident of 13 the State unless such individual voluntarily 14 elects not to be so treated for such purposes; 15 ‘‘(B) that if, at the time of relocation (as 16 described in subsection (uu)(1)), such active 17 duty relocated individual is on a home and com-18 munity-based services waiting list (as defined in 19 subsection (uu)(2)), such individual remains on 20 such list until— 21 ‘‘(i) the State completes an assess-22 ment and renders a decision with respect 23 to the eligibility of such individual to re-24 ceive the relevant home and community- 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00199 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 200 •HR 1768 IH based services at the time a slot for such 1 services becomes available and, in the case 2 such decision is a denial of such eligibility, 3 such individual has exhausted the individ-4 ual’s opportunity for a fair hearing; or 5 ‘‘(ii) such individual elects to be re-6 moved from such list; and 7 ‘‘(C) payment for medical assistance fur-8 nished under the State plan (or a waiver of the 9 plan) on behalf of such active duty relocated in-10 dividual in the military service relocation State 11 (as referred to in subsection (uu)(1)(B)(i)), to 12 the extent that such assistance is available in 13 such military service relocation State in accord-14 ance with such guidance as the Secretary may 15 issue to ensure access to such assistance.’’; and 16 (2) by adding at the end the following new sub-17 section: 18 ‘‘(uu) ACTIVE DUTY RELOCATED INDIVIDUAL; HOME 19 AND COMMUNITY-BASED SERVICES WAITING LIST.—For 20 purposes of subsection (a)(88) and this subsection: 21 ‘‘(1) A CTIVE DUTY RELOCATED INDIVIDUAL .— 22 The term ‘active duty relocated individual’ means an 23 individual— 24 ‘‘(A) who— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00200 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 201 •HR 1768 IH ‘‘(i) is enrolled under the State plan 1 (or waiver of such plan); or 2 ‘‘(ii) with respect to an individual de-3 scribed in subparagraph (C)(ii), would be 4 so enrolled pursuant to subsection 5 (a)(10)(A)(ii)(VI) if such individual began 6 receiving home and community-based serv-7 ices; 8 ‘‘(B) who— 9 ‘‘(i) is a member of the Armed Forces 10 engaged in active duty service and is relo-11 cated to another State (in this subsection 12 referred to as the ‘military service reloca-13 tion State’) by reason of such service; 14 ‘‘(ii) would be described in clause (i) 15 except that the individual stopped being 16 engaged in active duty service (including 17 by reason of retirement from such service) 18 and the last day on which the individual 19 was engaged in active duty service oc-20 curred not more than 12 months ago; or 21 ‘‘(iii) is a dependent (as defined by 22 the Secretary) of a member described in 23 clause (i) or (ii) who relocates to the mili-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00201 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 202 •HR 1768 IH tary service relocation State with such 1 member; and 2 ‘‘(C) who— 3 ‘‘(i) was receiving home and commu-4 nity-based services (as defined in section 5 9817(a)(2)(B) of the American Rescue 6 Plan Act of 2021) at the time of such relo-7 cation; or 8 ‘‘(ii) if the State maintains a home 9 and community-based services waiting list, 10 was on such home and community-based 11 services waiting list at the time of such re-12 location. 13 ‘‘(2) H OME AND COMMUNITY -BASED SERVICES 14 WAITING LIST .—The term ‘home and community- 15 based services waiting list’ means, in the case of a 16 State that has a limit on the number of individuals 17 who may receive home and community-based services 18 under section 1115(a), section 1915(c), or section 19 1915(j), a list maintained by such State of individ-20 uals who are requesting to receive such services 21 under 1 or more such sections but for whom the 22 State has not yet completed an assessment and ren-23 dered a decision with respect to the eligibility of 24 such individuals to receive the relevant home and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00202 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 203 •HR 1768 IH community-based services at the time a slot for such 1 services becomes available due to such limit.’’. 2 (b) I MPLEMENTATION FUNDING.—There are appro-3 priated, out of any funds in the Treasury not otherwise 4 obligated, $1,000,000 for each of fiscal years 2025 5 through 2029, to remain available until expended, to the 6 Secretary of Health and Human Services for purposes of 7 implementing the amendments made by subsection (a). 8 SEC. 105. ENSURING THE RELIABILITY OF ADDRESS INFOR-9 MATION PROVIDED UNDER THE MEDICAID 10 PROGRAM. 11 (a) IN GENERAL.—Section 1902(a) of the Social Se-12 curity Act (42 U.S.C. 1396a(a)), as previously amended 13 by this title, is amended— 14 (1) in paragraph (87), by striking ‘‘and’’ at the 15 end; 16 (2) in paragraph (88), by striking the period at 17 the end and inserting ‘‘; and’’; and 18 (3) by inserting after paragraph (88) the fol-19 lowing new paragraph: 20 ‘‘(89) beginning January 1, 2026, provide for a 21 process to regularly obtain address information for 22 individuals enrolled under such plan (or a waiver of 23 such plan) from reliable data sources (as described 24 in section 435.919(f)(1)(iii) of title 42, Code of Fed-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00203 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 204 •HR 1768 IH eral Regulations (or a successor regulation)) and act 1 on any changes to such an address based on such in-2 formation in accordance with such section (or suc-3 cessor regulation), except that this paragraph shall 4 only apply in the case of the 50 States and the Dis-5 trict of Columbia.’’. 6 (b) A PPLICATION TO CHIP.—Section 2107(e)(1) of 7 the Social Security Act (42 U.S.C. 1397gg(e)(1)) is 8 amended— 9 (1) by redesignating subparagraphs (H) 10 through (U) as subparagraphs (I) through (V), re-11 spectively; and 12 (2) by inserting after subparagraph (G) the fol-13 lowing new subparagraph: 14 ‘‘(H) Section 1902(a)(89) (relating to reg-15 ularly obtaining address information for enroll-16 ees).’’. 17 (c) E NSURING TRANSMISSION OF ADDRESS INFOR-18 MATION FROM MANAGED CARE ORGANIZATIONS.—Sec-19 tion 1932 of the Social Security Act (42 U.S.C. 1396u– 20 2) is amended by adding at the end the following new sub-21 section: 22 ‘‘(j) T RANSMISSION OF ADDRESS INFORMATION.— 23 Beginning January 1, 2026, each contract under a State 24 plan with a managed care entity under section 1903(m) 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00204 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 205 •HR 1768 IH shall provide that the entity transmits to the State any 1 address information for an individual enrolled with the en-2 tity that is provided to such entity directly from, or 3 verified by such entity directly with, such individual.’’. 4 SEC. 106. CODIFYING CERTAIN MEDICAID PROVIDER 5 SCREENING REQUIREMENTS RELATED TO 6 DECEASED PROVIDERS. 7 Section 1902(kk)(1) of the Social Security Act (42 8 U.S.C. 1396a(kk)(1)) is amended— 9 (1) by striking ‘‘The State’’ and inserting: 10 ‘‘(A) IN GENERAL .—The State’’; and 11 (2) by adding at the end the following new sub-12 paragraph: 13 ‘‘(B) A DDITIONAL PROVIDER SCREEN -14 ING.—Beginning January 1, 2027, as part of 15 the enrollment (or reenrollment or revalidation 16 of enrollment) of a provider or supplier under 17 this title, and not less frequently than quarterly 18 during the period that such provider or supplier 19 is so enrolled, the State conducts a check of the 20 Death Master File (as such term is defined in 21 section 203(d) of the Bipartisan Budget Act of 22 2013) to determine whether such provider or 23 supplier is deceased.’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00205 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 206 •HR 1768 IH SEC. 107. MODIFYING CERTAIN STATE REQUIREMENTS FOR 1 ENSURING DECEASED INDIVIDUALS DO NOT 2 REMAIN ENROLLED. 3 Section 1902 of the Social Security Act (42 U.S.C. 4 1396a), as previously amended by this title, is amended— 5 (1) in subsection (a)— 6 (A) in paragraph (88), by striking ‘‘; and’’ 7 and inserting a semicolon; 8 (B) in paragraph (89), by striking the pe-9 riod at the end and inserting ‘‘; and’’; and 10 (C) by inserting after paragraph (89) the 11 following new paragraph: 12 ‘‘(90) provide that the State shall comply with 13 the eligibility verification requirements under sub-14 section (vv), except that this paragraph shall apply 15 only in the case of the 50 States and the District 16 of Columbia.’’; and 17 (2) by adding at the end the following new sub-18 section: 19 ‘‘(vv) V ERIFICATION OF CERTAIN ELIGIBILITY CRI-20 TERIA.— 21 ‘‘(1) I N GENERAL .—For purposes of subsection 22 (a)(90), the eligibility verification requirements, be-23 ginning January 1, 2026, are as follows: 24 ‘‘(A) Q UARTERLY SCREENING TO VERIFY 25 ENROLLEE STATUS .—The State shall, not less 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00206 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 207 •HR 1768 IH frequently than quarterly, review the Death 1 Master File (as such term is defined in section 2 203(d) of the Bipartisan Budget Act of 2013) 3 to determine whether any individuals enrolled 4 for medical assistance under the State plan (or 5 waiver of such plan) are deceased. 6 ‘‘(B) D ISENROLLMENT UNDER STATE 7 PLAN.—If the State determines, based on infor-8 mation obtained from the Death Master File, 9 that an individual enrolled for medical assist-10 ance under the State plan (or waiver of such 11 plan) is deceased, the State shall— 12 ‘‘(i) treat such information as factual 13 information confirming the death of a ben-14 eficiary for purposes of section 431.213(a) 15 of title 42, Code of Federal Regulations (or 16 any successor regulation); 17 ‘‘(ii) disenroll such individual from the 18 State plan (or waiver of such plan); and 19 ‘‘(iii) discontinue any payments for 20 medical assistance under this title made on 21 behalf of such individual (other than pay-22 ments for any items or services furnished 23 to such individual prior to the death of 24 such individual). 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00207 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 208 •HR 1768 IH ‘‘(C) R EINSTATEMENT OF COVERAGE IN 1 THE EVENT OF ERROR .—If a State determines 2 that an individual was misidentified as deceased 3 based on information obtained from the Death 4 Master File, and was erroneously disenrolled 5 from medical assistance under the State plan 6 (or waiver of such plan) based on such 7 misidentification, the State shall immediately 8 reenroll such individual under the State plan 9 (or waiver of such plan), retroactive to the date 10 of such disenrollment. 11 ‘‘(2) RULE OF CONSTRUCTION .—Nothing under 12 this subsection shall be construed to preclude the 13 ability of a State to use other electronic data sources 14 to timely identify potentially deceased beneficiaries, 15 so long as the State is also in compliance with the 16 requirements of this subsection (and all other re-17 quirements under this title relating to Medicaid eli-18 gibility determination and redetermination).’’. 19 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00208 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 209 •HR 1768 IH SEC. 108. ONE-YEAR DELAY OF MEDICAID AND CHIP RE-1 QUIREMENTS FOR HEALTH SCREENINGS, RE-2 FERRALS, AND CASE MANAGEMENT SERV-3 ICES FOR ELIGIBLE JUVENILES IN PUBLIC 4 INSTITUTIONS; STATE INTERIM WORK PLANS. 5 (a) I N GENERAL.—Section 5121(d) of subtitle C of 6 title V of division FF of the Consolidated Appropriations 7 Act, 2023 (Public Law 117–328) is amended— 8 (1) by striking ‘‘The amendments made by this 9 section’’ and inserting the following: 10 ‘‘(1) I N GENERAL .—Subject to paragraph (2), 11 the amendments made by this section’’; and 12 (2) by adding at the end the following new 13 paragraph: 14 ‘‘(2) D ELAY OF DATE BY WHICH STATES MUST 15 COMPLY WITH CERTAIN JUVENILE JUSTICE -RE-16 LATED REQUIREMENTS .—A State shall not be re-17 garded as failing to comply with the requirements of 18 section 1902(a)(84)(D) or 2102(d)(2) of the Social 19 Security Act (42 U.S.C. 1396a(a)(84)(D), 20 1397bb(d)(2)) before January 1, 2026.’’. 21 (b) C LARIFYING NONAPPLICATION OF REQUIRE-22 MENTS TO INDIVIDUALS IN FEDERAL CUSTODY.— 23 (1) MEDICAID.— 24 (A) Subparagraph (D) of section 25 1902(a)(84) of the Social Security Act (42 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00209 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 210 •HR 1768 IH U.S.C. 1396a(a)(84)), as added by section 5121 1 of subtitle C of title V of division FF of the 2 Consolidated Appropriations Act, 2023 (Public 3 Law 117–328), is amended by striking ‘‘an in-4 dividual who is an eligible juvenile’’ and insert-5 ing ‘‘an individual (other than an individual 6 who is in Federal custody, including as an in-7 mate in a Federal prison) who is an eligible ju-8 venile’’. 9 (B) Section 5122(a) of subtitle C of title 10 V of division FF of the Consolidated Appropria-11 tions Act, 2023 (Public Law 117–328) is 12 amended— 13 (i) by striking ‘‘paragraph (31)’’ each 14 place it appears and inserting ‘‘the last 15 numbered paragraph’’; and 16 (ii) in paragraph (1), by striking ‘‘an 17 individual who is an eligible juvenile’’ and 18 inserting ‘‘an individual (other than an in-19 dividual who is in Federal custody, includ-20 ing as an inmate in a Federal prison) who 21 is an eligible juvenile’’. 22 (2) CHIP.— 23 (A) Subsection (d)(2) of section 2102 of 24 the Social Security Act (42 U.S.C. 1397bb), as 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00210 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 211 •HR 1768 IH added by section 5121 of subtitle C of title V 1 of division FF of the Consolidated Appropria-2 tions Act, 2023 (Public Law 117–328), is 3 amended by striking ‘‘a targeted low-income 4 child who’’ and inserting ‘‘a targeted low in-5 come child (other than a child who is in Federal 6 custody, including as an inmate in a Federal 7 prison) who’’. 8 (B) Section 5122(b)(2) of subtitle C of 9 title V of division FF of the Consolidated Ap-10 propriations Act, 2023 (Public Law 117–328) 11 is amended by striking ‘‘a child who is’’ and in-12 serting ‘‘a child (other than a child who is in 13 Federal custody, including as an inmate in a 14 Federal prison) who is’’. 15 (3) E FFECTIVE DATE .—The amendments made 16 by this subsection shall take effect as if enacted on 17 December 29, 2022. 18 (c) INTERIM WORK PLAN.—Not later than June 30, 19 2025, each State (as such term is defined in section 20 1101(a)(1) of the Social Security Act (42 U.S.C. 21 1301(a)(1)) for purposes of titles XIX and XXI of such 22 Act) shall submit to the Secretary of Health and Human 23 Services an interim work plan, in such form and con-24 taining such information as the Secretary may specify, de-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00211 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 212 •HR 1768 IH scribing the State’s progress towards implementing, and 1 its plans to come into compliance with, the requirements 2 imposed by the amendments made by section 5121 of sub-3 title C of title V of division FF of the Consolidated Appro-4 priations Act, 2023 (Public Law 117–328), consistent 5 with the guidance issued by the Centers for Medicare & 6 Medicaid Services in State Health Official Letter #24– 7 004 on July 23, 2024. 8 SEC. 109. STATE STUDIES AND HHS REPORT ON COSTS OF 9 PROVIDING MATERNITY, LABOR, AND DELIV-10 ERY SERVICES. 11 (a) STATE STUDY.— 12 (1) I N GENERAL .—Not later than 24 months 13 after the date of enactment of this Act, and every 14 5 years thereafter, each State (as such term is de-15 fined in section 1101(a)(1) of the Social Security 16 Act (42 U.S.C. 1301(a)(1)) for purposes of titles 17 XIX and XXI of such Act) shall conduct a study on 18 the costs of providing maternity, labor, and delivery 19 services in applicable hospitals (as defined in para-20 graph (3)) and submit the results of such study to 21 the Secretary of Health and Human Services (re-22 ferred to in this section as the ‘‘Secretary’’). 23 (2) C ONTENT OF STUDY .—A State study re-24 quired under paragraph (1) shall include the fol-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00212 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 213 •HR 1768 IH lowing information (to the extent practicable) with 1 respect to maternity, labor, and delivery services fur-2 nished by applicable hospitals located in the State: 3 (A) An estimate of the cost of providing 4 maternity, labor, and delivery services at appli-5 cable hospitals, based on the expenditures a 6 representative sample of such hospitals incurred 7 for providing such services during the 2 most 8 recent years for which data is available. 9 (B) An estimate of the cost of providing 10 maternity, labor, and delivery services at appli-11 cable hospitals that ceased providing labor and 12 delivery services within the past 5 years, based 13 on the expenditures a representative sample of 14 such hospitals incurred for providing such serv-15 ices during the 2 most recent years for which 16 data is available. 17 (C) To the extent data allows, an analysis 18 of the extent to which geographic location, com-19 munity demographics, and local economic fac-20 tors (as defined by the Secretary) affect the 21 cost of providing maternity, labor, and delivery 22 services at applicable hospitals, including the 23 cost of services that support the provision of 24 maternity, labor, and delivery services. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00213 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 214 •HR 1768 IH (D) The amounts applicable hospitals are 1 paid for maternity, labor, and delivery services, 2 by geographic location and hospital size, 3 under— 4 (i) Medicare; 5 (ii) the State Medicaid program, in-6 cluding payment amounts for such services 7 under fee-for-service payment arrange-8 ments and under managed care (as appli-9 cable); 10 (iii) the State CHIP plan, including 11 payment amounts for such services under 12 fee-for-service payment arrangements and 13 under managed care (as applicable); and 14 (iv) private health insurance. 15 (E) A comparative payment rate anal-16 ysis— 17 (i) comparing payment rates for ma-18 ternity, labor, and delivery services (inclu-19 sive of all payments received by applicable 20 hospitals for furnishing maternity, labor, 21 and delivery services) under the State 22 Medicaid fee-for-service program to such 23 payment rates for such services under 24 Medicare (as described in section 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00214 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 215 •HR 1768 IH 447.203(b)(3) of title 42, Code of Federal 1 Regulations), other Federally-funded or 2 State-funded programs (including, to the 3 extent data is available, Medicaid managed 4 care rates), and to the payment rates for 5 such services, to the extent data is avail-6 able, of private health insurers within geo-7 graphic areas of the State; and 8 (ii) analyzing different payment meth-9 ods for such services, such as the use of 10 bundled payments, quality incentives, and 11 low-volume adjustments. 12 (F) An evaluation, using such methodology 13 and parameters established by the Secretary, of 14 whether each hospital located in the State that 15 furnishes maternity, labor, and delivery services 16 is expected to experience in the next 3 years 17 significant changes in particular expenditures 18 or types of reimbursement for maternity, labor, 19 and delivery services. 20 (3) A PPLICABLE HOSPITAL DEFINED .—For 21 purposes of this subsection, the term ‘‘applicable 22 hospital’’ means any hospital located in a State that 23 meets either of the following criteria: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00215 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 216 •HR 1768 IH (A) The hospital provides labor and deliv-1 ery services and more than 50 percent of the 2 hospital’s births (in the most recent year for 3 which such data is available) are financed by 4 the Medicaid program or CHIP. 5 (B) The hospital— 6 (i) is located in a rural area (as de-7 fined by the Federal Office of Rural 8 Health Policy for the purpose of rural 9 health grant programs administered by 10 such Office); 11 (ii) based on the most recent 2 years 12 of data available (as determined by the 13 Secretary), furnished services for less than 14 an average of 300 births per year; and 15 (iii) provides labor and delivery serv-16 ices. 17 (4) A SSISTANCE TO SMALL HOSPITALS IN COM -18 PILING COST INFORMATION .—There are appro-19 priated to the Secretary for fiscal year 2025, 20 $10,000,000 for the purpose of providing grants and 21 technical assistance to a hospital described in para-22 graph (3)(B) to enable such hospital to compile de-23 tailed information for use in the State studies re-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00216 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 217 •HR 1768 IH quired under paragraph (1), to remain available 1 until expended. 2 (5) HHS REPORT ON STATE STUDIES .—For 3 each year in which a State is required to conduct a 4 study under paragraph (1), the Secretary shall issue, 5 not later than 12 months after the date on which 6 the State submits to the Secretary the data de-7 scribed in such paragraph, a publicly available re-8 port that compiles and details the results of such 9 study and includes the information described in 10 paragraph (2). 11 (b) HHS R EPORT ON NATIONAL DATA COLLECTION 12 FINDINGS.—Not later than 3 years after the date of en-13 actment of this Act, the Secretary shall submit to Con-14 gress, and make publicly available, a report analyzing the 15 first studies conducted by States under subsection (a)(1), 16 including recommendations for improving data collection 17 on the cost of providing maternity, labor, and delivery 18 services. 19 (c) IMPLEMENTATION FUNDING.—In addition to the 20 amount appropriated under subsection (a)(4), there are 21 appropriated, out of any funds in the Treasury not other-22 wise obligated, $3,000,000 for fiscal year 2025, to remain 23 available until expended, to the Secretary of Health and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00217 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 218 •HR 1768 IH Human Services for purposes of implementing this sec-1 tion. 2 SEC. 110. MODIFYING CERTAIN DISPROPORTIONATE SHARE 3 HOSPITAL ALLOTMENTS. 4 (a) E XTENDING TENNESSEE DSH A LLOTMENTS.— 5 Section 1923(f)(6)(A)(vi) of the Social Security Act (42 6 U.S.C. 1396r–4(f)(6)(A)(vi)) is amended— 7 (1) in the heading, by striking ‘‘ 2025’’ and in-8 serting ‘‘2026 AND FOR THE 1ST QUARTER OF FISCAL 9 YEAR 2027 ’’; 10 (2) by striking ‘‘fiscal year 2025’’ and inserting 11 ‘‘fiscal year 2026’’; and 12 (3) by inserting ‘‘, and the DSH allotment for 13 Tennessee for the 1st quarter of fiscal year 2027, 14 shall be $13,275,000’’ before the period. 15 (b) ELIMINATING AND DELAYING DSH ALLOTMENT 16 REDUCTIONS.—Section 1923(f) of the Social Security Act 17 (42 U.S.C. 1396r–4(f)) is amended— 18 (1) in paragraph (7)(A)— 19 (A) in clause (i), in the matter preceding 20 subclause (I), by striking ‘‘April 1, 2025,’’ and 21 all that follows through ‘‘2027’’ and inserting 22 ‘‘January 1, 2027, and ending September 30, 23 2027, and for fiscal year 2028’’; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00218 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 219 •HR 1768 IH (B) in clause (ii), by striking ‘‘April 1, 1 2025,’’ and all that follows through ‘‘2027’’ and 2 inserting ‘‘January 1, 2027, and ending Sep-3 tember 30, 2027, and for fiscal year 2028’’; 4 and 5 (2) in paragraph (8), by striking ‘‘2027’’ and 6 inserting ‘‘2028’’. 7 SEC. 111. MODIFYING CERTAIN LIMITATIONS ON DIS-8 PROPORTIONATE SHARE HOSPITAL PAY-9 MENT ADJUSTMENTS UNDER THE MEDICAID 10 PROGRAM. 11 (a) IN GENERAL.—Section 1923(g) of the Social Se-12 curity Act (42 U.S.C. 1396r–4(g)) is amended— 13 (1) in paragraph (1)— 14 (A) in subparagraph (A)— 15 (i) in the matter preceding clause (i), 16 by striking ‘‘(other than a hospital de-17 scribed in paragraph (2)(B))’’; 18 (ii) in clause (i), by inserting ‘‘with 19 respect to such hospital and year’’ after 20 ‘‘described in subparagraph (B)’’; and 21 (iii) in clause (ii)— 22 (I) in subclause (I), by striking 23 ‘‘and’’ at the end; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00219 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 220 •HR 1768 IH (II) in subclause (II), by striking 1 the period and inserting ‘‘; and’’; and 2 (III) by adding at the end the 3 following new subclause: 4 ‘‘(III) payments made under title 5 XVIII or by an applicable plan (as de-6 fined in section 1862(b)(8)(F)) for 7 such services.’’; and 8 (B) in subparagraph (B)— 9 (i) in the matter preceding clause (i), 10 by striking ‘‘in this clause are’’ and insert-11 ing ‘‘in this subparagraph are, with respect 12 to a hospital and a year,’’; and 13 (ii) by adding at the end the following 14 new clause: 15 ‘‘(iii) Individuals who are eligible for 16 medical assistance under the State plan or 17 under a waiver of such plan and for whom 18 the State plan or waiver is a payor for 19 such services after application of benefits 20 under title XVIII or under an applicable 21 plan (as defined in section 1862(b)(8)(F)), 22 but only if the hospital has in the aggre-23 gate incurred costs exceeding payments 24 under such State plan, waiver, title XVIII, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00220 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 221 •HR 1768 IH or applicable plan for such services fur-1 nished to such individuals during such 2 year.’’; 3 (2) by striking paragraph (2); 4 (3) by redesignating paragraph (3) as para-5 graph (2); and 6 (4) in paragraph (2), as so redesignated, by 7 striking ‘‘Notwithstanding paragraph (2) of this 8 subsection (as in effect on October 1, 2021), para-9 graph (2)’’ and inserting ‘‘Paragraph (2)’’. 10 (b) EFFECTIVE DATE.— 11 (1) I N GENERAL .—Except as provided in para-12 graph (2), the amendments made by this section 13 shall apply to payment adjustments made under sec-14 tion 1923 of the Social Security Act (42 U.S.C. 15 1396r–4) for Medicaid State plan rate years begin-16 ning on or after the date of enactment of this Act. 17 (2) S TATE OPTION TO DISTRIBUTE UNSPENT 18 DSH ALLOTMENTS FROM PRIOR YEARS UP TO MODI -19 FIED CAP .— 20 (A) I N GENERAL .—If, for any Medicaid 21 State plan rate year that begins on or after Oc-22 tober 1, 2021, and before the date of enactment 23 of this Act, a State did not spend the full 24 amount of its Federal fiscal year allotment 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00221 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 222 •HR 1768 IH under section 1923 of the Social Security Act 1 (42 U.S.C. 1396r–4) applicable to that State 2 plan rate year, the State may use the unspent 3 portion of such allotment to increase the 4 amount of any payment adjustment made to a 5 hospital for such rate year, provided that— 6 (i) such payment adjustment (as so 7 increased) is consistent with subsection (g) 8 of such section (as amended by this sec-9 tion); and 10 (ii) the total amount of all payment 11 adjustments for the State plan rate year 12 (as so increased) does not exceed the dis-13 proportionate share hospital allotment for 14 the State and applicable Federal fiscal 15 year under subsection (f) of such section. 16 (B) N O RECOUPMENT OF PAYMENTS AL -17 READY MADE TO HOSPITALS .—A State shall not 18 recoup any payment adjustment made by the 19 State to a hospital for a Medicaid State plan 20 rate year described in subparagraph (A) if such 21 payment adjustment is consistent with section 22 1923(g) of such Act (42 U.S.C. 1396r–4(g)) as 23 in effect on October 1, 2021. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00222 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 223 •HR 1768 IH (C) A UTHORITY TO PERMIT RETROACTIVE 1 MODIFICATION OF STATE PLAN AMENDMENTS 2 TO ALLOW FOR INCREASES .— 3 (i) I N GENERAL .—Subject to para-4 graph (2), solely for the purpose of allow-5 ing a State to increase the amount of a 6 payment adjustment to a hospital for a 7 Medicaid State plan rate year described in 8 subparagraph (A) pursuant to this para-9 graph, a State may retroactively modify a 10 provision of the Medicaid State plan, a 11 waiver of such plan, or a State plan 12 amendment that relates to such rate year 13 and the Secretary may approve such modi-14 fication. 15 (ii) D EADLINE.—A State may not 16 submit a request for approval of a retro-17 active modification to a provision of the 18 Medicaid State plan, a waiver of such plan, 19 or a State plan amendment for a Medicaid 20 State plan rate year after the date by 21 which the State is required to submit the 22 independent certified audit for that State 23 plan rate year as required under section 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00223 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 224 •HR 1768 IH 1923(j)(2) of the Social Security Act (42 1 U.S.C. 1396r–4(j)(2)). 2 (D) R EPORTING.—If a State increases a 3 payment adjustment made to a hospital for a 4 Medicaid State plan rate year pursuant to this 5 paragraph, the State shall include information 6 on such increased payment adjustment as part 7 of the next annual report submitted by the 8 State under section 1923(j)(1) of the Social Se-9 curity Act (42 U.S.C. 1396r–4(j)(1)). 10 SEC. 112. ENSURING ACCURATE PAYMENTS TO PHAR-11 MACIES UNDER MEDICAID. 12 (a) IN GENERAL.—Section 1927(f) of the Social Se-13 curity Act (42 U.S.C. 1396r–8(f)) is amended— 14 (1) in paragraph (1)(A)— 15 (A) by redesignating clause (ii) as clause 16 (iii); and 17 (B) by striking ‘‘and’’ after the semicolon 18 at the end of clause (i) and all that precedes it 19 through ‘‘(1)’’ and inserting the following: 20 ‘‘(1) D ETERMINING PHARMACY ACTUAL ACQUI -21 SITION COSTS .—The Secretary shall conduct a sur-22 vey of retail community pharmacy drug prices and 23 applicable non-retail pharmacy drug prices to deter-24 mine national average drug acquisition cost bench-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00224 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 225 •HR 1768 IH marks (as such term is defined by the Secretary) as 1 follows: 2 ‘‘(A) U SE OF VENDOR .—The Secretary 3 may contract services for— 4 ‘‘(i) with respect to retail community 5 pharmacies, the determination of retail 6 survey prices of the national average drug 7 acquisition cost for covered outpatient 8 drugs that represent a nationwide average 9 of consumer purchase prices for such 10 drugs, net of all discounts, rebates, and 11 other price concessions (to the extent any 12 information with respect to such discounts, 13 rebates, and other price concessions is 14 available) based on a monthly survey of 15 such pharmacies; and 16 ‘‘(ii) with respect to applicable non-re-17 tail pharmacies— 18 ‘‘(I) the determination of survey 19 prices, separate from the survey prices 20 described in clause (i), of the non-re-21 tail national average drug acquisition 22 cost for covered outpatient drugs that 23 represent a nationwide average of con-24 sumer purchase prices for such drugs, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00225 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 226 •HR 1768 IH net of all discounts, rebates, and other 1 price concessions (to the extent any 2 information with respect to such dis-3 counts, rebates, and other price con-4 cessions is available) based on a 5 monthly survey of such pharmacies; 6 and 7 ‘‘(II) at the discretion of the Sec-8 retary, for each type of applicable 9 non-retail pharmacy, the determina-10 tion of survey prices, separate from 11 the survey prices described in clause 12 (i) or subclause (I) of this clause, of 13 the national average drug acquisition 14 cost for such type of pharmacy for 15 covered outpatient drugs that rep-16 resent a nationwide average of con-17 sumer purchase prices for such drugs, 18 net of all discounts, rebates, and other 19 price concessions (to the extent any 20 information with respect to such dis-21 counts, rebates, and other price con-22 cessions is available) based on a 23 monthly survey of such pharmacies; 24 and’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00226 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 227 •HR 1768 IH (2) in subparagraph (B) of paragraph (1), by 1 striking ‘‘subparagraph (A)(ii)’’ and inserting ‘‘sub-2 paragraph (A)(iii)’’; 3 (3) in subparagraph (D) of paragraph (1), by 4 striking clauses (ii) and (iii) and inserting the fol-5 lowing: 6 ‘‘(ii) The vendor must update the Sec-7 retary no less often than monthly on the 8 survey prices for covered outpatient drugs. 9 ‘‘(iii) The vendor must differentiate, 10 in collecting and reporting survey data, for 11 all cost information collected, whether a 12 pharmacy is a retail community pharmacy 13 or an applicable non-retail pharmacy, in-14 cluding whether such pharmacy is an affil-15 iate (as defined in subsection (k)(14)), 16 and, in the case of an applicable non-retail 17 pharmacy, which type of applicable non-re-18 tail pharmacy it is using the relevant phar-19 macy type indicators included in the guid-20 ance required by subsection (d)(2) of sec-21 tion 112 of the Health Improvements, Ex-22 tenders, and Reauthorizations Act.’’; 23 (4) by adding at the end of paragraph (1) the 24 following: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00227 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 228 •HR 1768 IH ‘‘(F) S URVEY REPORTING .—In order to 1 meet the requirement of section 1902(a)(54), a 2 State shall require that any retail community 3 pharmacy or applicable non-retail pharmacy in 4 the State that receives any payment, reimburse-5 ment, administrative fee, discount, rebate, or 6 other price concession related to the dispensing 7 of covered outpatient drugs to individuals re-8 ceiving benefits under this title, regardless of 9 whether such payment, reimbursement, admin-10 istrative fee, discount, rebate, or other price 11 concession is received from the State or a man-12 aged care entity or other specified entity (as 13 such terms are defined in section 14 1903(m)(9)(D)) directly or from a pharmacy 15 benefit manager or another entity that has a 16 contract with the State or a managed care enti-17 ty or other specified entity (as so defined), shall 18 respond to surveys conducted under this para-19 graph. 20 ‘‘(G) S URVEY INFORMATION .—Information 21 on national drug acquisition prices obtained 22 under this paragraph shall be made publicly 23 available in a form and manner to be deter-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00228 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 229 •HR 1768 IH mined by the Secretary and shall include at 1 least the following: 2 ‘‘(i) The monthly response rate to the 3 survey including a list of pharmacies not in 4 compliance with subparagraph (F). 5 ‘‘(ii) The sampling methodology and 6 number of pharmacies sampled monthly. 7 ‘‘(iii) Information on price concessions 8 to pharmacies, including discounts, re-9 bates, and other price concessions, to the 10 extent that such information may be pub-11 licly released and has been collected by the 12 Secretary as part of the survey. 13 ‘‘(H) PENALTIES.— 14 ‘‘(i) I N GENERAL .—Subject to clauses 15 (ii), (iii), and (iv), the Secretary shall en-16 force the provisions of this paragraph with 17 respect to a pharmacy through the estab-18 lishment of civil money penalties applicable 19 to a retail community pharmacy or an ap-20 plicable non-retail pharmacy. 21 ‘‘(ii) B ASIS FOR PENALTIES .—The 22 Secretary shall impose a civil money pen-23 alty established under this subparagraph 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00229 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 230 •HR 1768 IH on a retail community pharmacy or appli-1 cable non-retail pharmacy if— 2 ‘‘(I) the retail pharmacy or appli-3 cable non-retail pharmacy refuses or 4 otherwise fails to respond to a request 5 for information about prices in con-6 nection with a survey under this sub-7 section; 8 ‘‘(II) knowingly provides false in-9 formation in response to such a sur-10 vey; or 11 ‘‘(III) otherwise fails to comply 12 with the requirements established 13 under this paragraph. 14 ‘‘(iii) P ARAMETERS FOR PEN -15 ALTIES.— 16 ‘‘(I) IN GENERAL .—A civil money 17 penalty established under this sub-18 paragraph may be assessed with re-19 spect to each violation, and with re-20 spect to each non-compliant retail 21 community pharmacy (including a 22 pharmacy that is part of a chain) or 23 non-compliant applicable non-retail 24 pharmacy (including a pharmacy that 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00230 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 231 •HR 1768 IH is part of a chain), in an amount not 1 to exceed $100,000 for each such vio-2 lation. 3 ‘‘(II) C ONSIDERATIONS.—In de-4 termining the amount of a civil money 5 penalty imposed under this subpara-6 graph, the Secretary may consider the 7 size, business structure, and type of 8 pharmacy involved, as well as the type 9 of violation and other relevant factors, 10 as determined appropriate by the Sec-11 retary. 12 ‘‘(iv) R ULE OF APPLICATION .—The 13 provisions of section 1128A (other than 14 subsections (a) and (b)) shall apply to a 15 civil money penalty under this subpara-16 graph in the same manner as such provi-17 sions apply to a civil money penalty or pro-18 ceeding under section 1128A(a). 19 ‘‘(I) L IMITATION ON USE OF APPLICABLE 20 NON-RETAIL PHARMACY PRICING INFORMA -21 TION.—No State shall use pricing information 22 reported by applicable non-retail pharmacies 23 under subparagraph (A)(ii) to develop or inform 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00231 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 232 •HR 1768 IH payment methodologies for retail community 1 pharmacies.’’; 2 (5) in paragraph (2)— 3 (A) in subparagraph (A), by inserting ‘‘, 4 including payment rates and methodologies for 5 determining ingredient cost reimbursement 6 under managed care entities or other specified 7 entities (as such terms are defined in section 8 1903(m)(9)(D)),’’ after ‘‘under this title’’; and 9 (B) in subparagraph (B), by inserting 10 ‘‘and the basis for such dispensing fees’’ before 11 the semicolon; 12 (6) by redesignating paragraph (4) as para-13 graph (5); 14 (7) by inserting after paragraph (3) the fol-15 lowing new paragraph: 16 ‘‘(4) OVERSIGHT.— 17 ‘‘(A) IN GENERAL .—The Inspector General 18 of the Department of Health and Human Serv-19 ices shall conduct periodic studies of the survey 20 data reported under this subsection, as appro-21 priate, including with respect to substantial 22 variations in acquisition costs or other applica-23 ble costs, as well as with respect to how internal 24 transfer prices and related party transactions 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00232 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 233 •HR 1768 IH may influence the costs reported by pharmacies 1 that are affiliates (as defined in subsection 2 (k)(14)) or are owned by, controlled by, or re-3 lated under a common ownership structure with 4 a wholesaler, distributor, or other entity that 5 acquires covered outpatient drugs relative to 6 costs reported by pharmacies not affiliated with 7 such entities. The Inspector General shall pro-8 vide periodic updates to Congress on the results 9 of such studies, as appropriate, in a manner 10 that does not disclose trade secrets or other 11 proprietary information. 12 ‘‘(B) A PPROPRIATION.—There is appro-13 priated to the Inspector General of the Depart-14 ment of Health and Human Services, out of 15 any money in the Treasury not otherwise ap-16 propriated, $5,000,000 for fiscal year 2025, to 17 remain available until expended, to carry out 18 this paragraph.’’; and 19 (8) in paragraph (5), as so redesignated— 20 (A) by inserting ‘‘, and $9,000,000 for fis-21 cal year 2025 and each fiscal year thereafter,’’ 22 after ‘‘2010’’; and 23 (B) by inserting ‘‘Funds appropriated 24 under this paragraph for fiscal year 2025 and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00233 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 234 •HR 1768 IH any subsequent fiscal year shall remain avail-1 able until expended.’’ after the period. 2 (b) DEFINITIONS.—Section 1927(k) of the Social Se-3 curity Act (42 U.S.C. 1396r–8(k)) is amended— 4 (1) in the matter preceding paragraph (1), by 5 striking ‘‘In the section’’ and inserting ‘‘In this sec-6 tion’’; and 7 (2) by adding at the end the following new 8 paragraphs: 9 ‘‘(12) A PPLICABLE NON -RETAIL PHARMACY .— 10 The term ‘applicable non-retail pharmacy’ means a 11 pharmacy that is licensed as a pharmacy by the 12 State and that is not a retail community pharmacy, 13 including a pharmacy that dispenses prescription 14 medications to patients primarily through mail and 15 specialty pharmacies. Such term does not include 16 nursing home pharmacies, long-term care facility 17 pharmacies, hospital pharmacies, clinics, charitable 18 or not-for-profit pharmacies, government phar-19 macies, or low dispensing pharmacies (as defined by 20 the Secretary). 21 ‘‘(13) A FFILIATE.—The term ‘affiliate’ means 22 any entity that is owned by, controlled by, or related 23 under a common ownership structure with a phar-24 macy benefit manager or a managed care entity or 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00234 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 235 •HR 1768 IH other specified entity (as such terms are defined in 1 section 1903(m)(9)(D)).’’. 2 (c) EFFECTIVE DATE.— 3 (1) I N GENERAL .—Subject to paragraph (2), 4 the amendments made by this section shall take ef-5 fect on the first day of the first quarter that begins 6 on or after the date that is 6 months after the date 7 of enactment of this Act. 8 (2) D ELAYED APPLICATION TO APPLICABLE 9 NON-RETAIL PHARMACIES .—The pharmacy survey 10 requirements established by the amendments to sec-11 tion 1927(f) of the Social Security Act (42 U.S.C. 12 1396r–8(f)) made by this section shall apply to re-13 tail community pharmacies beginning on the effec-14 tive date described in paragraph (1), but shall not 15 apply to applicable non-retail pharmacies until the 16 first day of the first quarter that begins on or after 17 the date that is 18 months after the date of enact-18 ment of this Act. 19 (d) I DENTIFICATION OF APPLICABLE NON-RETAIL 20 PHARMACIES.— 21 (1) I N GENERAL .—Not later than January 1, 22 2026, the Secretary of Health and Human Services 23 shall, in consultation with stakeholders as appro-24 priate, publish guidance specifying pharmacies that 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00235 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 236 •HR 1768 IH meet the definition of applicable non-retail phar-1 macies (as such term is defined in subsection 2 (k)(12) of section 1927 of the Social Security Act 3 (42 U.S.C. 1396r–8), as added by subsection (b)), 4 and that will be subject to the survey requirements 5 under subsection (f)(1) of such section, as amended 6 by subsection (a). 7 (2) I NCLUSION OF PHARMACY TYPE INDICA -8 TORS.—The guidance published under paragraph (1) 9 shall include pharmacy type indicators to distinguish 10 between different types of applicable non-retail phar-11 macies, such as pharmacies that dispense prescrip-12 tions primarily through the mail and pharmacies 13 that dispense prescriptions that require special han-14 dling or distribution. An applicable non-retail phar-15 macy may be identified through multiple pharmacy 16 type indicators. 17 (e) IMPLEMENTATION.— 18 (1) I N GENERAL .—Notwithstanding any other 19 provision of law, the Secretary of Health and 20 Human Services may implement the amendments 21 made by this section by program instruction or oth-22 erwise. 23 (2) NONAPPLICATION OF ADMINISTRATIVE PRO -24 CEDURE ACT .—Implementation of the amendments 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00236 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 237 •HR 1768 IH made by this section shall be exempt from the re-1 quirements of section 553 of title 5, United States 2 Code. 3 (f) N ONAPPLICATION OF PAPERWORK REDUCTION 4 ACT.—Chapter 35 of title 44, United States Code, shall 5 not apply to any data collection undertaken by the Sec-6 retary of Health and Human Services under section 7 1927(f) of the Social Security Act (42 U.S.C. 1396r–8(f)), 8 as amended by this section. 9 SEC. 113. PREVENTING THE USE OF ABUSIVE SPREAD PRIC-10 ING IN MEDICAID. 11 (a) I N GENERAL.—Section 1927 of the Social Secu-12 rity Act (42 U.S.C. 1396r–8) is amended— 13 (1) in subsection (e), by adding at the end the 14 following new paragraph: 15 ‘‘(6) T RANSPARENT PRESCRIPTION DRUG PASS - 16 THROUGH PRICING REQUIRED .— 17 ‘‘(A) I N GENERAL .—A contract between 18 the State and a pharmacy benefit manager (re-19 ferred to in this paragraph as a ‘PBM’), or a 20 contract between the State and a managed care 21 entity or other specified entity (as such terms 22 are defined in section 1903(m)(9)(D) and col-23 lectively referred to in this paragraph as the 24 ‘entity’) that includes provisions making the en-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00237 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 238 •HR 1768 IH tity responsible for coverage of covered out-1 patient drugs dispensed to individuals enrolled 2 with the entity, shall require that payment for 3 such drugs and related administrative services 4 (as applicable), including payments made by a 5 PBM on behalf of the State or entity, is based 6 on a transparent prescription drug pass- 7 through pricing model under which— 8 ‘‘(i) any payment made by the entity 9 or the PBM (as applicable) for such a 10 drug— 11 ‘‘(I) is limited to— 12 ‘‘(aa) ingredient cost; and 13 ‘‘(bb) a professional dis-14 pensing fee that is not less than 15 the professional dispensing fee 16 that the State would pay if the 17 State were making the payment 18 directly in accordance with the 19 State plan; 20 ‘‘(II) is passed through in its en-21 tirety (except as reduced under Fed-22 eral or State laws and regulations in 23 response to instances of waste, fraud, 24 or abuse) by the entity or PBM to the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00238 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 239 •HR 1768 IH pharmacy or provider that dispenses 1 the drug; and 2 ‘‘(III) is made in a manner that 3 is consistent with sections 447.502, 4 447.512, 447.514, and 447.518 of 5 title 42, Code of Federal Regulations 6 (or any successor regulation) as if 7 such requirements applied directly to 8 the entity or the PBM, except that 9 any payment by the entity or the 10 PBM for the ingredient cost of such 11 drug purchased by a covered entity 12 (as defined in subsection (a)(5)(B)) 13 may exceed the actual acquisition cost 14 (as defined in 447.502 of title 42, 15 Code of Federal Regulations, or any 16 successor regulation) for such drug 17 if— 18 ‘‘(aa) such drug was subject 19 to an agreement under section 20 340B of the Public Health Serv-21 ice Act; 22 ‘‘(bb) such payment for the 23 ingredient cost of such drug does 24 not exceed the maximum pay-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00239 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 240 •HR 1768 IH ment that would have been made 1 by the entity or the PBM for the 2 ingredient cost of such drug if 3 such drug had not been pur-4 chased by such covered entity; 5 and 6 ‘‘(cc) such covered entity re-7 ports to the Secretary (in a form 8 and manner specified by the Sec-9 retary), on an annual basis and 10 with respect to payments for the 11 ingredient costs of such drugs so 12 purchased by such covered entity 13 that are in excess of the actual 14 acquisition costs for such drugs, 15 the aggregate amount of such ex-16 cess; 17 ‘‘(ii) payment to the entity or the 18 PBM (as applicable) for administrative 19 services performed by the entity or PBM is 20 limited to an administrative fee that re-21 flects the fair market value (as defined by 22 the Secretary) of such services; 23 ‘‘(iii) the entity or the PBM (as appli-24 cable) makes available to the State, and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00240 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 241 •HR 1768 IH the Secretary upon request in a form and 1 manner specified by the Secretary, all costs 2 and payments related to covered outpatient 3 drugs and accompanying administrative 4 services (as described in clause (ii)) in-5 curred, received, or made by the entity or 6 the PBM, broken down (as specified by the 7 Secretary), to the extent such costs and 8 payments are attributable to an individual 9 covered outpatient drug, by each such 10 drug, including any ingredient costs, pro-11 fessional dispensing fees, administrative 12 fees (as described in clause (ii)), post-sale 13 and post-invoice fees, discounts, or related 14 adjustments such as direct and indirect re-15 muneration fees, and any and all other re-16 muneration, as defined by the Secretary; 17 and 18 ‘‘(iv) any form of spread pricing 19 whereby any amount charged or claimed by 20 the entity or the PBM (as applicable) that 21 exceeds the amount paid to the pharmacies 22 or providers on behalf of the State or enti-23 ty, including any post-sale or post-invoice 24 fees, discounts, or related adjustments 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00241 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 242 •HR 1768 IH such as direct and indirect remuneration 1 fees or assessments, as defined by the Sec-2 retary, (after allowing for an administra-3 tive fee as described in clause (ii)) is not 4 allowable for purposes of claiming Federal 5 matching payments under this title. 6 ‘‘(B) P UBLICATION OF INFORMATION .— 7 The Secretary shall publish, not less frequently 8 than on an annual basis and in a manner that 9 does not disclose the identity of a particular 10 covered entity or organization, information re-11 ceived by the Secretary pursuant to subpara-12 graph (A)(i)(III)(cc) that is broken out by 13 State and by each of the following categories of 14 covered entity within each such State: 15 ‘‘(i) Covered entities described in sub-16 paragraph (A) of section 340B(a)(4) of the 17 Public Health Service Act. 18 ‘‘(ii) Covered entities described in sub-19 paragraphs (B) through (K) of such sec-20 tion. 21 ‘‘(iii) Covered entities described in 22 subparagraph (L) of such section. 23 ‘‘(iv) Covered entities described in 24 subparagraph (M) of such section. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00242 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 243 •HR 1768 IH ‘‘(v) Covered entities described in sub-1 paragraph (N) of such section. 2 ‘‘(vi) Covered entities described in 3 subparagraph (O) of such section.’’; and 4 (2) in subsection (k), as previously amended by 5 this title, by adding at the end the following new 6 paragraph: 7 ‘‘(14) P HARMACY BENEFIT MANAGER .—The 8 term ‘pharmacy benefit manager’ means any person 9 or entity that, either directly or through an inter-10 mediary, acts as a price negotiator or group pur-11 chaser on behalf of a State, managed care entity (as 12 defined in section 1903(m)(9)(D)), or other specified 13 entity (as so defined), or manages the prescription 14 drug benefits provided by a State, managed care en-15 tity, or other specified entity, including the proc-16 essing and payment of claims for prescription drugs, 17 the performance of drug utilization review, the proc-18 essing of drug prior authorization requests, the man-19 aging of appeals or grievances related to the pre-20 scription drug benefits, contracting with pharmacies, 21 controlling the cost of covered outpatient drugs, or 22 the provision of services related thereto. Such term 23 includes any person or entity that acts as a price ne-24 gotiator (with regard to payment amounts to phar-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00243 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 244 •HR 1768 IH macies and providers for a covered outpatient drug 1 or the net cost of the drug) or group purchaser on 2 behalf of a State, managed care entity, or other 3 specified entity or that carries out 1 or more of the 4 other activities described in the preceding sentence, 5 irrespective of whether such person or entity calls 6 itself a pharmacy benefit manager.’’. 7 (b) C ONFORMING AMENDMENTS.—Section 1903(m) 8 of such Act (42 U.S.C. 1396b(m)) is amended— 9 (1) in paragraph (2)(A)(xiii)— 10 (A) by striking ‘‘and (III)’’ and inserting 11 ‘‘(III)’’; 12 (B) by inserting before the period at the 13 end the following: ‘‘, and (IV) if the contract in-14 cludes provisions making the entity responsible 15 for coverage of covered outpatient drugs, the 16 entity shall comply with the requirements of 17 section 1927(e)(6)’’; and 18 (C) by moving the margin 2 ems to the 19 left; and 20 (2) by adding at the end the following new 21 paragraph: 22 ‘‘(10) No payment shall be made under this 23 title to a State with respect to expenditures incurred 24 by the State for payment for services provided by an 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00244 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 245 •HR 1768 IH other specified entity (as defined in paragraph 1 (9)(D)(iii)) unless such services are provided in ac-2 cordance with a contract between the State and such 3 entity which satisfies the requirements of paragraph 4 (2)(A)(xiii).’’. 5 (c) E FFECTIVE DATE.—The amendments made by 6 this section shall apply to contracts between States and 7 managed care entities, other specified entities, or phar-8 macy benefit managers that have an effective date begin-9 ning on or after the date that is 18 months after the date 10 of enactment of this Act. 11 (d) IMPLEMENTATION.— 12 (1) I N GENERAL .—Notwithstanding any other 13 provision of law, the Secretary of Health and 14 Human Services may implement the amendments 15 made by this section by program instruction or oth-16 erwise. 17 (2) NONAPPLICATION OF ADMINISTRATIVE PRO -18 CEDURE ACT .—Implementation of the amendments 19 made by this section shall be exempt from the re-20 quirements of section 553 of title 5, United States 21 Code. 22 (e) N ONAPPLICATION OF PAPERWORK REDUCTION 23 ACT.—Chapter 35 of title 44, United States Code, shall 24 not apply to any data collection undertaken by the Sec-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00245 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 246 •HR 1768 IH retary of Health and Human Services under section 1 1927(e) of the Social Security Act (42 U.S.C. 1396r– 2 8(e)), as amended by this section. 3 TITLE II—MEDICARE 4 SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL 5 PAYMENT ADJUSTMENT FOR CERTAIN LOW- 6 VOLUME HOSPITALS. 7 (a) IN GENERAL.—Section 1886(d)(12) of the Social 8 Security Act (42 U.S.C. 1395ww(d)(12)) is amended— 9 (1) in subparagraph (B), in the matter pre-10 ceding clause (i), by striking ‘‘fiscal year 2025 be-11 ginning on April 1, 2025, and ending on September 12 30, 2025, and in fiscal year 2026’’ and inserting 13 ‘‘fiscal year 2026 beginning on January 1, 2026, 14 and ending on September 30, 2026, and in fiscal 15 year 2027’’; 16 (2) in subparagraph (C)(i)— 17 (A) in the matter preceding subclause 18 (I)— 19 (i) by striking ‘‘through 2024’’ and 20 inserting ‘‘through 2025’’; 21 (ii) by striking ‘‘fiscal year 2025’’ and 22 inserting ‘‘fiscal year 2026’’; 23 (iii) by striking ‘‘October 1, 2024’’ 24 and inserting ‘‘October 1, 2025’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00246 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 247 •HR 1768 IH (iv) by striking ‘‘March 31, 2025’’ 1 and inserting ‘‘December 31, 2025’’; 2 (B) in subclause (III)— 3 (i) by striking ‘‘through 2024’’ and 4 inserting ‘‘through 2025’’; 5 (ii) by striking ‘‘fiscal year 2025’’ and 6 inserting ‘‘fiscal year 2026’’; 7 (iii) by striking ‘‘October 1, 2024’’ 8 and inserting ‘‘October 1, 2025’’; and 9 (iv) by striking ‘‘March 31, 2025’’ 10 and inserting ‘‘December 31, 2025’’; and 11 (C) in subclause (IV)— 12 (i) by striking ‘‘fiscal year 2025’’ and 13 inserting ‘‘fiscal year 2026’’; 14 (ii) by striking ‘‘April 1, 2025’’ and 15 inserting ‘‘January 1, 2026’’; 16 (iii) by striking ‘‘September 30, 17 2025’’ and inserting ‘‘September 30, 18 2026’’; and 19 (iv) by striking ‘‘fiscal year 2026’’ 20 and inserting ‘‘fiscal year 2027’’; and 21 (3) in subparagraph (D)— 22 (A) in the matter preceding clause (i)— 23 (i) by striking ‘‘through 2024’’ and 24 inserting ‘‘through 2025’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00247 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 248 •HR 1768 IH (ii) by striking ‘‘fiscal year 2025’’ and 1 inserting ‘‘fiscal year 2026’’; 2 (iii) by striking ‘‘October 1, 2024’’ 3 and inserting ‘‘October 1, 2025’’; and 4 (iv) by striking ‘‘March 31, 2025’’ 5 and inserting ‘‘December 31, 2025’’; and 6 (B) in clause (ii)— 7 (i) by striking ‘‘through 2024’’ and 8 inserting ‘‘through 2025’’; 9 (ii) by striking ‘‘fiscal year 2025’’ and 10 inserting ‘‘fiscal year 2026’’; 11 (iii) by striking ‘‘October 1, 2024’’ 12 and inserting ‘‘October 1, 2025’’; and 13 (iv) by striking ‘‘March 31, 2025’’ 14 and inserting ‘‘December 31, 2025’’. 15 (b) I MPLEMENTATION.—Notwithstanding any other 16 provision of law, the Secretary of Health and Human 17 Services may implement the amendments made by this 18 section by program instruction or otherwise. 19 SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOS-20 PITAL (MDH) PROGRAM. 21 (a) IN GENERAL.—Section 1886(d)(5)(G) of the So-22 cial Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amend-23 ed— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00248 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 249 •HR 1768 IH (1) in clause (i), by striking ‘‘April 1, 2025’’ 1 and inserting ‘‘January 1, 2026’’; and 2 (2) in clause (ii)(II), by striking ‘‘April 1, 3 2025’’ and inserting ‘‘January 1, 2026’’. 4 (b) CONFORMING AMENDMENTS.— 5 (1) I N GENERAL .—Section 1886(b)(3)(D) of 6 the Social Security Act (42 U.S.C. 7 1395ww(b)(3)(D)) is amended— 8 (A) in the matter preceding clause (i), by 9 striking ‘‘April 1, 2025’’ and inserting ‘‘Janu-10 ary 1, 2026’’; and 11 (B) in clause (iv)— 12 (i) by striking ‘‘fiscal year 2024’’ and 13 inserting ‘‘fiscal year 2025’’; 14 (ii) by striking ‘‘fiscal year 2025’’ and 15 inserting ‘‘fiscal year 2026’’; 16 (iii) by striking ‘‘October 1, 2024’’ 17 and inserting ‘‘October 1, 2025’’; and 18 (iv) by striking ‘‘March 31, 2025’’ 19 and inserting ‘‘December 31, 2025’’. 20 (2) P ERMITTING HOSPITALS TO DECLINE RE -21 CLASSIFICATION.—Section 13501(e)(2) of the Omni-22 bus Budget Reconciliation Act of 1993 (42 U.S.C. 23 1395ww note) is amended— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00249 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 250 •HR 1768 IH (A) by striking ‘‘through 2024’’ and insert-1 ing ‘‘through 2025’’; 2 (B) by striking ‘‘fiscal year 2025’’ and in-3 serting ‘‘fiscal year 2026’’; 4 (C) by striking ‘‘October 1, 2024’’ and in-5 serting ‘‘October 1, 2025’’; and 6 (D) by striking ‘‘March 31, 2025’’ and in-7 serting ‘‘December 31, 2025’’. 8 SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBU-9 LANCE SERVICES. 10 Section 1834(l) of the Social Security Act (42 U.S.C. 11 1395m(l)) is amended— 12 (1) in paragraph (12)(A), by striking ‘‘April 1, 13 2025’’ and inserting ‘‘January 1, 2027’’; and 14 (2) in paragraph (13), by striking ‘‘April 1, 15 2025’’ each place it appears and inserting ‘‘January 16 1, 2027’’ in each such place. 17 SEC. 204. EXTENDING INCENTIVE PAYMENTS FOR PARTICI-18 PATION IN ELIGIBLE ALTERNATIVE PAYMENT 19 MODELS. 20 (a) IN GENERAL.—Section 1833(z) of the Social Se-21 curity Act (42 U.S.C. 1395l(z)) is amended— 22 (1) in paragraph (1)(A)— 23 (A) by striking ‘‘with 2026’’ and inserting 24 ‘‘with 2027’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00250 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 251 •HR 1768 IH (B) by inserting ‘‘, or, with respect to 1 2027, 3.53 percent’’ after ‘‘1.88 percent’’; 2 (2) in paragraph (2)— 3 (A) in subparagraph (B)— 4 (i) in the heading, by striking ‘‘2026’’ 5 and inserting ‘‘2027’’; and 6 (ii) in the matter preceding clause (i), 7 by striking ‘‘2026’’ and inserting ‘‘2027’’; 8 (B) in subparagraph (C)— 9 (i) in the heading, by striking ‘‘2027’’ 10 and inserting ‘‘2028’’; and 11 (ii) in the matter preceding clause (i), 12 by striking ‘‘2027’’ and inserting ‘‘2028’’; 13 and 14 (C) in subparagraph (D), by striking ‘‘and 15 2026’’ and inserting ‘‘2026, and 2027’’; and 16 (3) in paragraph (4)(B), by inserting ‘‘or, with 17 respect to 2027, 3.53 percent’’ after ‘‘1.88 percent’’. 18 (b) C ONFORMING AMENDMENTS.—Section 19 1848(q)(1)(C)(iii) of the Social Security Act (42 U.S.C. 20 1395w–4(q)(1)(C)(iii)) is amended— 21 (1) in subclause (II), by striking ‘‘2026’’ and 22 inserting ‘‘2027’’; and 23 (2) in subclause (III), by striking ‘‘2027’’ and 24 inserting ‘‘2028’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00251 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 252 •HR 1768 IH SEC. 205. TEMPORARY PAYMENT INCREASE UNDER THE 1 MEDICARE PHYSICIAN FEE SCHEDULE TO AC-2 COUNT FOR EXCEPTIONAL CIRCUMSTANCES. 3 (a) I N GENERAL.—Section 1848(t)(1) of the Social 4 Security Act (42 U.S.C. 1395w–4(t)(1)) is amended— 5 (1) in subparagraph (D), by striking ‘‘and’’ at 6 the end; 7 (2) in subparagraph (E), by striking the period 8 at the end and inserting ‘‘; and’’; and 9 (3) by adding at the end the following new sub-10 paragraph: 11 ‘‘(F) such services furnished on or after 12 January 1, 2025, and before January 1, 2026, 13 by 2.5 percent.’’. 14 (b) C ONFORMING AMENDMENT.—Section 15 1848(c)(2)(B)(iv)(V) is amended by striking ‘‘or 2024’’ 16 and inserting ‘‘2024, or 2025’’. 17 SEC. 206. EXTENSION OF FUNDING FOR QUALITY MEASURE 18 ENDORSEMENT, INPUT, AND SELECTION. 19 Section 1890(d)(2) of the Social Security Act (42 20 U.S.C. 1395aaa(d)(2)) is amended— 21 (1) in the first sentence— 22 (A) by striking ‘‘$11,030,000’’ and insert-23 ing ‘‘$20,030,000’’; and 24 (B) by striking ‘‘March 31’’ and inserting 25 ‘‘December 31’’; and 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00252 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 253 •HR 1768 IH (2) in the third sentence, by striking ‘‘March 1 31’’ and inserting ‘‘December 31’’. 2 SEC. 207. EXTENSION OF FUNDING OUTREACH AND ASSIST-3 ANCE FOR LOW-INCOME PROGRAMS. 4 (a) S TATE HEALTH INSURANCE ASSISTANCE PRO-5 GRAMS.—Subsection (a)(1)(B) of section 119 of the Medi-6 care Improvements for Patients and Providers Act of 2008 7 (42 U.S.C. 1395b–3 note) is amended— 8 (1) in clause (xiii), by striking ‘‘and’’ at the 9 end; 10 (2) in clause (xiv), by striking the period and 11 inserting ‘‘; and’’; and 12 (3) by inserting after clause (xiv) the following 13 new clause: 14 ‘‘(xv) for the period beginning on 15 April 1, 2025, and ending on December 16 31, 2026, $30,000,000.’’. 17 (b) A REA AGENCIES ON AGING.—Subsection 18 (b)(1)(B) of such section 119 is amended— 19 (1) in clause (xiii), by striking ‘‘and’’ at the 20 end; 21 (2) in clause (xiv), by striking the period and 22 inserting ‘‘; and’’; and 23 (3) by inserting after clause (xiv) the following 24 new clause: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00253 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 254 •HR 1768 IH ‘‘(xv) for the period beginning on 1 April 1, 2025, and ending on December 2 31, 2026, $30,000,000.’’. 3 (c) A GING AND DISABILITY RESOURCE CENTERS.— 4 Subsection (c)(1)(B) of such section 119 is amended— 5 (1) in clause (xiii), by striking ‘‘and’’ at the 6 end; 7 (2) in clause (xiv), by striking the period and 8 inserting ‘‘; and’’; and 9 (3) by inserting after clause (xiv) the following 10 new clause: 11 ‘‘(xv) for the period beginning on 12 April 1, 2025, and ending on December 13 31, 2026, $10,000,000.’’. 14 (d) COORDINATION OF EFFORTS TO INFORM OLDER 15 AMERICANS ABOUT BENEFITS AVAILABLE UNDER FED-16 ERAL AND STATE PROGRAMS.—Subsection (d)(2) of such 17 section 119 is amended— 18 (1) in clause (xiii), by striking ‘‘and’’ at the 19 end; 20 (2) in clause (xiv), by striking the period and 21 inserting ‘‘; and’’; and 22 (3) by inserting after clause (xiv) the following 23 new clause: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00254 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 255 •HR 1768 IH ‘‘(xv) for the period beginning on 1 April 1, 2025, and ending on December 2 31, 2026, $30,000,000.’’. 3 SEC. 208. EXTENSION OF THE WORK GEOGRAPHIC INDEX 4 FLOOR. 5 Section 1848(e)(1)(E) of the Social Security Act (42 6 U.S.C. 1395w–4(e)(1)(E)) is amended by striking ‘‘April 7 1, 2025’’ and inserting ‘‘January 1, 2026’’. 8 SEC. 209. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILI-9 TIES. 10 (a) R EMOVING GEOGRAPHIC REQUIREMENTS AND 11 EXPANDING ORIGINATING SITES FOR TELEHEALTH 12 SERVICES.—Section 1834(m) of the Social Security Act 13 (42 U.S.C. 1395m(m)) is amended— 14 (1) in paragraph (2)(B)(iii), by striking ‘‘end-15 ing March 31, 2025’’ and inserting ‘‘ending Decem-16 ber 31, 2026’’; and 17 (2) in paragraph (4)(C)(iii), by striking ‘‘ending 18 on March 31, 2025’’ and inserting ‘‘ending on De-19 cember 31, 2026’’. 20 (b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR-21 NISH TELEHEALTH SERVICES.—Section 1834(m)(4)(E) 22 of the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) 23 is amended by striking ‘‘ending on March 31, 2025’’ and 24 inserting ‘‘ending on December 31, 2026’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00255 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 256 •HR 1768 IH (c) E XTENDING TELEHEALTH SERVICES FOR FED-1 ERALLY QUALIFIED HEALTH CENTERS AND RURAL 2 HEALTH CLINICS.—Section 1834(m)(8) of the Social Se-3 curity Act (42 U.S.C. 1395m(m)(8)) is amended— 4 (1) in subparagraph (A), by striking ‘‘ending on 5 March 31, 2025’’ and inserting ‘‘ending on Decem-6 ber 31, 2026’’; 7 (2) in subparagraph (B)— 8 (A) in the subparagraph heading, by in-9 serting ‘‘BEFORE 2025 ’’ after ‘‘ RULE’’; 10 (B) in clause (i), by striking ‘‘during the 11 periods for which subparagraph (A) applies’’ 12 and inserting ‘‘before January 1, 2025’’; and 13 (C) in clause (ii), by inserting ‘‘furnished 14 to an eligible telehealth individual before Janu-15 ary 1, 2025’’ after ‘‘telehealth services’’; and 16 (3) by adding at the end the following new sub-17 paragraph: 18 ‘‘(C) P AYMENT RULE FOR 2025 AND 19 2026.— 20 ‘‘(i) I N GENERAL .—A telehealth serv-21 ice furnished to an eligible telehealth indi-22 vidual by a Federally qualified health cen-23 ter or rural health clinic on or after Janu-24 ary 1, 2025, and before January 1, 2027, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00256 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 257 •HR 1768 IH shall be paid as a Federally qualified 1 health center service or rural health clinic 2 service (as applicable) under the prospec-3 tive payment system established under sec-4 tion 1834(o) or the methodology for all-in-5 clusive rates established under section 6 1833(a)(3), respectively. 7 ‘‘(ii) T REATMENT OF COSTS .—Costs 8 associated with the furnishing of telehealth 9 services by a Federally qualified health 10 center or rural health clinic on or after 11 January 1, 2025, and before January 1, 12 2027, shall be considered allowable costs 13 for purposes of the prospective payment 14 system established under section 1834(o) 15 and the methodology for all-inclusive rates 16 established under section 1833(a)(3), as 17 applicable. 18 ‘‘(iii) R EQUIRING MODIFIERS .—Not 19 later than July 1, 2025, the Secretary 20 shall establish requirements to include 1 or 21 more codes or modifiers, as determined ap-22 propriate by the Secretary, in the case of 23 claims for telehealth services furnished to 24 an eligible telehealth individual by a Feder-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00257 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 258 •HR 1768 IH ally qualified health center or rural health 1 clinic.’’. 2 (d) D ELAYING THE IN-PERSON REQUIREMENTS 3 UNDER MEDICARE FOR MENTAL HEALTH SERVICES 4 FURNISHED THROUGH TELEHEALTH AND TELE-5 COMMUNICATIONS TECHNOLOGY.— 6 (1) D ELAY IN REQUIREMENTS FOR MENTAL 7 HEALTH SERVICES FURNISHED THROUGH TELE -8 HEALTH.—Section 1834(m)(7)(B)(i) of the Social 9 Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is 10 amended, in the matter preceding subclause (I), by 11 striking ‘‘on or after April 1, 2025’’ and inserting 12 ‘‘on or after January 1, 2027’’. 13 (2) M ENTAL HEALTH VISITS FURNISHED BY 14 RURAL HEALTH CLINICS .—Section 1834(y)(2) of the 15 Social Security Act (42 U.S.C. 1395m(y)(2)) is 16 amended by striking ‘‘April 1, 2025’’ and inserting 17 ‘‘January 1, 2027’’. 18 (3) M ENTAL HEALTH VISITS FURNISHED BY 19 FEDERALLY QUALIFIED HEALTH CENTERS .—Section 20 1834(o)(4)(B) of the Social Security Act (42 U.S.C. 21 1395m(o)(4)(B)) is amended by striking ‘‘April 1, 22 2025’’ and inserting ‘‘January 1, 2027.’’. 23 (e) A LLOWING FOR THE FURNISHING OF AUDIO- 24 ONLY TELEHEALTH SERVICES.—Section 1834(m)(9) of 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00258 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 259 •HR 1768 IH the Social Security Act (42 U.S.C. 1395m(m)(9)) is 1 amended by striking ‘‘ending on March 31, 2025’’ and in-2 serting ‘‘ending on December 31, 2026’’. 3 (f) EXTENDING USE OF TELEHEALTH TO CONDUCT 4 FACE-TO-FACE ENCOUNTER PRIOR TO RECERTIFICATION 5 OF ELIGIBILITY FOR HOSPICE CARE.—Section 6 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 7 1395f(a)(7)(D)(i)(II)) is amended— 8 (1) by striking ‘‘ending on March 31, 2025’’ 9 and inserting ‘‘ending on December 31, 2026’’; and 10 (2) by inserting ‘‘, except that this subclause 11 shall not apply in the case of such an encounter with 12 an individual occurring on or after January 1, 2025, 13 if such individual is located in an area that is sub-14 ject to a moratorium on the enrollment of hospice 15 programs under this title pursuant to section 16 1866(j)(7), if such individual is receiving hospice 17 care from a provider that is subject to enhanced 18 oversight under this title pursuant to section 19 1866(j)(3), or if such encounter is performed by a 20 hospice physician or nurse practitioner who is not 21 enrolled under section 1866(j) and is not an opt-out 22 physician or practitioner (as defined in section 23 1802(b)(6)(D))’’ before the semicolon. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00259 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 260 •HR 1768 IH (g) REQUIRING MODIFIERS FOR TELEHEALTH SERV-1 ICES IN CERTAIN INSTANCES.—Section 1834(m) of the 2 Social Security Act (42 U.S.C. 1395m(m)) is amended by 3 adding at the end the following new paragraph: 4 ‘‘(10) R EQUIRED USE OF MODIFIERS IN CER -5 TAIN INSTANCES .—Not later than January 1, 2026, 6 the Secretary shall establish requirements to include 7 1 or more codes or modifiers, as determined appro-8 priate by the Secretary, in the case of— 9 ‘‘(A) claims for telehealth services under 10 this subsection that are furnished through a 11 telehealth virtual platform— 12 ‘‘(i) by a physician or practitioner 13 that contracts with an entity that owns 14 such virtual platform; or 15 ‘‘(ii) for which a physician or practi-16 tioner has a payment arrangement with an 17 entity for use of such virtual platform; and 18 ‘‘(B) claims for telehealth services under 19 this subsection that are furnished incident to a 20 physician’s or practitioner’s professional serv-21 ice.’’. 22 (h) P ROGRAM INSTRUCTION AUTHORITY.—The Sec-23 retary of Health and Human Services may implement the 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00260 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 261 •HR 1768 IH amendments made by this section through program in-1 struction or otherwise. 2 SEC. 210. REQUIRING MODIFIER FOR USE OF TELEHEALTH 3 TO CONDUCT FACE-TO-FACE ENCOUNTER 4 PRIOR TO RECERTIFICATION OF ELIGIBILITY 5 FOR HOSPICE CARE. 6 Section 1814(a)(7)(D)(i)(II) of the Social Security 7 Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by sec-8 tion 209(f) of the Health Improvements, Extenders, and 9 Reauthorizations Act, is further amended by inserting ‘‘, 10 but only if, in the case of such an encounter occurring 11 on or after January 1, 2026, any hospice claim includes 12 1 or more modifiers or codes (as specified by the Sec-13 retary) to indicate that such encounter was conducted via 14 telehealth’’ after ‘‘as determined appropriate by the Sec-15 retary’’. 16 SEC. 211. EXTENDING ACUTE HOSPITAL CARE AT HOME 17 WAIVER FLEXIBILITIES. 18 Section 1866G of the Social Security Act (42 U.S.C. 19 1395cc–7) is amended— 20 (1) in the section heading, by inserting ‘‘ THE 21 THOMAS R . CARPER, TIM SCOTT , BRAD R . 22 WENSTRUP, D.P.M., AND EARL BLUMENAUER ’’ 23 after ‘‘EXTENSION OF’’; 24 (2) in subsection (a)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00261 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 262 •HR 1768 IH (A) in paragraph (1)— 1 (i) by striking ‘‘March 31, 2025’’ and 2 inserting ‘‘December 31, 2029’’; and 3 (ii) by striking ‘‘in the Acute Hospital 4 Care at Home initiative of the Secretary’’ 5 and inserting ‘‘in the Thomas R. Carper, 6 Tim Scott, Brad R. Wenstrup, D.P.M., 7 and Earl Blumenauer Acute Hospital Care 8 at Home initiative of the Secretary (in this 9 section referred to as the ‘Acute Hospital 10 Care at Home initiative’)’’; 11 (B) in paragraph (2), by striking ‘‘of the 12 Secretary’’; and 13 (C) in paragraph (3)(E), by adding at the 14 end the following new flush sentence: 15 ‘‘The Secretary may require that such data and 16 information be submitted through a hospital’s 17 cost report, through such survey instruments as 18 the Secretary may develop, through medical 19 record information, or through such other 20 means as the Secretary determines appro-21 priate.’’; 22 (3) in subsection (b)— 23 (A) in the subsection heading, by striking 24 ‘‘STUDY’’ and inserting ‘‘I NITIAL STUDY’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00262 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 263 •HR 1768 IH (B) in paragraph (1)(A), by striking ‘‘of 1 the Secretary’’; and 2 (C) in paragraph (3), by inserting ‘‘or sub-3 section (c)’’ before the period at the end; 4 (4) by redesignating subsections (c) and (d) as 5 subsections (d) and (e), respectively; and 6 (5) by inserting after subsection (b) the fol-7 lowing new subsection: 8 ‘‘(c) SUBSEQUENT STUDY AND REPORT.— 9 ‘‘(1) I N GENERAL .—Not later than September 10 30, 2028, the Secretary shall conduct a study to— 11 ‘‘(A) analyze, to the extent practicable, the 12 criteria established by hospitals under the Acute 13 Hospital Care at Home initiative to determine 14 which individuals may be furnished services 15 under such initiative; and 16 ‘‘(B) analyze and compare (both within 17 and between hospitals participating in the ini-18 tiative, and relative to comparable hospitals 19 that do not participate in the initiative, for rel-20 evant parameters such as diagnosis-related 21 groups)— 22 ‘‘(i) quality of care furnished to indi-23 viduals with similar conditions and charac-24 teristics in the inpatient setting and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00263 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 264 •HR 1768 IH through the Acute Hospital Care at Home 1 initiative, including health outcomes, hos-2 pital readmission rates (including readmis-3 sions both within and beyond 30 days post- 4 discharge), hospital mortality rates, length 5 of stay, infection rates, composition of care 6 team (including the types of labor used, 7 such as contracted labor), the ratio of 8 nursing staff, transfers from the hospital 9 to the home, transfers from the home to 10 the hospital (including the timing, fre-11 quency, and causes of such transfers), 12 transfers and discharges to post-acute care 13 settings (including the timing, frequency, 14 and causes of such transfers and dis-15 charges), and patient and caregiver experi-16 ence of care; 17 ‘‘(ii) clinical conditions treated and di-18 agnosis-related groups of discharges from 19 inpatient settings relative to discharges 20 from the Acute Hospital Care at Home ini-21 tiative; 22 ‘‘(iii) costs incurred by the hospital 23 for furnishing care in inpatient settings 24 relative to costs incurred by the hospital 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00264 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 265 •HR 1768 IH for furnishing care through the Acute Hos-1 pital Care at Home initiative, including 2 costs relating to staffing, equipment, food, 3 prescriptions, and other services, as deter-4 mined by the Secretary; 5 ‘‘(iv) the quantity, mix, and intensity 6 of services (such as in-person visits and 7 virtual contacts with patients and the in-8 tensity of such services) furnished in inpa-9 tient settings relative to the Acute Hospital 10 Care at Home initiative, and, to the extent 11 practicable, the nature and extent of family 12 or caregiver involvement; 13 ‘‘(v) socioeconomic information on in-14 dividuals treated in comparable inpatient 15 settings relative to the initiative, including 16 racial and ethnic data, income, housing, 17 geographic proximity to the brick-and-mor-18 tar facility and whether such individuals 19 are dually eligible for benefits under this 20 title and title XIX; and 21 ‘‘(vi) the quality of care, outcomes, 22 costs, quantity and intensity of services, 23 and other relevant metrics between individ-24 uals who entered into the Acute Hospital 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00265 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 266 •HR 1768 IH Care at Home initiative directly from an 1 emergency department compared with indi-2 viduals who entered into the Acute Hos-3 pital Care at Home initiative directly from 4 an existing inpatient stay in a hospital. 5 ‘‘(2) S ELECTION BIAS .—In conducting the 6 study under paragraph (1), the Secretary shall, to 7 the extent practicable, analyze and compare individ-8 uals who participate and do not participate in the 9 initiative controlling for selection bias or other fac-10 tors that may impact the reliability of data. 11 ‘‘(3) R EPORT.—Not later than September 30, 12 2028, the Secretary of Health and Human Services 13 shall post on a website of the Centers for Medicare 14 & Medicaid Services a report on the study conducted 15 under paragraph (1). 16 ‘‘(4) F UNDING.—In addition to amounts other-17 wise available, there is appropriated to the Centers 18 for Medicare & Medicaid Services Program Manage-19 ment Account for fiscal year 2025, out of any 20 amounts in the Treasury not otherwise appropriated, 21 $6,000,000, respectively, to remain available until 22 expended, for purposes of carrying out this section.’’. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00266 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 267 •HR 1768 IH SEC. 212. ENHANCING CERTAIN PROGRAM INTEGRITY RE-1 QUIREMENTS FOR DME UNDER MEDICARE. 2 (a) DURABLE MEDICAL EQUIPMENT.— 3 (1) I N GENERAL .—Section 1834(a) of the So-4 cial Security Act (42 U.S.C. 1395m(a)) is amended 5 by adding at the end the following new paragraph: 6 ‘‘(23) MASTER LIST INCLUSION AND CLAIM RE -7 VIEW FOR CERTAIN ITEMS .— 8 ‘‘(A) M ASTER LIST INCLUSION .—Begin-9 ning January 1, 2028, for purposes of the Mas-10 ter List described in section 414.234(b) of title 11 42, Code of Federal Regulations (or any suc-12 cessor regulation), an item for which payment 13 may be made under this subsection shall be 14 treated as having aberrant billing patterns (as 15 such term is used for purposes of such section) 16 if the Secretary determines that, without ex-17 planatory contributing factors (such as fur-18 nishing emergent care services), a substantial 19 number of claims for such items under this sub-20 section are for such items ordered by a physi-21 cian or practitioner who has not previously 22 (during a period of not less than 24 months, as 23 established by the Secretary) furnished to the 24 individual involved any item or service for which 25 payment may be made under this title. 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00267 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 268 •HR 1768 IH ‘‘(B) C LAIM REVIEW .—With respect to 1 items furnished on or after January 1, 2028, 2 that are included on the Master List pursuant 3 to subparagraph (A), if such an item is not sub-4 ject to a determination of coverage in advance 5 pursuant to paragraph (15)(C), the Secretary 6 may conduct prepayment review of claims for 7 payment for such item.’’. 8 (2) C ONFORMING AMENDMENT FOR PROS -9 THETIC DEVICES , ORTHOTICS, AND PROSTHETICS .— 10 Section 1834(h)(3) of the Social Security Act (42 11 U.S.C. 1395m(h)(3)) is amended by inserting ‘‘, and 12 paragraph (23) of subsection (a) shall apply to pros-13 thetic devices, orthotics, and prosthetics in the same 14 manner as such provision applies to items for which 15 payment may be made under such subsection’’ be-16 fore the period at the end. 17 (b) REPORT ON IDENTIFYING CLINICAL DIAGNOSTIC 18 LABORATORY TESTS AT HIGH RISK FOR FRAUD AND EF-19 FECTIVE MITIGATION MEASURES.—Not later than Janu-20 ary 1, 2026, the Inspector General of the Department of 21 Health and Human Services shall submit to Congress a 22 report assessing fraud risks relating to claims for clinical 23 diagnostic laboratory tests for which payment may be 24 made under section 1834A of the Social Security Act (42 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00268 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 269 •HR 1768 IH U.S.C. 1395m–1) and effective tools for reducing such 1 fraudulent claims. The report may include information re-2 garding— 3 (1) which, if any, clinical diagnostic laboratory 4 tests are identified as being at high risk of fraudu-5 lent claims, and an analysis of the factors that con-6 tribute to such risk; 7 (2) with respect to a clinical diagnostic labora-8 tory test identified under paragraph (1) as being at 9 high risk of fraudulent claims— 10 (A) the amount payable under such section 11 1834A with respect to such test; 12 (B) the number of such tests furnished to 13 individuals enrolled under part B of title XVIII 14 of the Social Security Act (42 U.S.C. 1395j et 15 seq.); 16 (C) whether an order for such a test was 17 more likely to come from a provider with whom 18 the individual involved did not have a prior re-19 lationship, as determined on the basis of prior 20 payment experience; and 21 (D) the frequency with which a claim for 22 payment under such section 1834A included the 23 payment modifier identified by code 59 or 91; 24 and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00269 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 270 •HR 1768 IH (3) suggested strategies for reducing the num-1 ber of fraudulent claims made with respect to tests 2 so identified as being at high risk, including— 3 (A) an analysis of whether the Centers for 4 Medicare & Medicaid Services can detect aber-5 rant billing patterns with respect to such tests 6 in a timely manner; 7 (B) any strategies for identifying and mon-8 itoring the providers who are outliers with re-9 spect to the number of such tests that such pro-10 viders order; and 11 (C) targeted education efforts to mitigate 12 improper billing for such tests; and 13 (4) such other information as the Inspector 14 General determines appropriate. 15 SEC. 213. GUIDANCE ON FURNISHING SERVICES VIA TELE-16 HEALTH TO INDIVIDUALS WITH LIMITED 17 ENGLISH PROFICIENCY. 18 (a) I N GENERAL.—Not later than 1 year after the 19 date of the enactment of this section, the Secretary of 20 Health and Human Services, in consultation with 1 or 21 more entities from each of the categories described in 22 paragraphs (1) through (7) of subsection (b), shall issue 23 and disseminate, or update and revise as applicable, guid-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00270 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 271 •HR 1768 IH ance for the entities described in such subsection on the 1 following: 2 (1) Best practices on facilitating and inte-3 grating use of interpreters during a telemedicine ap-4 pointment. 5 (2) Best practices on providing accessible in-6 structions on how to access telecommunications sys-7 tems (as such term is used for purposes of section 8 1834(m) of the Social Security Act (42 U.S.C. 9 1395m(m)) for individuals with limited English pro-10 ficiency. 11 (3) Best practices on improving access to dig-12 ital patient portals for individuals with limited 13 English proficiency. 14 (4) Best practices on integrating the use of 15 video platforms that enable multi-person video calls 16 furnished via a telecommunications system for pur-17 poses of providing interpretation during a telemedi-18 cine appointment for an individual with limited 19 English proficiency. 20 (5) Best practices for providing patient mate-21 rials, communications, and instructions in multiple 22 languages, including text message appointment re-23 minders and prescription information. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00271 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 272 •HR 1768 IH (b) E NTITIES DESCRIBED.—For purposes of sub-1 section (a), an entity described in this subsection is an 2 entity in 1 or more of the following categories: 3 (1) Health information technology service pro-4 viders, including— 5 (A) electronic medical record companies; 6 (B) remote patient monitoring companies; 7 and 8 (C) telehealth or mobile health vendors and 9 companies. 10 (2) Health care providers, including— 11 (A) physicians; and 12 (B) hospitals. 13 (3) Health insurers. 14 (4) Language service companies. 15 (5) Interpreter or translator professional asso-16 ciations. 17 (6) Health and language services quality certifi-18 cation organizations. 19 (7) Patient and consumer advocates, including 20 such advocates that work with individuals with lim-21 ited English proficiency. 22 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00272 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 273 •HR 1768 IH SEC. 214. IN-HOME CARDIOPULMONARY REHABILITATION 1 FLEXIBILITIES. 2 (a) IN GENERAL.—Section 1861(eee)(2) of the Social 3 Security Act (42 U.S.C. 1395x(eee)(2)) is amended— 4 (1) in subparagraph (A)(ii), by inserting ‘‘(in-5 cluding, with respect to items and services furnished 6 through audio and video real-time communications 7 technology (excluding audio-only) on or after April 8 1, 2025, and before January 1, 2027, in the home 9 of an individual who is an outpatient of the hos-10 pital)’’ after ‘‘outpatient basis’’; and 11 (2) in subparagraph (B), by inserting ‘‘(includ-12 ing, with respect to items and services furnished 13 through audio and video real-time communications 14 technology on or after April 1, 2025, and before 15 January 1, 2027, the virtual presence of such physi-16 cian, physician assistant, nurse practitioner, or clin-17 ical nurse specialist)’’ after ‘‘under the program’’. 18 (b) P ROGRAM INSTRUCTION AUTHORITY.—Notwith-19 standing any other provision of law, the Secretary of 20 Health and Human Services may implement the amend-21 ments made by this section by program instruction or oth-22 erwise. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00273 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 274 •HR 1768 IH SEC. 215. INCLUSION OF VIRTUAL DIABETES PREVENTION 1 PROGRAM SUPPLIERS IN MDPP EXPANDED 2 MODEL. 3 (a) I N GENERAL.—Not later than January 1, 2026, 4 the Secretary shall revise the regulations under parts 410 5 and 424 of title 42, Code of Federal Regulations, to pro-6 vide that, for the period beginning January 1, 2026, and 7 ending December 31, 2030— 8 (1) an entity may participate in the MDPP by 9 offering only online MDPP services via synchronous 10 or asynchronous technology or telecommunications if 11 such entity meets the conditions for enrollment as 12 an MDPP supplier (as specified in section 13 424.205(b) of title 42, Code of Federal Regulations 14 (or a successor regulation)); 15 (2) if an entity participates in the MDPP in the 16 manner described in paragraph (1)— 17 (A) the administrative location of such en-18 tity shall be the address of the entity on file 19 under the Diabetes Prevention Recognition Pro-20 gram; and 21 (B) in the case of online MDPP services 22 furnished by such entity to an MDPP bene-23 ficiary who was not located in the same State 24 as the entity at the time such services were fur-25 nished, the entity shall not be prohibited from 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00274 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 275 •HR 1768 IH submitting a claim for payment for such serv-1 ices solely by reason of the location of such ben-2 eficiary at such time; and 3 (3) no limit is applied on the number of times 4 an individual may enroll in the MDPP. 5 (b) DEFINITIONS.—In this section: 6 (1) MDPP.—The term ‘‘MDPP’’ means the 7 Medicare Diabetes Prevention Program conducted 8 under section 1115A of the Social Security Act (42 9 U.S.C. 1315a), as described in the final rule pub-10 lished in the Federal Register entitled ‘‘Medicare 11 and Medicaid Programs; CY 2024 Payment Policies 12 Under the Physician Fee Schedule and Other 13 Changes to Part B Payment and Coverage Policies; 14 Medicare Shared Savings Program Requirements; 15 Medicare Advantage; Medicare and Medicaid Pro-16 vider and Supplier Enrollment Policies; and Basic 17 Health Program’’ (88 Fed. Reg. 78818 (November 18 16, 2023)) (or a successor regulation). 19 (2) R EGULATORY TERMS .—The terms ‘‘Diabe-20 tes Prevention Recognition Program’’, ‘‘full CDC 21 DPRP recognition’’, ‘‘MDPP beneficiary’’, ‘‘MDPP 22 services’’, and ‘‘MDPP supplier’’ have the meanings 23 given each such term in section 410.79(b) of title 24 42, Code of Federal Regulations. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00275 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 276 •HR 1768 IH (3) S ECRETARY.—The term ‘‘Secretary’’ means 1 the Secretary of Health and Human Services. 2 SEC. 216. MEDICATION-INDUCED MOVEMENT DISORDER 3 OUTREACH AND EDUCATION. 4 Not later than January 1, 2026, the Secretary shall 5 use existing communications mechanisms to provide edu-6 cation and outreach to physicians and appropriate non- 7 physician practitioners participating under the Medicare 8 program under title XVIII of the Social Security Act (42 9 U.S.C. 1395 et seq.) with respect to periodic screening for 10 medication-induced movement disorders that are associ-11 ated with the treatment of mental health disorders in at- 12 risk patients, as well as resources related to clinical guide-13 lines and best practices for furnishing such screening serv-14 ices through telehealth. Such education and outreach shall 15 include information on how to account for such screening 16 services in evaluation and management code selection. The 17 Secretary shall, to the extent practicable, seek input from 18 relevant stakeholders to inform such education and out-19 reach. Such education and outreach may also address 20 other relevant screening services furnished through tele-21 health, as the Secretary determines appropriate. 22 SEC. 217. REPORT ON WEARABLE MEDICAL DEVICES. 23 Not later than 18 months after the date of the enact-24 ment of this Act, the Comptroller General of the United 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00276 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 277 •HR 1768 IH States shall conduct a technology assessment of, and sub-1 mit to Congress a report on, the capabilities and limita-2 tions of wearable medical devices used to support clinical 3 decision-making. Such report shall include a description 4 of— 5 (1) the potential for such devices to accurately 6 prescribe treatments; 7 (2) an examination of the benefits and chal-8 lenges of artificial intelligence to augment such ca-9 pabilities; and 10 (3) policy options to enhance the benefits and 11 mitigate potential challenges of developing or using 12 such devices. 13 SEC. 218. EXTENSION OF TEMPORARY INCLUSION OF AU-14 THORIZED ORAL ANTIVIRAL DRUGS AS COV-15 ERED PART D DRUGS. 16 Section 1860D–2(e)(1)(C) of the Social Security Act 17 (42 U.S.C. 1395w–102(e)(1)(C)) is amended by striking 18 ‘‘March 31, 2025’’ and inserting ‘‘December 31, 2025’’. 19 SEC. 219. EXTENSION OF ADJUSTMENT TO CALCULATION 20 OF HOSPICE CAP AMOUNT. 21 Section 1814(i)(2)(B) of the Social Security Act (42 22 U.S.C. 1395f(i)(2)(B)) is amended— 23 (1) in clause (ii), by striking ‘‘2033’’ and in-24 serting ‘‘2034’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00277 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 278 •HR 1768 IH (2) in clause (iii), by striking ‘‘2033’’ and in-1 serting ‘‘2034’’. 2 SEC. 220. MULTIYEAR CONTRACTING AUTHORITY FOR 3 MEDPAC AND MACPAC. 4 Section 3904 of title 41, United States Code, is 5 amended by adding at the end the following new sub-6 sections: 7 ‘‘(i) T HE MEDICARE PAYMENT ADVISORY COMMIS-8 SION.—The Medicare Payment Advisory Commission may 9 use available funds to enter into contracts for the procure-10 ment of severable services for a period that begins in one 11 fiscal year and ends in the next fiscal year and may enter 12 into multiyear contracts for the acquisition of property 13 and services to the same extent as executive agencies 14 under the authority of sections 3902 and 3903 of this 15 title. 16 ‘‘(j) T HE MEDICAID AND CHIP P AYMENT AND AC-17 CESS COMMISSION.—The Medicaid and CHIP Payment 18 and Access Commission may use available funds to enter 19 into contracts for the procurement of severable services 20 for a period that begins in one fiscal year and ends in 21 the next fiscal year and may enter into multiyear contracts 22 for the acquisition of property and services to the same 23 extent as executive agencies under the authority of sec-24 tions 3902 and 3903 of this title.’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00278 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 279 •HR 1768 IH SEC. 221. CONTRACTING PARITY FOR MEDPAC AND 1 MACPAC. 2 In fiscal year 2025 and thereafter, for all contracts 3 for goods and services to which the Medicare and Payment 4 Advisory Commission or the Medicaid and CHIP Payment 5 and Access Commission is a party, the following Federal 6 Acquisition Regulation (FAR) clauses will apply: FAR 7 52.232–39 and FAR 52.233–4 (or a successor clause). 8 SEC. 222. ADJUSTMENTS TO MEDICARE PART D COST-SHAR-9 ING REDUCTIONS FOR LOW-INCOME INDIVID-10 UALS. 11 Section 1860D–14(a) of the Social Security Act (42 12 U.S.C. 1395w–114(a)) is amended— 13 (1) in paragraph (1)(D)(ii), by striking ‘‘that 14 does not exceed $1 for’’ and all that follows through 15 the period at the end and inserting ‘‘that does not 16 exceed— 17 ‘‘(I) for a plan year before 18 2027— 19 ‘‘(aa) for a generic drug or a 20 preferred drug that is a multiple 21 source drug (as defined in section 22 1927(k)(7)(A)(i)), $1 or, if less, 23 the copayment amount applicable 24 to an individual under clause 25 (iii); and 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00279 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 280 •HR 1768 IH ‘‘(bb) for any other drug, $3 1 or, if less, the copayment amount 2 applicable to an individual under 3 clause (iii); and 4 ‘‘(II) for plan year 2027 and 5 each subsequent plan year— 6 ‘‘(aa) for a generic drug, $0; 7 ‘‘(bb) for a preferred drug 8 that is a multiple source drug (as 9 defined in section 10 1927(k)(7)(A)(i)), the dollar 11 amount applied under this clause 12 for such a drug for the preceding 13 plan year, increased by the an-14 nual percentage increase in the 15 consumer price index (all items; 16 U.S. city average) as of Sep-17 tember of such preceding year, 18 or, if less, the copayment amount 19 applicable to an individual under 20 clause (iii); and 21 ‘‘(cc) for a drug not de-22 scribed in either item (aa) or 23 (bb), the dollar amount applied 24 under this clause for such a drug 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00280 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 281 •HR 1768 IH for the preceding plan year, in-1 creased in the manner specified 2 in item (bb), or, if less, the co-3 payment amount applicable to an 4 individual under clause (iii). 5 Any amount established under item (bb) or 6 (cc) of subclause (II), that is based on an 7 increase of $1 or $3, that is not a multiple 8 of 5 cents or 10 cents, respectively, shall 9 be rounded to the nearest multiple of 5 10 cents or 10 cents, respectively.’’; and 11 (2) in paragraph (4)(A)(ii), by inserting ‘‘(be-12 fore 2027)’’ after ‘‘a subsequent year’’. 13 SEC. 223. REQUIRING ENHANCED AND ACCURATE LISTS OF 14 (REAL) HEALTH PROVIDERS ACT. 15 (a) IN GENERAL.—Section 1852(c) of the Social Se-16 curity Act (42 U.S.C. 1395w–22(c)) is amended— 17 (1) in paragraph (1)(C)— 18 (A) by striking ‘‘plan, and any’’ and insert-19 ing ‘‘plan, any’’; and 20 (B) by inserting the following before the 21 period at the end: ‘‘, and, in the case of a speci-22 fied MA plan (as defined in paragraph (3)(C)), 23 for plan year 2027 and subsequent plan years, 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00281 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 282 •HR 1768 IH the information described in paragraph (3)(B)’’; 1 and 2 (2) by adding at the end the following new 3 paragraph: 4 ‘‘(3) PROVIDER DIRECTORY ACCURACY .— 5 ‘‘(A) I N GENERAL .—For plan year 2027 6 and subsequent plan years, each MA organiza-7 tion offering a specified MA plan (as defined in 8 subparagraph (C)) shall, for each such plan of-9 fered by the organization— 10 ‘‘(i) maintain, on a publicly available 11 internet website, an accurate provider di-12 rectory that includes the information de-13 scribed in subparagraph (B); 14 ‘‘(ii) not less frequently than once 15 every 90 days (or, in the case of a hospital 16 or any other facility determined appro-17 priate by the Secretary, at a lesser fre-18 quency specified by the Secretary but in no 19 case less frequently than once every 12 20 months), verify the provider directory in-21 formation of each provider listed in such 22 directory and, if applicable, update such 23 provider directory information; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00282 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 283 •HR 1768 IH ‘‘(iii) if the organization is unable to 1 verify such information with respect to a 2 provider, include in such directory an indi-3 cation that the information of such pro-4 vider may not be up to date; and 5 ‘‘(iv) remove a provider from such di-6 rectory within 5 business days if the orga-7 nization determines that the provider is no 8 longer a provider participating in the net-9 work of such plan. 10 ‘‘(B) P ROVIDER DIRECTORY INFORMA -11 TION.—The information described in this sub-12 paragraph is information enrollees may need to 13 access covered benefits from a provider with 14 which such organization offering such plan has 15 an agreement for furnishing items and services 16 covered under such plan such as name, spe-17 cialty, contact information, primary office or fa-18 cility address, whether the provider is accepting 19 new patients, accommodations for people with 20 disabilities, cultural and linguistic capabilities, 21 and telehealth capabilities. 22 ‘‘(C) S PECIFIED MA PLAN .—In this para-23 graph, the term ‘specified MA plan’ means— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00283 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 284 •HR 1768 IH ‘‘(i) a network-based plan (as defined 1 in subsection (d)(5)(C)); or 2 ‘‘(ii) a Medicare Advantage private 3 fee-for-service plan (as defined in section 4 1859(b)(2)) that meets the access stand-5 ards under subsection (d)(4), in whole or 6 in part, through entering into contracts or 7 agreements as provided for under subpara-8 graph (B) of such subsection.’’. 9 (b) A CCOUNTABILITY FOR PROVIDER DIRECTORY 10 ACCURACY.— 11 (1) C OST SHARING FOR SERVICES FURNISHED 12 BASED ON RELIANCE ON INCORRECT PROVIDER DI -13 RECTORY INFORMATION .—Section 1852(d) of the 14 Social Security Act (42 U.S.C. 1395w–22(d)) is 15 amended— 16 (A) in paragraph (1)(C)— 17 (i) in clause (ii), by striking ‘‘or’’ at 18 the end; 19 (ii) in clause (iii), by striking the 20 semicolon at the end and inserting ‘‘, or’’; 21 and 22 (iii) by adding at the end the fol-23 lowing new clause: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00284 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 285 •HR 1768 IH ‘‘(iv) the services are furnished by a 1 provider that is not participating in the 2 network of a specified MA plan (as defined 3 in subsection (c)(3)(C)) but is listed in the 4 provider directory of such plan on the date 5 on which the appointment is made, as de-6 scribed in paragraph (7)(A);’’; and 7 (B) by adding at the end the following new 8 paragraph: 9 ‘‘(7) C OST SHARING FOR SERVICES FURNISHED 10 BASED ON RELIANCE ON INCORRECT PROVIDER DI -11 RECTORY INFORMATION .— 12 ‘‘(A) I N GENERAL .—For plan year 2027 13 and subsequent plan years, if an enrollee is fur-14 nished an item or service by a provider that is 15 not participating in the network of a specified 16 MA plan (as defined in subsection (c)(3)(C)) 17 but is listed in the provider directory of such 18 plan (as required to be provided to an enrollee 19 pursuant to subsection (c)(1)(C)) on the date 20 on which the appointment is made, and if such 21 item or service would otherwise be covered 22 under such plan if furnished by a provider that 23 is participating in the network of such plan, the 24 MA organization offering such plan shall ensure 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00285 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 286 •HR 1768 IH that the enrollee is only responsible for the less-1 er of— 2 ‘‘(i) the amount of cost sharing that 3 would apply if such provider had been par-4 ticipating in the network of such plan; or 5 ‘‘(ii) the amount of cost sharing that 6 would otherwise apply (without regard to 7 this subparagraph). 8 ‘‘(B) N OTIFICATION REQUIREMENT .—For 9 plan year 2027 and subsequent plan years, each 10 MA organization that offers a specified MA 11 plan shall— 12 ‘‘(i) notify enrollees of their cost-shar-13 ing protections under this paragraph and 14 make such notifications, to the extent 15 practicable, by not later than the first day 16 of an annual, coordinated election period 17 under section 1851(e)(3) with respect to a 18 year; 19 ‘‘(ii) include information regarding 20 such cost-sharing protections in the pro-21 vider directory of each specified MA plan 22 offered by the MA organization.; and 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00286 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 287 •HR 1768 IH ‘‘(iii) notify enrollees of their cost- 1 sharing protections under this paragraph 2 in an explanation of benefits.’’. 3 (2) R EQUIRED PROVIDER DIRECTORY ACCU -4 RACY ANALYSIS AND REPORTS .— 5 (A) I N GENERAL .—Section 1857(e) of the 6 Social Security Act (42 U.S.C. 1395w–27(e)) is 7 amended by adding at the end the following 8 new paragraph: 9 ‘‘(6) P ROVIDER DIRECTORY ACCURACY ANAL -10 YSIS AND REPORTS .— 11 ‘‘(A) I N GENERAL .—Beginning with plan 12 years beginning on or after January 1, 2027, 13 subject to subparagraph (C), a contract under 14 this section with an MA organization shall re-15 quire the organization, for each specified MA 16 plan (as defined in section 1852(c)(3)(C)) of-17 fered by the organization to annually do the fol-18 lowing: 19 ‘‘(i) Conduct an analysis estimating 20 the accuracy of the provider directory in-21 formation of such plan using a random 22 sample of providers included in such pro-23 vider directory as follows: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00287 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 288 •HR 1768 IH ‘‘(I) Such a random sample shall 1 include a random sample of each spe-2 cialty of providers with a high inaccu-3 racy rate of provider directory infor-4 mation relative to other specialties of 5 providers, as determined by the Sec-6 retary. 7 ‘‘(II) For purposes of subclause 8 (I), one type of specialty may be pro-9 viders specializing in mental health or 10 substance use disorder treatment. 11 ‘‘(ii) Submit to the Secretary a report 12 containing the results of the analysis con-13 ducted under clause (i), including an accu-14 racy score for such provider directory in-15 formation (as determined using a plan 16 verification method specified by the Sec-17 retary under subparagraph (B)(i)). 18 ‘‘(B) D ETERMINATION OF ACCURACY 19 SCORE.— 20 ‘‘(i) I N GENERAL .—The Secretary 21 shall specify plan verification methods, 22 such as using telephonic verification or 23 other approaches using data sources main-24 tained by an MA organization or using 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00288 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 289 •HR 1768 IH publicly available data sets, that MA orga-1 nizations may use for estimating accuracy 2 scores of the provider directory information 3 of specified MA plans offered by such or-4 ganizations. 5 ‘‘(ii) A CCURACY SCORE METHOD -6 OLOGY.—With respect to each such meth-7 od specified by the Secretary as described 8 in clause (i), the Secretary shall specify a 9 methodology for MA organizations to use 10 in estimating such accuracy scores. Each 11 such methodology shall take into account 12 the administrative burden on plans and 13 providers and the relative importance of 14 certain provider directory information on 15 enrollee ability to access care. 16 ‘‘(C) E XCEPTION.—The Secretary may 17 waive the requirements of this paragraph in the 18 case of a specified MA plan with low enrollment 19 (as defined by the Secretary). 20 ‘‘(D) T RANSPARENCY.—Beginning with 21 plan years beginning on or after January 1, 22 2028, the Secretary shall post accuracy scores 23 (as reported under subparagraph (A)(ii)), in a 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00289 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 290 •HR 1768 IH machine readable file, on the internet website of 1 the Centers for Medicare & Medicaid Services.’’. 2 (B) P ROVISION OF INFORMATION TO 3 BENEFICIARIES.—Section 1851(d)(4) of the So-4 cial Security Act (42 U.S.C. 1395w–21(d)(4)) 5 is amended by adding at the end the following 6 new subparagraph: 7 ‘‘(F) P ROVIDER DIRECTORY .—Beginning 8 with plan years beginning on or after January 9 1, 2028, the accuracy score of the plan’s pro-10 vider directory (as reported under section 11 1857(e)(6)(A)(ii)) listed prominently on the 12 plan’s provider directory.’’. 13 (C) F UNDING.—In addition to amounts 14 otherwise available, there is appropriated to the 15 Centers for Medicare & Medicaid Services Pro-16 gram Management Account, out of any money 17 in the Treasury not otherwise appropriated, 18 $4,000,000 for fiscal year 2025, to remain 19 available until expended, to carry out the 20 amendments made by this paragraph. 21 (3) GAO STUDY AND REPORT .— 22 (A) A NALYSIS.—The Comptroller General 23 of the United States (in this paragraph referred 24 to as the ‘‘Comptroller General’’) shall conduct 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00290 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 291 •HR 1768 IH a study of the implementation of the amend-1 ments made by paragraphs (1) and (2). To the 2 extent data are available and reliable, such 3 study shall include an analysis of— 4 (i) the use of cost-sharing protections 5 required under section 1852(d)(7)(A) of 6 the Social Security Act, as added by para-7 graph (1); 8 (ii) the trends in provider directory in-9 formation accuracy scores under section 10 1857(e)(6)(A)(ii) of the Social Security 11 Act (as added by paragraph (2)(A)), both 12 overall and among providers specializing in 13 mental health or substance use disorder 14 treatment; 15 (iii) provider response rates by plan 16 verification methods; 17 (iv) administrative costs to providers 18 and Medicare Advantage organizations; 19 and 20 (v) other items determined appro-21 priate by the Comptroller General. 22 (B) REPORT.—Not later than January 15, 23 2032, the Comptroller General shall submit to 24 Congress a report containing the results of the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00291 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 292 •HR 1768 IH study conducted under subparagraph (A), to-1 gether with recommendations for such legisla-2 tion and administrative action as the Comp-3 troller General determines appropriate. 4 (c) G UIDANCE ON MAINTAINING ACCURATE PRO-5 VIDER DIRECTORIES.— 6 (1) STAKEHOLDER MEETING .— 7 (A) I N GENERAL .—Not later than 3 8 months after the date of enactment of this Act, 9 the Secretary of Health and Human Services 10 (referred to in this subsection as the ‘‘Sec-11 retary’’) shall hold a public meeting to receive 12 input on approaches for maintaining accurate 13 provider directories for Medicare Advantage 14 plans under part C of title XVIII of the Social 15 Security Act (42 U.S.C. 1395w–21 et seq.), in-16 cluding input on approaches for reducing ad-17 ministrative burden, such as data standardiza-18 tion, and best practices to maintain accurate 19 provider directory information. 20 (B) P ARTICIPANTS.—Participants of the 21 meeting under subparagraph (A) shall include 22 representatives from the Centers for Medicare & 23 Medicaid Services and the Assistant Secretary 24 for Technology Policy and Office of the Na-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00292 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 293 •HR 1768 IH tional Coordinator for Health Information 1 Technology. Such meeting shall be open to the 2 public. To the extent practicable, the Secretary 3 shall include health care providers, companies 4 that specialize in relevant technologies, health 5 insurers, and patient advocates. 6 (2) G UIDANCE TO MEDICARE ADVANTAGE OR -7 GANIZATIONS.—Not later than 12 months after the 8 date of enactment of this Act, the Secretary shall 9 issue guidance to Medicare Advantage organizations 10 offering Medicare Advantage plans under part C of 11 title XVIII of the Social Security Act (42 U.S.C. 12 1395w–21 et seq.) on maintaining accurate provider 13 directories for such plans, taking into consideration 14 input received during the stakeholder meeting under 15 paragraph (1). Such guidance may include the fol-16 lowing, as determined appropriate by the Secretary: 17 (A) Best practices for Medicare Advantage 18 organizations on how to work with providers to 19 maintain the accuracy of provider directories 20 and reduce provider and Medicare Advantage 21 organization burden with respect to maintaining 22 the accuracy of provider directories. 23 (B) Information on data sets and data 24 sources with information that could be used by 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00293 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 294 •HR 1768 IH Medicare Advantage organizations to maintain 1 accurate provider directories. 2 (C) Approaches for utilizing data sources 3 maintained by Medicare Advantage organiza-4 tions and publicly available data sets to main-5 tain accurate provider directories. 6 (D) Information to be included in provider 7 directories that may be useful for Medicare 8 beneficiaries to assess plan networks when se-9 lecting a plan and accessing providers partici-10 pating in plan networks during the plan year. 11 (3) G UIDANCE TO PART B PROVIDERS .—Not 12 later than 12 months after the date of enactment of 13 this Act, the Secretary shall issue guidance to pro-14 viders of services and suppliers who furnish items or 15 services for which benefits are available under part 16 B of title XVIII of the Social Security Act (42 17 U.S.C. 1395j et seq.) on when to update the Na-18 tional Plan and Provider Enumeration System for 19 information changes. 20 SEC. 224. MEDICARE COVERAGE OF MULTI-CANCER EARLY 21 DETECTION SCREENING TESTS. 22 (a) COVERAGE.—Section 1861 of the Social Security 23 Act (42 U.S.C. 1395x) is amended— 24 (1) in subsection (s)(2)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00294 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 295 •HR 1768 IH (A) by striking the semicolon at the end of 1 subparagraph (JJ) and inserting ‘‘; and’’; and 2 (B) by adding at the end the following new 3 subparagraph: 4 ‘‘(KK) multi-cancer early detection screen-5 ing tests (as defined in subsection (nnn));’’; and 6 (2) by adding at the end the following new sub-7 section: 8 ‘‘(nnn) MULTI-CANCER EARLY DETECTION SCREEN-9 ING TESTS.— 10 ‘‘(1) I N GENERAL .—The term ‘multi-cancer 11 early detection screening test’ means a test fur-12 nished to an individual for the concurrent detection 13 of multiple cancer types across multiple organ sites 14 on or after January 1, 2029, that— 15 ‘‘(A) is cleared under section 510(k), clas-16 sified under section 513(f)(2), or approved 17 under section 515 of the Federal Food, Drug, 18 and Cosmetic Act; 19 ‘‘(B) is— 20 ‘‘(i) a genomic sequencing blood or 21 blood product test that includes the anal-22 ysis of cell-free nucleic acids; or 23 ‘‘(ii) a test based on samples of bio-24 logical material that provide results com-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00295 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 296 •HR 1768 IH parable to those obtained with a test de-1 scribed in clause (i), as determined by the 2 Secretary; and 3 ‘‘(C) the Secretary determines is— 4 ‘‘(i) reasonable and necessary for the 5 prevention or early detection of an illness 6 or disability; and 7 ‘‘(ii) appropriate for individuals enti-8 tled to benefits under part A or enrolled 9 under part B. 10 ‘‘(2) NCD PROCESS.—In making determina-11 tions under paragraph (1)(C) regarding the coverage 12 of a new test, the Secretary shall use the process for 13 making national coverage determinations (as defined 14 in section 1869(f)(1)(B)) under this title.’’. 15 (b) PAYMENT AND STANDARDS FOR MULTI-CANCER 16 EARLY DETECTION SCREENING TESTS.— 17 (1) I N GENERAL .—Section 1834 of the Social 18 Security Act (42 U.S.C. 1395m) is amended by add-19 ing at the end the following new subsection: 20 ‘‘(aa) P AYMENT AND STANDARDS FOR MULTI-CAN-21 CER EARLY DETECTION SCREENING TESTS.— 22 ‘‘(1) P AYMENT AMOUNT .—The payment 23 amount for a multi-cancer early detection screening 24 test (as defined in section 1861(nnn)) is— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00296 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 297 •HR 1768 IH ‘‘(A) with respect to such a test furnished 1 before January 1, 2031, equal to the payment 2 amount in effect on the date of the enactment 3 of this subsection for a multi-target stool 4 screening DNA test covered pursuant to section 5 1861(pp)(1)(D); and 6 ‘‘(B) with respect to such a test furnished 7 on or after January 1, 2031, equal to the lesser 8 of— 9 ‘‘(i) the amount described in subpara-10 graph (A); or 11 ‘‘(ii) the payment amount determined 12 for such test under section 1834A. 13 ‘‘(2) LIMITATIONS.— 14 ‘‘(A) I N GENERAL .—No payment may be 15 made under this part for a multi-cancer early 16 detection screening test furnished during a year 17 to an individual if— 18 ‘‘(i) such individual— 19 ‘‘(I) is under 50 years of age; or 20 ‘‘(II) as of January 1 of such 21 year, has attained the age specified in 22 subparagraph (B) for such year; or 23 ‘‘(ii) such a test was furnished to the 24 individual during the previous 11 months. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00297 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 298 •HR 1768 IH ‘‘(B) A GE SPECIFIED .—For purposes of 1 subparagraph (A)(i)(II), the age specified in 2 this subparagraph is— 3 ‘‘(i) for 2029, 65 years of age; and 4 ‘‘(ii) for a succeeding year, the age 5 specified in this subparagraph for the pre-6 ceding year, increased by 1 year. 7 ‘‘(C) S TANDARDS FOLLOWING USPSTF 8 RATING OF A OR B .—In the case of a multi-can-9 cer early detection screening test that is rec-10 ommended with a grade of A or B by the 11 United States Preventive Services Task Force, 12 beginning on the date on which coverage for 13 such test is provided pursuant to section 14 1861(ddd)(1), the preceding provisions of this 15 paragraph shall not apply.’’. 16 (2) CONFORMING AMENDMENTS .— 17 (A) Section 1833 of the Social Security 18 Act (42 U.S.C. 1395l) is amended— 19 (i) in subsection (a)— 20 (I) in paragraph (1)(D)(i)(I), by 21 striking ‘‘section 1834(d)(1)’’ and in-22 serting ‘‘subsection (d)(1) or (aa) of 23 section 1834’’; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00298 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 299 •HR 1768 IH (II) in paragraph (2)(D)(i)(I), by 1 striking ‘‘section 1834(d)(1)’’ and in-2 serting ‘‘subsection (d)(1) or (aa) of 3 section 1834’’; and 4 (ii) in subsection (h)(1)(A), by strik-5 ing ‘‘section 1834(d)(1)’’ and inserting 6 ‘‘subsections (d)(1) and (aa) of section 7 1834’’. 8 (B) Section 1862(a)(1)(A) of the Social 9 Security Act (42 U.S.C. 1395y(a)(1)(A)) is 10 amended— 11 (i) by striking ‘‘or additional preven-12 tive services’’ and inserting ‘‘, additional 13 preventive services’’; and 14 (ii) by inserting ‘‘, or multi-cancer 15 early detection screening tests (as defined 16 in section 1861(nnn))’’ after ‘‘(as de-17 scribed in section 1861(ddd)(1))’’. 18 (c) R ULE OF CONSTRUCTION RELATING TO OTHER 19 CANCER SCREENING TESTS.—Nothing in this section, in-20 cluding the amendments made by this section, shall be 21 construed— 22 (1) in the case of an individual who undergoes 23 a multi-cancer early detection screening test, to af-24 fect coverage under part B of title XVIII of the So-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00299 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 300 •HR 1768 IH cial Security Act for other cancer screening tests 1 covered under such title, such as screening tests for 2 breast, cervical, colorectal, lung, or prostate cancer; 3 or 4 (2) in the case of an individual who undergoes 5 another cancer screening test, to affect coverage 6 under such part for a multi-cancer early detection 7 screening test or the use of such a test as a diag-8 nostic or confirmatory test for a result of the other 9 cancer screening test. 10 SEC. 225. MEDICARE COVERAGE OF EXTERNAL INFUSION 11 PUMPS AND NON-SELF-ADMINISTRABLE 12 HOME INFUSION DRUGS. 13 (a) IN GENERAL.—Section 1861(n) of the Social Se-14 curity Act (42 U.S.C. 1395x(n)) is amended by adding 15 at the end the following new sentence: ‘‘Beginning with 16 the first calendar quarter beginning on or after the date 17 that is 1 year after the date of the enactment of this sen-18 tence, an external infusion pump and associated home in-19 fusion drug (as defined in subsection (iii)(3)(C)) or other 20 associated supplies that do not meet the appropriate for 21 use in the home requirement applied to the definition of 22 durable medical equipment under section 414.202 of title 23 42, Code of Federal Regulations (or any successor to such 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00300 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 301 •HR 1768 IH regulation) shall be treated as meeting such requirement 1 if each of the following criteria is satisfied: 2 ‘‘(1) The prescribing information approved by 3 the Food and Drug Administration for the home in-4 fusion drug associated with the pump instructs that 5 the drug should be administered by or under the su-6 pervision of a health care professional. 7 ‘‘(2) A qualified home infusion therapy supplier 8 (as defined in subsection (iii)(3)(D)) administers or 9 supervises the administration of the drug or biologi-10 cal in a safe and effective manner in the patient’s 11 home (as defined in subsection (iii)(3)(B)). 12 ‘‘(3) The prescribing information described in 13 paragraph (1) instructs that the drug should be in-14 fused at least 12 times per year— 15 ‘‘(A) intravenously or subcutaneously; or 16 ‘‘(B) at infusion rates that the Secretary 17 determines would require the use of an external 18 infusion pump.’’. 19 (b) C OST SHARING NOTIFICATION.—The Secretary 20 of Health and Human Services shall ensure that patients 21 are notified of the cost sharing for electing home infusion 22 therapy compared to other applicable settings of care for 23 the furnishing of infusion drugs under the Medicare pro-24 gram. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00301 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 302 •HR 1768 IH SEC. 226. ASSURING PHARMACY ACCESS AND CHOICE FOR 1 MEDICARE BENEFICIARIES. 2 (a) IN GENERAL.—Section 1860D–4(b)(1) of the So-3 cial Security Act (42 U.S.C. 1395w–104(b)(1)) is amend-4 ed by striking subparagraph (A) and inserting the fol-5 lowing: 6 ‘‘(A) IN GENERAL .— 7 ‘‘(i) P ARTICIPATION OF ANY WILLING 8 PHARMACY.—A PDP sponsor offering a 9 prescription drug plan shall permit any 10 pharmacy that meets the standard contract 11 terms and conditions under such plan to 12 participate as a network pharmacy of such 13 plan. 14 ‘‘(ii) C ONTRACT TERMS AND CONDI -15 TIONS.— 16 ‘‘(I) I N GENERAL .—Notwith-17 standing any other provision of law, 18 for plan years beginning on or after 19 January 1, 2028, in accordance with 20 clause (i), contract terms and condi-21 tions offered by such PDP sponsor 22 shall be reasonable and relevant ac-23 cording to standards established by 24 the Secretary under subclause (II). 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00302 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 303 •HR 1768 IH ‘‘(II) S TANDARDS.—Not later 1 than the first Monday in April of 2 2027, the Secretary shall establish 3 standards for reasonable and relevant 4 contract terms and conditions for pur-5 poses of this clause. 6 ‘‘(III) R EQUEST FOR INFORMA -7 TION.—Not later than April 1, 2026, 8 for purposes of establishing the stand-9 ards under subclause (II), the Sec-10 retary shall issue a request for infor-11 mation to seek input on trends in pre-12 scription drug plan and network phar-13 macy contract terms and conditions, 14 current prescription drug plan and 15 network pharmacy contracting prac-16 tices, whether pharmacy reimburse-17 ment and dispensing fees paid by 18 PDP sponsors to network pharmacies 19 sufficiently cover the ingredient and 20 operational costs of such pharmacies, 21 the use and application of pharmacy 22 quality measures by PDP sponsors for 23 network pharmacies, PDP sponsor re-24 strictions or limitations on the dis-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00303 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 304 •HR 1768 IH pensing of covered part D drugs by 1 network pharmacies (or any subsets of 2 such pharmacies), PDP sponsor au-3 diting practices for network phar-4 macies, areas in current regulations or 5 program guidance related to con-6 tracting between prescription drug 7 plans and network pharmacies requir-8 ing clarification or additional speci-9 ficity, factors for consideration in de-10 termining the reasonableness and rel-11 evance of contract terms and condi-12 tions between prescription drug plans 13 and network pharmacies, and other 14 issues as determined appropriate by 15 the Secretary.’’. 16 (b) E SSENTIAL RETAIL PHARMACIES.—Section 17 1860D–42 of the Social Security Act (42 U.S.C. 1395w– 18 152) is amended by adding at the end the following new 19 subsection: 20 ‘‘(e) ESSENTIAL RETAIL PHARMACIES.— 21 ‘‘(1) I N GENERAL .—With respect to plan years 22 beginning on or after January 1, 2028, the Sec-23 retary shall publish reports, at least once every 2 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00304 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 305 •HR 1768 IH years until 2034, and periodically thereafter, that 1 provide information, to the extent feasible, on— 2 ‘‘(A) trends in ingredient cost reimburse-3 ment, dispensing fees, incentive payments and 4 other fees paid by PDP sponsors offering pre-5 scription drug plans and MA organizations of-6 fering MA–PD plans under this part to essen-7 tial retail pharmacies (as defined in paragraph 8 (2)) with respect to the dispensing of covered 9 part D drugs, including a comparison of such 10 trends between essential retail pharmacies and 11 pharmacies that are not essential retail phar-12 macies; 13 ‘‘(B) trends in amounts paid to PDP spon-14 sors offering prescription drug plans and MA 15 organizations offering MA–PD plans under this 16 part by essential retail pharmacies with respect 17 to the dispensing of covered part D drugs, in-18 cluding a comparison of such trends between 19 essential retail pharmacies and pharmacies that 20 are not essential retail pharmacies; 21 ‘‘(C) trends in essential retail pharmacy 22 participation in pharmacy networks and pre-23 ferred pharmacy networks for prescription drug 24 plans offered by PDP sponsors and MA–PD 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00305 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 306 •HR 1768 IH plans offered by MA organizations under this 1 part, including a comparison of such trends be-2 tween essential retail pharmacies and phar-3 macies that are not essential retail pharmacies; 4 ‘‘(D) trends in the number of essential re-5 tail pharmacies, including variation in such 6 trends by geographic region or other factors; 7 ‘‘(E) a comparison of cost-sharing for cov-8 ered part D drugs dispensed by essential retail 9 pharmacies that are network pharmacies for 10 prescription drug plans offered by PDP spon-11 sors and MA–PD plans offered by MA organi-12 zations under this part and cost-sharing for 13 covered part D drugs dispensed by other net-14 work pharmacies for such plans located in simi-15 lar geographic areas that are not essential retail 16 pharmacies; 17 ‘‘(F) a comparison of the volume of cov-18 ered part D drugs dispensed by essential retail 19 pharmacies that are network pharmacies for 20 prescription drug plans offered by PDP spon-21 sors and MA–PD plans offered by MA organi-22 zations under this part and such volume of dis-23 pensing by network pharmacies for such plans 24 located in similar geographic areas that are not 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00306 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 307 •HR 1768 IH essential retail pharmacies, including informa-1 tion on any patterns or trends in such compari-2 son specific to certain types of covered part D 3 drugs, such as generic drugs or drugs specified 4 as specialty drugs by a PDP sponsor under a 5 prescription drug plan or an MA organization 6 under an MA–PD plan; and 7 ‘‘(G) a comparison of the information de-8 scribed in subparagraphs (A) through (F) be-9 tween essential retail pharmacies that are net-10 work pharmacies for prescription drug plans of-11 fered by PDP sponsors under this part and es-12 sential retail pharmacies that are network phar-13 macies for MA–PD plans offered by MA organi-14 zations under this part. 15 ‘‘(2) D EFINITION OF ESSENTIAL RETAIL PHAR -16 MACY.—In this subsection, the term ‘essential retail 17 pharmacy’ means, with respect to a plan year, a re-18 tail pharmacy that— 19 ‘‘(A) is not a pharmacy that is an affiliate 20 as defined in paragraph (4); and 21 ‘‘(B) is located in— 22 ‘‘(i) a medically underserved area (as 23 designated pursuant to section 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00307 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 308 •HR 1768 IH 330(b)(3)(A) of the Public Health Service 1 Act); 2 ‘‘(ii) a rural area in which there is no 3 other retail pharmacy within 10 miles, as 4 determined by the Secretary; 5 ‘‘(iii) a suburban area in which there 6 is no other retail pharmacy within 2 miles, 7 as determined by the Secretary; or 8 ‘‘(iv) an urban area in which there is 9 no other retail pharmacy within 1 mile, as 10 determined by the Secretary. 11 ‘‘(3) L IST OF ESSENTIAL RETAIL PHAR -12 MACIES.— 13 ‘‘(A) PUBLICATION OF LIST OF ESSENTIAL 14 RETAIL PHARMACIES .—For each plan year (be-15 ginning with plan year 2028), the Secretary 16 shall publish, on a publicly available internet 17 website of the Centers for Medicare & Medicaid 18 Services, a list of pharmacies that meet the cri-19 teria described in subparagraphs (A) and (B) of 20 paragraph (2) to be considered an essential re-21 tail pharmacy. 22 ‘‘(B) R EQUIRED SUBMISSIONS FROM PDP 23 SPONSORS.—For each plan year (beginning 24 with plan year 2028), each PDP sponsor offer-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00308 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 309 •HR 1768 IH ing a prescription drug plan and each MA orga-1 nization offering an MA–PD plan shall submit 2 to the Secretary, for the purposes of deter-3 mining retail pharmacies that meet the criterion 4 specified in subparagraph (A) of paragraph (2), 5 a list of retail pharmacies that are affiliates of 6 such sponsor or organization, or are affiliates of 7 a pharmacy benefit manager acting on behalf of 8 such sponsor or organization, at a time, and in 9 a form and manner, specified by the Secretary. 10 ‘‘(C) R EPORTING BY PDP SPONSORS AND 11 MA ORGANIZATIONS .—For each plan year be-12 ginning with plan year 2027, each PDP sponsor 13 offering a prescription drug plan and each MA 14 organization offering an MA–PD plan under 15 this part shall submit to the Secretary informa-16 tion on incentive payments and other fees paid 17 by such sponsor or organization to pharmacies, 18 insofar as any such payments or fees are not 19 otherwise reported, at a time, and in a form 20 and manner, specified by the Secretary. 21 ‘‘(D) I MPLEMENTATION.—Notwithstanding 22 any other provision of law, the Secretary may 23 implement this paragraph by program instruc-24 tion or otherwise. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00309 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 310 •HR 1768 IH ‘‘(E) N ONAPPLICATION OF PAPERWORK 1 REDUCTION ACT .—Chapter 35 of title 44, 2 United States Code, shall not apply to the im-3 plementation of this paragraph. 4 ‘‘(4) D EFINITION OF AFFILIATE ; PHARMACY 5 BENEFIT MANAGER .—In this subsection, the terms 6 ‘affiliate’ and ‘pharmacy benefit manager’ have the 7 meaning given those terms in section 1860D– 8 12(h)(7).’’. 9 (c) ENFORCEMENT.— 10 (1) I N GENERAL .—Section 1860D–4(b)(1) of 11 the Social Security Act (42 U.S.C. 1395w– 12 104(b)(1)) is amended by adding at the end the fol-13 lowing new subparagraph: 14 ‘‘(F) E NFORCEMENT OF STANDARDS FOR 15 REASONABLE AND RELEVANT CONTRACT TERMS 16 AND CONDITIONS .— 17 ‘‘(i) A LLEGATION SUBMISSION PROC -18 ESS.— 19 ‘‘(I) I N GENERAL .—Not later 20 than January 1, 2028, the Secretary 21 shall establish a process through 22 which a pharmacy may submit to the 23 Secretary an allegation of a violation 24 by a PDP sponsor offering a prescrip-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00310 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 311 •HR 1768 IH tion drug plan of the standards for 1 reasonable and relevant contract 2 terms and conditions under subpara-3 graph (A)(ii), or of subclause (VIII) 4 of this clause. 5 ‘‘(II) F REQUENCY OF SUBMIS -6 SION.— 7 ‘‘(aa) I N GENERAL .—Except 8 as provided in item (bb), the alle-9 gation submission process under 10 this clause shall allow pharmacies 11 to submit any allegations of vio-12 lations described in subclause (I) 13 not more frequently than once 14 per plan year per contract be-15 tween a pharmacy and a PDP 16 sponsor. 17 ‘‘(bb) A LLEGATIONS RELAT -18 ING TO CONTRACT MODIFICA -19 TIONS.—In the case where a con-20 tract between a pharmacy and a 21 PDP sponsor is modified fol-22 lowing the submission of allega-23 tions by a pharmacy with respect 24 to such contract and plan year, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00311 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 312 •HR 1768 IH the allegation submission process 1 under this clause shall allow such 2 pharmacy to submit an additional 3 allegation related to those modi-4 fications with respect to such 5 contract and plan year. 6 ‘‘(III) A CCESS TO RELEVANT 7 DOCUMENTS AND MATERIALS .—A 8 PDP sponsor subject to an allegation 9 under this clause— 10 ‘‘(aa) shall provide docu-11 ments or materials, as specified 12 by the Secretary, including con-13 tract offers made by such spon-14 sor to such pharmacy or cor-15 respondence related to such of-16 fers, to the Secretary at a time, 17 and in a form and manner, speci-18 fied by the Secretary; and 19 ‘‘(bb) shall not prohibit or 20 otherwise limit the ability of a 21 pharmacy to submit such docu-22 ments or materials to the Sec-23 retary for the purpose of submit-24 ting an allegation or providing 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00312 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 313 •HR 1768 IH evidence for such an allegation 1 under this clause. 2 ‘‘(IV) S TANDARDIZED TEM -3 PLATE.—The Secretary shall establish 4 a standardized template for phar-5 macies to use for the submission of al-6 legations described in subclause (I). 7 Such template shall require that the 8 submission include a certification by 9 the pharmacy that the information in-10 cluded is accurate, complete, and true 11 to the best of the knowledge, informa-12 tion, and belief of such pharmacy. 13 ‘‘(V) P REVENTING FRIVOLOUS 14 ALLEGATIONS.—In the case where the 15 Secretary determines that a pharmacy 16 has submitted frivolous allegations 17 under this clause on a routine basis, 18 the Secretary may temporarily pro-19 hibit such pharmacy from using the 20 allegation submission process under 21 this clause, as determined appropriate 22 by the Secretary. 23 ‘‘(VI) E XEMPTION FROM FREE -24 DOM OF INFORMATION ACT .—Allega-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00313 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 314 •HR 1768 IH tions submitted under this clause shall 1 be exempt from disclosure under sec-2 tion 552 of title 5, United States 3 Code. 4 ‘‘(VII) R ULE OF CONSTRUC -5 TION.—Nothing in this clause shall be 6 construed as limiting the ability of a 7 pharmacy to pursue other legal ac-8 tions or remedies, consistent with ap-9 plicable Federal or State law, with re-10 spect to a potential violation of a re-11 quirement described in this subpara-12 graph. 13 ‘‘(VIII) A NTI-RETALIATION AND 14 ANTI-COERCION.—Consistent with ap-15 plicable Federal or State law, a PDP 16 sponsor shall not— 17 ‘‘(aa) retaliate against a 18 pharmacy for submitting any al-19 legations under this clause; or 20 ‘‘(bb) coerce, intimidate, 21 threaten, or interfere with the 22 ability of a pharmacy to submit 23 any such allegations. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00314 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 315 •HR 1768 IH ‘‘(ii) I NVESTIGATION.—The Secretary 1 shall investigate, as determined appro-2 priate by the Secretary, allegations sub-3 mitted pursuant to clause (i). 4 ‘‘(iii) ENFORCEMENT.— 5 ‘‘(I) I N GENERAL .—In the case 6 where the Secretary determines that a 7 PDP sponsor offering a prescription 8 drug plan has violated the standards 9 for reasonable and relevant contract 10 terms and conditions under subpara-11 graph (A)(ii), the Secretary may use 12 authorities under sections 1857(g) 13 and 1860D–12(b)(3)(E) to impose 14 civil monetary penalties or other inter-15 mediate sanctions. 16 ‘‘(II) A PPLICATION OF CIVIL 17 MONETARY PENALTIES .—The provi-18 sions of section 1128A (other than 19 subsections (a) and (b)) shall apply to 20 a civil monetary penalty under this 21 clause in the same manner as such 22 provisions apply to a penalty or pro-23 ceeding under section 1128A(a).’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00315 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 316 •HR 1768 IH (2) C ONFORMING AMENDMENT .—Section 1 1857(g)(1) of the Social Security Act (42 U.S.C. 2 1395w–27(g)(1)) is amended— 3 (A) in subparagraph (J), by striking ‘‘or’’ 4 after the semicolon; 5 (B) by redesignating subparagraph (K) as 6 subparagraph (L); 7 (C) by inserting after subparagraph (J), 8 the following new subparagraph: 9 ‘‘(K) fails to comply with the standards for 10 reasonable and relevant contract terms and con-11 ditions under subparagraph (A)(ii) of section 12 1860D–4(b)(1); or’’; 13 (D) in subparagraph (L), as redesignated 14 by subparagraph (B), by striking ‘‘through (J)’’ 15 and inserting ‘‘through (K)’’; and 16 (E) in the flush matter following subpara-17 graph (L), as so redesignated, by striking ‘‘sub-18 paragraphs (A) through (K)’’ and inserting 19 ‘‘subparagraphs (A) through (L)’’. 20 (d) ACCOUNTABILITY OF PHARMACY BENEFIT MAN-21 AGERS FOR VIOLATIONS OF REASONABLE AND RELEVANT 22 CONTRACT TERMS AND CONDITIONS.— 23 (1) I N GENERAL .—Section 1860D–12(b) of the 24 Social Security Act (42 U.S.C. 1395w–112) is 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00316 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 317 •HR 1768 IH amended by adding at the end the following new 1 paragraph: 2 ‘‘(9) A CCOUNTABILITY OF PHARMACY BENEFIT 3 MANAGERS FOR VIOLATIONS OF REASONABLE AND 4 RELEVANT CONTRACT TERMS AND CONDITIONS .— 5 For plan years beginning on or after January 1, 6 2028, each contract entered into with a PDP spon-7 sor under this part with respect to a prescription 8 drug plan offered by such sponsor shall provide that 9 any pharmacy benefit manager acting on behalf of 10 such sponsor has a written agreement with the PDP 11 sponsor under which the pharmacy benefit manager 12 agrees to reimburse the PDP sponsor for any 13 amounts paid by such sponsor under section 1860D– 14 4(b)(1)(F)(iii)(I) to the Secretary as a result of a 15 violation described in such section if such violation 16 is related to a responsibility delegated to the phar-17 macy benefit manager by such PDP sponsor.’’. 18 (2) MA–PD PLANS.—Section 1857(f)(3) of the 19 Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 20 amended by adding at the end the following new 21 subparagraph: 22 ‘‘(F) A CCOUNTABILITY OF PHARMACY 23 BENEFIT MANAGERS FOR VIOLATIONS OF REA -24 SONABLE AND RELEVANT CONTRACT TERMS .— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00317 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 318 •HR 1768 IH For plan years beginning on or after January 1 1, 2028, section 1860D–12(b)(9).’’. 2 (e) B IENNIAL REPORT ON ENFORCEMENT AND 3 OVERSIGHT OF PHARMACY ACCESS REQUIREMENTS.— 4 Section 1860D–42 of the Social Security Act (42 U.S.C. 5 1395w–152), as amended by subsection (b), is amended 6 by adding at the end the following new subsection: 7 ‘‘(f) B IENNIAL REPORT ON ENFORCEMENT AND 8 OVERSIGHT OF PHARMACY ACCESS REQUIREMENTS.— 9 ‘‘(1) I N GENERAL .—Not later than 2 years 10 after the date of enactment of this subsection, and 11 at least once every 2 years thereafter, the Secretary 12 shall publish a report on enforcement and oversight 13 actions and activities undertaken by the Secretary 14 with respect to the requirements under section 15 1860D–4(b)(1). 16 ‘‘(2) L IMITATION.—A report under paragraph 17 (1) shall not disclose— 18 ‘‘(A) identifiable information about individ-19 uals or entities unless such information is oth-20 erwise publicly available; or 21 ‘‘(B) trade secrets with respect to any enti-22 ties.’’. 23 (f) F UNDING.—In addition to amounts otherwise 24 available, there is appropriated to the Centers for Medi-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00318 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 319 •HR 1768 IH care & Medicaid Services Program Management Account, 1 out of any money in the Treasury not otherwise appro-2 priated, $188,000,000 for fiscal year 2025, to remain 3 available until expended, to carry out this section. 4 SEC. 227. MODERNIZING AND ENSURING PBM ACCOUNT-5 ABILITY. 6 (a) IN GENERAL.— 7 (1) P RESCRIPTION DRUG PLANS .—Section 8 1860D–12 of the Social Security Act (42 U.S.C. 9 1395w–112) is amended by adding at the end the 10 following new subsection: 11 ‘‘(h) REQUIREMENTS RELATING TO PHARMACY BEN-12 EFIT MANAGERS.—For plan years beginning on or after 13 January 1, 2028: 14 ‘‘(1) A GREEMENTS WITH PHARMACY BENEFIT 15 MANAGERS.—Each contract entered into with a 16 PDP sponsor under this part with respect to a pre-17 scription drug plan offered by such sponsor shall 18 provide that any pharmacy benefit manager acting 19 on behalf of such sponsor has a written agreement 20 with the PDP sponsor under which the pharmacy 21 benefit manager, and any affiliates of such phar-22 macy benefit manager, as applicable, agree to meet 23 the following requirements: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00319 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 320 •HR 1768 IH ‘‘(A) NO INCOME OTHER THAN BONA FIDE 1 SERVICE FEES .— 2 ‘‘(i) I N GENERAL .—The pharmacy 3 benefit manager and any affiliate of such 4 pharmacy benefit manager shall not derive 5 any remuneration with respect to any serv-6 ices provided on behalf of any entity or in-7 dividual, in connection with the utilization 8 of covered part D drugs, from any such en-9 tity or individual other than bona fide serv-10 ice fees, subject to clauses (ii) and (iii). 11 ‘‘(ii) I NCENTIVE PAYMENTS .—For the 12 purposes of this subsection, an incentive 13 payment (as determined by the Secretary) 14 paid by a PDP sponsor to a pharmacy 15 benefit manager that is performing serv-16 ices on behalf of such sponsor shall be 17 deemed a ‘bona fide service fee’ (even if 18 such payment does not otherwise meet the 19 definition of such term under paragraph 20 (7)(B)) if such payment is a flat dollar 21 amount, is consistent with fair market 22 value (as specified by the Secretary), is re-23 lated to services actually performed by the 24 pharmacy benefit manager or affiliate of 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00320 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 321 •HR 1768 IH such pharmacy benefit manager, on behalf 1 of the PDP sponsor making such payment, 2 in connection with the utilization of cov-3 ered part D drugs, and meets additional 4 requirements, if any, as determined appro-5 priate by the Secretary. 6 ‘‘(iii) C LARIFICATION ON REBATES 7 AND DISCOUNTS USED TO LOWER COSTS 8 FOR COVERED PART D DRUGS .—Rebates, 9 discounts, and other price concessions re-10 ceived by a pharmacy benefit manager or 11 an affiliate of a pharmacy benefit manager 12 from manufacturers, even if such price 13 concessions are calculated as a percentage 14 of a drug’s price, shall not be considered a 15 violation of the requirements of clause (i) 16 if they are fully passed through to a PDP 17 sponsor and are compliant with all regu-18 latory and subregulatory requirements re-19 lated to direct and indirect remuneration 20 for manufacturer rebates under this part, 21 including in cases where a PDP sponsor is 22 acting as a pharmacy benefit manager on 23 behalf of a prescription drug plan offered 24 by such PDP sponsor. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00321 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 322 •HR 1768 IH ‘‘(iv) EVALUATION OF REMUNERATION 1 ARRANGEMENTS.—Components of subsets 2 of remuneration arrangements (such as 3 fees or other forms of compensation paid 4 to or retained by the pharmacy benefit 5 manager or affiliate of such pharmacy ben-6 efit manager), as determined appropriate 7 by the Secretary, between pharmacy ben-8 efit managers or affiliates of such phar-9 macy benefit managers, as applicable, and 10 other entities involved in the dispensing or 11 utilization of covered part D drugs (includ-12 ing PDP sponsors, manufacturers, phar-13 macies, and other entities as determined 14 appropriate by the Secretary) shall be sub-15 ject to review by the Secretary, in con-16 sultation with the Office of the Inspector 17 General of the Department of Health and 18 Human Services, as determined appro-19 priate by the Secretary. The Secretary, in 20 consultation with the Office of the Inspec-21 tor General, shall review whether remu-22 neration under such arrangements is con-23 sistent with fair market value (as specified 24 by the Secretary) through reviews and as-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00322 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 323 •HR 1768 IH sessments of such remuneration, as deter-1 mined appropriate. 2 ‘‘(v) D ISGORGEMENT.—The pharmacy 3 benefit manager shall disgorge any remu-4 neration paid to such pharmacy benefit 5 manager or an affiliate of such pharmacy 6 benefit manager in violation of this sub-7 paragraph to the PDP sponsor. 8 ‘‘(vi) A DDITIONAL REQUIREMENTS .— 9 The pharmacy benefit manager shall— 10 ‘‘(I) enter into a written agree-11 ment with any affiliate of such phar-12 macy benefit manager, under which 13 the affiliate shall identify and disgorge 14 any remuneration described in clause 15 (v) to the pharmacy benefit manager; 16 and 17 ‘‘(II) attest, subject to any re-18 quirements determined appropriate by 19 the Secretary, that the pharmacy ben-20 efit manager has entered into a writ-21 ten agreement described in subclause 22 (I) with any relevant affiliate of the 23 pharmacy benefit manager. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00323 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 324 •HR 1768 IH ‘‘(B) TRANSPARENCY REGARDING GUARAN -1 TEES AND COST PERFORMANCE EVALUA -2 TIONS.—The pharmacy benefit manager shall— 3 ‘‘(i) define, interpret, and apply, in a 4 fully transparent and consistent manner 5 for purposes of calculating or otherwise 6 evaluating pharmacy benefit manager per-7 formance against pricing guarantees or 8 similar cost performance measurements re-9 lated to rebates, discounts, price conces-10 sions, or net costs, terms such as— 11 ‘‘(I) ‘generic drug’, in a manner 12 consistent with the definition of the 13 term under section 423.4 of title 42, 14 Code of Federal Regulations, or a suc-15 cessor regulation; 16 ‘‘(II) ‘brand name drug’, in a 17 manner consistent with the definition 18 of the term under section 423.4 of 19 title 42, Code of Federal Regulations, 20 or a successor regulation; 21 ‘‘(III) ‘specialty drug’; 22 ‘‘(IV) ‘rebate’; and 23 ‘‘(V) ‘discount’; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00324 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 325 •HR 1768 IH ‘‘(ii) identify any drugs, claims, or 1 price concessions excluded from any pric-2 ing guarantee or other cost performance 3 measure in a clear and consistent manner; 4 and 5 ‘‘(iii) where a pricing guarantee or 6 other cost performance measure is based 7 on a pricing benchmark other than the 8 wholesale acquisition cost (as defined in 9 section 1847A(c)(6)(B)) of a drug, cal-10 culate and provide a wholesale acquisition 11 cost-based equivalent to the pricing guar-12 antee or other cost performance measure. 13 ‘‘(C) PROVISION OF INFORMATION .— 14 ‘‘(i) I N GENERAL .—Not later than 15 July 1 of each year, beginning in 2028, the 16 pharmacy benefit manager shall submit to 17 the PDP sponsor, and to the Secretary, a 18 report, in accordance with this subpara-19 graph, and shall make such report avail-20 able to such sponsor at no cost to such 21 sponsor in a format specified by the Sec-22 retary under paragraph (5). Each such re-23 port shall include, with respect to such 24 PDP sponsor and each plan offered by 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00325 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 326 •HR 1768 IH such sponsor, the following information 1 with respect to the previous plan year: 2 ‘‘(I) A list of all drugs covered by 3 the plan that were dispensed includ-4 ing, with respect to each such drug— 5 ‘‘(aa) the brand name, ge-6 neric or non-proprietary name, 7 and National Drug Code; 8 ‘‘(bb) the number of plan 9 enrollees for whom the drug was 10 dispensed, the total number of 11 prescription claims for the drug 12 (including original prescriptions 13 and refills, counted as separate 14 claims), and the total number of 15 dosage units of the drug dis-16 pensed; 17 ‘‘(cc) the number of pre-18 scription claims described in item 19 (bb) by each type of dispensing 20 channel through which the drug 21 was dispensed, including retail, 22 mail order, specialty pharmacy, 23 long term care pharmacy, home 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00326 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 327 •HR 1768 IH infusion pharmacy, or other types 1 of pharmacies or providers; 2 ‘‘(dd) the average wholesale 3 acquisition cost, listed as cost per 4 day’s supply, cost per dosage 5 unit, and cost per typical course 6 of treatment (as applicable); 7 ‘‘(ee) the average wholesale 8 price for the drug, listed as price 9 per day’s supply, price per dos-10 age unit, and price per typical 11 course of treatment (as applica-12 ble); 13 ‘‘(ff) the total out-of-pocket 14 spending by plan enrollees on 15 such drug after application of 16 any benefits under the plan, in-17 cluding plan enrollee spending 18 through copayments, coinsurance, 19 and deductibles; 20 ‘‘(gg) total rebates paid by 21 the manufacturer on the drug as 22 reported under the Detailed DIR 23 Report (or any successor report) 24 submitted by such sponsor to the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00327 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 328 •HR 1768 IH Centers for Medicare & Medicaid 1 Services; 2 ‘‘(hh) all other direct or in-3 direct remuneration on the drug 4 as reported under the Detailed 5 DIR Report (or any successor re-6 port) submitted by such sponsor 7 to the Centers for Medicare & 8 Medicaid Services; 9 ‘‘(ii) the average pharmacy 10 reimbursement amount paid by 11 the plan for the drug in the ag-12 gregate and disaggregated by dis-13 pensing channel identified in item 14 (cc); 15 ‘‘(jj) the average National 16 Average Drug Acquisition Cost 17 (NADAC); and 18 ‘‘(kk) total manufacturer-de-19 rived revenue, inclusive of bona 20 fide service fees, attributable to 21 the drug and retained by the 22 pharmacy benefit manager and 23 any affiliate of such pharmacy 24 benefit manager. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00328 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 329 •HR 1768 IH ‘‘(II) In the case of a pharmacy 1 benefit manager that has an affiliate 2 that is a retail, mail order, or spe-3 cialty pharmacy, with respect to drugs 4 covered by such plan that were dis-5 pensed, the following information: 6 ‘‘(aa) The percentage of 7 total prescriptions that were dis-8 pensed by pharmacies that are an 9 affiliate of the pharmacy benefit 10 manager for each drug. 11 ‘‘(bb) The interquartile 12 range of the total combined costs 13 paid by the plan and plan enroll-14 ees, per dosage unit, per course 15 of treatment, per 30-day supply, 16 and per 90-day supply for each 17 drug dispensed by pharmacies 18 that are not an affiliate of the 19 pharmacy benefit manager and 20 that are included in the phar-21 macy network of such plan. 22 ‘‘(cc) The interquartile 23 range of the total combined costs 24 paid by the plan and plan enroll-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00329 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 330 •HR 1768 IH ees, per dosage unit, per course 1 of treatment, per 30-day supply, 2 and per 90-day supply for each 3 drug dispensed by pharmacies 4 that are an affiliate of the phar-5 macy benefit manager and that 6 are included in the pharmacy 7 network of such plan. 8 ‘‘(dd) The lowest total com-9 bined cost paid by the plan and 10 plan enrollees, per dosage unit, 11 per course of treatment, per 30- 12 day supply, and per 90-day sup-13 ply, for each drug that is avail-14 able from any pharmacy included 15 in the pharmacy network of such 16 plan. 17 ‘‘(ee) The difference between 18 the average acquisition cost of 19 the affiliate, such as a pharmacy 20 or other entity that acquires pre-21 scription drugs, that initially ac-22 quires the drug and the amount 23 reported under subclause (I)(jj) 24 for each drug. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00330 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 331 •HR 1768 IH ‘‘(ff) A list inclusive of the 1 brand name, generic or non-pro-2 prietary name, and National 3 Drug Code of covered part D 4 drugs subject to an agreement 5 with a covered entity under sec-6 tion 340B of the Public Health 7 Service Act for which the phar-8 macy benefit manager or an affil-9 iate of the pharmacy benefit 10 manager had a contract or other 11 arrangement with such a covered 12 entity in the service area of such 13 plan. 14 ‘‘(III) Where a drug approved 15 under section 505(c) of the Federal 16 Food, Drug, and Cosmetic Act (re-17 ferred to in this subclause as the ‘list-18 ed drug’) is covered by the plan, the 19 following information: 20 ‘‘(aa) A list of currently 21 marketed generic drugs approved 22 under section 505(j) of the Fed-23 eral Food, Drug, and Cosmetic 24 Act pursuant to an application 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00331 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 332 •HR 1768 IH that references such listed drug 1 that are not covered by the plan, 2 are covered on the same for-3 mulary tier or a formulary tier 4 typically associated with higher 5 cost-sharing than the listed drug, 6 or are subject to utilization man-7 agement that the listed drug is 8 not subject to. 9 ‘‘(bb) The estimated average 10 beneficiary cost-sharing under 11 the plan for a 30-day supply of 12 the listed drug. 13 ‘‘(cc) Where a generic drug 14 listed under item (aa) is on a for-15 mulary tier typically associated 16 with higher cost-sharing than the 17 listed drug, the estimated aver-18 age cost-sharing that a bene-19 ficiary would have paid for a 30- 20 day supply of each of the generic 21 drugs described in item (aa), had 22 the plan provided coverage for 23 such drugs on the same for-24 mulary tier as the listed drug. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00332 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 333 •HR 1768 IH ‘‘(dd) A written justification 1 for providing more favorable cov-2 erage of the listed drug than the 3 generic drugs described in item 4 (aa). 5 ‘‘(ee) The number of cur-6 rently marketed generic drugs 7 approved under section 505(j) of 8 the Federal Food, Drug, and 9 Cosmetic Act pursuant to an ap-10 plication that references such 11 listed drug. 12 ‘‘(IV) Where a reference product 13 (as defined in section 351(i) of the 14 Public Health Service Act) is covered 15 by the plan, the following information: 16 ‘‘(aa) A list of currently 17 marketed biosimilar biological 18 products licensed under section 19 351(k) of the Public Health 20 Service Act pursuant to an appli-21 cation that refers to such ref-22 erence product that are not cov-23 ered by the plan, are covered on 24 the same formulary tier or a for-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00333 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 334 •HR 1768 IH mulary tier typically associated 1 with higher cost-sharing than the 2 reference product, or are subject 3 to utilization management that 4 the reference product is not sub-5 ject to. 6 ‘‘(bb) The estimated average 7 beneficiary cost-sharing under 8 the plan for a 30-day supply of 9 the reference product. 10 ‘‘(cc) Where a biosimilar bi-11 ological product listed under item 12 (aa) is on a formulary tier typi-13 cally associated with higher cost- 14 sharing than the reference prod-15 uct, the estimated average cost- 16 sharing that a beneficiary would 17 have paid for a 30-day supply of 18 each of the biosimilar biological 19 products described in item (aa), 20 had the plan provided coverage 21 for such products on the same 22 formulary tier as the reference 23 product. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00334 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 335 •HR 1768 IH ‘‘(dd) A written justification 1 for providing more favorable cov-2 erage of the reference product 3 than the biosimilar biological 4 product described in item (aa). 5 ‘‘(ee) The number of cur-6 rently marketed biosimilar bio-7 logical products licensed under 8 section 351(k) of the Public 9 Health Service Act, pursuant to 10 an application that refers to such 11 reference product. 12 ‘‘(V) Total gross spending on 13 covered part D drugs by the plan, not 14 net of rebates, fees, discounts, or 15 other direct or indirect remuneration. 16 ‘‘(VI) The total amount retained 17 by the pharmacy benefit manager or 18 an affiliate of such pharmacy benefit 19 manager in revenue related to utiliza-20 tion of covered part D drugs under 21 that plan, inclusive of bona fide serv-22 ice fees. 23 ‘‘(VII) The total spending on cov-24 ered part D drugs net of rebates, fees, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00335 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 336 •HR 1768 IH discounts, or other direct and indirect 1 remuneration by the plan. 2 ‘‘(VIII) An explanation of any 3 benefit design parameters under such 4 plan that encourage plan enrollees to 5 fill prescriptions at pharmacies that 6 are an affiliate of such pharmacy ben-7 efit manager, such as mail and spe-8 cialty home delivery programs, and re-9 tail and mail auto-refill programs. 10 ‘‘(IX) The following information: 11 ‘‘(aa) A list of all brokers, 12 consultants, advisors, and audi-13 tors that receive compensation 14 from the pharmacy benefit man-15 ager or an affiliate of such phar-16 macy benefit manager for refer-17 rals, consulting, auditing, or 18 other services offered to PDP 19 sponsors related to pharmacy 20 benefit management services. 21 ‘‘(bb) The amount of com-22 pensation provided by such phar-23 macy benefit manager or affiliate 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00336 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 337 •HR 1768 IH to each such broker, consultant, 1 advisor, and auditor. 2 ‘‘(cc) The methodology for 3 calculating the amount of com-4 pensation provided by such phar-5 macy benefit manager or affil-6 iate, for each such broker, con-7 sultant, advisor, and auditor. 8 ‘‘(X) A list of all affiliates of the 9 pharmacy benefit manager. 10 ‘‘(XI) A summary document sub-11 mitted in a standardized template de-12 veloped by the Secretary that includes 13 such information described in sub-14 clauses (I) through (X). 15 ‘‘(ii) WRITTEN EXPLANATION OF CON -16 TRACTS OR AGREEMENTS WITH DRUG 17 MANUFACTURERS.— 18 ‘‘(I) I N GENERAL .—The phar-19 macy benefit manager shall, not later 20 than 30 days after the finalization of 21 any contract or agreement between 22 such pharmacy benefit manager or an 23 affiliate of such pharmacy benefit 24 manager and a drug manufacturer (or 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00337 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 338 •HR 1768 IH subsidiary, agent, or entity affiliated 1 with such drug manufacturer) that 2 makes rebates, discounts, payments, 3 or other financial incentives related to 4 one or more covered part D drugs or 5 other prescription drugs, as applica-6 ble, of the manufacturer directly or 7 indirectly contingent upon coverage, 8 formulary placement, or utilization 9 management conditions on any other 10 covered part D drugs or other pre-11 scription drugs, as applicable, submit 12 to the PDP sponsor a written expla-13 nation of such contract or agreement. 14 ‘‘(II) R EQUIREMENTS.—A writ-15 ten explanation under subclause (I) 16 shall— 17 ‘‘(aa) include the manufac-18 turer subject to the contract or 19 agreement, all covered part D 20 drugs and other prescription 21 drugs, as applicable, subject to 22 the contract or agreement and 23 the manufacturers of such drugs, 24 and a high-level description of 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00338 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 339 •HR 1768 IH the terms of such contract or 1 agreement and how such terms 2 apply to such drugs; and 3 ‘‘(bb) be certified by the 4 Chief Executive Officer, Chief Fi-5 nancial Officer, or General Coun-6 sel of such pharmacy benefit 7 manager, or affiliate of such 8 pharmacy benefit manager, as 9 applicable, or an individual dele-10 gated with the authority to sign 11 on behalf of one of these officers, 12 who reports directly to the offi-13 cer. 14 ‘‘(III) D EFINITION OF OTHER 15 PRESCRIPTION DRUGS .—For purposes 16 of this clause, the term ‘other pre-17 scription drugs’ means prescription 18 drugs covered as supplemental bene-19 fits under this part or prescription 20 drugs paid outside of this part. 21 ‘‘(D) AUDIT RIGHTS .— 22 ‘‘(i) IN GENERAL .—Not less than once 23 a year, at the request of the PDP sponsor, 24 the pharmacy benefit manager shall allow 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00339 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 340 •HR 1768 IH for an audit of the pharmacy benefit man-1 ager to ensure compliance with all terms 2 and conditions under the written agree-3 ment described in this paragraph and the 4 accuracy of information reported under 5 subparagraph (C). 6 ‘‘(ii) A UDITOR.—The PDP sponsor 7 shall have the right to select an auditor. 8 The pharmacy benefit manager shall not 9 impose any limitations on the selection of 10 such auditor. 11 ‘‘(iii) P ROVISION OF INFORMATION .— 12 The pharmacy benefit manager shall make 13 available to such auditor all records, data, 14 contracts, and other information necessary 15 to confirm the accuracy of information 16 provided under subparagraph (C), subject 17 to reasonable restrictions on how such in-18 formation must be reported to prevent re-19 disclosure of such information. 20 ‘‘(iv) T IMING.—The pharmacy benefit 21 manager must provide information under 22 clause (iii) and other information, data, 23 and records relevant to the audit to such 24 auditor within 6 months of the initiation of 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00340 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 341 •HR 1768 IH the audit and respond to requests for addi-1 tional information from such auditor with-2 in 30 days after the request for additional 3 information. 4 ‘‘(v) I NFORMATION FROM AFFILI -5 ATES.—The pharmacy benefit manager 6 shall be responsible for providing to such 7 auditor information required to be reported 8 under subparagraph (C) or under clause 9 (iii) of this subparagraph that is owned or 10 held by an affiliate of such pharmacy ben-11 efit manager. 12 ‘‘(2) ENFORCEMENT.— 13 ‘‘(A) I N GENERAL .—Each PDP sponsor 14 shall— 15 ‘‘(i) disgorge to the Secretary any 16 amounts disgorged to the PDP sponsor by 17 a pharmacy benefit manager under para-18 graph (1)(A)(v); 19 ‘‘(ii) require, in a written agreement 20 with any pharmacy benefit manager acting 21 on behalf of such sponsor or affiliate of 22 such pharmacy benefit manager, that such 23 pharmacy benefit manager or affiliate re-24 imburse the PDP sponsor for any civil 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00341 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 342 •HR 1768 IH money penalty imposed on the PDP spon-1 sor as a result of the failure of the phar-2 macy benefit manager or affiliate to meet 3 the requirements of paragraph (1) that are 4 applicable to the pharmacy benefit man-5 ager or affiliate under the agreement; and 6 ‘‘(iii) require, in a written agreement 7 with any such pharmacy benefit manager 8 acting on behalf of such sponsor or affil-9 iate of such pharmacy benefit manager, 10 that such pharmacy benefit manager or af-11 filiate be subject to punitive remedies for 12 breach of contract for failure to comply 13 with the requirements applicable under 14 paragraph (1). 15 ‘‘(B) R EPORTING OF ALLEGED VIOLA -16 TIONS.—The Secretary shall make available and 17 maintain a mechanism for manufacturers, PDP 18 sponsors, pharmacies, and other entities that 19 have contractual relationships with pharmacy 20 benefit managers or affiliates of such pharmacy 21 benefit managers to report, on a confidential 22 basis, alleged violations of paragraph (1)(A) or 23 subparagraph (C). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00342 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 343 •HR 1768 IH ‘‘(C) A NTI-RETALIATION AND ANTI -COER-1 CION.—Consistent with applicable Federal or 2 State law, a PDP sponsor shall not— 3 ‘‘(i) retaliate against an individual or 4 entity for reporting an alleged violation 5 under subparagraph (B); or 6 ‘‘(ii) coerce, intimidate, threaten, or 7 interfere with the ability of an individual 8 or entity to report any such alleged viola-9 tions. 10 ‘‘(3) CERTIFICATION OF COMPLIANCE .— 11 ‘‘(A) I N GENERAL .—Each PDP sponsor 12 shall furnish to the Secretary (at a time and in 13 a manner specified by the Secretary) an annual 14 certification of compliance with this subsection, 15 as well as such information as the Secretary de-16 termines necessary to carry out this subsection. 17 ‘‘(B) I MPLEMENTATION.—Notwithstanding 18 any other provision of law, the Secretary may 19 implement this paragraph by program instruc-20 tion or otherwise. 21 ‘‘(4) R ULE OF CONSTRUCTION .—Nothing in 22 this subsection shall be construed as— 23 ‘‘(A) prohibiting flat dispensing fees or re-24 imbursement or payment for ingredient costs 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00343 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 344 •HR 1768 IH (including customary, industry-standard dis-1 counts directly related to drug acquisition that 2 are retained by pharmacies or wholesalers) to 3 entities that acquire or dispense prescription 4 drugs; or 5 ‘‘(B) modifying regulatory requirements or 6 sub-regulatory program instruction or guidance 7 related to pharmacy payment, reimbursement, 8 or dispensing fees. 9 ‘‘(5) STANDARD FORMATS .— 10 ‘‘(A) I N GENERAL .—Not later than June 11 1, 2027, the Secretary shall specify standard, 12 machine-readable formats for pharmacy benefit 13 managers to submit annual reports required 14 under paragraph (1)(C)(i). 15 ‘‘(B) I MPLEMENTATION.—Notwithstanding 16 any other provision of law, the Secretary may 17 implement this paragraph by program instruc-18 tion or otherwise. 19 ‘‘(6) CONFIDENTIALITY.— 20 ‘‘(A) I N GENERAL .—Information disclosed 21 by a pharmacy benefit manager, an affiliate of 22 a pharmacy benefit manager, a PDP sponsor, 23 or a pharmacy under this subsection that is not 24 otherwise publicly available or available for pur-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00344 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 345 •HR 1768 IH chase shall not be disclosed by the Secretary or 1 a PDP sponsor receiving the information, ex-2 cept that the Secretary may disclose the infor-3 mation for the following purposes: 4 ‘‘(i) As the Secretary determines nec-5 essary to carry out this part. 6 ‘‘(ii) To permit the Comptroller Gen-7 eral to review the information provided. 8 ‘‘(iii) To permit the Director of the 9 Congressional Budget Office to review the 10 information provided. 11 ‘‘(iv) To permit the Executive Direc-12 tor of the Medicare Payment Advisory 13 Commission to review the information pro-14 vided. 15 ‘‘(v) To the Attorney General for the 16 purposes of conducting oversight and en-17 forcement under this title. 18 ‘‘(vi) To the Inspector General of the 19 Department of Health and Human Serv-20 ices in accordance with its authorities 21 under the Inspector General Act of 1978 22 (section 406 of title 5, United States 23 Code), and other applicable statutes. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00345 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 346 •HR 1768 IH ‘‘(B) R ESTRICTION ON USE OF INFORMA -1 TION.—The Secretary, the Comptroller General, 2 the Director of the Congressional Budget Of-3 fice, and the Executive Director of the Medicare 4 Payment Advisory Commission shall not report 5 on or disclose information disclosed pursuant to 6 subparagraph (A) to the public in a manner 7 that would identify— 8 ‘‘(i) a specific pharmacy benefit man-9 ager, affiliate, pharmacy, manufacturer, 10 wholesaler, PDP sponsor, or plan; or 11 ‘‘(ii) contract prices, rebates, dis-12 counts, or other remuneration for specific 13 drugs in a manner that may allow the 14 identification of specific contracting parties 15 or of such specific drugs. 16 ‘‘(7) D EFINITIONS.—For purposes of this sub-17 section: 18 ‘‘(A) A FFILIATE.—The term ‘affiliate’ 19 means, with respect to any pharmacy benefit 20 manager or PDP sponsor, any entity that, di-21 rectly or indirectly— 22 ‘‘(i) owns or is owned by, controls or 23 is controlled by, or is otherwise related in 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00346 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 347 •HR 1768 IH any ownership structure to such pharmacy 1 benefit manager or PDP sponsor; or 2 ‘‘(ii) acts as a contractor, principal, or 3 agent to such pharmacy benefit manager 4 or PDP sponsor, insofar as such con-5 tractor, principal, or agent performs any of 6 the functions described under subpara-7 graph (C). 8 ‘‘(B) BONA FIDE SERVICE FEE .—The term 9 ‘bona fide service fee’ means a fee that is reflec-10 tive of the fair market value (as specified by the 11 Secretary, through notice and comment rule-12 making) for a bona fide, itemized service actu-13 ally performed on behalf of an entity, that the 14 entity would otherwise perform (or contract for) 15 in the absence of the service arrangement and 16 that is not passed on in whole or in part to a 17 client or customer, whether or not the entity 18 takes title to the drug. Such fee must be a flat 19 dollar amount and shall not be directly or indi-20 rectly based on, or contingent upon— 21 ‘‘(i) drug price, such as wholesale ac-22 quisition cost or drug benchmark price 23 (such as average wholesale price); 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00347 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 348 •HR 1768 IH ‘‘(ii) the amount of discounts, rebates, 1 fees, or other direct or indirect remunera-2 tion with respect to covered part D drugs 3 dispensed to enrollees in a prescription 4 drug plan, except as permitted pursuant to 5 paragraph (1)(A)(ii); 6 ‘‘(iii) coverage or formulary placement 7 decisions or the volume or value of any re-8 ferrals or business generated between the 9 parties to the arrangement; or 10 ‘‘(iv) any other amounts or meth-11 odologies prohibited by the Secretary. 12 ‘‘(C) PHARMACY BENEFIT MANAGER .—The 13 term ‘pharmacy benefit manager’ means any 14 person or entity that, either directly or through 15 an intermediary, acts as a price negotiator or 16 group purchaser on behalf of a PDP sponsor or 17 prescription drug plan, or manages the pre-18 scription drug benefits provided by such spon-19 sor or plan, including the processing and pay-20 ment of claims for prescription drugs, the per-21 formance of drug utilization review, the proc-22 essing of drug prior authorization requests, the 23 adjudication of appeals or grievances related to 24 the prescription drug benefit, contracting with 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00348 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 349 •HR 1768 IH network pharmacies, controlling the cost of cov-1 ered part D drugs, or the provision of related 2 services. Such term includes any person or enti-3 ty that carries out one or more of the activities 4 described in the preceding sentence, irrespective 5 of whether such person or entity calls itself a 6 ‘pharmacy benefit manager’.’’. 7 (2) MA–PD PLANS.—Section 1857(f)(3) of the 8 Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 9 amended by adding at the end the following new 10 subparagraph: 11 ‘‘(F) R EQUIREMENTS RELATING TO PHAR -12 MACY BENEFIT MANAGERS .—For plan years be-13 ginning on or after January 1, 2028, section 14 1860D–12(h).’’. 15 (3) N ONAPPLICATION OF PAPERWORK REDUC -16 TION ACT .—Chapter 35 of title 44, United States 17 Code, shall not apply to the implementation of this 18 subsection. 19 (4) FUNDING.— 20 (A) S ECRETARY.—In addition to amounts 21 otherwise available, there is appropriated to the 22 Centers for Medicare & Medicaid Services Pro-23 gram Management Account, out of any money 24 in the Treasury not otherwise appropriated, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00349 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 350 •HR 1768 IH $113,000,000 for fiscal year 2025, to remain 1 available until expended, to carry out this sub-2 section. 3 (B) OIG.—In addition to amounts other-4 wise available, there is appropriated to the In-5 spector General of the Department of Health 6 and Human Services, out of any money in the 7 Treasury not otherwise appropriated, 8 $20,000,000 for fiscal year 2025, to remain 9 available until expended, to carry out this sub-10 section. 11 (b) GAO S TUDY AND REPORT ON PRICE-RELATED 12 COMPENSATION ACROSS THE SUPPLY CHAIN.— 13 (1) S TUDY.—The Comptroller General of the 14 United States (in this subsection referred to as the 15 ‘‘Comptroller General’’) shall conduct a study de-16 scribing the use of compensation and payment struc-17 tures related to a prescription drug’s price within 18 the retail prescription drug supply chain in part D 19 of title XVIII of the Social Security Act (42 U.S.C. 20 1395w–101 et seq.). Such study shall summarize in-21 formation from Federal agencies and industry ex-22 perts, to the extent available, with respect to the fol-23 lowing: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00350 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 351 •HR 1768 IH (A) The type, magnitude, other features 1 (such as the pricing benchmarks used), and 2 prevalence of compensation and payment struc-3 tures related to a prescription drug’s price, 4 such as calculating fee amounts as a percentage 5 of a prescription drug’s price, between inter-6 mediaries in the prescription drug supply chain, 7 including— 8 (i) pharmacy benefit managers; 9 (ii) PDP sponsors offering prescrip-10 tion drug plans and Medicare Advantage 11 organizations offering MA–PD plans; 12 (iii) drug wholesalers; 13 (iv) pharmacies; 14 (v) manufacturers; 15 (vi) pharmacy services administrative 16 organizations; 17 (vii) brokers, auditors, consultants, 18 and other entities that— 19 (I) advise PDP sponsors offering 20 prescription drug plans and Medicare 21 Advantage organizations offering MA– 22 PD plans regarding pharmacy bene-23 fits; or 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00351 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 352 •HR 1768 IH (II) review PDP sponsor and 1 Medicare Advantage organization con-2 tracts with pharmacy benefit man-3 agers; and 4 (viii) other service providers that con-5 tract with any of the entities described in 6 clauses (i) through (vii) that may use 7 price-related compensation and payment 8 structures, such as rebate aggregators (or 9 other entities that negotiate or process 10 price concessions on behalf of pharmacy 11 benefit managers, plan sponsors, or phar-12 macies). 13 (B) The primary business models and com-14 pensation structures for each category of inter-15 mediary described in subparagraph (A). 16 (C) Variation in price-related compensation 17 structures between affiliated entities (such as 18 entities with common ownership, either full or 19 partial, and subsidiary relationships) and unaf-20 filiated entities. 21 (D) Potential conflicts of interest among 22 contracting entities related to the use of pre-23 scription drug price-related compensation struc-24 tures, such as the potential for fees or other 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00352 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 353 •HR 1768 IH payments set as a percentage of a prescription 1 drug’s price to advantage formulary selection, 2 distribution, or purchasing of prescription drugs 3 with higher prices. 4 (E) Notable differences, if any, in the use 5 and level of price-based compensation struc-6 tures over time and between different market 7 segments, such as under part D of title XVIII 8 of the Social Security Act (42 U.S.C. 1395w– 9 101 et seq.) and the Medicaid program under 10 title XIX of such Act (42 U.S.C. 1396 et seq.). 11 (F) The effects of drug price-related com-12 pensation structures and alternative compensa-13 tion structures on Federal health care programs 14 and program beneficiaries, including with re-15 spect to cost-sharing, premiums, Federal out-16 lays, biosimilar and generic drug adoption and 17 utilization, drug shortage risks, and the poten-18 tial for fees set as a percentage of a drug’s 19 price to advantage the formulary selection, dis-20 tribution, or purchasing of drugs with higher 21 prices. 22 (G) Other issues determined to be relevant 23 and appropriate by the Comptroller General. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00353 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 354 •HR 1768 IH (2) R EPORT.—Not later than 2 years after the 1 date of enactment of this section, the Comptroller 2 General shall submit to Congress a report containing 3 the results of the study conducted under paragraph 4 (1), together with recommendations for such legisla-5 tion and administrative action as the Comptroller 6 General determines appropriate. 7 (c) M EDPAC R EPORTS ON AGREEMENTS WITH 8 PHARMACY BENEFIT MANAGERS WITH RESPECT TO PRE-9 SCRIPTION DRUG PLANS AND MA–PD PLANS.— 10 (1) I N GENERAL .—The Medicare Payment Ad-11 visory Commission shall submit to Congress the fol-12 lowing reports: 13 (A) I NITIAL REPORT .—Not later than the 14 first March 15 occurring after the date that is 15 2 years after the date on which the Secretary 16 makes the data available to the Commission, a 17 report regarding agreements with pharmacy 18 benefit managers with respect to prescription 19 drug plans and MA–PD plans. Such report 20 shall include, to the extent practicable— 21 (i) a description of trends and pat-22 terns, including relevant averages, totals, 23 and other figures for the types of informa-24 tion submitted; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00354 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 355 •HR 1768 IH (ii) an analysis of any differences in 1 agreements and their effects on plan en-2 rollee out-of-pocket spending and average 3 pharmacy reimbursement, and other im-4 pacts; and 5 (iii) any recommendations the Com-6 mission determines appropriate. 7 (B) F INAL REPORT .—Not later than 2 8 years after the date on which the Commission 9 submits the initial report under subparagraph 10 (A), a report describing any changes with re-11 spect to the information described in subpara-12 graph (A) over time, together with any rec-13 ommendations the Commission determines ap-14 propriate. 15 (2) F UNDING.—In addition to amounts other-16 wise available, there is appropriated to the Medicare 17 Payment Advisory Commission, out of any money in 18 the Treasury not otherwise appropriated, 19 $1,000,000 for fiscal year 2025, to remain available 20 until expended, to carry out this subsection. 21 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00355 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 356 •HR 1768 IH SEC. 228. REQUIRING A SEPARATE IDENTIFICATION NUM-1 BER AND AN ATTESTATION FOR EACH OFF- 2 CAMPUS OUTPATIENT DEPARTMENT OF A 3 PROVIDER. 4 (a) IN GENERAL.—Section 1833(t) of the Social Se-5 curity Act (42 U.S.C. 1395l(t)) is amended by adding at 6 the end the following new paragraph: 7 ‘‘(23) U SE OF UNIQUE HEALTH IDENTIFIERS ; 8 ATTESTATION.— 9 ‘‘(A) I N GENERAL .—No payment may be 10 made under this subsection (or under an appli-11 cable payment system pursuant to paragraph 12 (21)) for items and services furnished on or 13 after January 1, 2026, by an off-campus out-14 patient department of a provider (as defined in 15 subparagraph (C)) unless— 16 ‘‘(i) such department has obtained, 17 and such items and services are billed 18 under, a standard unique health identifier 19 for health care providers (as described in 20 section 1173(b)) that is separate from 21 such identifier for such provider; 22 ‘‘(ii) such provider has submitted to 23 the Secretary, during the 2-year period 24 ending on the date such items and services 25 are so furnished, an initial provider-based 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00356 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 357 •HR 1768 IH status attestation that such department is 1 compliant with the requirements described 2 in section 413.65 of title 42, Code of Fed-3 eral Regulations (or a successor regula-4 tion); and 5 ‘‘(iii) after such provider has sub-6 mitted an attestation under clause (ii), 7 such provider has submitted a subsequent 8 attestation within the timeframe specified 9 by the Secretary. 10 ‘‘(B) P ROCESS FOR SUBMISSION AND RE -11 VIEW.—Not later than 1 year after the date of 12 enactment of this paragraph, the Secretary 13 shall, through notice and comment rulemaking, 14 establish a process for each provider with an 15 off-campus outpatient department of a provider 16 to submit an initial and subsequent attestation 17 pursuant to clauses (ii) and (iii), respectively, of 18 subparagraph (A), and for the Secretary to re-19 view each such attestation and determine, 20 through site visits, remote audits, or other 21 means (as determined appropriate by the Sec-22 retary), whether such department is compliant 23 with the requirements described in such sub-24 paragraph. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00357 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 358 •HR 1768 IH ‘‘(C) O FF-CAMPUS OUTPATIENT DEPART -1 MENT OF A PROVIDER DEFINED .—For purposes 2 of this paragraph, the term ‘off-campus out-3 patient department of a provider’ means a de-4 partment of a provider (as defined in section 5 413.65 of title 42, Code of Federal Regulations, 6 or any successor regulation) that is not lo-7 cated— 8 ‘‘(i) on the campus (as defined in such 9 section) of such provider; or 10 ‘‘(ii) within the distance (described in 11 such definition of campus) from a remote 12 location of a hospital facility (as defined in 13 such section).’’. 14 (b) HHS OIG A NALYSIS.—Not later than January 15 1, 2030, the Inspector General of the Department of 16 Health and Human Services shall submit to Congress— 17 (1) an analysis of the process established by the 18 Secretary of Health and Human Services to conduct 19 the reviews and determinations described in section 20 1833(t)(23)(B) of the Social Security Act, as added 21 by subsection (a) of this section; and 22 (2) recommendations based on such analysis, as 23 the Inspector General determines appropriate. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00358 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 359 •HR 1768 IH SEC. 229. MEDICARE SEQUESTRATION. 1 Section 251A(6) of the Balanced Budget and Emer-2 gency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is 3 amended— 4 (1) in subparagraph (D), by striking ‘‘such 5 that,’’ and all that follows and inserting ‘‘such that 6 the payment reduction shall be 2.0 percent.’’; and 7 (2) by adding at the end the following: 8 ‘‘(F) On the date on which the President sub-9 mits the budget under section 1105 of title 31, 10 United States Code, for fiscal year 2033, the Presi-11 dent shall order a sequestration of payments for the 12 Medicare programs specified in section 256(d), effec-13 tive upon issuance, such that, notwithstanding the 2 14 percent limit specified in subparagraph (A) for such 15 payments— 16 ‘‘(i) with respect to the first 2 months in 17 which such order is effective for such fiscal 18 year, the payment reduction shall be 2.0 per-19 cent; and 20 ‘‘(ii) with respect to the last 10 months in 21 which such order is effective for such fiscal 22 year, the payment reduction shall be 0 per-23 cent.’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00359 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 360 •HR 1768 IH TITLE III—OTHER MATTERS 1 SEC. 301. SEXUAL RISK AVOIDANCE EDUCATION EXTEN-2 SION. 3 Section 510 of the Social Security Act (42 U.S.C. 4 710) is amended— 5 (1) in subsection (a)— 6 (A) in paragraph (1)— 7 (i) by striking ‘‘and for the period’’ 8 and inserting ‘‘for the period’’; 9 (ii) by striking ‘‘March 31, 2025’’ and 10 inserting ‘‘September 30, 2025’’; 11 (iii) by inserting ‘‘and for the period 12 beginning on October 1, 2025, and ending 13 on December 31, 2025,’’ before ‘‘allot to 14 each State’’; and 15 (iv) by striking ‘‘for fiscal year 2024 16 or 2025’’ and inserting ‘‘for fiscal year 17 2024, 2025, or 2026’’; and 18 (B) in paragraph (2), by striking ‘‘or 19 2025’’ each place it appears and inserting ‘‘, 20 2025, or 2026’’; and 21 (2) in subsection (f)(1)— 22 (A) by striking ‘‘and for the period’’ and 23 inserting ‘‘for the period’’; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00360 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 361 •HR 1768 IH (B) by striking ‘‘March 31, 2025’’ and in-1 serting ‘‘September 30, 2025’’; and 2 (C) by inserting ‘‘, and for the period be-3 ginning on October 1, 2025, and ending on De-4 cember 31, 2025, an amount equal to the pro 5 rata portion of the amount appropriated for the 6 corresponding period for fiscal year 2025’’ after 7 ‘‘corresponding period for fiscal year 2024’’. 8 SEC. 302. PERSONAL RESPONSIBILITY EDUCATION EXTEN-9 SION. 10 Section 513 of the Social Security Act (42 U.S.C. 11 713) is amended— 12 (1) in subsection (a)(1)— 13 (A) in subparagraph (A), in the matter 14 preceding clause (i)— 15 (i) by striking ‘‘and for the period’’ 16 and inserting ‘‘for the period’’; 17 (ii) by striking ‘‘March 31, 2025’’ and 18 inserting ‘‘September 30, 2025’’; and 19 (iii) by inserting ‘‘and for the period 20 beginning on October 1, 2025, and ending 21 on December 31, 2025,’’ before ‘‘the Sec-22 retary shall allot’’; and 23 (B) in subparagraph (B)(i)— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00361 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 362 •HR 1768 IH (i) by striking ‘‘and for the period’’ 1 and inserting ‘‘for the period’’; 2 (ii) by striking ‘‘March 31, 2025’’ and 3 inserting ‘‘September 30, 2025’’; and 4 (iii) by inserting ‘‘, and for the period 5 beginning on October 1, 2025, and ending 6 on December 31, 2025’’ before the period; 7 (2) in subsection (c)(3), by striking ‘‘fiscal year 8 2024 or 2025’’ and inserting ‘‘fiscal year 2024, 9 2025, or 2026’’; and 10 (3) in subsection (f)— 11 (A) by striking ‘‘and for the period’’ and 12 inserting ‘‘for the period’’; 13 (B) by striking ‘‘March 31, 2025’’ and in-14 serting ‘‘September 30, 2025’’; and 15 (C) by inserting ‘‘, and for the period be-16 ginning on October 1, 2025, and ending on De-17 cember 31, 2025, an amount equal to the pro 18 rata portion of the amount appropriated for the 19 corresponding period for fiscal year 2025’’ after 20 ‘‘corresponding period for fiscal year 2024’’. 21 SEC. 303. EXTENSION OF FUNDING FOR FAMILY-TO-FAMILY 22 HEALTH INFORMATION CENTERS. 23 Section 501(c)(1)(A)(viii) of the Social Security Act 24 (42 U.S.C. 701(c)(1)(A)(viii)) is amended— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00362 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 363 •HR 1768 IH (1) by striking ‘‘$3,000,000’’ and inserting 1 ‘‘$7,500,000’’; and 2 (2) by striking ‘‘for the portion of fiscal year 3 2025 before April 1, 2025’’ and inserting ‘‘for the 4 period beginning on October 1, 2024, and ending on 5 December 31, 2025’’. 6 TITLE IV—PUBLIC HEALTH 7 EXTENDERS 8 Subtitle A—Extensions 9 SEC. 401. EXTENSION FOR COMMUNITY HEALTH CENTERS, 10 NATIONAL HEALTH SERVICE CORPS, AND 11 TEACHING HEALTH CENTERS THAT OPERATE 12 GME PROGRAMS. 13 (a) E XTENSION FOR COMMUNITY HEALTH CEN-14 TERS.—Section 10503(b)(1) of the Patient Protection and 15 Affordable Care Act (42 U.S.C. 254b–2(b)(1)) is amend-16 ed— 17 (1) in subparagraph (H), by striking ‘‘and’’ at 18 the end; 19 (2) in subparagraph (I), by striking the period 20 at the end and inserting a semicolon; and 21 (3) by adding at the end the following: 22 ‘‘(J) $2,315,342,466 for the period begin-23 ning on April 1, 2025, and ending on Sep-24 tember 30, 2025; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00363 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 364 •HR 1768 IH ‘‘(K) $4,600,000,000 for fiscal year 2026; 1 and’’. 2 (b) EXTENSION FOR THE NATIONAL HEALTH SERV-3 ICE CORPS.—Section 10503(b)(2) of the Patient Protec-4 tion and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) 5 is amended— 6 (1) in subparagraph (I), by striking ‘‘and’’ at 7 the end; 8 (2) in subparagraph (J), by striking the period 9 at the end and inserting a semicolon; and 10 (3) by adding at the end the following: 11 ‘‘(K) $176,712,329 for the period begin-12 ning on April 1, 2025, and ending on Sep-13 tember 30, 2025; and 14 ‘‘(L) $350,000,000 for fiscal year 2026.’’. 15 (c) T EACHING HEALTH CENTERS THAT OPERATE 16 GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 17 340H(g)(1) of the Public Health Service Act (42 U.S.C. 18 256h(g)(1)) is amended— 19 (1) in subparagraph (D), by striking ‘‘and’’ at 20 the end; 21 (2) in subparagraph (E), by striking the period 22 at the end and inserting a semicolon; and 23 (3) by adding at the end the following: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00364 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 365 •HR 1768 IH ‘‘(F) $112,849,315 for the period begin-1 ning on April 1, 2025, and ending on Sep-2 tember 30, 2025; 3 ‘‘(G) $225,000,000 for fiscal year 2026; 4 ‘‘(H) $250,000,000 for fiscal year 2027; 5 ‘‘(I) $275,000,000 for fiscal year 2028; 6 and 7 ‘‘(J) $300,000,000 for fiscal year 2029.’’. 8 (d) A PPLICATION OF PROVISIONS.—Amounts appro-9 priated pursuant to the amendments made by this section 10 shall be subject to the requirements contained in Public 11 Law 117–328 for funds for programs authorized under 12 sections 330 through 340 of the Public Health Service Act 13 (42 U.S.C. 254b et seq.). 14 (e) CONFORMING AMENDMENT.—Section 3014(h)(4) 15 of title 18, United States Code, is amended by striking 16 ‘‘and section 3101(d) of the Health Extensions and Other 17 Matters Act, 2025’’ and inserting ‘‘section 3101(d) of the 18 Health Extensions and Other Matters Act, 2025, and sec-19 tion 401 of the Lower Costs for Everyday Americans Act’’. 20 SEC. 402. EXTENSION OF SPECIAL DIABETES PROGRAMS. 21 (a) E XTENSION OF SPECIAL DIABETES PROGRAMS 22 FOR TYPE I DIABETES.—Section 330B(b)(2) of the Pub-23 lic Health Service Act (42 U.S.C. 254c–2(b)(2)) is amend-24 ed— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00365 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 366 •HR 1768 IH (1) in subparagraph (E), by striking ‘‘and’’ at 1 the end; 2 (2) in subparagraph (F), by striking the period 3 at the end and inserting a semicolon; and 4 (3) by adding at the end the following: 5 ‘‘(G) $110,327,296 for the period begin-6 ning on April 1, 2025, and ending on Sep-7 tember 30, 2025, to remain available until ex-8 pended; and 9 ‘‘(H) $200,000,000 for fiscal year 2026, to 10 remain available until expended.’’. 11 (b) E XTENDING FUNDING FOR SPECIAL DIABETES 12 PROGRAMS FOR INDIANS.—Section 330C(c)(2) of the 13 Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is 14 amended— 15 (1) in subparagraph (E), by striking ‘‘and’’ at 16 the end; 17 (2) in subparagraph (F), by striking the period 18 at the end and inserting a semicolon; and 19 (3) by adding at the end the following: 20 ‘‘(G) $110,327,296 for the period begin-21 ning on April 1, 2025, and ending on Sep-22 tember 30, 2025, to remain available until ex-23 pended; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00366 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 367 •HR 1768 IH ‘‘(H) $200,000,000 for fiscal year 2026, to 1 remain available until expended.’’. 2 Subtitle B—World Trade Center 3 Health Program 4 SEC. 411. 9/11 RESPONDER AND SURVIVOR HEALTH FUND-5 ING CORRECTIONS. 6 (a) I N GENERAL.—Section 3351(a)(2)(A) of the 7 Public Health Service Act (42 U.S.C. 300mm– 8 61(a)(2)(A)) is amended— 9 (1) in clause (x), by striking ‘‘; and’’ and insert-10 ing a semicolon; 11 (2) by redesignating clause (xi) as clause (xii); 12 and 13 (3) by inserting after clause (x), the following: 14 ‘‘(xi) for each of fiscal years 2026 15 through 2040— 16 ‘‘(I) the amount determined 17 under this subparagraph for the pre-18 vious fiscal year multiplied by 1.05; 19 multiplied by 20 ‘‘(II) the ratio of— 21 ‘‘(aa) the total number of 22 individuals enrolled in the WTC 23 Program on July 1 of such pre-24 vious fiscal year; to 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00367 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 368 •HR 1768 IH ‘‘(bb) the total number of 1 individuals so enrolled on July 1 2 of the fiscal year prior to such 3 previous fiscal year; and’’. 4 (b) REPORT TO CONGRESS.— 5 (1) I N GENERAL .—Not later than 3 years after 6 the date of enactment of this Act, the Secretary of 7 Health and Human Services (referred to in this sub-8 section as the ‘‘Secretary’’) shall conduct an assess-9 ment of anticipated budget authority and outlays of 10 the World Trade Center Health Program (referred 11 to in this subsection as the ‘‘Program’’) through the 12 duration of the Program and submit a report sum-13 marizing such assessment to— 14 (A) the Speaker and minority leader of the 15 House of Representatives; 16 (B) the majority and minority leaders of 17 the Senate; 18 (C) the Committee on Health, Education, 19 Labor, and Pensions and Committee on the 20 Budget of the Senate; and 21 (D) the Committee on Energy and Com-22 merce and the Committee on the Budget of the 23 House of Representatives. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00368 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 369 •HR 1768 IH (2) I NCLUSIONS.—The report required under 1 paragraph (1) shall include— 2 (A) a projection of Program budgetary 3 needs on a per-fiscal year basis through fiscal 4 year 2090; 5 (B) a review of Program modeling for each 6 of fiscal years 2017 through the fiscal year 7 prior to the fiscal year in which the report is 8 issued to assess how anticipated budgetary 9 needs compared to actual expenditures; 10 (C) an assessment of the projected budget 11 authority and expenditures of the Program 12 through fiscal year 2090 by comparing— 13 (i) such projected authority and ex-14 penditures resulting from application of 15 section 3351(a)(2)(A) of the Public Health 16 Service Act (42 U.S.C. 300mm– 17 61(a)(2)(A)), as amended by subsection 18 (a); 19 (ii) such projected authority and ex-20 penditures that would result if such section 21 were amended so that the formula under 22 clause (xi) of such section, as amended by 23 subsection (a), were to be extended 24 through fiscal year 2090; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00369 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 370 •HR 1768 IH (D) any recommendations of the Secretary 1 to make changes to the formula under such sec-2 tion 3351(a)(2)(A), as so amended, to fully off-3 set anticipated Program expenditures through 4 fiscal year 2090. 5 (c) TECHNICAL AMENDMENTS.—Title XXXIII of the 6 Public Health Service Act (42 U.S.C. 300mm et seq.) is 7 amended— 8 (1) in section 3352(d) (42 U.S.C. 300mm– 9 62(d)), by striking ‘‘Any amounts’’ and inserting 10 ‘‘Any unobligated amounts’’; 11 (2) in section 3353(d) (42 U.S.C. 300mm– 12 63(d)), by striking ‘‘Any amounts’’ and inserting 13 ‘‘Any unobligated amounts’’; and 14 (3) in section 3354(d) (42 U.S.C. 300mm– 15 64(d)), by striking ‘‘Any amounts’’ and inserting 16 ‘‘Any unobligated amounts’’. 17 TITLE V—SUPPORT ACT 18 REAUTHORIZATION 19 SEC. 501. SHORT TITLE. 20 This title may be cited as the ‘‘SUPPORT for Pa-21 tients and Communities Reauthorization Act of 2025’’. 22 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00370 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 371 •HR 1768 IH Subtitle A—Prevention 1 SEC. 511. PRENATAL AND POSTNATAL HEALTH. 2 Section 317L(d) of the Public Health Service Act (42 3 U.S.C. 247b–13(d)) is amended by striking ‘‘such sums 4 as may be necessary for each of the fiscal years 2019 5 through 2023’’ and inserting ‘‘$4,250,000 for each of fis-6 cal years 2025 through 2029’’. 7 SEC. 512. MONITORING AND EDUCATION REGARDING IN-8 FECTIONS ASSOCIATED WITH ILLICIT DRUG 9 USE AND OTHER RISK FACTORS. 10 Section 317N(d) of the Public Health Service Act (42 11 U.S.C. 247b–15(d)) is amended by striking ‘‘fiscal years 12 2019 through 2023’’ and inserting ‘‘fiscal years 2025 13 through 2029’’. 14 SEC. 513. PREVENTING OVERDOSES OF CONTROLLED SUB-15 STANCES. 16 (a) I N GENERAL.—Section 392A of the Public 17 Health Service Act (42 U.S.C. 280b–1) is amended— 18 (1) in subsection (a)(2)— 19 (A) in subparagraph (C), by inserting ‘‘and 20 associated risks’’ before the period at the end; 21 and 22 (B) in subparagraph (D), by striking 23 ‘‘opioids’’ and inserting ‘‘substances causing 24 overdose’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00371 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 372 •HR 1768 IH (2) in subsection (b)(2)— 1 (A) in subparagraph (B), by inserting ‘‘, 2 and associated risk factors,’’ after ‘‘such 3 overdoses’’; 4 (B) in subparagraph (C), by striking ‘‘cod-5 ing’’ and inserting ‘‘monitoring and identi-6 fying’’; 7 (C) in subparagraph (E)— 8 (i) by inserting a comma after ‘‘public 9 health laboratories’’; and 10 (ii) by inserting ‘‘and other emerging 11 substances related’’ after ‘‘analogues’’; and 12 (D) in subparagraph (F), by inserting 13 ‘‘and associated risk factors’’ after ‘‘overdoses’’. 14 (b) A DDITIONAL GRANTS.—Section 392A(a)(3) of 15 the Public Health Service Act (42 U.S.C. 280b–1(a)(3)) 16 is amended— 17 (1) in the matter preceding subparagraph (A), 18 by striking ‘‘and Indian Tribes—’’ and inserting 19 ‘‘and Indian Tribes for the following purposes:’’; 20 (2) by amending subparagraph (A) to read as 21 follows: 22 ‘‘(A) To carry out innovative projects for 23 grantees to detect, identify, and rapidly respond 24 to controlled substance misuse, abuse, and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00372 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 373 •HR 1768 IH overdoses, and associated risk factors, including 1 changes in patterns of such controlled sub-2 stance use. Such projects may include the use 3 of innovative, evidence-based strategies for de-4 tecting such patterns, such as wastewater sur-5 veillance, if proven to support actionable pre-6 vention strategies, in a manner consistent with 7 applicable Federal and State privacy laws.’’; 8 and 9 (3) in subparagraph (B), by striking ‘‘for any’’ 10 and inserting ‘‘For any’’. 11 (c) A UTHORIZATION OF APPROPRIATIONS.—Section 12 392A(e) of the Public Health Service Act (42 U.S.C. 13 280b–1(e)) is amended by striking ‘‘$496,000,000 for 14 each of fiscal years 2019 through 2023’’ and inserting 15 ‘‘$505,579,000 for each of fiscal years 2025 through 16 2029’’. 17 SEC. 514. SUPPORT FOR INDIVIDUALS AND FAMILIES IM-18 PACTED BY FETAL ALCOHOL SPECTRUM DIS-19 ORDER. 20 (a) I N GENERAL.—Part O of title III of the Public 21 Health Service Act (42 U.S.C. 280f et seq.) is amended 22 to read as follows: 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00373 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 374 •HR 1768 IH ‘‘PART O—FETAL ALCOHOL SYNDROME 1 PREVENTION AND SERVICES PROGRAM 2 ‘‘SEC. 399H. FETAL ALCOHOL SPECTRUM DISORDERS PRE-3 VENTION, INTERVENTION, AND SERVICES DE-4 LIVERY PROGRAM. 5 ‘‘(a) IN GENERAL.—The Secretary shall establish or 6 continue activities to support a comprehensive fetal alcohol 7 spectrum disorders (referred to in this section as ‘FASD’) 8 education, prevention, identification, intervention, and 9 services delivery program, which may include— 10 ‘‘(1) an education and public awareness pro-11 gram to support, conduct, and evaluate the effective-12 ness of— 13 ‘‘(A) educational programs targeting 14 health professions schools, social and other sup-15 portive services, educators and counselors and 16 other service providers in all phases of child-17 hood development, and other relevant service 18 providers, concerning the prevention, identifica-19 tion, and provision of services for infants, chil-20 dren, adolescents and adults with FASD; 21 ‘‘(B) strategies to educate school-age chil-22 dren, including pregnant and high-risk youth, 23 concerning FASD; 24 ‘‘(C) public and community awareness pro-25 grams concerning FASD; and 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00374 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 375 •HR 1768 IH ‘‘(D) strategies to coordinate information 1 and services across affected community agen-2 cies, including agencies providing social services 3 such as foster care, adoption, and social work, 4 agencies providing health services, and agencies 5 involved in education, vocational training and 6 civil and criminal justice; 7 ‘‘(2) supporting and conducting research on 8 FASD, as appropriate, including to— 9 ‘‘(A) develop appropriate medical diag-10 nostic methods for identifying FASD; and 11 ‘‘(B) develop effective culturally and lin-12 guistically appropriate evidence-based or evi-13 dence-informed interventions and appropriate 14 supports for preventing prenatal alcohol expo-15 sure, which may co-occur with exposure to other 16 substances; 17 ‘‘(3) building State and Tribal capacity for the 18 identification, treatment, and support of individuals 19 with FASD and their families, which may include— 20 ‘‘(A) utilizing and adapting existing Fed-21 eral, State, or Tribal programs to include 22 FASD identification and FASD-informed sup-23 port; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00375 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 376 •HR 1768 IH ‘‘(B) developing and expanding screening 1 and diagnostic capacity for FASD; 2 ‘‘(C) developing, implementing, and evalu-3 ating targeted FASD-informed intervention 4 programs for FASD; 5 ‘‘(D) providing training with respect to 6 FASD for professionals across relevant sectors; 7 and 8 ‘‘(E) disseminating information about 9 FASD and support services to affected individ-10 uals and their families; and 11 ‘‘(4) an applied research program concerning 12 intervention and prevention to support and conduct 13 service demonstration projects, clinical studies and 14 other research models providing advocacy, edu-15 cational and vocational training, counseling, medical 16 and mental health, and other supportive services, as 17 well as models that integrate and coordinate such 18 services, that are aimed at the unique challenges fac-19 ing individuals with Fetal Alcohol Syndrome or 20 Fetal Alcohol Effect and their families. 21 ‘‘(b) GRANTS AND TECHNICAL ASSISTANCE.— 22 ‘‘(1) I N GENERAL .—The Secretary may award 23 grants, cooperative agreements and contracts and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00376 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 377 •HR 1768 IH provide technical assistance to eligible entities to 1 carry out subsection (a). 2 ‘‘(2) ELIGIBLE ENTITIES .—To be eligible to re-3 ceive a grant, or enter into a cooperative agreement 4 or contract, under this section, an entity shall— 5 ‘‘(A) be a State, Indian Tribe or Tribal or-6 ganization, local government, scientific or aca-7 demic institution, or nonprofit organization; 8 and 9 ‘‘(B) prepare and submit to the Secretary 10 an application at such time, in such manner, 11 and containing such information as the Sec-12 retary may require, including a description of 13 the activities that the entity intends to carry 14 out using amounts received under this section. 15 ‘‘(3) A DDITIONAL APPLICATION CONTENTS .— 16 The Secretary may require that an eligible entity in-17 clude in the application submitted under paragraph 18 (2)(B)— 19 ‘‘(A) a designation of an individual to 20 serve as a FASD State or Tribal coordinator of 21 activities such eligible entity proposes to carry 22 out through a grant, cooperative agreement, or 23 contract under this section; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00377 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 378 •HR 1768 IH ‘‘(B) a description of an advisory com-1 mittee the entity will establish to provide guid-2 ance for the entity on developing and imple-3 menting a statewide or Tribal strategic plan to 4 prevent FASD and provide for the identifica-5 tion, treatment, and support of individuals with 6 FASD and their families. 7 ‘‘(c) D EFINITION OF FASD-INFORMED.—For pur-8 poses of this section, the term ‘FASD-informed’, with re-9 spect to support or an intervention program, means that 10 such support or intervention program uses culturally and 11 linguistically informed evidence-based or practice-based 12 interventions and appropriate resources to support an im-13 proved quality of life for an individual with FASD and 14 the family of such individual. 15 ‘‘SEC. 399I. STRENGTHENING CAPACITY AND EDUCATION 16 FOR FETAL ALCOHOL SPECTRUM DIS-17 ORDERS. 18 ‘‘(a) I N GENERAL.—The Secretary shall award 19 grants, contracts, or cooperative agreements, as the Sec-20 retary determines appropriate, to public or nonprofit pri-21 vate entities with demonstrated expertise in the field of 22 fetal alcohol spectrum disorders (referred to in this section 23 as ‘FASD’). Such awards shall be for the purposes of 24 building local, Tribal, State, and nationwide capacities to 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00378 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 379 •HR 1768 IH prevent the occurrence of FASD by carrying out the pro-1 grams described in subsection (b). 2 ‘‘(b) P ROGRAMS.—An entity receiving an award 3 under subsection (a) may use such award for the following 4 purposes: 5 ‘‘(1) Developing and supporting public edu-6 cation and outreach activities to raise public aware-7 ness of the risks associated with alcohol consumption 8 during pregnancy. 9 ‘‘(2) Acting as a clearinghouse for evidence- 10 based resources on FASD prevention, identification, 11 and culturally and linguistically appropriate best 12 practices to help inform systems of care for individ-13 uals with FASD across their lifespan. 14 ‘‘(3) Increasing awareness and understanding 15 of efficacious, evidence-based screening tools and 16 culturally and linguistically appropriate evidence- 17 based intervention services and best practices, which 18 may include improving the capacity for State, Trib-19 al, and local affiliates. 20 ‘‘(4) Providing technical assistance to recipients 21 of grants, cooperative agreements, or contracts 22 under section 399H, as appropriate. 23 ‘‘(c) A PPLICATION.—To be eligible for a grant, con-24 tract, or cooperative agreement under this section, an enti-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00379 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 380 •HR 1768 IH ty shall submit to the Secretary an application at such 1 time, in such manner, and containing such information as 2 the Secretary may require. 3 ‘‘(d) S UBCONTRACTING.—A public or private non-4 profit entity may carry out the following activities required 5 under this section through contracts or cooperative agree-6 ments with other public and private nonprofit entities with 7 demonstrated expertise in FASD: 8 ‘‘(1) Resource development and dissemination. 9 ‘‘(2) Intervention services. 10 ‘‘(3) Training and technical assistance. 11 ‘‘SEC. 399J. AUTHORIZATION OF APPROPRIATIONS. 12 ‘‘There are authorized to be appropriated to carry out 13 this part $12,500,000 for each of fiscal years 2025 14 through 2029.’’. 15 (b) R EPORT.—Not later than 4 years after the date 16 of enactment of this Act, and every year thereafter, the 17 Secretary of Health and Human Services shall prepare 18 and submit to the Committee on Health, Education, 19 Labor, and Pensions of the Senate and the Committee on 20 Energy and Commerce of the House of Representatives 21 a report containing— 22 (1) a review of the activities carried out pursu-23 ant to sections 399H and 399I of the Public Health 24 Service Act, as amended, to advance public edu-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00380 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 381 •HR 1768 IH cation and awareness of fetal alcohol spectrum dis-1 orders (referred to in this section as ‘‘FASD’’); 2 (2) a description of— 3 (A) the activities carried out pursuant to 4 such sections 399H and 399I to identify, pre-5 vent, and treat FASD; and 6 (B) methods used to evaluate the outcomes 7 of such activities; and 8 (3) an assessment of activities carried out pur-9 suant to such sections 399H and 399I to support in-10 dividuals with FASD. 11 SEC. 515. PROMOTING STATE CHOICE IN PDMP SYSTEMS. 12 Section 399O(h) of the Public Health Service Act (42 13 U.S.C. 280g–3(h)) is amended by adding at the end the 14 following: 15 ‘‘(5) P ROMOTING STATE CHOICE .—Nothing in 16 this section shall be construed to authorize the Sec-17 retary to require States to use a specific vendor or 18 a specific interoperability connection other than to 19 align with nationally recognized, consensus-based 20 open standards, such as in accordance with sections 21 3001 and 3004.’’. 22 SEC. 516. FIRST RESPONDER TRAINING PROGRAM. 23 Section 546 of the Public Health Service Act (42 24 U.S.C. 290ee–1) is amended— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00381 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 382 •HR 1768 IH (1) in subsection (a), by striking ‘‘tribes and 1 tribal’’ and inserting ‘‘Tribes and Tribal’’; 2 (2) in subsections (a), (c), and (d)— 3 (A) by striking ‘‘approved or cleared’’ each 4 place it appears and inserting ‘‘approved, 5 cleared, or otherwise legally marketed’’; and 6 (B) by striking ‘‘opioid’’ each place it ap-7 pears; 8 (3) in subsection (f)— 9 (A) by striking ‘‘approved or cleared’’ each 10 place it appears and inserting ‘‘approved, 11 cleared, or otherwise legally marketed’’; 12 (B) in paragraph (1), by striking ‘‘opioid’’; 13 (C) in paragraph (2)— 14 (i) by striking ‘‘opioid and heroin’’ 15 and inserting ‘‘opioid, heroin, and other 16 drug’’; and 17 (ii) by striking ‘‘opioid overdose’’ and 18 inserting ‘‘overdose’’; and 19 (D) in paragraph (3), by striking ‘‘opioid 20 and heroin’’; and 21 (4) in subsection (h), by striking ‘‘$36,000,000 22 for each of fiscal years 2019 through 2023’’ and in-23 serting ‘‘$56,000,000 for each of fiscal years 2025 24 through 2029’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00382 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 383 •HR 1768 IH SEC. 517. DONALD J. COHEN NATIONAL CHILD TRAUMATIC 1 STRESS INITIATIVE. 2 (a) TECHNICAL AMENDMENT.—The second part G of 3 title V of the Public Health Service Act (42 U.S.C. 290kk 4 et seq.), as added by section 144 of the Community Re-5 newal Tax Relief Act (Public Law 106–554), is amend-6 ed— 7 (1) by redesignating such part as part J; and 8 (2) by redesignating sections 581 through 584 9 as sections 596 through 596C, respectively. 10 (b) IN GENERAL.—Section 582 of the Public Health 11 Service Act (42 U.S.C. 290hh–1) is amended— 12 (1) in the section heading, by striking ‘‘ VIO-13 LENCE RELATED STRESS ’’ and inserting ‘‘ TRAU-14 MATIC EVENTS’’; 15 (2) in subsection (a)— 16 (A) in the matter preceding paragraph (1), 17 by striking ‘‘tribes and tribal’’ and inserting 18 ‘‘Tribes and Tribal’’; and 19 (B) in paragraph (2), by inserting ‘‘and 20 dissemination’’ after ‘‘the development’’; 21 (3) in subsection (b), by inserting ‘‘and dissemi-22 nation’’ after ‘‘the development’’; 23 (4) in subsection (d)— 24 (A) by striking ‘‘The NCTSI’’ and insert-25 ing the following: 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00383 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 384 •HR 1768 IH ‘‘(1) C OORDINATING CENTER .—The NCTSI’’; 1 and 2 (B) by adding at the end the following: 3 ‘‘(2) NCTSI GRANTEES.—In carrying out sub-4 section (a)(2), NCTSI grantees shall develop 5 trainings and other resources, as applicable and ap-6 propriate, to support implementation of the evi-7 dence-based practices developed and disseminated 8 under such subsection.’’; 9 (5) in subsection (e)— 10 (A) by redesignating paragraphs (1) and 11 (2) as subparagraphs (A) and (B), respectively, 12 and adjusting the margins accordingly; 13 (B) in subparagraph (A), as so redesig-14 nated, by inserting ‘‘and implementation’’ after 15 ‘‘the dissemination’’; 16 (C) by striking ‘‘The NCTSI’’ and insert-17 ing the following: 18 ‘‘(1) C OORDINATING CENTER .—The NCTSI’’; 19 and 20 (D) by adding at the end the following: 21 ‘‘(2) NCTSI GRANTEES.—NCTSI grantees 22 shall, as appropriate, collaborate with other such 23 grantees, the NCTSI coordinating center, and the 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00384 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 385 •HR 1768 IH Secretary in carrying out subsections (a)(2) and 1 (d)(2).’’; 2 (6) by amending subsection (h) to read as fol-3 lows: 4 ‘‘(h) APPLICATION AND EVALUATION.—To be eligible 5 to receive a grant, contract, or cooperative agreement 6 under subsection (a), a public or nonprofit private entity 7 or an Indian Tribe or Tribal organization shall submit to 8 the Secretary an application at such time, in such manner, 9 and containing such information and assurances as the 10 Secretary may require, including— 11 ‘‘(1) a plan for the evaluation of the activities 12 funded under the grant, contract, or agreement, in-13 cluding both process and outcomes evaluation, and 14 the submission of an evaluation at the end of the 15 project period; and 16 ‘‘(2) a description of how such entity, Indian 17 Tribe, or Tribal organization will support efforts led 18 by the Secretary or the NCTSI coordinating center, 19 as applicable, to evaluate activities carried out under 20 this section.’’; and 21 (7) by amending subsection (j) to read as fol-22 lows: 23 ‘‘(j) A UTHORIZATION OF APPROPRIATIONS.—There 24 is authorized to be appropriated to carry out this section— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00385 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 386 •HR 1768 IH ‘‘(1) $93,887,000 for fiscal year 2025; 1 ‘‘(2) $95,000,000 for fiscal year 2026; 2 ‘‘(3) $97,000,000 for fiscal year 2027; 3 ‘‘(4) $100,000,000 for fiscal year 2028; and 4 ‘‘(5) $100,000,000 for fiscal year 2029.’’. 5 SEC. 518. PROTECTING SUICIDE PREVENTION LIFELINE 6 FROM CYBERSECURITY INCIDENTS. 7 (a) NATIONAL SUICIDE PREVENTION LIFELINE PRO-8 GRAM.—Section 520E–3(b) of the Public Health Service 9 Act (42 U.S.C. 290bb–36c(b)) is amended— 10 (1) in paragraph (4), by striking ‘‘and’’ at the 11 end; 12 (2) in paragraph (5), by striking the period at 13 the end and inserting ‘‘; and’’; and 14 (3) by adding at the end the following: 15 ‘‘(6) taking such steps as may be necessary to 16 ensure the suicide prevention hotline is protected 17 from cybersecurity incidents and eliminates known 18 cybersecurity vulnerabilities.’’. 19 (b) R EPORTING.—Section 520E–3 of the Public 20 Health Service Act (42 U.S.C. 290bb–36c) is amended— 21 (1) by redesignating subsection (f) as sub-22 section (g); and 23 (2) by inserting after subsection (e) the fol-24 lowing: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00386 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 387 •HR 1768 IH ‘‘(f) CYBERSECURITY REPORTING.— 1 ‘‘(1) NOTIFICATION.— 2 ‘‘(A) I N GENERAL .—The program’s net-3 work administrator receiving Federal funding 4 pursuant to subsection (a) shall report to the 5 Assistant Secretary, in a manner that protects 6 personal privacy, consistent with applicable 7 Federal and State privacy laws— 8 ‘‘(i) any identified cybersecurity 9 vulnerabilities to the program within a rea-10 sonable amount of time after identification 11 of such a vulnerability; and 12 ‘‘(ii) any identified cybersecurity inci-13 dents to the program within a reasonable 14 amount of time after identification of such 15 incident. 16 ‘‘(B) L OCAL AND REGIONAL CRISIS CEN -17 TERS.—Local and regional crisis centers par-18 ticipating in the program shall report to the 19 program’s network administrator identified 20 under subparagraph (A), in a manner that pro-21 tects personal privacy, consistent with applica-22 ble Federal and State privacy laws— 23 ‘‘(i) any identified cybersecurity 24 vulnerabilities to the program within a rea-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00387 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 388 •HR 1768 IH sonable amount of time after identification 1 of such vulnerability; and 2 ‘‘(ii) any identified cybersecurity inci-3 dents to the program within a reasonable 4 amount of time after identification of such 5 incident. 6 ‘‘(2) N OTIFICATION.—If the program’s network 7 administrator receiving funding pursuant to sub-8 section (a) discovers, or is informed by a local or re-9 gional crisis center pursuant to paragraph (1)(B) of, 10 a cybersecurity vulnerability or incident, within a 11 reasonable amount of time after such discovery or 12 receipt of information, such entity shall report the 13 vulnerability or incident to the Assistant Secretary. 14 ‘‘(3) CLARIFICATION.— 15 ‘‘(A) OVERSIGHT.— 16 ‘‘(i) L OCAL AND REGIONAL CRISIS 17 CENTERS.—Except as provided in clause 18 (ii), local and regional crisis centers par-19 ticipating in the program shall oversee all 20 technology each center employs in the pro-21 vision of services as a participant in the 22 program. 23 ‘‘(ii) N ETWORK ADMINISTRATOR .— 24 The program’s network administrator re-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00388 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 389 •HR 1768 IH ceiving Federal funding pursuant to sub-1 section (a) shall oversee the technology 2 each crisis center employs in the provision 3 of services as a participant in the program 4 if such oversight responsibilities are estab-5 lished in the applicable network participa-6 tion agreement. 7 ‘‘(B) S UPPLEMENT, NOT SUPPLANT .—The 8 cybersecurity incident reporting requirements 9 under this subsection shall supplement, and not 10 supplant, cybersecurity incident reporting re-11 quirements under other provisions of applicable 12 Federal law that are in effect on the date of the 13 enactment of the SUPPORT for Patients and 14 Communities Reauthorization Act of 2025.’’. 15 (c) STUDY.—Not later than 180 days after the date 16 of the enactment of this Act, the Comptroller General of 17 the United States shall— 18 (1) conduct and complete a study that evaluates 19 cybersecurity risks and vulnerabilities associated 20 with the 9–8–8 National Suicide Prevention Lifeline; 21 and 22 (2) submit a report on the findings of such 23 study to the Committee on Health, Education, 24 Labor, and Pensions of the Senate and the Com-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00389 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 390 •HR 1768 IH mittee on Energy and Commerce of the House of 1 Representatives. 2 SEC. 519. BRUCE’S LAW. 3 (a) Y OUTH PREVENTION AND RECOVERY.—Section 4 7102(c) of the SUPPORT for Patients and Communities 5 Act (42 U.S.C. 290bb–7a(c)) is amended— 6 (1) in paragraph (3)(A)(i), by inserting ‘‘, 7 which may include strategies to increase education 8 and awareness of the potency and dangers of syn-9 thetic opioids (including drugs contaminated with 10 fentanyl) and, as appropriate, other emerging drug 11 use or misuse issues’’ before the semicolon; and 12 (2) in paragraph (4)(A), by inserting ‘‘and 13 strategies to increase education and awareness of 14 the potency and dangers of synthetic opioids (includ-15 ing drugs contaminated with fentanyl) and, as ap-16 propriate, emerging drug use or misuse issues’’ be-17 fore the semicolon. 18 (b) I NTERDEPARTMENTAL SUBSTANCE USE DIS-19 ORDERS COORDINATING COMMITTEE.—Section 7022 of 20 the SUPPORT for Patients and Communities Act (42 21 U.S.C. 290aa note) is amended— 22 (1) by striking subsection (g) and inserting the 23 following: 24 ‘‘(g) WORKING GROUPS.— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00390 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 391 •HR 1768 IH ‘‘(1) I N GENERAL .—The Committee may estab-1 lish working groups for purposes of carrying out the 2 duties described in subsection (e). Any such working 3 group shall be composed of members of the Com-4 mittee (or the designees of such members) and may 5 hold such meetings as are necessary to carry out the 6 duties delegated to the working group. 7 ‘‘(2) A DDITIONAL FEDERAL INTERAGENCY 8 WORK GROUP ON FENTANYL CONTAMINATION OF IL -9 LEGAL DRUGS .— 10 ‘‘(A) E STABLISHMENT.—The Secretary, 11 acting through the Committee, shall establish a 12 Federal Interagency Work Group on Fentanyl 13 Contamination of Illegal Drugs (referred to in 14 this paragraph as the ‘Work Group’) consisting 15 of representatives from relevant Federal depart-16 ments and agencies on the Committee. 17 ‘‘(B) C ONSULTATION.—The Work Group 18 shall consult with relevant stakeholders and 19 subject matter experts, including— 20 ‘‘(i) State, Tribal, and local subject 21 matter experts in reducing, preventing, and 22 responding to drug overdose caused by 23 fentanyl contamination of illicit drugs; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00391 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 392 •HR 1768 IH ‘‘(ii) family members of both adults 1 and youth who have overdosed by fentanyl- 2 contaminated illicit drugs. 3 ‘‘(C) DUTIES.—The Work Group shall— 4 ‘‘(i) examine Federal efforts to reduce 5 and prevent drug overdose by fentanyl-con-6 taminated illicit drugs; 7 ‘‘(ii) identify strategies to improve 8 State, Tribal, and local responses to over-9 dose by fentanyl-contaminated illicit drugs; 10 ‘‘(iii) coordinate with the Secretary, as 11 appropriate, in carrying out activities to 12 raise public awareness of synthetic opioids 13 and other emerging drug use and misuse 14 issues; 15 ‘‘(iv) make recommendations to Con-16 gress for improving Federal programs, in-17 cluding with respect to the coordination of 18 efforts across such programs; and 19 ‘‘(v) make recommendations for edu-20 cating youth on the potency and dangers of 21 drugs contaminated by fentanyl. 22 ‘‘(D) A NNUAL REPORT TO SECRETARY .— 23 The Work Group shall annually prepare and 24 submit to the Secretary, the Committee on 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00392 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 393 •HR 1768 IH Health, Education, Labor, and Pensions of the 1 Senate, and the Committee on Energy and 2 Commerce and the Committee on Education 3 and the Workforce of the House of Representa-4 tives, a report on the activities carried out by 5 the Work Group under subparagraph (C), in-6 cluding recommendations to reduce and prevent 7 drug overdose by fentanyl contamination of ille-8 gal drugs, in all populations, and specifically 9 among youth at risk for substance misuse.’’; 10 and 11 (2) by striking subsection (i) and inserting the 12 following: 13 ‘‘(i) S UNSET.—The Committee shall 14 terminate on September 30, 2029.’’. 15 SEC. 520. GUIDANCE ON AT-HOME DRUG DISPOSAL SYS-16 TEMS. 17 (a) IN GENERAL.—Not later than one year after the 18 date of enactment of this Act, the Secretary of Health and 19 Human Services, in consultation with the Administrator 20 of the Drug Enforcement Administration, shall publish 21 guidance to facilitate the use of at-home safe disposal sys-22 tems for applicable drugs. 23 (b) C ONTENTS.—The guidance under subsection (a) 24 shall include— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00393 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 394 •HR 1768 IH (1) recommended standards for effective at- 1 home drug disposal systems to meet applicable re-2 quirements enforced by the Food and Drug Adminis-3 tration; 4 (2) recommended information to include as in-5 structions for use to disseminate with at-home drug 6 disposal systems; 7 (3) best practices and educational tools to sup-8 port the use of an at-home drug disposal system, as 9 appropriate; and 10 (4) recommended use of licensed health pro-11 viders for the dissemination of education, instruc-12 tion, and at-home drug disposal systems, as appro-13 priate. 14 SEC. 521. ASSESSMENT OF OPIOID DRUGS AND ACTIONS. 15 (a) IN GENERAL.—Not later than one year after the 16 date of enactment of this Act, the Secretary of Health and 17 Human Services (referred to in this section as the ‘‘Sec-18 retary’’) shall publish on the website of the Food and 19 Drug Administration (referred to in this section as the 20 ‘‘FDA’’) a report that outlines a plan for assessing opioid 21 analgesic drugs that are approved under section 505 of 22 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 23 355) that addresses the public health effects of such opioid 24 analgesic drugs as part of the benefit-risk assessment and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00394 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 395 •HR 1768 IH the activities of the FDA that relate to facilitating the de-1 velopment of nonaddictive medical products intended to 2 treat pain or addiction. Such report shall include— 3 (1) an update on the actions taken by the FDA 4 to consider the effectiveness, safety, benefit-risk pro-5 file, and use of approved opioid analgesic drugs; 6 (2) a timeline for an assessment of the potential 7 need, as appropriate, for labeling changes, revised or 8 additional postmarketing requirements, enforcement 9 actions, or withdrawals for opioid analgesic drugs; 10 (3) an overview of the steps that the FDA has 11 taken to support the development and approval of 12 nonaddictive medical products intended to treat pain 13 or addiction, and actions planned to further support 14 the development and approval of such products; and 15 (4) an overview of the consideration by the 16 FDA of clinical trial methodologies for analgesic 17 drugs, including the enriched enrollment randomized 18 withdrawal methodology, and the benefits and draw-19 backs associated with different trial methodologies 20 for such drugs, incorporating any public input re-21 ceived under subsection (b). 22 (b) P UBLIC INPUT.—In carrying out subsection (a), 23 the Secretary shall provide an opportunity for public input 24 concerning the regulation by the FDA of opioid analgesic 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00395 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 396 •HR 1768 IH drugs, including scientific evidence that relates to condi-1 tions of use, safety, or benefit-risk assessment (including 2 consideration of the public health effects) of such opioid 3 analgesic drugs. 4 SEC. 522. GRANT PROGRAM FOR STATE AND TRIBAL RE-5 SPONSE TO OPIOID USE DISORDERS. 6 The activities carried out pursuant to section 7 1003(b)(4)(A) of the 21st Century Cures Act (42 U.S.C. 8 290ee–3a(b)(4)(A)) may include facilitating access to 9 products used to prevent overdose deaths by detecting the 10 presence of one or more substances, such as fentanyl and 11 xylazine test strips, to the extent the purchase and posses-12 sion of such products is consistent with Federal and State 13 law. 14 Subtitle B—Treatment 15 SEC. 531. RESIDENTIAL TREATMENT PROGRAM FOR PREG-16 NANT AND POSTPARTUM WOMEN. 17 Section 508 of the Public Health Service Act (42 18 U.S.C. 290bb–1) is amended— 19 (1) in subsection (d)(11)(C), by striking ‘‘pro-20 viding health services’’ and inserting ‘‘providing 21 health care services’’; 22 (2) in subsection (g)— 23 (A) by inserting ‘‘a plan describing’’ after 24 ‘‘will provide’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00396 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 397 •HR 1768 IH (B) by adding at the end the following: 1 ‘‘Such plan may include a description of how 2 such applicant will target outreach to women 3 disproportionately impacted by maternal sub-4 stance use disorder.’’; and 5 (3) in subsection (s), by striking ‘‘$29,931,000 6 for each of fiscal years 2019 through 2023’’ and in-7 serting ‘‘$38,931,000 for each of fiscal years 2025 8 through 2029’’. 9 SEC. 532. IMPROVING ACCESS TO ADDICTION MEDICINE 10 PROVIDERS. 11 Section 597 of the Public Health Service Act (42 12 U.S.C. 290ll) is amended— 13 (1) in subsection (a)(1), by inserting ‘‘diag-14 nosis,’’ after ‘‘related to’’; and 15 (2) in subsection (b), by inserting ‘‘addiction 16 medicine,’’ after ‘‘psychiatry,’’. 17 SEC. 533. MENTAL AND BEHAVIORAL HEALTH EDUCATION 18 AND TRAINING GRANTS. 19 Section 756(f) of the Public Health Service Act (42 20 U.S.C. 294e–1(f)) is amended by striking ‘‘fiscal years 21 2023 through 2027’’ and inserting ‘‘fiscal years 2025 22 through 2029’’. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00397 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 398 •HR 1768 IH SEC. 534. LOAN REPAYMENT PROGRAM FOR SUBSTANCE 1 USE DISORDER TREATMENT WORKFORCE. 2 Section 781(j) of the Public Health Service Act (42 3 U.S.C. 295h(j)) is amended by striking ‘‘$25,000,000 for 4 each of fiscal years 2019 through 2023’’ and inserting 5 ‘‘$40,000,000 for each of fiscal years 2025 through 6 2029’’. 7 SEC. 535. DEVELOPMENT AND DISSEMINATION OF MODEL 8 TRAINING PROGRAMS FOR SUBSTANCE USE 9 DISORDER PATIENT RECORDS. 10 Section 7053 of the SUPPORT for Patients and 11 Communities Act (42 U.S.C. 290dd–2 note) is amended 12 by striking subsection (e). 13 SEC. 536. TASK FORCE ON BEST PRACTICES FOR TRAUMA- 14 INFORMED IDENTIFICATION, REFERRAL, AND 15 SUPPORT. 16 Section 7132 of the SUPPORT for Patients and 17 Communities Act (Public Law 115–271; 132 Stat. 4046) 18 is amended— 19 (1) in subsection (b)(1)— 20 (A) by redesignating subparagraph (CC) as 21 subparagraph (DD); and 22 (B) by inserting after subparagraph (BB) 23 the following: 24 ‘‘(CC) The Administration for Community 25 Living.’’; 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00398 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 399 •HR 1768 IH (2) in subsection (d)(1), in the matter pre-1 ceding subparagraph (A), by inserting ‘‘, develop-2 mental disability service providers’’ before ‘‘, individ-3 uals who are’’; and 4 (3) in subsection (i), by striking ‘‘2023’’ and in-5 serting ‘‘2029’’. 6 SEC. 537. GRANTS TO ENHANCE ACCESS TO SUBSTANCE 7 USE DISORDER TREATMENT. 8 Section 3203 of the SUPPORT for Patients and 9 Communities Act (21 U.S.C. 823 note) is amended— 10 (1) by striking subsection (b); and 11 (2) by striking ‘‘(a) I N GENERAL.—The Sec-12 retary’’ and inserting the following: ‘‘The Sec-13 retary’’. 14 SEC. 538. STATE GUIDANCE RELATED TO INDIVIDUALS 15 WITH SERIOUS MENTAL ILLNESS AND CHIL-16 DREN WITH SERIOUS EMOTIONAL DISTURB-17 ANCE. 18 (a) R EVIEW OF USE OF CERTAIN FUNDING.—Not 19 later than 1 year after the date of enactment of this Act, 20 the Secretary of Health and Human Services (referred to 21 in this section as the ‘‘Secretary’’), acting through the As-22 sistant Secretary for Mental Health and Substance Use, 23 shall conduct a review of State use of funds made available 24 under the Community Mental Health Services Block 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00399 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 400 •HR 1768 IH Grant program under subpart I of part B of title XIX 1 of the Public Health Service Act (42 U.S.C. 300x et seq.) 2 (referred to in this section as the ‘‘block grant program’’) 3 for first episode psychosis activities. Such review shall con-4 sider the following: 5 (1) How States use funds for evidence-based 6 treatments and services according to the standard of 7 care for individuals with early serious mental illness 8 and children with a serious emotional disturbance. 9 (2) The percentages of the State funding under 10 the block grant program expended on early serious 11 mental illness and first episode psychosis, and the 12 number of individuals served under such funds. 13 (b) REPORT AND GUIDANCE.— 14 (1) R EPORT.—Not later than 180 days after 15 the completion of the review under subsection (a), 16 the Secretary shall submit to the Committee on 17 Health, Education, Labor, and Pensions and the 18 Committee on Appropriations of the Senate and the 19 Committee on Energy and Commerce and the Com-20 mittee on Appropriations of the House of Represent-21 atives a report describing— 22 (A) the findings of the review under sub-23 section (a); and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00400 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 401 •HR 1768 IH (B) any recommendations for changes to 1 the block grant program that would facilitate 2 improved outcomes for individuals with serious 3 mental illness and children with serious emo-4 tional disturbance. 5 (2) G UIDANCE.—Not later than 1 year after 6 the date on which the report is submitted under 7 paragraph (1), the Secretary shall update the guid-8 ance provided to States under the block grant pro-9 gram on coordinated specialty care and other evi-10 dence-based mental health care services for individ-11 uals with serious mental illness and children with a 12 serious emotional disturbance, based on the findings 13 and recommendations of such report. 14 SEC. 539. REVIEWING THE SCHEDULING OF APPROVED 15 PRODUCTS CONTAINING A COMBINATION OF 16 BUPRENORPHINE AND NALOXONE. 17 (a) S ECRETARY OF HHS.—The Secretary of Health 18 and Human Services shall, consistent with the require-19 ments and procedures set forth in sections 201 and 202 20 of the Controlled Substances Act (21 U.S.C. 811, 812)— 21 (1) review the relevant data pertaining to the 22 scheduling of products containing a combination of 23 buprenorphine and naloxone that have been ap-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00401 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 402 •HR 1768 IH proved under section 505 of the Federal Food, 1 Drug, and Cosmetic Act (21 U.S.C. 355); and 2 (2) if appropriate, request that the Attorney 3 General initiate rulemaking proceedings to revise the 4 schedules accordingly with respect to such products. 5 (b) A TTORNEY GENERAL.—The Attorney General 6 shall review any request made by the Secretary of Health 7 and Human Services under subsection (a)(2) and deter-8 mine whether to initiate proceedings to revise the sched-9 ules in accordance with the criteria set forth in sections 10 201 and 202 of the Controlled Substances Act (21 U.S.C. 11 811, 812). 12 Subtitle C—Recovery 13 SEC. 541. BUILDING COMMUNITIES OF RECOVERY. 14 Section 547(f) of the Public Health Service Act (42 15 U.S.C. 290ee–2(f)) is amended by striking ‘‘$5,000,000 16 for each of fiscal years 2019 through 2023’’ and inserting 17 ‘‘$16,000,000 for each of fiscal years 2025 through 18 2029’’. 19 SEC. 542. PEER SUPPORT TECHNICAL ASSISTANCE CEN-20 TER. 21 Section 547A of the Public Health Service Act (42 22 U.S.C. 290ee–2a) is amended— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00402 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 403 •HR 1768 IH (1) in subsection (b)(4), by striking ‘‘building; 1 and’’ and inserting the following: ‘‘building, such 2 as— 3 ‘‘(A) professional development of peer sup-4 port specialists; and 5 ‘‘(B) making recovery support services 6 available in nonclinical settings; and’’; 7 (2) by redesignating subsections (d) and (e) as 8 subsections (e) and (f), respectively; 9 (3) by inserting after subsection (c) the fol-10 lowing: 11 ‘‘(d) REGIONAL CENTERS.— 12 ‘‘(1) I N GENERAL .—The Secretary may estab-13 lish one regional technical assistance center (referred 14 to in this subsection as the ‘Regional Center’), with 15 existing resources, to assist the Center in carrying 16 out activities described in subsection (b) within the 17 geographic region of such Regional Center in a man-18 ner that is tailored to the needs of such region. 19 ‘‘(2) E VALUATION.—Not later than 4 years 20 after the date of enactment of the SUPPORT for 21 Patients and Communities Reauthorization Act of 22 2024, the Secretary shall evaluate the activities of 23 the Regional Center and submit to the Committee 24 on Health, Education, Labor, and Pensions of the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00403 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 404 •HR 1768 IH Senate and the Committee on Energy and Com-1 merce of the House of Representatives a report on 2 the findings of such evaluation, including— 3 ‘‘(A) a description of the distinct roles and 4 responsibilities of the Regional Center and the 5 Center; 6 ‘‘(B) available information relating to the 7 outcomes of the Regional Center under this 8 subsection, such as any impact on the oper-9 ations and efficiency of the Center relating to 10 requests for technical assistance and support 11 within the region of such Regional Center; 12 ‘‘(C) a description of any gaps or areas of 13 duplication relating to the activities of the Re-14 gional Center and the Center within such re-15 gion; and 16 ‘‘(D) recommendations relating to the 17 modification, expansion, or termination of the 18 Regional Center under this subsection. 19 ‘‘(3) T ERMINATION.—This subsection shall ter-20 minate on September 30, 2029.’’; and 21 (4) in subsection (f), as so redesignated, by 22 striking ‘‘$1,000,000 for each of fiscal years 2019 23 through 2023’’ and inserting ‘‘$2,000,000 for each 24 of fiscal years 2025 through 2029’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00404 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 405 •HR 1768 IH SEC. 543. COMPREHENSIVE OPIOID RECOVERY CENTERS. 1 Section 552 of the Public Health Service Act (42 2 U.S.C. 290ee–7) is amended— 3 (1) in subsection (d)(2)— 4 (A) in the matter preceding subparagraph 5 (A), by striking ‘‘and in such manner’’ and in-6 serting ‘‘, in such manner, and containing such 7 information and assurances, including relevant 8 documentation,’’; and 9 (B) in subparagraph (A), by striking ‘‘is 10 capable of coordinating with other entities to 11 carry out’’ and inserting ‘‘has the demonstrated 12 capability to carry out, through referral or con-13 tractual arrangements’’; 14 (2) in subsection (h)— 15 (A) by redesignating paragraphs (1) 16 through (4) as subparagraphs (A) through (D), 17 respectively, and adjusting the margins accord-18 ingly; 19 (B) by striking ‘‘With respect to’’ and in-20 serting the following: 21 ‘‘(1) IN GENERAL .—With respect to’’; and 22 (C) by adding at the end the following: 23 ‘‘(2) ADDITIONAL REPORTING FOR CERTAIN EL -24 IGIBLE ENTITIES .—An entity carrying out activities 25 described in subsection (g) through referral or con-26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00405 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 406 •HR 1768 IH tractual arrangements shall include in the submis-1 sions required under paragraph (1) information re-2 lated to the status of such referrals or contractual 3 arrangements, including an assessment of whether 4 such referrals or contractual arrangements are sup-5 porting the ability of such entity to carry out such 6 activities.’’; and 7 (3) in subsection (j), by striking ‘‘2019 through 8 2023’’ and inserting ‘‘2025 through 2029’’. 9 SEC. 544. YOUTH PREVENTION AND RECOVERY. 10 Section 7102(c) of the SUPPORT for Patients and 11 Communities Act (42 U.S.C. 290bb–7a(c)) (as amended 12 by section 110(a)) is amended— 13 (1) in paragraph (2)— 14 (A) in subparagraph (A)— 15 (i) in clause (i)— 16 (I) by inserting ‘‘, or a consor-17 tium of local educational agencies,’’ 18 after ‘‘a local educational agency’’; 19 and 20 (II) by striking ‘‘high schools’’ 21 and inserting ‘‘secondary schools’’; 22 and 23 (ii) in clause (vi), by striking ‘‘tribe, 24 or tribal’’ and inserting ‘‘Tribe, or Tribal’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00406 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 407 •HR 1768 IH (B) by amending subparagraph (E) to read 1 as follows: 2 ‘‘(E) I NDIAN TRIBE ; TRIBAL ORGANIZA -3 TION.—The terms ‘Indian Tribe’ and ‘Tribal 4 organization’ have the meanings given such 5 terms in section 4 of the Indian Self-Deter-6 mination and Education Assistance Act (25 7 U.S.C. 5304).’’; 8 (C) by redesignating subparagraph (K) as 9 subparagraph (L); and 10 (D) by inserting after subparagraph (J) 11 the following: 12 ‘‘(K) S ECONDARY SCHOOL .—The term 13 ‘secondary school’ has the meaning given such 14 term in section 8101 of the Elementary and 15 Secondary Education Act of 1965 (20 U.S.C. 16 7801).’’; 17 (2) in paragraph (3)(A), in the matter pre-18 ceding clause (i)— 19 (A) by striking ‘‘and abuse’’; and 20 (B) by inserting ‘‘at increased risk for sub-21 stance misuse’’ after ‘‘specific populations’’; 22 (3) in paragraph (4)— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00407 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 408 •HR 1768 IH (A) in the matter preceding subparagraph 1 (A), by striking ‘‘Indian tribes’’ and inserting 2 ‘‘Indian Tribes’’; 3 (B) in subparagraph (A), by striking ‘‘and 4 abuse’’; and 5 (C) in subparagraph (B), by striking ‘‘peer 6 mentoring’’ and inserting ‘‘peer-to-peer sup-7 port’’; 8 (4) in paragraph (5), by striking ‘‘tribal’’ and 9 inserting ‘‘Tribal’’; 10 (5) in paragraph (6)(A)— 11 (A) in clause (iv), by striking ‘‘; and’’ and 12 inserting a semicolon; and 13 (B) by adding at the end the following: 14 ‘‘(vi) a plan to sustain the activities 15 carried out under the grant program, after 16 the grant program has ended; and’’; 17 (6) in paragraph (8), by striking ‘‘2022’’ and 18 inserting ‘‘2027’’; and 19 (7) by amending paragraph (9) to read as fol-20 lows: 21 ‘‘(9) A UTHORIZATION OF APPROPRIATIONS .— 22 To carry out this subsection, there are authorized to 23 be appropriated— 24 ‘‘(A) $10,000,000 for fiscal year 2025; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00408 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 409 •HR 1768 IH ‘‘(B) $12,000,000 for fiscal year 2026; 1 ‘‘(C) $13,000,000 for fiscal year 2027; 2 ‘‘(D) $14,000,000 for fiscal year 2028; 3 and 4 ‘‘(E) $15,000,000 for fiscal year 2029.’’. 5 SEC. 545. CAREER ACT. 6 (a) I N GENERAL.—Section 7183 of the SUPPORT 7 for Patients and Communities Act (42 U.S.C. 290ee–8) 8 is amended— 9 (1) in the section heading, by inserting ‘‘ ; 10 TREATMENT, RECOVERY, AND WORKFORCE 11 SUPPORT GRANTS’’ after ‘‘CAREER ACT’’; 12 (2) in subsection (b), by inserting ‘‘each’’ before 13 ‘‘for a period’’; 14 (3) in subsection (c)— 15 (A) in paragraph (1), by striking ‘‘the 16 rates described in paragraph (2)’’ and inserting 17 ‘‘the average rates for calendar years 2018 18 through 2022 described in paragraph (2)’’; and 19 (B) by amending paragraph (2) to read as 20 follows: 21 ‘‘(2) RATES.—The rates described in this para-22 graph are the following: 23 ‘‘(A) The highest age-adjusted average 24 rates of drug overdose deaths for calendar years 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00409 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 410 •HR 1768 IH 2018 through 2022 based on data from the 1 Centers for Disease Control and Prevention, in-2 cluding, if necessary, provisional data for cal-3 endar year 2022. 4 ‘‘(B) The highest average rates of unem-5 ployment for calendar years 2018 through 2022 6 based on data provided by the Bureau of Labor 7 Statistics. 8 ‘‘(C) The lowest average labor force par-9 ticipation rates for calendar years 2018 through 10 2022 based on data provided by the Bureau of 11 Labor Statistics.’’; 12 (4) in subsection (g)— 13 (A) in each of paragraphs (1) and (3), by 14 redesignating subparagraphs (A) and (B) as 15 clauses (i) and (ii), respectively, and adjusting 16 the margins accordingly; 17 (B) by redesignating paragraphs (1) 18 through (3) as subparagraphs (A) through (C), 19 respectively, and adjusting the margins accord-20 ingly; 21 (C) in the matter preceding subparagraph 22 (A) (as so redesignated), by striking ‘‘An enti-23 ty’’ and inserting the following: 24 ‘‘(1) IN GENERAL .—An entity’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00410 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 411 •HR 1768 IH (D) by adding at the end the following: 1 ‘‘(2) T RANSPORTATION SERVICES .—An entity 2 receiving a grant under this section may use not 3 more than 5 percent of the funds for providing 4 transportation for individuals to participate in an ac-5 tivity supported by a grant under this section, which 6 transportation shall be to or from a place of work 7 or a place where the individual is receiving voca-8 tional education or job training services or receiving 9 services directly linked to treatment of or recovery 10 from a substance use disorder. 11 ‘‘(3) L IMITATION.—The Secretary may not re-12 quire an entity to, or give priority to an entity that 13 plans to, use the funds of a grant under this section 14 for activities that are not specified in this sub-15 section.’’; 16 (5) in subsection (i)(2), by inserting ‘‘, which 17 shall include employment and earnings outcomes de-18 scribed in subclauses (I) and (III) of section 19 116(b)(2)(A)(i) of the Workforce Innovation and 20 Opportunity Act (29 U.S.C. 3141(b)(2)(A)(i)) with 21 respect to the participation of such individuals with 22 a substance use disorder in programs and activities 23 funded by the grant under this section’’ after ‘‘sub-24 section (g)’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00411 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 412 •HR 1768 IH (6) in subsection (j)— 1 (A) in paragraph (1), by inserting ‘‘for 2 grants awarded prior to the date of enactment 3 of the SUPPORT for Patients and Commu-4 nities Reauthorization Act of 2025’’ after 5 ‘‘grant period under this section’’; and 6 (B) in paragraph (2)— 7 (i) in the matter preceding subpara-8 graph (A), by striking ‘‘2 years after sub-9 mitting the preliminary report required 10 under paragraph (1)’’ and inserting ‘‘Sep-11 tember 30, 2029’’; and 12 (ii) in subparagraph (A), by striking 13 ‘‘(g)(3)’’ and inserting ‘‘(g)(1)(C)’’; and 14 (7) in subsection (k), by striking ‘‘$5,000,000 15 for each of fiscal years 2019 through 2023’’ and in-16 serting ‘‘$12,000,000 for each of fiscal years 2025 17 through 2029’’. 18 (b) R EAUTHORIZATION OF THE CAREER A CT; R E-19 COVERY HOUSING PILOT PROGRAM.— 20 (1) I N GENERAL .—Section 8071 of the SUP-21 PORT for Patients and Communities Act (42 22 U.S.C. 5301 note; Public Law 115–271) is amend-23 ed— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00412 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 413 •HR 1768 IH (A) by striking the section heading and in-1 serting ‘‘CAREER ACT ; RECOVERY HOUSING 2 PILOT PROGRAM’’; 3 (B) in subsection (a), by striking ‘‘through 4 2023’’ and inserting ‘‘through 2029’’; 5 (C) in subsection (b)— 6 (i) in paragraph (1), by striking ‘‘not 7 later than 60 days after the date of enact-8 ment of this Act’’ and inserting ‘‘not later 9 than 60 days after the date of enactment 10 of SUPPORT for Patients and Commu-11 nities Reauthorization Act of 2025’’; and 12 (ii) in paragraph (2)(B)(i)— 13 (I) in subclause (I)— 14 (aa) by striking ‘‘for cal-15 endar years 2013 through 2017’’; 16 and 17 (bb) by inserting ‘‘for cal-18 endar years 2018 through 2022’’ 19 after ‘‘rates of unemployment’’; 20 (II) in subclause (II)— 21 (aa) by striking ‘‘for cal-22 endar years 2013 through 2017’’; 23 and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00413 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 414 •HR 1768 IH (bb) by inserting ‘‘for cal-1 endar years 2018 through 2022’’ 2 after ‘‘participation rates’’; and 3 (III) by striking subclause (III) 4 and inserting the following: 5 ‘‘(III) The highest age-adjusted 6 average rates of drug overdose deaths 7 for calendar years 2018 through 2022 8 based on data from the Centers for 9 Disease Control and Prevention, in-10 cluding, if necessary, provisional data 11 for calendar year 2022.’’; and 12 (D) in subsection (f), by striking ‘‘For the 13 2-year period following the date of enactment of 14 this Act, the’’ and inserting ‘‘The’’. 15 (2) C ONFORMING AMENDMENT .—Subtitle F of 16 title VIII of the SUPPORT for Patients and Com-17 munities Act (Public Law 115–271; 132 Stat. 4095) 18 is amended by striking the subtitle heading and in-19 serting the following: ‘‘ Subtitle F—CAREER 20 Act; Recovery Housing Pilot Program ’’ . 21 (c) CLERICAL AMENDMENTS.—The table of contents 22 in section 1(b) of the SUPPORT for Patients and Com-23 munities Act (Public Law 115–271; 132 Stat. 3894) is 24 amended— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00414 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 415 •HR 1768 IH (1) by striking the item relating to section 7183 1 and inserting the following: 2 ‘‘Sec. 7183. CAREER Act; treatment, recovery, and workforce support grants.’’; (2) by striking the item relating to subtitle F 3 of title VIII and inserting the following: 4 ‘‘Subtitle F—CAREER Act; Recovery Housing Pilot Program’’; and (3) by striking the item relating to section 8071 5 and inserting the following: 6 ‘‘Sec. 8071. CAREER Act; Recovery Housing Pilot Program.’’. SEC. 546. ADDRESSING ECONOMIC AND WORKFORCE IM-7 PACTS OF THE OPIOID CRISIS. 8 Section 8041(g)(1) of the SUPPORT for Patients 9 and Communities Act (29 U.S.C. 3225a(g)(1)) is amended 10 by striking ‘‘2023’’ and inserting ‘‘2029’’. 11 Subtitle D—Miscellaneous Matters 12 SEC. 551. DELIVERY OF A CONTROLLED SUBSTANCE BY A 13 PHARMACY TO A PRESCRIBING PRACTI-14 TIONER. 15 Section 309A(a) of the Controlled Substances Act 16 (21 U.S.C. 829a(a)) is amended by striking paragraph (2) 17 and inserting the following: 18 ‘‘(2) the controlled substance is a drug in 19 schedule III, IV, or V to be administered— 20 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00415 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 416 •HR 1768 IH ‘‘(A) by injection or implantation for the 1 purpose of maintenance or detoxification treat-2 ment; or 3 ‘‘(B) subject to a risk evaluation and miti-4 gation strategy pursuant to section 505–1 of 5 the Federal Food, Drug, and Cosmetic Act (21 6 U.S.C. 355–1) that includes elements to assure 7 safe use of the drug described in subsection 8 (f)(3)(E) of such section, including a require-9 ment for post-administration monitoring by a 10 health care provider.’’. 11 SEC. 552. TECHNICAL CORRECTION ON CONTROLLED SUB-12 STANCES DISPENSING. 13 Effective as if included in the enactment of Public 14 Law 117–328— 15 (1) section 1252(a) of division FF of Public 16 Law 117–328 (136 Stat. 5681) is amended, in the 17 matter being inserted into section 302(e) of the Con-18 trolled Substances Act, by striking ‘‘303(g)’’ and in-19 serting ‘‘303(h)’’; 20 (2) section 1262 of division FF of Public Law 21 117–328 (136 Stat. 5681) is amended— 22 (A) in subsection (a)— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00416 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 417 •HR 1768 IH (i) in the matter preceding paragraph 1 (1), by striking ‘‘303(g)’’ and inserting 2 ‘‘303(h)’’; 3 (ii) in the matter being stricken by 4 subsection (a)(2), by striking ‘‘(g)(1)’’ and 5 inserting ‘‘(h)(1)’’; and 6 (iii) in the matter being inserted by 7 subsection (a)(2), by striking ‘‘(g) Practi-8 tioners’’ and inserting ‘‘(h) Practitioners’’; 9 and 10 (B) in subsection (b)— 11 (i) in the matter being stricken by 12 paragraph (1), by striking ‘‘303(g)(1)’’ 13 and inserting ‘‘303(h)(1)’’; 14 (ii) in the matter being inserted by 15 paragraph (1), by striking ‘‘303(g)’’ and 16 inserting ‘‘303(h)’’; 17 (iii) in the matter being stricken by 18 paragraph (2)(A), by striking ‘‘303(g)(2)’’ 19 and inserting ‘‘303(h)(2)’’; 20 (iv) in the matter being stricken by 21 paragraph (3), by striking ‘‘303(g)(2)(B)’’ 22 and inserting ‘‘303(h)(2)(B)’’; 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00417 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 418 •HR 1768 IH (v) in the matter being stricken by 1 paragraph (5), by striking ‘‘303(g)’’ and 2 inserting ‘‘303(h)’’; and 3 (vi) in the matter being stricken by 4 paragraph (6), by striking ‘‘303(g)’’ and 5 inserting ‘‘303(h)’’; and 6 (3) section 1263(b) of division FF of Public 7 Law 117–328 (136 Stat. 5685) is amended— 8 (A) by striking ‘‘303(g)(2)’’ and inserting 9 ‘‘303(h)(2)’’; and 10 (B) by striking ‘‘(21 U.S.C. 823(g)(2))’’ 11 and inserting ‘‘(21 U.S.C. 823(h)(2))’’. 12 SEC. 553. REQUIRED TRAINING FOR PRESCRIBERS OF CON-13 TROLLED SUBSTANCES. 14 (a) I N GENERAL.—Section 303 of the Controlled 15 Substances Act (21 U.S.C. 823) is amended— 16 (1) by redesignating the second subsection des-17 ignated as subsection (l) as subsection (m); and 18 (2) in subsection (m)(1), as so redesignated— 19 (A) in subparagraph (A)— 20 (i) in clause (iv)— 21 (I) in subclause (I)— 22 (aa) by inserting ‘‘the Amer-23 ican Academy of Family Physi-24 cians, the American Podiatric 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00418 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 419 •HR 1768 IH Medical Association, the Acad-1 emy of General Dentistry, the 2 American Optometric Associa-3 tion,’’ before ‘‘or any other orga-4 nization’’; 5 (bb) by striking ‘‘or the 6 Commission’’ and inserting ‘‘the 7 Commission’’; and 8 (cc) by inserting ‘‘, or the 9 Council on Podiatric Medical 10 Education’’ before the semicolon 11 at the end; and 12 (II) in subclause (III), by insert-13 ing ‘‘or the American Academy of 14 Family Physicians’’ after ‘‘Associa-15 tion’’; and 16 (ii) in clause (v), in the matter pre-17 ceding subclause (I)— 18 (I) by striking ‘‘osteopathic medi-19 cine, dental surgery’’ and inserting 20 ‘‘osteopathic medicine, podiatric medi-21 cine, dental surgery’’; and 22 (II) by striking ‘‘or dental medi-23 cine curriculum’’ and inserting ‘‘or 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00419 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 420 •HR 1768 IH dental or podiatric medicine cur-1 riculum’’; and 2 (B) in subparagraph (B)— 3 (i) in clause (i)— 4 (I) by inserting ‘‘the American 5 Pharmacists Association, the Accredi-6 tation Council on Pharmacy Edu-7 cation, the American Psychiatric 8 Nurses Association, the American 9 Academy of Nursing, the American 10 Academy of Family Physicians,’’ be-11 fore ‘‘or any other organization’’; and 12 (II) by inserting ‘‘, the American 13 Academy of Family Physicians,’’ be-14 fore ‘‘or the Accreditation Council’’; 15 and 16 (ii) in clause (ii)— 17 (I) by striking ‘‘or accredited 18 school’’ and inserting ‘‘, an accredited 19 school’’; and 20 (II) by inserting ‘‘, or an accred-21 ited school of pharmacy’’ before ‘‘in 22 the United States’’. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00420 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 421 •HR 1768 IH (b) E FFECTIVE DATE.—The amendment made by 1 subsection (a) shall take effect as if enacted on December 2 29, 2022. 3 SEC. 554. EXTENSION OF TEMPORARY ORDER FOR 4 FENTANYL-RELATED SUBSTANCES. 5 Effective as if included in the enactment of the Tem-6 porary Reauthorization and Study of the Emergency 7 Scheduling of Fentanyl Analogues Act (Public Law 116– 8 114), section 2 of such Act is amended by striking ‘‘March 9 31, 2025’’ and inserting ‘‘September 30, 2026’’. 10 TITLE VI—PANDEMIC AND ALL- 11 HAZARDS PREPAREDNESS 12 AND RESPONSE 13 SEC. 601. SHORT TITLE. 14 This title may be cited as the ‘‘Pandemic and All- 15 Hazards Preparedness and Response Act’’. 16 Subtitle A—State and Local 17 Readiness and Response 18 SEC. 611. TEMPORARY REASSIGNMENT OF STATE AND 19 LOCAL PERSONNEL DURING A PUBLIC 20 HEALTH EMERGENCY. 21 Section 319(e) of the Public Health Service Act (42 22 U.S.C. 247d(e)) is amended— 23 (1) in paragraph (1), by striking ‘‘tribal organi-24 zation or such Governor or tribal organization’s des-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00421 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 422 •HR 1768 IH ignee’’ and inserting ‘‘Tribal organization or the des-1 ignee of the Governor or Tribal organization, or the 2 State or Tribal health official’’; 3 (2) in paragraph (2)(B)— 4 (A) in the matter preceding clause (i), by 5 striking ‘‘tribal organization’’ and inserting 6 ‘‘Tribal organization, or the State or Tribal 7 health official’’; and 8 (B) in clause (v), by striking ‘‘tribal orga-9 nization’’ and inserting ‘‘Tribal organization or 10 State or Tribal health official’’; 11 (3) in paragraph (6)— 12 (A) in the matter preceding subparagraph 13 (A)— 14 (i) by striking ‘‘Reauthorization Act 15 of 2013’’ and inserting ‘‘and Response 16 Act’’; and 17 (ii) by striking ‘‘appropriate commit-18 tees of the Congress’’ and inserting ‘‘Com-19 mittee on Health, Education, Labor, and 20 Pensions of the Senate and the Committee 21 on Energy and Commerce of the House of 22 Representatives’’; and 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00422 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 423 •HR 1768 IH (B) in subparagraph (A), by inserting ‘‘, 1 including requests from State or Tribal health 2 officials’’ before the semicolon; 3 (4) in paragraph (7)(A), by striking ‘‘tribal or-4 ganization’’ and inserting ‘‘Tribal organization’’; and 5 (5) in paragraph (8), by striking ‘‘March 31, 6 2025’’ and inserting ‘‘December 31, 2026’’. 7 SEC. 612. PUBLIC HEALTH EMERGENCY PREPAREDNESS 8 PROGRAM. 9 Section 319C–1 of the Public Health Service Act (42 10 U.S.C. 247d–3a) is amended— 11 (1) in subsection (b)(2)— 12 (A) in subparagraph (A)(ii), by striking 13 ‘‘influenza’’ and inserting ‘‘response planning’’; 14 and 15 (B) in subparagraph (H), by inserting ‘‘, 16 such as community-based organizations, includ-17 ing faith-based organizations, and other public 18 and private entities’’ after ‘‘stakeholders’’; 19 (2) in subsection (g)— 20 (A) in paragraph (1), in the matter pre-21 ceding subparagraph (A), by inserting ‘‘and the 22 ability of each entity receiving an award under 23 subsection (a) to respond to all-hazards 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00423 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 424 •HR 1768 IH threats’’ before the period at the end of the 1 first sentence; 2 (B) in paragraph (2)— 3 (i) in the paragraph heading, by strik-4 ing ‘‘ INFLUENZA’’ and inserting ‘‘ RE-5 SPONSE’’; and 6 (ii) in subparagraph (A)— 7 (I) by striking ‘‘to pandemic in-8 fluenza’’ and inserting ‘‘to a pathogen 9 causing a pandemic, including pan-10 demic influenza’’; and 11 (II) by striking ‘‘such pandemic 12 influenza’’ and inserting ‘‘such pan-13 demic response’’; 14 (C) in paragraph (5)— 15 (i) in the paragraph heading, by strik-16 ing ‘‘ INFLUENZA’’ and inserting ‘‘ PAN-17 DEMIC RESPONSE ’’; 18 (ii) in the matter preceding subpara-19 graph (A), by striking ‘‘2019’’ and insert-20 ing ‘‘2026’’; 21 (iii) in subparagraph (A), by striking 22 ‘‘2018’’ and inserting ‘‘2025’’; and 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00424 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 425 •HR 1768 IH (iv) in subparagraph (B), by striking 1 ‘‘pandemic influenza’’ and inserting ‘‘a 2 pathogen causing a pandemic’’; and 3 (D) in paragraph (6)— 4 (i) in subparagraph (A), in the matter 5 preceding clause (i), by striking ‘‘The 6 amounts described in this paragraph are 7 the following amounts that are payable to 8 an entity for activities described in this 9 section or section 319C–2’’ and inserting 10 ‘‘The Secretary shall withhold from an en-11 tity pursuant to paragraph (5) for non-12 compliance with the requirements of this 13 section or section 319C–2 as follows’’; and 14 (ii) in subparagraph (B), by inserting 15 ‘‘with respect to the requirements of this 16 section or section 319C–2’’ after ‘‘para-17 graph (5)’’; and 18 (3) in subsection (h)(1)(A), by striking 19 ‘‘$685,000,000 for each of fiscal years 2019 through 20 2023’’ and inserting ‘‘$735,000,000 for each of fis-21 cal years 2025 and 2026, to remain available 22 through December 31, 2026’’. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00425 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 426 •HR 1768 IH SEC. 613. HOSPITAL PREPAREDNESS PROGRAM. 1 (a) I NCREASING PARTICIPATION BY EMS IN THE 2 HOSPITAL PREPAREDNESS PROGRAM.— 3 (1) I N GENERAL .—Section 319C–2 of the Pub-4 lic Health Service Act (42 U.S.C. 247d–3b) is 5 amended— 6 (A) in subsection (b)(1)(A)— 7 (i) in clause (iii)(III), by striking ‘‘; 8 and’’ and inserting a semicolon; and 9 (ii) by striking clause (iv) and insert-10 ing the following: 11 ‘‘(iv) one or more emergency medical 12 service organizations; and 13 ‘‘(v) to the extent practicable, one or 14 more emergency management organiza-15 tions; and’’; and 16 (B) in subsection (g)(1)— 17 (i) by striking ‘‘(1) L OCAL RESPONSE 18 CAPABILITIES’’ and inserting: 19 ‘‘(1) LOCAL RESPONSE CAPABILITIES .— 20 ‘‘(A) PROGRAM COORDINATION .—’’; 21 (ii) by striking ‘‘extent practicable, 22 ensure’’ and inserting the following: ‘‘ex-23 tent practicable— 24 ‘‘(i) ensure’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00426 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 427 •HR 1768 IH (iii) by striking the period and insert-1 ing ‘‘; and’’; and 2 (iv) by adding at the end the fol-3 lowing: 4 ‘‘(ii) seek to increase participation of 5 eligible entities described in subsection 6 (b)(1)(A) with lower participation rates 7 relative to other eligible entities, such as 8 emergency medical services organizations 9 and health care facilities in underserved 10 areas.’’. 11 (2) P REFERENCES.—Section 319C– 12 2(d)(1)(A)(iii) of the Public Health Service Act (42 13 U.S.C. 247d–3b(d)(1)(A)(iii)) is amended by strik-14 ing ‘‘subsection (b)(1)(A)(ii)’’ and inserting ‘‘clauses 15 (ii) and (iv) of subsection (b)(1)(A)’’. 16 (b) IMPROVING MEDICAL READINESS AND RESPONSE 17 CAPABILITIES.—Section 319C–2 of the Public Health 18 Service Act (42 U.S.C. 247d–3b) is amended— 19 (1) in subsection (b)(2)— 20 (A) in subparagraph (A), by striking 21 ‘‘and’’ at the end; 22 (B) in subparagraph (B), by striking the 23 period and inserting ‘‘; and’’; and 24 (C) by inserting at the end the following: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00427 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 428 •HR 1768 IH ‘‘(C) designate a lead entity to administer such 1 award and support coordination between entities de-2 scribed in this subsection.’’; 3 (2) in subsection (g)(1), as amended by sub-4 section (a)(1)(B), by adding at the end the fol-5 lowing: 6 ‘‘(B) R EGIONAL OPERATIONS .—An eligible 7 entity shall establish and maintain, or leverage 8 an existing, capability to enable coordination of 9 regional medical operations, which may include 10 systems to facilitate information sharing and 11 coordination, within a coalition described under 12 subsection (b)(1)(A) and, as appropriate, 13 among multiple coalitions that are in close geo-14 graphic proximity to each other.’’; and 15 (3) in subsection (j)(1)— 16 (A) in subparagraph (A), by striking ‘‘for 17 each of fiscal years 2019 through 2023’’ and 18 inserting ‘‘for each of fiscal years 2025 and 19 2026, to remain available through December 20 31, 2026’’; and 21 (B) in subparagraph (B)(iii), by striking 22 ‘‘September 30, 2023’’ and inserting ‘‘Decem-23 ber 31, 2026’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00428 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 429 •HR 1768 IH SEC. 614. FACILITIES AND CAPACITIES OF THE CENTERS 1 FOR DISEASE CONTROL AND PREVENTION TO 2 COMBAT PUBLIC HEALTH SECURITY 3 THREATS. 4 Section 319D(h) of the Public Health Service Act (42 5 U.S.C. 247d–4(h)) is amended— 6 (1) in paragraph (1), by striking ‘‘$25,000,000 7 for each of fiscal years 2022 and 2023’’ and insert-8 ing ‘‘$40,000,000 for each of fiscal years 2025 and 9 2026, to remain available through December 31, 10 2026’’; and 11 (2) in paragraph (2), by striking ‘‘2022 and 12 2023’’ and inserting ‘‘2025 and 2026, to remain 13 available through December 31, 2026’’. 14 SEC. 615. PILOT PROGRAM TO SUPPORT STATE MEDICAL 15 STOCKPILES. 16 (a) I N GENERAL.—Section 319F–2(i) of the Public 17 Health Service Act (42 U.S.C. 247d–6b(i)) is amended— 18 (1) in paragraph (2)(B)(i)— 19 (A) in subclause (I), by striking ‘‘and 20 2024’’ and inserting ‘‘through 2025’’; and 21 (B) in subclause (II), by striking ‘‘2025’’ 22 and inserting ‘‘2026’’; 23 (2) in paragraph (4)— 24 (A) in subparagraph (G), by striking ‘‘; 25 and’’ at the end and inserting a semicolon; 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00429 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 430 •HR 1768 IH (B) by redesignating subparagraph (H) as 1 subparagraph (I); 2 (C) by inserting after subparagraph (G) 3 the following: 4 ‘‘(H) facilitate the sharing of best practices 5 among States within a consortia of States in re-6 ceipt of funding related to establishing and 7 maintaining a stockpile of medical products; 8 and’’; and 9 (D) in subparagraph (I), as so redesig-10 nated, by striking ‘‘State efforts’’ and inserting 11 ‘‘State or regional efforts’’; 12 (3) by redesignating paragraphs (5) through 13 (9) as paragraphs (6) through (10), respectively; 14 (4) by inserting after paragraph (4) the fol-15 lowing: 16 ‘‘(5) C OORDINATION.—An entity in receipt of 17 an award under paragraph (1), in carrying out the 18 activities under this subsection, shall coordinate with 19 appropriate health care entities, health officials, and 20 emergency management officials within the jurisdic-21 tion of such State or States.’’; and 22 (5) in paragraph (10), as so redesignated, by 23 striking ‘‘$3,500,000,000 for each of fiscal years 24 2023 and 2024’’ and inserting ‘‘$3,365,000,000 for 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00430 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 431 •HR 1768 IH fiscal year 2025, and $3,265,000,000 for fiscal year 1 2026’’. 2 (b) GAO R EPORT.—Section 2409(b) of the PRE-3 VENT Pandemics Act (Public Law 117–328) is amend-4 ed— 5 (1) in paragraph (2), by striking ‘‘; and’’ and 6 inserting a semicolon; 7 (2) in paragraph (3), by striking the period and 8 inserting ‘‘; and’’; and 9 (3) by adding at the end the following: 10 ‘‘(4) the impact of any regional stockpiling ap-11 proaches carried out under subsection (i)(1) of sec-12 tion 319F–2 of the Public Health Service Act (42 13 U.S.C. 247d–6b).’’. 14 SEC. 616. ENHANCING DOMESTIC WASTEWATER SURVEIL-15 LANCE FOR PATHOGEN DETECTION. 16 (a) I N GENERAL.—Title III of the Public Health 17 Service Act is amended by inserting after section 317V 18 (42 U.S.C. 247b–24) the following: 19 ‘‘SEC. 317W. WASTEWATER SURVEILLANCE FOR PATHOGEN 20 DETECTION. 21 ‘‘(a) W ASTEWATER SURVEILLANCE SYSTEM.—The 22 Secretary, acting through the Director of the Centers for 23 Disease Control and Prevention and in coordination with 24 other Federal departments and agencies, shall award 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00431 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 432 •HR 1768 IH grants, contracts, or cooperative agreements to eligible en-1 tities to establish, maintain, or improve activities related 2 to the detection and monitoring of infectious diseases 3 through wastewater for public health emergency prepared-4 ness and response purposes. 5 ‘‘(b) E LIGIBLE ENTITIES.—To be eligible to receive 6 an award under this section, an entity shall— 7 ‘‘(1) be a State, Tribal, or local health depart-8 ment, or a partnership between such a health de-9 partment and other public and private entities; and 10 ‘‘(2) submit to the Secretary an application at 11 such time, in such manner, and containing such in-12 formation as the Secretary may reasonably require, 13 which shall include— 14 ‘‘(A) a description of activities proposed to 15 be carried out pursuant to an award under sub-16 section (a); 17 ‘‘(B) factors such entity proposes to use to 18 select wastewater sampling sites; 19 ‘‘(C) factors such entity proposes to use to 20 determine whether a response to findings from 21 such wastewater sampling may be warranted, 22 and a plan for responding, as appropriate, con-23 sistent with applicable plans developed by such 24 entity pursuant to section 319C–1; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00432 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 433 •HR 1768 IH ‘‘(D) a plan to sustain such wastewater 1 surveillance activities described in such applica-2 tion following the conclusion of the award pe-3 riod; and 4 ‘‘(E) any additional information the Sec-5 retary may require. 6 ‘‘(c) CONSIDERATION.—In making awards under sub-7 section (a), the Secretary may give priority to eligible enti-8 ties that have submitted an application that— 9 ‘‘(1) details plans to provide public access to 10 deidentified data generated through such wastewater 11 surveillance activities in a manner that allows for 12 comparison to such data generated by other recipi-13 ents of an award under subsection (a); and 14 ‘‘(2) provides an assessment of community 15 needs related to ongoing infectious disease moni-16 toring, including estimates of the incidence and 17 prevalence of infectious diseases that can be detected 18 in wastewater and availability, at the time of the ap-19 plication, of other forms of infectious disease detec-20 tion in the jurisdiction. 21 ‘‘(d) USE OF FUNDS.—An eligible entity shall, as ap-22 propriate, use amounts awarded under this section to— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00433 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 434 •HR 1768 IH ‘‘(1) establish or enhance existing capacity and 1 capabilities to conduct wastewater sampling, testing, 2 and related analysis; 3 ‘‘(2) conduct wastewater surveillance, as appro-4 priate, in areas or facilities with increased risk of in-5 fectious disease outbreaks and limited ability to uti-6 lize other forms of infectious disease detection, such 7 as at individual facilities, institutions, and locations 8 in rural areas or areas in which wastewater is not 9 treated through the relevant local utility of the juris-10 diction; and 11 ‘‘(3) implement projects that use evidence-based 12 or innovative practices to conduct wastewater sur-13 veillance activities. 14 ‘‘(e) P ARTNERSHIPS.—In carrying out activities 15 under this section, eligible entities shall identify opportuni-16 ties to partner with other public or private entities to le-17 verage relevant capabilities maintained by such entities, 18 as appropriate and consistent with this section. 19 ‘‘(f) T ECHNICAL ASSISTANCE.—The Secretary, in 20 consultation with the heads of other applicable Federal 21 agencies and departments, as appropriate, shall provide 22 technical assistance to recipients of awards under this sec-23 tion to facilitate the planning, development, and imple-24 mentation of activities described in subsection (d). 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00434 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 435 •HR 1768 IH ‘‘(g) A UTHORIZATION OF APPROPRIATIONS.—To 1 carry out this section, there is authorized to be appro-2 priated $20,000,000 for each of fiscal years 2025 and 3 2026, to remain available through December 31, 2026.’’. 4 (b) WASTEWATER SURVEILLANCE RESEARCH.— 5 (1) IN GENERAL .—The Secretary of Health and 6 Human Services (in this subsection referred to as 7 the ‘‘Secretary’’) shall continue to conduct or sup-8 port research on the use of wastewater surveillance 9 to detect and monitor emerging infectious diseases, 10 which may include— 11 (A) research to improve the efficiency and 12 effectiveness of wastewater sample collection 13 and analysis and increase the sensitivity and 14 specificity of wastewater testing methods; and 15 (B) implementation and development of 16 evidence-based practices to facilitate the esti-17 mation of the incidence and prevalence of infec-18 tious disease within a community. 19 (2) N ON-DUPLICATION OF EFFORT .—The Sec-20 retary shall ensure that activities carried out under 21 this subsection do not unnecessarily duplicate efforts 22 of other agencies and offices within the Department 23 of Health and Human Services related to wastewater 24 surveillance. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00435 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 436 •HR 1768 IH SEC. 617. REAUTHORIZATION OF MOSQUITO ABATEMENT 1 FOR SAFETY AND HEALTH PROGRAM. 2 Section 317S of the Public Health Service Act (42 3 U.S.C. 247b–21) is amended— 4 (1) in subsection (a)(3)(A), by striking ‘‘sub-5 section (b)(3)’’ and inserting ‘‘subsection (b)(4)’’; 6 (2) in subsection (b)— 7 (A) by redesignating paragraphs (3) 8 through (6) as paragraphs (4) through (7), re-9 spectively; and 10 (B) by inserting after paragraph (2) the 11 following: 12 ‘‘(3) C ONSIDERATIONS.—The Secretary may 13 consider the use of innovative and novel technology 14 for mosquito prevention and control in making 15 grants under paragraph (1).’’; 16 (3) by amending subsection (d) to read as fol-17 lows: 18 ‘‘(d) USES OF FUNDS.—Amounts appropriated under 19 subsection (f) may be used by the Secretary to provide 20 training and technical assistance with respect to the plan-21 ning, development, and operation of assessments and 22 plans under subsection (a) and control programs under 23 subsection (b). The Secretary may provide such training 24 and technical assistance directly or through awards of 25 grants or contracts to public and private entities.’’; and 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00436 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 437 •HR 1768 IH (4) in subsection (f)(1), by striking ‘‘2019 1 through 2023’’ and inserting ‘‘2025 and 2026, to re-2 main available through December 31, 2026’’. 3 Subtitle B—Federal Planning and 4 Coordination 5 SEC. 621. ALL-HAZARDS EMERGENCY PREPAREDNESS AND 6 RESPONSE. 7 Section 2811 of the Public Health Service Act (42 8 U.S.C. 300hh–10) is amended— 9 (1) in subsection (b)— 10 (A) in paragraph (3)— 11 (i) by striking ‘‘Oversee advanced re-12 search, development, and procurement’’ 13 and inserting the following: 14 ‘‘(A) I N GENERAL .—Oversee advanced re-15 search, development, procurement, and replen-16 ishment’’; and 17 (ii) by adding at the end the fol-18 lowing: 19 ‘‘(B) D EVELOPMENT OF REQUIRE -20 MENTS.—Lead the development and approval, 21 and, on a routine basis, the review and update, 22 of requirements for such countermeasures and 23 products, including related capabilities, to in-24 form the advanced research, development, pro-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00437 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 438 •HR 1768 IH curement, and replenishment decisions of the 1 Secretary.’’; 2 (B) in paragraph (4)— 3 (i) in subparagraph (F)— 4 (I) in the matter preceding clause 5 (i), by striking ‘‘and in consultation 6 with the Secretary of Homeland Secu-7 rity,’’; and 8 (II) in clause (i), by inserting 9 ‘‘enhance’’ after ‘‘capabilities and’’; 10 (ii) in subparagraph (G)— 11 (I) in the matter preceding clause 12 (i), by inserting ‘‘the Office of Pan-13 demic Preparedness and Response 14 Policy,’’ after ‘‘Veterans Affairs,’’; 15 (II) in clause (i), by striking 16 ‘‘based on’’ and inserting ‘‘based on— 17 ’’; 18 (III) in clause (ii), by striking ‘‘; 19 and’’ at the end and inserting a semi-20 colon; 21 (IV) in clause (iii), by striking 22 the period and inserting ‘‘; and’’; and 23 (V) by adding at the end the fol-24 lowing: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00438 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 439 •HR 1768 IH ‘‘(iv) that include, as appropriate, par-1 ticipation by relevant industry, academia, 2 professional societies, and other stake-3 holders.’’; 4 (iii) in subparagraph (H)— 5 (I) by inserting ‘‘and the Direc-6 tor of the Office of Pandemic Pre-7 paredness and Response Policy’’ after 8 ‘‘Security Affairs’’; and 9 (II) by inserting ‘‘and medical 10 product and supply capacity planning 11 pursuant to subparagraph (J), includ-12 ing discussion of any relevant identi-13 fied supply chain vulnerabilities’’ be-14 fore the period at the end; 15 (iv) in subparagraph (I), by inserting 16 ‘‘the Director of the Office of Pandemic 17 Preparedness and Response Policy,’’ after 18 ‘‘Security Affairs,’’; and 19 (v) in subparagraph (J)(i), in the 20 matter preceding subclause (I), by insert-21 ing ‘‘(including ancillary medical supplies 22 and components of medical products, such 23 as active pharmaceutical ingredients, key 24 starting materials, medical device compo-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00439 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 440 •HR 1768 IH nents, testing kits, reagents, and other 1 testing supplies)’’ after ‘‘supply needs’’; 2 and 3 (C) in paragraph (7)— 4 (i) in the matter preceding subpara-5 graph (A), by inserting ‘‘and the require-6 ments developed pursuant to paragraph 7 (3)(B)’’ after ‘‘subsection (d)’’; 8 (ii) by redesignating subparagraphs 9 (E) and (F) as subparagraphs (F) and 10 (G), respectively; and 11 (iii) by inserting after subparagraph 12 (D) the following: 13 ‘‘(E) include a professional judgment of 14 anticipated budget needs for each future fiscal 15 year accounted for in such plan to account for 16 the full range of anticipated medical counter-17 measure needs and life-cycle costs to address 18 such priorities and requirements;’’; 19 (2) in subsection (d)— 20 (A) by amending paragraph (1) to read as 21 follows: 22 ‘‘(1) I N GENERAL .—Not later than March 15, 23 2020, and biennially thereafter, the Assistant Sec-24 retary for Preparedness and Response shall develop 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00440 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 441 •HR 1768 IH and submit to the Committee on Health, Education, 1 Labor, and Pensions of the Senate and the Com-2 mittee on Energy and Commerce of the House of 3 Representatives a coordinated strategy for medical 4 countermeasures to address chemical, biological, ra-5 diological, and nuclear threats, informed by the re-6 quirements developed pursuant to subsection 7 (b)(3)(B). Not later than 180 days after the submis-8 sion of such strategy to such committees, the Assist-9 ant Secretary for Preparedness and Response shall 10 submit an accompanying implementation plan to 11 such committees. In developing such a strategy and 12 plan, the Assistant Secretary for Preparedness and 13 Response shall consult with the Public Health Emer-14 gency Medical Countermeasures Enterprise estab-15 lished under section 2811–1. Such strategy and plan 16 shall be known as the Public Health Emergency 17 Medical Countermeasures Enterprise Strategy and 18 Implementation Plan.’’; and 19 (B) in paragraph (2), in the matter pre-20 ceding subparagraph (A), by inserting ‘‘strategy 21 and’’ before ‘‘plan’’; and 22 (3) in subsection (f)— 23 (A) in paragraph (1), in the matter pre-24 ceding subparagraph (A), by inserting ‘‘, includ-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00441 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 442 •HR 1768 IH ing such agents that are an emerging infectious 1 disease’’ after ‘‘become a pandemic’’; and 2 (B) in paragraph (2)(A), by striking 3 ‘‘$250,000,000 for each of fiscal years 2019 4 through 2023’’ and inserting ‘‘$335,000,000 5 for each of fiscal years 2025 and 2026, to re-6 main available through December 31, 2026’’. 7 SEC. 622. NATIONAL HEALTH SECURITY STRATEGY. 8 Section 2802 of the Public Health Service Act (42 9 U.S.C. 300hh–1) is amended— 10 (1) in subsection (a)(3)— 11 (A) by striking ‘‘In 2022, the’’ and insert-12 ing ‘‘The’’; and 13 (B) by inserting ‘‘, maintaining, and sus-14 taining’’ after ‘‘establishing’’; and 15 (2) in subsection (b)— 16 (A) in paragraph (2)— 17 (i) in subparagraph (A), by inserting 18 ‘‘that support interagency coordination and 19 availability of information, as appropriate’’ 20 before the period; and 21 (ii) in subparagraph (B), by inserting 22 ‘‘rapid testing,’’ after ‘‘and supplies,’’; 23 (B) in paragraph (3)— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00442 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 443 •HR 1768 IH (i) in the matter preceding subpara-1 graph (A), by inserting ‘‘and blood banks’’ 2 after ‘‘dental health facilities’’; 3 (ii) in subparagraph (C), by inserting 4 ‘‘and current capacity of facilities within 5 such systems, as applicable’’ before the pe-6 riod; and 7 (iii) in subparagraph (D), by inserting 8 ‘‘and other medical products and medical 9 supplies consistent with the activities car-10 ried out under section 2811(b)(4)(J)’’ be-11 fore the period; 12 (C) in paragraph (5), by inserting ‘‘appli-13 cable federally funded activities and’’ after ‘‘(in-14 cluding’’; 15 (D) in paragraph (8)— 16 (i) in subparagraph (A), by inserting 17 ‘‘public health and medical’’ before ‘‘activi-18 ties’’; and 19 (ii) in subparagraph (B), by striking 20 ‘‘familiarity with’’ and inserting ‘‘under-21 standing of, and coordination between,’’; 22 (E) by redesignating paragraphs (9) and 23 (10) as paragraphs (10) and (12), respectively; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00443 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 444 •HR 1768 IH (F) by inserting after paragraph (8) the 1 following: 2 ‘‘(9) O THER SETTINGS .—Supporting Federal, 3 State, local, and Tribal coordination and planning 4 with respect to facilities in which there is an in-5 creased risk of infectious disease outbreaks, includ-6 ing such facilities that address the needs of at-risk 7 individuals, in the event of a public health emer-8 gency declared under section 319.’’; 9 (G) by inserting after subparagraph (10), 10 as so redesignated, the following: 11 ‘‘(11) O THER HAZARDS .—Assessing current 12 and potential health security threats from natural 13 disasters with respect to public health and medical 14 preparedness and response.’’; 15 (H) by inserting after paragraph (12), as 16 so redesignated, the following: 17 ‘‘(13) CYBERSECURITY RESILIENCY OF HEALTH 18 CARE SYSTEMS .—Consistent with the requirements 19 of section 2218 of the Homeland Security Act of 20 2002, strengthening the ability of States, local com-21 munities, and Tribal communities to prepare for, re-22 spond to, and be resilient against cybersecurity 23 vulnerabilities or cybersecurity attacks that affect 24 public health and health information technology, and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00444 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 445 •HR 1768 IH encouraging health care facilities to use recognized 1 security practices meeting or exceeding the ap-2 proaches established under section 405(d) of the Cy-3 bersecurity Act of 2015.’’; and 4 (I) by striking ‘‘tribal’’ each place it ap-5 pears and inserting ‘‘Tribal’’. 6 SEC. 623. IMPROVING DEVELOPMENT AND DISTRIBUTION 7 OF DIAGNOSTIC TESTS. 8 Section 319B of the Public Health Service Act (42 9 U.S.C. 247d–2) is amended to read as follows: 10 ‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU-11 TION OF DIAGNOSTIC TESTS. 12 ‘‘(a) DIAGNOSTIC TESTING PREPAREDNESS PLAN.— 13 The Secretary shall develop, make publicly available, not 14 later than 1 year after the date of enactment of the Pan-15 demic and All-Hazards Preparedness and Response Act, 16 and update not less frequently than every 3 years there-17 after, a plan for the rapid development, validation, author-18 ization, manufacture, procurement, and distribution of di-19 agnostic tests, and for rapid scaling of testing capacity, 20 in response to chemical, biological, radiological, or nuclear 21 threats, including emerging infectious diseases, for which 22 a public health emergency is declared under section 319, 23 or that has significant potential to cause such a public 24 health emergency. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00445 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 446 •HR 1768 IH ‘‘(b) PURPOSES.—The purpose of the plan under sub-1 section (a) shall be to— 2 ‘‘(1) facilitate the development and utilization 3 of diagnostic tests; 4 ‘‘(2) describe the processes for the rapid devel-5 opment, validation, authorization, manufacture, pro-6 curement, and distribution of diagnostic tests, and 7 for rapid scaling of testing capacity; and 8 ‘‘(3) facilitate coordination and collaboration 9 among public and private entities to improve the 10 rapid development and utilization of diagnostic test-11 ing during a public health emergency. 12 ‘‘(c) C ONSIDERATIONS.—The plan under subsection 13 (a) shall take into consideration— 14 ‘‘(1) domestic capacity, including any such ca-15 pacity established through partnerships with public 16 and private entities pursuant to subsection (e), to 17 support the development, validation, manufacture, 18 procurement, and distribution of tests, and the rapid 19 scaling of testing capacity; 20 ‘‘(2) novel technologies and platforms that— 21 ‘‘(A) may be used to improve testing capa-22 bilities, including— 23 ‘‘(i) high-throughput laboratory 24 diagnostics; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00446 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 447 •HR 1768 IH ‘‘(ii) point-of-care diagnostics; and 1 ‘‘(iii) rapid at-home diagnostics; 2 ‘‘(B) improve the accessibility of diagnostic 3 tests; and 4 ‘‘(C) facilitate the development and manu-5 facture of diagnostic tests; 6 ‘‘(3) medical supply needs related to testing, in-7 cluding diagnostic testing, equipment, supplies, and 8 component parts, and any potential vulnerabilities 9 related to the availability of such medical supplies 10 and related planning needs, consistent with section 11 2811(b)(4)(J); 12 ‘‘(4) strategies for the rapid and efficient dis-13 tribution of tests locally, regionally, or nationwide 14 and appropriate scaling of laboratory testing capac-15 ity; and 16 ‘‘(5) assessment of such strategies through 17 drills and operational exercises carried out under 18 section 2811(b)(4)(G), as appropriate. 19 ‘‘(d) C OORDINATION.—To inform the development 20 and update of the plan under subsection (a), and in car-21 rying out activities to implement such plan, the Secretary 22 shall coordinate with industry, such as device manufactur-23 ers, clinical and reference laboratories, and medical prod-24 uct distributors, States, local governmental entities, In-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00447 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 448 •HR 1768 IH dian Tribes and Tribal organizations, and other relevant 1 public and private entities. 2 ‘‘(e) CAPACITY BUILDING.—The Secretary may con-3 tract with public and private entities, as appropriate, to 4 increase domestic capacity in the rapid development, vali-5 dation, authorization, manufacture, procurement, and dis-6 tribution of diagnostic tests, as appropriate, to State, 7 local, and Tribal health departments and other appro-8 priate entities for immediate public health response activi-9 ties to address an infectious disease with respect to which 10 a public health emergency is declared under section 319, 11 or that has significant potential to cause such a public 12 health emergency.’’. 13 SEC. 624. COMBATING ANTIMICROBIAL RESISTANCE. 14 (a) I N GENERAL.—Section 319E of the Public 15 Health Service Act (42 U.S.C. 247d–5) is amended— 16 (1) in subsection (a)— 17 (A) in paragraph (1), by inserting ‘‘and ac-18 tivities’’ after ‘‘Federal programs’’; 19 (B) in paragraph (2)— 20 (i) by striking ‘‘public health constitu-21 encies, manufacturers, veterinary and med-22 ical professional societies and others’’ and 23 inserting ‘‘the Advisory Council described 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00448 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 449 •HR 1768 IH in subsection (b) and relevant public and 1 private entities’’; and 2 (ii) by inserting ‘‘, pursuant to para-3 graph (4),’’ after ‘‘comprehensive plan’’; 4 (C) by amending paragraph (3) to read as 5 follows: 6 ‘‘(3) A GENDA.—The task force described in 7 paragraph (1) shall consider factors the Secretary 8 considers appropriate, including factors to— 9 ‘‘(A) slow the emergence of resistant bac-10 teria and fungi and prevent the spread of re-11 sistant infections; 12 ‘‘(B) strengthen activities to combat resist-13 ance with respect to zoonotic diseases; 14 ‘‘(C) advance development and use of rapid 15 and innovative capabilities, including diagnostic 16 tests, for identification and characterization of 17 resistant bacteria and fungi; 18 ‘‘(D) accelerate basic and applied research 19 and development for new antibiotics, 20 antifungals, and other related therapeutics and 21 vaccines; and 22 ‘‘(E) support international collaboration 23 and capacities for antimicrobial-resistance pre-24 vention, detection, and control.’’; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00449 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 450 •HR 1768 IH (D) by redesignating paragraph (4) as 1 paragraph (5); and 2 (E) by inserting after paragraph (3) the 3 following: 4 ‘‘(4) A CTION PLAN .—Not later than October 1, 5 2026, and every 5 years thereafter, the task force 6 described in paragraph (1) shall develop and submit 7 to the Committee on Health, Education, Labor, and 8 Pensions and the Committee on Appropriations of 9 the Senate and the Committee on Energy and Com-10 merce and the Committee on Appropriations of the 11 House of Representatives a plan regarding Federal 12 programs and activities to combat antimicrobial re-13 sistance, including measurable outcomes, as appro-14 priate, informed by— 15 ‘‘(A) the agenda described in paragraph 16 (3); 17 ‘‘(B) input provided by the Advisory Coun-18 cil described in subsection (b); and 19 ‘‘(C) input from other relevant stake-20 holders provided pursuant to paragraph (2).’’; 21 (2) by redesignating subsections (b) through (o) 22 as subsections (c) through (p), respectively; 23 (3) by inserting after subsection (a) the fol-24 lowing: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00450 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 451 •HR 1768 IH ‘‘(b) ADVISORY COUNCIL.— 1 ‘‘(1) I N GENERAL .—The Secretary may con-2 tinue the Presidential Advisory Council on Com-3 bating Antibiotic-Resistant Bacteria, referred to in 4 this subsection as the ‘Advisory Council’. 5 ‘‘(2) D UTIES.—The Advisory Council shall ad-6 vise and provide information and recommendations 7 to the Secretary, acting through the Task Force es-8 tablished under subsection (a), regarding Federal 9 programs and activities intended to reduce or com-10 bat antimicrobial-resistant bacteria or fungi that 11 may present a public health threat and improve ca-12 pabilities to prevent, diagnose, mitigate, or treat 13 such resistance. Such advice, information, and rec-14 ommendations may be related to improving Federal 15 efforts related to factors described in subsection 16 (a)(3) and other topics related to antimicrobial re-17 sistance, as appropriate. 18 ‘‘(3) MEETINGS AND COORDINATION .— 19 ‘‘(A) M EETINGS.—The Advisory Council 20 shall meet not less frequently than biannually 21 and, to the extent practicable, in coordination 22 with meetings of the task force established 23 under subsection (a). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00451 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 452 •HR 1768 IH ‘‘(B) C OORDINATION.—The Advisory 1 Council shall, to the greatest extent practicable, 2 coordinate activities carried out by the Council 3 with the task force established under subsection 4 (a). 5 ‘‘(4) FACA.—Chapter 10 of title 5, United 6 States Code, shall apply to the activities and duties 7 of the Advisory Council. 8 ‘‘(5) SUNSET.— 9 ‘‘(A) I N GENERAL .—The Advisory Council 10 under this subsection shall terminate on De-11 cember 31, 2026. 12 ‘‘(B) E XTENSION OF ADVISORY COUN -13 CIL.—Not later than October 1, 2026, the Sec-14 retary shall submit to the Committee on 15 Health, Education, Labor, and Pensions of the 16 Senate and the Committee on Energy and Com-17 merce of the House of Representatives a report 18 that includes a recommendation on whether the 19 Advisory Council should be extended, and iden-20 tifying whether there are other committees, 21 councils, or task forces that have overlapping or 22 similar duties to that of the Advisory Council, 23 and whether such committees, councils, or task 24 forces should be combined, restructured, or 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00452 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 453 •HR 1768 IH eliminated, including with respect to the task 1 force established under subsection (a).’’; and 2 (4) in subsection (n), as so redesignated, by 3 striking ‘‘(f) through (j)’’ and inserting ‘‘(g) through 4 (k)’’. 5 (b) CONFORMING AMENDMENT.—Section 505 of the 6 Pandemic and All-Hazards Preparedness and Advancing 7 Innovation Act of 2019 (42 U.S.C. 247d–5 note; Public 8 Law 116–22) is amended by striking subsection (a) and 9 all that follows through ‘‘Not later’’ in subsection (e) and 10 inserting the following: 11 ‘‘Not later’’. 12 SEC. 625. STRATEGIC NATIONAL STOCKPILE AND MATE-13 RIAL THREATS. 14 Section 319F–2 of the Public Health Service Act (42 15 U.S.C. 247d–6b) is amended— 16 (1) in subsection (a)— 17 (A) in paragraph (2)— 18 (i) in subparagraph (A), by inserting 19 ‘‘Such review shall include a description of 20 how the Secretary manages and mitigates 21 risks associated with gaps between current 22 inventory levels and stockpiling goals, 23 prioritizes such risks, and tracks progress 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00453 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 454 •HR 1768 IH toward mitigation of such risks.’’ after the 1 first sentence; and 2 (ii) in subparagraph (B)(i), by amend-3 ing subclause (IV) to read as follows: 4 ‘‘(IV) the emergency health secu-5 rity threat or threats such counter-6 measure procurement is intended to 7 address, including— 8 ‘‘(aa) whether such procure-9 ment is consistent with meeting 10 emergency health security needs 11 associated with such threat or 12 threats; and 13 ‘‘(bb) in the case of a coun-14 termeasure that addresses a bio-15 logical agent, whether such agent 16 has an increased likelihood to be-17 come resistant to, more resistant 18 to, or evade, such counter-19 measure relative to other avail-20 able medical countermeasures;’’; 21 (B) in paragraph (3)— 22 (i) in subparagraph (B), by striking 23 ‘‘are followed, regularly reviewed, and up-24 dated with respect to such stockpile’’ and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00454 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 455 •HR 1768 IH inserting ‘‘with respect to such stockpile 1 are followed, regularly reviewed, and up-2 dated to reflect best practices’’; 3 (ii) in subparagraph (I), by inserting 4 ‘‘, through a standard operating proce-5 dure,’’ after ‘‘ensure’’; 6 (iii) by redesignating subparagraphs 7 (H) through (K) as subparagraphs (I) 8 through (L), respectively; 9 (iv) by inserting after subparagraph 10 (G) the following: 11 ‘‘(H) utilize tools to enable the timely and 12 accurate tracking of the contents of the stock-13 pile throughout the deployment of such con-14 tents, including tracking of the location and ge-15 ographic distribution and utilization of such 16 contents;’’; 17 (v) in subparagraph (K), as so redes-18 ignated, by striking ‘‘; and’’ at the end and 19 inserting a semicolon; 20 (vi) in subparagraph (L), as so redes-21 ignated, by striking the period and insert-22 ing ‘‘; and’’; and 23 (vii) by adding at the end the fol-24 lowing: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00455 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 456 •HR 1768 IH ‘‘(M) communicate to relevant vendors re-1 garding modifications, renewals, extensions, or 2 terminations of contracts, or the intent to exer-3 cise options for such contracts, within 30 days, 4 as practicable, of such determination, including 5 through the development of a contract notifica-6 tion process.’’; 7 (C) in paragraph (5)(B), in the matter 8 preceding clause (i), by inserting ‘‘, which may 9 accompany the review required under paragraph 10 (2),’’ after ‘‘Representatives a report’’; and 11 (D) in paragraph (6)(A)— 12 (i) by redesignating clauses (viii) 13 through (x) as clauses (ix) through (xi), re-14 spectively; and 15 (ii) by inserting after clause (vii) the 16 following: 17 ‘‘(viii) with respect to any change in 18 the Federal organizational management of 19 the stockpile, an assessment and compari-20 son of any differences in the processes and 21 operations resulting from such change, in-22 cluding— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00456 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 457 •HR 1768 IH ‘‘(I) planning for potential coun-1 termeasure deployment, distribution, 2 or dispensing capabilities; 3 ‘‘(II) organizational structure; 4 ‘‘(III) communication with rel-5 evant stakeholders related to procure-6 ment decisions; 7 ‘‘(IV) processes related to pro-8 curement, deployment, and use of 9 stockpiled countermeasures; 10 ‘‘(V) communication and coordi-11 nation with the Public Health Emer-12 gency Medical Countermeasures En-13 terprise and other related Federal en-14 tities; 15 ‘‘(VI) inventory management; 16 and 17 ‘‘(VII) availability and use of re-18 sources for such activities;’’; and 19 (2) in subsection (c)(2)(C), by striking 20 ‘‘promptly’’ and inserting ‘‘, not later than 60 days 21 after each such determination,’’; 22 (3) in subsection (f)(1), by striking 23 ‘‘$610,000,000 for each of fiscal years 2019 through 24 2021, and $750,000,000 for each of fiscal years 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00457 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 458 •HR 1768 IH 2022 and 2023’’ and inserting ‘‘$1,100,000,000 for 1 fiscal year 2025, and $1,210,000,000 for fiscal year 2 2026’’; and 3 (4) in subsection (g)(1), by striking ‘‘2019 4 through 2028’’ and inserting ‘‘2025 through 2034’’. 5 SEC. 626. MEDICAL COUNTERMEASURES FOR VIRAL 6 THREATS WITH PANDEMIC POTENTIAL. 7 Section 319L of the Public Health Service Act (42 8 U.S.C. 247d–7e) is amended— 9 (1) in subsection (c)— 10 (A) in paragraph (4)— 11 (i) in subparagraph (D)— 12 (I) in clause (ii), by striking ‘‘; 13 and’’ and inserting a semicolon; 14 (II) by redesignating clause (iii) 15 as clause (iv); and 16 (III) by inserting after clause (ii) 17 the following: 18 ‘‘(iii) research and development of 19 medical countermeasures for priority virus 20 families that have significant potential to 21 cause a pandemic, including such counter-22 measures that take either pathogen-specific 23 or pathogen-agnostic approaches, and plat-24 form technologies to improve the develop-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00458 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 459 •HR 1768 IH ment and manufacture of such medical 1 countermeasures; and’’; and 2 (ii) in subparagraph (F)(ii), by insert-3 ing ‘‘or priority virus families and other 4 viral pathogens that pose a threat due to 5 their significant potential to cause a pan-6 demic,’’ after ‘‘pandemic influenza,’’; and 7 (B) in paragraph (5), by adding at the end 8 the following: 9 ‘‘(I) N OTIFICATION.—In awarding con-10 tracts, grants, cooperative agreements, or other 11 transactions under this section, the Secretary 12 shall communicate to relevant vendors regard-13 ing modifications, renewals, extensions, or ter-14 minations of contracts, including through the 15 development of a contract notification process, 16 within 30 days of such determination, as prac-17 ticable.’’; 18 (2) in subsection (d)(2), by striking 19 ‘‘$611,700,000 for each of fiscal years 2019 through 20 2023’’ and inserting ‘‘$950,000,000 for each of fis-21 cal years 2025 and 2026’’; and 22 (3) in subsection (e)(1), by amending subpara-23 graph (D) to read as follows: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00459 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 460 •HR 1768 IH ‘‘(D) SUNSET.—This paragraph shall cease 1 to have force or effect after December 31, 2 2026.’’. 3 SEC. 627. PUBLIC HEALTH EMERGENCY MEDICAL COUN-4 TERMEASURES ENTERPRISE. 5 Section 2811–1 of the Public Health Service Act (42 6 U.S.C. 300hh–10a) is amended— 7 (1) in subsection (b)— 8 (A) by redesignating paragraph (11) as 9 paragraph (13); 10 (B) by inserting after paragraph (10) the 11 following: 12 ‘‘(11) The Director of the Biomedical Advanced 13 Research and Development Authority. 14 ‘‘(12) The Director of the Strategic National 15 Stockpile.’’; and 16 (C) in paragraph (13), as so redesignated, 17 by striking ‘‘the Director of the Biomedical Ad-18 vanced Research and Development Authority, 19 the Director of the Strategic National Stock-20 pile, the Director of the National Institute of 21 Allergy and Infectious Diseases,’’ and inserting 22 ‘‘the Director of the National Institute of Al-23 lergy and Infectious Diseases’’; and 24 (2) in subsection (c)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00460 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 461 •HR 1768 IH (A) in paragraph (1)— 1 (i) by redesignating subparagraph (D) 2 as subparagraph (E); and 3 (ii) by inserting after subparagraph 4 (C) the following: 5 ‘‘(D) Assist the Secretary in developing 6 strategies for appropriate and evidence-based 7 allocation and distribution of countermeasures 8 to jurisdictions, in a manner that supports the 9 availability and use of such countermeasures, 10 for public health and medical preparedness and 11 response needs.’’; 12 (B) in paragraph (2), by inserting ‘‘rel-13 evant stakeholders, including industry,’’ after 14 ‘‘consider input from’’; and 15 (C) by adding at the end the following: 16 ‘‘(3) I NFORMATION SHARING .—The Secretary 17 shall, as appropriate and in a manner that does not 18 compromise national security, communicate and 19 share information related to recommendations made 20 and strategies developed under paragraph (1) with 21 relevant stakeholders, including industry and State, 22 local, and Tribal public health departments.’’. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00461 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 462 •HR 1768 IH SEC. 628. FELLOWSHIP AND TRAINING PROGRAMS. 1 Section 317G of the Public Health Service Act (42 2 U.S.C. 247b–8) is amended— 3 (1) by striking ‘‘The Secretary,’’ and inserting 4 the following: 5 ‘‘(a) IN GENERAL.—The Secretary,’’; and 6 (2) by adding at the end the following: 7 ‘‘(b) NONCOMPETITIVE CONVERSION.— 8 ‘‘(1) I N GENERAL .—The Secretary may non-9 competitively convert an individual who has com-10 pleted an epidemiology, surveillance, or laboratory 11 fellowship or training program under subsection (a) 12 to a career-conditional appointment without regard 13 to the provisions of subchapter I of chapter 33 of 14 title 5, United States Code, provided that such indi-15 vidual meets qualification requirements for the ap-16 pointment.’’. 17 SEC. 629. REGIONAL BIOCONTAINMENT RESEARCH LAB-18 ORATORIES. 19 (a) I N GENERAL.—The Secretary of Health and 20 Human Services (referred to in this section as the ‘‘Sec-21 retary’’) shall make awards to establish or maintain, as 22 applicable, not fewer than 12 regional biocontainment lab-23 oratories, for purposes of— 24 (1) conducting biomedical research to support 25 public health and medical preparedness for, and 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00462 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 463 •HR 1768 IH rapid response to, biological agents, including emerg-1 ing infectious diseases; 2 (2) ensuring the availability of surge capacity 3 for purposes of responding to such biological agents; 4 (3) supporting information sharing between, 5 and the dissemination of findings to, researchers and 6 other relevant individuals to facilitate collaboration 7 between industry and academia; and 8 (4) providing, as appropriate and applicable, 9 technical assistance and training to researchers and 10 other relevant individuals to support the biomedical 11 research workforce in improving the management 12 and mitigation of safety and security risks in the 13 conduct of research involving such biological agents. 14 (b) R EQUIREMENTS.—As a condition of receiving a 15 grant under this section, a regional biocontainment labora-16 tory shall agree to such oversight activities as the Sec-17 retary determines appropriate, including periodic meetings 18 with relevant officials of the Department of Health and 19 Human Services, facility inspections, and other activities 20 as necessary and appropriate to ensure compliance with 21 the terms and conditions of such award. 22 (c) WORKING GROUP.—The Secretary shall establish 23 a Working Group, consisting of a representative from each 24 entity in receipt of an award under subsection (a). The 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00463 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 464 •HR 1768 IH Working Group shall make recommendations to the Sec-1 retary in administering awards under this section, for pur-2 poses of— 3 (1) improving the quality and consistency of ap-4 plicable procedures and practices within laboratories 5 funded pursuant to subsection (a); and 6 (2) ensuring coordination, as appropriate, of 7 federally funded activities carried out at such labora-8 tories. 9 (d) DEFINITION.—In this section, the term ‘‘regional 10 biocontainment laboratory’’ means a Biosafety or Animal 11 Biosafety Level–3 and Level–2 facility located at an insti-12 tution in the United States that is designated by the Sec-13 retary to carry out the activities described in subsection 14 (a). 15 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 16 out this section, there are authorized to be appropriated 17 $52,000,000 for each of fiscal years 2025 and 2026, to 18 remain available through December 31, 2026. 19 (f) A DMINISTRATIVE EXPENSES.—Of the amount 20 available to carry out this section for a fiscal year, the 21 Secretary may use not more than 5 percent for the admin-22 istrative expenses of carrying out this section, including 23 expenses related to carrying out subsection (c). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00464 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 465 •HR 1768 IH (g) R EPORT TO CONGRESS.—Not later than 1 year 1 after the date of the enactment of this Act, and biannually 2 thereafter, the Secretary, in consultation with the heads 3 of applicable Federal departments and agencies shall re-4 port to the Committee on Health, Education, Labor, and 5 Pensions of the Senate and the Committee on Energy and 6 Commerce of the House of Representatives on— 7 (1) the activities and accomplishments of the 8 regional biocontainment laboratories; 9 (2) any published or disseminated research 10 findings based on research conducted in such labora-11 tories in the applicable year; 12 (3) oversight activities carried out by the Sec-13 retary pursuant to subsection (b); 14 (4) activities undertaken by the Secretary to 15 take into consideration the capacity and capabilities 16 of the network of regional biocontainment labora-17 tories in activities to prepare for and respond to bio-18 logical agents, which may include leveraging such ca-19 pacity and capabilities to support the Laboratory 20 Response Network, as applicable and appropriate; 21 (5) plans for the maintenance and sustainment 22 of federally funded activities conducted at the re-23 gional biocontainment laboratories, consistent with 24 the strategy required under section 2312 of the 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00465 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 466 •HR 1768 IH PREVENT Pandemics Act (Public Law 117–328); 1 and 2 (6) activities undertaken by the Secretary to co-3 ordinate with the heads of other relevant Federal de-4 partments and agencies to ensure that work carried 5 out by each such facility on behalf of the Secretary 6 and such other relevant heads is prioritized, is com-7 plementary to the work carried out by other such fa-8 cilities and other relevant federally funded activities, 9 and avoids unnecessary duplication. 10 SEC. 629A. LIMITATION RELATED TO COUNTRIES OF CON-11 CERN CONDUCTING CERTAIN RESEARCH. 12 Section 2315(c) of the PREVENT Pandemics Act 13 (42 U.S.C. 6627) is amended to read as follows: 14 ‘‘(c) LIMITATIONS ON COUNTRIES OF CONCERN CON-15 DUCTING CERTAIN RESEARCH.— 16 ‘‘(1) I N GENERAL .—The Secretary of Health 17 and Human Services (referred to in this subsection 18 as the ‘Secretary’) shall not fund research that may 19 reasonably be anticipated to involve the creation, 20 transfer, and use of enhanced pathogens of pan-21 demic potential or biological agents or toxins listed 22 pursuant to section 351A(a)(1) of the Public Health 23 Service Act if such research is conducted by a for-24 eign entity at a facility located in a country that is 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00466 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 467 •HR 1768 IH determined to be a country of concern as defined in 1 paragraph (2). 2 ‘‘(2) COUNTRIES OF CONCERN .— 3 ‘‘(A) D EFINITION.—For purposes of this 4 subsection, a ‘country of concern’ means the 5 People’s Republic of China, the Democratic 6 People’s Republic of Korea, the Russian Fed-7 eration, the Islamic Republic of Iran, and any 8 other country as determined pursuant to sub-9 paragraph (B). 10 ‘‘(B) A DDITIONAL COUNTRIES .—The Di-11 rector of National Intelligence (referred to in 12 this subsection as the ‘Director’) shall, in con-13 sultation with the Secretary, add additional 14 countries of concern for purposes of paragraph 15 (1), only if— 16 ‘‘(i) the Director determines that evi-17 dence exists that a country has malicious 18 intent related to the creation, enhance-19 ment, transfer, or use of pathogens of pan-20 demic potential or biological agents or tox-21 ins listed pursuant to such section 22 351A(a)(1); and 23 ‘‘(ii) in a manner that does not com-24 promise national security, the Director 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00467 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 468 •HR 1768 IH provides such evidence in a report sub-1 mitted to the Committee on Health, Edu-2 cation, Labor, and Pensions of the Senate 3 and the Committee on Energy and Com-4 merce of the House of Representatives. 5 ‘‘(C) L IMITATION.—Paragraph (1) shall 6 not take effect with respect to a country of con-7 cern identified under subparagraph (B) until 8 the date that is 15 days after the date on which 9 the Director submits the report described in 10 subparagraph (B)(ii). 11 ‘‘(3) CLARIFICATION.— 12 ‘‘(A) I N GENERAL .—The requirement of 13 paragraph (1) may be waived by the President 14 for the duration of the initial response to an 15 outbreak of a novel emerging infectious disease 16 if the President determines that such require-17 ment impedes the ability of the Federal Govern-18 ment to immediately respond to such outbreak. 19 ‘‘(B) N OTIFICATION.—The President shall 20 notify such committees of Congress not later 21 than 48 hours after exercising the waiver under 22 subparagraph (A), and shall provide updates to 23 such committees related to the use of such 24 waiver every 15 days thereafter. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00468 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 469 •HR 1768 IH ‘‘(4) S UNSET.—The limitation under this sub-1 section shall expire on December 31, 2026.’’. 2 Subtitle C—Addressing the Needs 3 of All Individuals 4 SEC. 631. IMPROVING ACCESS TO CERTAIN PROGRAMS. 5 (a) PROCEDURES RELATED TO THE TRANSITION OF 6 CERTAIN CLAIMS.— 7 (1) P ROCEDURES FOR CORRECTING SUBMIS -8 SIONS.— 9 (A) R EQUESTS INITIALLY SUBMITTED 10 UNDER SECTION 319F –4.— 11 (i) IN GENERAL .—In the case of a re-12 quest for compensation submitted under 13 section 319F–4 of the Public Health Serv-14 ice Act (42 U.S.C. 247d–6e) for an injury 15 or death related to a medical product for 16 active immunization to prevent coronavirus 17 disease 2019 that the Secretary determines 18 to be ineligible pursuant to subsection 19 (b)(4)(B) of such section 319F–4, the Sec-20 retary shall, not later than 30 days after 21 such determination, notify the individual 22 submitting the request of such determina-23 tion. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00469 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 470 •HR 1768 IH (ii) S UBMISSION OF PETITION .—An 1 individual who receives a notification de-2 scribed in clause (i) shall be eligible to sub-3 mit a petition to the United States Court 4 of Federal Claims under section 2111 of 5 the Public Health Service Act (42 U.S.C. 6 300aa–11) with respect to the same med-7 ical product administration claimed in the 8 request submitted under section 319F–4 of 9 such Act (42 U.S.C. 247d–6e), provided 10 such petition is submitted not later than 11 the later of— 12 (I) 1 year after receiving such 13 notification under clause (i); or 14 (II) the last date on which the 15 individual otherwise would be eligible 16 to submit a petition relating to such 17 injury, as specified in section 2116 of 18 such Act (42 U.S.C. 300aa–16). 19 (iii) E LIGIBILITY.—To be eligible to 20 submit a petition in accordance with clause 21 (ii), the petitioner shall have submitted the 22 request that was determined to be ineli-23 gible as described in clause (i) not later 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00470 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 471 •HR 1768 IH than the applicable deadline for filing a pe-1 tition under such section 2116. 2 (B) R EQUESTS INITIALLY SUBMITTED 3 UNDER SECTION 2111 .— 4 (i) I N GENERAL .—If a special master 5 determines that— 6 (I) a petition submitted under 7 section 2111 of the Public Health 8 Service Act (42 U.S.C. 300aa–11) re-9 lated to a medical product for active 10 immunization to prevent coronavirus 11 disease 2019 that is ineligible for the 12 program under subtitle 2 of title XXI 13 of the Public Health Service Act (42 14 U.S.C. 300aa–10 et seq.) because it 15 relates to a medical product adminis-16 tered at a time when the medical 17 product was not included in the table 18 under section 2114 of such Act (42 19 U.S.C. 300aa–14); and 20 (II) the medical product was ad-21 ministered when it was a covered 22 countermeasure subject to a declara-23 tion under section 319F–3(b) of such 24 Act (42 U.S.C. 247d–6d(b)), 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00471 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 472 •HR 1768 IH the special master shall, not later than 30 1 days after such determination, notify the 2 petitioner of such determination. 3 (ii) S UBMISSION OF REQUEST .—An 4 individual who receives a notification de-5 scribed in clause (i) shall be eligible to sub-6 mit a request for compensation under sec-7 tion 319F–4(b) of the Public Health Serv-8 ice Act (42 U.S.C. 247d–6e(b)) with re-9 spect to the same medical product adminis-10 tration claimed in the petition submitted 11 under section 2111 of such Act (42 U.S.C. 12 300aa–11)— 13 (I) not later than 1 year after re-14 ceiving such notification; or 15 (II) in the case that the notifica-16 tion is issued after judicial review of 17 the petition under subsection (e) or 18 (f) of section 2112 of such Act (42 19 U.S.C. 300aa–12), not later than 1 20 year after the judgment of the United 21 States Court of Federal Claims or the 22 mandate is issued by the United 23 States Court of Appeals for the Fed-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00472 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 473 •HR 1768 IH eral Circuit pursuant to such sub-1 section (e) or (f). 2 (iii) E LIGIBILITY.—To be eligible to 3 submit a request for compensation in ac-4 cordance with clause (ii), the individual 5 submitting the request shall have sub-6 mitted the petition under section 2111 of 7 the Public Health Service Act (42 U.S.C. 8 300aa–11) that was determined to be ineli-9 gible not later than 1 year after the date 10 of administration of the medical product. 11 (2) CHANGES TO CERTAIN PROGRAMS .— 12 (A) S ECTION 319F –4.—Section 319F–4 of 13 the Public Health Service Act (42 U.S.C. 14 247d–6e) is amended— 15 (i) in subsection (b)(4)— 16 (I) by striking ‘‘Except as pro-17 vided’’ and inserting the following: 18 ‘‘(A) I N GENERAL .—Except as provided’’; 19 and 20 (II) by adding at the end the fol-21 lowing: 22 ‘‘(B) E XCLUSION OF INJURIES ELIGIBLE 23 FOR PETITION UNDER TITLE XXI .—Notwith-24 standing any other provision of this section, no 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00473 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 474 •HR 1768 IH individual may be eligible for compensation 1 under this section with respect to a vaccine 2 that, at the time it was administered, was in-3 cluded in the Vaccine Injury Table under sec-4 tion 2114.’’; and 5 (ii) in subsection (d)(3)— 6 (I) by striking ‘‘This section’’ 7 and inserting the following: 8 ‘‘(A) IN GENERAL .—This section’’; and 9 (II) by adding at the end the fol-10 lowing: 11 ‘‘(B) E XHAUSTION OF REMEDIES .—A cov-12 ered individual shall not be considered to have 13 exhausted remedies as described in paragraph 14 (1), nor be eligible to seek remedy under section 15 319F–3(d), unless such individual has provided 16 to the Secretary all supporting documentation 17 necessary to facilitate the determinations re-18 quired under subsection (b)(4).’’. 19 (B) T ITLE XXI .—Title XXI of the Public 20 Health Service Act (42 U.S.C. 300aa–1 et seq.) 21 is amended— 22 (i) in section 2111(a)(2)(A) (42 23 U.S.C. 300aa–11(a)(2)(A)), in the matter 24 preceding clause (i), by inserting ‘‘con-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00474 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 475 •HR 1768 IH taining the information required under 1 subsection (c)’’ after ‘‘unless a petition’’; 2 (ii) in section 2112(d) (42 U.S.C. 3 300aa–12(d))— 4 (I) by adding at the end of para-5 graph (1) the following: ‘‘Such des-6 ignation shall not occur until the peti-7 tioner has filed all materials required 8 under section 2111(c).’’; and 9 (II) in paragraph (3)(A)(ii), by 10 striking ‘‘the petition was filed’’ and 11 inserting ‘‘on which the chief special 12 master makes the designation pursu-13 ant to paragraph (1)’’; 14 (iii) in section 2114(e) (42 U.S.C. 15 300aa–14(e)), by adding at the end the 16 following: 17 ‘‘(4) L ICENSURE REQUIREMENT .—Notwith-18 standing paragraphs (2) and (3), the Secretary may 19 not revise the Vaccine Injury Table to include a vac-20 cine for which the Centers for Disease Control and 21 Prevention has issued a recommendation for routine 22 use in children or pregnant women until at least one 23 application for such vaccine has been approved 24 under section 351. Upon such revision of the Vac-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00475 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 476 •HR 1768 IH cine Injury Table, all vaccines in a vaccine category 1 on the Vaccine Injury Table, including vaccines au-2 thorized under emergency use pursuant to section 3 564 of the Federal Food, Drug, and Cosmetic Act, 4 shall be considered included in the Vaccine Injury 5 Table.’’; and 6 (iv) in section 2116 (42 U.S.C. 7 300aa–16), by adding at the end the fol-8 lowing: 9 ‘‘(d) C LARIFICATION.—Notwithstanding subsections 10 (a) and (b), an injury or death related to a vaccine admin-11 istered at a time when the vaccine was a covered counter-12 measure subject to a declaration under section 319F–3(b) 13 shall not be eligible for compensation under the Pro-14 gram.’’. 15 (b) A CCELERATING INJURY COMPENSATION PRO-16 GRAM ADMINISTRATION AND ENSURING PROGRAM INTEG-17 RITY.— 18 (1) P ETITIONS FOR COMPENSATION .—Section 19 2111(a)(2)(A)(i) of the Public Health Service Act 20 (42 U.S.C. 300aa–11(a)(2)(A)(i)) is amended— 21 (A) in subclause (I), by striking ‘‘, and’’ 22 and inserting a semicolon; 23 (B) in subclause (II)— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00476 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 477 •HR 1768 IH (i) by moving the margin 2 ems to the 1 right; and 2 (ii) by striking ‘‘, or’’ and inserting ‘‘; 3 and’’; and 4 (C) by adding at the end the following: 5 ‘‘(III) the judgment described in subclause 6 (I) does not result from a petitioner’s motion to 7 dismiss the case; or’’. 8 (2) D ETERMINATION OF GOOD FAITH .—Section 9 2115(e)(1) of the Public Health Service Act (42 10 U.S.C. 300aa–15(e)(1)) is amended by adding at the 11 end the following: ‘‘When making a determination of 12 good faith under this paragraph, the special master 13 or court may consider whether the petitioner dem-14 onstrated an intention to obtain compensation on 15 such petition and was not merely seeking to satisfy 16 the exhaustion requirement under section 2121(b).’’. 17 (c) E XTENSION OF DEADLINES TO SUBMIT RE-18 QUESTS FOR COMPENSATION FOR CERTAIN INJURIES.— 19 (1) I N GENERAL .—With respect to claims filed 20 under section 319F–4 of the Public Health Service 21 Act (42 U.S.C. 247d–6e) alleging a covered injury 22 caused by the administration or use of a covered 23 countermeasure pursuant to a declaration under sec-24 tion 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)) 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00477 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 478 •HR 1768 IH relating to coronavirus disease 2019, the following 1 shall apply: 2 (A) Notwithstanding the filing deadline ap-3 plicable under such section 319F–4, the claim 4 shall be filed within 3 years of the administra-5 tion or use of the covered countermeasure, or 1 6 year after the date of enactment of this Act, 7 whichever is later, and, if a claim filed under 8 such section 319F–4 with respect to such ad-9 ministration or use was filed before the date of 10 enactment of this Act and denied on the basis 11 of having not been filed within the time period 12 required under subsection (b)(4) of such section 13 319F–4, such claim may be refiled pursuant to 14 this subparagraph. 15 (B) With respect to a claim relating to the 16 administration of a medical product for active 17 immunization to prevent coronavirus disease 18 2019 such a claim may be filed under such sec-19 tion 319F–4 only if the administration of such 20 vaccine occurred prior to the addition of the 21 vaccine to the Vaccine Injury Table under sec-22 tion 2114 of the Public Health Service Act (42 23 U.S.C. 300aa–14). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00478 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 479 •HR 1768 IH SEC. 632. SUPPORTING AT-RISK INDIVIDUALS DURING 1 EMERGENCY RESPONSES. 2 (a) T ECHNICAL ASSISTANCE FOR AT-RISK INDIVID-3 UALS AND DISASTERS.— 4 (1) IN GENERAL .—The Secretary of Health and 5 Human Services (referred to in this section as the 6 ‘‘Secretary’’) may provide appropriate technical as-7 sistance to States, localities, Tribes, and other appli-8 cable entities related to addressing the unique needs 9 and considerations of at-risk individuals, as defined 10 in section 2802(b)(4) of the Public Health Service 11 Act (42 U.S.C. 300hh–1(b)(4)), in the event of a 12 public health emergency declared by the Secretary 13 pursuant to section 319 of the Public Health Service 14 Act (42 U.S.C. 247d). 15 (2) T ECHNICAL ASSISTANCE .—The technical 16 assistance described in paragraph (1) shall include— 17 (A) developing, identifying, evaluating, and 18 disseminating evidence-based or evidence-in-19 formed strategies to improve health and address 20 other near-term or long-term outcomes for at- 21 risk individuals related to public health emer-22 gencies, including by addressing such unique 23 needs and considerations in carrying out public 24 health and medical activities to prepare for, re-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00479 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 480 •HR 1768 IH spond to, and recover from, such public health 1 emergencies; and 2 (B) assisting applicable entities, through 3 contracts or cooperative agreements, as appro-4 priate, in the implementation of such evidence- 5 based strategies. 6 (3) C ONSULTATION.—In carrying out activities 7 under paragraph (2), the Secretary shall take into 8 consideration relevant findings and recommendations 9 of, and, as appropriate, consult with, the National 10 Advisory Committee on Individuals with Disabilities 11 and Disasters established under section 2811C of 12 the Public Health Service Act (42 U.S.C. 300hh– 13 10d), the National Advisory Committee on Children 14 and Disasters under section 2811A of such Act (42 15 U.S.C. 300hh–10b), and the National Advisory 16 Committee on Seniors and Disasters under section 17 2811B of such Act (42 U.S.C. 300hh–10c). 18 (b) CRISIS STANDARDS OF CARE.—Not later than 2 19 years after the date of enactment of this Act, the Sec-20 retary, acting through the Director of the Office for Civil 21 Rights of the Department of Health and Human Services, 22 shall issue guidance to States and localities on the develop-23 ment or modification of State and local crisis standards 24 of care for use during the response to a public health 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00480 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 481 •HR 1768 IH emergency declared by the Governor of a State or by the 1 Secretary under section 319 of the Public Health Service 2 Act (42 U.S.C. 247d), or a major disaster or emergency 3 declared by the President under section 401 or 501, re-4 spectively, of the Robert T. Stafford Disaster Relief and 5 Emergency Assistance Act (42 U.S.C. 5170, 5191) to en-6 sure that such standards of care are consistent with the 7 nondiscrimination requirements of section 504 of the Re-8 habilitation Act of 1973 (29 U.S.C. 794), title II of the 9 Americans with Disabilities Act of 1990 (42 U.S.C. 12131 10 et seq.), and the Age Discrimination Act of 1975 (42 11 U.S.C. 6101 et seq.). 12 SEC. 633. NATIONAL ADVISORY COMMITTEES. 13 (a) NATIONAL ADVISORY COMMITTEE ON CHILDREN 14 AND DISASTERS.—Subsection (g) of section 2811A of the 15 Public Health Service Act (42 U.S.C. 300hh–10b) is 16 amended to read as follows: 17 ‘‘(g) SUNSET.— 18 ‘‘(1) I N GENERAL .—The Advisory Committee 19 shall terminate on December 31, 2026. 20 ‘‘(2) E XTENSION OF ADVISORY COMMITTEE .— 21 Not later than October 1, 2025, the Secretary shall 22 submit to Congress a recommendation on whether 23 the Advisory Committee should be extended beyond 24 the date described in paragraph (1).’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00481 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 482 •HR 1768 IH (b) N ATIONAL ADVISORY COMMITTEE ON SENIORS 1 AND DISASTERS.—Section 2811B of the Public Health 2 Service Act (42 U.S.C. 300hh–10c) is amended— 3 (1) in subsection (d)— 4 (A) in paragraph (1)— 5 (i) by inserting ‘‘and departments’’ 6 after ‘‘agencies’’; and 7 (ii) by striking ‘‘17 members’’ and in-8 serting ‘‘25 members’’; and 9 (B) in paragraph (2)— 10 (i) by striking subparagraphs (J) and 11 (K); 12 (ii) by redesignating subparagraphs 13 (A) through (I) and (L) as clauses (i) 14 through (x), respectively, and adjusting the 15 margins accordingly; 16 (iii) by inserting before clause (i), as 17 so redesignated, the following: 18 ‘‘(B) F EDERAL MEMBERS .—The Federal 19 members shall include the following:’’; and 20 (iv) by inserting before subparagraph 21 (B), as so designated, the following: 22 ‘‘(A) N ON-FEDERAL MEMBERS .—The Sec-23 retary in consultation with such other heads of 24 agencies and departments as may be appro-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00482 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 483 •HR 1768 IH priate, shall appoint to the Advisory Committee 1 under paragraph (1) at least 13 individuals, in-2 cluding the following: 3 ‘‘(i) At least 3 non-Federal health 4 care providers with expertise in geriatric 5 medical disaster planning, preparedness, 6 response, or recovery. 7 ‘‘(ii) At least 3 representatives of 8 State, local, territorial, or Tribal agencies 9 with expertise in geriatric disaster plan-10 ning, preparedness, response, or recovery. 11 ‘‘(iii) At least 2 non-Federal profes-12 sionals with training in gerontology, such 13 as social workers, scientists, human serv-14 ices specialists, or other non-medical pro-15 fessionals, with experience in disaster plan-16 ning, preparedness, response, or recovery 17 among other adults.’’; and 18 (2) by amending subsection (g) to read as fol-19 lows: 20 ‘‘(g) SUNSET.—The Advisory Committee shall termi-21 nate on December 31, 2026.’’. 22 (c) N ATIONAL ADVISORY COMMITTEE ON INDIVID-23 UALS WITH DISABILITIES AND DISASTERS.—Section 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00483 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 484 •HR 1768 IH 2811C of the Public Health Service Act (42 U.S.C. 1 300hh–10d) is amended— 2 (1) by redesignating subsections (c) through (g) 3 as subsections (d) through (h), respectively; 4 (2) by inserting after subsection (b) the fol-5 lowing: 6 ‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 7 may provide advice and recommendations to the Secretary 8 with respect to individuals with disabilities and the med-9 ical and public health grants and cooperative agreements 10 as applicable to preparedness and response activities 11 under this title and title III.’’; 12 (3) in subsection (d), as so redesignated— 13 (A) in paragraph (1), by striking ‘‘17 14 members’’ and inserting ‘‘25 members’’; 15 (B) in paragraph (2)— 16 (i) by striking subparagraphs (K) 17 through (M); 18 (ii) by redesignating subparagraphs 19 (A) through (J) as clauses (i) through (x), 20 respectively, and adjusting the margins ac-21 cordingly; 22 (iii) by inserting before clause (i), as 23 so redesignated, the following: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00484 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 485 •HR 1768 IH ‘‘(B) F EDERAL MEMBERS .—The Federal 1 members shall include the following:’’; 2 (iv) by adding at the end of subpara-3 graph (B), as so designated, the following: 4 ‘‘(xi) Representatives of such other 5 Federal agencies as the Secretary deter-6 mines necessary to fulfill the duties of the 7 Advisory Committee.’’; and 8 (v) by inserting before subparagraph 9 (B), as so designated, the following: 10 ‘‘(A) N ON-FEDERAL MEMBERS .—The Sec-11 retary in consultation with such other heads of 12 agencies and departments as may be appro-13 priate, shall appoint to the Advisory Committee 14 under paragraph (1) at least 13 individuals, in-15 cluding the following: 16 ‘‘(i) At least 4 non-Federal health 17 care professionals with expertise in dis-18 ability accessibility before, during, and 19 after disasters, medical and mass care dis-20 aster planning, preparedness, response, or 21 recovery. 22 ‘‘(ii) At least 3 representatives of 23 State, local, Tribal, or territorial agencies 24 with expertise in disaster planning, pre-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00485 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 486 •HR 1768 IH paredness, response, or recovery for indi-1 viduals with disabilities. 2 ‘‘(iii) At least 4 individuals with a dis-3 ability with expertise in disaster planning, 4 preparedness, response, or recovery for in-5 dividuals with disabilities. 6 ‘‘(iv) Other members as the Secretary 7 determines appropriate, of whom— 8 ‘‘(I) at least one such member 9 shall represent a local, State, or na-10 tional organization with expertise in 11 individuals with disabilities; 12 ‘‘(II) at least one such member 13 shall be an individual with a dis-14 ability; and 15 ‘‘(III) at least one such member 16 shall be an individual with expertise in 17 the needs of housing services, includ-18 ing during the response to, and recov-19 ery from, disasters.’’; and 20 (C) by adding at the end the following: 21 ‘‘(3) CONSIDERATION.—In appointing members, 22 including the Chair, to the Committee under this 23 subsection, the Secretary may give consideration to 24 disability status.’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00486 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 487 •HR 1768 IH (4) by amending subsection (h), as so redesig-1 nated, to read as follows: 2 ‘‘(h) SUNSET.—The Advisory Committee shall termi-3 nate on December 31, 2026.’’. 4 SEC. 634. NATIONAL ACADEMIES STUDY ON PRIZES. 5 (a) I N GENERAL.—Not later than 90 days after the 6 date of enactment of this Act, the Secretary of Health and 7 Human Services shall seek to enter into an agreement 8 with the National Academies of Sciences, Engineering, 9 and Medicine (referred to in this section as the ‘‘National 10 Academies’’) to conduct a study to examine— 11 (1) alternative models for directly funding, or 12 stimulating investment in, biomedical research and 13 development that delink research and development 14 costs from the prices of drugs, including the pro-15 gressive replacement of patents and regulatory 16 exclusivities on new drugs with a combination of ex-17 panded support for research and innovation prizes to 18 reward the successful development of drugs or 19 achievement of related milestones; 20 (2) the dollar amount of innovation prizes for 21 different stages of research and development of dif-22 ferent classes or types of drugs, and total annual 23 funding, that would be necessary to stimulate invest-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00487 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 488 •HR 1768 IH ment sufficient to achieve such successful drug de-1 velopment and related milestones; 2 (3) the relative effectiveness and efficiency of 3 such alternative models in stimulating innovation, 4 compared to the status quo that includes patents 5 and regulatory exclusivities; 6 (4) strategies to implement such alternative 7 models described in paragraph (1), including a 8 phased transition; and 9 (5) the anticipated economic and societal im-10 pacts of such alternative models, including an as-11 sessment of impact on— 12 (A) the number and variety of new drugs 13 that would be developed, approved, and mar-14 keted in the United States, including such new 15 drugs intended to prevent, diagnose, or treat a 16 rare disease or condition; 17 (B) the rate at which new drugs would be 18 developed, approved, and marketed in the 19 United States; 20 (C) access to medication; 21 (D) health outcomes; 22 (E) average lifespan and disease burden in 23 the United States; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00488 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 489 •HR 1768 IH (F) the number of manufacturers that 1 would be seeking approval for a drug or bring-2 ing a drug to market for the first time; 3 (G) Federal discretionary and mandatory 4 spending; and 5 (H) public and private insurance markets. 6 (b) REQUIREMENTS.—In conducting the study pursu-7 ant to subsection (a), the National Academies shall hold 8 not fewer than 2 public listening sessions to solicit feed-9 back from interested parties, including representatives of 10 academia, professional societies, patient advocates, public 11 health organizations, relevant Federal departments and 12 agencies, drug developers, representatives of other rel-13 evant industries, and subject matter experts. 14 (c) REPORT.—Not later than 2 years after the agree-15 ment under subsection (a), the National Academies shall 16 submit to the Committee on Health, Education, Labor, 17 and Pensions and the Committee on Appropriations of the 18 Senate and the Committee on Energy and Commerce and 19 the Committee on Appropriations of the House of Rep-20 resentatives a report on the study conducted pursuant to 21 subsection (a). 22 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00489 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 490 •HR 1768 IH Subtitle D—Additional 1 Reauthorizations 2 SEC. 641. MEDICAL COUNTERMEASURE PRIORITY REVIEW 3 VOUCHER. 4 Section 565A(g) of the Federal Food, Drug, and Cos-5 metic Act (21 U.S.C. 360bbb–4a) is amended by striking 6 ‘‘October 1, 2023’’ and inserting ‘‘December 31, 2026’’. 7 SEC. 642. EPIDEMIC INTELLIGENCE SERVICE. 8 Section 317F(c)(2) of the Public Health Service Act 9 (42 U.S.C. 247b–7(c)(2)) is amended by striking ‘‘2019 10 through 2023’’ and inserting ‘‘2025 and 2026, to remain 11 available through December 31, 2026’’. 12 SEC. 643. MONITORING AND DISTRIBUTION OF CERTAIN 13 MEDICAL COUNTERMEASURES. 14 Section 319A(e) of the Public Health Service Act (42 15 U.S.C. 247d–1(e)) is amended by striking ‘‘2019 through 16 2023’’ and inserting ‘‘2025 and 2026, to remain available 17 through December 31, 2026’’. 18 SEC. 644. REGIONAL HEALTH CARE EMERGENCY PRE-19 PAREDNESS AND RESPONSE SYSTEMS. 20 Section 319C–3 of the Public Health Service Act (42 21 U.S.C. 247d–3c) is amended— 22 (1) in subsection (b)(3), by striking ‘‘under 23 the’’ and all that follows through ‘‘such Act)’’ and 24 inserting ‘‘under law’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00490 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 491 •HR 1768 IH (2) in subsection (e)(2), by striking ‘‘September 1 30, 2023’’ and inserting ‘‘December 31, 2026’’. 2 SEC. 645. EMERGENCY SYSTEM FOR ADVANCE REGISTRA-3 TION OF VOLUNTEER HEALTH PROFES-4 SIONALS. 5 (1) I N GENERAL .—Section 319I of the Public 6 Health Service Act (42 U.S.C. 247d–7b) is amend-7 ed— 8 (A) in subsection (a), by striking ‘‘Not 9 later than 12 months after the date of enact-10 ment of the Pandemic and All-Hazards Pre-11 paredness Act, the Secretary shall link existing 12 State verification systems to maintain a single 13 national interoperable network of systems,’’ and 14 inserting ‘‘The Secretary shall continue to 15 maintain a single national interoperable net-16 work of verification systems,’’ and 17 (B) in subsection (k), by striking ‘‘2019 18 through 2023’’ and inserting ‘‘2025 and 2026, 19 to remain available through December 31, 20 2026’’. 21 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00491 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 492 •HR 1768 IH SEC. 646. ENSURING COLLABORATION AND COORDINATION 1 IN MEDICAL COUNTERMEASURE DEVELOP-2 MENT. 3 Section 319L–1(b) of the Public Health Service Act 4 (42 U.S.C. 247d–7f(b)) is amended by striking ‘‘March 5 31, 2025’’ and inserting ‘‘December 31, 2026’’. 6 SEC. 647. MILITARY AND CIVILIAN PARTNERSHIP FOR 7 TRAUMA READINESS. 8 Section 1291(g) of the Public Health Service Act (42 9 U.S.C. 300d–91(g)) is amended by striking ‘‘2019 10 through 2023’’ and inserting ‘‘2025 and 2026, to remain 11 available through December 31, 2026’’. 12 SEC. 648. NATIONAL DISASTER MEDICAL SYSTEM. 13 Section 2812 of the Public Health Service Act (42 14 U.S.C. 300hh–11) is amended— 15 (1) in subsection (c)(4)(B), by striking ‘‘March 16 31, 2025’’ and inserting ‘‘December 31, 2026’’; and 17 (2) in subsection (g), by striking ‘‘$57,400,000 18 for each of fiscal years 2019 through 2023’’ and in-19 serting ‘‘$65,900,000 for each of fiscal years 2025 20 and 2026, to remain available through December 31, 21 2026’’. 22 SEC. 649. VOLUNTEER MEDICAL RESERVE CORPS. 23 Section 2813(i) of the Public Health Service Act (42 24 U.S.C. 300hh–15(i)) is amended by striking ‘‘2019 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00492 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 493 •HR 1768 IH through 2023’’ and inserting ‘‘2025 through 2026, to re-1 main available through December 31, 2026’’. 2 SEC. 650. EPIDEMIOLOGY-LABORATORY CAPACITY. 3 Section 2821(b) of the Public Health Service Act (42 4 U.S.C. 300hh–31(b)) is amended, in the matter preceding 5 paragraph (1), by striking ‘‘2019 through 2023’’ and in-6 serting ‘‘2025 and 2026, to remain available through De-7 cember 31, 2026’’. 8 TITLE VII—PUBLIC HEALTH 9 PROGRAMS 10 SEC. 701. ACTION FOR DENTAL HEALTH. 11 Section 340G(f) of the Public Health Service Act (42 12 U.S.C. 256g(f)) is amended by striking ‘‘$13,903,000 for 13 each of fiscal years 2019 through 2023’’ and inserting 14 ‘‘$15,000,000 for each of fiscal years 2025 through 2029, 15 to remain available until expended’’. 16 SEC. 702. PREEMIE. 17 (a) RESEARCH RELATING TO PRETERM LABOR AND 18 DELIVERY AND THE CARE, TREATMENT, AND OUTCOMES 19 OF PRETERM AND LOW BIRTHWEIGHT INFANTS.— 20 (1) I N GENERAL .—Section 3(e) of the Pre-21 maturity Research Expansion and Education for 22 Mothers who deliver Infants Early Act (42 U.S.C. 23 247b–4f(e)) is amended by striking ‘‘fiscal years 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00493 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 494 •HR 1768 IH 2019 through 2023’’ and inserting ‘‘fiscal years 1 2025 through 2029’’. 2 (2) T ECHNICAL CORRECTION .—Effective as if 3 included in the enactment of the PREEMIE Reau-4 thorization Act of 2018 (Public Law 115–328), sec-5 tion 2 of such Act is amended, in the matter pre-6 ceding paragraph (1), by striking ‘‘Section 2’’ and 7 inserting ‘‘Section 3’’. 8 (b) I NTERAGENCY WORKING GROUP.—Section 5(a) 9 of the PREEMIE Reauthorization Act of 2018 (Public 10 Law 115–328) is amended by striking ‘‘The Secretary of 11 Health and Human Services, in collaboration with other 12 departments, as appropriate, may establish’’ and inserting 13 ‘‘Not later than 18 months after the date of the enactment 14 of Lower Costs for Everyday Americans Act, the Secretary 15 of Health and Human Services, in collaboration with other 16 departments, as appropriate, shall establish’’. 17 (c) STUDY ON PRETERM BIRTHS.— 18 (1) IN GENERAL .—The Secretary of Health and 19 Human Services shall enter into appropriate ar-20 rangements with the National Academies of 21 Sciences, Engineering, and Medicine under which 22 the National Academies shall— 23 (A) not later than 30 days after the date 24 of enactment of this Act, convene a committee 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00494 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 495 •HR 1768 IH of experts in maternal health to study pre-1 mature births in the United States; and 2 (B) upon completion of the study under 3 subparagraph (A)— 4 (i) approve by consensus a report on 5 the results of such study; 6 (ii) include in such report— 7 (I) an assessment of each of the 8 topics listed in paragraph (2); 9 (II) the analysis required by 10 paragraph (3); and 11 (III) the raw data used to de-12 velop such report; and 13 (iii) not later than 24 months after 14 the date of enactment of this Act, transmit 15 such report to— 16 (I) the Secretary of Health and 17 Human Services; 18 (II) the Committee on Energy 19 and Commerce of the House of Rep-20 resentatives; and 21 (III) the Committee on Finance 22 and the Committee on Health, Edu-23 cation, Labor, and Pensions of the 24 Senate. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00495 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 496 •HR 1768 IH (2) A SSESSMENT TOPICS .—The topics listed in 1 this subsection are each of the following: 2 (A) The financial costs of premature birth 3 to society, including— 4 (i) an analysis of stays in neonatal in-5 tensive care units and the cost of such 6 stays; 7 (ii) long-term costs of stays in such 8 units to society and the family involved 9 post-discharge; and 10 (iii) health care costs for families 11 post-discharge from such units (such as 12 medications, therapeutic services, co-pay-13 ments for visits, and specialty equipment). 14 (B) The factors that impact preterm birth 15 rates. 16 (C) Opportunities for earlier detection of 17 premature birth risk factors, including— 18 (i) opportunities to improve maternal 19 and infant health; and 20 (ii) opportunities for public health 21 programs to provide support and resources 22 for parents in-hospital, in non-hospital set-23 tings, and post-discharge. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00496 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 497 •HR 1768 IH (3) A NALYSIS.—The analysis required by this 1 subsection is an analysis of— 2 (A) targeted research strategies to develop 3 effective drugs, treatments, or interventions to 4 bring at-risk pregnancies to term; 5 (B) State and other programs’ best prac-6 tices with respect to reducing premature birth 7 rates; and 8 (C) precision medicine and preventative 9 care approaches starting early in the life course 10 (including during pregnancy) with a focus on 11 behavioral and biological influences on pre-12 mature birth, child health, and the trajectory of 13 such approaches into adulthood. 14 SEC. 703. PREVENTING MATERNAL DEATHS. 15 (a) M ATERNAL MORTALITY REVIEW COMMITTEE.— 16 Section 317K(d) of the Public Health Service Act (42 17 U.S.C. 247b–12(d)) is amended— 18 (1) in paragraph (1)(A), by inserting ‘‘(includ-19 ing obstetricians and gynecologists)’’ after ‘‘clinical 20 specialties’’; and 21 (2) in paragraph (3)(A)(i)— 22 (A) in subclause (I), by striking ‘‘as appli-23 cable’’ and inserting ‘‘if available’’; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00497 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 498 •HR 1768 IH (B) in subclause (III), by striking ‘‘, as ap-1 propriate’’ and inserting ‘‘and coordinating with 2 death certifiers to improve the collection of 3 death record reports and the quality of death 4 records, including by amending cause-of-death 5 information on a death certificate, as appro-6 priate’’. 7 (b) B EST PRACTICES RELATING TO THE PREVEN-8 TION OF MATERNAL MORTALITY.—Section 317K of the 9 Public Health Service Act (42 U.S.C. 247b–12) is amend-10 ed— 11 (1) by redesignating subsections (e) and (f) as 12 subsections (f) and (g), respectively; and 13 (2) by inserting after subsection (d) the fol-14 lowing: 15 ‘‘(e) B EST PRACTICES RELATING TO THE PREVEN-16 TION OF MATERNAL MORTALITY.— 17 ‘‘(1) I N GENERAL .—The Secretary, acting 18 through the Director of the Centers for Disease 19 Control and Prevention, shall, in consultation with 20 the Administrator of the Health Resources and Serv-21 ices Administration, disseminate to hospitals, State 22 professional society groups, and perinatal quality 23 collaboratives, best practices on how to prevent ma-24 ternal mortality and morbidity that consider and re-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00498 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 499 •HR 1768 IH flect best practices identified through other relevant 1 Federal maternal health programs. 2 ‘‘(2) F REQUENCY.—The Secretary, acting 3 through the Director of the Centers for Disease 4 Control and Prevention, shall disseminate the best 5 practices referred to in paragraph (1) not less than 6 once per fiscal year.’’. 7 (c) E XTENSION.—Subsection (g) of section 317K of 8 the Public Health Service Act (42 U.S.C. 247b–12), as 9 redesignated by subsection (b), is amended by striking 10 ‘‘$58,000,000 for each of fiscal years 2019 through 2023’’ 11 and inserting ‘‘$100,000,000 for each of fiscal years 2025 12 through 2029’’. 13 SEC. 704. SICKLE CELL DISEASE PREVENTION AND TREAT-14 MENT. 15 (a) I N GENERAL.—Section 1106(b) of the Public 16 Health Service Act (42 U.S.C. 300b–5(b)) is amended— 17 (1) in paragraph (1)(A)(iii), by striking ‘‘pre-18 vention and treatment of sickle cell disease’’ and in-19 serting ‘‘treatment of sickle cell disease and the pre-20 vention and treatment of complications of sickle cell 21 disease’’; 22 (2) in paragraph (2)(D), by striking ‘‘preven-23 tion and treatment of sickle cell disease’’ and insert-24 ing ‘‘treatment of sickle cell disease and the preven-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00499 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 500 •HR 1768 IH tion and treatment of complications of sickle cell dis-1 ease’’; 2 (3) in paragraph (3)— 3 (A) in subparagraph (A), by striking 4 ‘‘enter into a contract with’’ and inserting 5 ‘‘make a grant to, or enter into a contract or 6 cooperative agreement with,’’; and 7 (B) in subparagraph (B), in each of 8 clauses (ii) and (iii), by striking ‘‘prevention 9 and treatment of sickle cell disease’’ and insert-10 ing ‘‘treatment of sickle cell disease and the 11 prevention and treatment of complications of 12 sickle cell disease’’; and 13 (4) in paragraph (6), by striking ‘‘$4,455,000 14 for each of fiscal years 2019 through 2023’’ and in-15 serting ‘‘$8,205,000 for each of fiscal years 2025 16 through 2029’’. 17 (b) S ENSE OF CONGRESS.—It is the sense of Con-18 gress that further research should be undertaken to ex-19 pand the understanding of the causes of, and to find cures 20 for, heritable blood disorders, including sickle cell disease. 21 SEC. 705. TRAUMATIC BRAIN INJURIES. 22 (a) T HE BILL PASCRELL, J R., N ATIONAL PROGRAM 23 FOR TRAUMATIC BRAIN INJURY SURVEILLANCE AND 24 REGISTRIES.— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00500 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 501 •HR 1768 IH (1) P REVENTION OF TRAUMATIC BRAIN IN -1 JURY.—Section 393B of the Public Health Service 2 Act (42 U.S.C. 280b–1c) is amended— 3 (A) in subsection (a), by inserting ‘‘and 4 prevalence’’ after ‘‘incidence’’; 5 (B) in subsection (b)— 6 (i) in paragraph (1), by inserting 7 ‘‘and reduction of associated injuries and 8 fatalities’’ before the semicolon; 9 (ii) in paragraph (2), by inserting 10 ‘‘and related risk factors’’ before the semi-11 colon; and 12 (iii) in paragraph (3)— 13 (I) in the matter preceding sub-14 paragraph (A), by striking ‘‘2020’’ 15 each place it appears and inserting 16 ‘‘2030’’; and 17 (II) in subparagraph (A)— 18 (aa) in clause (i), by striking 19 ‘‘; and’’ and inserting a semi-20 colon; 21 (bb) by redesignating clause 22 (ii) as clause (iv); 23 (cc) by inserting after clause 24 (i) the following: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00501 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 502 •HR 1768 IH ‘‘(ii) populations at higher risk of 1 traumatic brain injury, including popu-2 lations whose increased risk is due to occu-3 pational or circumstantial factors; 4 ‘‘(iii) causes of, and risk factors for, 5 traumatic brain injury; and’’; and 6 (dd) in clause (iv), as so re-7 designated, by striking ‘‘arising 8 from traumatic brain injury’’ and 9 inserting ‘‘, which may include 10 related mental health and other 11 conditions, arising from trau-12 matic brain injury, including’’; 13 and 14 (C) in subsection (c), by inserting ‘‘, and 15 other relevant Federal departments and agen-16 cies’’ before the period at the end. 17 (2) N ATIONAL PROGRAM FOR TRAUMATIC 18 BRAIN INJURY SURVEILLANCE AND REGISTRIES .— 19 Section 393C of the Public Health Service Act (42 20 U.S.C. 280b–1d) is amended— 21 (A) by amending the section heading to 22 read as follows: ‘‘ THE BILL PASCRELL , JR., 23 NATIONAL PROGRAM FOR TRAUMATIC 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00502 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 503 •HR 1768 IH BRAIN INJURY SURVEILLANCE AND REG -1 ISTRIES’’; 2 (B) in subsection (a)— 3 (i) in the matter preceding paragraph 4 (1), by inserting ‘‘to identify populations 5 that may be at higher risk for traumatic 6 brain injuries, to collect data on the causes 7 of, and risk factors for, traumatic brain in-8 juries,’’ after ‘‘related disability,’’; 9 (ii) in paragraph (1), by inserting ‘‘, 10 including the occupation of the individual, 11 when relevant to the circumstances sur-12 rounding the injury’’ before the semicolon; 13 and 14 (iii) in paragraph (4), by inserting 15 ‘‘short- and long-term’’ before ‘‘outcomes’’; 16 (C) by striking subsection (b); 17 (D) by redesignating subsection (c) as sub-18 section (b); 19 (E) in subsection (b), as so redesignated, 20 by inserting ‘‘and evidence-based practices to 21 identify and address concussion’’ before the pe-22 riod at the end; and 23 (F) by adding at the end the following: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00503 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 504 •HR 1768 IH ‘‘(c) A VAILABILITY OF INFORMATION.—The Sec-1 retary, acting through the Director of the Centers for Dis-2 ease Control and Prevention, shall make publicly available 3 aggregated information on traumatic brain injury and 4 concussion described in this section, including on the 5 website of the Centers for Disease Control and Prevention. 6 Such website, to the extent feasible, shall include aggre-7 gated information on populations that may be at higher 8 risk for traumatic brain injuries and strategies for pre-9 venting or reducing risk of traumatic brain injury that are 10 tailored to such populations.’’. 11 (3) A UTHORIZATION OF APPROPRIATIONS .— 12 Section 394A of the Public Health Service Act (42 13 U.S.C. 280b–3) is amended— 14 (A) in subsection (a), by striking ‘‘1994, 15 and’’ and inserting ‘‘1994,’’; and 16 (B) in subsection (b), by striking ‘‘2020 17 through 2024’’ and inserting ‘‘2025 through 18 2029’’. 19 (b) STATE GRANT PROGRAMS.— 20 (1) S TATE GRANTS FOR PROJECTS REGARDING 21 TRAUMATIC BRAIN INJURY .—Section 1252 of the 22 Public Health Service Act (42 U.S.C. 300d–52) is 23 amended— 24 (A) in subsection (b)(2)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00504 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 505 •HR 1768 IH (i) by inserting ‘‘, taking into consid-1 eration populations that may be at higher 2 risk for traumatic brain injuries’’ after 3 ‘‘outreach programs’’; and 4 (ii) by inserting ‘‘Tribal,’’ after 5 ‘‘State,’’; 6 (B) in subsection (c), by adding at the end 7 the following: 8 ‘‘(3) M AINTENANCE OF EFFORT .—With respect 9 to activities for which a grant awarded under sub-10 section (a) is to be expended, a State or American 11 Indian consortium shall agree to maintain expendi-12 tures of non-Federal amounts for such activities at 13 a level that is not less than the level of such expendi-14 tures maintained by the State or American Indian 15 consortium for the fiscal year preceding the fiscal 16 year for which the State or American Indian consor-17 tium receives such a grant. 18 ‘‘(4) W AIVER.—The Secretary may, upon the 19 request of a State or American Indian consortium, 20 waive not more than 50 percent of the matching 21 fund amount under paragraph (1), if the Secretary 22 determines that such matching fund amount would 23 result in an inability of the State or American In-24 dian consortium to carry out the purposes under 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00505 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 506 •HR 1768 IH subsection (a). A waiver provided by the Secretary 1 under this paragraph shall apply only to the fiscal 2 year involved.’’; 3 (C) in subsection (e)(3)(B)— 4 (i) by striking ‘‘(such as third party 5 payers, State agencies, community-based 6 providers, schools, and educators)’’; and 7 (ii) by inserting ‘‘(such as third party 8 payers, State agencies, community-based 9 providers, schools, and educators)’’ after 10 ‘‘professionals’’; 11 (D) in subsection (h), by striking para-12 graphs (1) and (2) and inserting the following: 13 ‘‘(1) AMERICAN INDIAN CONSORTIUM ; STATE.— 14 The terms ‘American Indian consortium’ and ‘State’ 15 have the meanings given such terms in section 1253. 16 ‘‘(2) TRAUMATIC BRAIN INJURY .— 17 ‘‘(A) I N GENERAL .—Subject to subpara-18 graph (B), the term ‘traumatic brain injury’— 19 ‘‘(i) means an acquired injury to the 20 brain; 21 ‘‘(ii) may include— 22 ‘‘(I) brain injuries caused by an-23 oxia due to trauma; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00506 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 507 •HR 1768 IH ‘‘(II) damage to the brain from 1 an internal or external source that re-2 sults in infection, toxicity, surgery, or 3 vascular disorders not associated with 4 aging; and 5 ‘‘(iii) does not include brain dysfunc-6 tion caused by congenital or degenerative 7 disorders, or birth trauma. 8 ‘‘(B) R EVISIONS TO DEFINITION .—The 9 Secretary may revise the definition of the term 10 ‘traumatic brain injury’ under this paragraph, 11 as the Secretary determines necessary, after 12 consultation with States and other appropriate 13 public or nonprofit private entities.’’; and 14 (E) in subsection (i), by striking ‘‘2020 15 through 2024’’ and inserting ‘‘2025 through 16 2029’’. 17 (2) S TATE GRANTS FOR PROTECTION AND AD -18 VOCACY SERVICES .—Section 1253(l) of the Public 19 Health Service Act (42 U.S.C. 300d–53(l)) is 20 amended by striking ‘‘2020 through 2024’’ and in-21 serting ‘‘2025 through 2029’’. 22 (c) R EPORT TO CONGRESS.—Not later than 2 years 23 after the date of enactment of this Act, the Secretary of 24 Health and Human Services (referred to in this Act as 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00507 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 508 •HR 1768 IH the ‘‘Secretary’’) shall submit to the Committee on 1 Health, Education, Labor, and Pensions of the Senate and 2 the Committee on Energy and Commerce of the House 3 of Representatives a report that contains— 4 (1) an overview of populations who may be at 5 higher risk for traumatic brain injury, such as indi-6 viduals affected by domestic violence or sexual as-7 sault and public safety officers as defined in section 8 1204 of the Omnibus Crime Control and Safe 9 Streets Act of 1968 (34 U.S.C. 10284); 10 (2) an outline of existing surveys and activities 11 of the Centers for Disease Control and Prevention 12 on traumatic brain injuries and any steps the agency 13 has taken to address gaps in data collection related 14 to such higher risk populations, which may include 15 leveraging surveys such as the National Intimate 16 Partner and Sexual Violence Survey to collect data 17 on traumatic brain injuries; 18 (3) an overview of any outreach or education ef-19 forts to reach such higher risk populations; and 20 (4) any challenges associated with reaching 21 such higher risk populations. 22 (d) S TUDY ON LONG-TERM SYMPTOMS OR CONDI-23 TIONS RELATED TO TRAUMATIC BRAIN INJURY.— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00508 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 509 •HR 1768 IH (1) I N GENERAL .—The Secretary, in consulta-1 tion with stakeholders and the heads of other rel-2 evant Federal departments and agencies, as appro-3 priate, shall conduct, either directly or through a 4 contract with a nonprofit private entity, a study to— 5 (A) examine the incidence and prevalence 6 of long-term or chronic symptoms or conditions 7 in individuals who have experienced a traumatic 8 brain injury; 9 (B) examine the evidence base of research 10 related to the chronic effects of traumatic brain 11 injury across the lifespan; 12 (C) examine any correlations between trau-13 matic brain injury and increased risk of other 14 conditions, such as dementia and mental health 15 conditions; 16 (D) assess existing services available for 17 individuals with such long-term or chronic 18 symptoms or conditions; and 19 (E) identify any gaps in research related to 20 such long-term or chronic symptoms or condi-21 tions of individuals who have experienced a 22 traumatic brain injury. 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00509 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 510 •HR 1768 IH (2) P UBLIC REPORT .—Not later than 2 years 1 after the date of enactment of this Act, the Sec-2 retary shall— 3 (A) submit to the Committee on Energy 4 and Commerce of the House of Representatives 5 and the Committee on Health, Education, 6 Labor, and Pensions of the Senate a report de-7 tailing the findings, conclusions, and rec-8 ommendations of the study described in para-9 graph (1); and 10 (B) in the case that such study is con-11 ducted directly by the Secretary, make the re-12 port described in subparagraph (A) publicly 13 available on the website of the Department of 14 Health and Human Services. 15 SEC. 706. LIFESPAN RESPITE CARE. 16 (a) D EFINITION OF FAMILY CAREGIVER.—Section 17 2901(5) of the Public Health Service Act (42 U.S.C. 18 300ii(5)) is amended by striking ‘‘unpaid adult’’ and in-19 serting ‘‘unpaid individual’’. 20 (b) F UNDING.—Section 2905 of the Public Health 21 Service Act (42 U.S.C. 300ii–4) is amended by striking 22 ‘‘fiscal years 2020 through fiscal year 2024’’ and inserting 23 ‘‘fiscal years 2025 through 2029’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00510 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 511 •HR 1768 IH SEC. 707. DR. LORNA BREEN HEALTH CARE PROVIDER PRO-1 TECTION. 2 (a) D ISSEMINATION OF BEST PRACTICES.—Section 3 2 of the Dr. Lorna Breen Health Care Provider Protection 4 Act (Public Law 117–105) is amended by striking ‘‘2 5 years’’ and inserting ‘‘5 years’’. 6 (b) E DUCATION AND AWARENESS INITIATIVE EN-7 COURAGING USE OF MENTAL HEALTH AND SUBSTANCE 8 USE DISORDER SERVICES BY HEALTH CARE PROFES-9 SIONALS.—Section 3 of the Dr. Lorna Breen Health Care 10 Provider Protection Act (Public Law 117–105) is amend-11 ed— 12 (1) in subsection (b), by inserting ‘‘and annu-13 ally thereafter,’’ after ‘‘of this Act,’’; and 14 (2) in subsection (c), by striking ‘‘2022 through 15 2024’’ and inserting ‘‘2025 through 2029’’. 16 (c) P ROGRAMS TO PROMOTE MENTAL HEALTH 17 AMONG THE HEALTH PROFESSIONAL WORKFORCE.—The 18 second section 764 of the Public Health Service Act (42 19 U.S.C. 294t), as added by section 4 of the Dr. Lorna 20 Breen Health Care Provider Protection Act (Public Law 21 117–105), is amended— 22 (1) by redesignating such section 764 as section 23 764A; 24 (2) in subsection (a)(3)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00511 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 512 •HR 1768 IH (A) by striking ‘‘to eligible entities in’’ and 1 inserting ‘‘to eligible entities that— 2 ‘‘(A) are in’’; 3 (B) by striking the period and inserting ‘‘; 4 or’’; and 5 (C) by adding at the end the following: 6 ‘‘(B) have a focus on the reduction of ad-7 ministrative burden on health care workers.’’; 8 (3) in subsection (c), by inserting ‘‘not less 9 than’’ after ‘‘period of’’; and 10 (4) in subsection (f), by striking ‘‘2022 through 11 2024’’ and inserting ‘‘2025 through 2029’’. 12 SEC. 708. CONFORMING AMENDMENT TO INTERNAL REV-13 ENUE CODE OF 1986. 14 Section 9008(i)(2) of the Internal Revenue Code of 15 1986 (26 U.S.C. 9008(i)(2)) is amended by striking ‘‘10– 16 Year’’. 17 SEC. 709. SCREENS FOR CANCER. 18 (a) N ATIONAL BREAST AND CERVICAL CANCER 19 EARLY DETECTION PROGRAM.—Title XV of the Public 20 Health Service Act (42 U.S.C. 300k et seq.) is amended— 21 (1) in section 1501 (42 U.S.C. 300k)— 22 (A) in subsection (a)— 23 (i) in paragraph (2), by striking ‘‘the 24 provision of appropriate follow-up services 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00512 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 513 •HR 1768 IH and support services such as case manage-1 ment’’ and inserting ‘‘that appropriate fol-2 low-up services are provided’’; 3 (ii) in paragraph (3), by striking 4 ‘‘programs for the detection and control’’ 5 and inserting ‘‘for the prevention, detec-6 tion, and control’’; 7 (iii) in paragraph (4), by striking ‘‘the 8 detection and control’’ and inserting ‘‘the 9 prevention, detection, and control’’; 10 (iv) in paragraph (5)— 11 (I) by striking ‘‘monitor’’ and in-12 serting ‘‘ensure’’; and 13 (II) by striking ‘‘; and’’ and in-14 serting a semicolon; 15 (v) by redesignating paragraph (6) as 16 paragraph (9); 17 (vi) by inserting after paragraph (5) 18 the following: 19 ‘‘(6) to enhance appropriate support activities 20 to increase breast and cervical cancer screenings, 21 such as navigation of health care services, implemen-22 tation of evidence-based or evidence-informed strate-23 gies to increase breast and cervical cancer screening 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00513 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 514 •HR 1768 IH in health care settings, and facilitation of access to 1 health care settings; 2 ‘‘(7) to reduce disparities in breast and cervical 3 cancer incidence, morbidity, and mortality, including 4 in populations with higher than average rates; 5 ‘‘(8) to improve access to breast and cervical 6 cancer screening and diagnostic services and reduce 7 related barriers, including factors that relate to neg-8 ative health outcomes; and’’; and 9 (vii) in paragraph (9), as so redesig-10 nated, by striking ‘‘through (5)’’ and in-11 serting ‘‘through (8)’’; and 12 (B) by striking subsection (d); 13 (2) in section 1503 (42 U.S.C. 300m)— 14 (A) in subsection (a)— 15 (i) in paragraph (1), by striking 16 ‘‘that, initially’’ and all that follows 17 through the semicolon and inserting ‘‘that 18 appropriate breast and cervical cancer 19 screening and diagnostic services are pro-20 vided consistent with relevant evidence- 21 based recommendations; and’’; 22 (ii) by striking paragraphs (2) and 23 (4); 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00514 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 515 •HR 1768 IH (iii) by redesignating paragraph (3) as 1 paragraph (2); and 2 (iv) in paragraph (2), as so redesig-3 nated, by striking ‘‘; and’’ and inserting a 4 period; and 5 (B) by striking subsection (d); 6 (3) in section 1508(b) (42 U.S.C. 300n–4(b))— 7 (A) by striking ‘‘1 year after the date of 8 the enactment of the National Breast and Cer-9 vical Cancer Early Detection Program Reau-10 thorization of 2007, and annually thereafter,’’ 11 and inserting ‘‘2 years after the date of enact-12 ment of the Health Improvements, Extenders, 13 and Reauthorizations Act, and every 5 years 14 thereafter,’’; 15 (B) by striking ‘‘Labor and Human Re-16 sources’’ and inserting ‘‘Health, Education, 17 Labor, and Pensions’’; and 18 (C) by striking ‘‘preceding fiscal year’’ and 19 inserting ‘‘preceding 2 fiscal years in the case 20 of the first report after the date of enactment 21 of the Health Improvements, Extenders, and 22 Reauthorizations Act and preceding 5 fiscal 23 years for each report thereafter’’; and 24 (4) in section 1510(a) (42 U.S.C. 300n–5(a))— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00515 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 516 •HR 1768 IH (A) by striking ‘‘2011, and’’ and inserting 1 ‘‘2011,’’; and 2 (B) by inserting ‘‘, and $235,500,000 for 3 each of fiscal years 2025 through 2029’’ before 4 the period at the end before the period at the 5 end. 6 (b) GAO S TUDY.—Not later than September 30, 7 2027, the Comptroller General of the United States shall 8 report to the Committee on Health, Education, Labor, and 9 Pensions of the Senate and the Committee on Energy and 10 Commerce of the House of Representatives on the work 11 of the National Breast and Cervical Cancer Early Detec-12 tion Program, including— 13 (1) an estimate of the number of individuals eli-14 gible for services provided under such program; 15 (2) a summary of trends in the number of indi-16 viduals served through such program; and 17 (3) an assessment of any factors that may be 18 driving the trends identified under paragraph (2), 19 including any barriers to accessing breast and cer-20 vical cancer screenings provided by such program. 21 SEC. 710. DEONDRA DIXON INCLUDE PROJECT. 22 Part B of title IV of the Public Health Service Act 23 (42 U.S.C. 284 et seq.) is amended by adding at the end 24 the following: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00516 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 517 •HR 1768 IH ‘‘SEC. 409K. DOWN SYNDROME RESEARCH. 1 ‘‘(a) IN GENERAL.—The Director of NIH shall carry 2 out a program of research, training, and investigation re-3 lated to Down syndrome to be known as the ‘INvestigation 4 of Co-occurring conditions across the Lifespan to Under-5 stand Down syndromE Project’ or the ‘INCLUDE 6 Project’. 7 ‘‘(b) P ROGRAM ELEMENTS.—The program under 8 subsection (a) shall include— 9 ‘‘(1) high-risk, high reward research on the ef-10 fects of trisomy 21 on human development and 11 health; 12 ‘‘(2) promoting research for participants with 13 Down syndrome across the lifespan, including cohort 14 studies to facilitate improved understanding of 15 Down syndrome and co-occurring conditions and de-16 velopment of new interventions; 17 ‘‘(3) expanding the number of clinical trials 18 that are inclusive of, or expressly for, participants 19 with Down syndrome, including novel biomedical and 20 pharmacological interventions and other therapies 21 designed to promote or enhance activities of daily 22 living; 23 ‘‘(4) research on the biological mechanisms in 24 individuals with Down syndrome pertaining to struc-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00517 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 518 •HR 1768 IH tural, functional, and behavioral anomalies and dys-1 function as well as stunted growth; 2 ‘‘(5) supporting research to improve diagnosis 3 and treatment of conditions co-occurring with Down 4 syndrome, including the identification of biomarkers 5 related to risk factors, diagnosis, and clinical re-6 search and therapeutics; 7 ‘‘(6) research on the causes of increased preva-8 lence, and concurrent treatment, of co-occurring con-9 ditions, such as Alzheimer’s disease and related de-10 mentias and autoimmunity, in individuals with Down 11 syndrome; and 12 ‘‘(7) research, training, and investigation on im-13 proving the quality of life of individuals with Down 14 syndrome and their families. 15 ‘‘(c) C OORDINATION; P RIORITIZING NONDUPLICA-16 TIVE RESEARCH.—The Director of NIH shall ensure 17 that— 18 ‘‘(1) the programs and activities of the insti-19 tutes and centers of the National Institutes of 20 Health relating to Down syndrome and co-occurring 21 conditions are coordinated, including through the 22 Office of the Director of NIH and priority-setting 23 reviews conducted pursuant to section 402(b)(3); 24 and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00518 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 519 •HR 1768 IH ‘‘(2) such institutes and centers, prioritize, as 1 appropriate, Down syndrome research that does not 2 duplicate existing research activities of the National 3 Institutes of Health. 4 ‘‘(d) C ONSULTATION WITH STAKEHOLDERS.—In 5 carrying out activities under this section, the Director of 6 NIH shall, as appropriate and to the maximum extent fea-7 sible, consult with relevant stakeholders, including patient 8 advocates, to ensure that such activities take into consid-9 eration the needs of individuals with Down syndrome. 10 ‘‘(e) BIENNIAL REPORTS TO CONGRESS.— 11 ‘‘(1) I N GENERAL .—The Director of NIH shall 12 submit, on a biennial basis, to the Committee on 13 Energy and Commerce and the Subcommittee on 14 Labor, Health and Human Services, Education, and 15 Related Agencies of the Committee on Appropria-16 tions of the House of Representatives and the Com-17 mittee on Health, Education, Labor, and Pensions 18 and the Subcommittee on Labor, Health and 19 Human Services, Education, and Related Agencies 20 of the Committee on Appropriations of the Senate, 21 a report that catalogs the research conducted or 22 supported under this section. 23 ‘‘(2) C ONTENTS.—Each report under para-24 graph (1) shall include— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00519 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 520 •HR 1768 IH ‘‘(A) identification of the institute or cen-1 ter involved; 2 ‘‘(B) a statement of whether the research 3 is or was being carried out directly by such in-4 stitute or center or by multiple institutes and 5 centers; and 6 ‘‘(C) identification of any resulting real- 7 world evidence that is or may be used for clin-8 ical research and medical care for patients with 9 Down syndrome.’’. 10 SEC. 711. IMPROVE INITIATIVE. 11 Part B of title IV of the Public Health Service Act 12 (42 U.S.C. 284 et seq.), as amended by section 710, is 13 further amended by adding at the end the following: 14 ‘‘SEC. 409L. IMPROVE INITIATIVE. 15 ‘‘(a) IN GENERAL.—The Director of the National In-16 stitutes of Health shall carry out a program of research 17 to improve health outcomes to be known as the Imple-18 menting a Maternal health and PRegnancy Outcomes Vi-19 sion for Everyone Initiative (referred to in this section as 20 the ‘Initiative’). 21 ‘‘(b) OBJECTIVES.—The Initiative shall— 22 ‘‘(1) advance research to— 23 ‘‘(A) reduce preventable causes of maternal 24 mortality and severe maternal morbidity; 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00520 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 521 •HR 1768 IH ‘‘(B) reduce health disparities related to 1 maternal health outcomes, including such dis-2 parities associated with medically underserved 3 populations; and 4 ‘‘(C) improve health for pregnant and 5 postpartum women before, during, and after 6 pregnancy; 7 ‘‘(2) use an integrated approach to understand 8 the factors, including biological, behavioral, and 9 other factors, that affect maternal mortality and se-10 vere maternal morbidity by building an evidence 11 base for improved outcomes in specific regions of the 12 United States; and 13 ‘‘(3) target health disparities associated with 14 maternal mortality and severe maternal morbidity 15 by— 16 ‘‘(A) implementing and evaluating commu-17 nity-based interventions for disproportionately 18 affected women; and 19 ‘‘(B) identifying risk factors and the un-20 derlying biological mechanisms associated with 21 leading causes of maternal mortality and severe 22 maternal morbidity in the United States. 23 ‘‘(c) SUNSET.—The authority under this section shall 24 expire on September 30, 2029.’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00521 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 522 •HR 1768 IH SEC. 712. ORGAN PROCUREMENT AND TRANSPLANTATION 1 NETWORK. 2 Section 372 of the Public Health Service Act (42 3 U.S.C. 274) is amended— 4 (1) in subsection (b)(2)— 5 (A) by moving the margins of subpara-6 graphs (M) through (O) 2 ems to the left; 7 (B) in subparagraph (A)— 8 (i) in clause (i), by striking ‘‘, and’’ 9 and inserting ‘‘; and’’; and 10 (ii) in clause (ii), by striking the 11 comma at the end and inserting a semi-12 colon; 13 (C) in subparagraph (C), by striking 14 ‘‘twenty-four-hour telephone service’’ and in-15 serting ‘‘24-hour telephone or information tech-16 nology service’’; 17 (D) in each of subparagraphs (B) through 18 (M), by striking the comma at the end and in-19 serting a semicolon; 20 (E) in subparagraph (N), by striking 21 ‘‘transportation, and’’ and inserting ‘‘transpor-22 tation;’’; 23 (F) in subparagraph (O), by striking the 24 period and inserting a semicolon; and 25 (G) by adding at the end the following: 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00522 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 523 •HR 1768 IH ‘‘(P) encourage the integration of elec-1 tronic health records systems through applica-2 tion programming interfaces (or successor tech-3 nologies) among hospitals, organ procurement 4 organizations, and transplant centers, including 5 the use of automated electronic hospital refer-6 rals and the grant of remote, electronic access 7 to hospital electronic health records of potential 8 donors by organ procurement organizations, in 9 a manner that complies with the privacy regula-10 tions promulgated under the Health Insurance 11 Portability and Accountability Act of 1996, at 12 part 160 of title 45, Code of Federal Regula-13 tions, and subparts A, C, and E of part 164 of 14 such title (or any successor regulations); and 15 ‘‘(Q) consider establishing a dashboard to 16 display the number of transplants performed, 17 the types of transplants performed, the number 18 and types of organs that entered the Organ 19 Procurement and Transplantation Network sys-20 tem and failed to be transplanted, and other 21 appropriate statistics, which should be updated 22 more frequently than annually.’’; and 23 (2) by adding at the end the following: 24 ‘‘(d) REGISTRATION FEES.— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00523 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 524 •HR 1768 IH ‘‘(1) I N GENERAL .—The Secretary may collect 1 registration fees from any member of the Organ 2 Procurement and Transplantation Network for each 3 transplant candidate such member places on the list 4 described in subsection (b)(2)(A)(i). Such registra-5 tion fees shall be collected and distributed only to 6 support the operation of the Organ Procurement 7 and Transplantation Network. Such registration fees 8 are authorized to remain available until expended. 9 ‘‘(2) C OLLECTION.—The Secretary may collect 10 the registration fees under paragraph (1) directly or 11 through awards made under subsection (b)(1)(A). 12 ‘‘(3) D ISTRIBUTION.—Any amounts collected 13 under this subsection shall— 14 ‘‘(A) be credited to the currently applicable 15 appropriation, account, or fund of the Depart-16 ment of Health and Human Services as discre-17 tionary offsetting collections; and 18 ‘‘(B) be available, only to the extent and in 19 the amounts provided in advance in appropria-20 tions Acts, to distribute such fees among 21 awardees described in subsection (b)(1)(A). 22 ‘‘(4) TRANSPARENCY.—The Secretary shall— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00524 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 525 •HR 1768 IH ‘‘(A) promptly post on the website of the 1 Organ Procurement and Transplantation Net-2 work— 3 ‘‘(i) the amount of registration fees 4 collected under this subsection from each 5 member of the Organ Procurement and 6 Transplantation Network; and 7 ‘‘(ii) a list of activities such fees are 8 used to support; and 9 ‘‘(B) update the information posted pursu-10 ant to subparagraph (A), as applicable for each 11 calendar quarter for which fees are collected 12 under paragraph (1). 13 ‘‘(5) GAO REVIEW.—Not later than 2 years 14 after the date of enactment of this subsection, the 15 Comptroller General of the United States shall, to 16 the extent data are available— 17 ‘‘(A) conduct a review concerning the ac-18 tivities under this subsection; and 19 ‘‘(B) submit to the Committee on Health, 20 Education, Labor, and Pensions and the Com-21 mittee on Finance of the Senate and the Com-22 mittee on Energy and Commerce of the House 23 of Representatives, a report on such review, in-24 cluding related recommendations, as applicable. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00525 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 526 •HR 1768 IH ‘‘(6) S UNSET.—The authority to collect reg-1 istration fees under paragraph (1) shall expire on 2 the date that is 3 years after the date of enactment 3 of the Health Improvements, Extenders, and Reau-4 thorizations Act.’’. 5 SEC. 713. HONOR OUR LIVING DONORS. 6 (a) N O CONSIDERATION OF INCOME OF ORGAN RE-7 CIPIENT.—Section 377 of the Public Health Service Act 8 (42 U.S.C. 274f) is amended— 9 (1) by redesignating subsections (c) through (f) 10 as subsections (d) through (g), respectively; 11 (2) by inserting after subsection (b) the fol-12 lowing: 13 ‘‘(c) NO CONSIDERATION OF INCOME OF ORGAN RE-14 CIPIENT.—The recipient of a grant under this section, in 15 providing reimbursement to a donating individual through 16 such grant, shall not give any consideration to the income 17 of the organ recipient.’’; and 18 (3) in subsection (f), as so redesignated— 19 (A) in paragraph (1), by striking ‘‘sub-20 section (c)(1)’’ and inserting ‘‘subsection 21 (d)(1)’’; and 22 (B) in paragraph (2), by striking ‘‘sub-23 section (c)(2)’’ and inserting ‘‘subsection 24 (d)(2)’’. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00526 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 527 •HR 1768 IH (b) R EMOVAL OF EXPECTATION OF PAYMENTS BY 1 ORGAN RECIPIENTS.—Section 377(e) of the Public 2 Health Service Act (42 U.S.C. 274f(e)), as redesignated 3 by section 2(1), is amended— 4 (1) in paragraph (1), by adding ‘‘or’’ at the 5 end; 6 (2) in paragraph (2), by striking ‘‘; or’’ and in-7 serting a period; and 8 (3) by striking paragraph (3). 9 (c) A NNUAL REPORT.—Section 377 of the Public 10 Health Service Act (42 U.S.C. 274f), as amended by sec-11 tions 2 and 3, is amended by adding at the end the fol-12 lowing: 13 ‘‘(h) ANNUAL REPORT.—Not later than December 31 14 of each year, beginning in Fiscal Year 2026, the Secretary 15 shall— 16 ‘‘(1) prepare, submit to the Congress, and make 17 public a report on whether grants under this section 18 provided adequate funding during the preceding fis-19 cal year to reimburse all donating individuals par-20 ticipating in the grant program under this section 21 for all qualifying expenses; and 22 ‘‘(2) include in each such report— 23 ‘‘(A) the estimated number of all donating 24 individuals participating in the grant program 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00527 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 528 •HR 1768 IH under this section who did not receive reim-1 bursement for all qualifying expenses during 2 the preceding fiscal year; and 3 ‘‘(B) the total amount of funding that is 4 estimated to be necessary to fully reimburse all 5 donating individuals participating in the grant 6 program under this section for all qualifying ex-7 penses.’’. 8 SEC. 714. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 9 Section 409I(d)(1) of the Public Health Service Act 10 (42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 11 and all that follows through the period at the end and 12 inserting ‘‘section, $25,000,000 for each of fiscal years 13 2025 through 2027.’’. 14 TITLE VIII—FOOD AND DRUG 15 ADMINISTRATION 16 Subtitle A—Give Kids a Chance 17 SEC. 801. RESEARCH INTO PEDIATRIC USES OF DRUGS; AD-18 DITIONAL AUTHORITIES OF FOOD AND DRUG 19 ADMINISTRATION REGARDING MOLECU-20 LARLY TARGETED CANCER DRUGS. 21 (a) IN GENERAL.— 22 (1) A DDITIONAL ACTIVE INGREDIENT FOR AP -23 PLICATION DRUG ; LIMITATION REGARDING NOVEL - 24 COMBINATION APPLICATION DRUG .—Section 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00528 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 529 •HR 1768 IH 505B(a)(3) of the Federal Food, Drug, and Cos-1 metic Act (21 U.S.C. 355c(a)(3)) is amended— 2 (A) by redesignating subparagraphs (B) 3 and (C) as subparagraphs (C) and (D), respec-4 tively; and 5 (B) by striking subparagraph (A) and in-6 serting the following: 7 ‘‘(A) IN GENERAL .—For purposes of para-8 graph (1)(B), the investigation described in this 9 paragraph is a molecularly targeted pediatric 10 cancer investigation of— 11 ‘‘(i) the drug or biological product for 12 which the application referred to in such 13 paragraph is submitted; or 14 ‘‘(ii) such drug or biological product 15 used in combination with— 16 ‘‘(I) an active ingredient of a 17 drug or biological product— 18 ‘‘(aa) for which an approved 19 application under section 505(j) 20 under this Act or under section 21 351(k) of the Public Health 22 Service Act is in effect; and 23 ‘‘(bb) that is determined by 24 the Secretary, after consultation 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00529 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 530 •HR 1768 IH with the applicant, to be part of 1 the standard of care for treating 2 a pediatric cancer; or 3 ‘‘(II) an active ingredient of a 4 drug or biological product— 5 ‘‘(aa) for which an approved 6 application under section 505(b) 7 of this Act or section 351(a) of 8 the Public Health Service Act to 9 treat an adult cancer is in effect 10 and is held by the same person 11 submitting the application under 12 paragraph (1)(B); and 13 ‘‘(bb) that is directed at a 14 molecular target that the Sec-15 retary determines to be substan-16 tially relevant to the growth or 17 progression of a pediatric cancer. 18 ‘‘(B) ADDITIONAL REQUIREMENTS .— 19 ‘‘(i) D ESIGN OF INVESTIGATION .—A 20 molecularly targeted pediatric cancer inves-21 tigation referred to in subparagraph (A) 22 shall be designed to yield clinically mean-23 ingful pediatric study data that is gathered 24 using appropriate formulations for each 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00530 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 531 •HR 1768 IH age group for which the study is required, 1 regarding dosing, safety, and preliminary 2 efficacy to inform potential pediatric label-3 ing. 4 ‘‘(ii) L IMITATION.—An investigation 5 described in subparagraph (A)(ii) may be 6 required only if the drug or biological 7 product for which the application referred 8 to in paragraph (1)(B) contains either— 9 ‘‘(I) a single new active ingre-10 dient; or 11 ‘‘(II) more than one active ingre-12 dient, if an application for the com-13 bination of active ingredients has not 14 previously been approved but each ac-15 tive ingredient is in a drug product 16 that has been previously approved to 17 treat an adult cancer. 18 ‘‘(iii) R ESULTS OF ALREADY -COM-19 PLETED PRECLINICAL STUDIES OF APPLI -20 CATION DRUG .—With respect to an inves-21 tigation required pursuant to paragraph 22 (1)(B), the Secretary may require the re-23 sults of any completed preclinical studies 24 relevant to the initial pediatric study plan 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00531 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 532 •HR 1768 IH be submitted to the Secretary at the same 1 time that the initial pediatric study plan 2 required under subsection (e)(1) is sub-3 mitted. 4 ‘‘(iv) R ULE OF CONSTRUCTION RE -5 GARDING INACTIVE INGREDIENTS .—With 6 respect to a combination of active ingredi-7 ents referred to in subparagraph (A)(ii), 8 such subparagraph shall not be construed 9 as addressing the use of inactive ingredi-10 ents with such combination.’’. 11 (2) D ETERMINATION OF APPLICABLE REQUIRE -12 MENTS.—Section 505B(e)(1) of the Federal Food, 13 Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 14 amended by adding at the end the following: ‘‘The 15 Secretary shall determine whether subparagraph (A) 16 or (B) of subsection (a)(1) applies with respect to an 17 application before the date on which the applicant is 18 required to submit the initial pediatric study plan 19 under paragraph (2)(A).’’. 20 (3) C LARIFYING APPLICABILITY .—Section 21 505B(a)(1) of the Federal Food, Drug, and Cos-22 metic Act (21 U.S.C. 355c(a)(1)) is amended by 23 adding at the end the following: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00532 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 533 •HR 1768 IH ‘‘(C) R ULE OF CONSTRUCTION .—No appli-1 cation that is subject to the requirements of 2 subparagraph (B) shall be subject to the re-3 quirements of subparagraph (A), and no appli-4 cation (or supplement to an application) that is 5 subject to the requirements of subparagraph 6 (A) shall be subject to the requirements of sub-7 paragraph (B).’’. 8 (4) C ONFORMING AMENDMENTS .—Section 9 505B(a) of the Federal Food, Drug, and Cosmetic 10 Act (21 U.S.C. 355c(a)) is amended— 11 (A) in paragraph (3)(C), as redesignated 12 by paragraph (1)(A) of this subsection, by 13 striking ‘‘investigations described in this para-14 graph’’ and inserting ‘‘investigations referred to 15 in subparagraph (A)’’; and 16 (B) in paragraph (3)(D), as redesignated 17 by paragraph (1)(A) of this subsection, by 18 striking ‘‘the assessments under paragraph 19 (2)(B)’’ and inserting ‘‘the assessments re-20 quired under paragraph (1)(A)’’. 21 (b) G UIDANCE.—The Secretary of Health and 22 Human Services, acting through the Commissioner of 23 Food and Drugs, shall— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00533 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 534 •HR 1768 IH (1) not later than 12 months after the date of 1 enactment of this Act, issue draft guidance on the 2 implementation of the amendments made by sub-3 section (a); and 4 (2) not later than 12 months after closing the 5 comment period on such draft guidance, finalize 6 such guidance. 7 (c) APPLICABILITY.—The amendments made by this 8 section apply with respect to any application under section 9 505(b) of the Federal Food, Drug, and Cosmetic Act (21 10 U.S.C. 355(b)) and any application under section 351(a) 11 of the Public Health Service Act (42 U.S.C. 262(a)), that 12 is submitted on or after the date that is 3 years after the 13 date of enactment of this Act. 14 (d) REPORTS TO CONGRESS.— 15 (1) SECRETARY OF HEALTH AND HUMAN SERV -16 ICES.—Not later than 6 years after the date of en-17 actment of this Act, the Secretary of Health and 18 Human Services shall submit to the Committee on 19 Energy and Commerce of the House of Representa-20 tives and the Committee on Health, Education, 21 Labor, and Pensions of the Senate a report on the 22 Secretary’s efforts, in coordination with industry, to 23 ensure implementation of the amendments made by 24 subsection (a). 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00534 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 535 •HR 1768 IH (2) GAO STUDY AND REPORT .— 1 (A) S TUDY.—Not later than 8 years after 2 the date of enactment of this Act, the Comp-3 troller General of the United States shall con-4 duct a study of the effectiveness of requiring 5 assessments and investigations described in sec-6 tion 505B of the Federal Food, Drug, and Cos-7 metic Act (21 U.S.C.355c), as amended by sub-8 section (a), in the development of drugs and bi-9 ological products for pediatric cancer indica-10 tions, including consideration of any benefits to, 11 or burdens on, pediatric cancer drug develop-12 ment. 13 (B) F INDINGS.—Not later than 10 years 14 after the date of enactment of this Act, the 15 Comptroller General shall submit to the Com-16 mittee on Energy and Commerce of the House 17 of Representatives and the Committee on 18 Health, Education, Labor, and Pensions of the 19 Senate a report containing the findings of the 20 study conducted under subparagraph (A). 21 SEC. 802. ENSURING COMPLETION OF PEDIATRIC STUDY 22 REQUIREMENTS. 23 (a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 24 REQUIREMENTS.—Section 505B(d) of the Federal Food, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00535 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 536 •HR 1768 IH Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amend-1 ed— 2 (1) in paragraph (1), by striking ‘‘Beginning 3 270’’ and inserting ‘‘N ONCOMPLIANCE LETTER .— 4 Beginning 270’’; 5 (2) in paragraph (2)— 6 (A) by striking ‘‘The drug or’’ and insert-7 ing ‘‘E FFECT OF NONCOMPLIANCE .—The drug 8 or’’; and 9 (B) by striking ‘‘(except that the drug or 10 biological product shall not be subject to action 11 under section 303)’’ and inserting ‘‘(except that 12 the drug or biological product shall be subject 13 to action under section 303 only if such person 14 demonstrated a lack of due diligence in satis-15 fying the applicable requirement)’’; and 16 (3) by adding at the end the following: 17 ‘‘(3) L IMITATION.—The Secretary shall not 18 issue enforcement actions under section 303 for fail-19 ures under this subsection in the case of a drug or 20 biological product that is no longer marketed.’’. 21 (b) D UE DILIGENCE.—Section 505B(d) of the Fed-22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), 23 as amended by subsection (a), is further amended by add-24 ing at the end the following: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00536 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 537 •HR 1768 IH ‘‘(4) D UE DILIGENCE .—Before the Secretary 1 may conclude that a person failed to submit or oth-2 erwise meet a requirement as described in the mat-3 ter preceding paragraph (1), the Secretary shall— 4 ‘‘(A) issue a noncompliance letter pursuant 5 to paragraph (1); 6 ‘‘(B) provide such person with a 45-day 7 period beginning on the date of receipt of such 8 noncompliance letter to respond in writing as 9 set forth in such paragraph; and 10 ‘‘(C) after reviewing such written response, 11 determine whether the person demonstrated a 12 lack of due diligence in satisfying such require-13 ment.’’. 14 (c) C ONFORMING AMENDMENTS.—Section 15 303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act 16 (21 U.S.C. 333(f)(4)(A)) is amended by striking ‘‘or 505– 17 1’’ and inserting ‘‘505–1, or 505B’’. 18 (d) T RANSITION RULE.—The Secretary of Health 19 and Human Services may take enforcement action under 20 section 303 of the Federal Food, Drug, and Cosmetic Act 21 (21 U.S.C. 333) only for failures described in section 22 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on 23 or after the date that is 180 days after the date of enact-24 ment of this Act. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00537 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 538 •HR 1768 IH SEC. 803. FDA REPORT ON PREA ENFORCEMENT. 1 Section 508(b) of the Food and Drug Administration 2 Safety and Innovation Act (21 U.S.C. 355c–1(b)) is 3 amended— 4 (1) in paragraph (11), by striking the semicolon 5 at the end and inserting ‘‘, including an evaluation 6 of compliance with deadlines provided for in defer-7 rals and deferral extensions;’’; 8 (2) in paragraph (15), by striking ‘‘and’’ at the 9 end; 10 (3) in paragraph (16), by striking the period at 11 the end and inserting ‘‘; and’’; and 12 (4) by adding at the end the following: 13 ‘‘(17) a listing of penalties, settlements, or pay-14 ments under section 303 of the Federal Food, Drug, 15 and Cosmetic Act (21 U.S.C. 353) for failure to 16 comply with requirements under such section 505B, 17 including, for each penalty, settlement, or payment, 18 the name of the drug, the sponsor thereof, and the 19 amount of the penalty, settlement, or payment im-20 posed; and’’. 21 SEC. 804. EXTENSION OF AUTHORITY TO ISSUE PRIORITY 22 REVIEW VOUCHERS TO ENCOURAGE TREAT-23 MENTS FOR RARE PEDIATRIC DISEASES. 24 (a) EXTENSION.—Paragraph (5) of section 529(b) of 25 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 26 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00538 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 539 •HR 1768 IH 360ff(b)) is amended by striking ‘‘December 20, 2024, un-1 less’’ and all that follows through the period at the end 2 and inserting ‘‘September 30, 2029.’’. 3 (b) U SER FEE PAYMENT.—Section 529(c)(4) of the 4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5 360ff(c)(4)) is amended by striking subparagraph (A) and 6 inserting the following: 7 ‘‘(A) I N GENERAL .—The priority review 8 user fee required by this subsection shall be due 9 upon the submission of a human drug applica-10 tion under section 505(b)(1) or section 351(a) 11 of the Public Health Service Act for which the 12 priority review voucher is used. All other user 13 fees associated with the human drug application 14 shall be due as required by the Secretary or 15 under applicable law.’’. 16 (c) GAO R EPORT ON EFFECTIVENESS OF RARE PE-17 DIATRIC DISEASE PRIORITY VOUCHER AWARDS IN 18 INCENTIVIZING RARE PEDIATRIC DISEASE DRUG DEVEL-19 OPMENT.— 20 (1) GAO STUDY.— 21 (A) S TUDY.—The Comptroller General of 22 the United States shall conduct a study of the 23 effectiveness of awarding rare pediatric disease 24 priority vouchers under section 529 of the Fed-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00539 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 540 •HR 1768 IH eral Food, Drug, and Cosmetic Act (21 U.S.C. 1 360ff), as amended by subsection (a), in the de-2 velopment of human drug products that treat or 3 prevent rare pediatric diseases (as defined in 4 such section 529). 5 (B) C ONTENTS OF STUDY .—In conducting 6 the study under subparagraph (A), the Comp-7 troller General shall examine the following: 8 (i) The indications for each drug or 9 biological product that— 10 (I) is the subject of a rare pedi-11 atric disease product application (as 12 defined in section 529 of the Federal 13 Food, Drug, and Cosmetic Act (21 14 U.S.C. 360ff)) for which a priority re-15 view voucher was awarded; and 16 (II) was approved under section 17 505 of the Federal Food, Drug, and 18 Cosmetic Act (42 U.S.C. 355) or li-19 censed under section 351 of the Pub-20 lic Health Service Act (42 U.S.C. 21 262). 22 (ii) Whether, and to what extent, an 23 unmet need related to the treatment or 24 prevention of a rare pediatric disease was 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00540 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 541 •HR 1768 IH met through the approval or licensure of 1 such a drug or biological product. 2 (iii) The size of the company to which 3 a priority review voucher was awarded 4 under section 529 of the Federal Food, 5 Drug, and Cosmetic Act (21 U.S.C. 360ff) 6 for such a drug or biological product. 7 (iv) The value of such priority review 8 voucher if transferred. 9 (v) Identification of each drug for 10 which a priority review voucher awarded 11 under such section 529 was used. 12 (vi) The size of the company using 13 each priority review voucher awarded 14 under such section 529. 15 (vii) The length of the period of time 16 between the date on which a priority re-17 view voucher was awarded under such sec-18 tion 529 and the date on which it was 19 used. 20 (viii) Whether, and to what extent, an 21 unmet need related to the treatment or 22 prevention of a rare pediatric disease was 23 met through the approval under section 24 505 of the Federal Food, Drug, and Cos-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00541 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 542 •HR 1768 IH metic Act (42 U.S.C. 355) or licensure 1 under section 351 of the Public Health 2 Service Act (42 U.S.C. 262) of a drug for 3 which a priority review voucher was used. 4 (ix) Whether, and to what extent, 5 companies were motivated by the avail-6 ability of priority review vouchers under 7 section 529 of the Federal Food, Drug, 8 and Cosmetic Act (21 U.S.C. 360ff) to at-9 tempt to develop a drug for a rare pedi-10 atric disease. 11 (x) Whether, and to what extent, pedi-12 atric review vouchers awarded under such 13 section were successful in stimulating de-14 velopment and expedited patient access to 15 drug products for treatment or prevention 16 of a rare pediatric disease that wouldn’t 17 otherwise take place without the incentive 18 provided by such vouchers. 19 (xi) The impact of such priority re-20 view vouchers on the workload, review 21 process, and public health prioritization ef-22 forts of the Food and Drug Administra-23 tion. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00542 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 543 •HR 1768 IH (xii) Any other incentives in Federal 1 law that exist for companies developing 2 drugs or biological products described in 3 clause (i). 4 (2) R EPORT ON FINDINGS .—Not later than 5 5 years after the date of the enactment of this Act, the 6 Comptroller General of the United States shall sub-7 mit to the Committee on Energy and Commerce of 8 the House of Representatives and the Committee on 9 Health, Education, Labor, and Pensions of the Sen-10 ate a report containing the findings of the study 11 conducted under paragraph (1). 12 SEC. 805. LIMITATIONS ON EXCLUSIVE APPROVAL OR LI-13 CENSURE OF ORPHAN DRUGS. 14 (a) IN GENERAL.—Section 527 of the Federal Food, 15 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 16 (1) in subsection (a), in the matter following 17 paragraph (2), by striking ‘‘same disease or condi-18 tion’’ and inserting ‘‘same approved use or indica-19 tion within such rare disease or condition’’; 20 (2) in subsection (b)— 21 (A) in the matter preceding paragraph (1), 22 by striking ‘‘same rare disease or condition’’ 23 and inserting ‘‘same approved use or indication 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00543 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 544 •HR 1768 IH for which such 7-year period applies to such al-1 ready approved or licensed drug’’; and 2 (B) in paragraph (1), by inserting ‘‘, relat-3 ing to the approved use or indication,’’ after 4 ‘‘the needs’’; 5 (3) in subsection (c)(1), by striking ‘‘same rare 6 disease or condition as the already approved drug’’ 7 and inserting ‘‘same use or indication for which the 8 already approved or licensed drug was approved or 9 licensed’’; and 10 (4) by adding at the end the following: 11 ‘‘(f) A PPROVED USE OR INDICATION DEFINED.—In 12 this section, the term ‘approved use or indication’ means 13 the use or indication approved under section 505 of this 14 Act or licensed under section 351 of the Public Health 15 Service Act for a drug designated under section 526 for 16 a rare disease or condition.’’. 17 (b) A PPLICATION OF AMENDMENTS.—The amend-18 ments made by subsection (a) shall apply with respect to 19 any drug designated under section 526 of the Federal 20 Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-21 less of the date on which the drug was so designated, and 22 regardless of the date on which the drug was approved 23 under section 505 of such Act (21 U.S.C. 355) or licensed 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00544 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 545 •HR 1768 IH under section 351 of the Public Health Service Act (42 1 U.S.C. 262). 2 Subtitle B—United States-Abraham 3 Accords Cooperation and Security 4 SEC. 811. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 5 WITHIN FOOD AND DRUG ADMINISTRATION. 6 (a) I N GENERAL.—Chapter X of the Federal Food, 7 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-8 ed by adding at the end the following: 9 ‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 10 ‘‘(a) I N GENERAL.—The Secretary, acting through 11 the Commissioner of Food and Drugs, shall establish with-12 in the Food and Drug Administration an office, to be 13 known as the Abraham Accords Office, to be headed by 14 a director. 15 ‘‘(b) OFFICE.—Not later than 2 years after the date 16 of enactment of this section, the Secretary shall— 17 ‘‘(1) in consultation with the governments of 18 Abraham Accords countries, as well as appropriate 19 United States Government diplomatic and security 20 personnel— 21 ‘‘(A) select the location of the Abraham 22 Accords Office in an Abraham Accords country; 23 and 24 ‘‘(B) establish such office; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00545 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 546 •HR 1768 IH ‘‘(2) assign to such office such personnel of the 1 Food and Drug Administration as the Secretary de-2 termines necessary to carry out the functions of 3 such office. 4 ‘‘(c) DUTIES.—The Secretary, acting through the Di-5 rector of the Abraham Accords Office, shall— 6 ‘‘(1) after the Abraham Accords Office is estab-7 lished— 8 ‘‘(A) as part of the Food and Drug Admin-9 istration’s work to strengthen the international 10 oversight of regulated commodities, provide 11 technical assistance to regulatory partners in 12 Abraham Accords countries on strengthening 13 regulatory oversight and converging regulatory 14 requirements for the oversight of regulated 15 products, including good manufacturing prac-16 tices and other issues relevant to manufacturing 17 medical products that are regulated by the 18 Food and Drug Administration; and 19 ‘‘(B) facilitate interactions between the 20 Food and Drug Administration and interested 21 parties in Abraham Accords countries, including 22 by sharing relevant information regarding 23 United States regulatory pathways with such 24 parties, and facilitate feedback on the research, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00546 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 547 •HR 1768 IH development, and manufacturing of products 1 regulated in accordance with this Act; and 2 ‘‘(2) carry out other functions and activities as 3 the Secretary determines to be necessary to carry 4 out this section. 5 ‘‘(d) A BRAHAM ACCORDS COUNTRY DEFINED.—In 6 this section, the term ‘Abraham Accords country’ means 7 a country identified by the Department of State as having 8 signed the Abraham Accords Declaration. 9 ‘‘(e) N ATIONAL SECURITY.—Nothing in this section 10 shall be construed to require any action inconsistent with 11 a national security recommendation provided by the Fed-12 eral Government.’’. 13 (b) REPORT TO CONGRESS.— 14 (1) I N GENERAL .—Not later than 3 years after 15 the date of enactment of this Act, the Secretary of 16 Health and Human Services shall submit to the 17 Congress a report on the Abraham Accords Office, 18 including— 19 (A) an evaluation of how the Office has ad-20 vanced progress toward conformance with Food 21 and Drug Administration regulatory require-22 ments by manufacturers in the Abraham Ac-23 cords countries; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00547 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 548 •HR 1768 IH (B) a numerical count of parties that the 1 Office has helped facilitate interactions or feed-2 back pursuant to section 1015(c)(1)(B) of the 3 Federal Food, Drug, and Cosmetic Act (as 4 added by subsection (a)); 5 (C) a summary of technical assistance pro-6 vided to regulatory partners in Abraham Ac-7 cords countries pursuant to subparagraph (A) 8 of such section 1015(c)(1); and 9 (D) recommendations for increasing and 10 improving coordination between the Food and 11 Drug Administration and entities in Abraham 12 Accords countries. 13 (2) A BRAHAM ACCORDS COUNTRY DEFINED .— 14 In this subsection, the term ‘‘Abraham Accords 15 country’’ has the meaning given such term in section 16 1015(d) of the Federal Food, Drug, and Cosmetic 17 Act (as added by subsection (a)). 18 TITLE IX—LOWERING 19 PRESCRIPTION DRUG COSTS 20 SEC. 901. OVERSIGHT OF PHARMACY BENEFIT MANAGE-21 MENT SERVICES. 22 (a) PUBLIC HEALTH SERVICE ACT.—Title XXVII of 23 the Public Health Service Act (42 U.S.C. 300gg et seq.) 24 is amended— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00548 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 549 •HR 1768 IH (1) in part D (42 U.S.C. 300gg–111 et seq.), 1 by adding at the end the following new section: 2 ‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE 3 PHARMACY BENEFIT MANAGEMENT SERV-4 ICES. 5 ‘‘(a) I N GENERAL.—For plan years beginning on or 6 after the date that is 30 months after the date of enact-7 ment of this section (referred to in this subsection and 8 subsection (b) as the ‘effective date’), a group health plan 9 or a health insurance issuer offering group health insur-10 ance coverage, or an entity providing pharmacy benefit 11 management services on behalf of such a plan or issuer, 12 shall not enter into a contract, including an extension or 13 renewal of a contract, entered into on or after the effective 14 date, with an applicable entity unless such applicable enti-15 ty agrees to— 16 ‘‘(1) not limit or delay the disclosure of infor-17 mation to the group health plan (including such a 18 plan offered through a health insurance issuer) in 19 such a manner that prevents an entity providing 20 pharmacy benefit management services on behalf of 21 a group health plan or health insurance issuer offer-22 ing group health insurance coverage from making 23 the reports described in subsection (b); and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00549 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 550 •HR 1768 IH ‘‘(2) provide the entity providing pharmacy ben-1 efit management services on behalf of a group health 2 plan or health insurance issuer relevant information 3 necessary to make the reports described in sub-4 section (b). 5 ‘‘(b) REPORTS.— 6 ‘‘(1) I N GENERAL .—For plan years beginning 7 on or after the effective date, in the case of any con-8 tract between a group health plan or a health insur-9 ance issuer offering group health insurance coverage 10 offered in connection with such a plan and an entity 11 providing pharmacy benefit management services on 12 behalf of such plan or issuer, including an extension 13 or renewal of such a contract, entered into on or 14 after the effective date, the entity providing phar-15 macy benefit management services on behalf of such 16 a group health plan or health insurance issuer, not 17 less frequently than every 6 months (or, at the re-18 quest of a group health plan, not less frequently 19 than quarterly, and under the same conditions, 20 terms, and cost of the semiannual report under this 21 subsection), shall submit to the group health plan a 22 report in accordance with this section. Each such re-23 port shall be made available to such group health 24 plan in plain language, in a machine-readable for-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00550 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 551 •HR 1768 IH mat, and as the Secretary may determine, other for-1 mats. Each such report shall include the information 2 described in paragraph (2). 3 ‘‘(2) I NFORMATION DESCRIBED .—For purposes 4 of paragraph (1), the information described in this 5 paragraph is, with respect to drugs covered by a 6 group health plan or group health insurance cov-7 erage offered by a health insurance issuer in connec-8 tion with a group health plan during each reporting 9 period— 10 ‘‘(A) in the case of a group health plan 11 that is offered by a specified large employer or 12 that is a specified large plan, and is not offered 13 as health insurance coverage, or in the case of 14 health insurance coverage for which the election 15 under paragraph (3) is made for the applicable 16 reporting period— 17 ‘‘(i) a list of drugs for which a claim 18 was filed and, with respect to each such 19 drug on such list— 20 ‘‘(I) the contracted compensation 21 paid by the group health plan or 22 health insurance issuer for each cov-23 ered drug (identified by the National 24 Drug Code) to the entity providing 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00551 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 552 •HR 1768 IH pharmacy benefit management serv-1 ices or other applicable entity on be-2 half of the group health plan or health 3 insurance issuer; 4 ‘‘(II) the contracted compensa-5 tion paid to the pharmacy, by any en-6 tity providing pharmacy benefit man-7 agement services or other applicable 8 entity on behalf of the group health 9 plan or health insurance issuer, for 10 each covered drug (identified by the 11 National Drug Code); 12 ‘‘(III) for each such claim, the 13 difference between the amount paid 14 under subclause (I) and the amount 15 paid under subclause (II); 16 ‘‘(IV) the proprietary name, es-17 tablished name or proper name, and 18 the National Drug Code; 19 ‘‘(V) for each claim for the drug 20 (including original prescriptions and 21 refills) and for each dosage unit of the 22 drug for which a claim was filed, the 23 type of dispensing channel used to 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00552 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 553 •HR 1768 IH furnish the drug, including retail, mail 1 order, or specialty pharmacy; 2 ‘‘(VI) with respect to each drug 3 dispensed, for each type of dispensing 4 channel (including retail, mail order, 5 or specialty pharmacy)— 6 ‘‘(aa) whether such drug is a 7 brand name drug or a generic 8 drug, and— 9 ‘‘(AA) in the case of a 10 brand name drug, the whole-11 sale acquisition cost, listed 12 as cost per days supply and 13 cost per dosage unit, on the 14 date such drug was dis-15 pensed; and 16 ‘‘(BB) in the case of a 17 generic drug, the average 18 wholesale price, listed as 19 cost per days supply and 20 cost per dosage unit, on the 21 date such drug was dis-22 pensed; and 23 ‘‘(bb) the total number of— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00553 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 554 •HR 1768 IH ‘‘(AA) prescription 1 claims (including original 2 prescriptions and refills); 3 ‘‘(BB) participants and 4 beneficiaries for whom a 5 claim for such drug was 6 filed through the applicable 7 dispensing channel; 8 ‘‘(CC) dosage units and 9 dosage units per fill of such 10 drug; and 11 ‘‘(DD) days supply of 12 such drug per fill; 13 ‘‘(VII) the net price per course of 14 treatment or single fill, such as a 30- 15 day supply or 90-day supply to the 16 plan or coverage after rebates, fees, 17 alternative discounts, or other remu-18 neration received from applicable enti-19 ties; 20 ‘‘(VIII) the total amount of out- 21 of-pocket spending by participants 22 and beneficiaries on such drug, in-23 cluding spending through copayments, 24 coinsurance, and deductibles, but not 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00554 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 555 •HR 1768 IH including any amounts spent by par-1 ticipants and beneficiaries on drugs 2 not covered under the plan or cov-3 erage, or for which no claim is sub-4 mitted under the plan or coverage; 5 ‘‘(IX) the total net spending on 6 the drug; 7 ‘‘(X) the total amount received, 8 or expected to be received, by the plan 9 or issuer from any applicable entity in 10 rebates, fees, alternative discounts, or 11 other remuneration; 12 ‘‘(XI) the total amount received, 13 or expected to be received, by the enti-14 ty providing pharmacy benefit man-15 agement services, from applicable en-16 tities, in rebates, fees, alternative dis-17 counts, or other remuneration from 18 such entities— 19 ‘‘(aa) for claims incurred 20 during the reporting period; and 21 ‘‘(bb) that is related to utili-22 zation of such drug or spending 23 on such drug; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00555 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 556 •HR 1768 IH ‘‘(XII) to the extent feasible, in-1 formation on the total amount of re-2 muneration for such drug, including 3 copayment assistance dollars paid, co-4 payment cards applied, or other dis-5 counts provided by each drug manu-6 facturer (or entity administering co-7 payment assistance on behalf of such 8 drug manufacturer), to the partici-9 pants and beneficiaries enrolled in 10 such plan or coverage; 11 ‘‘(ii) a list of each therapeutic class 12 (as defined by the Secretary) for which a 13 claim was filed under the group health 14 plan or health insurance coverage during 15 the reporting period, and, with respect to 16 each such therapeutic class— 17 ‘‘(I) the total gross spending on 18 drugs in such class before rebates, 19 price concessions, alternative dis-20 counts, or other remuneration from 21 applicable entities; 22 ‘‘(II) the net spending in such 23 class after such rebates, price conces-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00556 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 557 •HR 1768 IH sions, alternative discounts, or other 1 remuneration from applicable entities; 2 ‘‘(III) the total amount received, 3 or expected to be received, by the enti-4 ty providing pharmacy benefit man-5 agement services, from applicable en-6 tities, in rebates, fees, alternative dis-7 counts, or other remuneration from 8 such entities— 9 ‘‘(aa) for claims incurred 10 during the reporting period; and 11 ‘‘(bb) that is related to utili-12 zation of drugs or drug spending; 13 ‘‘(IV) the average net spending 14 per 30-day supply and per 90-day 15 supply by the plan or by the issuer 16 with respect to such coverage and its 17 participants and beneficiaries, among 18 all drugs within the therapeutic class 19 for which a claim was filed during the 20 reporting period; 21 ‘‘(V) the number of participants 22 and beneficiaries who filled a prescrip-23 tion for a drug in such class, includ-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00557 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 558 •HR 1768 IH ing the National Drug Code for each 1 such drug; 2 ‘‘(VI) if applicable, a description 3 of the formulary tiers and utilization 4 mechanisms (such as prior authoriza-5 tion or step therapy) employed for 6 drugs in that class; and 7 ‘‘(VII) the total out-of-pocket 8 spending under the plan or coverage 9 by participants and beneficiaries, in-10 cluding spending through copayments, 11 coinsurance, and deductibles, but not 12 including any amounts spent by par-13 ticipants and beneficiaries on drugs 14 not covered under the plan or cov-15 erage or for which no claim is sub-16 mitted under the plan or coverage; 17 ‘‘(iii) with respect to any drug for 18 which gross spending under the group 19 health plan or health insurance coverage 20 exceeded $10,000 during the reporting pe-21 riod or, in the case that gross spending 22 under the group health plan or coverage 23 exceeded $10,000 during the reporting pe-24 riod with respect to fewer than 50 drugs, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00558 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 559 •HR 1768 IH with respect to the 50 prescription drugs 1 with the highest spending during the re-2 porting period— 3 ‘‘(I) a list of all other drugs in 4 the same therapeutic class as such 5 drug; 6 ‘‘(II) if applicable, the rationale 7 for the formulary placement of such 8 drug in that therapeutic category or 9 class, selected from a list of standard 10 rationales established by the Sec-11 retary, in consultation with stake-12 holders; and 13 ‘‘(III) any change in formulary 14 placement compared to the prior plan 15 year; and 16 ‘‘(iv) in the case that such plan or 17 issuer (or an entity providing pharmacy 18 benefit management services on behalf of 19 such plan or issuer) has an affiliated phar-20 macy or pharmacy under common owner-21 ship, including mandatory mail and spe-22 cialty home delivery programs, retail and 23 mail auto-refill programs, and cost sharing 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00559 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 560 •HR 1768 IH assistance incentives funded by an entity 1 providing pharmacy benefit services— 2 ‘‘(I) an explanation of any ben-3 efit design parameters that encourage 4 or require participants and bene-5 ficiaries in the plan or coverage to fill 6 prescriptions at mail order, specialty, 7 or retail pharmacies; 8 ‘‘(II) the percentage of total pre-9 scriptions dispensed by such phar-10 macies to participants or beneficiaries 11 in such plan or coverage; and 12 ‘‘(III) a list of all drugs dis-13 pensed by such pharmacies to partici-14 pants or beneficiaries enrolled in such 15 plan or coverage, and, with respect to 16 each drug dispensed— 17 ‘‘(aa) the amount charged, 18 per dosage unit, per 30-day sup-19 ply, or per 90-day supply (as ap-20 plicable) to the plan or issuer, 21 and to participants and bene-22 ficiaries; 23 ‘‘(bb) the median amount 24 charged to such plan or issuer, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00560 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 561 •HR 1768 IH and the interquartile range of the 1 costs, per dosage unit, per 30- 2 day supply, and per 90-day sup-3 ply, including amounts paid by 4 the participants and bene-5 ficiaries, when the same drug is 6 dispensed by other pharmacies 7 that are not affiliated with or 8 under common ownership with 9 the entity and that are included 10 in the pharmacy network of such 11 plan or coverage; 12 ‘‘(cc) the lowest cost per 13 dosage unit, per 30-day supply 14 and per 90-day supply, for each 15 such drug, including amounts 16 charged to the plan or coverage 17 and to participants and bene-18 ficiaries, that is available from 19 any pharmacy included in the 20 network of such plan or coverage; 21 and 22 ‘‘(dd) the net acquisition 23 cost per dosage unit, per 30-day 24 supply, and per 90-day supply, if 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00561 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 562 •HR 1768 IH such drug is subject to a max-1 imum price discount; and 2 ‘‘(B) with respect to any group health 3 plan, including group health insurance coverage 4 offered in connection with such a plan, regard-5 less of whether the plan or coverage is offered 6 by a specified large employer or whether it is a 7 specified large plan— 8 ‘‘(i) a summary document for the 9 group health plan that includes such infor-10 mation described in clauses (i) through (iv) 11 of subparagraph (A), as specified by the 12 Secretary through guidance, program in-13 struction, or otherwise (with no require-14 ment of notice and comment rulemaking), 15 that the Secretary determines useful to 16 group health plans for purposes of select-17 ing pharmacy benefit management serv-18 ices, such as an estimated net price to 19 group health plan and participant or bene-20 ficiary, a cost per claim, the fee structure 21 or reimbursement model, and estimated 22 cost per participant or beneficiary; 23 ‘‘(ii) a summary document for plans 24 and issuers to provide to participants and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00562 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 563 •HR 1768 IH beneficiaries, which shall be made available 1 to participants or beneficiaries upon re-2 quest to their group health plan (including 3 in the case of group health insurance cov-4 erage offered in connection with such a 5 plan), that— 6 ‘‘(I) contains such information 7 described in clauses (iii), (iv), (v), and 8 (vi), as applicable, as specified by the 9 Secretary through guidance, program 10 instruction, or otherwise (with no re-11 quirement of notice and comment 12 rulemaking) that the Secretary deter-13 mines useful to participants or bene-14 ficiaries in better understanding the 15 plan or coverage or benefits under 16 such plan or coverage; 17 ‘‘(II) contains only aggregate in-18 formation; and 19 ‘‘(III) states that participants 20 and beneficiaries may request specific, 21 claims-level information required to be 22 furnished under subsection (c) from 23 the group health plan or health insur-24 ance issuer; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00563 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 564 •HR 1768 IH ‘‘(iii) with respect to drugs covered by 1 such plan or coverage during such report-2 ing period— 3 ‘‘(I) the total net spending by the 4 plan or coverage for all such drugs; 5 ‘‘(II) the total amount received, 6 or expected to be received, by the plan 7 or issuer from any applicable entity in 8 rebates, fees, alternative discounts, or 9 other remuneration; and 10 ‘‘(III) to the extent feasible, in-11 formation on the total amount of re-12 muneration for such drugs, including 13 copayment assistance dollars paid, co-14 payment cards applied, or other dis-15 counts provided by each drug manu-16 facturer (or entity administering co-17 payment assistance on behalf of such 18 drug manufacturer) to participants 19 and beneficiaries; 20 ‘‘(iv) amounts paid directly or indi-21 rectly in rebates, fees, or any other type of 22 compensation (as defined in section 23 408(b)(2)(B)(ii)(dd)(AA) of the Employee 24 Retirement Income Security Act) to bro-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00564 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 565 •HR 1768 IH kerage firms, brokers, consultants, advi-1 sors, or any other individual or firm, for— 2 ‘‘(I) the referral of the group 3 health plan’s or health insurance 4 issuer’s business to an entity pro-5 viding pharmacy benefit management 6 services, including the identity of the 7 recipient of such amounts; 8 ‘‘(II) consideration of the entity 9 providing pharmacy benefit manage-10 ment services by the group health 11 plan or health insurance issuer; or 12 ‘‘(III) the retention of the entity 13 by the group health plan or health in-14 surance issuer; 15 ‘‘(v) an explanation of any benefit de-16 sign parameters that encourage or require 17 participants and beneficiaries in such plan 18 or coverage to fill prescriptions at mail 19 order, specialty, or retail pharmacies that 20 are affiliated with or under common own-21 ership with the entity providing pharmacy 22 benefit management services under such 23 plan or coverage, including mandatory mail 24 and specialty home delivery programs, re-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00565 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 566 •HR 1768 IH tail and mail auto-refill programs, and 1 cost-sharing assistance incentives directly 2 or indirectly funded by such entity; and 3 ‘‘(vi) total gross spending on all drugs 4 under the plan or coverage during the re-5 porting period. 6 ‘‘(3) O PT-IN FOR GROUP HEALTH INSURANCE 7 COVERAGE OFFERED BY A SPECIFIED LARGE EM -8 PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9 the case of group health insurance coverage offered 10 in connection with a group health plan that is of-11 fered by a specified large employer or is a specified 12 large plan, such group health plan may, on an an-13 nual basis, for plan years beginning on or after the 14 date that is 30 months after the date of enactment 15 of this section, elect to require an entity providing 16 pharmacy benefit management services on behalf of 17 the health insurance issuer to submit to such group 18 health plan a report that includes all of the informa-19 tion described in paragraph (2)(A), in addition to 20 the information described in paragraph (2)(B). 21 ‘‘(4) PRIVACY REQUIREMENTS .— 22 ‘‘(A) I N GENERAL .—An entity providing 23 pharmacy benefit management services on be-24 half of a group health plan or a health insur-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00566 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 567 •HR 1768 IH ance issuer offering group health insurance cov-1 erage shall report information under paragraph 2 (1) in a manner consistent with the privacy reg-3 ulations promulgated under section 13402(a) of 4 the Health Information Technology for Eco-5 nomic and Clinical Health Act and consistent 6 with the privacy regulations promulgated under 7 the Health Insurance Portability and Account-8 ability Act of 1996 in part 160 and subparts A 9 and E of part 164 of title 45, Code of Federal 10 Regulations (or successor regulations) (referred 11 to in this paragraph as the ‘HIPAA privacy 12 regulations’) and shall restrict the use and dis-13 closure of such information according to such 14 privacy regulations and such HIPAA privacy 15 regulations. 16 ‘‘(B) ADDITIONAL REQUIREMENTS .— 17 ‘‘(i) I N GENERAL .—An entity pro-18 viding pharmacy benefit management serv-19 ices on behalf of a group health plan or 20 health insurance issuer offering group 21 health insurance coverage that submits a 22 report under paragraph (1) shall ensure 23 that such report contains only summary 24 health information, as defined in section 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00567 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 568 •HR 1768 IH 164.504(a) of title 45, Code of Federal 1 Regulations (or successor regulations). 2 ‘‘(ii) R ESTRICTIONS.—In carrying out 3 this subsection, a group health plan shall 4 comply with section 164.504(f) of title 45, 5 Code of Federal Regulations (or a suc-6 cessor regulation), and a plan sponsor shall 7 act in accordance with the terms of the 8 agreement described in such section. 9 ‘‘(C) RULE OF CONSTRUCTION .— 10 ‘‘(i) Nothing in this section shall be 11 construed to modify the requirements for 12 the creation, receipt, maintenance, or 13 transmission of protected health informa-14 tion under the HIPAA privacy regulations. 15 ‘‘(ii) Nothing in this section shall be 16 construed to affect the application of any 17 Federal or State privacy or civil rights law, 18 including the HIPAA privacy regulations, 19 the Genetic Information Nondiscrimination 20 Act of 2008 (Public Law 110–233) (in-21 cluding the amendments made by such 22 Act), the Americans with Disabilities Act 23 of 1990 (42 U.S.C. 12101 et seq.), section 24 504 of the Rehabilitation Act of 1973 (29 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00568 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 569 •HR 1768 IH U.S.C. 794), section 1557 of the Patient 1 Protection and Affordable Care Act (42 2 U.S.C. 18116), title VI of the Civil Rights 3 Act of 1964 (42 U.S.C. 2000d), and title 4 VII of the Civil Rights Act of 1964 (42 5 U.S.C. 2000e). 6 ‘‘(D) W RITTEN NOTICE .—Each plan year, 7 group health plans, including with respect to 8 group health insurance coverage offered in con-9 nection with a group health plan, shall provide 10 to each participant or beneficiary written notice 11 informing the participant or beneficiary of the 12 requirement for entities providing pharmacy 13 benefit management services on behalf of the 14 group health plan or health insurance issuer of-15 fering group health insurance coverage to sub-16 mit reports to group health plans under para-17 graph (1), as applicable, which may include in-18 corporating such notification in plan documents 19 provided to the participant or beneficiary, or 20 providing individual notification. 21 ‘‘(E) L IMITATION TO BUSINESS ASSOCI -22 ATES.—A group health plan receiving a report 23 under paragraph (1) may disclose such informa-24 tion only to the entity from which the report 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00569 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 570 •HR 1768 IH was received or to that entity’s business associ-1 ates as defined in section 160.103 of title 45, 2 Code of Federal Regulations (or successor regu-3 lations) or as permitted by the HIPAA privacy 4 regulations. 5 ‘‘(F) C LARIFICATION REGARDING PUBLIC 6 DISCLOSURE OF INFORMATION .—Nothing in 7 this section shall prevent an entity providing 8 pharmacy benefit management services on be-9 half of a group health plan or health insurance 10 issuer offering group health insurance coverage, 11 from placing reasonable restrictions on the pub-12 lic disclosure of the information contained in a 13 report described in paragraph (1), except that 14 such plan, issuer, or entity may not— 15 ‘‘(i) restrict disclosure of such report 16 to the Department of Health and Human 17 Services, the Department of Labor, or the 18 Department of the Treasury; or 19 ‘‘(ii) prevent disclosure for the pur-20 poses of subsection (c), or any other public 21 disclosure requirement under this section. 22 ‘‘(G) L IMITED FORM OF REPORT .—The 23 Secretary shall define through rulemaking a 24 limited form of the report under paragraph (1) 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00570 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 571 •HR 1768 IH required with respect to any group health plan 1 established by a plan sponsor that is, or is af-2 filiated with, a drug manufacturer, drug whole-3 saler, or other direct participant in the drug 4 supply chain, in order to prevent anti-competi-5 tive behavior. 6 ‘‘(5) S TANDARD FORMAT AND REGULATIONS .— 7 ‘‘(A) I N GENERAL .—Not later than 18 8 months after the date of enactment of this sec-9 tion, the Secretary shall specify through rule-10 making a standard format for entities providing 11 pharmacy benefit management services on be-12 half of group health plans and health insurance 13 issuers offering group health insurance cov-14 erage, to submit reports required under para-15 graph (1). 16 ‘‘(B) A DDITIONAL REGULATIONS .—Not 17 later than 18 months after the date of enact-18 ment of this section, the Secretary shall, 19 through rulemaking, promulgate any other final 20 regulations necessary to implement the require-21 ments of this section. In promulgating such 22 regulations, the Secretary shall, to the extent 23 practicable, align the reporting requirements 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00571 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 572 •HR 1768 IH under this section with the reporting require-1 ments under section 2799A–10. 2 ‘‘(c) R EQUIREMENT TO PROVIDE INFORMATION TO 3 PARTICIPANTS OR BENEFICIARIES.—A group health plan, 4 including with respect to group health insurance coverage 5 offered in connection with a group health plan, upon re-6 quest of a participant or beneficiary, shall provide to such 7 participant or beneficiary— 8 ‘‘(1) the summary document described in sub-9 section (b)(2)(B)(ii); and 10 ‘‘(2) the information described in subsection 11 (b)(2)(A)(i)(III) with respect to a claim made by or 12 on behalf of such participant or beneficiary. 13 ‘‘(d) ENFORCEMENT.— 14 ‘‘(1) IN GENERAL .—The Secretary shall enforce 15 this section. The enforcement authority under this 16 subsection shall apply only with respect to group 17 health plans (including group health insurance cov-18 erage offered in connection with such a plan) to 19 which the requirements of subparts I and II of part 20 A and part D apply in accordance with section 2722, 21 and with respect to entities providing pharmacy ben-22 efit management services on behalf of such plans 23 and applicable entities providing services on behalf 24 of such plans. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00572 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 573 •HR 1768 IH ‘‘(2) F AILURE TO PROVIDE INFORMATION .—A 1 group health plan, a health insurance issuer offering 2 group health insurance coverage, an entity providing 3 pharmacy benefit management services on behalf of 4 such a plan or issuer, or an applicable entity pro-5 viding services on behalf of such a plan or issuer 6 that violates subsection (a); an entity providing 7 pharmacy benefit management services on behalf of 8 such a plan or issuer that fails to provide the infor-9 mation required under subsection (b); or a group 10 health plan that fails to provide the information re-11 quired under subsection (c), shall be subject to a 12 civil monetary penalty in the amount of $10,000 for 13 each day during which such violation continues or 14 such information is not disclosed or reported. 15 ‘‘(3) FALSE INFORMATION .—A health insurance 16 issuer, an entity providing pharmacy benefit man-17 agement services, or a third party administrator pro-18 viding services on behalf of such issuer offered by a 19 health insurance issuer that knowingly provides false 20 information under this section shall be subject to a 21 civil monetary penalty in an amount not to exceed 22 $100,000 for each item of false information. Such 23 civil monetary penalty shall be in addition to other 24 penalties as may be prescribed by law. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00573 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 574 •HR 1768 IH ‘‘(4) P ROCEDURE.—The provisions of section 1 1128A of the Social Security Act, other than sub-2 sections (a) and (b) and the first sentence of sub-3 section (c)(1) of such section shall apply to civil 4 monetary penalties under this subsection in the 5 same manner as such provisions apply to a penalty 6 or proceeding under such section. 7 ‘‘(5) W AIVERS.—The Secretary may waive pen-8 alties under paragraph (2), or extend the period of 9 time for compliance with a requirement of this sec-10 tion, for an entity in violation of this section that 11 has made a good-faith effort to comply with the re-12 quirements in this section. 13 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-14 tion shall be construed to permit a health insurance issuer, 15 group health plan, entity providing pharmacy benefit man-16 agement services on behalf of a group health plan or 17 health insurance issuer, or other entity to restrict disclo-18 sure to, or otherwise limit the access of, the Secretary to 19 a report described in subsection (b)(1) or information re-20 lated to compliance with subsections (a), (b), (c), or (d) 21 by such issuer, plan, or entity. 22 ‘‘(f) DEFINITIONS.—In this section: 23 ‘‘(1) A PPLICABLE ENTITY .—The term ‘applica-24 ble entity’ means— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00574 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 575 •HR 1768 IH ‘‘(A) an applicable group purchasing orga-1 nization, drug manufacturer, distributor, whole-2 saler, rebate aggregator (or other purchasing 3 entity designed to aggregate rebates), or associ-4 ated third party; 5 ‘‘(B) any subsidiary, parent, affiliate, or 6 subcontractor of a group health plan, health in-7 surance issuer, entity that provides pharmacy 8 benefit management services on behalf of such 9 a plan or issuer, or any entity described in sub-10 paragraph (A); or 11 ‘‘(C) such other entity as the Secretary 12 may specify through rulemaking. 13 ‘‘(2) A PPLICABLE GROUP PURCHASING ORGANI -14 ZATION.—The term ‘applicable group purchasing or-15 ganization’ means a group purchasing organization 16 that is affiliated with or under common ownership 17 with an entity providing pharmacy benefit manage-18 ment services. 19 ‘‘(3) C ONTRACTED COMPENSATION .—The term 20 ‘contracted compensation’ means the sum of any in-21 gredient cost and dispensing fee for a drug (inclusive 22 of the out-of-pocket costs to the participant or bene-23 ficiary), or another analogous compensation struc-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00575 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 576 •HR 1768 IH ture that the Secretary may specify through regula-1 tions. 2 ‘‘(4) G ROSS SPENDING .—The term ‘gross 3 spending’, with respect to prescription drug benefits 4 under a group health plan or health insurance cov-5 erage, means the amount spent by a group health 6 plan or health insurance issuer on prescription drug 7 benefits, calculated before the application of rebates, 8 fees, alternative discounts, or other remuneration. 9 ‘‘(5) NET SPENDING .—The term ‘net spending’, 10 with respect to prescription drug benefits under a 11 group health plan or health insurance coverage, 12 means the amount spent by a group health plan or 13 health insurance issuer on prescription drug bene-14 fits, calculated after the application of rebates, fees, 15 alternative discounts, or other remuneration. 16 ‘‘(6) P LAN SPONSOR .—The term ‘plan sponsor’ 17 has the meaning given such term in section 3(16)(B) 18 of the Employee Retirement Income Security Act of 19 1974. 20 ‘‘(7) R EMUNERATION.—The term ‘remunera-21 tion’ has the meaning given such term by the Sec-22 retary through rulemaking, which shall be reevalu-23 ated by the Secretary every 5 years. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00576 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 577 •HR 1768 IH ‘‘(8) S PECIFIED LARGE EMPLOYER .—The term 1 ‘specified large employer’ means, in connection with 2 a group health plan (including group health insur-3 ance coverage offered in connection with such a 4 plan) established or maintained by a single em-5 ployer, with respect to a calendar year or a plan 6 year, as applicable, an employer who employed an 7 average of at least 100 employees on business days 8 during the preceding calendar year or plan year and 9 who employs at least 1 employee on the first day of 10 the calendar year or plan year. 11 ‘‘(9) SPECIFIED LARGE PLAN .—The term ‘spec-12 ified large plan’ means a group health plan (includ-13 ing group health insurance coverage offered in con-14 nection with such a plan) established or maintained 15 by a plan sponsor described in clause (ii) or (iii) of 16 section 3(16)(B) of the Employee Retirement In-17 come Security Act of 1974 that had an average of 18 at least 100 participants on business days during 19 the preceding calendar year or plan year, as applica-20 ble. 21 ‘‘(10) W HOLESALE ACQUISITION COST .—The 22 term ‘wholesale acquisition cost’ has the meaning 23 given such term in section 1847A(c)(6)(B) of the 24 Social Security Act.’’; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00577 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 578 •HR 1768 IH (2) in section 2723 (42 U.S.C. 300gg–22)— 1 (A) in subsection (a)— 2 (i) in paragraph (1), by inserting 3 ‘‘(other than section 2799A–11)’’ after 4 ‘‘part D’’; and 5 (ii) in paragraph (2), by inserting 6 ‘‘(other than section 2799A–11)’’ after 7 ‘‘part D’’; and 8 (B) in subsection (b)— 9 (i) in paragraph (1), by inserting 10 ‘‘(other than section 2799A–11)’’ after 11 ‘‘part D’’; 12 (ii) in paragraph (2)(A), by inserting 13 ‘‘(other than section 2799A–11)’’ after 14 ‘‘part D’’; and 15 (iii) in paragraph (2)(C)(ii), by insert-16 ing ‘‘(other than section 2799A–11)’’ after 17 ‘‘part D’’. 18 (b) EMPLOYEE RETIREMENT INCOME SECURITY ACT 19 OF 1974.— 20 (1) I N GENERAL .—Subtitle B of title I of the 21 Employee Retirement Income Security Act of 1974 22 (29 U.S.C. 1021 et seq.) is amended— 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00578 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 579 •HR 1768 IH (A) in subpart B of part 7 (29 U.S.C. 1 1185 et seq.), by adding at the end the fol-2 lowing: 3 ‘‘SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-4 MACY BENEFIT MANAGEMENT SERVICES. 5 ‘‘(a) I N GENERAL.—For plan years beginning on or 6 after the date that is 30 months after the date of enact-7 ment of this section (referred to in this subsection and 8 subsection (b) as the ‘effective date’), a group health plan 9 or a health insurance issuer offering group health insur-10 ance coverage, or an entity providing pharmacy benefit 11 management services on behalf of such a plan or issuer, 12 shall not enter into a contract, including an extension or 13 renewal of a contract, entered into on or after the effective 14 date, with an applicable entity unless such applicable enti-15 ty agrees to— 16 ‘‘(1) not limit or delay the disclosure of infor-17 mation to the group health plan (including such a 18 plan offered through a health insurance issuer) in 19 such a manner that prevents an entity providing 20 pharmacy benefit management services on behalf of 21 a group health plan or health insurance issuer offer-22 ing group health insurance coverage from making 23 the reports described in subsection (b); and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00579 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 580 •HR 1768 IH ‘‘(2) provide the entity providing pharmacy ben-1 efit management services on behalf of a group health 2 plan or health insurance issuer relevant information 3 necessary to make the reports described in sub-4 section (b). 5 ‘‘(b) REPORTS.— 6 ‘‘(1) I N GENERAL .—For plan years beginning 7 on or after the effective date, in the case of any con-8 tract between a group health plan or a health insur-9 ance issuer offering group health insurance coverage 10 offered in connection with such a plan and an entity 11 providing pharmacy benefit management services on 12 behalf of such plan or issuer, including an extension 13 or renewal of such a contract, entered into on or 14 after the effective date, the entity providing phar-15 macy benefit management services on behalf of such 16 a group health plan or health insurance issuer, not 17 less frequently than every 6 months (or, at the re-18 quest of a group health plan, not less frequently 19 than quarterly, and under the same conditions, 20 terms, and cost of the semiannual report under this 21 subsection), shall submit to the group health plan a 22 report in accordance with this section. Each such re-23 port shall be made available to such group health 24 plan in plain language, in a machine-readable for-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00580 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 581 •HR 1768 IH mat, and as the Secretary may determine, other for-1 mats. Each such report shall include the information 2 described in paragraph (2). 3 ‘‘(2) I NFORMATION DESCRIBED .—For purposes 4 of paragraph (1), the information described in this 5 paragraph is, with respect to drugs covered by a 6 group health plan or group health insurance cov-7 erage offered by a health insurance issuer in connec-8 tion with a group health plan during each reporting 9 period— 10 ‘‘(A) in the case of a group health plan 11 that is offered by a specified large employer or 12 that is a specified large plan, and is not offered 13 as health insurance coverage, or in the case of 14 health insurance coverage for which the election 15 under paragraph (3) is made for the applicable 16 reporting period— 17 ‘‘(i) a list of drugs for which a claim 18 was filed and, with respect to each such 19 drug on such list— 20 ‘‘(I) the contracted compensation 21 paid by the group health plan or 22 health insurance issuer for each cov-23 ered drug (identified by the National 24 Drug Code) to the entity providing 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00581 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 582 •HR 1768 IH pharmacy benefit management serv-1 ices or other applicable entity on be-2 half of the group health plan or health 3 insurance issuer; 4 ‘‘(II) the contracted compensa-5 tion paid to the pharmacy, by any en-6 tity providing pharmacy benefit man-7 agement services or other applicable 8 entity on behalf of the group health 9 plan or health insurance issuer, for 10 each covered drug (identified by the 11 National Drug Code); 12 ‘‘(III) for each such claim, the 13 difference between the amount paid 14 under subclause (I) and the amount 15 paid under subclause (II); 16 ‘‘(IV) the proprietary name, es-17 tablished name or proper name, and 18 National Drug Code; 19 ‘‘(V) for each claim for the drug 20 (including original prescriptions and 21 refills) and for each dosage unit of the 22 drug for which a claim was filed, the 23 type of dispensing channel used to 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00582 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 583 •HR 1768 IH furnish the drug, including retail, mail 1 order, or specialty pharmacy; 2 ‘‘(VI) with respect to each drug 3 dispensed, for each type of dispensing 4 channel (including retail, mail order, 5 or specialty pharmacy)— 6 ‘‘(aa) whether such drug is a 7 brand name drug or a generic 8 drug, and— 9 ‘‘(AA) in the case of a 10 brand name drug, the whole-11 sale acquisition cost, listed 12 as cost per days supply and 13 cost per dosage unit, on the 14 date such drug was dis-15 pensed; and 16 ‘‘(BB) in the case of a 17 generic drug, the average 18 wholesale price, listed as 19 cost per days supply and 20 cost per dosage unit, on the 21 date such drug was dis-22 pensed; and 23 ‘‘(bb) the total number of— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00583 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 584 •HR 1768 IH ‘‘(AA) prescription 1 claims (including original 2 prescriptions and refills); 3 ‘‘(BB) participants and 4 beneficiaries for whom a 5 claim for such drug was 6 filed through the applicable 7 dispensing channel; 8 ‘‘(CC) dosage units and 9 dosage units per fill of such 10 drug; and 11 ‘‘(DD) days supply of 12 such drug per fill; 13 ‘‘(VII) the net price per course of 14 treatment or single fill, such as a 30- 15 day supply or 90-day supply to the 16 plan or coverage after rebates, fees, 17 alternative discounts, or other remu-18 neration received from applicable enti-19 ties; 20 ‘‘(VIII) the total amount of out- 21 of-pocket spending by participants 22 and beneficiaries on such drug, in-23 cluding spending through copayments, 24 coinsurance, and deductibles, but not 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00584 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 585 •HR 1768 IH including any amounts spent by par-1 ticipants and beneficiaries on drugs 2 not covered under the plan or cov-3 erage, or for which no claim is sub-4 mitted under the plan or coverage; 5 ‘‘(IX) the total net spending on 6 the drug; 7 ‘‘(X) the total amount received, 8 or expected to be received, by the plan 9 or issuer from any applicable entity in 10 rebates, fees, alternative discounts, or 11 other remuneration; 12 ‘‘(XI) the total amount received, 13 or expected to be received, by the enti-14 ty providing pharmacy benefit man-15 agement services, from applicable en-16 tities, in rebates, fees, alternative dis-17 counts, or other remuneration from 18 such entities— 19 ‘‘(aa) for claims incurred 20 during the reporting period; and 21 ‘‘(bb) that is related to utili-22 zation of such drug or spending 23 on such drug; and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00585 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 586 •HR 1768 IH ‘‘(XII) to the extent feasible, in-1 formation on the total amount of re-2 muneration for such drug, including 3 copayment assistance dollars paid, co-4 payment cards applied, or other dis-5 counts provided by each drug manu-6 facturer (or entity administering co-7 payment assistance on behalf of such 8 drug manufacturer), to the partici-9 pants and beneficiaries enrolled in 10 such plan or coverage; 11 ‘‘(ii) a list of each therapeutic class 12 (as defined by the Secretary) for which a 13 claim was filed under the group health 14 plan or health insurance coverage during 15 the reporting period, and, with respect to 16 each such therapeutic class— 17 ‘‘(I) the total gross spending on 18 drugs in such class before rebates, 19 price concessions, alternative dis-20 counts, or other remuneration from 21 applicable entities; 22 ‘‘(II) the net spending in such 23 class after such rebates, price conces-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00586 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 587 •HR 1768 IH sions, alternative discounts, or other 1 remuneration from applicable entities; 2 ‘‘(III) the total amount received, 3 or expected to be received, by the enti-4 ty providing pharmacy benefit man-5 agement services, from applicable en-6 tities, in rebates, fees, alternative dis-7 counts, or other remuneration from 8 such entities— 9 ‘‘(aa) for claims incurred 10 during the reporting period; and 11 ‘‘(bb) that is related to utili-12 zation of drugs or drug spending; 13 ‘‘(IV) the average net spending 14 per 30-day supply and per 90-day 15 supply by the plan or by the issuer 16 with respect to such coverage and its 17 participants and beneficiaries, among 18 all drugs within the therapeutic class 19 for which a claim was filed during the 20 reporting period; 21 ‘‘(V) the number of participants 22 and beneficiaries who filled a prescrip-23 tion for a drug in such class, includ-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00587 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 588 •HR 1768 IH ing the National Drug Code for each 1 such drug; 2 ‘‘(VI) if applicable, a description 3 of the formulary tiers and utilization 4 mechanisms (such as prior authoriza-5 tion or step therapy) employed for 6 drugs in that class; and 7 ‘‘(VII) the total out-of-pocket 8 spending under the plan or coverage 9 by participants and beneficiaries, in-10 cluding spending through copayments, 11 coinsurance, and deductibles, but not 12 including any amounts spent by par-13 ticipants and beneficiaries on drugs 14 not covered under the plan or cov-15 erage or for which no claim is sub-16 mitted under the plan or coverage; 17 ‘‘(iii) with respect to any drug for 18 which gross spending under the group 19 health plan or health insurance coverage 20 exceeded $10,000 during the reporting pe-21 riod or, in the case that gross spending 22 under the group health plan or coverage 23 exceeded $10,000 during the reporting pe-24 riod with respect to fewer than 50 drugs, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00588 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 589 •HR 1768 IH with respect to the 50 prescription drugs 1 with the highest spending during the re-2 porting period— 3 ‘‘(I) a list of all other drugs in 4 the same therapeutic class as such 5 drug; 6 ‘‘(II) if applicable, the rationale 7 for the formulary placement of such 8 drug in that therapeutic category or 9 class, selected from a list of standard 10 rationales established by the Sec-11 retary, in consultation with stake-12 holders; and 13 ‘‘(III) any change in formulary 14 placement compared to the prior plan 15 year; and 16 ‘‘(iv) in the case that such plan or 17 issuer (or an entity providing pharmacy 18 benefit management services on behalf of 19 such plan or issuer) has an affiliated phar-20 macy or pharmacy under common owner-21 ship, including mandatory mail and spe-22 cialty home delivery programs, retail and 23 mail auto-refill programs, and cost sharing 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00589 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 590 •HR 1768 IH assistance incentives funded by an entity 1 providing pharmacy benefit services— 2 ‘‘(I) an explanation of any ben-3 efit design parameters that encourage 4 or require participants and bene-5 ficiaries in the plan or coverage to fill 6 prescriptions at mail order, specialty, 7 or retail pharmacies; 8 ‘‘(II) the percentage of total pre-9 scriptions dispensed by such phar-10 macies to participants or beneficiaries 11 in such plan or coverage; and 12 ‘‘(III) a list of all drugs dis-13 pensed by such pharmacies to partici-14 pants or beneficiaries enrolled in such 15 plan or coverage, and, with respect to 16 each drug dispensed— 17 ‘‘(aa) the amount charged, 18 per dosage unit, per 30-day sup-19 ply, or per 90-day supply (as ap-20 plicable) to the plan or issuer, 21 and to participants and bene-22 ficiaries; 23 ‘‘(bb) the median amount 24 charged to such plan or issuer, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00590 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 591 •HR 1768 IH and the interquartile range of the 1 costs, per dosage unit, per 30- 2 day supply, and per 90-day sup-3 ply, including amounts paid by 4 the participants and bene-5 ficiaries, when the same drug is 6 dispensed by other pharmacies 7 that are not affiliated with or 8 under common ownership with 9 the entity and that are included 10 in the pharmacy network of such 11 plan or coverage; 12 ‘‘(cc) the lowest cost per 13 dosage unit, per 30-day supply 14 and per 90-day supply, for each 15 such drug, including amounts 16 charged to the plan or coverage 17 and to participants and bene-18 ficiaries, that is available from 19 any pharmacy included in the 20 network of such plan or coverage; 21 and 22 ‘‘(dd) the net acquisition 23 cost per dosage unit, per 30-day 24 supply, and per 90-day supply, if 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00591 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 592 •HR 1768 IH such drug is subject to a max-1 imum price discount; and 2 ‘‘(B) with respect to any group health 3 plan, including group health insurance coverage 4 offered in connection with such a plan, regard-5 less of whether the plan or coverage is offered 6 by a specified large employer or whether it is a 7 specified large plan— 8 ‘‘(i) a summary document for the 9 group health plan that includes such infor-10 mation described in clauses (i) through (iv) 11 of subparagraph (A), as specified by the 12 Secretary through guidance, program in-13 struction, or otherwise (with no require-14 ment of notice and comment rulemaking), 15 that the Secretary determines useful to 16 group health plans for purposes of select-17 ing pharmacy benefit management serv-18 ices, such as an estimated net price to 19 group health plan and participant or bene-20 ficiary, a cost per claim, the fee structure 21 or reimbursement model, and estimated 22 cost per participant or beneficiary; 23 ‘‘(ii) a summary document for plans 24 and issuers to provide to participants and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00592 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 593 •HR 1768 IH beneficiaries, which shall be made available 1 to participants or beneficiaries upon re-2 quest to their group health plan (including 3 in the case of group health insurance cov-4 erage offered in connection with such a 5 plan), that— 6 ‘‘(I) contains such information 7 described in clauses (iii), (iv), (v), and 8 (vi), as applicable, as specified by the 9 Secretary through guidance, program 10 instruction, or otherwise (with no re-11 quirement of notice and comment 12 rulemaking) that the Secretary deter-13 mines useful to participants or bene-14 ficiaries in better understanding the 15 plan or coverage or benefits under 16 such plan or coverage; 17 ‘‘(II) contains only aggregate in-18 formation; and 19 ‘‘(III) states that participants 20 and beneficiaries may request specific, 21 claims-level information required to be 22 furnished under subsection (c) from 23 the group health plan or health insur-24 ance issuer; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00593 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 594 •HR 1768 IH ‘‘(iii) with respect to drugs covered by 1 such plan or coverage during such report-2 ing period— 3 ‘‘(I) the total net spending by the 4 plan or coverage for all such drugs; 5 ‘‘(II) the total amount received, 6 or expected to be received, by the plan 7 or issuer from any applicable entity in 8 rebates, fees, alternative discounts, or 9 other remuneration; and 10 ‘‘(III) to the extent feasible, in-11 formation on the total amount of re-12 muneration for such drugs, including 13 copayment assistance dollars paid, co-14 payment cards applied, or other dis-15 counts provided by each drug manu-16 facturer (or entity administering co-17 payment assistance on behalf of such 18 drug manufacturer) to participants 19 and beneficiaries; 20 ‘‘(iv) amounts paid directly or indi-21 rectly in rebates, fees, or any other type of 22 compensation (as defined in section 23 408(b)(2)(B)(ii)(dd)(AA)) to brokerage 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00594 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 595 •HR 1768 IH firms, brokers, consultants, advisors, or 1 any other individual or firm, for— 2 ‘‘(I) the referral of the group 3 health plan’s or health insurance 4 issuer’s business to an entity pro-5 viding pharmacy benefit management 6 services, including the identity of the 7 recipient of such amounts; 8 ‘‘(II) consideration of the entity 9 providing pharmacy benefit manage-10 ment services by the group health 11 plan or health insurance issuer; or 12 ‘‘(III) the retention of the entity 13 by the group health plan or health in-14 surance issuer; 15 ‘‘(v) an explanation of any benefit de-16 sign parameters that encourage or require 17 participants and beneficiaries in such plan 18 or coverage to fill prescriptions at mail 19 order, specialty, or retail pharmacies that 20 are affiliated with or under common own-21 ership with the entity providing pharmacy 22 benefit management services under such 23 plan or coverage, including mandatory mail 24 and specialty home delivery programs, re-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00595 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 596 •HR 1768 IH tail and mail auto-refill programs, and 1 cost-sharing assistance incentives directly 2 or indirectly funded by such entity; and 3 ‘‘(vi) total gross spending on all drugs 4 under the plan or coverage during the re-5 porting period. 6 ‘‘(3) O PT-IN FOR GROUP HEALTH INSURANCE 7 COVERAGE OFFERED BY A SPECIFIED LARGE EM -8 PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9 the case of group health insurance coverage offered 10 in connection with a group health plan that is of-11 fered by a specified large employer or is a specified 12 large plan, such group health plan may, on an an-13 nual basis, for plan years beginning on or after the 14 date that is 30 months after the date of enactment 15 of this section, elect to require an entity providing 16 pharmacy benefit management services on behalf of 17 the health insurance issuer to submit to such group 18 health plan a report that includes all of the informa-19 tion described in paragraph (2)(A), in addition to 20 the information described in paragraph (2)(B). 21 ‘‘(4) PRIVACY REQUIREMENTS .— 22 ‘‘(A) I N GENERAL .—An entity providing 23 pharmacy benefit management services on be-24 half of a group health plan or a health insur-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00596 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 597 •HR 1768 IH ance issuer offering group health insurance cov-1 erage shall report information under paragraph 2 (1) in a manner consistent with the privacy reg-3 ulations promulgated under section 13402(a) of 4 the Health Information Technology for Eco-5 nomic and Clinical Health Act (42 U.S.C. 6 17932(a)) and consistent with the privacy regu-7 lations promulgated under the Health Insur-8 ance Portability and Accountability Act of 1996 9 in part 160 and subparts A and E of part 164 10 of title 45, Code of Federal Regulations (or suc-11 cessor regulations) (referred to in this para-12 graph as the ‘HIPAA privacy regulations’) and 13 shall restrict the use and disclosure of such in-14 formation according to such privacy regulations 15 and such HIPAA privacy regulations. 16 ‘‘(B) ADDITIONAL REQUIREMENTS .— 17 ‘‘(i) I N GENERAL .—An entity pro-18 viding pharmacy benefit management serv-19 ices on behalf of a group health plan or 20 health insurance issuer offering group 21 health insurance coverage that submits a 22 report under paragraph (1) shall ensure 23 that such report contains only summary 24 health information, as defined in section 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00597 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 598 •HR 1768 IH 164.504(a) of title 45, Code of Federal 1 Regulations (or successor regulations). 2 ‘‘(ii) R ESTRICTIONS.—In carrying out 3 this subsection, a group health plan shall 4 comply with section 164.504(f) of title 45, 5 Code of Federal Regulations (or a suc-6 cessor regulation), and a plan sponsor shall 7 act in accordance with the terms of the 8 agreement described in such section. 9 ‘‘(C) RULE OF CONSTRUCTION .— 10 ‘‘(i) Nothing in this section shall be 11 construed to modify the requirements for 12 the creation, receipt, maintenance, or 13 transmission of protected health informa-14 tion under the HIPAA privacy regulations. 15 ‘‘(ii) Nothing in this section shall be 16 construed to affect the application of any 17 Federal or State privacy or civil rights law, 18 including the HIPAA privacy regulations, 19 the Genetic Information Nondiscrimination 20 Act of 2008 (Public Law 110–233) (in-21 cluding the amendments made by such 22 Act), the Americans with Disabilities Act 23 of 1990 (42 U.S.C. 12101 et seq.), section 24 504 of the Rehabilitation Act of 1973 (29 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00598 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 599 •HR 1768 IH U.S.C. 794), section 1557 of the Patient 1 Protection and Affordable Care Act (42 2 U.S.C. 18116), title VI of the Civil Rights 3 Act of 1964 (42 U.S.C. 2000d), and title 4 VII of the Civil Rights Act of 1964 (42 5 U.S.C. 2000e). 6 ‘‘(D) W RITTEN NOTICE .—Each plan year, 7 group health plans, including with respect to 8 group health insurance coverage offered in con-9 nection with a group health plan, shall provide 10 to each participant or beneficiary written notice 11 informing the participant or beneficiary of the 12 requirement for entities providing pharmacy 13 benefit management services on behalf of the 14 group health plan or health insurance issuer of-15 fering group health insurance coverage to sub-16 mit reports to group health plans under para-17 graph (1), as applicable, which may include in-18 corporating such notification in plan documents 19 provided to the participant or beneficiary, or 20 providing individual notification. 21 ‘‘(E) L IMITATION TO BUSINESS ASSOCI -22 ATES.—A group health plan receiving a report 23 under paragraph (1) may disclose such informa-24 tion only to the entity from which the report 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00599 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 600 •HR 1768 IH was received or to that entity’s business associ-1 ates as defined in section 160.103 of title 45, 2 Code of Federal Regulations (or successor regu-3 lations) or as permitted by the HIPAA privacy 4 regulations. 5 ‘‘(F) C LARIFICATION REGARDING PUBLIC 6 DISCLOSURE OF INFORMATION .—Nothing in 7 this section shall prevent an entity providing 8 pharmacy benefit management services on be-9 half of a group health plan or health insurance 10 issuer offering group health insurance coverage, 11 from placing reasonable restrictions on the pub-12 lic disclosure of the information contained in a 13 report described in paragraph (1), except that 14 such plan, issuer, or entity may not— 15 ‘‘(i) restrict disclosure of such report 16 to the Department of Health and Human 17 Services, the Department of Labor, or the 18 Department of the Treasury; or 19 ‘‘(ii) prevent disclosure for the pur-20 poses of subsection (c), or any other public 21 disclosure requirement under this section. 22 ‘‘(G) L IMITED FORM OF REPORT .—The 23 Secretary shall define through rulemaking a 24 limited form of the report under paragraph (1) 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00600 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 601 •HR 1768 IH required with respect to any group health plan 1 established by a plan sponsor that is, or is af-2 filiated with, a drug manufacturer, drug whole-3 saler, or other direct participant in the drug 4 supply chain, in order to prevent anti-competi-5 tive behavior. 6 ‘‘(5) S TANDARD FORMAT AND REGULATIONS .— 7 ‘‘(A) I N GENERAL .—Not later than 18 8 months after the date of enactment of this sec-9 tion, the Secretary shall specify through rule-10 making a standard format for entities providing 11 pharmacy benefit management services on be-12 half of group health plans and health insurance 13 issuers offering group health insurance cov-14 erage, to submit reports required under para-15 graph (1). 16 ‘‘(B) A DDITIONAL REGULATIONS .—Not 17 later than 18 months after the date of enact-18 ment of this section, the Secretary shall, 19 through rulemaking, promulgate any other final 20 regulations necessary to implement the require-21 ments of this section. In promulgating such 22 regulations, the Secretary shall, to the extent 23 practicable, align the reporting requirements 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00601 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 602 •HR 1768 IH under this section with the reporting require-1 ments under section 725. 2 ‘‘(c) R EQUIREMENT TO PROVIDE INFORMATION TO 3 PARTICIPANTS OR BENEFICIARIES.—A group health plan, 4 including with respect to group health insurance coverage 5 offered in connection with a group health plan, upon re-6 quest of a participant or beneficiary, shall provide to such 7 participant or beneficiary— 8 ‘‘(1) the summary document described in sub-9 section (b)(2)(B)(ii); and 10 ‘‘(2) the information described in subsection 11 (b)(2)(A)(i)(III) with respect to a claim made by or 12 on behalf of such participant or beneficiary. 13 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-14 tion shall be construed to permit a health insurance issuer, 15 group health plan, entity providing pharmacy benefit man-16 agement services on behalf of a group health plan or 17 health insurance issuer, or other entity to restrict disclo-18 sure to, or otherwise limit the access of, the Secretary to 19 a report described in subsection (b)(1) or information re-20 lated to compliance with subsections (a), (b), or (c) of this 21 section or section 502(c)(13) by such issuer, plan, or enti-22 ty. 23 ‘‘(e) DEFINITIONS.—In this section: 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00602 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 603 •HR 1768 IH ‘‘(1) A PPLICABLE ENTITY .—The term ‘applica-1 ble entity’ means— 2 ‘‘(A) an applicable group purchasing orga-3 nization, drug manufacturer, distributor, whole-4 saler, rebate aggregator (or other purchasing 5 entity designed to aggregate rebates), or associ-6 ated third party; 7 ‘‘(B) any subsidiary, parent, affiliate, or 8 subcontractor of a group health plan, health in-9 surance issuer, entity that provides pharmacy 10 benefit management services on behalf of such 11 a plan or issuer, or any entity described in sub-12 paragraph (A); or 13 ‘‘(C) such other entity as the Secretary 14 may specify through rulemaking. 15 ‘‘(2) A PPLICABLE GROUP PURCHASING ORGANI -16 ZATION.—The term ‘applicable group purchasing or-17 ganization’ means a group purchasing organization 18 that is affiliated with or under common ownership 19 with an entity providing pharmacy benefit manage-20 ment services. 21 ‘‘(3) C ONTRACTED COMPENSATION .—The term 22 ‘contracted compensation’ means the sum of any in-23 gredient cost and dispensing fee for a drug (inclusive 24 of the out-of-pocket costs to the participant or bene-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00603 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 604 •HR 1768 IH ficiary), or another analogous compensation struc-1 ture that the Secretary may specify through regula-2 tions. 3 ‘‘(4) G ROSS SPENDING .—The term ‘gross 4 spending’, with respect to prescription drug benefits 5 under a group health plan or health insurance cov-6 erage, means the amount spent by a group health 7 plan or health insurance issuer on prescription drug 8 benefits, calculated before the application of rebates, 9 fees, alternative discounts, or other remuneration. 10 ‘‘(5) NET SPENDING .—The term ‘net spending’, 11 with respect to prescription drug benefits under a 12 group health plan or health insurance coverage, 13 means the amount spent by a group health plan or 14 health insurance issuer on prescription drug bene-15 fits, calculated after the application of rebates, fees, 16 alternative discounts, or other remuneration. 17 ‘‘(6) P LAN SPONSOR .—The term ‘plan sponsor’ 18 has the meaning given such term in section 19 3(16)(B). 20 ‘‘(7) R EMUNERATION.—The term ‘remunera-21 tion’ has the meaning given such term by the Sec-22 retary through rulemaking, which shall be reevalu-23 ated by the Secretary every 5 years. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00604 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 605 •HR 1768 IH ‘‘(8) S PECIFIED LARGE EMPLOYER .—The term 1 ‘specified large employer’ means, in connection with 2 a group health plan (including group health insur-3 ance coverage offered in connection with such a 4 plan) established or maintained by a single em-5 ployer, with respect to a calendar year or a plan 6 year, as applicable, an employer who employed an 7 average of at least 100 employees on business days 8 during the preceding calendar year or plan year and 9 who employs at least 1 employee on the first day of 10 the calendar year or plan year. 11 ‘‘(9) SPECIFIED LARGE PLAN .—The term ‘spec-12 ified large plan’ means a group health plan (includ-13 ing group health insurance coverage offered in con-14 nection with such a plan) established or maintained 15 by a plan sponsor described in clause (ii) or (iii) of 16 section 3(16)(B) that had an average of at least 100 17 participants on business days during the preceding 18 calendar year or plan year, as applicable. 19 ‘‘(10) W HOLESALE ACQUISITION COST .—The 20 term ‘wholesale acquisition cost’ has the meaning 21 given such term in section 1847A(c)(6)(B) of the 22 Social Security Act (42 U.S.C. 1395w– 23 3a(c)(6)(B)).’’; 24 (B) in section 502 (29 U.S.C. 1132)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00605 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 606 •HR 1768 IH (i) in subsection (a)(6), by striking 1 ‘‘or (9)’’ and inserting ‘‘(9), or (13)’’; 2 (ii) in subsection (b)(3), by striking 3 ‘‘under subsection (c)(9)’’ and inserting 4 ‘‘under paragraphs (9) and (13) of sub-5 section (c)’’; and 6 (iii) in subsection (c), by adding at 7 the end the following: 8 ‘‘(13) SECRETARIAL ENFORCEMENT AUTHORITY 9 RELATING TO OVERSIGHT OF PHARMACY BENEFIT 10 MANAGEMENT SERVICES .— 11 ‘‘(A) F AILURE TO PROVIDE INFORMA -12 TION.—The Secretary may impose a penalty 13 against a plan administrator of a group health 14 plan, a health insurance issuer offering group 15 health insurance coverage, or an entity pro-16 viding pharmacy benefit management services 17 on behalf of such a plan or issuer, or an appli-18 cable entity (as defined in section 726(f)) that 19 violates section 726(a); an entity providing 20 pharmacy benefit management services on be-21 half of such a plan or issuer that fails to pro-22 vide the information required under section 23 726(b); or any person who causes a group 24 health plan to fail to provide the information 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00606 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 607 •HR 1768 IH required under section 726(c), in the amount of 1 $10,000 for each day during which such viola-2 tion continues or such information is not dis-3 closed or reported. 4 ‘‘(B) F ALSE INFORMATION .—The Sec-5 retary may impose a penalty against a plan ad-6 ministrator of a group health plan, a health in-7 surance issuer offering group health insurance 8 coverage, an entity providing pharmacy benefit 9 management services, or an applicable entity 10 (as defined in section 726(f)) that knowingly 11 provides false information under section 726, in 12 an amount not to exceed $100,000 for each 13 item of false information. Such penalty shall be 14 in addition to other penalties as may be pre-15 scribed by law. 16 ‘‘(C) W AIVERS.—The Secretary may waive 17 penalties under subparagraph (A), or extend 18 the period of time for compliance with a re-19 quirement of this section, for an entity in viola-20 tion of section 726 that has made a good-faith 21 effort to comply with the requirements of sec-22 tion 726.’’; and 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00607 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 608 •HR 1768 IH (C) in section 732(a) (29 U.S.C. 1 1191a(a)), by striking ‘‘section 711’’ and in-2 serting ‘‘sections 711 and 726’’. 3 (2) C LERICAL AMENDMENT .—The table of con-4 tents in section 1 of the Employee Retirement In-5 come Security Act of 1974 (29 U.S.C. 1001 et seq.) 6 is amended by inserting after the item relating to 7 section 725 the following new item: 8 ‘‘Sec. 726. Oversight of entities that provide pharmacy benefit management services.’’. (c) INTERNAL REVENUE CODE OF 1986.— 9 (1) I N GENERAL .—Chapter 100 of the Internal 10 Revenue Code of 1986 is amended— 11 (A) by adding at the end of subchapter B 12 the following: 13 ‘‘SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-14 MACY BENEFIT MANAGEMENT SERVICES. 15 ‘‘(a) I N GENERAL.—For plan years beginning on or 16 after the date that is 30 months after the date of enact-17 ment of this section (referred to in this subsection and 18 subsection (b) as the ‘effective date’), a group health plan, 19 or an entity providing pharmacy benefit management serv-20 ices on behalf of such a plan, shall not enter into a con-21 tract, including an extension or renewal of a contract, en-22 tered into on or after the effective date, with an applicable 23 entity unless such applicable entity agrees to— 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00608 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 609 •HR 1768 IH ‘‘(1) not limit or delay the disclosure of infor-1 mation to the group health plan in such a manner 2 that prevents an entity providing pharmacy benefit 3 management services on behalf of a group health 4 plan from making the reports described in sub-5 section (b); and 6 ‘‘(2) provide the entity providing pharmacy ben-7 efit management services on behalf of a group health 8 plan relevant information necessary to make the re-9 ports described in subsection (b). 10 ‘‘(b) REPORTS.— 11 ‘‘(1) I N GENERAL .—For plan years beginning 12 on or after the effective date, in the case of any con-13 tract between a group health plan and an entity pro-14 viding pharmacy benefit management services on be-15 half of such plan, including an extension or renewal 16 of such a contract, entered into on or after the effec-17 tive date, the entity providing pharmacy benefit 18 management services on behalf of such a group 19 health plan, not less frequently than every 6 months 20 (or, at the request of a group health plan, not less 21 frequently than quarterly, and under the same con-22 ditions, terms, and cost of the semiannual report 23 under this subsection), shall submit to the group 24 health plan a report in accordance with this section. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00609 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 610 •HR 1768 IH Each such report shall be made available to such 1 group health plan in plain language, in a machine- 2 readable format, and as the Secretary may deter-3 mine, other formats. Each such report shall include 4 the information described in paragraph (2). 5 ‘‘(2) I NFORMATION DESCRIBED .—For purposes 6 of paragraph (1), the information described in this 7 paragraph is, with respect to drugs covered by a 8 group health plan during each reporting period— 9 ‘‘(A) in the case of a group health plan 10 that is offered by a specified large employer or 11 that is a specified large plan, and is not offered 12 as health insurance coverage, or in the case of 13 health insurance coverage for which the election 14 under paragraph (3) is made for the applicable 15 reporting period— 16 ‘‘(i) a list of drugs for which a claim 17 was filed and, with respect to each such 18 drug on such list— 19 ‘‘(I) the contracted compensation 20 paid by the group health plan for each 21 covered drug (identified by the Na-22 tional Drug Code) to the entity pro-23 viding pharmacy benefit management 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00610 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 611 •HR 1768 IH services or other applicable entity on 1 behalf of the group health plan; 2 ‘‘(II) the contracted compensa-3 tion paid to the pharmacy, by any en-4 tity providing pharmacy benefit man-5 agement services or other applicable 6 entity on behalf of the group health 7 plan, for each covered drug (identified 8 by the National Drug Code); 9 ‘‘(III) for each such claim, the 10 difference between the amount paid 11 under subclause (I) and the amount 12 paid under subclause (II); 13 ‘‘(IV) the proprietary name, es-14 tablished name or proper name, and 15 National Drug Code; 16 ‘‘(V) for each claim for the drug 17 (including original prescriptions and 18 refills) and for each dosage unit of the 19 drug for which a claim was filed, the 20 type of dispensing channel used to 21 furnish the drug, including retail, mail 22 order, or specialty pharmacy; 23 ‘‘(VI) with respect to each drug 24 dispensed, for each type of dispensing 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00611 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 612 •HR 1768 IH channel (including retail, mail order, 1 or specialty pharmacy)— 2 ‘‘(aa) whether such drug is a 3 brand name drug or a generic 4 drug, and— 5 ‘‘(AA) in the case of a 6 brand name drug, the whole-7 sale acquisition cost, listed 8 as cost per days supply and 9 cost per dosage unit, on the 10 date such drug was dis-11 pensed; and 12 ‘‘(BB) in the case of a 13 generic drug, the average 14 wholesale price, listed as 15 cost per days supply and 16 cost per dosage unit, on the 17 date such drug was dis-18 pensed; and 19 ‘‘(bb) the total number of— 20 ‘‘(AA) prescription 21 claims (including original 22 prescriptions and refills); 23 ‘‘(BB) participants and 24 beneficiaries for whom a 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00612 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 613 •HR 1768 IH claim for such drug was 1 filed through the applicable 2 dispensing channel; 3 ‘‘(CC) dosage units and 4 dosage units per fill of such 5 drug; and 6 ‘‘(DD) days supply of 7 such drug per fill; 8 ‘‘(VII) the net price per course of 9 treatment or single fill, such as a 30- 10 day supply or 90-day supply to the 11 plan after rebates, fees, alternative 12 discounts, or other remuneration re-13 ceived from applicable entities; 14 ‘‘(VIII) the total amount of out- 15 of-pocket spending by participants 16 and beneficiaries on such drug, in-17 cluding spending through copayments, 18 coinsurance, and deductibles, but not 19 including any amounts spent by par-20 ticipants and beneficiaries on drugs 21 not covered under the plan, or for 22 which no claim is submitted under the 23 plan; 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00613 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 614 •HR 1768 IH ‘‘(IX) the total net spending on 1 the drug; 2 ‘‘(X) the total amount received, 3 or expected to be received, by the plan 4 from any applicable entity in rebates, 5 fees, alternative discounts, or other 6 remuneration; 7 ‘‘(XI) the total amount received, 8 or expected to be received, by the enti-9 ty providing pharmacy benefit man-10 agement services, from applicable en-11 tities, in rebates, fees, alternative dis-12 counts, or other remuneration from 13 such entities— 14 ‘‘(aa) for claims incurred 15 during the reporting period; and 16 ‘‘(bb) that is related to utili-17 zation of such drug or spending 18 on such drug; and 19 ‘‘(XII) to the extent feasible, in-20 formation on the total amount of re-21 muneration for such drug, including 22 copayment assistance dollars paid, co-23 payment cards applied, or other dis-24 counts provided by each drug manu-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00614 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 615 •HR 1768 IH facturer (or entity administering co-1 payment assistance on behalf of such 2 drug manufacturer), to the partici-3 pants and beneficiaries enrolled in 4 such plan; 5 ‘‘(ii) a list of each therapeutic class 6 (as defined by the Secretary) for which a 7 claim was filed under the group health 8 plan during the reporting period, and, with 9 respect to each such therapeutic class— 10 ‘‘(I) the total gross spending on 11 drugs in such class before rebates, 12 price concessions, alternative dis-13 counts, or other remuneration from 14 applicable entities; 15 ‘‘(II) the net spending in such 16 class after such rebates, price conces-17 sions, alternative discounts, or other 18 remuneration from applicable entities; 19 ‘‘(III) the total amount received, 20 or expected to be received, by the enti-21 ty providing pharmacy benefit man-22 agement services, from applicable en-23 tities, in rebates, fees, alternative dis-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00615 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 616 •HR 1768 IH counts, or other remuneration from 1 such entities— 2 ‘‘(aa) for claims incurred 3 during the reporting period; and 4 ‘‘(bb) that is related to utili-5 zation of drugs or drug spending; 6 ‘‘(IV) the average net spending 7 per 30-day supply and per 90-day 8 supply by the plan and its partici-9 pants and beneficiaries, among all 10 drugs within the therapeutic class for 11 which a claim was filed during the re-12 porting period; 13 ‘‘(V) the number of participants 14 and beneficiaries who filled a prescrip-15 tion for a drug in such class, includ-16 ing the National Drug Code for each 17 such drug; 18 ‘‘(VI) if applicable, a description 19 of the formulary tiers and utilization 20 mechanisms (such as prior authoriza-21 tion or step therapy) employed for 22 drugs in that class; and 23 ‘‘(VII) the total out-of-pocket 24 spending under the plan by partici-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00616 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 617 •HR 1768 IH pants and beneficiaries, including 1 spending through copayments, coin-2 surance, and deductibles, but not in-3 cluding any amounts spent by partici-4 pants and beneficiaries on drugs not 5 covered under the plan or for which 6 no claim is submitted under the plan; 7 ‘‘(iii) with respect to any drug for 8 which gross spending under the group 9 health plan exceeded $10,000 during the 10 reporting period or, in the case that gross 11 spending under the group health plan ex-12 ceeded $10,000 during the reporting pe-13 riod with respect to fewer than 50 drugs, 14 with respect to the 50 prescription drugs 15 with the highest spending during the re-16 porting period— 17 ‘‘(I) a list of all other drugs in 18 the same therapeutic class as such 19 drug; 20 ‘‘(II) if applicable, the rationale 21 for the formulary placement of such 22 drug in that therapeutic category or 23 class, selected from a list of standard 24 rationales established by the Sec-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00617 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 618 •HR 1768 IH retary, in consultation with stake-1 holders; and 2 ‘‘(III) any change in formulary 3 placement compared to the prior plan 4 year; and 5 ‘‘(iv) in the case that such plan (or an 6 entity providing pharmacy benefit manage-7 ment services on behalf of such plan) has 8 an affiliated pharmacy or pharmacy under 9 common ownership, including mandatory 10 mail and specialty home delivery programs, 11 retail and mail auto-refill programs, and 12 cost sharing assistance incentives funded 13 by an entity providing pharmacy benefit 14 services— 15 ‘‘(I) an explanation of any ben-16 efit design parameters that encourage 17 or require participants and bene-18 ficiaries in the plan to fill prescrip-19 tions at mail order, specialty, or retail 20 pharmacies; 21 ‘‘(II) the percentage of total pre-22 scriptions dispensed by such phar-23 macies to participants or beneficiaries 24 in such plan; and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00618 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 619 •HR 1768 IH ‘‘(III) a list of all drugs dis-1 pensed by such pharmacies to partici-2 pants or beneficiaries enrolled in such 3 plan, and, with respect to each drug 4 dispensed— 5 ‘‘(aa) the amount charged, 6 per dosage unit, per 30-day sup-7 ply, or per 90-day supply (as ap-8 plicable) to the plan, and to par-9 ticipants and beneficiaries; 10 ‘‘(bb) the median amount 11 charged to such plan, and the 12 interquartile range of the costs, 13 per dosage unit, per 30-day sup-14 ply, and per 90-day supply, in-15 cluding amounts paid by the par-16 ticipants and beneficiaries, when 17 the same drug is dispensed by 18 other pharmacies that are not af-19 filiated with or under common 20 ownership with the entity and 21 that are included in the phar-22 macy network of such plan; 23 ‘‘(cc) the lowest cost per 24 dosage unit, per 30-day supply 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00619 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 620 •HR 1768 IH and per 90-day supply, for each 1 such drug, including amounts 2 charged to the plan and to par-3 ticipants and beneficiaries, that 4 is available from any pharmacy 5 included in the network of such 6 plan; and 7 ‘‘(dd) the net acquisition 8 cost per dosage unit, per 30-day 9 supply, and per 90-day supply, if 10 such drug is subject to a max-11 imum price discount; and 12 ‘‘(B) with respect to any group health 13 plan, regardless of whether the plan is offered 14 by a specified large employer or whether it is a 15 specified large plan— 16 ‘‘(i) a summary document for the 17 group health plan that includes such infor-18 mation described in clauses (i) through (iv) 19 of subparagraph (A), as specified by the 20 Secretary through guidance, program in-21 struction, or otherwise (with no require-22 ment of notice and comment rulemaking), 23 that the Secretary determines useful to 24 group health plans for purposes of select-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00620 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 621 •HR 1768 IH ing pharmacy benefit management serv-1 ices, such as an estimated net price to 2 group health plan and participant or bene-3 ficiary, a cost per claim, the fee structure 4 or reimbursement model, and estimated 5 cost per participant or beneficiary; 6 ‘‘(ii) a summary document for plans 7 to provide to participants and beneficiaries, 8 which shall be made available to partici-9 pants or beneficiaries upon request to their 10 group health plan, that— 11 ‘‘(I) contains such information 12 described in clauses (iii), (iv), (v), and 13 (vi), as applicable, as specified by the 14 Secretary through guidance, program 15 instruction, or otherwise (with no re-16 quirement of notice and comment 17 rulemaking) that the Secretary deter-18 mines useful to participants or bene-19 ficiaries in better understanding the 20 plan or benefits under such plan; 21 ‘‘(II) contains only aggregate in-22 formation; and 23 ‘‘(III) states that participants 24 and beneficiaries may request specific, 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00621 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 622 •HR 1768 IH claims-level information required to be 1 furnished under subsection (c) from 2 the group health plan; and 3 ‘‘(iii) with respect to drugs covered by 4 such plan during such reporting period— 5 ‘‘(I) the total net spending by the 6 plan for all such drugs; 7 ‘‘(II) the total amount received, 8 or expected to be received, by the plan 9 from any applicable entity in rebates, 10 fees, alternative discounts, or other 11 remuneration; and 12 ‘‘(III) to the extent feasible, in-13 formation on the total amount of re-14 muneration for such drugs, including 15 copayment assistance dollars paid, co-16 payment cards applied, or other dis-17 counts provided by each drug manu-18 facturer (or entity administering co-19 payment assistance on behalf of such 20 drug manufacturer) to participants 21 and beneficiaries; 22 ‘‘(iv) amounts paid directly or indi-23 rectly in rebates, fees, or any other type of 24 compensation (as defined in section 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00622 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 623 •HR 1768 IH 408(b)(2)(B)(ii)(dd)(AA) of the Employee 1 Retirement Income Security Act (29 2 U.S.C. 1108(b)(2)(B)(ii)(dd)(AA))) to bro-3 kerage firms, brokers, consultants, advi-4 sors, or any other individual or firm, for— 5 ‘‘(I) the referral of the group 6 health plan’s business to an entity 7 providing pharmacy benefit manage-8 ment services, including the identity 9 of the recipient of such amounts; 10 ‘‘(II) consideration of the entity 11 providing pharmacy benefit manage-12 ment services by the group health 13 plan; or 14 ‘‘(III) the retention of the entity 15 by the group health plan; 16 ‘‘(v) an explanation of any benefit de-17 sign parameters that encourage or require 18 participants and beneficiaries in such plan 19 to fill prescriptions at mail order, specialty, 20 or retail pharmacies that are affiliated with 21 or under common ownership with the enti-22 ty providing pharmacy benefit management 23 services under such plan, including manda-24 tory mail and specialty home delivery pro-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00623 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 624 •HR 1768 IH grams, retail and mail auto-refill pro-1 grams, and cost-sharing assistance incen-2 tives directly or indirectly funded by such 3 entity; and 4 ‘‘(vi) total gross spending on all drugs 5 under the plan during the reporting period. 6 ‘‘(3) O PT-IN FOR GROUP HEALTH INSURANCE 7 COVERAGE OFFERED BY A SPECIFIED LARGE EM -8 PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9 the case of group health insurance coverage offered 10 in connection with a group health plan that is of-11 fered by a specified large employer or is a specified 12 large plan, such group health plan may, on an an-13 nual basis, for plan years beginning on or after the 14 date that is 30 months after the date of enactment 15 of this section, elect to require an entity providing 16 pharmacy benefit management services on behalf of 17 the health insurance issuer to submit to such group 18 health plan a report that includes all of the informa-19 tion described in paragraph (2)(A), in addition to 20 the information described in paragraph (2)(B). 21 ‘‘(4) PRIVACY REQUIREMENTS .— 22 ‘‘(A) I N GENERAL .—An entity providing 23 pharmacy benefit management services on be-24 half of a group health plan shall report infor-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00624 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 625 •HR 1768 IH mation under paragraph (1) in a manner con-1 sistent with the privacy regulations promul-2 gated under section 13402(a) of the Health In-3 formation Technology for Economic and Clin-4 ical Health Act (42 U.S.C. 17932(a)) and con-5 sistent with the privacy regulations promul-6 gated under the Health Insurance Portability 7 and Accountability Act of 1996 in part 160 and 8 subparts A and E of part 164 of title 45, Code 9 of Federal Regulations (or successor regula-10 tions) (referred to in this paragraph as the 11 ‘HIPAA privacy regulations’) and shall restrict 12 the use and disclosure of such information ac-13 cording to such privacy regulations and such 14 HIPAA privacy regulations. 15 ‘‘(B) ADDITIONAL REQUIREMENTS .— 16 ‘‘(i) I N GENERAL .—An entity pro-17 viding pharmacy benefit management serv-18 ices on behalf of a group health plan that 19 submits a report under paragraph (1) shall 20 ensure that such report contains only sum-21 mary health information, as defined in sec-22 tion 164.504(a) of title 45, Code of Fed-23 eral Regulations (or successor regulations). 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00625 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 626 •HR 1768 IH ‘‘(ii) R ESTRICTIONS.—In carrying out 1 this subsection, a group health plan shall 2 comply with section 164.504(f) of title 45, 3 Code of Federal Regulations (or a suc-4 cessor regulation), and a plan sponsor shall 5 act in accordance with the terms of the 6 agreement described in such section. 7 ‘‘(C) RULE OF CONSTRUCTION .— 8 ‘‘(i) Nothing in this section shall be 9 construed to modify the requirements for 10 the creation, receipt, maintenance, or 11 transmission of protected health informa-12 tion under the HIPAA privacy regulations. 13 ‘‘(ii) Nothing in this section shall be 14 construed to affect the application of any 15 Federal or State privacy or civil rights law, 16 including the HIPAA privacy regulations, 17 the Genetic Information Nondiscrimination 18 Act of 2008 (Public Law 110–233) (in-19 cluding the amendments made by such 20 Act), the Americans with Disabilities Act 21 of 1990 (42 U.S.C. 12101 et seq.), section 22 504 of the Rehabilitation Act of 1973 (29 23 U.S.C. 794), section 1557 of the Patient 24 Protection and Affordable Care Act (42 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00626 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 627 •HR 1768 IH U.S.C. 18116), title VI of the Civil Rights 1 Act of 1964 (42 U.S.C. 2000d), and title 2 VII of the Civil Rights Act of 1964 (42 3 U.S.C. 2000e). 4 ‘‘(D) W RITTEN NOTICE .—Each plan year, 5 group health plans shall provide to each partici-6 pant or beneficiary written notice informing the 7 participant or beneficiary of the requirement for 8 entities providing pharmacy benefit manage-9 ment services on behalf of the group health 10 plan to submit reports to group health plans 11 under paragraph (1), as applicable, which may 12 include incorporating such notification in plan 13 documents provided to the participant or bene-14 ficiary, or providing individual notification. 15 ‘‘(E) L IMITATION TO BUSINESS ASSOCI -16 ATES.—A group health plan receiving a report 17 under paragraph (1) may disclose such informa-18 tion only to the entity from which the report 19 was received or to that entity’s business associ-20 ates as defined in section 160.103 of title 45, 21 Code of Federal Regulations (or successor regu-22 lations) or as permitted by the HIPAA privacy 23 regulations. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00627 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 628 •HR 1768 IH ‘‘(F) C LARIFICATION REGARDING PUBLIC 1 DISCLOSURE OF INFORMATION .—Nothing in 2 this section shall prevent an entity providing 3 pharmacy benefit management services on be-4 half of a group health plan, from placing rea-5 sonable restrictions on the public disclosure of 6 the information contained in a report described 7 in paragraph (1), except that such plan or enti-8 ty may not— 9 ‘‘(i) restrict disclosure of such report 10 to the Department of Health and Human 11 Services, the Department of Labor, or the 12 Department of the Treasury; or 13 ‘‘(ii) prevent disclosure for the pur-14 poses of subsection (c), or any other public 15 disclosure requirement under this section. 16 ‘‘(G) L IMITED FORM OF REPORT .—The 17 Secretary shall define through rulemaking a 18 limited form of the report under paragraph (1) 19 required with respect to any group health plan 20 established by a plan sponsor that is, or is af-21 filiated with, a drug manufacturer, drug whole-22 saler, or other direct participant in the drug 23 supply chain, in order to prevent anti-competi-24 tive behavior. 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00628 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 629 •HR 1768 IH ‘‘(5) S TANDARD FORMAT AND REGULATIONS .— 1 ‘‘(A) I N GENERAL .—Not later than 18 2 months after the date of enactment of this sec-3 tion, the Secretary shall specify through rule-4 making a standard format for entities providing 5 pharmacy benefit management services on be-6 half of group health plans, to submit reports re-7 quired under paragraph (1). 8 ‘‘(B) A DDITIONAL REGULATIONS .—Not 9 later than 18 months after the date of enact-10 ment of this section, the Secretary shall, 11 through rulemaking, promulgate any other final 12 regulations necessary to implement the require-13 ments of this section. In promulgating such 14 regulations, the Secretary shall, to the extent 15 practicable, align the reporting requirements 16 under this section with the reporting require-17 ments under section 9825. 18 ‘‘(c) R EQUIREMENT TO PROVIDE INFORMATION TO 19 PARTICIPANTS OR BENEFICIARIES.—A group health plan, 20 upon request of a participant or beneficiary, shall provide 21 to such participant or beneficiary— 22 ‘‘(1) the summary document described in sub-23 section (b)(2)(B)(ii); and 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00629 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 630 •HR 1768 IH ‘‘(2) the information described in subsection 1 (b)(2)(A)(i)(III) with respect to a claim made by or 2 on behalf of such participant or beneficiary. 3 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-4 tion shall be construed to permit a health insurance issuer, 5 group health plan, entity providing pharmacy benefit man-6 agement services on behalf of a group health plan or 7 health insurance issuer, or other entity to restrict disclo-8 sure to, or otherwise limit the access of, the Secretary to 9 a report described in subsection (b)(1) or information re-10 lated to compliance with subsections (a), (b), or (c) of this 11 section or section 4980D(g) by such issuer, plan, or entity. 12 ‘‘(e) DEFINITIONS.—In this section: 13 ‘‘(1) A PPLICABLE ENTITY .—The term ‘applica-14 ble entity’ means— 15 ‘‘(A) an applicable group purchasing orga-16 nization, drug manufacturer, distributor, whole-17 saler, rebate aggregator (or other purchasing 18 entity designed to aggregate rebates), or associ-19 ated third party; 20 ‘‘(B) any subsidiary, parent, affiliate, or 21 subcontractor of a group health plan, health in-22 surance issuer, entity that provides pharmacy 23 benefit management services on behalf of such 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00630 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 631 •HR 1768 IH a plan or issuer, or any entity described in sub-1 paragraph (A); or 2 ‘‘(C) such other entity as the Secretary 3 may specify through rulemaking. 4 ‘‘(2) A PPLICABLE GROUP PURCHASING ORGANI -5 ZATION.—The term ‘applicable group purchasing or-6 ganization’ means a group purchasing organization 7 that is affiliated with or under common ownership 8 with an entity providing pharmacy benefit manage-9 ment services. 10 ‘‘(3) C ONTRACTED COMPENSATION .—The term 11 ‘contracted compensation’ means the sum of any in-12 gredient cost and dispensing fee for a drug (inclusive 13 of the out-of-pocket costs to the participant or bene-14 ficiary), or another analogous compensation struc-15 ture that the Secretary may specify through regula-16 tions. 17 ‘‘(4) G ROSS SPENDING .—The term ‘gross 18 spending’, with respect to prescription drug benefits 19 under a group health plan, means the amount spent 20 by a group health plan on prescription drug benefits, 21 calculated before the application of rebates, fees, al-22 ternative discounts, or other remuneration. 23 ‘‘(5) NET SPENDING .—The term ‘net spending’, 24 with respect to prescription drug benefits under a 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00631 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 632 •HR 1768 IH group health plan, means the amount spent by a 1 group health plan on prescription drug benefits, cal-2 culated after the application of rebates, fees, alter-3 native discounts, or other remuneration. 4 ‘‘(6) P LAN SPONSOR .—The term ‘plan sponsor’ 5 has the meaning given such term in section 3(16)(B) 6 of the Employee Retirement Income Security Act of 7 1974 (29 U.S.C. 1002(16)(B)). 8 ‘‘(7) R EMUNERATION.—The term ‘remunera-9 tion’ has the meaning given such term by the Sec-10 retary, through rulemaking, which shall be reevalu-11 ated by the Secretary every 5 years. 12 ‘‘(8) S PECIFIED LARGE EMPLOYER .—The term 13 ‘specified large employer’ means, in connection with 14 a group health plan established or maintained by a 15 single employer, with respect to a calendar year or 16 a plan year, as applicable, an employer who em-17 ployed an average of at least 100 employees on busi-18 ness days during the preceding calendar year or plan 19 year and who employs at least 1 employee on the 20 first day of the calendar year or plan year. 21 ‘‘(9) SPECIFIED LARGE PLAN .—The term ‘spec-22 ified large plan’ means a group health plan estab-23 lished or maintained by a plan sponsor described in 24 clause (ii) or (iii) of section 3(16)(B) of the Em-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00632 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 633 •HR 1768 IH ployee Retirement Income Security Act of 1974 (29 1 U.S.C. 1002(16)(B)) that had an average of at least 2 100 participants on business days during the pre-3 ceding calendar year or plan year, as applicable. 4 ‘‘(10) W HOLESALE ACQUISITION COST .—The 5 term ‘wholesale acquisition cost’ has the meaning 6 given such term in section 1847A(c)(6)(B) of the 7 Social Security Act (42 U.S.C. 1395w– 8 3a(c)(6)(B)).’’; 9 (2) E XCEPTION FOR CERTAIN GROUP HEALTH 10 PLANS.—Section 9831(a)(2) of the Internal Revenue 11 Code of 1986 is amended by inserting ‘‘other than 12 with respect to section 9826,’’ before ‘‘any group 13 health plan’’. 14 (3) E NFORCEMENT.—Section 4980D of the In-15 ternal Revenue Code of 1986 is amended by adding 16 at the end the following new subsection: 17 ‘‘(g) A PPLICATION TO REQUIREMENTS IMPOSED ON 18 CERTAIN ENTITIES PROVIDING PHARMACY BENEFIT 19 MANAGEMENT SERVICES.—In the case of any requirement 20 under section 9826 that applies with respect to an entity 21 providing pharmacy benefit management services on be-22 half of a group health plan, any reference in this section 23 to such group health plan (and the reference in subsection 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00633 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 634 •HR 1768 IH (e)(1) to the employer) shall be treated as including a ref-1 erence to such entity.’’. 2 (4) C LERICAL AMENDMENT .—The table of sec-3 tions for subchapter B of chapter 100 of the Inter-4 nal Revenue Code of 1986 is amended by adding at 5 the end the following new item: 6 ‘‘Sec. 9826. Oversight of entities that provide pharmacy benefit management services.’’. SEC. 902. FULL REBATE PASS THROUGH TO PLAN; EXCEP-7 TION FOR INNOCENT PLAN FIDUCIARIES. 8 (a) I N GENERAL.—Section 408(b)(2) of the Em-9 ployee Retirement Income Security Act of 1974 (29 10 U.S.C. 1108(b)(2)) is amended— 11 (1) in subparagraph (B)(viii)— 12 (A) by redesignating subclauses (II) 13 through (IV) as subclauses (III) through (V), 14 respectively; 15 (B) in subclause (I)— 16 (i) by striking ‘‘subclause (II)’’ and 17 inserting ‘‘subclause (III)’’; and 18 (ii) by striking ‘‘subclauses (II) and 19 (III)’’ and inserting ‘‘subclauses (III) and 20 (IV)’’; and 21 (C) by inserting after subclause (I) the fol-22 lowing: 23 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00634 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 635 •HR 1768 IH ‘‘(II) Pursuant to subsection (a), subpara-1 graphs (C) and (D) of section 406(a)(1) shall not 2 apply to a responsible plan fiduciary, notwith-3 standing any failure to remit required amounts 4 under subparagraph (C)(i), if the following condi-5 tions are met: 6 ‘‘(aa) The responsible plan fiduciary did 7 not know that the covered service provider 8 failed or would fail to make required remit-9 tances and reasonably believed that the covered 10 service provider remitted such required 11 amounts. 12 ‘‘(bb) The responsible plan fiduciary, upon 13 discovering that the covered service provider 14 failed to remit the required amounts, requests 15 in writing that the covered service provider 16 remit such amounts. 17 ‘‘(cc) If the covered service provider fails 18 to comply with a written request described in 19 subclause (III) within 90 days of the request, 20 the responsible plan fiduciary notifies the Sec-21 retary of the covered service provider’s failure, 22 in accordance with subclauses (III) and (IV).’’; 23 and 24 (2) by adding at the end the following: 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00635 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 636 •HR 1768 IH ‘‘(C)(i)(I) For plan years beginning on or after 1 the date that is 30 months after the date of enact-2 ment of this subparagraph (referred to in this clause 3 as the ‘effective date’), no contract or arrangement 4 or renewal or extension of a contract or arrange-5 ment, entered into on or after the effective date, for 6 services between a covered plan and a covered serv-7 ice provider, through a health insurance issuer offer-8 ing group health insurance coverage, a third party 9 administrator, an entity providing pharmacy benefit 10 management services, or other entity, for pharmacy 11 benefit management services, is reasonable within 12 the meaning of this paragraph unless such entity 13 providing pharmacy benefit management services— 14 ‘‘(aa) remits 100 percent of rebates, fees, 15 alternative discounts, and other remuneration 16 received from any applicable entity that are re-17 lated to utilization of drugs or drug spending 18 under such health plan or health insurance cov-19 erage, to the group health plan or health insur-20 ance issuer offering group health insurance cov-21 erage; and 22 ‘‘(bb) does not enter into any contract for 23 pharmacy benefit management services on be-24 half of such a plan or coverage, with an applica-25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00636 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 637 •HR 1768 IH ble entity unless 100 percent of rebates, fees, 1 alternative discounts, and other remuneration 2 received under such contract that are related to 3 the utilization of drugs or drug spending under 4 such group health plan or health insurance cov-5 erage are remitted to the group health plan or 6 health insurance issuer by the entity providing 7 pharmacy benefit management services. 8 ‘‘(II) Nothing in subclause (I) shall be con-9 strued to affect the term of a contract or arrange-10 ment, as in effect on the effective date (as described 11 in such subclause), except that such subclause shall 12 apply to any renewal or extension of such a contract 13 or arrangement entered into on or after such effec-14 tive date, as so described. 15 ‘‘(ii) With respect to such rebates, fees, alter-16 native discounts, and other remuneration— 17 ‘‘(I) the rebates, fees, alternative dis-18 counts, and other remuneration under clause 19 (i)(I) shall be— 20 ‘‘(aa) remitted— 21 ‘‘(AA) on a quarterly basis, to 22 the group health plan or the group 23 health insurance issuer, not later than 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00637 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 638 •HR 1768 IH 90 days after the end of each quarter; 1 or 2 ‘‘(BB) in the case of an under-3 payment in a remittance for a prior 4 quarter, as soon as practicable, but 5 not later than 90 days after notice of 6 the underpayment is first given; 7 ‘‘(bb) fully disclosed and enumerated 8 to the group health plan or health insur-9 ance issuer; and 10 ‘‘(cc) returned to the covered service 11 provider for pharmacy benefit management 12 services on behalf of the group health plan 13 if any audit by a plan sponsor, issuer or a 14 third party designated by a plan sponsor, 15 indicates that the amounts received are in-16 correct after such amounts have been paid 17 to the group health plan or health insur-18 ance issuer; 19 ‘‘(II) the Secretary may establish proce-20 dures for the remittance of rebates fees, alter-21 native discounts, and other remuneration under 22 subclause (I)(aa) and the disclosure of rebates, 23 fees, alternative discounts, and other remunera-24 tion under subclause (I)(bb); and 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00638 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 639 •HR 1768 IH ‘‘(III) the records of such rebates, fees, al-1 ternative discounts, and other remuneration 2 shall be available for audit by the plan sponsor, 3 issuer, or a third party designated by a plan 4 sponsor, not less than once per plan year. 5 ‘‘(iii) To ensure that an entity providing phar-6 macy benefit management services is able to meet 7 the requirements of clause (ii)(I), a rebate 8 aggregator (or other purchasing entity designed to 9 aggregate rebates) and an applicable group pur-10 chasing organization shall remit such rebates to the 11 entity providing pharmacy benefit management serv-12 ices not later than 45 days after the end of each 13 quarter. 14 ‘‘(iv) A third-party administrator of a group 15 health plan, a health insurance issuer offering group 16 health insurance coverage, or a covered service pro-17 vider for pharmacy benefit management services 18 under such health plan or health insurance coverage 19 shall make rebate contracts with rebate aggregators 20 or drug manufacturers available for audit by such 21 plan sponsor or designated third party, subject to 22 reasonable restrictions (as determined by the Sec-23 retary) on confidentiality to prevent re-disclosure of 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00639 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 640 •HR 1768 IH such contracts or use of such information in audits 1 for purposes unrelated to this section. 2 ‘‘(v) Audits carried out under clauses (ii)(III) 3 and (iv) shall be performed by an auditor selected by 4 the responsible plan fiduciary. Payment for such au-5 dits shall not be made, whether directly or indirectly, 6 by the entity providing pharmacy benefit manage-7 ment services. 8 ‘‘(vi) Nothing in this subparagraph shall be 9 construed to— 10 ‘‘(I) prohibit reasonable payments to enti-11 ties offering pharmacy benefit management 12 services for bona fide services using a fee struc-13 ture not described in this subparagraph, pro-14 vided that such fees are transparent and quan-15 tifiable to group health plans and health insur-16 ance issuers; 17 ‘‘(II) require a third-party administrator of 18 a group health plan or covered service provider 19 for pharmacy benefit management services 20 under such health plan or health insurance cov-21 erage to remit bona fide service fees to the 22 group health plan; 23 ‘‘(III) limit the ability of a group health 24 plan or health insurance issuer to pass through 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00640 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 641 •HR 1768 IH rebates, fees, alternative discounts, and other 1 remuneration to the participant or beneficiary; 2 or 3 ‘‘(IV) modify the requirements for the cre-4 ation, receipt, maintenance, or transmission of 5 protected health information under the privacy 6 regulations promulgated under the Health In-7 surance Portability and Accountability Act of 8 1996 in part 160 and subparts A and E of part 9 164 of title 45, Code of Federal Regulations (or 10 successor regulations). 11 ‘‘(vii) For purposes of this subparagraph— 12 ‘‘(I) the terms ‘applicable entity’ and ‘ap-13 plicable group purchasing organization’ have 14 the meanings given such terms in section 15 726(e); 16 ‘‘(II) the terms ‘covered plan’, ‘covered 17 service provider’, and ‘responsible plan fidu-18 ciary’ have the meanings given such terms in 19 subparagraph (B); and 20 ‘‘(III) the terms ‘group health insurance 21 coverage’, ‘health insurance coverage’, and 22 ‘health insurance issuer’ have the meanings 23 given such terms in section 733.’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00641 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 642 •HR 1768 IH (b) RULE OF CONSTRUCTION.—Subclause (II)(aa) of 1 section 408(b)(2)(B)(viii) of the Employee Retirement In-2 come Security Act of 1974 (29 U.S.C. 3 1108(b)(2)(B)(viii)), as amended by subsection (a), shall 4 not be construed to relieve or limit a responsible plan fidu-5 ciary from the duty to monitor the practices of any covered 6 service provider that contracts with the applicable covered 7 plan, including for the purposes of ensuring the reason-8 ableness of compensation. For purposes of this subsection, 9 the terms ‘‘covered plan’’, ‘‘covered service provider’’, and 10 ‘‘responsible plan fiduciary’’ have the meanings given such 11 terms in section 408(b)(2)(B)(ii) of the Employee Retire-12 ment Income Security Act of 1974 (29 U.S.C. 13 1108(b)(2)(B)(ii)). 14 (c) C LARIFICATION OF COVERED SERVICE PRO-15 VIDER.— 16 (1) SERVICES.— 17 (A) I N GENERAL .—Section 18 408(b)(2)(B)(ii)(I)(bb) of the Employee Retire-19 ment Income Security Act of 1974 (29 U.S.C. 20 1108(b)(2)(B)(ii)(I)(bb)) is amended— 21 (i) in subitem (AA) by striking ‘‘Bro-22 kerage services,’’ and inserting ‘‘Services 23 (including brokerage services),’’; and 24 (ii) in subitem (BB)— 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00642 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 643 •HR 1768 IH (I) by striking ‘‘Consulting,’’ and 1 inserting ‘‘Other services,’’; and 2 (II) by striking ‘‘related to the 3 development or implementation of 4 plan design’’ and all that follows 5 through the period at the end and in-6 serting ‘‘including any of the fol-7 lowing: plan design, insurance or in-8 surance product selection (including 9 vision and dental), recordkeeping, 10 medical management, benefits admin-11 istration selection (including vision 12 and dental), stop-loss insurance, phar-13 macy benefit management services, 14 wellness design and management serv-15 ices, transparency tools, group pur-16 chasing organization agreements and 17 services, participation in and services 18 from preferred vendor panels, disease 19 management, compliance services, em-20 ployee assistance programs, or third 21 party administration services, or con-22 sulting services related to any such 23 services.’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00643 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 644 •HR 1768 IH (B) S ENSE OF CONGRESS .—It is the sense 1 of Congress that the amendment made by sub-2 paragraph (A) clarifies the existing requirement 3 of covered service providers with respect to 4 services described in section 5 408(b)(2)(B)(ii)(I)(bb)(BB) of the Employee 6 Retirement Income Security Act of 1974 (29 7 U.S.C. 1108(b)(2)(B)(ii)(I)(bb)(BB)) that were 8 in effect since the application date described in 9 section 202(e) of the No Surprises Act (Public 10 Law 116–260; 29 U.S.C. 1108 note), and does 11 not impose any additional requirement under 12 section 408(b)(2)(B) of such Act. 13 (2) C ERTAIN ARRANGEMENTS FOR PHARMACY 14 BENEFIT MANAGEMENT SERVICES CONSIDERED AS 15 INDIRECT.— 16 (A) IN GENERAL .—Section 408(b)(2)(B)(i) 17 of the Employee Retirement Income Security 18 Act of 1974 (29 U.S.C. 1108(b)(2)(B)(i)) is 19 amended— 20 (i) by striking ‘‘requirements of this 21 clause’’ and inserting ‘‘requirements of this 22 subparagraph’’; and 23 (ii) by adding at the end the fol-24 lowing: ‘‘For purposes of applying section 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00644 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 645 •HR 1768 IH 406(a)(1)(C) with respect to a transaction 1 described under this subparagraph or sub-2 paragraph (C), a contract or arrangement 3 for services between a covered plan and an 4 entity providing services to the plan, in-5 cluding a health insurance issuer providing 6 health insurance coverage in connection 7 with the covered plan, in which such entity 8 contracts, in connection with such plan, 9 with a service provider for pharmacy ben-10 efit management services, shall be consid-11 ered an indirect furnishing of goods, serv-12 ices, or facilities between the covered plan 13 and the service provider for pharmacy ben-14 efit management services acting as the 15 party in interest.’’. 16 (B) H EALTH INSURANCE ISSUER AND 17 HEALTH INSURANCE COVERAGE DEFINED .— 18 Section 408(b)(2)(B)(ii)(I)(aa) of such Act (29 19 U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is amended by 20 inserting before the period at the end ‘‘and the 21 terms ‘health insurance coverage’ and ‘health 22 insurance issuer’ have the meanings given such 23 terms in section 733(b)’’. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00645 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 646 •HR 1768 IH (C) T ECHNICAL AMENDMENT .—Section 1 408(b)(2)(B)(ii)(I)(aa) of the Employee Retire-2 ment Income Security Act of 1974 (29 U.S.C. 3 1108(b)(2)(B)(ii)(I)(aa)) is amended by insert-4 ing ‘‘in’’ after ‘‘defined’’. 5 SEC. 903. INCREASING TRANSPARENCY IN GENERIC DRUG 6 APPLICATIONS. 7 (a) I N GENERAL.—Section 505(j)(3) of the Federal 8 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 9 amended by adding at the end the following: 10 ‘‘(H)(i) Upon request (in controlled correspondence 11 or an analogous process) by a person that has submitted 12 or intends to submit an abbreviated application under this 13 subsection for a drug that is required by regulation to con-14 tain one or more of the same inactive ingredients in the 15 same concentrations as the listed drug referred to, or for 16 which the Secretary determines there is a scientific jus-17 tification for an approach that is in vitro, in whole or in 18 part, to be used to demonstrate bioequivalence for a drug 19 if such a drug contains one or more of the same inactive 20 ingredients in the same concentrations as the listed drug 21 referred to, the Secretary shall inform the person whether 22 such drug is qualitatively and quantitatively the same as 23 the listed drug. The Secretary may also provide such infor-24 mation to such a person on the Secretary’s own initiative 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00646 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 647 •HR 1768 IH during the review of an abbreviated application under this 1 subsection for such drug. 2 ‘‘(ii) Notwithstanding section 301(j), if the Secretary 3 determines that such drug is not qualitatively or quan-4 titatively the same as the listed drug, the Secretary shall 5 identify and disclose to the person— 6 ‘‘(I) the ingredient or ingredients that cause 7 such drug not to be qualitatively or quantitatively 8 the same as the listed drug; and 9 ‘‘(II) for any ingredient for which there is an 10 identified quantitative deviation, the amount of such 11 deviation. 12 ‘‘(iii) If the Secretary determines that such drug is 13 qualitatively and quantitatively the same as the listed 14 drug, the Secretary shall not change or rescind such deter-15 mination after the submission of an abbreviated applica-16 tion for such drug under this subsection unless— 17 ‘‘(I) the formulation of the listed drug has been 18 changed and the Secretary has determined that the 19 prior listed drug formulation was withdrawn for rea-20 sons of safety or effectiveness; or 21 ‘‘(II) the Secretary makes a written determina-22 tion that the prior determination must be changed 23 because an error has been identified. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00647 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 648 •HR 1768 IH ‘‘(iv) If the Secretary makes a written determination 1 described in clause (iii)(II), the Secretary shall provide no-2 tice and a copy of the written determination to the person 3 making the request under clause (i). 4 ‘‘(v) The disclosures authorized under clauses (i) and 5 (ii) are disclosures authorized by law, including for pur-6 poses of section 1905 of title 18, United States Code. This 7 subparagraph shall not otherwise be construed to author-8 ize the disclosure of nonpublic qualitative or quantitative 9 information about the ingredients in a listed drug, or to 10 affect the status, if any, of such information as trade se-11 cret or confidential commercial information for purposes 12 of section 301(j) of this Act, section 552 of title 5, United 13 States Code, or section 1905 of title 18, United States 14 Code.’’. 15 (b) GUIDANCE.— 16 (1) I N GENERAL .—Not later than one year 17 after the date of enactment of this Act, the Sec-18 retary of Health and Human Services shall issue 19 draft guidance, or update guidance, describing how 20 the Secretary will determine whether a drug is quali-21 tatively and quantitatively the same as the listed 22 drug (as such terms are used in section 23 505(j)(3)(H) of the Federal Food, Drug, and Cos-24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00648 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 649 •HR 1768 IH metic Act, as added by subsection (a)), including 1 with respect to assessing pH adjusters. 2 (2) P ROCESS.—In issuing guidance under this 3 subsection, the Secretary of Health and Human 4 Services shall— 5 (A) publish draft guidance; 6 (B) provide a period of at least 60 days for 7 comment on the draft guidance; and 8 (C) after considering any comments re-9 ceived and not later than one year after the 10 close of the comment period on the draft guid-11 ance, publish final guidance. 12 (c) A PPLICABILITY.—Section 505(j)(3)(H) of the 13 Federal Food, Drug, and Cosmetic Act, as added by sub-14 section (a), applies beginning on the date of enactment 15 of this Act, irrespective of the date on which the guidance 16 required by subsection (b) is finalized. 17 SEC. 904. TITLE 35 AMENDMENTS. 18 (a) IN GENERAL.—Section 271(e) of title 35, United 19 States Code, is amended— 20 (1) in paragraph (2)(C), in the flush text fol-21 lowing clause (ii), by adding at the end the fol-22 lowing: ‘‘With respect to a submission described in 23 clause (ii), the act of infringement shall extend to 24 any patent that claims the biological product, a 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00649 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 650 •HR 1768 IH method of using the biological product, or a method 1 or product used to manufacture the biological prod-2 uct.’’; and 3 (2) by adding at the end the following: 4 ‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 5 if the sponsor of an approved application for a reference 6 product, as defined in section 351(i) of the Public Health 7 Service Act (42 U.S.C. 262(i)) (referred to in this para-8 graph as the ‘reference product sponsor’), brings an action 9 for infringement under this section against an applicant 10 for approval of a biological product under section 351(k) 11 of such Act that references that reference product (re-12 ferred to in this paragraph as the ‘subsection (k) appli-13 cant’), the reference product sponsor may assert in the 14 action a total of not more than 20 patents of the type 15 described in subparagraph (B), not more than 10 of which 16 shall have issued after the date specified in section 17 351(l)(7)(A) of such Act. 18 ‘‘(B) The patents described in this subparagraph are 19 patents that satisfy each of the following requirements: 20 ‘‘(i) Patents that claim the biological product 21 that is the subject of an application under section 22 351(k) of the Public Health Service Act (42 U.S.C. 23 262(k)) (or a use of that product) or a method or 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00650 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 651 •HR 1768 IH product used in the manufacture of such biological 1 product. 2 ‘‘(ii) Patents that are included on the list of 3 patents described in paragraph (3)(A) of section 4 351(l) of the Public Health Service Act (42 U.S.C. 5 262(l)), including as provided under paragraph (7) 6 of such section 351(l). 7 ‘‘(iii) Patents that— 8 ‘‘(I) have an actual filing date of more 9 than 4 years after the date on which the ref-10 erence product is approved; or 11 ‘‘(II) include a claim to a method in a 12 manufacturing process that is not used by the 13 reference product sponsor. 14 ‘‘(C) The court in which an action described in sub-15 paragraph (A) is brought may increase the number of pat-16 ents limited under that subparagraph— 17 ‘‘(i) if the request to increase that number is 18 made without undue delay; and 19 ‘‘(ii)(I) if the interest of justice so requires; or 20 ‘‘(II) for good cause shown, which— 21 ‘‘(aa) shall be established if the subsection 22 (k) applicant fails to provide information re-23 quired under section 351(k)(2)(A) of the Public 24 Health Service Act (42 U.S.C. 262(k)(2)(A)) 25 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00651 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 652 •HR 1768 IH that would enable the reference product sponsor 1 to form a reasonable belief with respect to 2 whether a claim of infringement under this sec-3 tion could reasonably be asserted; and 4 ‘‘(bb) may be established— 5 ‘‘(AA) if there is a material change to 6 the biological product (or process with re-7 spect to the biological product) of the sub-8 section (k) applicant that is the subject of 9 the application; 10 ‘‘(BB) if, with respect to a patent on 11 the supplemental list described in section 12 351(l)(7)(A) of Public Health Service Act 13 (42 U.S.C. 262(l)(7)(A)), the patent would 14 have issued before the date specified in 15 such section 351(l)(7)(A) but for the fail-16 ure of the Office to issue the patent or a 17 delay in the issuance of the patent, as de-18 scribed in paragraph (1) of section 154(b) 19 and subject to the limitations under para-20 graph (2) of such section 154(b); or 21 ‘‘(CC) for another reason that shows 22 good cause, as determined appropriate by 23 the court. 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00652 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 653 •HR 1768 IH ‘‘(D) In determining whether good cause has been 1 shown for the purposes of subparagraph (C)(ii)(II), a 2 court may consider whether the reference product sponsor 3 has provided a reasonable description of the identity and 4 relevance of any information beyond the subsection (k) ap-5 plication that the court believes is necessary to enable the 6 court to form a belief with respect to whether a claim of 7 infringement under this section could reasonably be as-8 serted. 9 ‘‘(E) The limitation imposed under subparagraph 10 (A)— 11 ‘‘(i) shall apply only if the subsection (k) appli-12 cant completes all actions required under paragraphs 13 (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 14 section 351(l) of the Public Health Service Act (42 15 U.S.C. 262(l)); and 16 ‘‘(ii) shall not apply with respect to any patent 17 that claims, with respect to a biological product, a 18 method for using that product in therapy, diagnosis, 19 or prophylaxis, such as an indication or method of 20 treatment or other condition of use.’’. 21 (b) APPLICABILITY.—The amendments made by sub-22 section (a) shall apply with respect to an application sub-23 mitted under section 351(k) of the Public Health Service 24 VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00653 Fmt 6652 Sfmt 6201 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS 654 •HR 1768 IH Act (42 U.S.C. 262(k)) on or after the date of enactment 1 of this Act. 2 TITLE X—MISCELLANEOUS 3 SEC. 1001. TWO-YEAR EXTENSION OF SAFE HARBOR FOR 4 ABSENCE OF DEDUCTIBLE FOR TELEHEALTH. 5 (a) IN GENERAL.—Section 223(c)(2)(E)(ii) of the In-6 ternal Revenue Code of 1986 is amended by striking ‘‘Jan-7 uary 1, 2025’’ and inserting ‘‘January 1, 2027’’. 8 (b) E FFECTIVE DATE.—The amendments made by 9 this section shall apply to plan years beginning after De-10 cember 31, 2024. 11 Æ VerDate Sep 11 2014 21:22 Jun 10, 2025 Jkt 059200 PO 00000 Frm 00654 Fmt 6652 Sfmt 6301 E:\BILLS\H1768.IH H1768ssavage on LAPJG3WLY3PROD with BILLS