MAH-4056Enacted

Drug Stewardship Program (M.G.L. c.94G)

Jurisdiction:
Massachusetts
Type:
EPR
Last action:
Mar 14, 2016
Pharmaceuticals
Next steps for producers

No producer action is triggered yet — track this measure

Applies toAny pharmaceutical product manufacturer selling or distributing a covered drug to consumers in the Commonwealth of Massachusetts, whether directly or through a wholesaler, retailer or other agent; defined as an entity…

Obligations under this law
  • ·Operate a drug stewardship program approved by the Department of Public Health, individually or jointly with other manufacturers; OR enter into an agreement with a stewardship organization to operate an approved drug stewardship program; OR enter into an agreement with the department to operate an alternative plan under Section 6 of Chapter 94G
  • ·Submit an application for approval within 180 calendar days of receipt of initial notice from the department if not already compliant
  • ·File an annual written report to the department by March 1 each year describing the program's activities for the prior year and the volume and type of unwanted drugs collected
Program page →

No designated program action is recorded for this measure yet — treat the above as the general obligation and verify against the source text.

Acts of 2016, Chapter 52; manufacturers of covered drugs must operate or fund an approved take-back program.
Covered Products
  • ·Brand name or generic opioid drugs placed in Schedule II or Schedule III of M.G.L. c.94C §3
  • ·Benzodiazepines
  • ·Exclusions: drugs intended solely for veterinary care; cosmetic products under 21 U.S.C. §301 et seq.; compounded drugs under specialty license per M.G.L. c.112 §§39G-39J; hypodermic needles, lancets or other sharps subject to c.94C §27A; drugs approved and used primarily for medication-assisted substance use disorder treatment
Producer Obligations
  • ·Operate a drug stewardship program approved by the Department of Public Health, individually or jointly with other manufacturers; OR enter into an agreement with a stewardship organization to operate an approved drug stewardship program; OR enter into an agreement with the department to operate an alternative plan under Section 6 of Chapter 94G
  • ·Submit an application for approval within 180 calendar days of receipt of initial notice from the department if not already compliant
  • ·File an annual written report to the department by March 1 each year describing the program's activities for the prior year and the volume and type of unwanted drugs collected
  • ·Ensure the drug stewardship program includes a collection system with at least 2 collection methods as recommended by the department (e.g., mail-back program, collection kiosks, drop-off day events, in-home disposal methods, or DEA-guideline methods)
  • ·Ensure adequate provisions for security of unwanted drugs throughout the collection process and safety of persons involved
  • ·Develop and implement a plan for public outreach and education about the drug stewardship program
  • ·Bear all operational and administrative costs of the program; no point-of-sale, point-of-collection, processing fees or other drug cost increases may be charged to individual consumers
  • ·Attest that the program complies with all applicable state and federal requirements for collection, security, transport and disposal of drug products, including DEA and EPA requirements
  • ·Take corrective steps to reestablish compliance or submit a written appeal within 90 days of receipt of a notice of noncompliance
  • ·If participating in the alternative plan under Section 6, may make contributions to the Substance Abuse Services Fund (c.111 §2I) and shall not pass the cost of any contribution on to the consumer or a health insurance carrier
Exemptions
  • ·Drugs intended for use solely in veterinary care
  • ·Substances regulated as cosmetic products under 21 U.S.C. §301 et seq.
  • ·Drugs compounded under a specialty license pursuant to M.G.L. c.112 §§39G-39J
  • ·Hypodermic needles, lancets or other sharps products subject to collection and disposal procedures under c.94C §27A
  • ·Drugs approved and used primarily for medication-assisted substance use disorder treatment
  • ·Waste or unused drug products from a pharmacy, hospital, health clinic or other commercial sources that the department may determine by regulation to be a nonresidential source (excluded from definition of 'unwanted drug')
  • ·Drug products seized by law enforcement officers in the course of their law enforcement duties (excluded from definition of 'unwanted drug')
  • ·Retail pharmacies and pharmacists practicing in a retail setting are not required to participate in collection, securing, transport or disposal of unwanted drugs
  • ·Outpatient pharmacies cannot be required to participate in collection or maintain a collection kiosk unless the pharmacy certifies in writing that participation is voluntary
  • ·Manufacturers who opt into the alternative plan under Section 6 are exempt from Sections 2 to 5 of Chapter 94G
  • ·Institutional pharmacies (as defined in c.112 §39D) are excluded from the definition of 'pharmaceutical product manufacturer'
  • ·Wholesalers are excluded from the definition of 'pharmaceutical product manufacturer'
Key Deadlines
Jan 1, 2017compliance: Section 31 (Chapter 94G Drug Stewardship Program) takes effect January 1, 2017
—reporting: Annual written report due to the department not later than March 1 each year describing prior year program activities and volume/type of unwanted drugs collected
—registration: Manufacturer must submit application for approval within 180 calendar days of receipt of initial notice from the department
—compliance: Manufacturer in receipt of notice of noncompliance must take corrective steps or submit written appeal within 90 days of receipt
Dec 31, 2021other: Section 55 repeals Chapter 94G (the Drug Stewardship Program) effective December 31, 2021
Producer Definition
Any pharmaceutical product manufacturer selling or distributing a covered drug to consumers in the Commonwealth of Massachusetts, whether directly or through a wholesaler, retailer or other agent; defined as an entity that manufactures a controlled substance under a U.S. FDA manufacturer's license, excluding institutional pharmacies (as defined in c.112 §39D) and wholesalers.
Fee Structure
Unknown: No specific fee amounts or per-unit/per-ton fee structure is specified. Manufacturers bear all operational and administrative costs of the program. An alternative plan may permit contributions to the Substance Abuse Services Fund. No fees may be passed to consumers.
Enforcement
Massachusetts Department of Public Health: If the department determines a manufacturer continues to be in noncompliance after consideration of an appeal or if the manufacturer does not appeal within 90 days of receipt of the notice of noncompliance, the department may assess the manufacturer a penalty in a manner to be determined by the department. The department shall send notice of the penalty and the right to appeal the penalty to the manufacturer. Specific penalty amounts are not specified in the statute.
Preemption Notes
The statute provides that requirements established by the department may exceed, but shall not conflict with, any obligations imposed on a manufacturer by a risk evaluation and mitigation strategy (REMS) approved by the U.S. FDA. No explicit federal preemption provision is included. The program is set to be repealed on December 31, 2021 per Section 55/Section 77.
Compliance Dimensions
PenaltiesPenalties for non-compliance

“If after consideration of an appeal or if the manufacturer does not appeal within 90 days of receipt of the notice of noncompliance the department determines that the manufacturer continues to be in noncompliance with this chapter, the department may assess the manufacturer a penalty in a manner to be determined by the department. If the department plans to assess a noncompliance penalty against a manufacturer pursuant to this section, the department shall send notice of the penalty and the right to appeal the penalty to the manufacturer.”

PRO StructureCompetitive Pros

“"Stewardship organization", an organization designated by a manufacturer or a group of manufacturers to act as an agent on behalf of the manufacturer or the group of manufacturers to implement and operate a drug stewardship program.”

Tracking dates like these across a whole portfolio of jurisdictions is what Upcoming Deadlines does.

Full bill text

1 of 42 HOUSE . . . . . . . . . . . . . . No. 4056 The Commonwealth of Massachusetts _______________ The committee of conference on the disagreeing votes of the two branches with reference to the Senate amendment (striking out all after the enacting clause and inserting in place thereof the text contained in Senate document numbered 2103) of the House Bill relative to substance use, treatment, education and prevention (House, No. 3947), reports (on the residue) recommending passage of the accompanying bill (House, No. 4056). March 8, 2016. Brian S. Dempsey Karen E. Spilka Elizabeth A. Malia Jennifer L. Flanagan Randy Hunt Viriato Manuel deMacedo HOUSE DOCKET, NO. FILED ON: 3/8/2016 2 of 42 HOUSE . . . . . . . . . . . . . . . No. 4056 The Commonwealth of Massachusetts _______________ In the One Hundred and Eighty-Ninth General Court (2015-2016) _______________ An Act relative to substance use, treatment, education and prevention. Whereas, The deferred operation of this act would tend to defeat its purpose, which is to increase forthwith the availability of substance use treatment, education and prevention, therefore, it is hereby declared to be an emergency law, necessary for the immediate preservation of the public convenience. Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows: 1 SECTION 1. Section 118 of chapter 6 of the General Laws, as appearing in the 2014 2 Official Edition, is hereby amended by adding the following subsection:- 3 The municipal police training committee may establish a course within the recruit basic 4 training curriculum for regional and municipal police training schools to train law enforcement 5 officers on the application of section 34A of chapter 94C and section 12FF of chapter 112 and 6 the procedures for response to calls for assistance for drug-related overdoses. The committee 7 may periodically include within its in-service training curriculum a course of instruction on the 8 application of said section 34A of said chapter 94C and the procedures for response to calls for 9 assistance for drug-related overdoses. Upon request, the executive office of public safety and 10 security, in collaboration with the department of public health, shall facilitate the collection and 11 sharing of resources regarding the application of said section 34A of said chapter 94C. 3 of 42 12 SECTION 2. Section 4 of chapter 17 of the General Laws, as so appearing, is hereby 13 amended by striking out, in line 11, the following words:- with the advice of the advisory council 14 on alcoholism and. 15 SECTION 3. Said section 4 of said chapter 17, as so appearing, is hereby further 16 amended by striking out, in lines 14 and 15, the following words:- with the advice of the drug 17 rehabilitation advisory board and. 18 SECTION 4. Section 13 of said chapter 17, as amended by section 5 of chapter 10 of the 19 acts of 2015, is hereby further amended by adding the following subsection:- 20 (e) The commission shall also identify and publish a list of non-opioid drug products that 21 have been approved by the United States Food and Drug Administration that are effective pain 22 management alternatives and have a lesser potential for abuse than an opioid drug product 23 contained in Schedules II and III of section 3 of chapter 94C. 24 The commission shall provide for distribution, including electronic distribution, of copies 25 of the list and revisions to the list among all prescribers and dispensers licensed to practice in the 26 commonwealth and to other appropriate individuals and shall supply a copy to any person on 27 request and upon payment of the cost of printing. 28 The list shall be revised not less frequently than annually to include new pertinent 29 information on non-opioid drug products approved for inclusion or non-opioid drug products to 30 be deleted and to reflect current information as to the therapeutic efficacy of drugs and 31 pharmaceuticals. 32 SECTION 5. Section 14 of said chapter 17, as so appearing, is hereby repealed. 4 of 42 33 SECTION 6. Section 19 of said chapter 17, as appearing in the 2014 Official Edition, is 34 hereby amended by inserting after the word “treatment”, in line 16, the following words:- , 35 including information on United States Food and Drug Administration-approved medication 36 assisted-treatment and the availability of such treatments in each geographic region of the 37 commonwealth. 38 SECTION 7. Said section 19 of said chapter 17, as so appearing, is hereby further 39 amended by striking out, in lines 27 and 28, the words “and (6)” and inserting in place thereof 40 the following words:- (6) provide information to the patient prior to discharge about the 41 patient’s option to file a voluntary non-opiate directive form pursuant to section 18B of chapter 42 94C; and 43 (7). 44 SECTION 8. Section 17M of chapter 32A of the General Laws, as so appearing, is 45 hereby amended by inserting after the word “treatment” in line 3, the following words:- ; a 46 substance abuse evaluation as defined in section 51½ of chapter 111. 47 SECTION 9. Section 17N of said chapter 32A, as so appearing, is hereby amended by 48 inserting after the figure “7”, in line 28, the following words:- ; and provided further, that the 49 commission shall provide to any active or retired employee of the commonwealth who is insured 50 under the group insurance commission coverage for, without preauthorization, substance abuse 51 evaluations ordered pursuant to section 51½ of chapter 111. 52 SECTION 10. Section 16 of chapter 38 of the General Laws, as so appearing, is hereby 53 amended by striking out subsection (b) and inserting in place thereof the following subsection:- 5 of 42 54 (b) Acute hospitals, as defined in section 64 of chapter 118E, shall file a monthly report 55 regarding the exposure of children to controlled substances with the commissioner of public 56 health in a manner to be determined by the commissioner of public health. The report shall 57 include, but not be limited to: (i) the number of infants born in the previous month identified by 58 the hospital as having been exposed to a Schedule I or Schedule II controlled substance under 59 chapter 94C or those controlled substances in Schedule III under said chapter 94C that the drug 60 formulary commission, established by section 13 of chapter 17, has determined have a 61 heightened level of public health risk due to the drug’s potential for abuse and misuse; and (ii) 62 the number and specific causes of hospitalizations of children under the age of 11 caused by 63 ingestion of a Schedule I or Schedule II controlled substance under said chapter 94C or those 64 controlled substances in Schedule III under said chapter 94C that the drug formulary commission 65 has determined have a heightened level of public health risk due to the drug’s potential for abuse 66 and misuse. 67 SECTION 11. Section 1P of chapter 69 of the General Laws, as so appearing, is hereby 68 amended by striking out, in line 97, the figure “18” and inserting in place thereof the following 69 figure:- 19. 70 SECTION 12. Said section 1P of said chapter 69, as so appearing, is hereby further 71 amended by striking out, in line 127, the figure “3” and inserting in place thereof the following 72 figure: 4. 73 SECTION 13. Said section 1P of said chapter 69, as so appearing, is hereby further 74 amended by inserting after the word “framework”, in line 133, the following words:- ; 1 of 6 of 42 75 whom shall be a representative of Massachusetts recovery high schools with expertise in 76 adolescent substance use disorders. 77 SECTION 14. Section 13D of chapter 71 of the General Laws, as so appearing, is hereby 78 amended by adding the following paragraph:- 79 A driver education course shall include a module on the science related to addiction and 80 addictive substances, including the impact of psychoactive substances on the brain and the effect 81 of such substances on a person while operating a motor vehicle. 82 SECTION 15. Said chapter 71 is hereby further amended by striking out section 96, as so 83 appearing, and inserting in place thereof the following 2 sections:- 84 Section 96. Each public school shall have a policy regarding substance use prevention 85 and the education of its students about the dangers of substance abuse. The school shall notify 86 the parents or guardians of all students attending the school of the policy and shall post the 87 policy on the school's website. The policy, and any standards and rules enforcing the policy, 88 shall be prescribed by the school committee in conjunction with the superintendent or the board 89 of trustees of a charter school. 90 The department of elementary and secondary education, in consultation with the 91 department of public health, shall provide guidance and recommendations to assist schools with 92 developing and implementing effective substance use prevention and abuse education policies 93 and shall make such guidance and recommendations publicly available on the department’s 94 website. Guidance and recommendations may include educating parents or guardians on 95 recognizing warning signs of substance abuse and providing available resources. Guidance and 7 of 42 96 recommendations shall be reviewed and regularly updated to reflect applicable research and best 97 practices. 98 Each school district and charter school shall file its substance use prevention and abuse 99 education policies with the department of elementary and secondary education in a manner and 100 form prescribed by the department. 101 Section 97. (a) Subject to appropriation, each city, town, regional school district, charter 102 school or vocational school district shall utilize a verbal screening tool to screen pupils for 103 substance use disorders. Screenings shall occur on an annual basis and occur at 2 different grade 104 levels as recommended by the department of elementary and secondary education, in 105 consultation with the department of public health. Parents or guardians of a pupil to be screened 106 pursuant to this section shall be notified prior to the start of the school year. Verbal screening 107 tools shall be approved by the department of elementary and secondary education, in conjunction 108 with the department of public health. De-identified screening results shall be reported to the 109 department of public health, in a manner to be determined by the department of public health, not 110 later than 90 days after completion of the screening. 111 (b) A pupil or the pupil’s parent or guardian may opt out of the screening by written 112 notification at any time prior to or during the screening. A city, town, regional school district, 113 charter school or vocational school district utilizing a verbal screening tool shall comply with the 114 department of elementary and secondary education’s regulations relative to consent. 115 (c) Any statement, response or disclosure made by a pupil during a verbal substance use 116 disorder screening shall be considered confidential information and shall not be disclosed by a 117 person receiving the statement, response or disclosure to any other person without the prior 8 of 42 118 written consent of the pupil, parent or guardian, except in cases of immediate medical emergency 119 or a disclosure is otherwise required by state law. Such consent shall be documented on a form 120 approved by the department of public health and shall not be subject to discovery or subpoena in 121 any civil, criminal, legislative or administrative proceeding. No record of any statement, 122 response or disclosure shall be made in any form, written, electronic or otherwise, that includes 123 information identifying the pupil. 124 (d) The department of elementary and secondary education shall notify each school 125 district in writing of the requirement to screen students for substance use disorders pursuant to 126 this section. School districts with alternative substance use screening policies may, on a form 127 provided by the department, opt out of the required verbal screening tool. The form shall be 128 signed by the school superintendent and provide a detailed description of the alternative 129 substance use program the district has implemented and the reasons why the required verbal 130 screening tool is not appropriate for the district. 131 (e) No person shall have a cause of action for loss or damage caused by an act or 132 omission resulting from the implementation of this section. 133 SECTION 16. Section 8 of chapter 90 of the General Laws, as so appearing, is hereby 134 amended by inserting after the word “course”, in line 50, the following words:- , including a 135 module on the science related to addiction and addictive substances which shall also include the 136 impact of psychoactive substances on the brain and the effect of such substances on a person 137 while operating a motor vehicle,. 138 SECTION 17. Said section 8 of said chapter 90, as so appearing, is hereby further 139 amended by inserting after the word “curriculum”, in line 71, the following words:- , including a 9 of 42 140 module on the science related to addiction and addictive substances which shall also include the 141 impact of psychoactive substances on the brain and the effect of such substances on a person 142 while operating a motor vehicle. 143 SECTION 18. The nineteenth paragraph of section 32G of said chapter 90, as so 144 appearing, is hereby amended by inserting after the first sentence the following sentence:- The 145 curriculum shall include a module on the science related to addiction and addictive substances, 146 which shall also include the impact of psychoactive substances on the brain and the effect of 147 such substances on a person while operating a motor vehicle. 148 SECTION 19. Section 1 of chapter 94C of the General Laws is hereby amended by 149 inserting after the definition of “drug paraphernalia”, as so appearing, the following definition:- 150 “Extended-release long-acting opioid in a non-abuse deterrent form”, a drug that is: (i) 151 subject to the United States Food and Drug Administration’s extended release and long-acting 152 opioid analgesics risk evaluation and mitigation strategy; (ii) an opioid approved for medical use 153 that does not meet the requirements for listing as a drug with abuse deterrent properties pursuant 154 to section 13 of chapter 17; and (iii) identified by the drug formulary commission pursuant to 155 said section 13 of said chapter 17 as posing a heightened level of public health risk. 156 SECTION 20. Section 18 of said chapter 94C, as so appearing, is hereby amended by 157 striking out, in line 70, the words “A prescription” and inserting in place thereof the following 158 words:- Except as provided in section 18A, a prescription. 159 SECTION 21. Said section 18 of said chapter 94C, as so appearing, is hereby further 160 amended by inserting after subsection (d½) the following subsection:- 10 of 42 161 (d¾) A registered pharmacist filling a prescription for an opioid substance in schedule II 162 of section 3 may dispense the prescribed substance in a lesser quantity than the recommended 163 full quantity indicated on the prescription if requested by the patient provided that the 164 prescription complies with subsection (c) of section 22. The remaining quantity in excess of the 165 quantity requested by the patient shall be void. If the dispensed quantity is less than the 166 recommended full quantity, the pharmacist or a designee shall, within a reasonable time 167 following a reduction in quantity but not more than 7 days, notify the prescribing practitioner of 168 the quantity actually dispensed. The notification shall be conveyed by a notation in the 169 interoperable electronic health record of the patient as defined in section 1 of chapter 118I or, if 170 the pharmacist does not have the ability to make a notation in the patient’s interoperable 171 electronic health record, by facsimile, electronic transmission or by making a notation in the 172 patient’s record maintained by the pharmacy which shall be accessible to the practitioner by 173 request. Nothing in this subsection shall be interpreted to conflict with or supersede any other 174 requirement established in this section for a prescription of an opiate substance or any 175 requirements or conditions for drug substitutions established in chapter 112. 176 SECTION 22. Said section 18 of said chapter 94C, as so appearing, is hereby further 177 amended by striking out subsection (e) and inserting in place thereof the following subsection:- 178 (e) Practitioners who prescribe controlled substances, except veterinarians, shall be 179 required, as a prerequisite to obtaining or renewing their professional licenses, to complete 180 appropriate training relative to: (i) effective pain management; (ii) the risks of abuse and 181 addiction associated with opioid medication; (iii) identification of patients at risk for substance 182 use disorders; (iv) counseling patients about the side effects, addictive nature and proper storage 183 and disposal of prescription medications; (v) appropriate prescription quantities for prescription 11 of 42 184 medications that have an increased risk of abuse; and (vi) opioid antagonists, overdose 185 prevention treatments and instances in which a patient may be advised on both the use of and 186 ways to access opioid antagonists and overdose prevention treatments. The boards of registration 187 for each professional license that requires this training shall develop the standards for appropriate 188 training programs. 189 SECTION 23. Said chapter 94C is hereby further amended by inserting after section 18 190 the following 3 sections:- 191 Section 18A. (a) Prior to issuing an extended-release long-acting opioid in a non-abuse 192 deterrent form for outpatient use for the first time, a practitioner registered under section 7 shall: 193 (i) evaluate the patient’s current condition, risk factors, history of substance abuse, if any, and 194 current medications; and (ii) inform the patient and note in the patient’s medical record that the 195 prescribed medication, in the prescriber’s medical opinion, is an appropriate course of treatment 196 based on the medical need of the patient. 197 (b) In the event that a practitioner recommends that an extended-release long-acting 198 opioid be utilized during the course of long-term pain management, the practitioner registered 199 under section 7 shall enter into a written pain management treatment agreement with the patient 200 that appropriately addresses the benefits as well as the risk factors for abuse or misuse of the 201 prescribed substance under guidelines published by the department. Such an agreement shall be 202 filed in the patient’s medical record or included in the patient’s electronic health record. 203 Section 18B. (a) The department shall establish a voluntary non-opiate directive form. 204 The form shall indicate to all practitioners that an individual shall not be administered or offered 205 a prescription or medication order for an opiate. The form shall be posted on the department’s 12 of 42 206 searchable website. An individual may execute and file a voluntary non-opiate directive form 207 with a practitioner registered under section 7 or other authority authorized by the secretary to 208 accept the voluntary non-opiate directive form for filing. An individual may revoke the voluntary 209 non-opiate directive form for any reason and may do so by written or oral means. 210 (b) The department shall promulgate regulations for the implementation of the voluntary 211 non-opiate directive form which shall include, but not be limited to: 212 (i) procedures to record the voluntary non-opiate directive form in the individual’s 213 interoperable electronic health record and in the prescription drug monitoring program 214 established in section 24A; 215 (ii) a standard form for the recording and transmission of the voluntary non-opiate 216 directive form, which shall include verification by a practitioner registered under section 7 and 217 which shall comply with the written consent requirements of the Public Health Service Act, 42 218 U.S.C. § 290dd-2(b), and 42 CFR Part 2; provided, however, that the voluntary non-opiate 219 directive form shall also provide the basic procedures necessary to revoke the voluntary non- 220 opiate directive form; 221 (iii) requirements for an individual to appoint a duly authorized guardian or health care 222 proxy to override a previously recorded voluntary non-opiate directive form; 223 (iv) procedures to ensure that any recording, sharing or distribution of data relative to the 224 voluntary non-opiate directive form complies with all state and federal confidentiality laws; and 225 (v) appropriate exemptions for emergency medical personnel. 13 of 42 226 (c) A written prescription that is presented at an outpatient pharmacy or a prescription 227 that is electronically transmitted to an outpatient pharmacy shall be presumed to be valid for the 228 purposes of this section and a pharmacist in an outpatient setting shall not be held in violation of 229 this section for dispensing a controlled substance in contradiction to a voluntary non-opiate 230 directive form, except upon evidence that the pharmacist acted knowingly against the voluntary 231 non-opiate directive form. 232 (d) No health care provider or employee of a health care provider acting in good faith 233 shall be subject to criminal or civil liability or be considered to have engaged in unprofessional 234 conduct for failing to offer or administer a prescription or medication order for an opiate under 235 the voluntary non-opiate directive form. 236 No person acting as an agent pursuant to a health care proxy shall be subject to criminal 237 or civil liability for making a decision under clause (iii) of subsection (b) in good faith. 238 (e) Any board of professional licensure may limit, condition or suspend the license of or 239 assess fines against a licensed health care provider who recklessly or negligently fails to comply 240 with a person’s voluntary non-opiate directive form. 241 Section 18C. Prior to issuing a prescription for an opioid contained in Schedule II of 242 section 3, a practitioner registered under section 7 shall: (i) consult with a the patient regarding 243 the quantity of the opioid and a patient’s option to fill the prescription in a lesser quantity; and 244 (ii) inform the patient of the risks associated with the opioid prescribed. 245 SECTION 24. Said chapter 94C is hereby amended by inserting after section 19C the 246 following section:- 14 of 42 247 Section 19D. (a) When issuing a prescription for an opiate to an adult patient for 248 outpatient use for the first time, a practitioner shall not issue a prescription for more than a 7-day 249 supply. A practitioner shall not issue an opiate prescription to a minor for more than a 7-day 250 supply at any time and shall discuss with the parent or guardian of the minor the risks associated 251 with opiate use and the reasons why the prescription is necessary. 252 (b) Notwithstanding subsection (a), if, in the professional medical judgment of a 253 practitioner, more than a 7-day supply of an opiate is required to treat the adult or minor patient’s 254 acute medical condition or is necessary for the treatment of chronic pain management, pain 255 associated with a cancer diagnoses or for palliative care, then the practitioner may issue a 256 prescription for the quantity needed to treat such acute medical condition, chronic pain, pain 257 associated with a cancer diagnosis or pain experienced while the patient is in palliative care. The 258 condition triggering the prescription of an opiate for more than a 7-day supply shall be 259 documented in the patient’s medical record and the practitioner shall indicate that a non-opiate 260 alternative was not appropriate to address the medical condition. 261 (c) Notwithstanding subsections (a) and subsection (b), this section shall not apply to 262 medications designed for the treatment of substance abuse or opioid dependence. 263 SECTION 25. Section 21 of said chapter 94C, as appearing in the 2014 Official Edition, 264 is hereby amended by inserting after the word “drugs”, in line 19, the following words:- , 265 specifically opiates,. 266 SECTION 26. Section 22 of said chapter 94C, as so appearing, is hereby amended by 267 adding the following subsection:- 15 of 42 268 (c) Any prescription issued by a practitioner for an opioid substance contained in 269 Schedule II of section 3 shall include a notation on the prescription that the patient may fill, upon 270 request, the prescription in compliance with subsection (d ¾) of section 18 in an amount not to 271 exceed the recommended full quantity indicated. 272 SECTION 27. The second paragraph of subsection (c) of section 24A of said chapter 273 94C, as so appearing, is hereby amended by striking out the first sentence and inserting in place 274 thereof the following sentence:- The department shall promulgate rules and regulations relative 275 to the use of the prescription monitoring program by registered participants which shall include 276 the requirement that prior to issuance, participants shall utilize the prescription monitoring 277 program each time a prescription for a narcotic drug that is contained in Schedule II or III is 278 issued. 279 SECTION 28. Said section 24A of said chapter 94C is hereby further amended by 280 striking out subsection (h), as so appearing, and inserting in place thereof the following 281 subsection:- 282 (h) The department may provide de-identified information to a public or private entity for 283 statistical research or educational purposes. 284 SECTION 29. Said chapter 94C is hereby further amended by inserting after section 24A 285 the following section:- 286 Section 24B. The department shall annually determine, through the prescription drug 287 monitoring system established in section 24A, the mean and median quantity and volume of 288 prescriptions for opiates contained in Schedules II and III of section 3 issued by practitioners 289 registered under section 7; provided, however, that mean and median prescription quantities and 16 of 42 290 volumes shall be determined within categories of practitioners of a similar specialty or practice 291 type as determined by the department. 292 The department shall work in conjunction with the respective boards of licensure to 293 annually determine each practitioner’s Schedule II and Schedule III opiate prescribing quantity 294 and volume and the practitioner’s standing with regard to the mean and median quantity and 295 volume for the practitioner’s category of specialty or practice type; provided, however, that the 296 practitioner’s standing shall be expressed as a percentile ranking for the practitioner within the 297 practitioner’s category. Each practitioner whose prescribing exceeds the mean or median within 298 the practitioner’s category shall be sent notice of the practitioner’s percentile ranking in a manner 299 determined by the department. Any practitioner may request the practitioner’s own percentile 300 ranking within the practitioner’s own category of practice. The ranking determined for each 301 practitioner shall be confidential, and shall be distributed by the department or by the relevant 302 board of licensure only to the practitioner to which the information pertains. Such information 303 shall not; (a) constitute a public record as defined in clause twenty-sixth of section 7 of chapter 304 4; (b) be admissible as evidence in a civil or criminal proceeding; or (c) be the sole basis for 305 investigation by a licensure board. 306 The department shall also coordinate with the respective boards of licensure to make 307 resources available to prescribers regarding ways to change prescribing practices and incorporate 308 alternative pain management options into a prescriber’s practice. 309 SECTION 30. Subsection (b) of Class B of section 31 of said chapter 94C, as so 310 appearing, is hereby amended by striking out clause (1) and inserting in place thereof the 311 following 2 clauses:- 17 of 42 312 (1) Acetyl fentanyl 313 (1½) Alphaprodine 314 SECTION 31. The General Laws are hereby further amended by inserting after chapter 315 94F the following chapter:- 316 CHAPTER 94G. 317 DRUG STEWARDSHIP PROGRAM. 318 Section 1. As used in this chapter, the following words shall have the following meanings 319 unless the context clearly requires otherwise: 320 “Covered drug”, any brand name or generic opioid drug placed in Schedule II or 321 Schedule III of section 3 of chapter 94C; provided, however, that “covered drug” shall also 322 include benzodiazepines; provided, further, that “covered drug” shall not include: (i) drugs 323 intended for use solely in veterinary care; (ii) substances that are regulated as cosmetic products 324 under the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.; (iii) drugs that 325 are compounded under a specialty license pursuant to sections 39G to 39J, inclusive, of chapter 326 112; (iv) hypodermic needles, lancets or other sharps products subject to collection and disposal 327 procedures established in section 27A of chapter 94C; or (v) drugs approved and used primarily 328 for medication-assisted substance use disorder treatment. 329 “Department”, the department of public health. 330 “Drug stewardship program”, a program financed by a pharmaceutical product 331 manufacturer or a group of manufacturers to collect, secure, transport and safely dispose of 332 unwanted drugs. 18 of 42 333 “Pharmaceutical product manufacturer” or “manufacturer”, an entity that manufactures a 334 controlled substance under a United States Food and Drug Administration manufacturer’s 335 license, except for an institutional pharmacy, as defined in section 39D of chapter 112 or a 336 wholesaler. 337 “Prescription drug”, any drug product which may be dispensed pursuant to chapter 94C 338 under a written prescription by an authorized prescriber. 339 “Stewardship organization”, an organization designated by a manufacturer or a group of 340 manufacturers to act as an agent on behalf of the manufacturer or the group of manufacturers to 341 implement and operate a drug stewardship program. 342 “Unwanted drug”, a covered drug: (i) that is no longer wanted or intended to be 343 consumed, or that is abandoned, discarded, expired or surrendered by the person to whom it was 344 prescribed; or (ii) voluntarily deposited at collection points co-located with a law enforcement 345 agency; provided, however, that “unwanted drug” shall not include: (A) waste or unused drug 346 products from a pharmacy, hospital or health clinic or other commercial sources that the 347 department may determine by regulation to be a nonresidential source; or (B) drug products 348 seized by law enforcement officers in the course of their law enforcement duties. 349 “Wholesaler”, an entity licensed pursuant to section 36B of chapter 112. 350 Section 2. (a) Any pharmaceutical product manufacturer selling or distributing a covered 351 drug to consumers in the commonwealth, whether directly or through a wholesaler, retailer or 352 other agent, shall: (i) operate a drug stewardship program approved by the department 353 individually or jointly with other manufacturers; (ii) enter into an agreement with a stewardship 19 of 42 354 organization that shall operate a drug stewardship program approved by the department; or (iii) 355 enter into an agreement with the department to operate an alternative plan under section 6. 356 (b) The department shall establish a process to review applications for approval and 357 renewal of a manufacturer’s drug stewardship plan. The department shall consult with the 358 Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other 359 interested parties in developing the requirements of a drug stewardship program. 360 (c) Each operator of a drug stewardship program shall file an annual written report to the 361 department describing the program’s activities for the prior year and the volume and type of 362 unwanted drugs collected not later than March 1. 363 (d) The department shall review for renewal each drug stewardship program at a 364 frequency to be determined by the department. 365 (e) The department shall publish and make publicly available a list and description of 366 each approved drug stewardship program and shall update this list at a frequency determined by 367 the department. 368 (f) The department may promulgate regulations to implement this chapter. 369 Section 3. A manufacturer or stewardship organization seeking approval for a drug 370 stewardship program shall submit, in a manner and form determined by the department, a plan 371 that meets, but is not limited to, the following requirements: 372 (i) a collection system to provide convenient, ongoing collection services to all persons 373 seeking to dispose of unwanted drugs; provided, however, that the collection system may accept 374 any covered drug and any other prescription drug in a pill formulation regardless of its schedule, 20 of 42 375 brand or source of manufacture; provided further, that the collection system shall include 2 376 methods as recommended by the department, which may include, but not be limited to: (A) a 377 mail-back program that provides prepaid and preaddressed packaging for a pharmacy to 378 distribute when filling a prescription for a covered drug or upon request by a consumer; (B) 379 collection kiosks; (C) drop-off day events at regional locations; (D) in-home disposal methods 380 that render a product safe from misuse and that comply with applicable controlled substance 381 regulations and environmental safety regulations; or (E) any other method recommended 382 pursuant to United States Drug Enforcement Administration guidelines; 383 (ii) adequate provisions for the security of unwanted drugs throughout the collection 384 process and the safety of any person involved in monitoring, staffing or servicing the 385 stewardship program; 386 (iii) a plan for public outreach and education about the drug stewardship program; 387 (iv) a plan for the manufacturer or stewardship organization that provides the operational 388 and administrative costs associated with the program; provided, however, that no point-of-sale, 389 point-of-collection, processing fees or other drug cost increases may be charged to individual 390 consumers to recoup program costs; 391 (v) an attestation that the program shall comply with all applicable state and federal 392 requirements for the collection, security, transport and disposal of drug products, including any 393 requirements established by rule or regulation of either the United States Drug Enforcement 394 Administration or the United States Environmental Protection Agency; and 395 (vi) any other requirements established by the department for the safe and effective 396 administration of a drug stewardship program. 21 of 42 397 Section 4. (a) The department shall send a notice to a pharmaceutical product 398 manufacturer that sells or distributes a covered drug in the commonwealth that has not submitted 399 an application for approval under section 2, informing the manufacturer of the requirements to 400 comply with this chapter. Any manufacturer in receipt of a notice shall submit an application for 401 approval under said section 2 within 180 calendar days of receipt of such initial notice. 402 (b) Upon becoming aware that a pharmaceutical product manufacturer has discontinued 403 its drug stewardship program or has altered the program such that the program no longer fulfills 404 the requirements of this chapter, the department shall send a notice of noncompliance to the 405 manufacturer. A manufacturer in receipt of a notice of noncompliance shall take all required 406 corrective steps to reestablish compliance with this chapter or submit a written appeal of the 407 notice of noncompliance to the department within 90 days of receipt of the notice of 408 noncompliance. 409 (c) If after consideration of an appeal or if the manufacturer does not appeal within 90 410 days of receipt of the notice of noncompliance the department determines that the manufacturer 411 continues to be in noncompliance with this chapter, the department may assess the manufacturer 412 a penalty in a manner to be determined by the department. If the department plans to assess a 413 noncompliance penalty against a manufacturer pursuant to this section, the department shall send 414 notice of the penalty and the right to appeal the penalty to the manufacturer. 415 Section 5. (a) The requirements established by the department, in consultation with 416 Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other 417 stakeholders, may exceed, but shall not conflict with, any obligations imposed on a manufacturer 22 of 42 418 by a risk evaluation and mitigation strategy approved by the United States Food and Drug 419 Administration. 420 (b) Nothing in this chapter shall require a retail pharmacy or a pharmacist practicing in a 421 retail setting to participate in the collection, securing, transport or disposal of unwanted drugs. 422 (c) No stewardship program shall require an outpatient pharmacy to participate in the 423 collection, securing, transport or disposal of unwanted drugs or to provide a space for or to 424 maintain a collection kiosk within an outpatient pharmacy unless the pharmacy certifies, in 425 writing, that this participation is voluntary. 426 Section 6. The department shall, in consultation with the Massachusetts Biotechnology 427 Council, the Interagency Council on Substance Abuse and other interested parties, develop an 428 alternative plan to the drug stewardship program established under sections 2 to 5, inclusive. A 429 manufacturer who opts into a plan established under this section shall be exempt from sections 2 430 to 5, inclusive. 431 A plan established under this section may permit contributions by manufacturers to the 432 Substance Abuse Services Fund established in section 2I of chapter 111, in a manner determined 433 by the department. A manufacturer participating in a plan established under this section shall not 434 pass the cost of any contribution on to the consumer or a health insurance carrier. 435 SECTION 32. Chapter 111 of the General Laws, as appearing in the 2014 Official 436 Edition, is hereby amended by inserting after section 51 the following section:- 437 Section 51½. (a) For the purposes of this section, the following words shall have the 438 following meanings:- 23 of 42 439 “Acute-care hospital”, any hospital licensed under section 51 that contains a majority of 440 medical-surgical, pediatric, obstetric, and maternity beds, as defined by the department and the 441 teaching hospital of the University of Massachusetts Medical School. 442 “Licensed mental health professional”, a licensed physician who specializes in the 443 practice of psychiatry or addiction medicine, a licensed psychologist, a licensed independent 444 social worker, a licensed mental health counselor, a licensed psychiatric clinical nurse specialist 445 or a licensed alcohol and drug counselor I as defined in section 1 of chapter 111J. 446 “Satellite emergency facility”, a health care facility that operates on a 7-day per week, 447 24-hour per day basis that is located off the premises of a hospital, but is listed on the license of a 448 hospital, and is authorized to accept patients transported to the facility by ambulance. 449 “Substance abuse evaluation”, an evaluation ordered pursuant to subsection (b) that is 450 conducted by a licensed mental health professional or through an emergency services program, 451 which shall include, but not be limited to, the following information: (1) history of the patient’s 452 use of alcohol, tobacco and other drugs, including age of onset, duration, patterns and 453 consequences of use; (2) the use of alcohol, tobacco and other drugs by family members; (3) 454 types of and responses to previous treatment for substance use disorders or other psychological 455 disorders; (4) an assessment of the patient’s psychological status including co-occurring 456 disorders, trauma history and history of compulsive behaviors; and (4) an assessment of the 457 patient’s human immunodeficiency virus, hepatitis C, and tuberculosis risk status. 458 (b) A person presenting in an acute-care hospital or a satellite emergency facility who 459 is reasonably believed by the treating clinician to be experiencing an opiate-related overdose, or 460 who has been administered naloxone prior to arriving at the hospital or facility, shall receive a 24 of 42 461 substance abuse evaluation within 24 hours of receiving emergency room services. A substance 462 abuse evaluation shall conclude with a diagnosis of the status and nature of the patient’s 463 substance use disorder, using standardized definitions as set forth in the Diagnostic and 464 Statistical Manual of Mental Disorders as published by the American Psychiatric Association a 465 diagnosis of a mental or behavioral disorder due to the use of psychoactive substances, as 466 defined and coded by the World Health Organization. Each patient shall be presented with the 467 findings of the evaluation in person and in writing, and the findings shall include 468 recommendations for further treatment, if necessary, with an assessment of the appropriate level 469 of care needed. Findings from the evaluation shall be entered into the patient’s medical record. 470 No acute-care hospital or satellite emergency facility shall permit early discharge, defined as less 471 than 24 hours after presentation or before the conclusion of a substance abuse evaluation, 472 whichever occurs sooner. If a patient does not receive an evaluation within 24 hours, the treating 473 clinician shall note in the medical record the reason the evaluation did not take place and 474 authorize the discharge of the patient. No clinician shall be held liable in a civil suit for releasing 475 a patient who does not wish to remain in the emergency department after stabilization, but before 476 a substance abuse evaluation has taken place. 477 (c) After a substance abuse evaluation has been completed pursuant to subsection (b) 478 a patient may consent to further treatment. Treatment may occur within the acute-care hospital or 479 satellite emergency facility, if appropriate services are available; provided, however, that if the 480 hospital or satellite emergency facility is unable to provide such services, the hospital or satellite 481 emergency facility shall refer the patient to treatment center outside of the hospital or satellite 482 emergency facility. Medical necessity for further treatment shall be determined by the treating 483 clinician in consultation with the patient and noted in the medical record. If a patient refuses 25 of 42 484 further treatment after the evaluation is complete, and is otherwise medically stable, the hospital 485 or satellite emergency facility may initiate discharge proceedings. All patients receiving an 486 evaluation under subsection (b) shall receive, upon discharge, information on local and statewide 487 treatment options, providers and other relevant information as deemed appropriate by the treating 488 clinician. 489 (d) If a person has received a substance abuse evaluation within the past 3 months, 490 further treatment and the need for a further evaluation shall be determined by the treating 491 clinician according to best practices and procedures. 492 (e) If a person under 18 years of age is ordered to undergo a substance abuse 493 evaluation, a parent or guardian shall be notified that the minor has suffered from an opiate- 494 related overdose and that an evaluation has been ordered. A parent or guardian may be present 495 when the findings of the evaluation are presented to the minor. 496 (f) Upon discharge of a patient who experienced an opiate-related overdose, the acute- 497 care hospital or satellite emergency facility shall notify the patient’s primary care physician, if 498 known, of the opiate-related overdose and any recommendations for further treatment. 499 (g) Upon discharge of a patient who experienced an opiate-related overdose, the acute- 500 care hospital or satellite emergency facility shall record the opiate-related overdose on the 501 patient’s electronic medical record. 502 (h) Nothing in this section shall interfere with an individual’s right to refuse medical care. 503 SECTION 33. Subsection (a) of section 222 of said chapter 111, as so appearing, is 504 hereby amended by adding the following paragraph:- 26 of 42 505 The bureau of substance abuse services shall provide educational materials on the 506 dangers of opiate use and misuse to those persons participating in the annual head injury safety 507 program required by this section. The educational materials shall also be distributed in written 508 form to all students participating in an extracurricular athletic activity prior to the 509 commencement of their athletic seasons. 510 SECTION 34. Section 1 of chapter 111E of the General Laws, as appearing in the 2014 511 Official Edition, is hereby amended by striking out the definition of ‘advisory board’. 512 SECTION 35. Section 3 of said chapter 111E, as so appearing, is hereby repealed. 513 SECTION 36. Section 4 of said chapter 111E, as so appearing, is hereby amended by 514 striking out, in lines 6 and 7, the words “the advisory board,”. 515 SECTION 37. Chapter 112 of the General Laws, is hereby amended by inserting after 516 section 12EE the following section:- 517 Section 12FF. Any person who, in good faith, attempts to render emergency care by 518 administering naloxone or any other opioid antagonist, as defined in section 19B of chapter 94C, 519 to a person reasonably believed to be experiencing an opiate-related overdose, shall not be liable 520 for acts or omissions resulting from the attempt to render this emergency care; provided, 521 however, that this section shall not apply to acts of gross negligence or willful or wanton 522 misconduct. 523 SECTION 38. Said chapter 112 is hereby further amended by inserting after section 24G 524 the following section:- 27 of 42 525 Section 24H. (a) The board of registration in pharmacy shall establish a rehabilitation 526 program for registered pharmacists, pharmacy interns and pharmacy technicians who have a 527 substance use issue. 528 (b) The rehabilitation program shall: (i) serve as a voluntary alternative to traditional 529 disciplinary actions; (ii) establish criteria for the acceptance, denial or termination of registered 530 pharmacists, pharmacy interns and pharmacy technicians in the program; and (iii) establish an 531 outreach program to identify registered pharmacists, pharmacy interns and pharmacy technicians 532 who may have a substance use disorder and to provide education about the rehabilitation 533 program. 534 Only a registered pharmacist, pharmacy intern or pharmacy technician who has requested 535 rehabilitation and supervision shall be eligible to participate in the program. 536 (c) The board shall appoint a rehabilitation evaluation committee, 2 of whom shall be 537 registered pharmacists with demonstrated experience in the field of substance use disorders, 1 of 538 whom shall be a medical doctor with experience in the treatment of substance use disorders, 1 of 539 whom shall be a pharmacy technician with demonstrated experience in the field of substance use 540 disorders, 1 of whom shall be a registered pharmacist who has recovered from drug or alcohol 541 addiction and has been drug and alcohol free for a minimum of 5 years and 2 of whom shall be 542 representatives of the public who are knowledgeable about substance use disorders or mental 543 health. Three members of the committee shall constitute a quorum. The committee shall elect a 544 chairperson and a vice chairperson. Members of the committee shall serve for terms of 4 years. 545 At the time of appointment or reappointment to the committee, no member of the committee who 546 is licensed to practice by the department of public health, division of professional licensure or by 28 of 42 547 the board of registration in medicine shall have had any type of disciplinary or enforcement 548 action taken against them by their respective licensing board, the United States Food and Drug 549 Administration or the United States Drug Enforcement Administration during the 5 years 550 preceding their appointment to the committee. No member of the board of registration in 551 pharmacy shall serve on the committee. Meetings of the committee shall not be subject to 552 sections 18 to 25, inclusive, of chapter 30A. 553 (d) The board shall employ a pharmacist supervisor with demonstrated professional 554 expertise in the field of substance use disorders to oversee participants in the rehabilitation 555 program. The supervisor shall serve as a liaison among the board, the committee, approved 556 treatment programs and providers and participants. Following consultation with members of the 557 committee, the supervisor may authorize and implement changes to a participant’s individualized 558 rehabilitation program based on information that the supervisor may receive concerning a 559 participant’s failure to comply with the participant’s individualized rehabilitation program as 560 necessary to protect public health, safety and welfare; provided, however, that the changes shall 561 remain in effect until review by the board takes place. Any information obtained by a supervisor 562 pursuant to this section shall be exempt from disclosure and shall be confidential, subject to 563 subsections (f) and (g). 564 (e) All rehabilitation evaluation committee findings shall be submitted to the board as 565 recommendations and shall be subject to final approval of the board. The committee shall have 566 the following duties and responsibilities: 567 (i) to evaluate, according to guidelines established by the board, registered pharmacists, 568 pharmacy interns or pharmacy technicians who request to participate in the program and 29 of 42 569 consider the recommendations of the pharmacist supervisor regarding the admission of a 570 registered pharmacist, pharmacy intern or pharmacy technician into the program; 571 (ii) to review and designate treatment facilities and services to which participants may be 572 referred; 573 (iii) to receive and review information concerning a participant in the program; 574 (iv) to consider, for each participant, whether the participant may continue or may resume 575 practice within the full scope of the participant’s license; 576 (v) to call meetings as necessary to review the request of a registered pharmacist, 577 pharmacy intern or pharmacy technician to participate in the program and review reports 578 regarding participants; 579 (vi) to prepare reports to be submitted to the board; 580 (vii) to provide each participant with an individualized rehabilitation plan with 581 requirements for supervision and surveillance; and 582 (viii) to provide information to pharmacists, pharmacy interns or pharmacy technicians 583 who request to participate in the program. 584 (f) A registered pharmacist, pharmacy intern or pharmacy technician who requests to 585 participate in the program shall agree to cooperate with the individualized rehabilitation plan 586 recommended by the rehabilitation evaluation committee and approved by the board. Any failure 587 to comply with the rehabilitation program may result in termination of the participant from the 588 rehabilitation program. The committee shall report to the board the name and license number of a 30 of 42 589 registered pharmacist, pharmacy intern or pharmacy technician terminated from the program for 590 failure to comply with the provisions of an individualized rehabilitation plan. 591 (g) After the committee, in its discretion, has determined that a registered pharmacist, 592 pharmacy intern or pharmacy technician has successfully completed an individualized 593 rehabilitation plan through the program, the board shall seal all records pertaining to the 594 participation of the registered pharmacist, pharmacy intern or pharmacy technician in the 595 program; provided, however, that no record shall be sealed sooner than 5 years from the 596 participant’s date of entry into the program. All board and committee records and records of a 597 participant’s involvement in the program shall be kept confidential and shall not be subject to 598 discovery or subpoena in any civil, criminal, legislative or administrative proceeding without the 599 prior written consent of the participant. 600 SECTION 39. Section 10H of chapter 118E of the General Laws, as added by section 19 601 of chapter 258 of the acts of 2014, is hereby amended by inserting after the figure “7”, in line 45, 602 the following words:- ; and provided further, that the division and its contracted health insurers, 603 health plans, health maintenance organizations, behavioral health management firms and third 604 party administrators under contract to a Medicaid managed care organization or primary care 605 clinician plan shall cover, without preauthorization, substance abuse evaluations ordered 606 pursuant to section 51½ of chapter 111. 607 SECTION 40. The third paragraph of section 35 of chapter 123 of the General Laws, as 608 appearing in the 2014 Official Edition, is hereby amended by striking out the fifth sentence 609 inserting in place thereof the following sentence:- If such person is not immediately presented 610 before a judge of the district court, the warrant shall continue day after day for up to 5 31 of 42 611 consecutive days, excluding Saturdays, Sundays and legal holidays, or until such time as the 612 person is presented to the court, whichever is sooner; provided, however that an arrest on such 613 warrant shall not be made unless the person may be presented immediately before a judge of the 614 district court. 615 SECTION 41. Section 1 of chapter 138 of the General Laws, as so appearing , is hereby 616 amended by inserting after the definition of “malt beverages”, the following definition:- 617 “Powdered alcohol”, a nonmedicinal product in powdered or crystalline form that 618 contains alcohol and is intended for consumption by direct use or when mixed with water or 619 another substance. 620 SECTION 42. Said chapter 138 is hereby further amended by inserting after section 2 the 621 following section:- 622 Section 2A. No person shall sell, offer for sale, manufacture or possess powdered 623 alcohol. Whoever violates this section shall be punished by a fine of not less than $100 or more 624 than $1,000. 625 SECTION 43. Section 47FF of chapter 175 of the General Laws, as appearing in the 626 2014 Official Edition, is hereby amended by inserting after the word “treatment”, in line 3, the 627 following words:- ; a substance abuse evaluation, as defined in section 51½ of chapter 111. 628 SECTION 44. Section 47GG of said chapter 175, as so appearing, is hereby amended by 629 striking out, in line 21, the word ‘118M’ and inserting in place thereof the following word:- 630 111M. 32 of 42 631 SECTION 45. Section 47GG of said chapter 175, as so appearing, is hereby amended by 632 inserting after the figure “7”, in line 29, the following words:- ; provided further, any policy, 633 contract, agreement, plan or certificate of insurance issued, delivered or renewed within the 634 commonwealth, which is considered creditable coverage pursuant to section 1 of chapter 111M, 635 shall cover, without preauthorization, a substance abuse evaluation ordered pursuant to section 636 51½ of chapter 111. 637 SECTION 46. Section 8HH of chapter 176A of the General Laws, as appearing in the 638 2014 Official Edition, is hereby amended by inserting after the word “treatment”, in line 3, the 639 following words:- ; a substance abuse evaluation, as defined in section 51½ of chapter 111. 640 SECTION 47. Section 8II of said chapter 176A, as so appearing, is hereby amended by 641 inserting after the figure ‘7’, in line 28, the following words:- ; provided further, any contract 642 between a subscriber and the corporation under an individual or group hospital service plan 643 which is delivered, issued or renewed within the commonwealth, shall cover, without 644 preauthorization, a substance abuse evaluation ordered pursuant to section 51½ of chapter 111. 645 SECTION 48. Section 4HH of chapter 176B of the General Laws, as appearing in the 646 2014 Official Edition, is hereby amended by inserting after the word “treatment”, in line 3, the 647 following words:- ; a substance abuse evaluation, as defined in section 51½ of chapter 111. 648 SECTION 49. Section 4II of said chapter 176B, as so appearing, is hereby amended by 649 inserting after the words figure ‘7’, in line 28, the following words:- ; provided further, any 650 subscription certificate under an individual or group medical service agreement delivered, issued 651 or renewed within the commonwealth shall provide coverage for, without preauthorization, a 652 substance abuse evaluation ordered pursuant to section 51½ of chapter 111. 33 of 42 653 SECTION 50. Section 4Z of chapter 176G of the General Laws, as appearing in the 2014 654 Official Edition, is hereby amended by inserting after the word “treatment”, in line 3, the 655 following words:- ; a substance abuse evaluation, as defined in section 51½ of chapter 111. 656 SECTION 51. Section 4AA of said chapter 176G, as so appearing, is hereby amended by 657 inserting after the figure ‘7’, in line 27, the following words:- ; provided further, an individual or 658 group health maintenance contract that is issued or renewed shall provide coverage for, without 659 preauthorization, a substance abuse evaluation ordered pursuant to section 51½ of chapter 111. 660 SECTION 52. Section 7 of chapter 176O of the General Laws, as appearing in the 2014 661 Official Edition, is hereby amended by striking out, in line 59, the word “and”. 662 SECTION 53. Said section 7 of said chapter 176O, as so appearing, is hereby further 663 amended by inserting after the word “age”, in line 68, the following words:- ; and 664 (5) a report detailing for the previous calendar year the total number of: (i) medical or 665 surgical claims submitted to the carrier; (ii) medical or surgical claims denied by the carrier; (iii) 666 mental health or substance use disorder claims submitted to the carrier; (iv) mental health or 667 substance use disorder claims denied by the carrier; and (v) medical or surgical claims and 668 mental health or substance use disorder claims denied by the carrier because: (A) the insured 669 failed to obtain pre-treatment authorization or referral for services; (B) the service was not 670 medically necessary; (C) the service was experimental or investigational; (D) the insured was not 671 covered or eligible for benefits at the time services occurred; (E) the carrier does not cover the 672 service or the provider under the insured’s plan; (F) duplicate claims had been submitted; (G) 673 incomplete claims had been submitted; (H) coding errors had occurred; or (I) of any other 674 specified reason. 34 of 42 675 SECTION 54. Subsection (b) of section 24 of said chapter 176O, as so appearing, is 676 hereby amended by adding the following sentence:- The decision on the appeal shall prominently 677 provide information on the patient’s right to appeal the decision to the office of patient protection 678 including, but not limited to: (i) contact information for the office of patient protection,; (ii) a 679 notice of a patient’s right to file a grievance with the office of patient protection; and (iii) 680 information on how to file a grievance with the office of patient protection. 681 SECTION 55. Chapter 94G of the General Laws is hereby repealed. 682 SECTION 56. Item 4000-0005 of section 2 of chapter 46 of the acts of 2015 is hereby 683 amended by inserting after the word “programs,” the second time it appears, the following 684 words:- provided further, that any grant awarded may also be used to target youth and adult 685 substance misuse. 686 SECTION 57. The health policy commission, in consultation with the department of 687 public health and the department of mental health, shall conduct a study on the availability of 688 health care providers that serve patients with dual diagnoses of substance use disorder and 689 mental illness, in inpatient and outpatient settings. The study shall include: (i) an inventory of 690 health care providers with the capability of caring for patients with dual diagnoses, including the 691 location and nature of services offered at each such provider; (ii) an inventory of health care 692 providers specializing in caring for child and adolescent patients with dual diagnoses, including 693 the location and nature of services offered at each such provider; and (iii) an assessment of the 694 sufficiency of dual diagnosis resources in the commonwealth considering multiple factors, 695 including but not limited to population density, geographic barriers to access, insurance coverage 696 and network design, incidence of mental illness and substance use disorders and the needs of 35 of 42 697 individuals with dual diagnoses. The study shall also consider barriers to access to 698 comprehensive mental health and substance use disorder treatment for adults, seniors, children 699 and adolescents and shall include recommendations to reduce barriers to treatment for patients 700 with dual diagnoses, including the appropriate supply and distribution of health care providers 701 with such capability. The commission shall report to the joint committee on mental health and 702 substance abuse and the house and senate committees on ways and means not later than 12 703 months following the completion of the study. 704 SECTION 58. (a) There shall be a special commission to study the incorporation of safe 705 and effective pain treatment and prescribing practices into the professional training of students, 706 except veterinarian students, that may prescribe controlled substances. 707 (b) The special commission shall consist of the following members or their designees: the 708 chancellor of the University of Massachusetts medical school; the dean of Harvard Medical 709 School; the dean of Boston University School of Medicine; the dean of Tufts University School 710 of Medicine; a representative of The Massachusetts Association of Physician Assistants, Inc.; a 711 representative of the Massachusetts Nurses Association; a representative of the Massachusetts 712 Medical Society; a representative of The Massachusetts Hospital Association, Inc.; a 713 representative of the Massachusetts Pain Initiative; and 6 members to be appointed by the 714 governor, 2 of whom shall be representatives of the pharmacy industry, 1 of whom shall be a 715 representative of a nursing school and 1 of whom shall be a representative of a physician 716 assistant training program. The governor shall appoint a chair of the committee; provided, 717 however, that the first meeting of the commission shall take place on or before than June 1, 2016. 36 of 42 718 (c) The special commission shall develop recommendations to ensure future prescribers 719 have an understanding of: (i) pain treatment; (ii) the development of a pain management 720 treatment plan and safe prescribing practices of controlled substances; (iii) the effective use of 721 the prescription monitoring program; (iv) substance use disorder symptoms and treatment 722 options; (v) alternative pain management options; and (vi) state and federal laws and regulations 723 related to controlled substances. 724 (d) The special commission shall submit its recommendations, together with drafts of any 725 legislation, to the clerks of the house of representative and the senate, the chairs of the joint 726 committee on higher education and the chairs of the joint committee on mental health and 727 substance abuse on or before December 1, 2016. 728 SECTION 59. (a) There shall be a special commission to examine the feasibility of 729 establishing a pain management access program, with the goal of increasing access to pain 730 management for patients in need of comprehensive pain management resources. 731 (b) The commission shall review: (i) the development of a referral process to make pain 732 management specialists accessible to primary care providers, including a process similar to the 733 Massachusetts child psychiatry access project; (ii) the establishment of a pain management 734 specialty certification through the board of registration in medicine to refer a primary care 735 provider through the referral system described in clause (i); (iii) ways to incorporate a full 736 spectrum of pain management methods into provider care practices including, but not limited to, 737 acupuncture, exercise and other non-pharmaceutical interventions; (iv) the current coverage of 738 pain management through commercial and public insurers; and (v) ways to ensure a full 37 of 42 739 spectrum of pain management interventions are covered through commercial and public 740 insurance health plans. 741 (c) The special commission shall consist of the following members or their designees: the 742 secretary of health and human services, who shall serve as co-chair; the chancellor of the 743 University of Massachusetts medical school, who shall serve as co-chair; the assistant director of 744 Medicaid; the commissioner of the group insurance commission; the commissioner of insurance; 745 the executive director of the health policy commission; the executive director of the center for 746 health information and analysis; the commissioner of public health; the chair of the board of 747 registration in medicine; the chair of the board of registration in nursing; 1 representative of the 748 Massachusetts Association of Health Plans, Inc.; 1 representative of the Massachusetts Medical 749 Society; 1 representative of the Massachusetts Hospital Association, Inc.; 1 representative of the 750 Massachusetts Pain Initiative; a representative of the Massachusetts Chiropractic Society, Inc.; 751 and 6 members who shall be appointed by the governor, 1 of whom shall be an oncologist, 1 of 752 whom shall be a physician, 1 of whom shall be an advanced practice nurse, 1 of whom shall be a 753 health economist, 1 of whom shall be a physician specializing in pain management and 1 of 754 whom shall be a professor of medicine. 755 (d) The special commission shall file an initial report of its recommendations and drafts 756 of proposed legislation or regulations, if any, on clauses (i) and (ii) of subsection (b) with the 757 clerks of the house of representatives and the senate, the chairs of the joint committee on health 758 care financing, the chairs of the joint committee on mental health and substance abuse, the chairs 759 of the joint committee on public health and the chairs of the house and senate committees on 760 ways and means on or before November 1, 2016. The special commission shall file a final report 761 providing a full report regarding said subsection (b) on or before November 1, 2017. 38 of 42 762 SECTION 60. There shall be a special commission to investigate and study state licensed 763 addiction treatment centers. 764 The commission shall consist of: the secretary of health and human services or a 765 designee, who shall serve as chair; the commissioner of mental health or a designee; the 766 commissioner of public health or a designee; the director of medicaid or a designee; the inspector 767 general or a designee; and 6 members who shall be appointed by the secretary of health and 768 human services: 3 of whom shall be advocates from the addiction treatment community and 3 of 769 whom shall be a family members of individuals who have been treated at a state licensed 770 addition treatment center. 771 The commission shall: (1) solicit information and input from addiction treatment service 772 providers, consumers, families and any other parties or entities the commission considers 773 appropriate; (2) examine the effectiveness of addiction treatment services in promoting 774 successful outcomes of recovery and wellness; (3) examine ways to encourage engagement from 775 individuals in recovery from substance use disorders in policy development related to service 776 delivery and the training and evaluation of services; (4) consider best practice models of delivery 777 and the provision of recovery oriented services in other states; (6) examine mental health 778 considerations when an individual enters an addiction treatment center, including, but not limited 779 to, patient access to mental health services; and (7) recommend legislation to improve services 780 for people in a state licensed addiction treatment center. 781 The commission shall submit a report to the general court of the results of its 782 investigation and its recommendations, if any, together with any drafts of proposed legislation, 783 with the clerks of the senate and the house of representatives, the chairs of the joint committee on 39 of 42 784 mental health and substance abuse, and the chairs of the senate and house committees on ways 785 and means not later than January 1, 2017. 786 SECTION 61. Notwithstanding any general or special law to the contrary, the 787 Massachusetts behavioral health access (MABHA) website, operated by the office of medicaid’s 788 behavioral health vendor, shall post contact information for all insurance payers, including a 789 phone number which is accessible 24 hours per day, for the purpose of enhancing 790 communication between payers and providers. 791 SECTION 62. Notwithstanding any general or special law to the contrary, the department 792 of public health shall consult with the secretary of public safety, the superintendent of the 793 department of state police, the Massachusetts Chiefs of Police Association Incorporated and 794 others as necessary to develop an education and training program on the statewide centralized 795 substance abuse service referral and education system. The education and training program shall 796 enable municipal police officers to obtain information by phone or online regarding referral to 797 treatment for individuals seeking treatment at local police departments. The department of 798 public health shall ensure that the program provides daily updates and that the program is fully 799 implemented under the second and third sentences of subsection (b) and section (c) of section 18 800 of chapter 17 of the General Laws. 801 SECTION 63. Each city, town, regional school district, charter school or vocational 802 school district shall implement the verbal substance use disorder screenings required by section 803 97 of chapter 71 of the General Laws by the 2017-2018 school year. 40 of 42 804 SECTION 64. The department of elementary and secondary education, in consultation 805 with the department of public health, shall create a notice and opt out form relative to substance 806 use disorder screenings required by section 97 of chapter 71 of the General Laws. 807 SECTION 65. Not later than 180 days after the effective date of this act, the division of 808 insurance shall develop and implement regulations providing that there shall be no financial 809 penalty for a patient’s choice to receive a lesser quantity of an opioid contained in schedule II or 810 III of section 3 of chapter 94C of the General Laws. 811 SECTION 66. Not later than July 1, 2016, the Massachusetts Association of School 812 Committees, Inc., the Massachusetts Association of School Superintendents, Inc. and the 813 Massachusetts Charter Public School Association, Inc. shall each provide an update to the 814 department of elementary and secondary education, the joint committee on education, and the 815 joint committee on mental health and substance abuse on their ongoing efforts to ensure 816 compliance with the requirements set forth in section 96 of chapter 71of the General Laws. 817 SECTION 67. The division of insurance, in consultation with the department of mental 818 health, the department of public health and the bureau of substance abuse services, shall 819 recommend a universal intake form to streamline the administrative process for intake of a 820 behavioral health or substance use disorder patient. The form shall: (i) ensure adequate 821 recordkeeping; (ii) lessen the current documentation burden for providers of behavioral health or 822 substance use disorder services; and (iii) be available in electronic form. The form may be 823 incorporated by all payers of behavioral health and substance use disorder services. The division 824 shall hold not fewer than 4 public hearings on the development of the universal intake form. The 825 division shall post the universal intake form on its website not later than October 1, 2016. 41 of 42 826 SECTION 68. The department of public health shall promulgate rules and regulations 827 relative to practitioners, as defined in section 1 of chapter 94C of the General Laws, advertising 828 opiates, benzodiazepines, and narcotics on their premises by posting or distributing written 829 material. 830 For the purposes of this section, the following terms shall have the following meanings: 831 narcotic shall mean “narcotic” as defined in said section 1 of said chapter 94C; opiate shall mean 832 “opiate” as defined in said section 1 of said chapter 94C; and benzodiazepine shall mean any 833 substance or drug which contains a benzene ring fused to a 7 member diazepine ring, results in 834 the depression of the central nervous system and is primarily intended to treat insomnia and 835 anxiety, including alprazolam, clonazepam, diazepam, lorazepam, and temazepam. 836 SECTION 69. The department of public health shall promulgate regulations to classify 837 gabapentin and its chemical equivalents as “additional drugs” for the purposes of section 24A of 838 chapter 94C of the General Laws. 839 SECTION 70. The first distribution to individual practitioners of the prescribing trends 840 and profiles set forth in section 29 shall occur not later than March 1, 2017. The department of 841 public health shall establish educational resources on prescribing practices and alternative pain 842 management options not later than March 1, 2017. 843 SECTION 71. Sections 8, 9, 32, 39 and 43 to 51, inclusive, shall take effect July 1, 2016. 844 SECTION 72. Section 4 shall take effect September 1, 2016. 845 SECTION 73. Section 27 shall take effect October 15, 2016. 42 of 42 846 SECTION 74. Section 18B of chapter 94C of the General Laws, as inserted by section 23 847 of this act, shall take effect December 1, 2016. 848 SECTION 75. Sections 7, 29 and 69 shall take effect on December 1, 2016. 849 SECTION 76. Section 31 shall take effect January 1, 2017. 850 SECTION 77. Section 55 shall take effect on December 31, 2021.

Full text as ingested · via legiscan. Verify against the official source above.

Explore more circular-economy legislation on the Atlas Circular legislation tracker.