Massachusetts Senate Bill S2520 Latest Draft

                            SENATE . . . . . . . . . . . . . . No. 2520
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Second General Court
(2021-2022)
_______________
SENATE, November 15, 2023.
The committee on Senate Bills in the Third Reading to whom was referred the Senate 
Bill relative to pharmaceutical access, costs and transparency (Senate, No. 2499, amended); 
reports, recommending that the same be amended as follows, and that, when so amended, it will 
be correctly drawn:-- by substituting a new with the same title (Senate, No. 2520).
For the committee,
Sal N. DiDomenico 1 of 100
        FILED ON: 11/15/2023
SENATE . . . . . . . . . . . . . . No. 2520
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Third General Court
(2023-2024)
_______________
An Act relative to pharmaceutical access, costs and transparency.
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 1 of chapter 6D of the General Laws, as appearing in the 2022 
2Official Edition, is hereby amended by inserting after the definition of “Alternative payment 
3methodologies or methods” the following 2 definitions:-
4 “Biosimilar”, a drug that is produced or distributed under a biologics license application 
5approved under 42 U.S.C. 262(k)(3).
6 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
7drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
8application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
9is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
10Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
11application that was approved by the United States Secretary of Health and Human Services 
12under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
13date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of  2 of 100
141984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
15C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
16under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the carrier as a brand name drug based on 
17available data resources such as Medi-Span.
18 SECTION 2. Said section 1 of said chapter 6D, as so appearing, is hereby further 
19amended by inserting after the definition of “Disproportionate share hospital” the following 
20definition:-
21 “Early notice”, advanced notification by a pharmaceutical manufacturing company of a: 
22(i) new drug, device or other product coming to market; or (ii) a price increase, as described in 
23subsection (b) of section 15A.
24 SECTION 3. Said section 1 of said chapter 6D, as so appearing, is hereby further 
25amended by inserting after the definition of “Fiscal year” the following definition:-
26 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
27abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
28drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
29and was not originally marketed under a new drug application; or (iv) identified by the carrier as 
30a generic drug based on available data resources such as Medi-Span.
31 SECTION 4. Said section 1 of said chapter 6D, as so appearing, is hereby further 
32amended by striking out, in line 189, the words “not include excludes ERISA plans” and 
33inserting in place thereof the following words:- include self-insured plans to the extent allowed 
34under the federal Employee Retirement Income Security Act of 1974. 3 of 100
35 SECTION 5. Said section 1 of said chapter 6D, as so appearing, is hereby further 
36amended by inserting after the definition of “Performance penalty” the following 2 definitions:- 
37 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production, 
38preparation, propagation, compounding, conversion or processing of prescription drugs, directly 
39or indirectly, by extraction from substances of natural origin, independently by means of 
40chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, 
41repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that 
42“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed 
43under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said 
44chapter 112.
45 “Pharmacy benefit manager”, a person, business or other entity, however organized, that 
46directly or through a subsidiary provides pharmacy benefit management services for prescription 
47drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
48insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit 
49management services shall include, but not be limited to: (i) the processing and payment of 
50claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing 
51of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or 
52grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii) 
53drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) 
54clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of 
55covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a 
56health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages 
57its own prescription drug benefits unless specifically exempted by the commission. 4 of 100
58 SECTION 6. Said section 1 of said chapter 6D, as so appearing, is hereby further 
59amended by inserting after the definition of “Physician” the following definition:-
60 “Pipeline drug”, a prescription drug product containing a new molecular entity for which 
61the sponsor has submitted a new drug application or biologics license application and received an 
62action date from the United States Food and Drug Administration.
63 SECTION 7. Said section 1 of said chapter 6D, as so appearing, is hereby further 
64amended by adding the following definition:-
65 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C. 
661395w-3a(c)(6)(B).
67 SECTION 8. Said chapter 6D is hereby further amended by striking out section 2A, as so 
68appearing, and inserting in place thereof the following section:- 
69 Section 2A. The commission shall keep confidential all nonpublic clinical, financial, 
70strategic or operational documents or information provided or reported to the commission in 
71connection with any care delivery, quality improvement process, performance improvement 
72plan, early notification or access and affordability improvement plan activities authorized under 
73sections 7, 10, 14, 15, 15A, 20 or 21 of this chapter or under section 2GGGG of chapter 29 and 
74shall not disclose the information or documents to any person without the consent of the entity 
75providing or reporting the information or documents under said sections 7, 10, 14, 15, 15A, 20 or 
7621 of this chapter or under said section 2GGGG of said chapter 29, except in summary form in 
77evaluative reports of such activities or when the commission believes that such disclosure should 
78be made in the public interest after taking into account any privacy, trade secret or 
79anticompetitive considerations. The confidential information and documents shall not be public  5 of 100
80records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 
81or under chapter 66.
82 SECTION 9. Section 4 of said chapter 6D, as so appearing, is hereby amended by 
83striking out, in line 8, the word “manufacturers” and inserting in place thereof the following 
84words:- manufacturing companies, pharmacy benefit managers.
85 SECTION 10. Section 6 of said chapter 6D, as so appearing, is hereby amended by 
86inserting after the word “center”, in line 1, the following words:- , pharmaceutical and 
87biopharmaceutical manufacturing company, pharmacy benefit manager.
88 SECTION 11. Said section 6 of said chapter 6D, as so appearing, is hereby further 
89amended by striking out, in lines 5 and 36, the figure “33” and inserting in place thereof, in each 
90instance, the following figure:- 25.
91 SECTION 12. Said section 6 of said chapter 6D, as so appearing, is hereby further 
92amended by adding the following paragraph:-
93 The assessed amount for pharmaceutical and biopharmaceutical manufacturing 
94companies and pharmacy benefit managers shall be not less than 25 per cent of the amount 
95appropriated by the general court for the expenses of the commission minus amounts collected 
96from: (i) filing fees; (ii) fees and charges generated by the commission's publication or 
97dissemination of reports and information; and (iii) federal matching revenues received for these 
98expenses or received retroactively for expenses of predecessor agencies. A pharmacy benefit 
99manager that is a surcharge payor subject to the preceding paragraph and manages its own 
100prescription drug benefits shall not be subject to additional assessment under this paragraph. 6 of 100
101 SECTION 13. Section 8 of said chapter 6D, as so appearing, is hereby amended by 
102inserting after the word “organization”, in lines 6 and 7, the following words:- , pharmacy benefit 
103manager, pharmaceutical manufacturing company.
104 SECTION 14. Said section 8 of said chapter 6D, as so appearing, is hereby further 
105amended by inserting after the word “organizations”, in line 15, the following words:- , 
106pharmacy benefit managers, pharmaceutical manufacturing companies.
107 SECTION 15. Said section 8 of said chapter 6D, as so appearing, is hereby further 
108amended by striking out, in line 33, the words “and (xi)” and inserting in place thereof the 
109following words:- (xi) not less than 3 representatives of the pharmaceutical industry; (xii) at least 
1101 representative of the pharmacy benefit management industry; and (xiii).
111 SECTION 16. Said section 8 of said chapter 6D, as so appearing, is hereby further 
112amended by striking out, in line 49, the first time it appears, the word:- and.
113 SECTION 17. Said section 8 of said chapter 6D, as so appearing, is hereby further 
114amended by inserting after the word “commission”, in line 60, the first time it appears, the 
115following words:- ; and (iii) in the case of pharmacy benefit managers and pharmaceutical 
116manufacturing companies, testimony concerning factors underlying prescription drug costs and 
117price changes including, but not limited to, the initial prices of drugs coming to market and 
118subsequent price changes, changes in industry profit levels, marketing expenses, reverse payment 
119patent settlements, the impact of manufacturer rebates, discounts and other price concessions on 
120net pricing, the availability of alternative drugs or treatments, corporate ownership organizational 
121structure and any other matters as determined by the commission. 7 of 100
122 SECTION 18. Subsection (g) of said section 8 of said chapter 6D, as so appearing, is 
123hereby amended by striking out the second sentence and inserting in place thereof the following 
1242 sentences:- The report shall be based on the commission’s analysis of information provided at 
125the hearings by witnesses, providers, provider organizations, payers, pharmaceutical 
126manufacturing companies and pharmacy benefit managers, registration data collected under 
127section 11, data collected or analyzed by the center under sections 8, 9, 10 and 10A of chapter 
12812C and any other available information that the commission considers necessary to fulfill its 
129duties under this section as defined in regulations promulgated by the commission. To the extent 
130practicable, the report shall not contain any data that is likely to compromise the financial, 
131competitive or proprietary nature of the information.
132 SECTION 19. Section 9 of said chapter 6D, as so appearing, is hereby amended by 
133inserting after the word “organization”, in line 72, the following words:- , pharmacy benefit 
134manager, pharmaceutical manufacturing company.
135 SECTION 20. Said chapter 6D is hereby further amended by inserting after section 15 
136the following section:-
137 Section 15A. (a) A pharmaceutical manufacturing company shall provide early notice to 
138the commission in a manner described in this section for a: (i) pipeline drug; (ii) generic drug; or 
139(iii) biosimilar drug. The commission shall provide nonconfidential information received under 
140this section to the office of Medicaid, the division of insurance and the group insurance 
141commission.
142 Early notice under this subsection shall be submitted to the commission in writing not 
143later than 30 days after receipt of the United States Food and Drug Administration approval date. 8 of 100
144 For each pipeline drug, early notice shall include a brief description of the: (i) primary 
145disease, health condition or therapeutic area being studied and the indication; (ii) route of 
146administration being studied; (iii) clinical trial comparators; and (iv) estimated date of market 
147entry. To the extent possible, information shall be collected using data fields consistent with 
148those used by the federal National Institutes of Health for clinical trials. 
149 For each pipeline drug, early notice shall include whether the drug has been designated 
150by the United States Food and Drug Administration: (i) as an orphan drug; (ii) for fast track; (iii) 
151as a breakthrough therapy; (iv) for accelerated approval; or (v) for priority review for a new 
152molecular entity; provided, however, that notwithstanding clause (v), submissions for drugs in 
153development that are designated as new molecular entities by the United States Food and Drug 
154Administration shall be provided as soon as practical upon receipt of the relevant designations. 
155For each generic drug, early notice shall include a copy of the drug label approved by the United 
156States Food and Drug Administration.
157 (b) A pharmaceutical manufacturing company shall provide early notice to the 
158commission if it plans to increase the wholesale acquisition cost of a: (i) brand-name drug by 
159more than 15 per cent per wholesale acquisition cost unit during any 12-month period; or (ii) 
160generic drug or biosimilar drug with a significant price increase as determined by the 
161commission during any 12-month period. The commission shall provide non-confidential 
162information received under this section to the office of Medicaid, the division of insurance and 
163the group insurance commission.
164 Early notice under this subsection shall be submitted to the commission in writing not 
165less than 60 days before the planned effective date of the increase. 9 of 100
166 A pharmaceutical manufacturing company required to notify the commission of a price 
167increase under this subsection shall, not less than 30 days before the planned effective date of the 
168increase, report to the commission any information regarding the price increase that is relevant to 
169the commission including, but not limited to: (i) drug identification information; (ii) drug sales 
170volume information; (iii) wholesale price and related information for the drug; (iv) net price and 
171related information for the drug; (v) drug acquisition information, if applicable; (vi) revenue 
172from the sale of the drug; and (vii) manufacturer costs.
173 (c) The commission shall conduct an annual study of pharmaceutical manufacturing 
174companies subject to the requirements in subsections (a) and (b). The commission may contract 
175with a third-party entity to implement this section.
176 (d) If a pharmaceutical manufacturing company fails to timely comply with the 
177requirements under subsection (a) or subsection (b), or otherwise knowingly obstructs the 
178commission’s ability to receive early notice under this section, including, but not limited to, 
179providing incomplete, false or misleading information, the commission may impose appropriate 
180sanctions against the manufacturer, including reasonable monetary penalties not to exceed 
181$500,000, in each instance. The commission shall seek to promote compliance with this section 
182and shall only impose a civil penalty on the manufacturer as a last resort. Amounts collected 
183under this section shall be deposited into the Prescription Drug Cost Assistance Trust Fund 
184established in section 2EEEEEE of chapter 29.
185 SECTION 21. Said chapter 6D is hereby further amended by adding the following 3 
186sections:- 10 of 100
187 Section 21. (a) As used in this section, the following words shall have the following 
188meanings unless the context clearly requires otherwise:
189 “Eligible drug”, (i) a brand name drug or biologic, not including a biosimilar, that has a 
190launch wholesale acquisition cost of $50,000 or more for a 1-year supply or full course of 
191treatment; (ii) a biosimilar drug that has a launch wholesale acquisition cost that is not at least 15 
192per cent lower than the referenced brand biologic at the time the biosimilar is launched; (iii) a 
193public health essential drug, as defined in subsection (f) of section 13 of chapter 17, with a 
194significant price increase over a defined period of time as determined by the commission by 
195regulation or with a wholesale acquisition cost of $25,000 or more for a 1-year supply or full 
196course of treatment; (iv) all drugs, continuous glucose monitoring system components, all 
197components of the continuous glucose monitoring system of which the component is a part and, 
198when applicable, delivery devices selected pursuant to section 17T of chapter 32A, section 10R 
199of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of 
200chapter 176B and section 4NN of chapter 176G; or (v) other prescription drug products that may 
201have a direct and significant impact and create affordability challenges for the state’s health care 
202system and patients, as determined by the commission; provided, however, that the commission 
203shall promulgate regulations to establish the type of prescription drug products classified under 
204clause (v) prior to classification of any such prescription drug product under said clause (v).
205 “Manufacturer”, a pharmaceutical manufacturer of an eligible drug, or, when applicable, 
206the manufacturer of a delivery device selected pursuant to section 17T of chapter 32A, section 
20710R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV 
208of chapter 176B and section 4NN of chapter 176G.  11 of 100
209 “Public health essential drug”, shall have the same meaning as defined in subsection (f) 
210of section 13 of chapter 17. 
211 (b) The commission shall review the impact of eligible drug costs on patient access; 
212provided, however, that the commission may prioritize the review of eligible drugs based on 
213potential impact to consumers.
214 In conducting a review of eligible drugs, the commission may request information 
215relating to the pricing of an eligible drug from the manufacturer of said eligible drug. Upon 
216receiving a request for information from the commission, a manufacturer shall disclose to the 
217commission, within a reasonable time period, as determined by the commission, applicable 
218information relating to the manufacturer’s pricing of an eligible drug. 
219 The disclosed information shall be on a standard reporting form developed by the 
220commission with the input of the manufacturers and shall include, but not be limited to:
221 (i) a schedule of the drug’s wholesale acquisition cost increases over the previous 5 
222calendar years;
223 (ii) the total amount of federal and state tax credits, incentives, grants and other subsidies 
224provided to the manufacturer over the previous 10 calendar years that have been used to assist in 
225the research and development of eligible drugs;
226 (iii) the manufacturer’s aggregate, company-level research and development and other 
227relevant capital expenditures, including facility construction, for the most recent year for which 
228final audited data are available; 12 of 100
229 (iv) a narrative description, absent proprietary information and written in plain language, 
230of factors that contributed to reported changes in wholesale acquisition cost during the previous 5 
231calendar years; and
232 (v) any other information that the manufacturer wishes to provide to the commission or 
233that the commission requests.
234 (c) Based on the records provided under subsection (b) and available information from 
235the center for health information and analysis or an outside third party, the commission shall 
236identify a proposed value for the eligible drug. The commission may request additional relevant 
237information that it deems necessary from the manufacturer and from other entities, including, but 
238not limited to, pharmacy benefit managers.
239 Any information, analyses or reports regarding an eligible drug review shall be provided 
240to the manufacturer. The commission shall consider any clarifications or data provided by the 
241manufacturer with respect to the eligible drug. The commission shall not base its determination 
242on the proposed value of the eligible drug solely on the analysis or research of an outside third 
243party and shall not employ a measure or metric that assigns a reduced value to the life extension 
244provided by a treatment based on a pre-existing disability or chronic health condition of the 
245individuals whom the treatment would benefit. If the commission relies upon a third party to 
246provide cost-effectiveness analysis or research related to the proposed value of the eligible drug, 
247such analysis or research shall also include, but not be limited to: (i) a description of the 
248methodologies and models used in its analysis; (ii) any assumptions and potential limitations of 
249research findings in the context of the results; and (iii) outcomes for affected subpopulations that 
250utilize the drug, including, but not limited to, potential impacts on individuals of marginalized  13 of 100
251racial or ethnic groups and on individuals with specific disabilities or health conditions who 
252regularly utilize the eligible drug.
253 (d) If, after review of an eligible drug and after receiving information from the 
254manufacturer under subsection (b) or subsection (e), the commission determines that the 
255manufacturer’s pricing of the eligible drug does not substantially exceed the proposed value of 
256the drug, the commission shall notify the manufacturer, in writing, of its determination and shall 
257evaluate other ways to mitigate the eligible drug’s cost in order to improve patient access to the 
258eligible drug. The commission may engage with the manufacturer and other relevant 
259stakeholders, including, but not limited to, patients, patient advocacy organizations, consumer 
260advocacy organizations, providers, provider organizations and payers, to explore options for 
261mitigating the cost of the eligible drug. Upon the conclusion of a stakeholder engagement 
262process under this subsection, the commission shall issue recommendations on ways to reduce 
263the cost of the eligible drug for the purpose of improving patient access to the eligible drug. 
264Recommendations may include, but shall not be limited to: (i) an alternative payment plan or 
265methodology; (ii) a bulk purchasing program; (iii) co-payment, deductible, co-insurance or other 
266cost-sharing restrictions; and (iv) a reinsurance program to subsidize the cost of the eligible drug. 
267The recommendations shall be publicly posted on the commission’s website and provided to the 
268clerks of the house of representatives and senate, the joint committee on health care financing 
269and the house and senate committees on ways and means; provided, however, that the report 
270shall be published on the website of the commission.
271 (e) If, after review of an eligible drug, the commission determines that the manufacturer’s 
272pricing of the eligible drug substantially exceeds the proposed value of the drug, the commission 
273shall request that the manufacturer provide further information related to the pricing of the  14 of 100
274eligible drug and the manufacturer’s reasons for the pricing not later than 30 days after receiving 
275the request.
276 (f) Not later than 60 days after receiving information from the manufacturer under 
277subsection (b) or subsection (e), the commission shall confidentially issue a determination on 
278whether the manufacturer’s pricing of an eligible drug substantially exceeds the commission’s 
279proposed value of the drug. If the commission determines that the manufacturer’s pricing of an 
280eligible drug substantially exceeds the proposed value of the drug, the commission shall 
281confidentially notify the manufacturer, in writing, of its determination and may require the 
282manufacturer to enter into an access and affordability improvement plan under section 22.
283 (g) Records disclosed by a manufacturer under this section shall: (i) be accompanied by 
284an attestation that all information provided is true and correct; (ii) not be public records under 
285clause Twenty-sixth of section 7 of chapter 4 or under chapter 66; and (iii) remain confidential; 
286provided, however, that the commission may produce reports summarizing any findings; 
287provided further, that any such report shall not be in a form that identifies specific prices charged 
288for or rebate amounts associated with drugs by a manufacturer or in a manner that is likely to 
289compromise the financial, competitive or proprietary nature of the information.
290 Any request for further information made by the commission under subsection (e) or any 
291determination issued or written notification made by the commission under subsection (f) shall 
292not be public records under said clause Twenty-sixth of said section 7 of said chapter 4 or under 
293said chapter 66.
294 (h) The commission’s proposed value of an eligible drug and the commission’s 
295underlying analysis of the eligible drug is not intended to be used to determine whether any  15 of 100
296individual patient meets prior authorization or utilization management criteria for the eligible 
297drug. The proposed value and underlying analysis shall not be the sole factor in determining 
298whether a drug is included in a formulary or whether the drug is subject to step therapy.
299 (i) If the manufacturer fails to timely comply with the commission’s request for records 
300under subsection (b) or subsection (e), or otherwise knowingly obstructs the commission’s 
301ability to issue its determination under subsection (f), including, but not limited to, by providing 
302incomplete, false or misleading information, the commission may impose appropriate sanctions 
303against the manufacturer, including reasonable monetary penalties not to exceed $500,000, in 
304each instance. The commission shall seek to promote compliance with this section and shall only 
305impose a civil penalty on the manufacturer as a last resort. Penalties collected under this 
306subsection shall be deposited into the Prescription Drug Cost Assistance Trust Fund established 
307in section 2EEEEEE of chapter 29.
308 (j) The commission shall adopt any written policies, procedures or regulations that the 
309commission determines are necessary to effectuate the purpose of this section.
310 Section 22. (a) The commission shall establish procedures to assist manufacturers in 
311filing and implementing an access and affordability improvement plan.
312 Upon providing written notice provided under subsection (f) of section 21, the 
313commission may require that a manufacturer whose pricing of an eligible drug substantially 
314exceeds the commission’s proposed value of the drug file an access and affordability 
315improvement plan with the commission. Not later than 45 days after receipt of a notice under 
316said subsection (f) of said section 21, a manufacturer shall: (i) file an access and affordability  16 of 100
317improvement plan; or (ii) provide written notice declining participation in the access and 
318affordability improvement plan. 
319 (b) An access and affordability improvement plan shall: (i) be generated by the 
320manufacturer; (ii) identify the reasons for the manufacturer’s drug price; and (iii) include, but not 
321be limited to, specific strategies, adjustments and action steps the manufacturer proposes to 
322implement to address the cost of the eligible drug in order to improve the accessibility and 
323affordability of the eligible drug for patients and the state’s health system. The proposed access 
324and affordability improvement plan shall include specific identifiable and measurable expected 
325outcomes and a timetable for implementation. The timetable for an access and affordability 
326improvement plan shall not exceed 18 months.
327 (c) The commission shall approve any access and affordability improvement plan that it 
328determines: (i) is reasonably likely to address the cost of an eligible drug in order to substantially 
329improve the accessibility and affordability of the eligible drug for patients and the state’s health 
330system; and (ii) has a reasonable expectation for successful implementation.
331 (d) If the commission determines that the proposed access and affordability improvement 
332plan is unacceptable or incomplete, the commission may provide consultation on the criteria that 
333have not been met and may allow an additional time period of not more than 30 calendar days for 
334resubmission; provided, however, that all aspects of the access plan shall be proposed by the 
335manufacturer and the commission shall not require specific elements for approval.
336 (e) Upon approval of the proposed access and 	affordability improvement plan, the 
337commission shall notify the manufacturer to begin immediate implementation of the access and 
338affordability improvement plan. Public notice shall be provided by the commission on its  17 of 100
339website, identifying that the manufacturer is implementing an access and affordability 
340improvement plan; provided, however, that upon the successful completion of the access and 
341affordability improvement plan, the identity of the manufacturer shall be removed from the 
342commission's website. All manufacturers implementing an approved access improvement plan 
343shall be subject to additional reporting requirements and compliance monitoring as determined 
344by the commission. The commission shall provide assistance to the manufacturer in the 
345successful implementation of the access and affordability improvement plan.
346 (f) All manufacturers shall work in good faith to implement the access and affordability 
347improvement plan. At any point during the implementation of the access and affordability 
348improvement plan, the manufacturer may file amendments to the access improvement plan, 
349subject to approval of the commission.
350 (g) At the conclusion of the timetable established in the access and affordability 
351improvement plan, the manufacturer shall report to the commission regarding the outcome of the 
352access and affordability improvement plan. If the commission determines that the access and 
353affordability improvement plan was unsuccessful, the commission shall: (i) extend the 
354implementation timetable of the existing access and affordability improvement plan; (ii) approve 
355amendments to the access and affordability improvement plan as proposed by the manufacturer; 
356(iii) require the manufacturer to submit a new access and affordability improvement plan; or (iv) 
357waive or delay the requirement to file any additional access and affordability improvement plans.
358 (h) The commission shall submit a recommendation for proposed legislation to the joint 
359committee on health care financing if the commission determines that further legislative  18 of 100
360authority is needed to assist manufacturers with the implementation of access and affordability 
361improvement plans or to otherwise ensure compliance with this section.
362 (i) An access and affordability improvement plan under this section shall remain 
363confidential in accordance with section 2A.
364 (j) The commission may assess a civil penalty to a manufacturer of not more than 
365$500,000, in each instance, if the commission determines that the manufacturer: (i) declined or 
366willfully neglected to file an access and affordability improvement plan with the commission 
367under subsection (a); (ii) failed to file an acceptable access and affordability improvement plan in 
368good faith with the commission; (iii) failed to implement the access and affordability 
369improvement plan in good faith; or (iv) knowingly failed to provide information required by this 
370section to the commission or knowingly falsified the information. The commission shall seek to 
371promote compliance with this section and shall only impose a civil penalty as a last resort. 
372Penalties collected under this subsection shall be deposited into the Prescription Drug Cost 
373Assistance Trust Fund established in section 2EEEEEE of chapter 29.
374 (k) If a manufacturer declines to enter into an access and affordability improvement plan 
375under this section, the commission may publicly post 	the proposed value of the eligible drug, 
376hold a public hearing on the proposed value of the eligible drug and solicit public comment. The 
377manufacturer shall appear and testify at the public hearing held on the eligible drug’s proposed 
378value. Upon the conclusion of a public hearing under this subsection, the commission shall issue 
379recommendations on ways to reduce the cost of an eligible drug for the purpose of improving 
380patient access to the eligible drug. The recommendations shall be publicly posted on the 
381commission’s website and provided to the clerks of the house of representatives and senate, the  19 of 100
382joint committee on health care financing and the house and senate committees on ways and 
383means.
384 If a manufacturer is deemed to not be acting in good faith to develop an acceptable or 
385complete access and affordability improvement plan, the commission may publicly post the 
386proposed value of the eligible drug, hold a public hearing on the proposed value of the eligible 
387drug and solicit public comment. The manufacturer shall appear and testify at any hearing held 
388on the eligible drug’s proposed value. Upon the conclusion of a public hearing under this 
389subsection, the commission shall issue recommendations on ways to reduce the cost of an 
390eligible drug for the purpose of improving patient access to the eligible drug. The 
391recommendations shall be publicly posted on the commission’s website and provided to the 
392clerks of the house of representatives and senate, the joint committee on health care financing 
393and the house and senate committees on ways and means.
394 Before making a determination that the manufacturer is not acting in good faith, the 
395commission shall send a written notice to the manufacturer that the commission shall deem the 
396manufacturer to not be acting in good faith if the manufacturer does not submit an acceptable 
397access and affordability improvement plan within 30 days of receipt of notice; provided, 
398however, that the commission shall not send a notice under this paragraph within 120 calendar 
399days from the date that the commission notified the manufacturer of its requirement to enter into 
400the access and affordability improvement plan.
401 (l) The commission shall promulgate regulations necessary to implement this section.
402 Section 23. Every 2 years, the commission, in consultation with the center for health 
403information and analysis, the group insurance commission, the office of Medicaid and the  20 of 100
404division of insurance shall evaluate the impact of section 17T of chapter 32A, section 10R of 
405chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of 
406chapter 176B and section 4NN of chapter 176G on the effects of capping co-payments and 
407eliminating deductible and co-insurance requirements for those drugs for individuals with 
408diabetes, asthma and chronic heart conditions on health care access and system cost, including, 
409but not limited to: (i) utilization rates of the drugs selected pursuant to section 10R of chapter 
410118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B 
411and section 4NN of chapter 176G; (ii) an analysis of the use of those drugs, broken down by 
412patient demographics, geographic region and, where applicable, delivery device; (iii) annual plan 
413costs and member premiums; (iv) the average price of those drugs; (v) the average price of those 
414drugs net of rebates or discounts received by or accrued directly or indirectly by health insurance 
415carriers; (vi) average and total out-of-pocket expenditures on delivery devices used for those 
416drugs and glucose monitoring tests that are not included as part of the underlying drug 
417prescription; (vii) an analysis of the impact of capping co-payments and eliminating deductible 
418and co-insurance requirements for those drugs on patient access to and cost of care by patient 
419demographics and geographic region; and (viii) any barriers to accessing those drugs for 
420individuals with the conditions for which those drugs are prescribed and policy recommendations 
421for resolving such barriers. This section shall also apply to selected continuous glucose 
422monitoring system components, all components of the continuous glucose monitoring system of 
423which the component is a part and delivery devices, when applicable.
424 Biennially, not later than November 30, the commission shall file a report of its findings 
425with the clerks of the house of representatives and senate, the chairs of the joint committee on  21 of 100
426public health, the chairs of the joint committee on health care financing and the chairs of house 
427and senate committees on ways and means.
428 SECTION 22. Section 1 of chapter 12C of the General Laws, as appearing in the 2022 
429Official Edition, is hereby amended by inserting after the definition of “Ambulatory surgical 
430center services” the following 3 definitions:-
431 “Average manufacturer price”, the average price paid to a manufacturer for a drug in the 
432commonwealth by a: (i) wholesaler for drugs distributed to pharmacies; and (ii) pharmacy that 
433purchases drugs directly from the manufacturer.
434 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license 
435application approved under 42 U.S.C. 262(k)(3).
436 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
437drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
438application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
439is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
440Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
441application that was approved by the United States Secretary of Health and Human Services 
442under section 505(c) of the federal Food, Drug and Cosmetic Act, 21 U.S.C. 355(c), before the 
443date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 
4441984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
445C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
446under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the carrier as a brand name drug based on 
447available data resources such as Medi-Span. 22 of 100
448 SECTION 23. Said section 1 of said chapter 12C, as so appearing, is hereby further 
449amended by inserting after the definition of “General health supplies, care or rehabilitative 
450services and accommodations” the following definition:-
451 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
452abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
453drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
454that was not originally marketed under a new drug application; or (iv) identified by the carrier as 
455a generic drug based on available data resources such as Medi-Span.
456 SECTION 24. Said section 1 of said chapter 12C, as so appearing, is hereby further 
457amended by inserting after the definition of “Patient-centered medical home” the following 2 
458definitions:-
459 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production, 
460preparation, propagation, compounding, conversion or processing of prescription drugs, directly 
461or indirectly, by extraction from substances of natural origin, independently by means of 
462chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, 
463repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that 
464“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed 
465under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said 
466chapter 112.
467 “Pharmacy benefit manager”, a person, business or other entity, however organized, that, 
468directly or through a subsidiary, provides pharmacy benefit management services for prescription 
469drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- 23 of 100
470insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit 
471management services shall include, but not be limited to: (i) the processing and payment of 
472claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing 
473of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or 
474grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii) 
475drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) 
476clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of 
477covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a 
478health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages 
479its own prescription drug benefits unless specifically exempted by the commission.
480 SECTION 25. Said section 1 of said chapter 12C, as so appearing, is hereby further 
481amended by adding the following definition:-
482 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C. 
4831395w-3a(c)(6)(B).
484 SECTION 26. Section 3 of said chapter 12C, as so appearing, is hereby amended by 
485inserting after the word “organizations”, in lines 13 and 14, the following words:- , 
486pharmaceutical manufacturing companies, pharmacy benefit managers.
487 SECTION 27. Said section 3 of said chapter 12C, as so appearing, is hereby further 
488amended by striking out, in line 24, the words “and payer” and inserting in place thereof the 
489following words:- , payer, pharmaceutical manufacturing company and pharmacy benefit 
490manager. 24 of 100
491 SECTION 28. Section 5 of said chapter 12C, as so appearing, is hereby amended by 
492striking out, in lines 11 and 12, the words “and public health care payers” and inserting in place 
493thereof the following words:- , public health care payers, pharmaceutical manufacturing 
494companies and pharmacy benefit managers.
495 SECTION 29. Said section 5 of said chapter 12C, as so appearing, is hereby further 
496amended by striking out, in line 15, the words “and affected payers” and inserting in place 
497thereof the following words:- affected payers, affected pharmaceutical manufacturing companies 
498and affected pharmacy benefit managers.
499 SECTION 30. The 	first paragraph of section 7 of said chapter 12C, as so appearing, is 
500hereby amended by adding the following sentence:- Each pharmaceutical and biopharmaceutical 
501manufacturing company and pharmacy benefit manager shall pay to the commonwealth an 
502amount for the estimated expenses of the center and for the other purposes described in this 
503chapter.
504 SECTION 31. Said section 7 of said chapter 12C, as so appearing, is hereby further 
505amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each 
506instance, the following figure:- 25.
507 SECTION 32. Said section 7 of said chapter 12C, as so appearing, is hereby further 
508amended by adding the following paragraph:-
509 The assessed amount for pharmaceutical and biopharmaceutical manufacturing 
510companies and pharmacy benefit managers shall be not less than 25 per cent of the amount 
511appropriated by the general court for the expenses of the center minus amounts collected from: 
512(i) filing fees; (ii) fees and charges generated by the commission's publication or dissemination  25 of 100
513of reports and information; and (iii) federal matching revenues received for these expenses or 
514received retroactively for expenses of predecessor agencies. A pharmacy benefit manager that is 
515also a surcharge payor subject to the preceding paragraph and manages its own prescription drug 
516benefits shall not be subject to additional assessment under this paragraph.
517 SECTION 33. Said chapter 12C is hereby further amended by inserting after section 10 
518the following section:-
519 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform 
520reporting of information from pharmaceutical manufacturing companies to enable the center to 
521analyze: (i) year-over-year changes in wholesale acquisition cost and average manufacturer price 
522for prescription drug products; (ii) year-over-year trends in net expenditures; (iii) net 
523expenditures on subsets of biosimilar, brand name and generic drugs identified by the center; (iv) 
524trends in estimated aggregate drug rebates, discounts or other remuneration paid or provided by a 
525pharmaceutical manufacturing company to a pharmacy benefit manager, wholesaler, distributor, 
526health carrier client, health plan sponsor or pharmacy in connection with utilization of the 
527pharmaceutical drug products offered by the pharmaceutical manufacturing company; (v) 
528discounts provided by a pharmaceutical manufacturing company to a consumer in connection 
529with utilization of the pharmaceutical drug products offered by the pharmaceutical 
530manufacturing company, including any discount, rebate, product voucher, coupon or other 
531reduction in a consumer’s out-of-pocket expenses including co-payments and deductibles under 
532section 3 of chapter 175H; (vi) research and development costs as a percentage of revenue; (vii) 
533annual marketing and advertising costs, identifying costs for direct-to-consumer advertising; 
534(viii) annual profits over the most recent 5-year period; (ix) disparities between prices charged to  26 of 100
535purchasers in the commonwealth and purchasers outside of the United States; and (x) any other 
536information deemed necessary by the center.
537 The center shall require the submission of available data and other information from 
538pharmaceutical manufacturing companies including, but not limited to: (i) wholesale acquisition 
539costs and average manufacturer prices for prescription drug products as identified by the center; 
540(ii) true net typical prices charged to pharmacy benefits managers by payor type for prescription 
541drug products identified by the center, net of any rebate or other payments from the manufacturer 
542to the pharmacy benefits manager and from the pharmacy benefits manager to the manufacturer; 
543(iii) aggregate, company-level research and development costs to the extent attributable to a 
544specific product and other relevant capital expenditures for the most recent year for which final 
545audited data is available for prescription drug products as identified by the center; (iv) annual 
546marketing and advertising 	expenditure; (v) the total amount of federal and state tax credits, 
547incentives, grants and other subsidies provided to the manufacturer over the previous 10 calendar 
548years that have been used to assist in the research and development of eligible drugs; and (vi) a 
549description, absent proprietary information and written in plain language, of factors that 
550contributed to reported changes in wholesale acquisition costs, net prices and average 
551manufacturer prices for prescription drug products as identified by the center. 
552 (b) The center shall promulgate regulations necessary to ensure the uniform reporting of 
553information from pharmacy benefit managers to enable the center to analyze: (i) trends in 
554estimated aggregate drug rebates and other drug price reductions, if any, provided by a pharmacy 
555benefit manager to a health carrier client or health plan sponsor or passed through from a 
556pharmacy benefit manager 	to a health carrier client or health plan sponsor in connection with 
557utilization of drugs in the commonwealth offered through the pharmacy benefit manager and a  27 of 100
558measure of lives covered by each health carrier client or health plan sponsor in the 
559commonwealth; (ii) pharmacy benefit manager practices with regard to drug rebates and other 
560drug price reductions, if any, provided by a pharmacy benefit manager to a health carrier client 
561or health plan sponsor or to consumers in the commonwealth or passed through from a pharmacy 
562benefit manager to a health carrier client or health plan sponsor or to consumers in the 
563commonwealth; and (iii) any other information deemed necessary by the center.
564 The center shall require the submission of available data and other information from 
565pharmacy benefit managers including, but not limited to: (i) true net typical prices paid by 
566pharmacy benefits managers for prescription drug products identified by the center, net of any 
567rebate or other payments from the manufacturer to the pharmacy benefit manager and from the 
568pharmacy benefit manager 	to the manufacturer; (ii) the amount of all rebates that the pharmacy 
569benefit manager received from all pharmaceutical manufacturing companies: (A) for all health 
570carrier clients in the aggregate; (B) for each health carrier client or health plan sponsor 
571individually; and (C) by drug, for 30 of the most utilized drugs in the commonwealth as 
572determined by the center; (iii) the administrative fees that the pharmacy benefit manager 
573received from all health carrier clients or health plan sponsors in the aggregate and for each 
574health carrier client or health plans sponsors individually; (iv) the aggregate amount of rebates a 
575pharmacy benefit manager: (A) retains based on its contractual arrangement with each health 
576plan client or health plan sponsor individually; and (B) passes through to each health care client 
577individually; (v) the aggregate amount of all retained rebates that the pharmacy benefit manager 
578received from all pharmaceutical manufacturing companies and did not pass through to each 
579pharmacy benefit manager’s health carrier client or health plan sponsor individually; (vi) the 
580percentage of contracts that a pharmacy benefit manager holds where the pharmacy benefit  28 of 100
581manager: (A) retains all rebates; (B) passes all rebates through to the client; and (C) shares 
582rebates with the client; and (vii) other information as determined by the center, including, but not 
583limited to, pharmacy benefit manager practices related to spread pricing, administrative fees, 
584claw backs and formulary placement.
585 (c) Except as specifically provided otherwise by the center or under this chapter, data 
586collected by the center pursuant to this section from pharmaceutical manufacturing companies 
587and pharmacy benefit managers shall not be a public record under clause Twenty-sixth of section 
5887 of chapter 4 or under chapter 66.
589 SECTION 34. Said chapter 12C is hereby further amended by striking out section 11, as 
590appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
591 Section 11. The center shall ensure the timely reporting of information required under 
592sections 8, 9, 10 and 10A. The center shall notify private health care payers, providers, provider 
593organizations, pharmacy benefit managers, pharmaceutical manufacturing companies and their 
594parent organization and other affiliates of any applicable reporting deadlines. The center shall 
595notify, in writing, a private health care payer, provider, provider organization, pharmacy benefit 
596manager or pharmaceutical manufacturing company and their parent organization and other 
597affiliates, that has failed to meet a reporting deadline of such failure and that failure to respond 
598within 2 weeks of the receipt of the notice shall result in penalties. The center shall assess a 
599penalty against a private health care payer, provider, provider organization, pharmacy benefit 
600manager or pharmaceutical manufacturing company and their parent organization and other 
601affiliates, that fails, without just cause, to provide the requested information, including subsets of 
602the requested information, within 2 weeks following receipt of the written notice required under  29 of 100
603this section, of not more than $2,000 per week for each week of delay after the 2-week period 
604following receipt of the notice. Amounts collected under this section shall be deposited in the 
605Healthcare Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011. 
606The center may promulgate regulations to define “just cause” for the purpose of this section.
607 SECTION 35. Section 12 of said chapter 12C, as so appearing, is hereby amended by 
608striking out, in line 2, the words “and 10” and inserting in place thereof the following words:- , 
60910 and 10A.
610 SECTION 36. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby 
611amended by striking out the first sentence and inserting in place thereof the following sentence:- 
612The center shall publish an annual report based on the information submitted under: (i) sections 
6138, 9, 10 and 10A concerning health care provider, provider organization, private and public 
614health care payer, pharmaceutical manufacturing company and pharmacy benefit manager costs 
615and cost and price trends; (ii) section 13 of chapter 6D relative to market power reviews; and (iii) 
616section 15 of said chapter 6D relative to quality data.
617 SECTION 37. Said section 16 of said chapter 12C, as so appearing, is hereby further 
618amended by striking out, in line 18, the words:- “in the aggregate”.
619 SECTION 38. Said section 16 of said chapter 12C, as so appearing, is hereby further 
620amended by inserting after the second paragraph the following paragraph:-
621 As part of its annual report, the center shall report on prescription drug utilization and 
622spending for pharmaceutical drugs provided in an outpatient setting or sold in a retail setting for 
623private and public health care payers, including, but not limited to, information sufficient to 
624show the: (i) highest utilization drugs; (ii) drugs with the greatest increases in utilization; (iii)  30 of 100
625drugs that are most impactful on plan spending, net of rebates; and (iv) drugs with the highest 
626year-over-year price increases, net of rebates. The report shall not contain any data that is likely 
627to compromise the financial, competitive or proprietary nature of the information contained in 
628the report. The report shall be published on the website of the center.
629 SECTION 39. Section 13 of chapter 17 of the General Laws, as so appearing, is hereby 
630amended by adding the following subsection:-
631 (f) As used in this subsection, the following words shall have the following meanings 
632unless the context clearly requires otherwise:
633 “Public health essential drug”, a prescription drug, biologic or biosimilar approved by the 
634United States Food and Drug Administration that: (i) appears on the Model List of Essential 
635Medicines most recently adopted by the World Health Organization; (ii) is selected pursuant to 
636section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of chapter 175, section 
6378VV of chapter 176A, section 4VV of chapter 176B and section 4NN of chapter 176G; or (iii) is 
638deemed an essential medicine by the commission due to its efficacy in treating a life-threatening 
639health condition or a chronic health condition that substantially impairs an individual’s ability to 
640engage in activities of daily living or because limited access to a certain population would pose a 
641public health challenge. “Public health essential drug” shall also include all continuous glucose 
642monitoring system components, all components of the continuous glucose monitoring system of 
643which the component is a part and delivery devices selected pursuant to section 17T of chapter 
64432A, section 10R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, 
645section 4VV of chapter 176B and section 4NN of chapter 176G.  31 of 100
646 The commission shall identify and publish a list of public health essential drugs. The list 
647shall be updated not less than annually and be made publicly available on the department’s 
648website; provided, however, that the commission may provide an interim listing of a public 
649health essential drug prior to an annual update. The commission shall notify and forward a copy 
650of the list to the health policy commission established under chapter 6D.
651 SECTION 40. Chapter 29 of the General Laws is hereby amending by inserting after 
652section 2DDDDDD the following section:- 
653 2EEEEEE. (a) There shall be a Prescription Drug Cost Assistance Trust Fund. The 
654secretary of health and human services shall administer the fund and shall make expenditures 
655from the fund, without further appropriation, to provide financial assistance to residents of the 
656commonwealth for the cost of prescription drugs through the prescription drug costs assistance 
657program established under section 245 of chapter 111. For the purpose of this section, 
658“prescription drug” shall include the prescription drug and any drug delivery device needed to 
659administer the drug that is not included as part of the underlying drug prescription.
660 The fund shall consist of: (i) revenue from appropriations or other money authorized by 
661the general court and specifically designated to be credited to the fund; and (ii) funds from public 
662or private sources, including, but not limited to, gifts, 	grants, donations, rebates and settlements 
663received by the commonwealth that are specifically designated to be credited to the fund. Money 
664remaining in the fund at the close of a fiscal year shall not revert to the General Fund and shall 
665be available for expenditure in the following fiscal year. 
666 (b) Annually, not later than March 1, the secretary shall report on the fund’s activities 
667detailing expenditures from the previous calendar year. The report shall include: (i) the number  32 of 100
668of individuals who received financial assistance from the fund; (ii) the breakdown of fund 
669recipients by race, gender, age range, geographic region and income level; (iii) a list of all 
670prescription drugs that were covered by money from the fund; and (iv) the total cost savings 
671received by all fund recipients and the cost savings broken down by race, gender, age range and 
672income level. The report shall be submitted to the clerks of the senate and house of 
673representatives, senate and house committees on ways and means and the joint committee on 
674health care financing; provided, however, that annually, not later than March 1, the report shall 
675be published on the website of the executive office of health and human services.
676 (c) The secretary shall promulgate regulations or issue other guidance for the expenditure 
677of the funds under this section.
678 SECTION 41. Chapter 32A of the General Laws is hereby amended by inserting after 
679section 17S the following section:- 
680 Section 17T. (a) As used in this section, the following words shall have the following 
681meanings unless the context clearly requires otherwise:
682 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
683drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
684application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
685is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
686Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
687application that was approved by the United States Secretary of Health and Human Services 
688under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
689date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of  33 of 100
6901984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
691C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
692under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug 
693based on available data resources such as Medi-Span.
694 “Continuous glucose monitoring system”, a system to continuously sense, transmit and 
695display blood glucose levels.
696 “Continuous glucose monitoring system component”, a component of a system to 
697continuously monitor blood glucose levels such as a sensor, transmitter or display.
698 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic 
699drug; and (ii) an individual can obtain with a prescription.
700 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not 
701limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home 
702use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, 
703lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose 
704monitors for use by the legally blind and visual magnifying aids for use by the legally blind; 
705provided, however, that “diabetes treatment supplies” shall not include a brand name drug, a 
706generic drug, a continuous glucose monitoring system component, or a delivery device.
707 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
708abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
709drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
710and was not originally marketed under a new drug application; or (iv) identified by the health 
711benefit plan as a generic drug based on available data resources such as Medi-Span. 34 of 100
712 “Separate delivery device”, a device that is used to deliver a brand name drug or a 
713generic drug and that can be obtained with a prescription separate from, or in addition to, the 
714brand name drug or generic drug that the device delivers.
715 (b) The commission shall select 1 generic drug and 1 brand name drug used to treat each 
716of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart 
717conditions that disproportionately impact a particular demographic group, including people of 
718color, as determined by the center for health information analysis; provided, however, that for 
719diabetes, the commission shall also select a continuous glucose monitoring system component. 
720 The commission shall select insulin as the drug used to treat diabetes. In selecting 1 
721insulin brand name drug and 1 insulin generic drug per dosage and type, including rapid-acting, 
722short-acting, intermediate-acting, long-acting, ultra long-acting and premixed, subject to such 
723generic drug’s availability. 
724 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when 
725applicable, used to treat each chronic condition pursuant to subsection (b), the commission shall 
726select a drug that is among the top 3 of the commission’s most prescribed or of the highest 
727volume for the chronic condition and shall consider whether the drug is:
728 (i) of clear benefit and strongly supported by clinical evidence;
729 (ii) likely to reduce hospitalizations or emergency department visits, reduce future 
730exacerbations of illness progression or improve quality of life;
731 (iii) relatively low cost when compared to the cost of an acute illness or incident 
732prevented or delayed by the use of the service, treatment or drug; 35 of 100
733 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 
734 (v) likely to have a considerable financial impact on individual patients by reducing or 
735eliminating patient cost-sharing pursuant to this section; and 
736 (vi) likely to enhance equity in disproportionately impacted demographic groups, 
737including people of color.
738 (d) The continuous glucose monitoring system component shall be selected in the same 
739manner in which the 1 generic drug and 1 brand name drug are selected. 
740 (e)(1) The commission shall provide coverage for the brand name drugs and generic 
741drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be 
742subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to 
743any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or 
744co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, 
745that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand 
746name drugs from being reduced below the amount specified in this section.
747 (2) If use of a brand name drug or generic drug that the commission selects requires a 
748separate delivery device, the commission shall select a delivery device for that drug in 
749accordance with the criteria established in subsection (c) for selecting brand name drugs and 
750generic drugs, to the extent possible. The commission shall provide coverage for the delivery 
751device and the delivery device shall not be subject to any cost-sharing, including co-payments 
752and co-insurance, and shall not be subject to any deductible. 36 of 100
753 (3) The commission shall provide coverage for the continuous glucose monitoring system 
754component selected pursuant to subsection (b) and all components of the blood glucose 
755monitoring system of which the selected component is a part. All components of the applicable 
756continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
757payments and co-insurance, and shall not be subject to any deductible.
758 (4) The commission shall provide coverage for necessary diabetes treatment supplies. 
759Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, 
760and shall not be subject to any deductible.
761 (f) A member and their prescribing health care provider shall have access to a clear, 
762readily accessible and convenient process to request to use a different brand name drug or 
763generic drug of the same pharmacological class in place of a brand name drug or generic drug 
764selected under subsection (b). Such request for an exception shall be granted if: (i) the brand 
765name drugs and generic drugs selected under subsection (b) are contraindicated or will likely 
766cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs 
767and generic drugs selected under subsection (b) are expected to be ineffective based on the 
768known clinical characteristics of the member and the known characteristics of the prescription 
769drug regimen; (iii) the member or prescribing health care provider: (A) has provided 
770documentation to the commission establishing that the member has previously tried the brand 
771name drugs and generic drugs selected under subsection (b) ; and (B) such prescription drug was 
772discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or 
773(iv) the member or prescribing health care provider has provided documentation to the 
774commission establishing that the member: (A) is stable on a prescription drug prescribed by the 
775health care provider; and (B) switching drugs will likely cause an adverse reaction in or physical  37 of 100
776or mental harm to the member. This subsection shall apply to continuous glucose monitoring 
777system components and, when applicable, delivery devices.
778 (g) The commission shall implement a continuity of coverage policy for members that are 
779new to the commission, which shall provide coverage for a 90-day fill of a United States Food 
780and Drug Administration-approved drug reimbursed through a pharmacy benefit that the member 
781has already been prescribed and on which the member is stable, upon documentation by the 
782member’s prescriber, and which was selected by the member’s previous payer pursuant to 
783subsection (b); provided, however, that the commission shall not apply any greater deductible, 
784co-insurance, co-payments or out-of-pocket limits than would otherwise apply to other drugs 
785selected pursuant to subsection (b) by the plan; and provided further, that the commission shall 
786provide a member or their prescribing health care provider with information regarding the 
787request pursuant to subsection (f) within 30 days of a member or their health care provider 
788contacting the commission to use a different brand name drug or generic drug of the same 
789pharmacological class as the drugs selected pursuant to subsection (b). This subsection shall 
790apply to continuous glucose monitoring system components and, when applicable, delivery 
791devices.
792 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of 
793coverage pursuant to subsection (g), the commission shall provide coverage for the prescription 
794drug, continuous glucose monitoring system component or delivery device prescribed by the 
795member’s health care provider at the same cost as required under subsection (e). A denial of an 
796exception shall be eligible for appeal by a member. 38 of 100
797 (i) The commission shall grant or deny a request pursuant to subsection (f) or (g) not 
798more than 3 business days following the receipt of all necessary information to establish the 
799medical necessity of the prescribed treatment; provided, however, that if additional delay would 
800result in significant risk to the member’s health or well-being, the commission shall respond not 
801more than 24 hours following the receipt of all necessary information to establish the medical 
802necessity of the prescribed treatment. If a response by the commission is not received within the 
803time required under this subsection, an exception shall be deemed granted.
804 (j) The commission shall make changes in selected drugs not more than annually and 
805shall provide notice to the division of insurance not less than 90 days before making changes to 
806the selected drugs and an explanation of such changes. Upon verification by the division of 
807insurance that the selected drugs meet the criteria identified in subsection (c), the commission 
808shall provide notice to its members not less than 30 days before any changes to the selected 
809drugs are made. This subsection shall apply to continuous glucose monitoring system 
810components and, when applicable, delivery devices, in the same manner in which it applies to 
811drugs.
812 (k) The commission shall make public the drugs, continuous glucose monitoring system 
813components, all components of the system of which the component is a part and delivery devices 
814selected pursuant to this section. 
815 (l) If a high deductible health plan subject to this section is used to establish a savings 
816account that is tax-exempt under the federal Internal Revenue Code, the provisions of this 
817section shall apply to the plan to the maximum extent possible without causing the account to 
818lose its tax-exempt status. 39 of 100
819 SECTION 42. Chapter 111 of the General Laws is hereby amended by adding the 
820following section:-
821 Section 245. (a) The department shall establish and administer a prescription drug cost 
822assistance program, which shall be funded by the Prescription Drug Cost Assistance Trust Fund 
823established in section 2EEEEEE of chapter 29. The program shall provide financial assistance 
824for prescription drugs used to treat: (i) chronic respiratory conditions, including, but not limited 
825to, chronic obstructive pulmonary disease and asthma; (ii) chronic heart conditions, including, 
826but not limited to, those heart conditions that disproportionately impact a particular demographic 
827group, including people of color; (iii) diabetes; and (iv) any other chronic condition identified by 
828the department that disproportionately impacts a particular demographic group, including people 
829of color; provided, however, that “prescription drug” shall include the prescription drug and any 
830drug delivery device needed to administer the drug that is not included as part of the underlying 
831drug prescription. Financial assistance shall cover the cost of any copayment, coinsurance and 
832deductible for the prescription drug for an individual who is eligible for the program.
833 (b) An individual shall be eligible for the program if the individual: (i) is a resident of the 
834commonwealth; (ii) has a current prescription from a health care provider for a drug that is used 
835to treat a chronic condition listed in subsection (a); (iii) has a family income of not more than 
836500 per cent of the federal poverty level; and (iv) is not enrolled in MassHealth.
837 (c) The department shall create an application process, which shall be available 
838electronically and in hard copy form, to determine whether an individual meets the program 
839eligibility requirements under subsection (b). The department shall determine an applicant’s 
840eligibility and notify the applicant of the department’s determination within 10 business days of  40 of 100
841receiving the application. If necessary for its determination, the department may request 
842additional information from the applicant; provided, however, that the department shall notify 
843the applicant within 5 business days of receipt of the original application as to what specific 
844additional information is being requested. If additional information is requested, the department 
845shall, within 3 business days of receipt of the additional information, determine the applicant’s 
846eligibility and notify said applicant of the department’s determination. 
847 If the department determines that an applicant is not eligible for the program, the 
848department shall notify the applicant and shall include in said notification the specific reasons 
849why the applicant is not eligible. The applicant may appeal this determination to the department 
850within 30 days of receiving such notification. 
851 If the department determines that an applicant is eligible for the program, the department 
852shall provide the applicant with a prescription drug cost assistance program identification card, 
853which shall indicate the applicant’s eligibility; provided, however, that the program identification 
854card shall include, but not be limited to, the applicant’s full name and the full name of the 
855prescription drug that the applicant is eligible to receive under the program without having to pay 
856a co-payment, co-insurance or deductible. An applicant’s program identification card shall be 
857valid for 12 months and shall be renewable upon a redetermination of program eligibility.
858 (d) An individual with a valid program identification card may present such card at any 
859pharmacy in the commonwealth and, upon presentation of such card, the pharmacy shall fill the 
860individual’s prescription and provide the prescribed drug to the individual without requiring the 
861individual to pay a co-payment, co-insurance or deductible; provided, however, that the 
862pharmacy shall be reimbursed by the Prescription Drug Cost Assistance Trust Fund established  41 of 100
863in section 2EEEEEE of chapter 29 in a manner determined by the department, in an amount 
864equal to what the pharmacy would have received had the individual been required to pay a co-
865payment, co-insurance or deductible.
866 (e) The department, in collaboration with the division of insurance, board of registration 
867in pharmacy and stakeholders representing consumers, pharmacists, providers, hospitals and 
868carriers, shall develop and implement a plan to educate consumers, pharmacists, providers, 
869hospitals and carriers regarding eligibility for and enrollment in the program under this section. 
870The plan shall include, but not be limited to, appropriate staff training, notices provided to 
871consumers at the pharmacy and a designated website with information for consumers, 
872pharmacists and other health care professionals. 
873 (f) The department shall compile a report detailing information about the program from 
874the previous calendar year. The report shall include: (i) the number of applications received, 
875approved, denied and appealed; (ii) the total number of applicants approved, and the number of 
876applicants approved broken down by race, gender, age range and income level; (iii) a list of all 
877prescription drugs that qualify for the program under subsection (b) and a list of prescription 
878drugs for which applicants actually received financial assistance; and (iv) the total cost savings 
879received by all approved applicants and the cost savings broken down by race, gender, age range 
880and income level. The report shall be submitted annually, not later than March 1, to the clerks of 
881the senate and house of representatives, the house and senate committees on ways and means and 
882the joint committee on health care financing; provided, however, that annually, not later than 
883March 1, the report shall be published on the website of the department. 42 of 100
884 (g) The department shall promulgate regulations or issue guidance for the implementation 
885and enforcement of this section.
886 SECTION 43. Chapter 112 of the General Laws is hereby amended by inserting after 
887section 39J the following section:-
888 Section 39K. (a) For the purposes of this section, “specialty pharmacy” may include any 
889pharmacy engaged in the dispensing of specialty drugs as defined by the board.
890 The board shall establish a specialty pharmacy licensure category for pharmacies that 
891ship, mail, sell or dispense specialty drugs into, within or from the commonwealth. The board 
892shall ensure that all shipments of specialty pharmaceutical drugs from in-state pharmacies to out-
893of-state destinations comply with the licensing procedures applicable to pharmacies in the 
894commonwealth. 
895 (b) A specialty pharmacy shall designate a manager of record who shall disclose to the 
896board the location, name and title of all principal managers and the name and Massachusetts 
897license number of the designated manager of record annually and within 30 days after any 
898change of office, corporate office or manager of record. 
899 (c) The board shall: (i) adopt written policies or procedures or promulgate regulations 
900that the board determines are necessary to implement this section; and (ii) establish standards for 
901special handling, administration, quality, safety, and monitoring of specialty drugs; provided, 
902however, that the board shall define the term “specialty drug” for the purposes of this section; 
903and provided further, that the board shall consult with industry leaders and experts and shall base 
904said policies, procedures or regulations on best evidence-based practices. 43 of 100
905 SECTION 44. Chapter 118E of the General Laws is hereby amended by inserting after 
906section 10Q the following section:- 
907 Section 10R. (a) As used in this section, the following words shall have the following 
908meanings unless the context clearly requires otherwise:
909 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
910drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
911application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
912is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
913Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
914application that was approved by the United States Secretary of Health and Human Services 
915under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
916date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 
9171984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
918C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
919under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug 
920based on available data resources such as Medi-Span.
921 “Continuous glucose monitoring system”, a system to continuously sense, transmit and 
922display blood glucose levels.
923 “Continuous glucose monitoring system component”, a component of a system to 
924continuously monitor blood glucose levels such as a sensor, transmitter or display.
925 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic 
926drug; and (ii) an individual can obtain with a prescription. 44 of 100
927 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not 
928limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home 
929use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, 
930lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose 
931monitors for use by the legally blind and visual magnifying aids for use by the legally blind; 
932provided, however, that diabetes treatment supplies shall not include a brand name drug, a 
933generic drug, a continuous glucose monitoring system component or a delivery device.
934 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
935abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
936drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
937and was not originally marketed under a new drug application; or (iv) identified by the health 
938benefit plan as a generic drug based on available data resources such as Medi-Span.
939 “Separate delivery device”, a device that is used to deliver a brand name drug or a 
940generic drug and that can be obtained with a prescription separate from, or in addition to, the 
941brand name drug or generic drug that the device delivers.
942 (b) The division shall select 1 generic drug and 1 brand name drug used to treat each of 
943the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart 
944conditions that disproportionately impact a particular demographic group, including people of 
945color, determined by the center for health information analysis;  provided, however, that for 
946diabetes, the division shall also select a continuous glucose monitoring system component.
947 The division shall select insulin as the drug used to treat diabetes. In selecting 1 insulin 
948brand name drug and 1 insulin generic drug, the division shall select 1 insulin brand name drug  45 of 100
949per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
950long-acting and premixed. 	To the extent possible, the division shall select 1 insulin generic drug 
951per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
952long-acting and premixed, 	subject to the generic drug’s availability. 
953 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when 
954applicable, used to treat each chronic condition pursuant to subsection (b), the division shall 
955select a drug that is among the top 3 of the division’s most prescribed or of the highest volume 
956for the chronic condition and shall consider whether the drug is:
957 (i) of clear benefit and strongly supported by clinical evidence;
958 (ii) likely to reduce hospitalizations or emergency department visits, reduce future 
959exacerbations of illness progression or improve quality of life;
960 (iii) relatively low cost when compared to the cost of an acute illness or incident 
961prevented or delayed by the use of the service, treatment or drug;
962 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
963 (v) likely to have a considerable financial impact on individual patients by reducing or 
964eliminating patient cost-sharing pursuant to this section; and 
965 (vi) likely to enhance equity in disproportionately impacted demographic groups, 
966including people of color.
967 (d) The continuous glucose monitoring system component shall be selected in the same 
968manner in which the 1 generic drug and 1 brand name drug are selected. 46 of 100
969 (e)(1) The division shall provide coverage for the brand name drugs and generic drugs 
970selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject 
971to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any 
972deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
973insurance and any co-payment per 30-day supply shall not exceed the amount established in the 
974fourth paragraph of subsection (5) of section 25, regardless of whether the beneficiary is enrolled 
975in managed care; provided, however, that nothing in this section shall prevent co-payments for a 
97630-day supply of the selected brand name drugs from being reduced below the amount specified 
977in this section.
978 (2) If use of a brand name drug or generic drug that the division selects requires a 
979separate delivery device, the division shall select a delivery device for that drug in accordance 
980with the criteria established in subsection (c) for selecting brand name drugs and generic drugs, 
981to the extent possible. The division shall provide coverage for the delivery device and the 
982delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance, 
983and shall not be subject to any deductible.
984 (3) The division shall provide coverage for the continuous glucose monitoring system 
985component selected pursuant to subsection (b) and all components of the blood glucose 
986monitoring system of which the selected component is a part. All components of the applicable 
987continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
988payments and co-insurance, and shall not be subject to any deductible. 47 of 100
989 (4) The division shall provide coverage for necessary diabetes treatment supplies. Such 
990supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
991shall not be subject to any deductible.
992 (f) An enrollee and their prescribing health care provider shall have access to a clear, 
993readily accessible and convenient process to request to use a different brand name drug or 
994generic drug of the same pharmacological class in place of a brand name drug or generic drug 
995selected under subsection (b). Such request for an exception shall be granted if: (i) the brand 
996name drugs and generic drugs selected under subsection (b) are contraindicated or will likely 
997cause an adverse reaction in or physical or mental harm to the enrollee; (ii) the brand name drugs 
998and generic drugs selected under subsection (b) are expected to be ineffective based on the 
999known clinical characteristics of the enrollee and the known characteristics of the prescription 
1000drug regimen; (iii) the member or prescribing health care provider: (A) has provided 
1001documentation to the division establishing that the enrollee has previously tried the brand name 
1002drugs and generic drugs selected under subsection (b) while covered by the division or by a 
1003previous health insurance carrier or a health benefit plan; and (B) such prescription drug was 
1004discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or 
1005(iv) the enrollee or prescribing health care provider has provided documentation to the division 
1006establishing that the enrollee: (A) is stable on a prescription drug prescribed by the health care 
1007provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental 
1008harm to the enrollee. This subsection shall apply to continuous glucose monitoring system 
1009components and, when applicable, delivery devices.
1010 (g) This section shall not apply to health plans providing coverage in the Senior Care 
1011Options program to MassHealth-only members who are ages 65 and older.  48 of 100
1012 (h) The division shall implement a continuity of coverage policy for enrollees that are 
1013new to the Medicaid program, which shall provide coverage for a 90-day fill of a United States 
1014Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the 
1015member has already been prescribed and on which the member is stable, upon documentation by 
1016the member’s prescriber, and which was selected by the member’s previous payer pursuant to 
1017subsection (b); provided, however, that the division shall not apply any greater deductible, 
1018coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs 
1019covered by the plan; and provided further, that the division shall provide a member or their 
1020prescribing health care provider with information regarding the request pursuant to subsection (f) 
1021within 30 days of a member or their health care provider contacting the division to use a different 
1022brand name drug or generic drug of the same pharmacological class as the drugs selected 
1023pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system 
1024components and, when applicable, delivery devices.
1025 (i) Upon granting a request pursuant to subsection (f) or implementing a continuity of 
1026coverage pursuant to subsection (h), the division shall provide coverage for the prescription drug, 
1027continuous glucose monitoring system component or delivery device prescribed by the member’s 
1028health care provider at the same cost as required under subsection (e). A denial of an exception 
1029shall be eligible for appeal by a member.
1030 (j) The division shall grant or deny a request pursuant to subsection (f) or (h) not more 
1031than 3 business days following the receipt of all necessary information to establish the medical 
1032necessity of the prescribed treatment; provided, however, that if additional delay would result in 
1033significant risk to the member’s health or well-being, the division shall respond not more than 24 
1034hours following the receipt of all necessary information to establish the medical necessity of the  49 of 100
1035prescribed treatment. If a response by the division is not received within the time required under 
1036this subsection, an exception shall be deemed granted.
1037 (k) The division shall make changes in selected drugs not more than once annually and 
1038shall provide notice to the division of insurance not less than 90 days before making changes to 
1039the selected drugs and an explanation of such changes. Upon verification by the division of 
1040insurance that the selected drugs meet the criteria identified in subsection (c), the division shall 
1041provide notice to its enrollees not less than 30 days before any changes to the selected drugs are 
1042made. This subsection shall apply to continuous glucose monitoring system components and, 
1043when applicable, delivery devices in the same manner in which it applies to drugs.
1044 (l) The division shall make public the drugs, continuous glucose monitoring system 
1045components, all components of the system of which the component is a part and delivery devices 
1046selected pursuant to this section. 
1047 (m) If a high deductible health plan subject to this section is used to establish a savings 
1048account that is tax-exempt under the federal Internal Revenue Code, the provisions of this 
1049section shall apply to the plan to the maximum extent possible without causing the account to 
1050lose its tax-exempt status.
1051 SECTION 45. Chapter 175 of the General Laws is hereby amended by inserting after 
1052section 47TT the following section:- 
1053 Section 47UU. (a) As used in this section, the following words shall have the following 
1054meanings unless the context clearly requires otherwise: 50 of 100
1055 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
1056drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
1057application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
1058is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
1059Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
1060application that was approved by the United States Secretary of Health and Human Services 
1061under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
1062date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 
10631984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
1064C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
1065under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug 
1066based on available data resources such as Medi-Span.
1067 “Continuous glucose monitoring system”, a system to continuously sense, transmit and 
1068display blood glucose levels.
1069 “Continuous glucose monitoring system component”, a component of a system to 
1070continuously monitor blood glucose levels such as a sensor, transmitter or display.
1071 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic 
1072drug; and (ii) an individual can obtain with a prescription.
1073 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not 
1074limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home 
1075use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, 
1076lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose  51 of 100
1077monitors for use by the legally blind and visual magnifying aids for use by the legally blind; 
1078provided, however, that diabetes treatment supplies shall not include a brand name drug, a 
1079generic drug, a continuous glucose monitoring system component or a delivery device.
1080 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
1081abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
1082drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
1083and was not originally marketed under a new drug application; or (iv) identified by the health 
1084benefit plan as a generic drug based on available data resources such as Medi-Span.
1085 “Separate delivery device”, a device that is used to deliver a brand name drug or a 
1086generic drug and that can be obtained with a prescription separate from, or in addition to, the 
1087brand name drug or generic drug that the device delivers.
1088 (b) Any carrier offering a policy, contract or certificate of health insurance under this 
1089chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following 
1090chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that 
1091disproportionately impact a particular demographic group, including people of color, determined 
1092by the center for health information analysis; provided, however, that for diabetes, the carrier 
1093shall also select a continuous glucose monitoring system component.
1094 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin 
1095brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per 
1096dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1097long-acting and premixed. 	To the extent possible, the carrier shall select 1 insulin generic drug  52 of 100
1098per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1099long-acting and premixed, 	subject to such generic drug’s availability. 
1100 (c) In selecting the1 generic drug, the 1 brand name drug and the delivery device, when 
1101applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select 
1102a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the 
1103chronic condition, and shall consider whether the drug is:
1104 (i) of clear benefit and strongly supported by clinical evidence;
1105 (ii) likely to reduce hospitalizations or emergency department visits, reduce future 
1106exacerbations of illness progression or improve quality of life;
1107 (iii) relatively low cost when compared to the cost of an acute illness or incident 
1108prevented or delayed by the use of the service, treatment or drug;
1109 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 
1110 (v) likely to have a considerable financial impact on individual patients by reducing or 
1111eliminating patient cost-sharing pursuant to this section; and 
1112 (vi) likely to enhance equity in disproportionately impacted demographic groups, 
1113including people of color. 
1114 (d) The continuous glucose monitoring system component shall be selected in the same 
1115manner in which the 1 generic drug and 1 brand name drug are selected.
1116 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs 
1117selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject  53 of 100
1118to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any 
1119deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1120insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that 
1121nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name 
1122drugs from being reduced below the amount specified in this section.
1123 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate 
1124delivery device, the carrier shall select a delivery device for that drug in accordance with the 
1125criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the 
1126extent possible. The carrier shall provide coverage for the delivery device and the delivery 
1127device shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1128shall not be subject to any deductible.
1129 (3) The carrier shall provide coverage for the continuous glucose monitoring system 
1130component selected pursuant to subsection (b) and all components of the blood glucose 
1131monitoring system of which the selected component is a part. All components of the applicable 
1132continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1133payments and co-insurance, and shall not be subject to any deductible.
1134 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such 
1135supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1136shall not be subject to any deductible.
1137 (f) A member and their prescribing health care provider shall have access to a clear, 
1138readily accessible and convenient process to request to use a different brand name drug or 
1139generic drug of the same pharmacological class in place of a brand name drug or generic drug  54 of 100
1140selected under subsection (b). Such request for an exception shall be granted if: (i) the brand 
1141name drugs and generic drugs selected under subsection (b) are contraindicated or will likely 
1142cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs 
1143and generic drugs selected under subsection (b) are expected to be ineffective based on the 
1144known clinical characteristics of the member and the known characteristics of the prescription 
1145drug regimen; (iii) the member or prescribing health care provider: (A) has provided 
1146documentation to the carrier establishing that the member has previously tried the brand name 
1147drugs and generic drugs selected under subsection (b) ; and (B) such prescription drug was 
1148discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or 
1149(iv) the member or prescribing health care provider has provided documentation to the carrier 
1150establishing that the member: (A) is stable on a prescription drug prescribed by the health care 
1151provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental 
1152harm to the member. This subsection shall apply to continuous glucose monitoring system 
1153components and, when applicable, delivery devices.
1154 (g) The carrier shall implement a continuity of coverage policy for members that are new 
1155to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug 
1156Administration-approved drug reimbursed through a pharmacy benefit that the member has 
1157already been prescribed and on which the member is stable, upon documentation by the 
1158member’s prescriber, and which was selected by the member’s previous payer pursuant to 
1159subsection (b); provided, however, that a carrier shall not apply any greater deductible, 
1160coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs 
1161covered by the plan; and provided further, that the carrier shall provide a member or their 
1162prescribing health care provider with information regarding the request pursuant to subsection (f)  55 of 100
1163within 30 days of a member or their health care provider contacting the carrier to use a different 
1164brand name drug or generic drug of the same pharmacological class as the drugs selected 
1165pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system 
1166components and, when applicable, delivery devices.
1167 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of 
1168coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug, 
1169continuous glucose monitoring system component or delivery device prescribed by the member’s 
1170health care provider at the same cost as required under subsection (e). A denial of an exception 
1171shall be eligible for appeal by a member.
1172 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than 
11733 business days following the receipt of all necessary information to establish the medical 
1174necessity of the prescribed treatment; provided, however, that if additional delay would result in 
1175significant risk to the member’s health or well-being, the carrier shall respond not more than 24 
1176hours following the receipt of all necessary information to establish the medical necessity of the 
1177prescribed treatment. If a response by the carrier is not received within the time required under 
1178this subsection, an exception shall be deemed granted.
1179 (j) The carrier shall make changes in selected 	drugs not more than once annually and 
1180shall provide notice to the division of insurance not less than 90 days before making changes to 
1181the selected drugs and an explanation of such changes. Upon verification by the division of 
1182insurance that the selected drugs meet the criteria identified in subsection (c), the carrier shall 
1183provide notice to its members not less than 30 days before any changes to the selected drugs are  56 of 100
1184made. This subsection shall apply to continuous glucose monitoring system components and, 
1185when applicable, delivery devices in the same manner in which it applies to drugs.
1186 (k) The carrier shall make public the drugs, continuous glucose monitoring system 
1187components, all components of the system of which the component is a part and delivery devices 
1188selected pursuant to this section.
1189 (l) If a high deductible health plan subject to this section is used to establish a savings 
1190account that is tax-exempt under the federal Internal Revenue Code, the provisions of this 
1191section shall apply to the plan to the maximum extent possible without causing the account to 
1192lose its tax-exempt status.
1193 SECTION 45A. Said chapter 175 of the General Laws is hereby further amended by 
1194inserting after section 47UU, inserted by section 45, the following section:-
1195 Section 47VV. (a) As used in this section, the following words shall have the following 
1196meanings unless the context clearly requires otherwise:
1197 “340B drug”, a drug that has been subject to any offer for reduced prices by a 
1198manufacturer pursuant to 42 U.S.C. 256b and is purchased by a 340B grantee as defined in this 
1199section.
1200 “340B grantee”, a federally qualified health center, a non-state, government public safety 
1201net hospital system established pursuant to chapter 147 of the acts of 1996 or a non-profit acute 
1202care hospital in the commonwealth that received not less than 60 per cent of its gross patient 
1203service revenue in fiscal year 2021 from government payers, including Medicare, MassHealth 
1204and the Health Safety Net Trust Fund based on the hospital’s fiscal year 2021 cost report and that  57 of 100
1205is also authorized to participate in the federal drug discount program under 42 U.S.C 256b, 
1206including its pharmacies or any contracted pharmacy.
1207 “Distributor”, a person engaged in the sale, distribution or delivery, at wholesale, of 
1208drugs or medicines within the commonwealth, including entities operating outside of the 
1209commonwealth that cause deliveries of drugs or medicines to be made within the 
1210commonwealth.
1211 “Federally qualified health center”, an entity receiving a grant under 42 U.S.C. 254(b).
1212 “Manufacturer”, an entity engaged in the production, preparation, propagation, 
1213compounding, conversion or processing of prescription drugs or medical devices, either directly 
1214or indirectly, by extraction from substances of natural origin, or independently by means of 
1215chemical synthesis or by a combination of extraction and chemical synthesis, or any entity 
1216engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs.
1217 “Pharmacy”, an entity engaged in the drug business, as defined in section 37 of chapter 
1218112, or engaged in the practice of compounding to fulfill a practitioner prescription.
1219 (b) A manufacturer or distributor shall not:
1220 (i) deny, restrict, prohibit, or otherwise interfere with, either directly or indirectly, the 
1221acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract 
1222with a 340B grantee and is authorized under such contract to receive and dispense 340B drugs on 
1223behalf of the covered entity unless such receipt is prohibited by the United States Department of 
1224Health and Human Services; or
1225 (ii) interfere with a contract between a pharmacy and a 340B grantee. 58 of 100
1226 (c) The commission of any act prohibited under subsection (b) of this section shall 
1227constitute an unfair or deceptive practice within the meaning of section 2 of chapter 93A. Each 
1228commission of a prohibited act shall constitute a separate violation.
1229 (d) The attorney general shall have jurisdiction, consistent with the provisions of chapter 
123093A, to enforce the provisions of this section. The attorney general shall issue regulations to 
1231implement this chapter.
1232 (e) The board of registration in pharmacy shall promulgate regulations to implement and 
1233enforce of this section and may investigate any complaint of a violation of this section by an 
1234individual or entity licensed by the board and may impose discipline, suspension or revocation of 
1235any such license.
1236 (f) Nothing in this section shall be construed or applied to be less restrictive than any 
1237federal law as to any person or entity regulated by this section or to conflict with: (i) any 
1238applicable federal law and related regulations; or (ii) any other general law that is compatible 
1239with applicable federal law.
1240 (g) Limited distribution of a drug required under 21 U.S.C. 355-1 shall not be a violation 
1241of this section.
1242 SECTION 46. Section 226 of said chapter 175, as appearing in the 2022 Official Edition, 
1243is hereby amended by striking out subsection (a) and 	inserting in place thereof the following 
1244subsection:-
1245 (a) For the purposes of this section, the term “pharmacy benefit manager” shall mean a 
1246person, business or other entity, however organized, that directly or through a subsidiary  59 of 100
1247provides pharmacy benefit management services for prescription drugs and devices on behalf of 
1248a health benefit plan sponsor, including, but not limited to, a self-insurance plan, labor union or 
1249other third-party payer; provided, however, that pharmacy benefit management services shall 
1250include, but not be limited to: (i) the processing and payment of claims for prescription drugs; 
1251(ii) the performance of drug utilization review; (iii) the processing of drug prior authorization 
1252requests; (iv) pharmacy contracting; (v) the adjudication of appeals or grievances related to 
1253prescription drug coverage contracts; (vi) formulary administration; (vii) drug benefit design; 
1254(viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) clinical, safety and 
1255adherence programs for pharmacy services; and (xi) managing the cost of covered prescription 
1256drugs; provided further, that “pharmacy benefit manager” shall include a health benefit plan 
1257sponsor that does not contract with a pharmacy benefit manager and manages its own 
1258prescription drug benefits unless specifically exempted.
1259 SECTION 47. Chapter 176A of the General Laws is hereby amended by inserting after 
1260section 8UU the following section:- 
1261 Section 8VV. (a) As used in this section, the following words shall have the following 
1262meanings unless the context clearly requires otherwise:
1263 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
1264drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
1265application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
1266is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
1267Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
1268application that was approved by the United States Secretary of Health and Human Services  60 of 100
1269under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
1270date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 
12711984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
1272C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
1273under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug 
1274based on available data resources such as Medi-Span.
1275 “Continuous glucose monitoring system”, a system to continuously sense, transmit and 
1276display blood glucose levels.
1277 “Continuous glucose monitoring system component”, a component of a system to 
1278continuously monitor blood glucose levels such as a sensor, transmitter or display.
1279 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic 
1280drug; and (ii) an individual can obtain with a prescription.
1281 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not 
1282limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home 
1283use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, 
1284lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose 
1285monitors for use by the legally blind and visual magnifying aids for use by the legally blind; 
1286provided, however, that diabetes treatment supplies shall not include a brand name drug, a 
1287generic drug, a continuous glucose monitoring system component, or a delivery device.
1288 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
1289abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
1290drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962  61 of 100
1291and was not originally marketed under a new drug application; or (iv) identified by the health 
1292benefit plan as a generic drug based on available data resources such as Medi-Span.
1293 “Separate delivery device”, a device that is used to deliver a brand name drug or a 
1294generic drug and that can be obtained with a prescription separate from, or in addition to, the 
1295brand name drug or generic drug that the device delivers.
1296 (b) Any carrier offering a policy, contract or certificate of health insurance under this 
1297chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following 
1298chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that 
1299disproportionately impact a particular demographic group, including people of color, determined 
1300by the center for health information analysis; provided, however, that for diabetes, the carrier 
1301shall also select a continuous glucose monitoring system component. 
1302 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin 
1303brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per 
1304dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1305long-acting and premixed. 	To the extent possible, the carrier shall select 1 insulin generic drug 
1306per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1307long-acting and premixed, 	subject to such generic drug’s availability. 
1308 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when 
1309applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select 
1310a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the 
1311chronic condition and shall consider whether the drug is:
1312 (i) of clear benefit and strongly supported by clinical evidence; 62 of 100
1313 (ii) likely to reduce hospitalizations or emergency department visits, reduce future 
1314exacerbations of illness progression or improve quality of life;
1315 (iii) relatively low cost when compared to the cost of an acute illness or incident 
1316prevented or delayed by the use of the service, treatment or drug;
1317 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 
1318 (v) likely to have a considerable financial impact on individual patients by reducing or 
1319eliminating patient cost-sharing pursuant to this section; and 
1320 (vi) likely to enhance equity in disproportionately impacted demographic groups, 
1321including people of color.
1322 (d) The continuous glucose monitoring system component shall be selected in the same 
1323manner in which the 1 generic drug and 1 brand name drug are selected.
1324 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs 
1325selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject 
1326to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any 
1327deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1328insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that 
1329nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name 
1330drugs from being reduced below the amount specified in this section.
1331 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate 
1332delivery device, the carrier shall select a delivery device for that drug in accordance with the 
1333criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the  63 of 100
1334extent possible. The carrier shall provide coverage for the delivery device and the delivery 
1335device shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1336shall not be subject to any deductible.
1337 (3) The carrier shall provide coverage for the continuous glucose monitoring system 
1338component selected pursuant to subsection (b) and all components of the blood glucose 
1339monitoring system of which the selected component is a part. All components of the applicable 
1340continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1341payments and co-insurance, and shall not be subject to any deductible.
1342 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such 
1343supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1344shall not be subject to any deductible.
1345 (f) A member and their prescribing health care provider shall have access to a clear, 
1346readily accessible and convenient process to request to use a different brand name drug or 
1347generic drug of the same pharmacological class in place of a brand name drug or generic drug 
1348selected under subsection (b). Such request for an exception shall be granted if: (i) the brand 
1349name drugs and generic drugs selected under subsection (b) are contraindicated or will likely 
1350cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs 
1351and generic drugs selected under said subsection (b) are expected to be ineffective based on the 
1352known clinical characteristics of the member and the known characteristics of the prescription 
1353drug regimen; (iii) the member or prescribing health care provider: (A) has provided 
1354documentation to the carrier establishing that the member has previously tried the brand name 
1355drugs and generic drugs selected under subsection (b) ; and (B) such prescription drug was  64 of 100
1356discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or 
1357(iv) the member or prescribing health care provider has provided documentation to the carrier 
1358establishing that the member: (A) is stable on a prescription drug prescribed by the health care 
1359provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental 
1360harm to the member. This subsection shall apply to continuous glucose monitoring system 
1361components and, when applicable, delivery devices. 
1362 (g) The carrier shall implement a continuity of coverage policy for members that are new 
1363to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug 
1364Administration-approved drug reimbursed through a pharmacy benefit that the member has 
1365already been prescribed and on which the member is stable, upon documentation by the 
1366member’s prescriber, and which was selected by the member’s previous payer pursuant to 
1367subsection (b); provided, however, that a carrier shall not apply any greater deductible, 
1368coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs 
1369covered by the plan; and provided further, that the carrier shall provide a member or their 
1370prescribing health care provider with information regarding the request pursuant to subsection (f) 
1371within 30 days of a member or their health care provider contacting the carrier to use a different 
1372brand name drug or generic drug of the same pharmacological class as the drugs selected 
1373pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system 
1374components and, when applicable, delivery devices.
1375 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of 
1376coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug, 
1377continuous glucose monitoring system component or delivery device prescribed by the member’s  65 of 100
1378health care provider at the same cost as required under subsection (e). A denial of an exception 
1379shall be eligible for appeal by a member.
1380 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than 
13813 business days following the receipt of all necessary information to establish the medical 
1382necessity of the prescribed treatment; provided, however, that if additional delay would result in 
1383significant risk to the member’s health or well-being, the carrier shall respond not more than 24 
1384hours following the receipt of all necessary information to establish the medical necessity of the 
1385prescribed treatment. If a response by the carrier is not received within the time required under 
1386this subsection, an exception shall be deemed granted.
1387 (j) The carrier shall make changes in selected 	drugs not more than once annually and 
1388shall provide notice to the division of insurance not less than 90 days before making changes to 
1389the selected drugs and an explanation of such changes. Upon verification by the division of 
1390insurance that the selected drugs meet the criteria identified in suIction (c), the carrier shall 
1391provide notice to its members not less than 30 days before any changes to the selected drugs are 
1392made. This subsection shall apply to continuous glucose monitoring system components and, 
1393when applicable, delivery devices in the same manner in which it applies to drugs.
1394 (k) The carrier shall make public the drugs, continuous glucose monitoring system 
1395components, all components of the system of which the component is a part and delivery devices 
1396selected pursuant to this section. 
1397 (l) If a high deductible health plan subject to this section is used to establish a savings 
1398account that is tax-exempt under the federal Internal Revenue Code, the provisions of this  66 of 100
1399section shall apply to the plan to the maximum extent possible without causing the account to 
1400lose its tax-exempt status.
1401 SECTION 48. Chapter 176B of the General Laws is hereby amended by inserting after 
1402section 4UU the following section:- 
1403 Section 4VV. (a) As used in this section, the following words shall have the following 
1404meanings unless the context clearly requires otherwise:
1405 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
1406drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
1407application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
1408is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
1409Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
1410application that was approved by the United States Secretary of Health and Human Services 
1411under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
1412date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 
14131984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
1414C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
1415under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug 
1416based on available data resources such as Medi-Span.
1417 “Continuous glucose monitoring system”, a system to continuously sense, transmit and 
1418display blood glucose levels.
1419 “Continuous glucose monitoring system component”, a component of a system to 
1420continuously monitor blood glucose levels such as a sensor, transmitter or display. 67 of 100
1421 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic 
1422drug; and (ii) an individual can obtain with a prescription.
1423 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not 
1424limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home 
1425use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, 
1426lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose 
1427monitors for use by the legally blind and visual magnifying aids for use by the legally blind; 
1428provided, however, that diabetes treatment supplies shall not include a brand name drug, a 
1429generic drug, a continuous glucose monitoring system component or a delivery device.
1430 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
1431abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
1432drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
1433and was not originally marketed under a new drug application; or (iv) identified by the health 
1434benefit plan as a generic drug based on available data resources such as Medi-Span. 
1435 “Separate delivery device”, a device that is used to deliver a brand name drug or a 
1436generic drug and that can be obtained with a prescription separate from, or in addition to, the 
1437brand name drug or generic drug that the device delivers.
1438 (b) Any carrier offering a policy, contract or certificate of health insurance under this 
1439chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following 
1440chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that 
1441disproportionately impact a particular demographic group, including people of color, determined  68 of 100
1442by the center for health information analysis; provided, however, that for diabetes, the carrier 
1443shall also select a continuous glucose monitoring system component.
1444 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin 
1445brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per 
1446dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1447long-acting and premixed. 	To the extent possible, the carrier shall select 1 insulin generic drug 
1448per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1449long-acting and premixed, 	subject to such generic drug’s availability. 
1450 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when 
1451applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select 
1452a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the 
1453chronic condition, and shall consider whether the drug is:
1454 (i) of clear benefit and strongly supported by clinical evidence;
1455 (ii) likely to reduce hospitalizations or emergency department visits, reduce future 
1456exacerbations of illness progression or improve quality of life;
1457 (iii) relatively low cost when compared to the cost of an acute illness or incident 
1458prevented or delayed by the use of the service, treatment or drug;
1459 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 
1460 (v) likely to have a considerable financial impact on individual patients by reducing or 
1461eliminating patient cost-sharing pursuant to this section; and  69 of 100
1462 (vi) likely to enhance equity in disproportionately impacted demographic groups, 
1463including people of color.
1464 (d) The continuous glucose monitoring system component shall be selected in the same 
1465manner in which the 1 generic drug and 1 brand name drug are selected.
1466 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs 
1467selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject 
1468to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any 
1469deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1470insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that 
1471nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name 
1472drugs from being reduced below the amount specified in this section.
1473 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate 
1474delivery device, the carrier shall select a delivery device for that drug in accordance with the 
1475criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the 
1476extent possible. The carrier shall provide coverage for the delivery device and the delivery 
1477device shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1478shall not be subject to any deductible.
1479 (3) The carrier shall provide coverage for the continuous glucose monitoring system 
1480component selected pursuant to subsection (b) and all components of the blood glucose 
1481monitoring system of which the selected component is a part. All components of the applicable 
1482continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1483payments and co-insurance, and shall not be subject to any deductible. 70 of 100
1484 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such 
1485supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1486shall not be subject to any deductible.
1487 (f) A member and their prescribing health care provider shall have access to a clear, 
1488readily accessible and convenient process to request to use a different brand name drug or 
1489generic drug of the same pharmacological class in place of a brand name drug or generic drug 
1490selected under subsection (b). Such request for an exception shall be granted if: (i) the brand 
1491name drugs and generic drugs selected under said subsection (b) are contraindicated or will 
1492likely cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name 
1493drugs and generic drugs selected under said subsection (b) are expected to be ineffective based 
1494on the known clinical characteristics of the member and the known characteristics of the 
1495prescription drug regimen; (iii) the member or prescribing health care provider: (A) has provided 
1496documentation to the carrier establishing that the member has previously tried the brand name 
1497drugs and generic drugs selected under said subsection (b) while covered by the carrier or by a 
1498previous health insurance carrier or a health benefit plan; and (B) such prescription drug was 
1499discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or 
1500(iv) the member or prescribing health care provider has provided documentation to the carrier 
1501establishing that the member: (A) is stable on a prescription drug prescribed by the health care 
1502provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental 
1503harm to the member. This subsection shall apply to continuous glucose monitoring system 
1504components and, when applicable, delivery devices.
1505 (g) The carrier shall implement a continuity of coverage policy for members that are new 
1506to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug  71 of 100
1507Administration-approved drug reimbursed through a pharmacy benefit that the member has 
1508already been prescribed and on which the member is stable, upon documentation by the 
1509member’s prescriber, and which was selected by the member’s previous payer pursuant to 
1510subsection (b); provided, however, that a carrier shall not apply any greater deductible, 
1511coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs 
1512covered by the plan; and provided further, that the carrier shall provide a member or their 
1513prescribing health care provider with information regarding the request pursuant to subsection (f) 
1514within 30 days of a member or their health care provider contacting the carrier to use a different 
1515brand name drug or generic drug of the same pharmacological class as the drugs selected 
1516pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system 
1517components and, when applicable, delivery devices.
1518 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of 
1519coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug, 
1520continuous glucose monitoring system component or delivery device prescribed by the member’s 
1521health care provider at the same cost as required under subsection (e). A denial of an exception 
1522shall be eligible for appeal by a member.
1523 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than 
15243 business days following the receipt of all necessary information to establish the medical 
1525necessity of the prescribed treatment; provided, however, that if additional delay would result in 
1526significant risk to the member’s health or well-being, the carrier shall respond not more than 24 
1527hours following the receipt of all necessary information to establish the medical necessity of the 
1528prescribed treatment. If a response by the carrier is not received within the time required under 
1529this subsection, an exception shall be deemed granted. 72 of 100
1530 (j) The carrier shall make changes in selected 	drugs not more than once annually and 
1531shall provide notice to the division of insurance not less than 90 days before making such 
1532changes to the selected drugs and an explanation of those changes. Upon verification by the 
1533division of insurance that the selected drugs meet the criteria identified in subsection (c), the 
1534carrier shall provide notice to its members not less than 30 days before any changes to the 
1535selected drugs are made. This subsection shall apply to continuous glucose monitoring system 
1536components and, when applicable, delivery devices in the same manner in which it applies to 
1537drugs.
1538 (k) The carrier shall make public the drugs, continuous glucose monitoring system 
1539components, all components of the system of which the component is a part and delivery devices 
1540selected pursuant to this section.
1541 (l) If a high deductible health plan subject to this section is used to establish a savings 
1542account that is tax-exempt under the federal Internal Revenue Code, the provisions of this 
1543section shall apply to the plan to the maximum extent possible without causing the account to 
1544lose its tax-exempt status.
1545 SECTION 49. The 	fourth paragraph of section 3B of chapter 176D of the General Laws, 
1546as appearing in the 2022 Official Edition, is hereby amended by inserting after the second 
1547sentence the following sentence:- Neither a carrier nor the group insurance commission may 
1548prohibit the dispensing of a specialty drug that is included in its pharmaceutical drug benefits to 
1549an insured by any network specialty pharmacy licensed under section 39K of chapter 112; 
1550provided, however, that the pharmacy: (i) agrees to the in-network reimbursement rate for the 
1551specialty drug; (ii) is able to comply with the standards for special handling, administration,  73 of 100
1552quality, safety and monitoring established under subsection (c) of said section 39K of said 
1553chapter 112; and (iii) complies with all reasonable carrier network terms and conditions for 
1554dispensing the specialty drug; provided further, that neither a carrier nor the group insurance 
1555commission may impose any terms or conditions on a specialty pharmacy licensed under said 
1556section 39K of said chapter 112 that are unreasonable or prevent the specialty pharmacy from 
1557providing the specialty drug; provided further, that the commissioner may grant a waiver 
1558exempting a carrier from the requirements of this sentence to a carrier whose percentage of 
1559members enrolled in government programs is 80 per cent or more, as indicated in the most recent 
1560enrollment data published by the center for health information and analysis; and provided 
1561further, that for the purposes of this sentence, the term “carrier” shall apply to the division of 
1562medical assistance to the extent allowed under federal law.
1563 SECTION 50. Said section 3B of said chapter 176D, as so appearing, is hereby further 
1564amended by striking out the fifth paragraph and inserting in place thereof the following 
1565paragraph:-  
1566 A carrier shall not prohibit a network pharmacy from offering and providing mail 
1567delivery services to an insured; provided, however, that the network pharmacy agrees to the 
1568reimbursement terms and conditions and discloses to the insured any delivery service fee 
1569associated with the delivery service.
1570 SECTION 51. The 	eighth paragraph of said section 3B of said chapter 176D, as so 
1571appearing, is hereby amended by adding the following sentence:- The term “specialty drugs” 
1572shall mean a specialty drug as defined under section 39K of chapter 112.  74 of 100
1573 SECTION 52. Chapter 176G of the General Laws is hereby amended by inserting after 
1574section 4MM the following section:- 
1575 Section 4NN. (a) As used in this section, the following words shall have the following 
1576meanings unless the context clearly requires otherwise:
1577 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new 
1578drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 
1579application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that 
1580is pharmaceutically equivalent, as that term is defined by the United States Food and Drug 
1581Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 
1582application that was approved by the United States Secretary of Health and Human Services 
1583under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 
1584date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 
15851984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 
1586C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 
1587under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug 
1588based on available data resources such as Medi-Span.
1589 “Continuous glucose monitoring system”, a system to continuously sense, transmit and 
1590display blood glucose levels.
1591 “Continuous glucose monitoring system component”, a component of a system to 
1592continuously monitor blood glucose levels such as a sensor, transmitter or display.
1593 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic 
1594drug; and (ii) an individual can obtain with a prescription. 75 of 100
1595 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not 
1596limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home 
1597use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips, 
1598lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose 
1599monitors for use by the legally blind and visual magnifying aids for use by the legally blind; 
1600provided, however, that diabetes treatment supplies shall not include a brand name drug, a 
1601generic drug, a continuous glucose monitoring system component, or a delivery device.”
1602 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an 
1603abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic 
1604drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 
1605and was not originally marketed under a new drug application; or (iv) identified by the health 
1606benefit plan as a generic drug based on available data resources such as Medi-Span.
1607 “Separate delivery device”, a device that is used to deliver a brand name drug or a 
1608generic drug and that can be obtained with a prescription separate from, or in addition to, the 
1609brand name drug or generic drug that the device delivers.
1610 (b) Any carrier offering a policy, contract or certificate of health insurance under this 
1611chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following 
1612chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that 
1613disproportionately impact a particular demographic group, including people of color, determined 
1614by the center for health information analysis; provided, however, that for diabetes, the carrier 
1615shall also select a continuous glucose monitoring system component. 76 of 100
1616 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin 
1617brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per 
1618dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1619long-acting and premixed. 	To the extent possible, the carrier shall select 1 insulin generic drug 
1620per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra 
1621long-acting and premixed, 	subject to such generic drug’s availability. 
1622 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when 
1623applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select 
1624a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the 
1625chronic condition, and shall consider whether the drug is:
1626 (i) of clear benefit and strongly supported by clinical evidence;
1627 (ii) likely to reduce hospitalizations or emergency department visits, reduce future 
1628exacerbations of illness progression or improve quality of life;
1629 (iii) relatively low cost when compared to the cost of an acute illness or incident 
1630prevented or delayed by the use of the service, treatment or drug;
1631 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 
1632 (v) likely to have a considerable financial impact on individual patients by reducing or 
1633eliminating patient cost-sharing pursuant to this section; and 
1634 (vi) likely to enhance equity in disproportionately impacted demographic groups, 
1635including people of color. 77 of 100
1636 (d) The continuous glucose monitoring system component shall be selected in the same 
1637manner in which the 1 generic drug and 1 brand name drug are selected.
1638 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs 
1639selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject 
1640to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any 
1641deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1642insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that 
1643nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name 
1644drugs from being reduced below the amount specified in this section.
1645 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate 
1646delivery device, the carrier shall select a delivery device for that drug in accordance with the 
1647criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the 
1648extent possible. The carrier shall provide coverage for the delivery device and the delivery 
1649device shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1650shall not be subject to any deductible.
1651 (3) The carrier shall provide coverage for the continuous glucose monitoring system 
1652component selected pursuant to subsection (b) and all components of the blood glucose 
1653monitoring system of which the selected component is a part. All components of the applicable 
1654continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1655payments and co-insurance, and shall not be subject to any deductible. 78 of 100
1656 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such 
1657supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and 
1658shall not be subject to any deductible.
1659 (f) A member and their prescribing health care provider shall have access to a clear, 
1660readily accessible and convenient process to request to use a different brand name drug or 
1661generic drug of the same pharmacological class in place of a brand name drug or generic drug 
1662selected under subsection (b). Such request for an exception shall be granted if: (i) the brand 
1663name drugs and generic drugs selected under said subsection (b) are contraindicated or will 
1664likely cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name 
1665drugs and generic drugs selected under said subsection (b) are expected to be ineffective based 
1666on the known clinical characteristics of the member and the known characteristics of the 
1667prescription drug regimen; (iii) the member or prescribing health care provider: (A) has provided 
1668documentation to the carrier establishing that the member has previously tried the brand name 
1669drugs and generic drugs selected under said subsection (b); and (B) such prescription drug was 
1670discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or 
1671(iv) the member or prescribing health care provider has provided documentation to the carrier 
1672establishing that the member: (A) is stable on a prescription drug prescribed by the health care 
1673provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental 
1674harm to the member. This subsection shall apply to continuous glucose monitoring system 
1675components and, when applicable, delivery devices.
1676 (g) The carrier shall implement a continuity of coverage policy for members that are new 
1677to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug 
1678Administration-approved drug reimbursed through a pharmacy benefit that the member has  79 of 100
1679already been prescribed and on which the member is stable, upon documentation by the 
1680member’s prescriber, and which was selected by the member’s previous payer pursuant to 
1681subsection (b); provided, however, that a carrier shall not apply any greater deductible, 
1682coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs 
1683covered by the plan; and provided further, that the carrier shall provide a member or their 
1684prescribing health care provider with information regarding the request pursuant to subsection (f) 
1685within 30 days of a member or their health care provider contacting the carrier to use a different 
1686brand name drug or generic drug of the same pharmacological class as the drugs selected 
1687pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system 
1688components and, when applicable, delivery devices.
1689 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of 
1690coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug, 
1691continuous glucose monitoring system component or delivery device prescribed by the member’s 
1692health care provider at the same cost as required under subsection (e). A denial of an exception 
1693shall be eligible for appeal by a member.
1694 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than 
16953 business days following the receipt of all necessary information to establish the medical 
1696necessity of the prescribed treatment; provided, however, that if additional delay would result in 
1697significant risk to the member’s health or well-being, the carrier shall respond not more than 24 
1698hours following the receipt of all necessary information to establish the medical necessity of the 
1699prescribed treatment. If a response by the carrier is not received within the time required under 
1700this subsection, an exception shall be deemed granted. 80 of 100
1701 (j) The carrier shall make changes in selected 	drugs not more than once annually and 
1702shall provide notice to the division of insurance not less than 90 days before making such 
1703changes to the selected drugs and an explanation of those changes. Upon verification by the 
1704division of insurance that the selected drugs meet the criteria identified in subsection (c), the 
1705carrier shall provide notice to its members not less than 30 days before any changes to the 
1706selected drugs are made. This subsection shall apply to continuous glucose monitoring system 
1707components and, when applicable, delivery devices in the same manner in which it applies to 
1708drugs.
1709 (k) The carrier shall make public the drugs, continuous glucose monitoring system 
1710components, all components of the system of which the component is a part and delivery device 
1711selected pursuant to this section. 
1712 (l) If a high deductible health plan subject to this section is used to establish a savings 
1713account that is tax-exempt under the federal Internal Revenue Code, the provisions of this 
1714section shall apply to the plan to the maximum extent possible without causing the account to 
1715lose its tax-exempt status.
1716 SECTION 53. Section 2 of chapter 176O of the General Laws, as appearing in the 2022 
1717Official Edition, is hereby amended by adding the following subsection:-
1718 (i) Every 3 years, a carrier that contracts with a pharmacy benefit manager shall 
1719coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with 
1720this chapter and to examine the pricing and rebates applicable to prescription drugs that are 
1721provided to the carrier’s covered persons. 81 of 100
1722 SECTION 54. Said chapter 176O is hereby further amended by inserting after section 22 
1723the following section:-
1724 Section 22A. Notwithstanding any other general or special law to the contrary, each 
1725carrier shall require that a pharmacy benefit manager receive a license from the division under 
1726chapter 176Y as a condition of contracting with that carrier.
1727 SECTION 55. Said chapter 176O is hereby further amended by adding the following 
1728section:-
1729 Section 30. (a) For the purposes of this section, the following words shall have the 
1730following meanings unless the context clearly requires otherwise:
1731 “Cost-sharing”, an amount owed by an individual under the terms of the individual’s 
1732health benefit plan.
1733 “Pharmacy retail price”, the amount an individual would pay for a prescription drug at a 
1734pharmacy if the individual purchased that prescription drug at that pharmacy without using a 
1735health benefit plan or any other prescription drug benefit or discount.
1736 (b) At the point of sale, a pharmacy shall charge an individual the lesser of: (i) 
1737appropriate cost-sharing amount; or (ii) pharmacy retail price; provided, however, that a carrier, 
1738or an entity that manages or administers benefits for a carrier, shall not require an individual to 
1739make a payment for a prescription drug at the point of sale in an amount that exceeds the lesser 
1740of the: (A) individual’s cost share; or (B) pharmacy retail price.
1741 (c) A contract shall not: (i) prohibit a pharmacist from complying with this section; or (ii) 
1742impose a penalty on the pharmacist or pharmacy for complying with this section. 82 of 100
1743 SECTION 56. The 	General Laws are hereby amended by inserting after chapter 176X the 
1744following chapter:-
1745 Chapter 176Y. LICENSING AND REGULATION OF PHARMACY BENEFIT 
1746MANAGERS.
1747 Section 1. As used in this chapter, the following words shall have the following meanings 
1748unless the context clearly requires otherwise:
1749 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health 
1750insurance under chapter 175, a nonprofit hospital service corporation organized under chapter 
1751176A, a non-profit medical service corporation organized under chapter 176B, a health 
1752maintenance organization organized under chapter 176G and an organization entering into a 
1753preferred provider arrangement under chapter 176I; provided, however, that “carrier” shall not 
1754include an employer purchasing coverage or acting on behalf of its employees or the employees 
1755of any subsidiary or affiliated corporation of the employer; and provided further, that unless 
1756otherwise provided, “carrier” shall not include any entity to the extent it offers a policy, 
1757certificate or contract that provides coverage solely for dental care services or vision care 
1758services.
1759 “Center”, the center for health information and analysis established in chapter 12C.
1760 “Commissioner”, the commissioner of insurance.
1761 “Division”, the division of insurance.
1762 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued 
1763by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care  83 of 100
1764services; provided, however, that the commissioner may by regulation define other health 
1765coverage as a “health benefit plan” for the purposes of this chapter.
1766 “Pharmacy”, a physical or electronic facility under the direction or supervision of a 
1767registered pharmacist that is authorized to dispense prescription drugs and has entered into a 
1768network contract with a pharmacy benefit manager or a carrier.
1769 “Pharmacy benefit manager”, a person, business or other entity, however organized, that 
1770directly or through a subsidiary provides pharmacy benefit management services for prescription 
1771drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
1772insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit 
1773management services shall include, but not be limited to: (i) the processing and payment of 
1774claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing 
1775of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or 
1776grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii) 
1777drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) 
1778clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of 
1779covered prescription drugs; provided further, that “pharmacy benefit manager” shall not include 
1780a health benefit plan sponsor unless otherwise specified by the division.
1781 Section 2. (a) No person, business or other entity shall establish or operate as a pharmacy 
1782benefit manager without obtaining a license from the division pursuant to this section. A license 
1783may be granted only when the division is satisfied that the entity possesses the necessary 
1784organization, background expertise financial integrity to supply the services sought to be offered. 
1785A pharmacy benefit manager license shall be valid for a period of 3 years and shall be renewable  84 of 100
1786for additional 3-year periods. Initial application and renewal fees for the license shall be 
1787established pursuant to section 3B of chapter 7.
1788 (b) A license granted pursuant to this section and any rights or interests therein shall not 
1789be transferable.
1790 (c) A person, business or other entity licensed as a pharmacy benefit manager shall 
1791submit data and reporting information to the center according to the standards and methods 
1792specified by the center pursuant to section 10A of chapter 12C.
1793 (d) The division may issue or renew a license pursuant to this section, subject to 
1794restrictions in order to protect the interests of consumers. Such restrictions may include: (i) 
1795limiting the type of services that a license holder may provide; (ii) limiting the activities in which 
1796the license holder may be engaged; or (iii) addressing conflicts of interest between pharmacy 
1797benefit managers and health plan sponsors.
1798 (e) The division shall develop an application for licensure of pharmacy benefit managers 
1799that shall include, but not be limited to: (i) the name of the applicant or pharmacy benefit 
1800manager; (ii) the address and contact telephone number for the applicant or pharmacy benefit 
1801manager; (iii) the name and address of the agent of the applicant or pharmacy benefit manager 
1802for service of process in the commonwealth; (iv) the name and address of any person with 
1803management or control over the applicant or pharmacy benefit manager; and (v) any audited 
1804financial statements specific to the applicant or pharmacy benefit manager. An applicant or 
1805pharmacy benefit manager 	shall report to the division any material change to the information 
1806contained in its application, certified by an officer of the pharmacy benefit manager, within 30 
1807days of such a change. 85 of 100
1808 (f) The division may suspend, revoke, refuse to issue or renew or place on probation a 
1809pharmacy benefit manager 	license for cause, which shall include, but not be limited to: (i) the 
1810applicant or pharmacy benefit manager engaging in fraudulent activity that is found by a court of 
1811law to be a violation of state or federal law; (ii) the division receiving consumer complaints that 
1812justify an action under this chapter to protect the health, safety and interests of consumers; (iii) 
1813the applicant or pharmacy benefit manager failing to pay an application or renewal fee for a 
1814license; (iv) the applicant or pharmacy benefit manager failing to comply with reporting 
1815requirements of the center under section 10A of chapter 12C; or (v) the applicant pharmacy 
1816benefit manager’s failing to comply with a requirement of this chapter.
1817 The division shall provide written notice to the applicant or pharmacy benefit manager 
1818and advise in writing of the reason for any suspension, revocation, refusal to issue or renew or 
1819placement on probation of a pharmacy benefit manager license under this chapter. A copy of the 
1820notice shall be forwarded to the center. The applicant or pharmacy benefit manager may make 
1821written demand upon the division within 30 days of receipt of such notification for a hearing 
1822before the division to determine the reasonableness of the division’s action. The hearing shall be 
1823held pursuant to chapter 30A.
1824 The division shall not suspend or cancel a license unless the division has first afforded 
1825the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A.
1826 (g) If a person, business or other entity performs the functions of a pharmacy benefit 
1827manager in violation of this chapter, the person, business or other entity shall be subject to a fine 
1828of $5,000 per day for each day that the person, business or other entity is found to be in violation.  86 of 100
1829Penalties collected under this subsection shall be deposited into the Prescription Drug Cost 
1830Assistance Trust Fund established in section 2EEEEEE of chapter 29.
1831 (h) A pharmacy benefit manager licensed under this section shall notify a health carrier 
1832client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit 
1833manager that directly or indirectly presents any conflict of interest with the pharmacy benefit 
1834manager’s relationship with or obligation to the health carrier client.
1835 (i) The division shall adopt any written policies, procedures or regulations that the 
1836division determines are necessary to implement this section.
1837 Section 3. (a) The commissioner may make an examination of the affairs of a pharmacy 
1838benefit manager when the commissioner deems prudent but not less frequently than once every 3 
1839years. The focus of the examination shall be to ensure that a pharmacy benefit manager is able to 
1840meet its responsibilities under contracts with carriers licensed under chapters 175, 176A, 176B, 
1841or 176G. The examination shall be conducted according to the procedures set forth in paragraph 
1842(6) of section 4 of chapter 175. 
1843 (b) The commissioner, a deputy or an examiner may conduct an on-site examination of 
1844each pharmacy benefit manager in the commonwealth to thoroughly inspect and examine its 
1845affairs.
1846 (c) The charge for each such examination shall be determined annually according to the 
1847procedures set forth in paragraph (6) of section 4 of chapter 175.
1848 (d) Not later than 60 days following completion of the examination, the examiner in 
1849charge shall file with the commissioner a verified written report of examination under oath.  87 of 100
1850Upon receipt of the verified report, the commissioner shall transmit the report to the pharmacy 
1851benefit manager examined with a notice that shall afford the pharmacy benefit manager 
1852examined a reasonable opportunity of not more than 30 days to make a written submission or 
1853rebuttal with respect to any matters contained in the examination report. Within 30 days of the 
1854end of the period allowed for the receipt of written submissions or rebuttals, the commissioner 
1855shall consider and review the reports together with any written submissions or rebuttals and any 
1856relevant portions of the examiner’s work papers and enter an order:
1857 (i) adopting the examination report as filed with modifications or corrections and, if the 
1858examination report reveals that the pharmacy benefit manager is operating in violation of this 
1859section or any regulation or prior order of the commissioner, the commissioner may order the 
1860pharmacy benefit manager 	to take any action the commissioner considers necessary and 
1861appropriate to cure such violation;
1862 (ii) rejecting the examination report with directions to examiners to reopen the 
1863examination for the purposes of obtaining additional data, documentation or information and re-
1864filing pursuant to this section; or
1865 (iii) calling for an investigatory hearing with not less than 20 days’ notice to the 
1866pharmacy benefit manager 	for purposes of obtaining additional documentation, data, information 
1867and testimony.
1868 (e) Notwithstanding any general or special law to the contrary, including clause Twenty-
1869sixth of section 7 of chapter 4 and chapter 66, the records of any such audit, examination or other 
1870inspection and the information contained in the records, reports or books of any pharmacy 
1871benefit manager examined pursuant to this section shall be confidential and open only to the  88 of 100
1872inspection of the commissioner, or the examiners and assistants. Access to such confidential 
1873material may be granted by the commissioner to law enforcement officials of the commonwealth 
1874or any other state or agency of the federal government at any time if the agency or office 
1875receiving the information agrees in writing to keep such material confidential. Nothing in this 
1876subsection shall be construed to prohibit the required production of such records, and 
1877information contained in the reports of such company or organization before any court of the 
1878commonwealth or any master or auditor appointed by any such court, in any criminal or civil 
1879proceeding, affecting such pharmacy benefit manager, its officers, partners, directors or 
1880employees. The final report of any such audit, examination or any other inspection by or on 
1881behalf of the division of insurance shall be a public record.
1882 Section 4. (a) A pharmacy benefit manager shall not make payments to a pharmacy 
1883benefit consultant or broker whose services were obtained by a health plan sponsor to work on 
1884the pharmacy benefit bidding or contracting process if the payment constitutes a conflict of 
1885interest, as determined by the commissioner. For purposes of this section, payments from a 
1886pharmacy benefit manager 	to a pharmacy benefit consultant or broker shall include, but not be 
1887limited to: (i) shared rebates from pharmaceutical manufacturers; (ii) per prescription fees; (iii) 
1888per member fees; (iv) referral fees; (v) bonuses; or (vi) any other financial arrangement the 
1889commissioner considers to be a conflict of interest.
1890 (b) The division shall adopt any written policies or procedures or promulgate regulations 
1891that the division determines are necessary to implement this section.
1892 Section 5. A pharmacy benefit manager shall not, by contract, written policy or written 
1893procedure, require that a pharmacy designated by the pharmacy benefit manager dispense a  89 of 100
1894medication directly to a patient with the expectation or intention that the patient will transport the 
1895medication to a physician’s office, hospital or clinic for administration.
1896 SECTION 57. (a) Notwithstanding any general or special law to the contrary, the 
1897commonwealth health insurance connector authority, in consultation with the division of 
1898insurance, shall report on the impact of pharmaceutical pricing on health care costs and outcomes 
1899for ConnectorCare and non-group and small group plans offered through the connector and its 
1900members. 
1901 The report shall include, but not be limited to: (i) information on the differential between 
1902drug list price and price net of rebates for plans offered and the impact of those differentials on 
1903member premiums; (ii) the relationship between drug list price and member cost-sharing 
1904requirements; (iii) the impact of drug price changes over time on premium and out-of-pocket 
1905costs in plans authorized under section 3 of chapter 176J of the General Laws offered through the 
1906commonwealth health insurance connector authority; (iv) trends in changes in drug list price and 
1907price net of rebates by health plan; (v) an analysis of the impact of member out-of-pocket costs 
1908on drug utilization and member experience; and (vi) an analysis of the impact of drug list price 
1909and price net of rebates on member formulary access to drug. Data collected under this 
1910subsection shall be protected as confidential and shall not be a public record under clause 
1911Twenty-sixth of section 7 of chapter 4 of the General Laws or under chapter 66 of the General 
1912Laws.
1913 The report shall be submitted to the joint committee on health care financing and the 
1914house and senate committees on ways and means not later than July 1, 2025; provided, however,  90 of 100
1915that the report shall be published on the website of the commonwealth health insurance 
1916connector authority not later than July 1, 2025.
1917 (b) In fiscal year 2024, the amount required to be paid pursuant to the last paragraph of 
1918section 6 of chapter 6D of the General Laws shall be increased by $500,000; provided, however, 
1919that said $500,000 shall be provided to the commonwealth health insurance connector authority 
1920not later than March 14, 2024 for data collection and analysis costs associated with the report 
1921required by this section. 
1922 SECTION 58. Notwithstanding any general or special law to the contrary, there shall be a 
1923special commission to examine the feasibility of: (i) establishing a system for the bulk 
1924purchasing and distribution of pharmaceutical products with a significant public health benefit 
1925and the potential for significant health care cost savings for consumers through overall increased 
1926purchase capacity; and (ii) making bulk purchase pricing information available to purchasers in 
1927other states.
1928 The commission shall consist of: the commissioner of public health or a designee, who 
1929shall serve as chair; the executive director of the group insurance commission or a designee; the 
1930chief of pharmacy of the state office for pharmacy services; the MassHealth director of 
1931pharmacy; the secretary of technology services and security; and 9 members to be appointed by 
1932the commissioner of public health, 2 of whom shall be health care economists, 1 of whom shall 
1933be an expert in health law and policy innovation, 1 of whom shall be an academic with relevant 
1934expertise in the field, 1 of whom shall be a representative from a community health center, 1 of 
1935whom shall be the chief executive officer of a hospital licensed in the commonwealth, 1 of 
1936whom shall be a representative of the Massachusetts Association of Health Plans, Inc., 1 of  91 of 100
1937whom shall be a representative of Blue Cross Blue Shield of Massachusetts, Inc. and 1 of whom 
1938shall be a member of the public with experience with health care and consumer protection.
1939 The commission shall hold not less than 3 public hearings in different geographic areas of 
1940the commonwealth, accept input from the public and solicit expert testimony from individuals 
1941representing health insurance carriers, pharmaceutical companies, independent and chain 
1942pharmacies, hospitals, municipalities, health care practitioners, health care technology 
1943professionals, community health centers, substance use disorder providers, public health 
1944educational institutions and other experts identified by the commission.
1945 The commission shall consider: (i) the process by which the commonwealth could make 
1946bulk purchases of pharmaceutical products with a significant public health benefit and the 
1947potential for significant health care cost savings to consumers; (ii) the process by which both 
1948governmental and nongovernmental entities may participate in a collaborative to purchase 
1949pharmaceutical products with a significant public health benefit and the potential for significant 
1950health care cost savings; (iii) the feasibility of developing an electronic information interchange 
1951system to exchange bulk purchase price information with partnering states; (iv) potential sources 
1952of funding available to implement bulk purchases; (v) potential cost savings of bulk purchases to 
1953the commonwealth or other participating nongovernmental entities; (vi) the feasibility of 
1954partnering with the federal government, other states in the New England region or the state of 
1955New York ; and (vii) any other factors that the commission deems relevant.
1956 The commission shall file a report of its analysis, along with any recommended 
1957legislation, if any, to the clerks of the senate and house of representatives, the house and senate 
1958committees on ways and means, the joint committee on health care financing, the joint  92 of 100
1959committee on public health, the joint committee on elder affairs and the joint committee on 
1960mental health, substance use and recovery not later than September 1, 2024; provided, however, 
1961that the report shall be published on the website of the department of public health not later than 
1962September 1, 2024.
1963 SECTION 59. (a) As used in this section, the following words shall have the following 
1964meanings unless the context clearly requires otherwise:
1965 “Chain pharmacist”, a pharmacist employed by a retail drug organization operating not 
1966less than 10 retail drug stores within the commonwealth under section 39 of chapter 112 of the 
1967General Laws. 
1968 “Independent pharmacist”, a pharmacist actively engaged in the business of retail 
1969pharmacy and employed in an organization of not more than 9 registered retail drugstores in the 
1970commonwealth under said section 39 of said chapter 112 that employs not more than a total of 
197120 full-time pharmacists.
1972 (b) There shall be a task force to: (i) review the drug supply chain and reimbursement 
1973structures including, but not limited to: (A) plan and pharmacy benefit manager reimbursements 
1974to pharmacies; (B) wholesaler prices to pharmacies; (C) pharmacy services administrative 
1975organization fees and contractual relationships with pharmacies; and (D) drug manufacturer 
1976prices to wholesalers; (ii) review ways to recognize the unique challenges of small and 
1977independent pharmacies; (iii) identify methods to increase pricing transparency throughout the 
1978supply chain; (iv) make recommendations on the use of multiple maximum allowable costs lists 
1979and their frequency of use for mail order products; (v) review the utilization of maximum 
1980allowable costs lists or similar reimbursement structures established by a pharmacy benefit  93 of 100
1981manager or payer; (vi) review the availability of drugs to independent and chain pharmacies on 
1982the maximum allowable cost list or any similar reimbursement structures established by a 
1983pharmacy benefit manager 	or payer; (vii) review the pharmacy acquisition cost from national or 
1984regional wholesalers that serve pharmacies compared to the reimbursement amount provided 
1985through a maximum allowable cost list or any similar reimbursement structures established by a 
1986pharmacy benefit manager 	or payer and the conditions under which an adjustment to a 
1987reimbursement is appropriate; (viii) review the timing of pharmacy purchases of products and the 
1988relative risk of list price changes related to the timing of dispensing the products; (ix) assess 
1989ways to increase transparency for chain and independent pharmacists to understand the 
1990methodology used by a pharmacy benefit manager or payer to develop a maximum allowable 
1991cost list or any similar reimbursement structure established by the pharmacy benefit manager or 
1992payer; (x) assess the prevalence and appropriateness of pharmacy benefit managers requiring, or 
1993using financial incentives or penalties to incentivize, customer use of pharmacies with whom the 
1994pharmacy benefit manager 	has an ownership or financial interest; (xi) examine the impact of the 
1995merger or consolidation of pharmacy benefit managers and health carrier clients on drug costs; 
1996(xii) review current appeals processes for a chain or independent pharmacist to request an 
1997adjustment on a reimbursement subject to a maximum allowable cost list or any similar 
1998reimbursement structure established by a pharmacy benefit manager or payer; and (xiii) evaluate 
1999the effect of differences between pharmacy benefit manager payments to pharmacies and charges 
2000made to health carrier clients on drug price.
2001 (c) The task force shall consist of: the commissioner of insurance or a designee, who shall 
2002serve as chair; and 9 members to be appointed by the commissioner, 2 of whom shall be 
2003independent pharmacists employed in the independent pharmacy setting or representatives of  94 of 100
2004independent pharmacies, 2 of whom shall be chain pharmacists employed in the chain pharmacy 
2005setting or representatives of chain pharmacies, 2 of whom shall be representatives of a pharmacy 
2006benefit managers or payers who manage their own pharmacy benefit services, 1 of whom shall 
2007represent the Massachusetts Association of Health Plans, Inc., 1 of whom shall represent Blue 
2008Cross Blue Shield of Massachusetts, Inc. and 1 of whom shall be a representative of wholesalers 
2009or pharmacy services administrative organizations. If more than 1 independent pharmacist is 
2010appointed, each appointee shall represent a distinct practice setting. If more than 1 chain 
2011pharmacist is appointed, each appointee shall represent a distinct practice setting. A pharmacy 
2012benefit manager or payer appointed to the task force shall not be co-owned or have any 
2013ownership relationship with any other payer, pharmacy benefit manager or chain pharmacist also 
2014appointed to the task force. 
2015 (d) The commissioner shall file the task force’s findings with the clerks of the house of 
2016representatives and the senate, the joint committee on health care financing and the house and 
2017senate committees on ways and means not later than December 1, 2024; provided, however, that 
2018the findings shall be published on the website of the division of insurance not later than 
2019December 1, 2024.
2020 SECTION 60. The 	health policy commission shall consult with relevant stakeholders, 
2021including, but not limited to, consumers, consumer advocacy organizations, organizations 
2022representing people with disabilities and chronic health conditions, providers, provider 
2023organizations, payers, pharmaceutical manufacturers, pharmacy benefit managers and health care 
2024economists and other academics, to assist in the development and periodic review of regulations 
2025to implement section 21 of chapter 6D of the General Laws, including, but not limited to: (i) 
2026establishing the criteria and processes for identifying 	the proposed value of an eligible drug as  95 of 100
2027defined in said section 21 of said chapter 6D; and (ii) 	determining the appropriate price increase 
2028for a public health essential drug as described within the definition of eligible drug in said 
2029section 21 of said chapter 6D. 
2030 The commission shall hold its first public outreach not more than 45 days after the 
2031effective date of this act and shall, to the extent possible, ensure fair representation and input 
2032from a diverse array of stakeholders.
2033 SECTION 61. Annually, each carrier shall report to the division of insurance the drugs 
2034selected to be provided with no or limited cost-sharing under section 17T of chapter 32A of the 
2035General Laws, section 10R of chapter 118E of the General Laws, section 47UU of chapter 175 of 
2036the General Laws, section 8VV of chapter 176A of the General Laws, section 4VV of chapter 
2037176B of the General Laws and section 4NN of chapter 176G of the General Laws. The division 
2038of insurance shall consult with the health policy commission and the center for health and 
2039information analysis to review the drugs to verify that the selected drugs meet the criteria 
2040identified in said section 17T of said chapter 32A, said section 10R of said chapter 118E, said 
2041section 47UU of said chapter 175, said section 8VV of said chapter 176A, said section 4VV of 
2042said chapter 176B and said section 4NN of said chapter 176G. If a selected drug shall be deemed 
2043by the division to not meet the criteria, the division may require a different drug to be selected. 
2044The division shall disclose the list of drugs selected by each entity annually on the division’s 
2045website. This section shall also apply to selected continuous glucose monitoring system 
2046components and, when applicable, delivery devices.
2047 SECTION 62. Notwithstanding subsection (b) of section 15A of chapter 6D of the 
2048General Laws, for the purposes of providing early notice under said section 15A of said chapter  96 of 100
20496D, the health policy commission shall determine a significant price increase for a generic drug 
2050to be defined as a generic drug priced at $100 or more per wholesale acquisition cost unit that 
2051increases in cost by 100 per cent or more during any 12-month period.
2052 SECTION 63. Section 62 is hereby repealed.
2053 SECTION 64. The 	health policy commission, in consultation with the department of 
2054public health, the office of Medicaid, the group insurance commission and the division of 
2055insurance, shall study and analyze health insurance payer, including public and private payer, 
2056specialty pharmacy networks in the commonwealth. The study shall include: (i) a description of 
2057the type of specialty drugs most often provided by specialty pharmacies; (ii) the impact of 
2058existing health insurance payers’ specialty pharmacy networks on patient access, availability of 
2059clinical support, continuity of care, safety, quality, cost sharing and health care costs; and (iii) 
2060any recommendations for increasing patient access to and choice of specialty drugs, maintaining 
2061high-quality specialty pharmacy standards and meeting the commonwealth’s health care cost 
2062containment goals.
2063 The commission shall submit a report of its findings and recommendations to the clerks 
2064of the senate and house of representatives, the senate and house committees on ways and means, 
2065the joint committee on health care financing and the joint committee on public health not later 
2066than July 1, 2024.
2067 SECTION 64A. The department of public health, in consultation with the department of 
2068elementary and secondary education, executive office of public safety and security and the center 
2069for health information and analysis established under section 2 of chapter 12C of the General 
2070Laws, shall conduct a study on a state-wide policy on: (i) maintaining a stock supply of non- 97 of 100
2071patient specific epinephrine in elementary and secondary public schools for use by students in 
2072schools, including students with individualized health care plans prescribing epinephrine 
2073injections, in lieu of a policy that relies on parents and guardians to supply epinephrine for use by 
2074students in schools; and (ii) police stations and fire stations maintaining a stock supply of non-
2075patient specific epinephrine for emergency community use. The study shall consider: (i) the 
2076impacts of the policy on the health and safety of schools and the community as a whole; (ii) the 
2077impacts of the policy on costs and savings for students’ families, municipalities, school districts, 
2078MassHealth and other insurance plans; (iii) the number of types of epinephrine injectors that a 
2079school would be required to stock to ensure student health and safety; (iv) training that would be 
2080necessary to implement the policy, including training related to the use of epinephrine dose 
2081calculation devices; (v) funding and cost-reduction mechanisms for the policy, including bulk 
2082purchasing and an assessment on surcharge payors as defined in section 64 of chapter 118E of 
2083the General Laws; (vi) the number of types of epinephrine injectors that a fire station or police 
2084station would be required to stock to ensure community safety; and (vii) any additional 
2085regulations necessary to implement the policy. The department of public health shall submit a 
2086report of its findings and recommendations to the house and senate committees on ways and 
2087means, the joint committee on education, the joint committee on public safety, the joint 
2088committee on financial services and the joint committee on health care financing not later than 
2089June 30, 2025.
2090 SECTION 64B. The department shall compile a report detailing the effectiveness, safety 
2091and long-term public health impacts of weight loss medication for preventative care including, 
2092but not limited to: (i) heart conditions; (ii) stroke; (iii) asthma; and (iv) diabetes. The report shall 
2093be submitted to the clerks of the senate and house of representatives, the house and senate  98 of 100
2094committees on ways and means and the joint committee on health care financing not later than 
2095July 1, 2025.
2096 SECTION 64C.The health policy commission, in consultation with the board of 
2097registration in pharmacy and the division of insurance, shall study and analyze the performance 
2098of pharmacists of primary care functions within their authorized scope of practice. The study 
2099shall include, but not be limited to: (i) reimbursements that carriers currently provide to 
2100pharmacists for the performance of primary care services that are authorized in a pharmacist’s 
2101scope of practice in the commonwealth; (ii) primary care services that are authorized in a 
2102pharmacist’s scope of practice in the commonwealth but are not currently reimbursed or are 
2103inadequately reimbursed by carriers; (iii) primary care services that pharmacists are authorized to 
2104perform; (iv) the extent to which pharmacists currently perform primary care services; (v) 
2105reimbursement rates for comparable services performed by pharmacists in other states; (vi) 
2106impact of pharmacist-provided primary care services 	on access to health care and overall costs of 
2107the commonwealth’s health care system; and (vii) reimbursement levels needed to achieve 
2108sustainability in delivery of primary care services by pharmacists. The commission shall submit a 
2109report of its findings and recommendations to the clerks of the senate and house of 
2110representatives, the senate and house committees on ways and means, the joint committee on 
2111health care financing and the joint committee on public health not later than July 1, 2024. The 
2112report shall be published on the website of the commission.
2113 SECTION 64D. The department of public health, in consultation with the attorney 
2114general, district attorneys, patient advocates, health care practitioners and other relevant 
2115stakeholders, shall analyze the effectiveness and sufficiency of the marketing code of conduct 
2116established pursuant to chapter 111N of the General Laws. The department’s analysis shall  99 of 100
2117include, but not be limited to: (i) an evaluation of the reports, compliance information and data 
2118required under sections 2A, 5 and 6 of said chapter 111N; (ii) a comparison of the marketing 
2119code of conduct with similar rules established in other states; (iii) a review of any enforcement 
2120actions taken for violations of said chapter 111N; (iv) a review of opioid marketing practices and 
2121the direct impact of said practices on increased substance use disorders and related deaths; and 
2122(v) an assessment of the need, and recommendations for implementation, for further 
2123requirements to ensure marketing activities by pharmaceutical and medical device manufacturers 
2124do not influence prescribing patterns in a manner that adversely affects patient care, which shall 
2125include, but not be limited to, requiring the licensing of all pharmaceutical and medical device 
2126representatives, including pharmaceutical or medical 	device manufacturing agents, as defined in 
2127section 1 of said chapter 111N.
2128 The department shall file a report of its findings with the clerks of the senate and house of 
2129representatives, the joint committee on public health, the joint committee on health care 
2130financing, the senate committee on steering and policy and the senate and house committees on 
2131ways and means not later than May 1, 2024.
2132 SECTION 65. The 	regulations required by subsection (c) of section 39K of chapter 112 
2133of the General Laws shall be promulgated not later than December 31, 2023.
2134 SECTION 65A. The regulations required by subsections (e) and (f) of section 47VV of 
2135chapter 175 of the General Laws shall be promulgated not later than 3 months after the effective 
2136date of this act.
2137 SECTION 66. Sections 21 and 39 shall take effect on July 1, 2024.
2138 SECTION 67. Sections 41, 44, 45, 47, 48, 52 	and 61 shall take effect on July 1, 2025.  100 of 100
2139 SECTION 68. Section 43 shall take effect on April 1, 2024.
2140 SECTION 69. Section 54 shall take effect on July 1, 2024. 
2141 SECTION 70. Section 56 shall take effect on March 30, 2024.
2142 SECTION 71. Section 63 shall take effect on January 1, 2025.