SENATE . . . . . . . . . . . . . . No. 2499
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Third General Court
(2023-2024)
_______________
SENATE, November 9, 2023.
The committee on Senate Ways and Means to whom was referred the Senate Bill relative
to pharmaceutical access, costs and transparency (Senate, No. 2492), - reports, recommending
that the same ought to pass with an amendment substituting a new draft with the same title
(Senate, No. 2499).
For the committee,
Michael J. Rodrigues 1 of 85
FILED ON: 11/9/2023
SENATE . . . . . . . . . . . . . . No. 2499
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 85
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 85
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 85
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 85
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 85
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 increases including, but not limited to, the initial prices of drugs coming to market and
118subsequent price increases, changes in industry profit levels, marketing expenses, reverse
119payment patent settlements, the impact of manufacturer rebates, discounts and other price
120concessions on net pricing, the availability of alternative drugs or treatments, corporate
121ownership organizational structure and any other matters as determined by the commission. 7 of 85
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 85
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 85
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 2BBBBBB of chapter 29.
185 SECTION 21. Said chapter 6D is hereby further amended by adding the following 3
186sections:- 10 of 85
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 selected pursuant to section 17T of chapter 32A, section 10R
197of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of
198chapter 176B and section 4NN of chapter 176G; or (v) other prescription drug products that may
199have a direct and significant impact and create affordability challenges for the state’s health care
200system and patients, as determined by the commission; provided, however, that the commission
201shall promulgate regulations to establish the type of prescription drug products classified under
202clause (v) prior to classification of any such prescription drug product under said clause (v).
203 “Manufacturer”, a pharmaceutical manufacturer of an eligible drug, or, when applicable,
204the manufacturer of a delivery device selected pursuant to section 17T of chapter 32A, section
20510R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV
206of chapter 176B and section 4NN of chapter 176G.
207 “Public health essential drug”, shall have the same meaning as defined in subsection (f)
208of section 13 of chapter 17. 11 of 85
209 (b) The commission shall review the impact of eligible drug costs on patient access;
210provided, however, that the commission may prioritize the review of eligible drugs based on
211potential impact to consumers.
212 In conducting a review of eligible drugs, the commission may require a manufacturer to
213disclose to the commission, within a reasonable time period, information relating to said
214manufacturer’s pricing of an eligible drug. The disclosed information shall be on a standard
215reporting form developed by the commission with the input of the manufacturers and shall
216include, but not be limited to:
217 (i) a schedule of the drug’s wholesale acquisition cost increases over the previous 5
218calendar years;
219 (ii) the manufacturer’s aggregate, company-level research and development and other
220relevant capital expenditures, including facility construction, for the most recent year for which
221final audited data are available;
222 (iii) a narrative description, absent proprietary information and written in plain language,
223of factors that contributed to reported changes in wholesale acquisition cost during the previous 5
224calendar years; and
225 (iv) any other information that the manufacturer wishes to provide to the commission or
226that the commission requests.
227 (c) Based on the records provided under subsection (b) and available information from
228the center for health information and analysis or an outside third party, the commission shall
229identify a proposed value for the eligible drug. The commission may request additional relevant 12 of 85
230information that it deems necessary from the manufacturer and from other entities, including, but
231not limited to, pharmacy benefit managers.
232 Any information, analyses or reports regarding an eligible drug review shall be provided
233to the manufacturer. The commission shall consider any clarifications or data provided by the
234manufacturer with respect to the eligible drug. The commission shall not base its determination
235on the proposed value of the eligible drug solely on the analysis or research of an outside third
236party and shall not employ a measure or metric that assigns a reduced value to the life extension
237provided by a treatment based on a pre-existing disability or chronic health condition of the
238individuals whom the treatment would benefit. If the commission relies upon a third party to
239provide cost-effectiveness analysis or research related to the proposed value of the eligible drug,
240such analysis or research shall also include, but not be limited to: (i) a description of the
241methodologies and models used in its analysis; (ii) any assumptions and potential limitations of
242research findings in the context of the results; and (iii) outcomes for affected subpopulations that
243utilize the drug, including, but not limited to, potential impacts on individuals of marginalized
244racial or ethnic groups and on individuals with specific disabilities or health conditions who
245regularly utilize the eligible drug.
246 (d) If, after review of an eligible drug and after receiving information from the
247manufacturer under subsection (b) or subsection (e), the commission determines that the
248manufacturer’s pricing of the eligible drug does not substantially exceed the proposed value of
249the drug, the commission shall notify the manufacturer, in writing, of its determination and shall
250evaluate other ways to mitigate the eligible drug’s cost in order to improve patient access to the
251eligible drug. The commission may engage with the manufacturer and other relevant
252stakeholders, including, but not limited to, patients, patient advocacy organizations, consumer 13 of 85
253advocacy organizations, providers, provider organizations and payers, to explore options for
254mitigating the cost of the eligible drug. Upon the conclusion of a stakeholder engagement
255process under this subsection, the commission shall issue recommendations on ways to reduce
256the cost of the eligible drug for the purpose of improving patient access to the eligible drug.
257Recommendations may include, but shall not be limited to: (i) an alternative payment plan or
258methodology; (ii) a bulk purchasing program; (iii) co-payment, deductible, co-insurance or other
259cost-sharing restrictions; and (iv) a reinsurance program to subsidize the cost of the eligible drug.
260The recommendations shall be publicly posted on the commission’s website and provided to the
261clerks of the house of representatives and senate, the joint committee on health care financing
262and the house and senate committees on ways and means.
263 (e) If, after review of an eligible drug, the commission determines that the manufacturer’s
264pricing of the eligible drug substantially exceeds the proposed value of the drug, the commission
265shall request that the manufacturer provide further information related to the pricing of the
266eligible drug and the manufacturer’s reasons for the pricing not later than 30 days after receiving
267the request.
268 (f) Not later than 60 days after receiving information from the manufacturer under
269subsection (b) or subsection (e), the commission shall confidentially issue a determination on
270whether the manufacturer’s pricing of an eligible drug substantially exceeds the commission’s
271proposed value of the drug. If the commission determines that the manufacturer’s pricing of an
272eligible drug substantially exceeds the proposed value of the drug, the commission shall
273confidentially notify the manufacturer, in writing, of its determination and may require the
274manufacturer to enter into an access and affordability improvement plan under section 22. 14 of 85
275 (g) Records disclosed by a manufacturer under this section shall: (i) be accompanied by
276an attestation that all information provided is true and correct; (ii) not be public records under
277clause Twenty-sixth of section 7 of chapter 4 or under chapter 66; and (iii) remain confidential;
278provided, however, that the commission may produce reports summarizing any findings;
279provided further, that any such report shall not be in a form that identifies specific prices charged
280for or rebate amounts associated with drugs by a manufacturer or in a manner that is likely to
281compromise the financial, competitive or proprietary nature of the information.
282 Any request for further information made by the commission under subsection (e) or any
283determination issued or written notification made by the commission under subsection (f) shall
284not be public records under said clause Twenty-sixth of said section 7 of said chapter 4 or under
285said chapter 66.
286 (h) The commission’s proposed value of an eligible drug and the commission’s
287underlying analysis of the eligible drug is not intended to be used to determine whether any
288individual patient meets prior authorization or utilization management criteria for the eligible
289drug. The proposed value and underlying analysis shall not be the sole factor in determining
290whether a drug is included in a formulary or whether the drug is subject to step therapy.
291 (i) If the manufacturer fails to timely comply with the commission’s request for records
292under subsection (b) or subsection (e), or otherwise knowingly obstructs the commission’s
293ability to issue its determination under subsection (f), including, but not limited to, by providing
294incomplete, false or misleading information, the commission may impose appropriate sanctions
295against the manufacturer, including reasonable monetary penalties not to exceed $500,000, in
296each instance. The commission shall seek to promote compliance with this section and shall only 15 of 85
297impose a civil penalty on the manufacturer as a last resort. Penalties collected under this
298subsection shall be deposited into the Prescription Drug Cost Assistance Trust Fund established
299in section 2BBBBBB of chapter 29.
300 (j) The commission shall adopt any written policies, procedures or regulations that the
301commission determines are necessary to effectuate the purpose of this section.
302 Section 22. (a) The commission shall establish procedures to assist manufacturers in
303filing and implementing an access and affordability improvement plan.
304 Upon providing written notice provided under subsection (f) of section 21, the
305commission may require that a manufacturer whose pricing of an eligible drug substantially
306exceeds the commission’s proposed value of the drug file an access and affordability
307improvement plan with the commission. Not later than 45 days after receipt of a notice under
308said subsection (f) of said section 21, a manufacturer shall: (i) file an access and affordability
309improvement plan; or (ii) provide written notice declining participation in the access and
310affordability improvement plan.
311 (b) An access and affordability improvement plan shall: (i) be generated by the
312manufacturer; (ii) identify the reasons for the manufacturer’s drug price; and (iii) include, but not
313be limited to, specific strategies, adjustments and action steps the manufacturer proposes to
314implement to address the cost of the eligible drug in order to improve the accessibility and
315affordability of the eligible drug for patients and the state’s health system. The proposed access
316and affordability improvement plan shall include specific identifiable and measurable expected
317outcomes and a timetable for implementation. The timetable for an access and affordability
318improvement plan shall not exceed 18 months. 16 of 85
319 (c) The commission shall approve any access and affordability improvement plan that it
320determines: (i) is reasonably likely to address the cost of an eligible drug in order to substantially
321improve the accessibility and affordability of the eligible drug for patients and the state’s health
322system; and (ii) has a reasonable expectation for successful implementation.
323 (d) If the commission determines that the proposed access and affordability improvement
324plan is unacceptable or incomplete, the commission may provide consultation on the criteria that
325have not been met and may allow an additional time period of not more than 30 calendar days for
326resubmission; provided, however, that all aspects of the access plan shall be proposed by the
327manufacturer and the commission shall not require specific elements for approval.
328 (e) Upon approval of the proposed access and affordability improvement plan, the
329commission shall notify the manufacturer to begin immediate implementation of the access and
330affordability improvement plan. Public notice shall be provided by the commission on its
331website, identifying that the manufacturer is implementing an access and affordability
332improvement plan; provided, however, that upon the successful completion of the access and
333affordability improvement plan, the identity of the manufacturer shall be removed from the
334commission's website. All manufacturers implementing an approved access improvement plan
335shall be subject to additional reporting requirements and compliance monitoring as determined
336by the commission. The commission shall provide assistance to the manufacturer in the
337successful implementation of the access and affordability improvement plan.
338 (f) All manufacturers shall work in good faith to implement the access and affordability
339improvement plan. At any point during the implementation of the access and affordability 17 of 85
340improvement plan, the manufacturer may file amendments to the access improvement plan,
341subject to approval of the commission.
342 (g) At the conclusion of the timetable established in the access and affordability
343improvement plan, the manufacturer shall report to the commission regarding the outcome of the
344access and affordability improvement plan. If the commission determines that the access and
345affordability improvement plan was unsuccessful, the commission shall: (i) extend the
346implementation timetable of the existing access and affordability improvement plan; (ii) approve
347amendments to the access and affordability improvement plan as proposed by the manufacturer;
348(iii) require the manufacturer to submit a new access and affordability improvement plan; or (iv)
349waive or delay the requirement to file any additional access and affordability improvement plans.
350 (h) The commission shall submit a recommendation for proposed legislation to the joint
351committee on health care financing if the commission determines that further legislative
352authority is needed to assist manufacturers with the implementation of access and affordability
353improvement plans or to otherwise ensure compliance with this section.
354 (i) An access and affordability improvement plan under this section shall remain
355confidential in accordance with section 2A.
356 (j) The commission may assess a civil penalty to a manufacturer of not more than
357$500,000, in each instance, if the commission determines that the manufacturer: (i) declined or
358willfully neglected to file an access and affordability improvement plan with the commission
359under subsection (a); (ii) failed to file an acceptable access and affordability improvement plan in
360good faith with the commission; (iii) failed to implement the access and affordability
361improvement plan in good faith; or (iv) knowingly failed to provide information required by this 18 of 85
362section to the commission or knowingly falsified the information. The commission shall seek to
363promote compliance with this section and shall only impose a civil penalty as a last resort.
364Penalties collected under this subsection shall be deposited into the Prescription Drug Cost
365Assistance Trust Fund established in section 2BBBBBB of chapter 29.
366 (k) If a manufacturer declines to enter into an access and affordability improvement plan
367under this section, the commission may publicly post the proposed value of the eligible drug,
368hold a public hearing on the proposed value of the eligible drug and solicit public comment. The
369manufacturer shall appear and testify at the public hearing held on the eligible drug’s proposed
370value. Upon the conclusion of a public hearing under this subsection, the commission shall issue
371recommendations on ways to reduce the cost of an eligible drug for the purpose of improving
372patient access to the eligible drug. The recommendations shall be publicly posted on the
373commission’s website and provided to the clerks of the house of representatives and senate, the
374joint committee on health care financing and the house and senate committees on ways and
375means.
376 If a manufacturer is deemed to not be acting in good faith to develop an acceptable or
377complete access and affordability improvement plan, the commission may publicly post the
378proposed value of the eligible drug, hold a public hearing on the proposed value of the eligible
379drug and solicit public comment. The manufacturer shall appear and testify at any hearing held
380on the eligible drug’s proposed value. Upon the conclusion of a public hearing under this
381subsection, the commission shall issue recommendations on ways to reduce the cost of an
382eligible drug for the purpose of improving patient access to the eligible drug. The
383recommendations shall be publicly posted on the commission’s website and provided to the 19 of 85
384clerks of the house of representatives and senate, the joint committee on health care financing
385and the house and senate committees on ways and means.
386 Before making a determination that the manufacturer is not acting in good faith, the
387commission shall send a written notice to the manufacturer that the commission shall deem the
388manufacturer to not be acting in good faith if the manufacturer does not submit an acceptable
389access and affordability improvement plan within 30 days of receipt of notice; provided,
390however, that the commission shall not send a notice under this paragraph within 120 calendar
391days from the date that the commission notified the manufacturer of its requirement to enter into
392the access and affordability improvement plan.
393 (l) The commission shall promulgate regulations necessary to implement this section.
394 Section 23. Every 2 years, the commission, in consultation with the center for health
395information and analysis, the group insurance commission, the office of Medicaid and the
396division of insurance shall evaluate the impact of section 17T of chapter 32A, section 10R of
397chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of
398chapter 176B and section 4NN of chapter 176G on the effects of capping co-payments and
399eliminating deductible and co-insurance requirements for those drugs for individuals with
400diabetes, asthma and chronic heart conditions on health care access and system cost, including,
401but not limited to: (i) utilization rates of the drugs selected pursuant to section 10R of chapter
402118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B
403and section 4NN of chapter 176G; (ii) an analysis of the use of those drugs, broken down by
404patient demographics, geographic region and, where applicable, delivery device; (iii) annual plan
405costs and member premiums; (iv) the average price of those drugs; (v) the average price of those 20 of 85
406drugs net of rebates or discounts received by or accrued directly or indirectly by health insurance
407carriers; (vi) average and total out-of-pocket expenditures on delivery devices used for those
408drugs and glucose monitoring tests that are not included as part of the underlying drug
409prescription; (vii) an analysis of the impact of capping co-payments and eliminating deductible
410and co-insurance requirements for those drugs on patient access to and cost of care by patient
411demographics and geographic region; and (viii); any barriers to accessing those drugs for
412individuals with the conditions for which those drugs are prescribed and policy recommendations
413for resolving such barriers.
414 Biennially, not later than November 30, the commission shall file a report of its findings
415with the clerks of the house of representatives and senate, the chairs of the joint committee on
416public health, the chairs of the joint committee on health care financing and the chairs of house
417and senate committees on ways and means.
418 SECTION 22. Section 1 of chapter 12C of the General Laws, as appearing in the 2022
419Official Edition, is hereby amended by inserting after the definition of “Ambulatory surgical
420center services” the following 3 definitions:-
421 “Average manufacturer price”, the average price paid to a manufacturer for a drug in the
422commonwealth by a: (i) wholesaler for drugs distributed to pharmacies; and (ii) pharmacy that
423purchases drugs directly from the manufacturer.
424 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
425application approved under 42 U.S.C. 262(k)(3).
426 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
427drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 21 of 85
428application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
429is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
430Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
431application that was approved by the United States Secretary of Health and Human Services
432under section 505(c) of the federal Food, Drug and Cosmetic Act, 21 U.S.C. 355(c), before the
433date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
4341984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
435C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
436under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the carrier as a brand name drug based on
437available data resources such as Medi-Span.
438 SECTION 23. Said section 1 of said chapter 12C, as so appearing, is hereby further
439amended by inserting after the definition of “General health supplies, care or rehabilitative
440services and accommodations” the following definition:-
441 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
442abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
443drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
444that was not originally marketed under a new drug application; or (iv) identified by the carrier as
445a generic drug based on available data resources such as Medi-Span.
446 SECTION 24. Said section 1 of said chapter 12C, as so appearing, is hereby further
447amended by inserting after the definition of “Patient-centered medical home” the following 2
448definitions:- 22 of 85
449 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
450preparation, propagation, compounding, conversion or processing of prescription drugs, directly
451or indirectly, by extraction from substances of natural origin, independently by means of
452chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
453repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
454“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
455under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
456chapter 112.
457 “Pharmacy benefit manager”, a person, business or other entity, however organized, that,
458directly or through a subsidiary, provides pharmacy benefit management services for prescription
459drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
460insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
461management services shall include, but not be limited to: (i) the processing and payment of
462claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
463of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
464grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
465drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
466clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
467covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a
468health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages
469its own prescription drug benefits unless specifically exempted by the commission.
470 SECTION 25. Said section 1 of said chapter 12C, as so appearing, is hereby further
471amended by adding the following definition:- 23 of 85
472 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
4731395w-3a(c)(6)(B).
474 SECTION 26. Section 3 of said chapter 12C, as so appearing, is hereby amended by
475inserting after the word “organizations”, in lines 13 and 14, the following words:- ,
476pharmaceutical manufacturing companies, pharmacy benefit managers.
477 SECTION 27. Said section 3 of said chapter 12C, as so appearing, is hereby further
478amended by striking out, in line 24, the words “and payer” and inserting in place thereof the
479following words:- , payer, pharmaceutical manufacturing company and pharmacy benefit
480manager.
481 SECTION 28. Section 5 of said chapter 12C, as so appearing, is hereby amended by
482striking out, in lines 11 and 12, the words “and public health care payers” and inserting in place
483thereof the following words:- , public health care payers, pharmaceutical manufacturing
484companies and pharmacy benefit managers.
485 SECTION 29. Said section 5 of said chapter 12C, as so appearing, is hereby further
486amended by striking out, in line 15, the words “and affected payers” and inserting in place
487thereof the following words:- affected payers, affected pharmaceutical manufacturing companies
488and affected pharmacy benefit managers.
489 SECTION 30. The first paragraph of section 7 of said chapter 12C, as so appearing, is
490hereby amended by adding the following sentence:- Each pharmaceutical and biopharmaceutical
491manufacturing company and pharmacy benefit manager shall pay to the commonwealth an
492amount for the estimated expenses of the center and for the other purposes described in this
493chapter. 24 of 85
494 SECTION 31. Said section 7 of said chapter 12C, as so appearing, is hereby further
495amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each
496instance, the following figure:- 25.
497 SECTION 32. Said section 7 of said chapter 12C, as so appearing, is hereby further
498amended by adding the following paragraph:-
499 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
500companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
501appropriated by the general court for the expenses of the center minus amounts collected from:
502(i) filing fees; (ii) fees and charges generated by the commission's publication or dissemination
503of reports and information; and (iii) federal matching revenues received for these expenses or
504received retroactively for expenses of predecessor agencies. A pharmacy benefit manager that is
505also a surcharge payor subject to the preceding paragraph and manages its own prescription drug
506benefits shall not be subject to additional assessment under this paragraph.
507 SECTION 33. Said chapter 12C is hereby further amended by inserting after section 10
508the following section:-
509 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform
510reporting of information from pharmaceutical manufacturing companies to enable the center to
511analyze: (i) year-over-year changes in wholesale acquisition cost and average manufacturer price
512for prescription drug products; (ii) year-over-year trends in net expenditures; (iii) net
513expenditures on subsets of biosimilar, brand name and generic drugs identified by the center; (iv)
514trends in estimated aggregate drug rebates, discounts or other remuneration paid or provided by a
515pharmaceutical manufacturing company to a pharmacy benefit manager, wholesaler, distributor, 25 of 85
516health carrier client, health plan sponsor or pharmacy in connection with utilization of the
517pharmaceutical drug products offered by the pharmaceutical manufacturing company; (v)
518discounts provided by a pharmaceutical manufacturing company to a consumer in connection
519with utilization of the pharmaceutical drug products offered by the pharmaceutical
520manufacturing company, including any discount, rebate, product voucher, coupon or other
521reduction in a consumer’s out-of-pocket expenses including co-payments and deductibles under
522section 3 of chapter 175H; (vi) research and development costs as a percentage of revenue; (vii)
523annual marketing and advertising costs, identifying costs for direct-to-consumer advertising;
524(viii) annual profits over the most recent 5-year period; (ix) disparities between prices charged to
525purchasers in the commonwealth and purchasers outside of the United States; and (x) any other
526information deemed necessary by the center.
527 The center shall require the submission of available data and other information from
528pharmaceutical manufacturing companies including, but not limited to: (i) wholesale acquisition
529costs and average manufacturer prices for prescription drug products as identified by the center;
530(ii) true net typical prices charged to pharmacy benefits managers by payor type for prescription
531drug products identified by the center, net of any rebate or other payments from the manufacturer
532to the pharmacy benefits manager and from the pharmacy benefits manager to the manufacturer;
533(iii) aggregate, company-level research and development costs to the extent attributable to a
534specific product and other relevant capital expenditures for the most recent year for which final
535audited data is available for prescription drug products as identified by the center; (iv) annual
536marketing and advertising expenditures; and (v) a description, absent proprietary information and
537written in plain language, of factors that contributed to reported changes in wholesale acquisition 26 of 85
538costs, net prices and average manufacturer prices for prescription drug products as identified by
539the center.
540 (b) The center shall promulgate regulations necessary to ensure the uniform reporting of
541information from pharmacy benefit managers to enable the center to analyze: (i) trends in
542estimated aggregate drug rebates and other drug price reductions, if any, provided by a pharmacy
543benefit manager to a health carrier client or health plan sponsor or passed through from a
544pharmacy benefit manager to a health carrier client or health plan sponsor in connection with
545utilization of drugs in the commonwealth offered through the pharmacy benefit manager and a
546measure of lives covered by each health carrier client or health plan sponsor in the
547commonwealth; (ii) pharmacy benefit manager practices with regard to drug rebates and other
548drug price reductions, if any, provided by a pharmacy benefit manager to a health carrier client
549or health plan sponsor or to consumers in the commonwealth or passed through from a pharmacy
550benefit manager to a health carrier client or health plan sponsor or to consumers in the
551commonwealth; and (iii) any other information deemed necessary by the center.
552 The center shall require the submission of available data and other information from
553pharmacy benefit managers including, but not limited to: (i) true net typical prices paid by
554pharmacy benefits managers for prescription drug products identified by the center, net of any
555rebate or other payments from the manufacturer to the pharmacy benefit manager and from the
556pharmacy benefit manager to the manufacturer; (ii) the amount of all rebates that the pharmacy
557benefit manager received from all pharmaceutical manufacturing companies for all health carrier
558clients in the aggregate and for each health carrier client or health plan sponsor individually,
559attributable to patient utilization in the commonwealth; (iii) the administrative fees that the
560pharmacy benefit manager received from all health carrier clients or health plan sponsors in the 27 of 85
561aggregate and for each health carrier client or health plans sponsors individually; (iv) the
562aggregate amount of rebates a pharmacy benefit manager: (A) retains based on its contractual
563arrangement with each health plan client or health plan sponsor individually; and (B) passes
564through to each health care client individually; (v) the aggregate amount of all retained rebates
565that the pharmacy benefit manager received from all pharmaceutical manufacturing companies
566and did not pass through to each pharmacy benefit manager’s health carrier client or health plan
567sponsor individually; (vi) the percentage of contracts that a pharmacy benefit manager holds
568where the pharmacy benefit manager: (A) retains all rebates; (B) passes all rebates through to the
569client; and (C) shares rebates with the client; and (vii) other information as determined by the
570center, including, but not limited to, pharmacy benefit manager practices related to spread
571pricing, administrative fees, claw backs and formulary placement.
572 (c) Except as specifically provided otherwise by the center or under this chapter, data
573collected by the center pursuant to this section from pharmaceutical manufacturing companies
574and pharmacy benefit managers shall not be a public record under clause Twenty-sixth of section
5757 of chapter 4 or under chapter 66.
576 SECTION 34. Said chapter 12C is hereby further amended by striking out section 11, as
577appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
578 Section 11. The center shall ensure the timely reporting of information required under
579sections 8, 9, 10 and 10A. The center shall notify private health care payers, providers, provider
580organizations, pharmacy benefit managers, pharmaceutical manufacturing companies and their
581parent organization and other affiliates of any applicable reporting deadlines. The center shall
582notify, in writing, a private health care payer, provider, provider organization, pharmacy benefit 28 of 85
583manager or pharmaceutical manufacturing company and their parent organization and other
584affiliates, that has failed to meet a reporting deadline of such failure and that failure to respond
585within 2 weeks of the receipt of the notice may result in penalties. The center may assess a
586penalty against a private health care payer, provider, provider organization, pharmacy benefit
587manager or pharmaceutical manufacturing company and their parent organization and other
588affiliates, that fails, without just cause, to provide the requested information, including subsets of
589the requested information, within 2 weeks following receipt of the written notice required under
590this section, of not more than $2,000 per week for each week of delay after the 2-week period
591following receipt of the notice. Amounts collected under this section shall be deposited in the
592Healthcare Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011.
593 SECTION 35. Section 12 of said chapter 12C, as so appearing, is hereby amended by
594striking out, in line 2, the words “and 10” and inserting in place thereof the following words:- ,
59510 and 10A.
596 SECTION 36. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby
597amended by striking out the first sentence and inserting in place thereof the following sentence:-
598The center shall publish an annual report based on the information submitted under: (i) sections
5998, 9, 10 and 10A concerning health care provider, provider organization, private and public
600health care payer, pharmaceutical manufacturing company and pharmacy benefit manager costs
601and cost and price trends; (ii) section 13 of chapter 6D relative to market power reviews; and (iii)
602section 15 of said chapter 6D relative to quality data.
603 SECTION 37. Said section 16 of said chapter 12C, as so appearing, is hereby further
604amended by striking out, in line 18, the words:- “in the aggregate”. 29 of 85
605 SECTION 38. Said section 16 of said chapter 12C, as so appearing, is hereby further
606amended by inserting after the second paragraph the following paragraph:-
607 As part of its annual report, the center shall report on prescription drug utilization and
608spending for pharmaceutical drugs provided in an outpatient setting or sold in a retail setting for
609private and public health care payers, including, but not limited to, information sufficient to
610show the: (i) highest utilization drugs; (ii) drugs with the greatest increases in utilization; (iii)
611drugs that are most impactful on plan spending, net of rebates; and (iv) drugs with the highest
612year-over-year price increases, net of rebates. The report shall not contain any data that is likely
613 to compromise the financial, competitive or proprietary nature of the information
614contained in the report.
615 SECTION 39. Section 13 of chapter 17 of the General Laws, as so appearing, is hereby
616amended by adding the following subsection:-
617 (f) As used in this subsection, the following words shall have the following meanings
618unless the context clearly requires otherwise:
619 “Public health essential drug”, a prescription drug, biologic or biosimilar approved by the
620United States Food and Drug Administration that: (i) appears on the Model List of Essential
621Medicines most recently adopted by the World Health Organization; (ii) is selected pursuant to
622section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of chapter 175, section
6238VV of chapter 176A, section 4VV of chapter 176B and section 4NN of chapter 176G; or (iii) is
624deemed an essential medicine by the commission due to its efficacy in treating a life-threatening
625health condition or a chronic health condition that substantially impairs an individual’s ability to
626engage in activities of daily living or because limited access to a certain population would pose a 30 of 85
627public health challenge. “Public health essential drug” shall also include all delivery devices
628selected pursuant to section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of
629chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B and section 4NN of
630chapter 176G.
631 The commission shall identify and publish a list of public health essential drugs. The list
632shall be updated not less than annually and be made publicly available on the department’s
633website; provided, however, that the commission may provide an interim listing of a public
634health essential drug prior to an annual update. The commission shall notify and forward a copy
635of the list to the health policy commission established under chapter 6D.
636 SECTION 40. Chapter 29 of the General Laws is hereby amending by inserting after
637section 2AAAAAA the following section:-
638 2BBBBBB. (a) There shall be a Prescription Drug Cost Assistance Trust Fund. The
639secretary of health and human services shall administer the fund and shall make expenditures
640from the fund, without further appropriation, to provide financial assistance to residents of the
641commonwealth for the cost of prescription drugs through the prescription drug costs assistance
642program established under section 245 of chapter 111. For the purpose of this section,
643“prescription drug” shall include the prescription drug and any drug delivery device needed to
644administer the drug that is not included as part of the underlying drug prescription.
645 The fund shall consist of: (i) revenue from appropriations or other money authorized by
646the general court and specifically designated to be credited to the fund; and (ii) funds from public
647or private sources, including, but not limited to, gifts, grants, donations, rebates and settlements
648received by the commonwealth that are specifically designated to be credited to the fund. Money 31 of 85
649remaining in the fund at the close of a fiscal year shall not revert to the General Fund and shall
650be available for expenditure in the following fiscal year.
651 (b) Annually, not later than March 1, the secretary shall report on the fund’s activities
652detailing expenditures from the previous calendar year. The report shall include: (i) the number
653of individuals who received financial assistance from the fund; (ii) the breakdown of fund
654recipients by race, gender, age range, geographic region and income level; (iii) a list of all
655prescription drugs that were covered by money from the fund; and (iv) the total cost savings
656received by all fund recipients and the cost savings broken down by race, gender, age range and
657income level. The report shall be submitted to the clerks of the senate and house of
658representatives, senate and house committees on ways and means and the joint committee on
659health care financing.
660 (c) The secretary shall promulgate regulations or issue other guidance for the expenditure
661of the funds under this section.
662 SECTION 41. Chapter 32A of the General Laws is hereby amended by inserting after
663section 17S the following section:-
664 Section 17T. (a) As used in this section, the following terms shall have the following
665meanings, unless the context clearly requires otherwise:
666 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
667drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
668application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
669is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
670Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 32 of 85
671application that was approved by the United States Secretary of Health and Human Services
672under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
673date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
6741984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
675C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
676under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
677based on available data resources such as Medi-Span.
678 “Delivery device”, a device that is used to deliver a brand name drug or generic drug and
679that an individual can obtain with a prescription.
680 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
681abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
682drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962,
683and was not originally marketed under a new drug application; or (iv) identified by the health
684benefit plan as a generic drug based on available data resources such as Medi-Span.
685 “Separate delivery device”, a device that is used to deliver a brand name drug or a
686generic drug and that can be obtained with a prescription separate from, or in addition to, the
687brand name drug or generic drug that the device delivers.
688 (b) The commission shall select 1 generic drug and 1 brand name drug used to treat each
689of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including,
690but not limited to, those heart conditions that disproportionately impact a particular demographic
691group, including people of color. 33 of 85
692 The commission shall select insulin as the drug used to treat diabetes. In selecting 1
693insulin brand name drug and 1 insulin generic drug as the drug used to treat diabetes, the
694commission shall select 1 insulin brand name drug per dosage and type, including rapid-acting,
695short-acting, intermediate-acting, long-acting, ultra long-acting and premixed. To the extent
696possible, the commission shall select 1 generic insulin per dosage and type, including rapid-
697acting, short-acting, intermediate-acting, long-acting, ultra long-acting and premixed, subject to
698such generic drug’s availability.
699 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
700applicable, used to treat each chronic condition pursuant to subsection (b), the commission shall
701select a drug that is among the top three of the commission’s most prescribed or of the highest
702volume for the chronic condition, and shall consider whether the drug is:
703 (i) of clear benefit and strongly supported by clinical evidence;
704 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
705exacerbations of illness progression or improve quality of life;
706 (iii) relatively low cost when compared to the cost of an acute illness of incident
707prevented or delayed by the use of the service, treatment or drug;
708 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
709 (v) likely to have a considerable financial impact on individual patients by reducing or
710eliminating patient cost-sharing pursuant to this section; and
711 (vi) likely to enhance equity in disproportionately impacted demographic groups,
712including people of color. 34 of 85
713 (d) The commission shall provide coverage for the brand name drugs, generic drugs and
714delivery devices selected pursuant to subsection (b). Coverage for the selected generic drugs
715shall not be subject to any cost-sharing, including copayments and coinsurance, and shall not be
716subject to any deductible. Coverage for selected brand name drugs shall not be subject to any
717deductible or coinsurance and a copayment shall not exceed $25 per 30-day supply; provided,
718however, that nothing in this section shall prevent co-payments for a 30-day supply of the
719selected brand name drugs from being reduced below the amount specified in this section.
720 (e) If use of a brand name drug or generic drug that the commission selects requires a
721separate delivery device, the commission shall select a delivery device for that drug in
722accordance with the factors established in subsection (c) for selecting brand name drugs and
723generic drugs, to the extent possible. The commission shall provide coverage for the delivery
724device and the delivery device shall not be subject to any cost-sharing, including co-payments
725and co-insurance, and shall not be subject to any deductible.
726 (f) A member and their prescribing health care provider shall have access to a clear,
727readily accessible and convenient process to request to use a different brand name drug or
728generic drug of the same pharmacological class in place of a brand name drug or generic drug
729selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
730name drugs and generic drugs selected under subsection (b) are contraindicated or will likely
731cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs
732and generic drugs selected under subsection (b) are expected to be ineffective based on the
733known clinical characteristics of the member and the known characteristics of the prescription
734drug regimen; (iii) the member or prescribing health care provider: (A) has provided
735documentation to the commission establishing that the member has previously tried the brand 35 of 85
736name drugs and generic drugs selected under subsection (b), or another prescription drug in the
737same pharmacologic class or with the same mechanism of action, while covered by the
738commission or by a previous health insurance carrier or a health benefit plan; and (B) such
739prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect or
740an adverse event; or (iv) the member or prescribing health care provider has provided
741documentation to the commission establishing that the member: (A) is stable on a prescription
742drug prescribed by the health care provider; and (B) switching drugs will likely cause an adverse
743reaction in or physical or mental harm to the member. When applicable this subsection shall
744apply to delivery devices.
745 (g) The commission shall implement a continuity of coverage to apply to members that
746are new to the commission and that provides coverage for a 90-day fill of a United States Food
747and Drug Administration-approved drug reimbursed through a pharmacy benefit that the member
748has already been prescribed and on which the member is stable, upon documentation by the
749member’s prescriber; provided, however, that the commission shall not apply any greater
750deductible, co-insurance, co-payments or out-of-pocket limits than would otherwise apply to
751other drugs covered by the plan; and provided further, that the commission shall provide a
752member or their prescribing health care provider with information regarding the request pursuant
753to subsection (f) within 30 days of a member or their health care provider contacting the
754commission to use a different brand name drug or generic drug of the same pharmacological
755class as the drugs selected pursuant to subsection (b).
756 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
757coverage pursuant to subsection (g), the commission shall provide coverage for the prescription 36 of 85
758drug or delivery device prescribed by the member’s health care provider at the same cost as
759required under subsection (d). A denial of an exception shall be eligible for appeal by a member.
760 (i) The commission shall grant or deny a request pursuant to subsection (f) and (g) not
761more than 3 business days following the receipt of all necessary information to establish the
762medical necessity of the prescribed treatment; provided, however, that if additional delay would
763result in significant risk to the member’s health or well-being, the commission shall respond not
764more than 24 hours following the receipt of all necessary information to establish the medical
765necessity of the prescribed treatment. If a response by the commission is not received within the
766time required under this subsection, an exception shall be deemed granted.
767 (j) The commission shall make changes in selected drugs and delivery devices not more
768than annually and shall provide notice to the health policy commission not less than 90 days
769before making changes to the selected drugs and delivery devices and an explanation of such
770changes. Upon verification by the health policy commission that the selected drugs meet the
771criteria identified in subsection (c), the commission shall provide notice to its members not less
772than 30 days before any changes to the selected drugs are made.
773 (k) The commission shall make public the drugs and delivery devices selected pursuant to
774this section.
775 (l) If a high deductible health plan subject to this section is used to establish a savings
776account that is tax-exempt under the federal Internal Revenue Code, the provisions in this section
777shall apply to the plan to the maximum extent possible without causing the account to lose its
778tax-exempt status. 37 of 85
779 SECTION 42. Chapter 111 of the General Laws is hereby amended by adding the
780following section:-
781 Section 245. (a) The department shall establish and administer a prescription drug cost
782assistance program, which shall be funded by the Prescription Drug Cost Assistance Trust Fund
783established in section 2BBBBBB of chapter 29. The program shall provide financial assistance
784for prescription drugs used to treat: (i) chronic respiratory conditions, including, but not limited
785to, chronic obstructive pulmonary disease and asthma; (ii) chronic heart conditions, including,
786but not limited to, those heart conditions that disproportionately impact a particular demographic
787group, including people of color; (iii) diabetes; and (iv) any other chronic condition identified by
788the department that disproportionately impacts a particular demographic group, including people
789of color; provided, however, that “prescription drug” shall include the prescription drug and any
790drug delivery device needed to administer the drug that is not included as part of the underlying
791drug prescription. Financial assistance shall cover the cost of any copayment, coinsurance and
792deductible for the prescription drug for an individual who is eligible for the program.
793 (b) An individual shall be eligible for the program if the individual: (i) is a resident of the
794commonwealth; (ii) has a current prescription from a health care provider for a drug that is used
795to treat a chronic condition listed in subsection (a); (iii) has a family income of not more than
796500 per cent of the federal poverty level; and (iv) is not enrolled in MassHealth.
797 (c) The department shall create an application process, which shall be available
798electronically and in hard copy form, to determine whether an individual meets the program
799eligibility requirements under subsection (b). The department shall determine an applicant’s
800eligibility and notify the applicant of the department’s determination within 10 business days of 38 of 85
801receiving the application. If necessary for its determination, the department may request
802additional information from the applicant; provided, however, that the department shall notify
803the applicant within 5 business days of receipt of the original application as to what specific
804additional information is being requested. If additional information is requested, the department
805shall, within 3 business days of receipt of the additional information, determine the applicant’s
806eligibility and notify said applicant of the department’s determination.
807 If the department determines that an applicant is not eligible for the program, the
808department shall notify the applicant and shall include in said notification the specific reasons
809why the applicant is not eligible. The applicant may appeal this determination to the department
810within 30 days of receiving such notification.
811 If the department determines that an applicant is eligible for the program, the department
812shall provide the applicant with a prescription drug cost assistance program identification card,
813which shall indicate the applicant’s eligibility; provided, however, that the program identification
814card shall include, but not be limited to, the applicant’s full name and the full name of the
815prescription drug that the applicant is eligible to receive under the program without having to pay
816a co-payment, co-insurance or deductible. An applicant’s program identification card shall be
817valid for 12 months and shall be renewable upon a redetermination of program eligibility.
818 (d) An individual with a valid program identification card may present such card at any
819pharmacy in the commonwealth and, upon presentation of such card, the pharmacy shall fill the
820individual’s prescription and provide the prescribed drug to the individual without requiring the
821individual to pay a co-payment, co-insurance or deductible; provided, however, that the
822pharmacy shall be reimbursed by the Prescription Drug Cost Assistance Trust Fund established 39 of 85
823in section 2BBBBBB of chapter 29 in a manner determined by the department, in an amount
824equal to what the pharmacy would have received had the individual been required to pay a co-
825payment, co-insurance or deductible.
826 (e) The department, in collaboration with the division of insurance, board of registration
827in pharmacy and stakeholders representing consumers, pharmacists, providers, hospitals and
828carriers, shall develop and implement a plan to educate consumers, pharmacists, providers,
829hospitals and carriers regarding eligibility for and enrollment in the program under this section.
830The plan shall include, but not be limited to, appropriate staff training, notices provided to
831consumers at the pharmacy and a designated website with information for consumers,
832pharmacists and other health care professionals.
833 (f) The department shall compile a report detailing information about the program from
834the previous calendar year. The report shall include: (i) the number of applications received,
835approved, denied and appealed; (ii) the total number of applicants approved, and the number of
836applicants approved broken down by race, gender, age range and income level; (iii) a list of all
837prescription drugs that qualify for the program under subsection (b) and a list of prescription
838drugs for which applicants actually received financial assistance; and (iv) the total cost savings
839received by all approved applicants and the cost savings broken down by race, gender, age range
840and income level. The report shall be submitted annually, not later than March 1, to the clerks of
841the senate and house of representatives, the house and senate committees on ways and means and
842the joint committee on health care financing.
843 (g) The department shall promulgate regulations or issue guidance for the implementation
844and enforcement of this section. 40 of 85
845 SECTION 43. Chapter 112 of the General Laws is hereby amended by inserting after
846section 39J the following section:-
847 Section 39K. (a) For the purposes of this section, “specialty pharmacy” may include any
848pharmacy engaged in the dispensing of specialty drugs as defined by the board.
849 The board shall establish a specialty pharmacy licensure category for pharmacies that
850ship, mail, sell or dispense specialty drugs into, within or from the commonwealth. The board
851shall ensure that all shipments of specialty pharmaceutical drugs from in-state pharmacies to out-
852of-state destinations comply with the licensing procedures applicable to pharmacies in the
853commonwealth.
854 (b) A specialty pharmacy shall designate a manager of record who shall disclose to the
855board the location, name and title of all principal managers and the name and Massachusetts
856license number of the designated manager of record annually and within 30 days after any
857change of office, corporate office or manager of record.
858 (c) The board shall: (i) adopt written policies or procedures or promulgate regulations
859that the board determines are necessary to implement this section; and (ii) establish standards for
860special handling, administration, quality, safety, and monitoring of specialty drugs; provided,
861however, that the board shall define the term “specialty drug” for the purposes of this section.
862 SECTION 44. Chapter 118E of the General Laws is hereby amended by inserting after
863section 10Q the following section:-
864 Section 10R. (a) As used in this section, the following terms shall have the following
865meanings unless the context clearly requires otherwise: 41 of 85
866 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
867drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
868application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
869is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
870Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
871application that was approved by the United States Secretary of Health and Human Services
872under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
873date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
8741984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
875C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
876under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
877based on available data resources such as Medi-Span.
878 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
879drug; and (ii) an individual can obtain with a prescription.
880 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
881abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
882drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
883and was not originally marketed under a new drug application; or (iv) identified by the health
884benefit plan as a generic drug based on available data resources such as Medi-Span.
885 “Separate delivery device”, a device that is used to deliver a brand name drug or a
886generic drug and that can be obtained with a prescription separate from, or in addition to, the
887brand name drug or generic drug that the device delivers. 42 of 85
888 (b) The division shall select 1 generic drug and 1 brand name drug used to treat each of
889the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including,
890but not limited to those heart conditions that disproportionately impact a particular demographic
891group, including people of color.
892 The division shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
893brand name drug and 1 insulin generic drug, the division shall select 1 insulin brand name drug
894per dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
895long-acting and premixed. To the extent possible, the division shall select 1 generic insulin per
896dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-
897acting and premixed, subject to such generic drug’s availability.
898 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
899condition, the division shall select a drug that is among the top three of the division’s most
900prescribed or of the highest volume for the chronic condition, and shall consider whether the
901drug is:
902 (i) of clear benefit and strongly supported by clinical evidence;
903 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
904exacerbations of illness progression or improve quality of life;
905 (iii) relatively low-cost when compared to the cost of an acute illness of incident
906prevented or delayed by the use of the service, treatment or drug;
907 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and 43 of 85
908 (v) likely to have a considerable financial impact on individual patients by reducing or
909eliminating patient cost-sharing pursuant to this section; and
910 (vi) likely to enhance equity in disproportionately impacted demographic groups,
911including people of color.
912 (d) The division and its contracted Medicaid managed care organizations, accountable
913care organizations, behavioral health management firms and third-party administrators shall
914provide coverage for the brand name drugs, generic drugs and delivery devices selected pursuant
915to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-
916sharing, including co-payments and co-insurance, and shall not be subject to any deductible.
917Coverage for selected brand name drugs and delivery devices shall not be subject to any
918deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply;
919provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of
920the selected brand name drugs from being reduced below the amount specified in this section.
921 (e) If use of a brand name drug or generic drug that the division selects requires a
922separate delivery device, the division shall select a delivery device for that drug in accordance
923with the provisions this section establishes for selecting brand name drugs and generic drugs, to
924the extent possible. The division shall provide coverage for the delivery device and the delivery
925device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
926shall not be subject to any deductible.
927 (f) An enrollee and their prescribing health care provider shall have access to a clear,
928readily accessible and convenient process to request to use a different brand name drug or
929generic drug of the same pharmacological class in place of a brand name drug or generic drug. 44 of 85
930Such request for an exception shall be granted if any of the following conditions are satisfied: (i)
931the brand name drugs and generic drugs selected pursuant to subsection (b) are contraindicated
932or will likely cause an adverse reaction in or physical or mental harm to the enrollee; (ii) the
933brand name drugs and generic drugs selected pursuant to subsection (b) are expected to be
934ineffective based on the known clinical characteristics of the enrollee and the known
935characteristics of the prescription drug regimen; (iii) the member or prescribing health care
936provider: (A) has provided documentation to the division establishing that the enrollee has
937previously tried the brand name drugs and generic drugs selected pursuant to subsection (b), or
938another prescription drug in the same pharmacologic class or with the same mechanism of
939action, while covered by the division or by a previous health insurance carrier or a health benefit
940plan; and (B) such prescription drug was discontinued due to lack of efficacy or effectiveness,
941diminished effect or an adverse event; (iv) the enrollee or prescribing health care provider has
942provided documentation to the division establishing that the enrollee: (A) is stable on a
943prescription drug prescribed by the health care provider; and (B) switching drugs will likely
944cause an adverse reaction in or physical or mental harm to the enrollee. When applicable this
945subsection shall apply to delivery devices.
946 (g) This section shall not apply to health plans providing coverage in the Senior Care
947Options program to MassHealth-only members who are ages 65 and older.
948 (h) The division shall implement a continuity of coverage policy for enrollees that are
949new to the Medicaid program and that provides coverage for a 90-day fill of a United States
950Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the
951member has already been prescribed and on which the member is stable, upon documentation by
952the member’s prescriber; provided, however, that the division shall not apply any greater 45 of 85
953deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to other
954drugs covered by the plan; and provided further, that the commission shall provide a member or
955their prescribing health care provider with information regarding the request pursuant to
956subsection (f) within 30 days of a member or their health care provider contacting the
957commission to use a different brand name drug or generic drug of the same pharmacological
958class as the drugs selected pursuant to subsection (b).
959 (i) Upon granting a request pursuant to subsection (f) or (h), the division shall provide
960coverage for the prescription drug or delivery device prescribed by the member’s health care
961provider at the same cost as required under subsection (d). A denial of an exception shall be
962eligible for appeal by a member.
963 (j) The division shall grant or deny a request pursuant to subsection (f) or (h) not more
964than 3 business days following the receipt of all necessary information to establish the medical
965necessity of the prescribed treatment. If additional delay would result in significant risk to the
966member’s health or well-being, the division shall respond not more than 24 hours following the
967receipt of all necessary information to establish the medical necessity of the prescribed treatment.
968If a response by the division is not received within the time required under this subsection, an
969exception shall be deemed granted.
970 (k) The division shall make changes in selected drugs not more than once annually and
971shall provide notice to the health policy commission not less than 90 days before making
972changes to the selected drugs and delivery devices and an explanation of such changes. Upon
973verification by the health policy commission that the selected drugs meet the criteria identified in 46 of 85
974subsection (c), the division shall provide notice to its enrollees not less than 30 days before any
975changes to the selected drugs are made.
976 (l) The division shall make public the drugs and delivery devices selected pursuant to this
977section.
978 (m) If a high deductible health plan subject to this section is used to establish a savings
979account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
980section shall apply to the plan to the maximum extent possible without causing the account to
981lose its tax-exempt status.
982 SECTION 45. Chapter 175 of the General Laws is hereby amended by inserting after
983section 47TT the following section:-
984 Section 47UU. (a) The following terms shall have the following meanings, unless the
985context clearly requires otherwise:
986 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
987drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
988application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
989is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
990Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
991application that was approved by the United States Secretary of Health and Human Services
992under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
993date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
9941984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
995C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 47 of 85
996under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
997based on available data resources such as Medi-Span.
998 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
999drug; and (ii) an individual can obtain with a prescription.
1000 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1001abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1002drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1003and was not originally marketed under a new drug application; or (iv) identified by the health
1004benefit plan as a generic drug based on available data resources such as Medi-Span.
1005 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1006generic drug and that can be obtained with a prescription separate from, or in addition to, the
1007brand name drug or generic drug that the device delivers.
1008 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1009chapter shall provide coverage for the brand name drugs, generic drugs and delivery devices
1010used to treat: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited to,
1011those heart conditions that disproportionately impact a particular demographic group, including
1012people of color.
1013 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1014brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per
1015dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-
1016acting and premixed. To the extent possible, the carrier shall select 1 generic insulin per dosage 48 of 85
1017and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting
1018and premixed, subject to such generic drug’s availability.
1019 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1020condition, the carrier shall select a drug that is among the top three of the carrier’s most
1021prescribed or of the highest volume for the chronic condition, and shall consider whether the
1022drug is:
1023 (i) of clear benefit and strongly supported by clinical evidence;
1024 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1025exacerbations of illness progression or improve quality of life;
1026 (iii) relatively low cost when compared to the cost of an acute illness of incident
1027prevented or delayed by the use of the service, treatment or drug;
1028 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1029 (v) likely to have a considerable financial impact on individual patients by reducing or
1030eliminating patient cost-sharing pursuant to this section; and
1031 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1032including people of color.
1033 (d) Any carrier offering a policy, contract or certificate of health insurance under this
1034chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1035subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1036including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1037selected brand name drugs shall not be subject to any deductible or co-insurance and any co- 49 of 85
1038payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section
1039shall prevent co-payments for a 30-day supply of the selected brand name drugs from being
1040reduced below the amount specified in this section.
1041 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1042delivery device, the carrier shall select a delivery device for that drug in accordance with the
1043criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1044extent possible. The carrier shall provide coverage for the delivery device and the delivery
1045device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1046shall not be subject to any deductible.
1047 (f) A member and their prescribing health care provider shall have access to a clear,
1048readily accessible and convenient process to request to use a different brand name drug or
1049generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1050Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs
1051selected pursuant to subsection (b) are contraindicated or will likely cause an adverse reaction in
1052or physical or mental harm to the member; (ii) the brand name drugs and generic drugs selected
1053pursuant to subsection (b) are expected to be ineffective based on the known clinical
1054characteristics of the member and the known characteristics of the prescription drug regimen;
1055(iii) the member or prescribing health care provider: (A) has provided documentation to the
1056carrier establishing that the member has previously tried the brand name drugs and generic drugs
1057selected pursuant to subsection (b), or another prescription drug in the same pharmacologic class
1058or with the same mechanism of action, while covered by the carrier or by a previous health
1059insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to
1060lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the member or 50 of 85
1061prescribing health care provider has provided documentation to the carrier establishing that the
1062member: (A) is stable on a prescription drug prescribed by the health care provider; and (B)
1063switching drugs will likely cause an adverse reaction in or physical or mental harm to the
1064member. When applicable this subsection shall apply to delivery devices.
1065 (g) The carrier shall implement a continuity of coverage policy to apply to members that
1066are new to the carrier and that provides coverage for a 90-day fill of a United States Food and
1067Drug Administration-approved drug reimbursed through a pharmacy benefit that the member has
1068already been prescribed and on which the member is stable, upon documentation by the
1069member’s prescriber; provided, however, that a carrier shall not apply any greater deductible,
1070coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1071covered by the plan; and provided further, that the commission shall provide a member or their
1072prescribing health care provider with information regarding the request pursuant to subsection (f)
1073within 30 days of a member or their health care provider contacting the commission to use a
1074different brand name drug or generic drug of the same pharmacological class as the drugs
1075selected pursuant to subsection (b).
1076 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1077coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1078or delivery device prescribed by the member’s health care provider at the same cost as required
1079under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1080 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
10813 business days following the receipt of all necessary information to establish the medical
1082necessity of the prescribed treatment. If additional delay would result in significant risk to the 51 of 85
1083member’s health or well-being, the carrier shall respond not more than 24 hours following the
1084receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1085If a response by the carrier is not received within the time required under this subsection, an
1086exception shall be deemed granted.
1087 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1088once annually and shall provide notice to the health policy commission not less than 90 days
1089before making changes to the selected drugs and delivery devices and an explanation of such
1090changes. Upon verification by the health policy commission that the selected drugs meet the
1091criteria identified in subsection (c), the carrier shall provide notice to its members not less than
109230 days before any changes to the selected drugs are made.
1093 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1094section.
1095 (j) If a high deductible health plan subject to this section is used to establish a savings
1096account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1097section shall apply to the plan to the maximum extent possible without causing the account to
1098lose its tax-exempt status.
1099 SECTION 46. Section 226 of said chapter 175, as appearing in the 2022 Official Edition,
1100is hereby amended by striking out subsection (a) and inserting in place thereof the following
1101subsection:-
1102 (a) For the purposes of this section, the term “pharmacy benefit manager” shall mean a
1103person, business or other entity, however organized, that directly or through a subsidiary
1104provides pharmacy benefit management services for prescription drugs and devices on behalf of 52 of 85
1105a health benefit plan sponsor, including, but not limited to, a self-insurance plan, labor union or
1106other third-party payer; provided, however, that pharmacy benefit management services shall
1107include, but not be limited to: (i) the processing and payment of claims for prescription drugs;
1108(ii) the performance of drug utilization review; (iii) the processing of drug prior authorization
1109requests; (iv) pharmacy contracting; (v) the adjudication of appeals or grievances related to
1110prescription drug coverage contracts; (vi) formulary administration; (vii) drug benefit design;
1111(viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) clinical, safety and
1112adherence programs for pharmacy services; and (xi) managing the cost of covered prescription
1113drugs; provided further, that “pharmacy benefit manager” shall include a health benefit plan
1114sponsor that does not contract with a pharmacy benefit manager and manages its own
1115prescription drug benefits unless specifically exempted.
1116 SECTION 47. Chapter 176A of the General Laws is hereby amended by inserting after
1117section 8UU the following section:-
1118 Section 8VV. (a) As used in this section, the following terms shall have the following
1119meanings unless the context clearly requires otherwise:
1120 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1121drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1122application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1123is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1124Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1125application that was approved by the United States Secretary of Health and Human Services
1126under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 53 of 85
1127date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
11281984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1129C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
1130under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1131based on available data resources such as Medi-Span.
1132 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1133drug; and (ii) an individual can obtain with a prescription.
1134 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1135abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1136drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1137and was not originally marketed under a new drug application; or (iv) identified by the health
1138benefit plan as a generic drug based on available data resources such as Medi-Span.
1139 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1140generic drug and that can be obtained with a prescription separate from, or in addition to, the
1141brand name drug or generic drug that the device delivers.
1142 (b) Any carrier offering a policy, contract, or certificate of health insurance under this
1143chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1144chronic conditions.
1145 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1146brand name drug and 1 insulin generic drug, the commission shall select 1 insulin brand name
1147drug per dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting,
1148ultra long-acting and premixed. To the extent possible, the commission shall select 1 generic 54 of 85
1149insulin per dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting,
1150ultra long-acting and premixed, subject to such generic drug’s availability.
1151 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1152condition, the carrier shall select a drug that is among the top three of the carrier’s most
1153prescribed or of the highest volume for the chronic condition, and shall consider whether the
1154drug is:
1155 (i) of clear benefit and strongly supported by clinical evidence;
1156 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1157exacerbations of illness progression or improve quality of life;
1158 (iii) relatively low-cost when compared to the cost of an acute illness of incident
1159prevented or delayed by the use of the service, treatment or drug;
1160 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1161 (v) likely to have a considerable financial impact on individual patients by reducing or
1162eliminating patient cost-sharing pursuant to this section; and
1163 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1164including people of color.
1165 (d) Any carrier offering a policy, contract or certificate of health insurance under this
1166chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1167subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1168including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1169selected brand name drugs shall not be subject to any deductible or coinsurance and any 55 of 85
1170copayment shall not exceed $25 per 30-day supply; provided, however, that nothing in this
1171section shall prevent co-payments for a 30-day supply of the selected brand name drugs from
1172being reduced below the amount specified in this section.
1173 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1174delivery device, the carrier shall select a delivery device for that drug in accordance with the
1175criteria established under subsection (c) for selecting brand name drugs and generic drugs, to the
1176extent possible. The carrier shall provide coverage for the delivery device, and the delivery
1177device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1178shall not be subject to any deductible.
1179 (f) A member and their prescribing health care provider shall have access to a clear,
1180readily accessible and convenient process to request to use a different brand name drug or
1181generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1182Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs
1183selected pursuant to subsection (b) are contraindicated or will likely cause an adverse reaction in
1184or physical or mental harm to the member; (ii) the brand name drugs and generic drugs selected
1185pursuant to subsection (b) are expected to be ineffective based on the known clinical
1186characteristics of the member and the known characteristics of the prescription drug regimen;
1187(iii) the member or prescribing health care provider: (A) has provided documentation to the
1188carrier establishing that the member has previously tried the brand name drugs and generic drugs
1189selected pursuant to subsection (b), or another prescription drug in the same pharmacologic class
1190or with the same mechanism of action, while covered by the carrier or by a previous health
1191insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to
1192lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the member or 56 of 85
1193prescribing health care provider has provided documentation to the carrier establishing that the
1194member: (A) is stable on a prescription drug prescribed by the health care provider; and (B)
1195switching drugs will likely cause an adverse reaction in or physical or mental harm to the
1196member. When applicable this subsection shall apply to delivery devices.
1197 (g) The carrier shall implement a continuity of coverage policy to apply to members that
1198are new to the plan and that provides coverage for a 90-day fill of a United States Food and Drug
1199Administration-approved drug reimbursed through a pharmacy benefit that the member has
1200already been prescribed and on which the member is stable, upon documentation by the
1201member’s prescriber; provided, however, that a carrier shall not apply any greater deductible,
1202coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1203covered by the plan; and provided further, that the commission shall provide a member or their
1204prescribing health care provider with information regarding the request pursuant to subsection (f)
1205within 30 days of a member or their health care provider contacting the commission to use a
1206different brand name drug or generic drug of the same pharmacological class as the drugs
1207selected pursuant to subsection (b).
1208 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1209coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1210or delivery device prescribed by the member’s health care provider at the same cost as required
1211under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1212 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
12133 business days following the receipt of all necessary information to establish the medical
1214necessity of the prescribed treatment. If additional delay would result in significant risk to the 57 of 85
1215member’s health or well-being, the carrier shall respond not more than 24 hours following the
1216receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1217If a response by the carrier is not received within the time required under this subsection, an
1218exception shall be deemed granted.
1219 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1220once annually and shall provide notice to the health policy commission not less than 90 days
1221before making changes to the selected drugs and delivery devices and an explanation of such
1222changes. Upon verification by the health policy commission that the selected drugs meet the
1223criteria identified in subsection (c), the carrier shall provide notice to its members not less than
122430 days before any changes to the selected drugs are made.
1225 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1226section.
1227 (l) If a high deductible health plan subject to this section is used to establish a savings
1228account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1229section shall apply to the plan to the maximum extent possible without causing the account to
1230lose its tax-exempt status.
1231 SECTION 48. Chapter 176B of the General Laws is hereby amended by inserting after
1232section 4UU the following section:-
1233 Section 4VV. (a) As used in this section, the following words shall have the following
1234meanings unless the context clearly requires otherwise: 58 of 85
1235 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1236drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1237application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
1238is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1239Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1240application that was approved by the United States Secretary of Health and Human Services
1241under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1242date of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984,
1243Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 C.F.R.
1244447.502; (ii) produced or distributed pursuant to a biologics license application approved under
124542 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug based
1246on available data resources, including Medi-Span.
1247 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1248drug; and (ii) an individual can obtain with a prescription.
1249 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1250abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1251drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1252and was not originally marketed under a new drug application; or (iv) identified by the health
1253benefit plan as a generic drug based on available data resources such as Medi-Span.
1254 “Separate delivery device”, a device that: (i) is used to deliver a brand name drug or a
1255generic drug; and (ii)can be obtained with a prescription separate from or in addition to the brand
1256name drug or generic drug that the device delivers. 59 of 85
1257 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1258chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1259chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited
1260to, those heart conditions that disproportionately impact a particular demographic group,
1261including people of color.
1262 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1263brand name drug and 1 insulin generic drug, the commission shall select 1 insulin brand name
1264drug per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting,
1265ultra long-acting and premixed. To the extent possible, the commission shall select 1 generic
1266insulin per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-
1267acting, ultra long-acting and premixed, subject to such generic drug’s availability.
1268 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1269condition, the carrier shall select a drug that is among the top three of the carrier’s most
1270prescribed or of the highest volume for the chronic condition, and shall consider whether the
1271drug is:
1272 (i) of clear benefit and strongly supported by clinical evidence;
1273 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1274exacerbations of illness progression or improve quality of life;
1275 (iii) relatively low cost when compared to the cost of an acute illness or incident
1276prevented or delayed by the use of the service, treatment or drug;
1277 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 60 of 85
1278 (v) likely to have a considerable financial impact on individual patients by reducing or
1279eliminating patient cost-sharing pursuant to this section; and
1280 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1281including people of color.
1282 (d) Any carrier offering a policy, contract or certificate of health insurance under this
1283chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1284subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1285including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1286selected brand name drugs shall not be subject to any deductible or coinsurance and no
1287copayment shall exceed $25 per 30-day supply; provided, however, that nothing in this section
1288shall prevent co-payments for a 30-day supply of the selected brand name drugs from being
1289reduced below the amount specified in this section.
1290 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1291delivery device, the carrier shall select a delivery device for that drug in accordance with the
1292criteria established under subsection (c) for selecting brand name drugs and generic drugs, to the
1293extent possible. The carrier shall provide coverage for the delivery device and the delivery
1294device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1295shall not be subject to any deductible.
1296 (f) A member and their prescribing health care provider shall have access to a clear,
1297readily accessible and convenient process to request to use a different brand name drug or
1298generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1299Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs 61 of 85
1300selected pursuant to said subsection (b) are contraindicated or will likely cause an adverse
1301reaction in or physical or mental harm to the member; (ii) the brand name drugs and generic
1302drugs selected pursuant to said subsection (b) are expected to be ineffective based on the known
1303clinical characteristics of the member and the known characteristics of the prescription drug
1304regimen; (iii) the member or prescribing health care provider: (A) has provided documentation to
1305the carrier establishing that the member has previously tried the brand name drugs and generic
1306drugs selected pursuant to said subsection (b) or another prescription drug in the same
1307pharmacologic class or with the same mechanism of action while covered by the carrier or by a
1308previous health insurance carrier or a health benefit plan; and (B) such prescription drug was
1309discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1310(iv) the member or prescribing health care provider has provided documentation to the carrier
1311establishing that the member: (A) is stable on a prescription drug prescribed by the health care
1312provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1313harm to the member. When applicable this subsection shall apply to delivery devices.
1314 (g) The carrier shall implement a continuity of coverage policy to apply to members who
1315are new to the plan and that provides coverage for a 90-day fill of a United States Food and Drug
1316Administration-approved drug reimbursed through a pharmacy benefit that the member has
1317already been prescribed and on which the member is stable, upon documentation by the
1318member’s prescriber; provided, however, that a carrier shall not apply any greater deductible,
1319coinsurance, copayment or out-of-pocket limit than would otherwise apply to other drugs
1320covered by the plan; and provided further, that the commission shall provide a member or their
1321prescribing health care provider with information regarding the request pursuant to subsection (f)
1322within 30 days of a member or their health care provider contacting the commission to use a 62 of 85
1323different brand name drug or generic drug of the same pharmacological class as the drugs
1324selected pursuant to subsection (b).
1325 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1326coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1327or delivery device prescribed by the member’s health care provider at the same cost as required
1328under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1329 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
13303 business days following the receipt of all necessary information to establish the medical
1331necessity of the prescribed treatment. If additional delay would result in significant risk to the
1332member’s health or well-being, the carrier shall respond not more than 24 hours following the
1333receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1334If a response by the carrier is not received within the time required under this subsection, an
1335exception shall be deemed granted.
1336 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1337once annually and shall provide notice to the health policy commission not less than 90 days
1338before making any such changes to the selected drugs and delivery devices and an explanation of
1339those changes. Upon verification by the health policy commission that the selected drugs meet
1340the criteria identified in subsection (c), the carrier shall provide notice to its members not less
1341than 30 days before any changes to the selected drugs are made.
1342 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1343section. 63 of 85
1344 (l) If a high deductible health plan subject to this section is used to establish a savings
1345account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1346section shall apply to the plan to the maximum extent possible without causing the account to
1347lose its tax-exempt status.
1348 SECTION 49. The fourth paragraph of section 3B of chapter 176D of the General Laws,
1349as appearing in the 2022 Official Edition, is hereby amended by inserting after the second
1350sentence the following sentence:- A carrier shall not prohibit the dispensing of specialty drugs
1351that are included in its pharmaceutical drug benefits to insureds by any network specialty
1352pharmacy licensed under section 39K of chapter 112; provided, however, that the pharmacy
1353agrees to the in-network reimbursement rate for the specialty drug.
1354 SECTION 50. Said section 3B of said chapter 176D, as so appearing, is hereby further
1355amended by striking out the fifth paragraph and inserting in place thereof the following
1356paragraph:-
1357 A carrier shall not prohibit a network pharmacy from offering and providing mail
1358delivery services to an insured; provided, however, that the network pharmacy agrees to the
1359reimbursement terms and conditions and discloses to the insured any delivery service fee
1360associated with the delivery service.
1361 SECTION 51. The eighth paragraph of said section 3B of said chapter 176D, as so
1362appearing, is hereby amended by adding the following sentence:- The term “specialty drugs”
1363shall mean a specialty drug as defined under section 39K of chapter 112.
1364 SECTION 52. Chapter 176G of the General Laws is hereby amended by inserting after
1365section 4MM the following section:- 64 of 85
1366 Section 4NN. (a) As used in this section. the following words shall have the following
1367meanings unless the context clearly requires otherwise:
1368 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1369drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1370application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
1371is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1372Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1373application that was approved by the United States Secretary of Health and Human Services
1374under section 505(c) of said federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1375date of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984,
1376Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 C.F.R.
1377447.502; (ii) produced or distributed pursuant to a biologics license application approved under
137842 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug based
1379on available data resources, such as Medi-Span.
1380 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1381drug; and (ii) an individual can obtain with a prescription.
1382 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1383abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1384drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1385and was not originally marketed under a new drug application; or (iv) identified by the health
1386benefit plan as a generic drug based on available data resources, such as Medi-Span. 65 of 85
1387 “Separate delivery device”, a device that: (i) is used to deliver a brand name drug or a
1388generic drug; and (ii) can be obtained with a prescription separate from or in addition to the
1389brand name drug or generic drug that the device delivers.
1390 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1391chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1392chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited
1393to, those heart conditions that disproportionately impact a particular demographic group,
1394including people of color.
1395 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1396brand name drug and 1 insulin generic drug, the commission shall select 1 insulin brand name
1397drug per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting,
1398ultra long-acting and premixed. To the extent possible, the commission shall select 1 generic
1399insulin per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-
1400acting, ultra long-acting and premixed, subject to such generic drug’s availability.
1401 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1402condition, the carrier shall select a drug that is among the top three of the commission’s most
1403prescribed or of the highest volume for the chronic condition, and shall consider whether the
1404drug is:
1405 (i) of clear benefit and strongly supported by clinical evidence;
1406 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1407exacerbations of illness progression or improve quality of life; 66 of 85
1408 (iii) relatively low cost when compared to the cost of an acute illness or incident
1409prevented or delayed by the use of the service, treatment or drug;
1410 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1411 (v) likely to have a considerable financial impact on individual patients by reducing or
1412eliminating patient cost-sharing pursuant to this section; and
1413 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1414including people of color.
1415 (d) Any carrier offering a policy, contract, or certificate of health insurance under this
1416chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1417subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1418including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1419selected brand name drugs shall not be subject to any deductible or co-insurance and any co-
1420payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section
1421shall prevent co-payments for a 30-day supply of the selected brand name drugs from being
1422reduced below the amount specified in this section.
1423 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1424delivery device, the carrier shall select a delivery device for that drug in accordance with the
1425criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1426extent possible. The carrier shall provide coverage for the delivery device and the delivery
1427device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1428shall not be subject to any deductible. 67 of 85
1429 (f) A member and their prescribing health care provider shall have access to a clear,
1430readily accessible and convenient process to request to use a different brand name drug or
1431generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1432Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs
1433selected pursuant to said subsection (b) are contraindicated or will likely cause an adverse
1434reaction in or physical or mental harm to the member; (ii) the brand name drugs and generic
1435drugs selected pursuant to said subsection (b) are expected to be ineffective based on the known
1436clinical characteristics of the member and the known characteristics of the prescription drug
1437regimen; (iii) the member or prescribing health care provider: (A) has provided documentation to
1438the carrier establishing that the member has previously tried the brand name drugs and generic
1439drugs selected pursuant to subsection (b), or another prescription drug in the same pharmacologic
1440class or with the same mechanism of action, while covered by the carrier or by a previous health
1441insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to
1442lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the member or
1443prescribing health care provider has provided documentation to the carrier establishing that the
1444member: (A) is stable on a prescription drug prescribed by the health care provider; and (B)
1445switching drugs will likely cause an adverse reaction in or physical or mental harm to the
1446member. When applicable this subsection shall apply to delivery devices.
1447 (g) The carrier shall implement a continuity of coverage policy to apply to members who
1448are new to the plan and that provides coverage for a 90-day fill of a United States Food and Drug
1449Administration-approved drug reimbursed through a pharmacy benefit that the member has
1450already been prescribed and on which the member is stable, upon documentation by the
1451member’s prescriber; provided, however, that a carrier shall not apply any greater deductible, 68 of 85
1452coinsurance, copayment or out-of-pocket limit than would otherwise apply to other drugs
1453covered by the plan; and provided further, that the commission shall provide a member or their
1454prescribing health care provider with information regarding the request pursuant to subsection (f)
1455within 30 days of a member or their health care provider contacting the commission to use a
1456different brand name drug or generic drug of the same pharmacological class as the drugs
1457selected pursuant to subsection (b).
1458 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1459coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1460or delivery device prescribed by the member’s health care provider at the same cost as required
1461under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1462 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
14633 business days following the receipt of all necessary information to establish the medical
1464necessity of the prescribed treatment. If additional delay would result in significant risk to the
1465member’s health or well-being, the carrier shall respond not more than 24 hours following the
1466receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1467If a response by the carrier is not received within the time required under this subsection, an
1468exception shall be deemed granted.
1469 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1470once annually and shall provide notice to the health policy commission not less than 90 days
1471before making any such changes to the selected drugs and delivery devices and an explanation of
1472those changes. Upon verification by the health policy commission that the selected drugs meet 69 of 85
1473the criteria identified in subsection (c), the carrier shall provide notice to its members not less
1474than 30 days before any changes to the selected drugs are made.
1475 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1476section.
1477 (l) If a high deductible health plan subject to this section is used to establish a savings
1478account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1479section shall apply to the plan to the maximum extent possible without causing the account to
1480lose its tax-exempt status.
1481 SECTION 53. Section 2 of chapter 176O of the General Laws, as appearing in the 2022
1482Official Edition, is hereby amended by adding the following subsection:-
1483 (i) Every 3 years, a carrier that contracts with a pharmacy benefit manager shall
1484coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with
1485this chapter and to examine the pricing and rebates applicable to prescription drugs that are
1486provided to the carrier’s covered persons.
1487 SECTION 54. Said chapter 176O is hereby further amended by inserting after section 22
1488the following section:-
1489 Section 22A. Notwithstanding any other general or special law to the contrary, each
1490carrier shall require that a pharmacy benefit manager receive a license from the division under
1491chapter 176Y as a condition of contracting with that carrier.
1492 SECTION 55. Said chapter 176O is hereby further amended by adding the following
1493section:- 70 of 85
1494 Section 30. (a) For the purposes of this section, the following words shall have the
1495following meanings unless the context clearly requires otherwise:
1496 “Cost-sharing”, an amount owed by an individual under the terms of the individual’s
1497health benefit plan.
1498 “Pharmacy retail price”, the amount an individual would pay for a prescription drug at a
1499pharmacy if the individual purchased that prescription drug at that pharmacy without using a
1500health benefit plan or any other prescription drug benefit or discount.
1501 (b) At the point of sale, a pharmacy shall charge an individual the lesser of: (i)
1502appropriate cost-sharing amount; or (ii) pharmacy retail price; provided, however, that a carrier,
1503or an entity that manages or administers benefits for a carrier, shall not require an individual to
1504make a payment for a prescription drug at the point of sale in an amount that exceeds the lesser
1505of the: (A) individual’s cost share; or (B) pharmacy retail price.
1506 (c) A contract shall not: (i) prohibit a pharmacist from complying with this section; or (ii)
1507impose a penalty on the pharmacist or pharmacy for complying with this section.
1508 SECTION 56. The General Laws are hereby amended by inserting after chapter 176X the
1509following chapter:-
1510 Chapter 176Y. LICENSING AND REGULATION OF PHARMACY BENEFIT
1511MANAGERS.
1512 Section 1. As used in this chapter, the following words shall have the following meanings
1513unless the context clearly requires otherwise: 71 of 85
1514 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health
1515insurance under chapter 175, a nonprofit hospital service corporation organized under chapter
1516176A, a non-profit medical service corporation organized under chapter 176B, a health
1517maintenance organization organized under chapter 176G and an organization entering into a
1518preferred provider arrangement under chapter 176I; provided, however, that “carrier” shall not
1519include an employer purchasing coverage or acting on behalf of its employees or the employees
1520of any subsidiary or affiliated corporation of the employer; and provided further, that unless
1521otherwise provided, “carrier” shall not include any entity to the extent it offers a policy,
1522certificate or contract that provides coverage solely for dental care services or vision care
1523services.
1524 “Center”, the center for health information and analysis established in chapter 12C.
1525 “Commissioner”, the commissioner of insurance.
1526 “Division”, the division of insurance.
1527 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued
1528by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care
1529services; provided, however, that the commissioner may by regulation define other health
1530coverage as a “health benefit plan” for the purposes of this chapter.
1531 “Pharmacy”, a physical or electronic facility under the direction or supervision of a
1532registered pharmacist that is authorized to dispense prescription drugs and has entered into a
1533network contract with a pharmacy benefit manager or a carrier. 72 of 85
1534 “Pharmacy benefit manager”, a person, business or other entity, however organized, that
1535directly or through a subsidiary provides pharmacy benefit management services for prescription
1536drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
1537insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
1538management services shall include, but not be limited to: (i) the processing and payment of
1539claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
1540of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
1541grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
1542drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
1543clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
1544covered prescription drugs; provided further, that “pharmacy benefit manager” shall not include
1545a health benefit plan sponsor unless otherwise specified by the division.
1546 Section 2. (a) No person, business or other entity shall establish or operate as a pharmacy
1547benefit manager without obtaining a license from the division pursuant to this section. A license
1548may be granted only when the division is satisfied that the entity possesses the necessary
1549organization, background expertise, and financial integrity to supply the services sought to be
1550offered. A pharmacy benefit manager license shall be valid for a period of 3 years and shall be
1551renewable for additional 3-year periods. Initial application and renewal fees for the license shall
1552be established pursuant to section 3B of chapter 7.
1553 (b) A license granted pursuant to this section and any rights or interests therein shall not
1554be transferable. 73 of 85
1555 (c) A person, business or other entity licensed as a pharmacy benefit manager shall
1556submit data and reporting information to the center according to the standards and methods
1557specified by the center pursuant to section 10A of chapter 12C.
1558 (d) The division may issue or renew a license pursuant to this section, subject to
1559restrictions in order to protect the interests of consumers. Such restrictions may include: (i)
1560limiting the type of services that a license holder may provide; (ii) limiting the activities in which
1561the license holder may be engaged; or (iii) addressing conflicts of interest between pharmacy
1562benefit managers and health plan sponsors.
1563 (e) The division shall develop an application for licensure of pharmacy benefit managers
1564that shall include, but not be limited to: (i) the name of the applicant or pharmacy benefit
1565manager; (ii) the address and contact telephone number for the applicant or pharmacy benefit
1566manager; (iii) the name and address of the agent of the applicant or pharmacy benefit manager
1567for service of process in the commonwealth; (iv) the name and address of any person with
1568management or control over the applicant or pharmacy benefit manager; and (v) any audited
1569financial statements specific to the applicant or pharmacy benefit manager. An applicant or
1570pharmacy benefit manager shall report to the division any material change to the information
1571contained in its application, certified by an officer of the pharmacy benefit manager, within 30
1572days of such a change.
1573 (f) The division may suspend, revoke, refuse to issue or renew or place on probation a
1574pharmacy benefit manager license for cause, which shall include, but not be limited to: (i) the
1575applicant or pharmacy benefit manager engaging in fraudulent activity that is found by a court of
1576law to be a violation of state or federal law; (ii) the division receiving consumer complaints that 74 of 85
1577justify an action under this chapter to protect the health, safety and interests of consumers; (iii)
1578the applicant or pharmacy benefit manager failing to pay an application or renewal fee for a
1579license; (iv) the applicant or pharmacy benefit manager failing to comply with reporting
1580requirements of the center under section 10A of chapter 12C; or (v) the applicant pharmacy
1581benefit manager’s failing to comply with a requirement of this chapter.
1582 The division shall provide written notice to the applicant or pharmacy benefit manager
1583and advise in writing of the reason for any suspension, revocation, refusal to issue or renew or
1584placement on probation of a pharmacy benefit manager license under this chapter. A copy of the
1585notice shall be forwarded to the center. The applicant or pharmacy benefit manager may make
1586written demand upon the division within 30 days of receipt of such notification for a hearing
1587before the division to determine the reasonableness of the division’s action. The hearing shall be
1588held pursuant to chapter 30A.
1589 The division shall not suspend or cancel a license unless the division has first afforded
1590the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A.
1591 (g) If a person, business or other entity performs the functions of a pharmacy benefit
1592manager in violation of this chapter, the person, business or other entity shall be subject to a fine
1593of $5,000 per day for each day that the person, business or other entity is found to be in violation.
1594Penalties collected under this subsection shall be deposited into the Prescription Drug Cost
1595Assistance Trust Fund established in section 2BBBBBB of chapter 29.
1596 (h) A pharmacy benefit manager licensed under this section shall notify a health carrier
1597client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit 75 of 85
1598manager that directly or indirectly presents any conflict of interest with the pharmacy benefit
1599manager’s relationship with or obligation to the health carrier client.
1600 (i) The division shall adopt any written policies, procedures or regulations that the
1601division determines are necessary to implement this section.
1602 Section 3. (a) The commissioner may make an examination of the affairs of a pharmacy
1603benefit manager when the commissioner deems prudent but not less frequently than once every 3
1604years. The focus of the examination shall be to ensure that a pharmacy benefit manager is able to
1605meet its responsibilities under contracts with carriers licensed under chapters 175, 176A, 176B,
1606or 176G. The examination shall be conducted according to the procedures set forth in paragraph
1607(6) of section 4 of chapter 175.
1608 (b) The commissioner, a deputy or an examiner may conduct an on-site examination of
1609each pharmacy benefit manager in the commonwealth to thoroughly inspect and examine its
1610affairs.
1611 (c) The charge for each such examination shall be determined annually according to the
1612procedures set forth in paragraph (6) of section 4 of chapter 175.
1613 (d) Not later than 60 days following completion of the examination, the examiner in
1614charge shall file with the commissioner a verified written report of examination under oath.
1615Upon receipt of the verified report, the commissioner shall transmit the report to the pharmacy
1616benefit manager examined with a notice that shall afford the pharmacy benefit manager
1617examined a reasonable opportunity of not more than 30 days to make a written submission or
1618rebuttal with respect to any matters contained in the examination report. Within 30 days of the
1619end of the period allowed for the receipt of written submissions or rebuttals, the commissioner 76 of 85
1620shall consider and review the reports together with any written submissions or rebuttals and any
1621relevant portions of the examiner’s work papers and enter an order:
1622 (i) adopting the examination report as filed with modifications or corrections and, if the
1623examination report reveals that the pharmacy benefit manager is operating in violation of this
1624section or any regulation or prior order of the commissioner, the commissioner may order the
1625pharmacy benefit manager to take any action the commissioner considers necessary and
1626appropriate to cure such violation;
1627 (ii) rejecting the examination report with directions to examiners to reopen the
1628examination for the purposes of obtaining additional data, documentation or information and re-
1629filing pursuant to the above provisions; or
1630 (iii) calling for an investigatory hearing with not less than 20 days’ notice to the
1631pharmacy benefit manager for purposes of obtaining additional documentation, data, information
1632and testimony.
1633 (e) Notwithstanding any general or special law to the contrary, including clause Twenty-
1634sixth of section 7 of chapter 4 and chapter 66, the records of any such audit, examination or other
1635inspection and the information contained in the records, reports or books of any pharmacy
1636benefit manager examined pursuant to this section shall be confidential and open only to the
1637inspection of the commissioner, or the examiners and assistants. Access to such confidential
1638material may be granted by the commissioner to law enforcement officials of the commonwealth
1639or any other state or agency of the federal government at any time if the agency or office
1640receiving the information agrees in writing to keep such material confidential. Nothing in this
1641subsection shall be construed to prohibit the required production of such records, and 77 of 85
1642information contained in the reports of such company or organization before any court of the
1643commonwealth or any master or auditor appointed by any such court, in any criminal or civil
1644proceeding, affecting such pharmacy benefit manager, its officers, partners, directors or
1645employees. The final report of any such audit, examination or any other inspection by or on
1646behalf of the division of insurance shall be a public record.
1647 SECTION 57. (a) Notwithstanding any general or special law to the contrary, the
1648commonwealth health insurance connector authority, in consultation with the division of
1649insurance, shall report on the impact of pharmaceutical pricing on health care costs and outcomes
1650for ConnectorCare and non-group and small group plans offered through the connector and its
1651members.
1652 The report shall include, but not be limited to: (i) information on the differential between
1653drug list price and price net of rebates for plans offered and the impact of those differentials on
1654member premiums; (ii) the relationship between drug list price and member cost-sharing
1655requirements; (iii) the impact of drug price changes over time on premium and out-of-pocket
1656costs in plans authorized under section 3 of chapter 176J of the General Laws offered through the
1657commonwealth health insurance connector authority; (iv) trends in changes in drug list price and
1658price net of rebates by health plan; (v) an analysis of the impact of member out-of-pocket costs
1659on drug utilization and member experience; and (vi) an analysis of the impact of drug list price
1660and price net of rebates on member formulary access to drug. Data collected under this
1661subsection shall be protected as confidential and shall not be a public record under clause
1662Twenty-sixth of section 7 of chapter 4 of the General Laws or under chapter 66 of the General
1663Laws. 78 of 85
1664 The report shall be submitted to the joint committee on health care financing and the
1665house and senate committees on ways and means not later than July 1, 2025.
1666 (b) In fiscal year 2024, the amount required to be paid pursuant to the last paragraph of
1667section 6 of chapter 6D of the General Laws shall be increased by $500,000; provided, however,
1668that said $500,000 shall be provided to the commonwealth health insurance connector authority
1669not later than March 14, 2024 for data collection and analysis costs associated with the report
1670required by this section.
1671 SECTION 58. Notwithstanding any general or special law to the contrary, there shall be a
1672special commission to examine the feasibility of: (i) establishing a system for the bulk
1673purchasing and distribution of pharmaceutical products with a significant public health benefit
1674and the potential for significant health care cost savings for consumers through overall increased
1675purchase capacity; and (ii) making bulk purchase pricing information available to purchasers in
1676other states.
1677 The commission shall consist of: the commissioner of public health or a designee, who
1678shall serve as chair; the executive director of the group insurance commission or a designee; the
1679chief of pharmacy of the state office for pharmacy services; the MassHealth director of
1680pharmacy; the secretary of technology services and security; and 9 members to be appointed by
1681the commissioner of public health, 2 of whom shall be health care economists, 1 of whom shall
1682be an expert in health law and policy innovation, 1 of whom shall be an academic with relevant
1683expertise in the field, 1 of whom shall be a representative from a community health center, 1 of
1684whom shall be the chief executive officer of a hospital licensed in the commonwealth, 1 of
1685whom shall be a representative of the Massachusetts Association of Health Plans, Inc., 1 of 79 of 85
1686whom shall be a representative of Blue Cross Blue Shield of Massachusetts, Inc. and 1 of whom
1687shall be a member of the public with experience with health care and consumer protection.
1688 The commission shall hold not less than 3 public hearings in different geographic areas of
1689the commonwealth, accept input from the public and solicit expert testimony from individuals
1690representing health insurance carriers, pharmaceutical companies, independent and chain
1691pharmacies, hospitals, municipalities, health care practitioners, health care technology
1692professionals, community health centers, substance abuse disorder providers, public health
1693educational institutions and other experts identified by the commission.
1694 The commission shall consider: (i) the process by which the commonwealth could make
1695bulk purchases of pharmaceutical products with a significant public health benefit and the
1696potential for significant health care cost savings to consumers; (ii) the process by which both
1697governmental and nongovernmental entities may participate in a collaborative to purchase
1698pharmaceutical products with a significant public health benefit and the potential for significant
1699health care cost savings; (iii) the feasibility of developing an electronic information interchange
1700system to exchange bulk purchase price information with partnering states; (iv) potential sources
1701of funding available to implement bulk purchases; (v) potential cost savings of bulk purchases to
1702the commonwealth or other participating nongovernmental entities; (vi) the feasibility of
1703partnering with the federal government or other states in the New England region; and (vii) any
1704other factors that the commission deems relevant.
1705 The commission shall file a report of its analysis, along with any recommended
1706legislation, if any, to the clerks of the senate and house of representatives, the house and senate
1707committees on ways and means, the joint committee on health care financing, the joint 80 of 85
1708committee on public health, the joint committee on elder affairs and the joint committee on
1709mental health, substance abuse and recovery not later than September 1, 2024.
1710 SECTION 59. (a) As used in this section, the following words shall have the following
1711meanings unless the context clearly requires otherwise:
1712 “Chain pharmacist”, a pharmacist employed by a retail drug organization operating not
1713less than 10 retail drug stores within the commonwealth under section 39 of chapter 112 of the
1714General Laws.
1715 “Independent pharmacist”, a pharmacist actively engaged in the business of retail
1716pharmacy and employed in an organization of not more than 9 registered retail drugstores in the
1717commonwealth under said section 39 of said chapter 112 that employs not more than a total of
171820 full-time pharmacists.
1719 (b) There shall be a task force to: (i) review the drug supply chain and reimbursement
1720structures including, but not limited to: (A) plan and pharmacy benefit manager reimbursements
1721to pharmacies; (B) wholesaler prices to pharmacies; (C) pharmacy services administrative
1722organization fees and contractual relationships with pharmacies; and (D) drug manufacturer
1723prices to wholesalers; (ii) review ways to recognize the unique challenges of small and
1724independent pharmacies; (iii) identify methods to increase pricing transparency throughout the
1725supply chain; (iv) make recommendations on the use of multiple maximum allowable costs lists
1726and their frequency of use for mail order products; (v) review the utilization of maximum
1727allowable costs lists or similar reimbursement structures established by a pharmacy benefit
1728manager or payer; (vi) review the availability of drugs to independent and chain pharmacies on
1729the maximum allowable cost list or any similar reimbursement structures established by a 81 of 85
1730pharmacy benefit manager or payer; (vii) review the pharmacy acquisition cost from national or
1731regional wholesalers that serve pharmacies compared to the reimbursement amount provided
1732through a maximum allowable cost list or any similar reimbursement structures established by a
1733pharmacy benefit manager or payer and the conditions under which an adjustment to a
1734reimbursement is appropriate; (viii) review the timing of pharmacy purchases of products and the
1735relative risk of list price changes related to the timing of dispensing the products; (ix) assess
1736ways to increase transparency for chain and independent pharmacists to understand the
1737methodology used by a pharmacy benefit manager or payer to develop a maximum allowable
1738cost list or any similar reimbursement structure established by the pharmacy benefit manager or
1739payer; (x) assess the prevalence and appropriateness of pharmacy benefit managers requiring, or
1740using financial incentives or penalties to incentivize, customer use of pharmacies with whom the
1741pharmacy benefit manager has an ownership or financial interest; (xi) examine the impact of the
1742merger or consolidation of pharmacy benefit managers and health carrier clients on drug costs;
1743(xii) review current appeals processes for a chain or independent pharmacist to request an
1744adjustment on a reimbursement subject to a maximum allowable cost list or any similar
1745reimbursement structure established by a pharmacy benefit manager or payer; and (xiii) evaluate
1746the effect of differences between pharmacy benefit manager payments to pharmacies and charges
1747made to health carrier clients on drug price.
1748 (c) The task force shall consist of: the commissioner of insurance or a designee, who shall
1749serve as chair; and 9 members to be appointed by the commissioner, 2 of whom shall be
1750independent pharmacists employed in the independent pharmacy setting or representatives of
1751independent pharmacies, 2 of whom shall be chain pharmacists employed in the chain pharmacy
1752setting or representatives of chain pharmacies, 2 of whom shall be representatives of a pharmacy 82 of 85
1753benefit managers or payers who manage their own pharmacy benefit services, 1 of whom shall
1754represent the Massachusetts Association of Health Plans, Inc., 1 of whom shall represent Blue
1755Cross Blue Shield of Massachusetts, Inc. and 1 of whom shall be a representative of wholesalers
1756or pharmacy services administrative organizations. If more than 1 independent pharmacist is
1757appointed, each appointee shall represent a distinct practice setting. If more than 1 chain
1758pharmacist is appointed, each appointee shall represent a distinct practice setting. A pharmacy
1759benefit manager or payer appointed to the task force shall not be co-owned or have any
1760ownership relationship with any other payer, pharmacy benefit manager or chain pharmacist also
1761appointed to the task force.
1762 (d) The commissioner shall file the task force’s findings with the clerks of the house of
1763representatives and the senate, the joint committee on health care financing and the house and
1764senate committees on ways and means not later than December 1, 2024.
1765 SECTION 60. The health policy commission shall consult with relevant stakeholders,
1766including, but not limited to, consumers, consumer advocacy organizations, organizations
1767representing people with disabilities and chronic health conditions, providers, provider
1768organizations, payers, pharmaceutical manufacturers, pharmacy benefit managers and health care
1769economists and other academics, to assist in the development and periodic review of regulations
1770to implement section 21 of chapter 6D of the General Laws, including, but not limited to: (i)
1771establishing the criteria and processes for identifying the proposed value of an eligible drug as
1772defined in said section 21 of said chapter 6D; and (ii) determining the appropriate price increase
1773for a public health essential drug as described within the definition of eligible drug in said
1774section 21 of said chapter 6D. 83 of 85
1775 The commission shall hold its first public outreach not more than 45 days after the
1776effective date of this act and shall, to the extent possible, ensure fair representation and input
1777from a diverse array of stakeholders.
1778 SECTION 61. Annually, each carrier shall report to the division of insurance the drugs
1779selected to be provided with no or limited cost-sharing under section 17T of chapter 32A of the
1780General Laws, section 10R of chapter 118E of the General Laws, section 47UU of chapter 175 of
1781the General Laws, section 8VV of chapter 176A of the General Laws, section 4VV of chapter
1782176B of the General Laws and section 4NN of chapter 176G of the General Laws. The division
1783of insurance shall consult with the health policy commission and the center for health and
1784information analysis to review the drugs to verify that the selected drugs meet the criteria
1785identified in said section 17T of said chapter 32A, said section 10R of said chapter 118E, said
1786section 47UU of said chapter 175, said section 8VV of said chapter 176A, said section 4VV of
1787said chapter 176B and said section 4NN of said chapter 176G. If a selected drug shall be deemed
1788by the division to not meet the criteria, the division may require a different drug to be selected.
1789The division shall disclose the list of drugs selected by each entity annually on the division’s
1790website.
1791 SECTION 62. Notwithstanding subsection (b) of section 15A of chapter 6D of the
1792General Laws, for the purposes of providing early notice under said section 15A of said chapter
17936D, the health policy commission shall determine a significant price increase for a generic drug
1794to be defined as a generic drug priced at $100 or more per wholesale acquisition cost unit that
1795increases in cost by 100 per cent or more during any 12-month period.
1796 SECTION 63. Section 62 is hereby repealed. 84 of 85
1797 SECTION 64. The health policy commission, in consultation with the department of
1798public health, the office of Medicaid, the group insurance commission and the division of
1799insurance, shall study and analyze health insurance payer, including public and private payer,
1800specialty pharmacy networks in the commonwealth. The study shall include: (i) a description of
1801the type of specialty drugs most often provided by specialty pharmacies; (ii) the impact of
1802existing health insurance payers’ specialty pharmacy networks on patient access, availability of
1803clinical support, continuity of care, safety, quality, cost sharing and health care costs; and (iii)
1804any recommendations for increasing patient access to and choice of specialty drugs, maintaining
1805high-quality specialty pharmacy standards and meeting the commonwealth’s health care cost
1806containment goals.
1807 The commission shall submit a report of its findings and recommendations to the clerks
1808of the senate and house of representatives, the senate and house committees on ways and means,
1809the joint committee on health care financing and the joint committee on public health not later
1810than July 1, 2024.
1811 SECTION 65. The regulations required by subsection (d) of section 39K of chapter 112
1812of the General Laws shall be promulgated not later than December 31, 2023.
1813 SECTION 66. Sections 21 and 39 shall take effect on July 1, 2024.
1814 SECTION 67. Sections 41, 44, 45, 47, 48, 52 and 61 shall take effect as of July 1, 2025.
1815 SECTION 68. Section 43 shall take effect on April 1, 2024.
1816 SECTION 69. Section 54 shall take effect on July 1, 2024.
1817 SECTION 70. Section 56 shall take effect on March 30, 2024. 85 of 85
1818 SECTION 71. Section 63 shall take effect on January 1, 2025.