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HOUSE DOCKET, NO. 3583 FILED ON: 1/17/2025
HOUSE . . . . . . . . . . . . . . . No. 1092
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Christine P. Barber
_________________
To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act to ensure affordable prescription medications through accountability standards.
_______________
PETITION OF:
NAME:DISTRICT/ADDRESS :DATE ADDED:Christine P. Barber34th Middlesex1/17/2025James C. Arena-DeRosa8th Middlesex3/6/2025James K. Hawkins2nd Bristol2/11/2025Patrick Joseph Kearney4th Plymouth1/31/2025Mary S. Keefe15th Worcester3/4/2025Jason M. LewisFifth Middlesex2/18/2025 1 of 8
HOUSE DOCKET, NO. 3583 FILED ON: 1/17/2025
HOUSE . . . . . . . . . . . . . . . No. 1092
By Representative Barber of Somerville, a petition (accompanied by bill, House, No. 1092) of
Christine P. Barber and others relative to prescription medications. Financial Services.
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Fourth General Court
(2025-2026)
_______________
An Act to ensure affordable prescription medications through accountability standards.
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, is hereby
2amended by inserting after the definition of “Alternative payment methodologies or methods”
3the following 2 definitions:-
4 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
5application approved under 42 U.S.C. 262(k)(3).
6 SECTION 2. Said chapter 6D, as so appearing, is hereby further amended by adding the
7following section:-Section 22. (a) For the purposes of this section, “Manufacturer” shall mean an
8entity that manufactures a pharmaceutical drug.
9 (b) The commission may require a manufacturer specified in subsection (c) to disclose to
10the commission within a reasonable time information relating to the manufacturer’s pricing of
11that drug, on a standard reporting form developed by the commission with the input of the
12manufacturers, which includes, but shall not be limited to, the following: 2 of 8
13 (1) A schedule of the drug’s wholesale acquisition cost increases over the previous 5
14calendar years;
15 (2) The manufacturer’s aggregate, company-level research and development and other
16relevant capital expenditures, including facility construction, for the most recent year for which
17final audited data are available;
18 (3) A written, narrative description, suitable for public release, of factors that contributed
19to reported changes in wholesale acquisition cost during the previous 5 calendar years; and
20 (4) Any other information that the manufacturer wishes to provide to the commission.
21 Based on the records furnished, the commission may identify a proposed value for a
22prescribed drug specified in subsection (c). The Commission may request additional relevant
23information that it deems necessary.
24 (c) A manufacturer of a drug for which the commission has received a referral from the
25center under subsection (b) of section 25 of chapter 12C shall comply with the requirements set
26forth in this section; provided that the commission may select or prioritize a subset of the
27referred drugs for the commission’s review.
28 (d) Records disclosed by a manufacturer under this section shall: (i) be accompanied by
29an attestation that all information provided is true and correct; (ii) not be public records under
30section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the
31commission may produce reports summarizing any findings; provided that any such report shall
32not be in a form that identifies specific prices charged for or rebate amounts associated with 3 of 8
33drugs by a manufacturer, or in a manner that is likely to compromise the financial, competitive or
34proprietary nature of the information.
35 (e) If, after review of any records furnished to the commission under subsection (b), the
36commission determines that the manufacturer’s pricing of the drug is potentially unreasonable or
37excessive in relation to the commission’s proposed value under subsection (b), the commission
38shall require that the manufacturer provide within 30 days further information related to the
39pricing of the prescribed drug and the manufacturer’s justification for the pricing. In addition to
40the manufacturer, the commission may identify other relevant parties including but not limited to
41patients, providers, provider organizations and payers who may provide information to the
42commission.
43 (f) The commission shall provide to the manufacturer for review and input any
44information, analyses or reports regarding a particular drug reviewed or relied on by the
45commission in assessing the proposed value of the drug shall be provided to the manufacturer.
46The commission shall consider any clarifications or data provided by the manufacturer with
47respect to its drug. The commission may not rely solely on the analysis or research of an outside
48third party in reaching its determination regarding the proposed value or the reasonableness of
49the drug pricing.
50 (g) If the commission relies upon a third party to provide cost-effectiveness analysis or
51research related to the proposed value, such analysis or research shall also provide, without
52limitation (i) a description of the methodologies and models used by the third party in its
53analysis; (ii) any assumptions and potential limitations of research findings in the context of the
54results; and (iii) outcomes for affected subpopulations that utilize the drug, including but not 4 of 8
55limited to potential impacts on individuals of minority racial or ethnic groups, and on individuals
56with specific disabilities or health conditions who regularly utilize the eligible drug.
57 (h) Not later than 60 days after receiving information from the manufacturer, as required
58under subsections (b) or (e), the commission shall issue a determination on whether the
59manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s
60proposed value of the drug. Following the determination, the commission shall issue
61recommendations on measures to reduce the cost of the drug and to improve the affordability of
62the drug for patients. Recommendations may include, but not be limited to: (i) an alternative
63purchasing plan or value-based payment methodology; (ii) a bulk purchasing program; (iii)
64changes to co-pay, deductibles, coinsurance or other cost-sharing requirements; or (iv) a
65reinsurance program to subsidize the cost of the eligible drug. The commission shall make its
66determination and recommendations public and shall post them on its website and shall provide
67them to private and public health care payers.
68 (i) If the manufacturer fails to timely comply with the commission’s request for records
69under subsections (b) or (e), or otherwise knowingly obstructs the commission’s ability to issue
70its determination under subsection (h), including, but not limited to, providing incomplete, false
71or misleading information, the commission may assess a civil penalty to a manufacturer of not
72more than $500,000. A civil penalty assessed under this subsection shall be deposited into the
73Payment Reform Fund established pursuant to section 100 of chapter 194 of the acts of 2011.
74The commission shall seek to promote compliance with this section and shall only impose a civil
75penalty on the manufacturer as a last resort. 5 of 8
76 (j) Neither the proposed value, nor the analysis produced via the process to determine a
77proposed value, is intended to be used by MassHealth, health insurance carriers, managed care
78organizations, accountable care organizations, hospitals or pharmacies to determine whether a
79treatment should be approved for an individual patient, whether any individual patient should be
80subjected to step therapy or other utilization management methodology,
81 (k) The commission shall adopt any written policies, procedures or regulations that the
82commission determines necessary to implement this section.
83 SECTION 3. Section 11N of chapter 12 of the General Laws, as so appearing, is hereby
84amended by striking out subsection (a) and inserting in place thereof the following subsection:-
85 (a) The attorney general shall monitor trends in the health care market including, but not
86limited to, trends in provider organization size and composition, consolidation in the provider
87market, payer contracting trends, patient access and quality issues in the health care market and
88prescription drug cost trends. The attorney general may obtain the following information from a
89private health care payer, public health care payer, pharmaceutical manufacturing company,
90pharmacy benefit manager, provider or provider organization as any of those terms may be
91defined in section 1 of chapter 6D: (i) any information that is required to be submitted under
92sections 8, 9 10 of chapter 12C; (ii) filings, applications and supporting documentation related to
93any cost and market impact review under section 13 of said chapter 6D; (iii) filings, applications
94and supporting documentation related to a determination of need application filed under section
9525C of chapter 111; and (iv) filings, applications and supporting documentation submitted to the
96federal Centers for Medicare and Medicaid Services or the Office of the Inspector General for
97any demonstration project. Under section 17 of said chapter 12C and section 8 of said chapter 6D 6 of 8
98and subject to the limitations stated in those sections, the attorney general may require that any
99provider, provider organization, pharmaceutical manufacturing company, pharmacy benefit
100manager, private health care payer or public health care payer produce documents, answer
101interrogatories and provide testimony under oath related to health care costs and cost trends,
102pharmaceutical costs, pharmaceutical cost trends, the factors that contribute to cost growth
103within the commonwealth's health care system and the relationship between provider costs and
104payer premium rates and the relationship between pharmaceutical drug costs and payer premium
105rates.
106 SECTION 4. Said chapter 12C is hereby further amended by striking out section 11, as so
107appearing, and inserting in place thereof the following section:-
108 Section 11. The center shall ensure the timely reporting of information required under
109sections 8, 9, 10. The center shall notify payers, providers, provider organizations, pharmacy
110benefit managers and pharmaceutical manufacturing companies of any applicable reporting
111deadlines. The center shall notify, in writing, a private health care payer, provider, provider
112organization, pharmacy benefit manager or pharmaceutical manufacturing company that it has
113failed to meet a reporting deadline and that failure to respond within 2 weeks of the receipt of the
114notice may result in penalties. The center may assess a penalty against a private health care
115payer, provider, provider organization, pharmacy benefit manager or pharmaceutical
116manufacturing company that fails, without just cause, to provide the requested information
117within 2 weeks following receipt of the written notice required under this section of not more
118than $2,000 per week for each week of delay after the 2-week period following receipt of the
119written notice. Amounts collected under this section shall be deposited in the Healthcare
120Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011. 7 of 8
121 SECTION 5. Said chapter 12C is hereby further amended by adding the following
122section:-
123 Section 25. (a) The center shall analyze data on Massachusetts drug utilization and
124spending, including but not limited to data reported under Sections 10. Annually, the center shall
125refer drugs to the health policy commission for review under section 8A of chapter 6D that meet
126any of the following criteria: (i) a current average annual gross cost per utilizer for public and
127private health care payers in Massachusetts of greater than $50,000; (ii) a biosimilar drug that
128has a launch wholesale acquisition cost that is not at least 15 per cent lower than the referenced
129brand biologic at the time the biosimilar is launched; or (iii) among the 25 drugs determined by
130the center to have the most impact on health care spending in the most recent year of available
131data, based upon utilization, price, utilization and price growth, patient cost sharing amounts, net
132spending and other factors as determined by the center. The center shall provide notice of the
133referral to the manufacturer of the drug.
134 (b) Not later than May 1, the center shall publish an annual report detailing, at minimum,
135each drug referred to the health policy commission under subsection (a).
136 (c) The center shall adopt any written policies, procedures or regulations necessary to
137implement this section.
138 SECTION 6. Section 2 of Chapter 176O of the General Laws, as so appearing, is hereby
139amended by adding the following subsection:-
140 (i) At least annually, a carrier that contracts with a pharmacy benefit manager shall
141coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with 8 of 8
142this chapter and to examine the pricing and rebates applicable to prescription drugs that are
143provided to the carrier’s covered persons.
144 SECTION 7. Said chapter 176O of the General Laws is hereby further amended by
145inserting after section 22 the following section:-
146 Section 22A. Notwithstanding any other general or special law to the contrary, each
147carrier shall require that a pharmacy benefit manager receive a license from the division under
148chapter 176O as a condition of contracting with that carrier.