Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H1092 Compare Versions

Only one version of the bill is available at this time.

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2	2	HOUSE DOCKET, NO. 3583 FILED ON: 1/17/2025
3	3	HOUSE . . . . . . . . . . . . . . . No. 1092
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Christine P. Barber
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act to ensure affordable prescription medications through accountability standards.
13	13	_______________
14	14	PETITION OF:
15	15	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
16	16	HOUSE DOCKET, NO. 3583 FILED ON: 1/17/2025
17	17	HOUSE . . . . . . . . . . . . . . . No. 1092
18	18	By Representative Barber of Somerville, a petition (accompanied by bill, House, No. 1092) of
19	19	Christine P. Barber and others relative to prescription medications. Financial Services.
20	20	The Commonwealth of Massachusetts
21	21	_______________
22	22	In the One Hundred and Ninety-Fourth General Court
23	23	(2025-2026)
24	24	_______________
25	25	An Act to ensure affordable prescription medications through accountability standards.
26	26	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
27	27	of the same, as follows:
28	28	1 SECTION 1. Section 1 of chapter 6D of the General Laws, as appearing, is hereby
29	29	2amended by inserting after the definition of “Alternative payment methodologies or methods”
30	30	3the following 2 definitions:-
31	31	4 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
32	32	5application approved under 42 U.S.C. 262(k)(3).
33	33	6 SECTION 2. Said chapter 6D, as so appearing, is hereby further amended by adding the
34	34	7following section:-Section 22. (a) For the purposes of this section, “Manufacturer” shall mean an
35	35	8entity that manufactures a pharmaceutical drug.
36	36	9 (b) The commission may require a manufacturer specified in subsection (c) to disclose to
37	37	10the commission within a reasonable time information relating to the manufacturer’s pricing of
38	38	11that drug, on a standard reporting form developed by the commission with the input of the
39	39	12manufacturers, which includes, but shall not be limited to, the following: 2 of 8
40	40	13 (1) A schedule of the drug’s wholesale acquisition cost increases over the previous 5
41	41	14calendar years;
42	42	15 (2) The manufacturer’s aggregate, company-level research and development and other
43	43	16relevant capital expenditures, including facility construction, for the most recent year for which
44	44	17final audited data are available;
45	45	18 (3) A written, narrative description, suitable for public release, of factors that contributed
46	46	19to reported changes in wholesale acquisition cost during the previous 5 calendar years; and
47	47	20 (4) Any other information that the manufacturer wishes to provide to the commission.
48	48	21 Based on the records furnished, the commission may identify a proposed value for a
49	49	22prescribed drug specified in subsection (c). The Commission may request additional relevant
50	50	23information that it deems necessary.
51	51	24 (c) A manufacturer of a drug for which the commission has received a referral from the
52	52	25center under subsection (b) of section 25 of chapter 12C shall comply with the requirements set
53	53	26forth in this section; provided that the commission may select or prioritize a subset of the
54	54	27referred drugs for the commission’s review.
55	55	28 (d) Records disclosed by a manufacturer under this section shall: (i) be accompanied by
56	56	29an attestation that all information provided is true and correct; (ii) not be public records under
57	57	30section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the
58	58	31commission may produce reports summarizing any findings; provided that any such report shall
59	59	32not be in a form that identifies specific prices charged for or rebate amounts associated with 3 of 8
60	60	33drugs by a manufacturer, or in a manner that is likely to compromise the financial, competitive or
61	61	34proprietary nature of the information.
62	62	35 (e) If, after review of any records furnished to the commission under subsection (b), the
63	63	36commission determines that the manufacturer’s pricing of the drug is potentially unreasonable or
64	64	37excessive in relation to the commission’s proposed value under subsection (b), the commission
65	65	38shall require that the manufacturer provide within 30 days further information related to the
66	66	39pricing of the prescribed drug and the manufacturer’s justification for the pricing. In addition to
67	67	40the manufacturer, the commission may identify other relevant parties including but not limited to
68	68	41patients, providers, provider organizations and payers who may provide information to the
69	69	42commission.
70	70	43 (f) The commission shall provide to the manufacturer for review and input any
71	71	44information, analyses or reports regarding a particular drug reviewed or relied on by the
72	72	45commission in assessing the proposed value of the drug shall be provided to the manufacturer.
73	73	46The commission shall consider any clarifications or data provided by the manufacturer with
74	74	47respect to its drug. The commission may not rely solely on the analysis or research of an outside
75	75	48third party in reaching its determination regarding the proposed value or the reasonableness of
76	76	49the drug pricing.
77	77	50 (g) If the commission relies upon a third party to provide cost-effectiveness analysis or
78	78	51research related to the proposed value, such analysis or research shall also provide, without
79	79	52limitation (i) a description of the methodologies and models used by the third party in its
80	80	53analysis; (ii) any assumptions and potential limitations of research findings in the context of the
81	81	54results; and (iii) outcomes for affected subpopulations that utilize the drug, including but not 4 of 8
82	82	55limited to potential impacts on individuals of minority racial or ethnic groups, and on individuals
83	83	56with specific disabilities or health conditions who regularly utilize the eligible drug.
84	84	57 (h) Not later than 60 days after receiving information from the manufacturer, as required
85	85	58under subsections (b) or (e), the commission shall issue a determination on whether the
86	86	59manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s
87	87	60proposed value of the drug. Following the determination, the commission shall issue
88	88	61recommendations on measures to reduce the cost of the drug and to improve the affordability of
89	89	62the drug for patients. Recommendations may include, but not be limited to: (i) an alternative
90	90	63purchasing plan or value-based payment methodology; (ii) a bulk purchasing program; (iii)
91	91	64changes to co-pay, deductibles, coinsurance or other cost-sharing requirements; or (iv) a
92	92	65reinsurance program to subsidize the cost of the eligible drug. The commission shall make its
93	93	66determination and recommendations public and shall post them on its website and shall provide
94	94	67them to private and public health care payers.
95	95	68 (i) If the manufacturer fails to timely comply with the commission’s request for records
96	96	69under subsections (b) or (e), or otherwise knowingly obstructs the commission’s ability to issue
97	97	70its determination under subsection (h), including, but not limited to, providing incomplete, false
98	98	71or misleading information, the commission may assess a civil penalty to a manufacturer of not
99	99	72more than $500,000. A civil penalty assessed under this subsection shall be deposited into the
100	100	73Payment Reform Fund established pursuant to section 100 of chapter 194 of the acts of 2011.
101	101	74The commission shall seek to promote compliance with this section and shall only impose a civil
102	102	75penalty on the manufacturer as a last resort. 5 of 8
103	103	76 (j) Neither the proposed value, nor the analysis produced via the process to determine a
104	104	77proposed value, is intended to be used by MassHealth, health insurance carriers, managed care
105	105	78organizations, accountable care organizations, hospitals or pharmacies to determine whether a
106	106	79treatment should be approved for an individual patient, whether any individual patient should be
107	107	80subjected to step therapy or other utilization management methodology,
108	108	81 (k) The commission shall adopt any written policies, procedures or regulations that the
109	109	82commission determines necessary to implement this section.
110	110	83 SECTION 3. Section 11N of chapter 12 of the General Laws, as so appearing, is hereby
111	111	84amended by striking out subsection (a) and inserting in place thereof the following subsection:-
112	112	85 (a) The attorney general shall monitor trends in the health care market including, but not
113	113	86limited to, trends in provider organization size and composition, consolidation in the provider
114	114	87market, payer contracting trends, patient access and quality issues in the health care market and
115	115	88prescription drug cost trends. The attorney general may obtain the following information from a
116	116	89private health care payer, public health care payer, pharmaceutical manufacturing company,
117	117	90pharmacy benefit manager, provider or provider organization as any of those terms may be
118	118	91defined in section 1 of chapter 6D: (i) any information that is required to be submitted under
119	119	92sections 8, 9 10 of chapter 12C; (ii) filings, applications and supporting documentation related to
120	120	93any cost and market impact review under section 13 of said chapter 6D; (iii) filings, applications
121	121	94and supporting documentation related to a determination of need application filed under section
122	122	9525C of chapter 111; and (iv) filings, applications and supporting documentation submitted to the
123	123	96federal Centers for Medicare and Medicaid Services or the Office of the Inspector General for
124	124	97any demonstration project. Under section 17 of said chapter 12C and section 8 of said chapter 6D 6 of 8
125	125	98and subject to the limitations stated in those sections, the attorney general may require that any
126	126	99provider, provider organization, pharmaceutical manufacturing company, pharmacy benefit
127	127	100manager, private health care payer or public health care payer produce documents, answer
128	128	101interrogatories and provide testimony under oath related to health care costs and cost trends,
129	129	102pharmaceutical costs, pharmaceutical cost trends, the factors that contribute to cost growth
130	130	103within the commonwealth's health care system and the relationship between provider costs and
131	131	104payer premium rates and the relationship between pharmaceutical drug costs and payer premium
132	132	105rates.
133	133	106 SECTION 4. Said chapter 12C is hereby further amended by striking out section 11, as so
134	134	107appearing, and inserting in place thereof the following section:-
135	135	108 Section 11. The center shall ensure the timely reporting of information required under
136	136	109sections 8, 9, 10. The center shall notify payers, providers, provider organizations, pharmacy
137	137	110benefit managers and pharmaceutical manufacturing companies of any applicable reporting
138	138	111deadlines. The center shall notify, in writing, a private health care payer, provider, provider
139	139	112organization, pharmacy benefit manager or pharmaceutical manufacturing company that it has
140	140	113failed to meet a reporting deadline and that failure to respond within 2 weeks of the receipt of the
141	141	114notice may result in penalties. The center may assess a penalty against a private health care
142	142	115payer, provider, provider organization, pharmacy benefit manager or pharmaceutical
143	143	116manufacturing company that fails, without just cause, to provide the requested information
144	144	117within 2 weeks following receipt of the written notice required under this section of not more
145	145	118than $2,000 per week for each week of delay after the 2-week period following receipt of the
146	146	119written notice. Amounts collected under this section shall be deposited in the Healthcare
147	147	120Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011. 7 of 8
148	148	121 SECTION 5. Said chapter 12C is hereby further amended by adding the following
149	149	122section:-
150	150	123 Section 25. (a) The center shall analyze data on Massachusetts drug utilization and
151	151	124spending, including but not limited to data reported under Sections 10. Annually, the center shall
152	152	125refer drugs to the health policy commission for review under section 8A of chapter 6D that meet
153	153	126any of the following criteria: (i) a current average annual gross cost per utilizer for public and
154	154	127private health care payers in Massachusetts of greater than $50,000; (ii) a biosimilar drug that
155	155	128has a launch wholesale acquisition cost that is not at least 15 per cent lower than the referenced
156	156	129brand biologic at the time the biosimilar is launched; or (iii) among the 25 drugs determined by
157	157	130the center to have the most impact on health care spending in the most recent year of available
158	158	131data, based upon utilization, price, utilization and price growth, patient cost sharing amounts, net
159	159	132spending and other factors as determined by the center. The center shall provide notice of the
160	160	133referral to the manufacturer of the drug.
161	161	134 (b) Not later than May 1, the center shall publish an annual report detailing, at minimum,
162	162	135each drug referred to the health policy commission under subsection (a).
163	163	136 (c) The center shall adopt any written policies, procedures or regulations necessary to
164	164	137implement this section.
165	165	138 SECTION 6. Section 2 of Chapter 176O of the General Laws, as so appearing, is hereby
166	166	139amended by adding the following subsection:-
167	167	140 (i) At least annually, a carrier that contracts with a pharmacy benefit manager shall
168	168	141coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with 8 of 8
169	169	142this chapter and to examine the pricing and rebates applicable to prescription drugs that are
170	170	143provided to the carrier’s covered persons.
171	171	144 SECTION 7. Said chapter 176O of the General Laws is hereby further amended by
172	172	145inserting after section 22 the following section:-
173	173	146 Section 22A. Notwithstanding any other general or special law to the contrary, each
174	174	147carrier shall require that a pharmacy benefit manager receive a license from the division under
175	175	148chapter 176O as a condition of contracting with that carrier.