Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H1364 Compare Versions

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22 HOUSE DOCKET, NO. 3091 FILED ON: 1/16/2025
33 HOUSE . . . . . . . . . . . . . . . No. 1364
44 The Commonwealth of Massachusetts
55 _________________
66 PRESENTED BY:
77 Carole A. Fiola
88 _________________
99 To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
1010 Court assembled:
1111 The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
1212 An Act relative to promoting healthcare access and affordability for patients.
1313 _______________
1414 PETITION OF:
1515 NAME:DISTRICT/ADDRESS :DATE ADDED:Carole A. Fiola6th Bristol1/16/2025 1 of 5
1616 HOUSE DOCKET, NO. 3091 FILED ON: 1/16/2025
1717 HOUSE . . . . . . . . . . . . . . . No. 1364
1818 By Representative Fiola of Fall River, a petition (accompanied by bill, House, No. 1364) of
1919 Carole A. Fiola relative to healthcare access and affordability for patients. Health Care
2020 Financing.
2121 The Commonwealth of Massachusetts
2222 _______________
2323 In the One Hundred and Ninety-Fourth General Court
2424 (2025-2026)
2525 _______________
2626 An Act relative to promoting healthcare access and affordability for patients.
2727 Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
2828 of the same, as follows:
2929 1 SECTION 1. Sections 131 and 226 of chapter 139 of the acts of 2012 are hereby
3030 2repealed.
3131 3 SECTION 2:  Chapter 176O of the General Laws is hereby amended by adding the
3232 4following section:-
3333 5 Section 31. (a) As used in this section, the following words shall, unless the context
3434 6clearly requires otherwise, have the following meanings:
3535 7 “Cost-sharing”, as defined in subsection (a) of section 21C of chapter 94C.
3636 8 “Estimated rebate”, any: (i) negotiated price concessions, whether described as a rebate
3737 9or otherwise, including, but not limited to, base price concessions, and reasonable estimates of
3838 10any price protection rebates and performance-based price concessions that may accrue, directly
3939 11or indirectly, to a carrier, pharmacy benefit manager or other party on a carrier’s behalf during a 2 of 5
4040 12carrier’s plan year from a pharmaceutical manufacturing company, dispensing pharmacy or other
4141 13party to the transaction based on the amounts the carrier received in the prior quarter or
4242 14reasonably expects to receive in the current quarter; and (ii) reasonable estimates of any price
4343 15concessions, fees and other administrative costs that are passed through, or are reasonably
4444 16anticipated to be passed through to the carrier, pharmacy benefit manager or other party on the
4545 17carrier’s behalf and that serve to reduce the carrier’s prescription drug liabilities for the plan year
4646 18based on the amounts the carrier received in the prior quarter or reasonably expects to receive in
4747 19the current quarter.
4848 20 “Pharmacy benefit manager”, as defined in section 1 of chapter 176Y.
4949 21 “Price protection rebate”, a negotiated price concession that accrues directly or indirectly
5050 22to the carrier, or other party on behalf of the carrier, including a pharmacy benefit manager, in
5151 23the event of an increase in the wholesale acquisition cost of a drug that is greater than a specified
5252 24threshold.
5353 25 (b) A carrier, or any pharmacy benefit manager, shall make available to an insured at
5454 26least 80 per cent of the estimated rebates received by such carrier, or any pharmacy benefit
5555 27manager, by reducing the amount of defined cost-sharing that the carrier would otherwise charge
5656 28at the point of sale, except that the reduction amount shall not result in a credit at the point of
5757 29sale. Neither the insured nor the carrier shall be responsible for any difference between the
5858 30estimated rebate amount and the actual rebate amount the carrier receives; provided, that such
5959 31estimates were calculated in good faith.
6060 32 (c) Nothing in this section shall preclude a pharmacy benefit manager from decreasing an
6161 33insured’s defined cost-sharing by an amount greater than that required under subsection (b). 3 of 5
6262 34 (d) Annually, not later than April 1, a carrier shall file with the division a report in the
6363 35manner and form determined by the commissioner demonstrating the manner in which the carrier
6464 36has complied with this section. If the commissioner determines that a carrier has not complied
6565 37with 1 or more requirements of this section, the commissioner shall notify the carrier of such
6666 38noncompliance and a date by which the carrier must demonstrate compliance. If the carrier does
6767 39not come into compliance by such date, the division shall impose a fine not to exceed $5,000 for
6868 40each day during which such noncompliance continues.
6969 41 (e) In implementing the requirements of this section, the division shall only regulate a
7070 42carrier or pharmacy benefit manager to the extent permissible under applicable law.
7171 43 (f) A pharmacy benefit manager, its agent or any third-party administrator shall not
7272 44publish or otherwise disclose information regarding the actual amount of rebates a carrier
7373 45receives on a specific product or therapeutic class of products, manufacturer or pharmacy-
7474 46specific basis. Such information shall be considered to be a trade secret and confidential
7575 47commercial information, shall not be a public record as defined by clause Twenty-sixth of
7676 48section 7 of chapter 4 or section 10 of chapter 66, and shall not be disclosed directly or
7777 49indirectly, or in a manner that would allow for the identification of an individual product,
7878 50therapeutic class of products or manufacturer, or in a manner that would have the potential to
7979 51compromise the financial, competitive or proprietary nature of the information. A pharmacy
8080 52benefit manager shall impose the confidentiality protections and requirements of this section on
8181 53any agent or third-party administrator that performs health care or administrative services on
8282 54behalf of the pharmacy benefit manager that may receive or have access to rebate related
8383 55information. 4 of 5
8484 56 SECTION 3. (a) Notwithstanding any general or special law to the contrary, the health
8585 57policy commission, together with the secretary of the executive office of health and human
8686 58services, shall conduct an analysis and issue a report on the future of cell and gene therapy in the
8787 59commonwealth with the objective of addressing anticipated barriers to access that may exist with
8888 60respect to such treatments for patients covered by MassHealth programs and other vulnerable
8989 61populations.  The analysis and report shall include, but not be limited to:
9090 62 (1) a projection of the estimated total number of cell and gene therapy products, including
9191 63information on the diseases and conditions such products will be approved to treat (including the
9292 64total estimated number of lives impacted in the commonwealth, and the total number receiving
9393 65care under MassHealth), that are expected to come to market in the U.S. (hereinafter the
9494 66“products”) during a forecast period of 2027 to 2037 (hereinafter, the “forecast period”);
9595 67 (2) an assessment of existing reimbursement frameworks and methodologies employed
9696 68by MassHealth for the products to the extent purchased by health care facilities for
9797 69administration to MassHealth beneficiaries during inpatient hospital stays;
9898 70 (3) an assessment of whether the reimbursement frameworks and methodologies
9999 71identified in subdivision (2) would lead to barriers to access to the products during the forecast
100100 72period in light of the projected costs to the Massachusetts health care system associated with the
101101 73utilization of the products, and whether such barriers to access, if any, would disproportionately
102102 74impact MassHealth beneficiaries or other vulnerable populations, including population groups
103103 75that may be more likely to have adverse health outcomes due to experience with historic
104104 76disparities or discrimination, including racial or ethnic minority population groups; 5 of 5
105105 77 (4) An assessment of whether the health care facility infrastructure in place and planned
106106 78for development during the forecast period, and that is necessary of the administration of the
107107 79products, will be adequate to ensure equitable access for patients in need of treatment with the
108108 80products.
109109 81 (b) To the extent that the analysis required under subdivision (3) of subsection (a)
110110 82identifies any barriers to access, the commission and the secretary shall analyze and report on the
111111 83reasons for such barriers and shall propose corrective policy solutions.  If any identified barriers
112112 84are the result of or otherwise related to current MassHealth reimbursement methodologies for
113113 85gene and cell therapies, the commission and the secretary shall propose modifications to such
114114 86methodologies to the extent authorized under Federal law.  Such proposed modifications shall
115115 87address and be designed to eliminate any disproportionate impact of the access barriers on
116116 88MassHealth beneficiaries or other vulnerable populations. 
117117 89 (c)  In conducting the analysis and producing the report as required by subsection (a), the
118118 90secretary and the commission shall consult with the Massachusetts Biotechnology Council or a
119119 91designee, the Massachusetts Hospital Association or a designee, the Conference of Boston
120120 92Teaching Hospitals or a designee, and the rare disease advisory council established pursuant to
121121 93section 26 of chapter 260 of the acts of 2020. 
122122 94 (d)  The report shall be made available electronically on the commission’s website, and
123123 95shall be filed with the secretary of administration and finance, the clerks of the house of
124124 96representatives and the senate, the house and senate committees on ways and means and the joint
125125 97committee on health care financing no later than July 30, 2028.