Amendment #11 to H4888

COVID-19 Medication Access Amendment

Representatives Barber of Somerville, Moran of Lawrence, Moran of Boston, Livingstone of Boston, Balser of Newton, Elugardo of Boston, Garballey of Arlington, Hay of Fitchburg, Higgins of Leominster, Lewis of Framingham, Provost of Somerville and Sabadosa of Northampton move to amend the amendment by inserting after Section XX the following section:-

SECTION XX.

(a) As used in this section, the word “manufacturer” shall mean an entity that manufactures a pharmaceutical drug.

(b) Notwithstanding any general or special law to the contrary, there shall be established a program for cost-sharing reductions for targeted medications used to treat certain chronic conditions, all FDA-approved COVID-19 vaccinations and all FDA-approved COVID-19 pharmaceutical drug treatments. In order to implement this program, the commissioner of the department of public health, in consultation with the center for health information and analysis, shall identify the three highest cost and most widely utilized pharmaceutical drugs in Massachusetts used to treat each of the following chronic conditions: diabetes, heart conditions, respiratory diseases, autoimmune disorders and HIV/AIDS. The commissioner shall further identify a list of all FDA-approved COVID-19 vaccinations and a list of all FDA-approved COVID-19 pharmaceutical drug treatments. Any policy, contract or certificate of health insurance subject to chapters 32A, 118E, 175, 176A, 176B, 176G or 176Q of the General Laws shall provide coverage for the identified vaccinations and pharmaceutical drugs. Such coverage shall be subject to reduced cost-sharing, including reduced co-payments and co-insurance, and shall not be subject to any deductible, pursuant to guidance from the commissioner of the department of public health. The commissioner of the division of insurance shall adopt any written policies, procedures or regulations the commissioner determines necessary to implement this program.

The center for health information and analysis shall collect, analyze and evaluate data on the impact of this program, including but not limited to: (1) the impact on utilization of the identified drugs; (2) average monthly out-of-pocket costs for each identified drug; (3) the average price of each identified drug, net of rebates or discounts received by or accrued directly or indirectly by health insurance carriers; and (4) the impact on member premiums. The center shall file a report on its findings, which shall be filed with the clerks of the house of representatives and senate, the joint committee on public health, the joint committee on health care financing and the house and senate committees on ways and means.

(c) The commission shall require a manufacturer specified in subsection (d) to disclose to the commission within a reasonable time information relating to the manufacturer’s pricing of that drug, on a standard reporting form developed by the commission with the input of the manufacturers, which includes but shall not be limited to, the following:

(1) A schedule of the drug’s wholesale acquisition cost increases over the previous five calendar years;

(2) The manufacturer’s aggregate, company-level research and development and other relevant capital expenditures, including facility construction, for the most recent year for which final audited data are available;

(3) A written, narrative description, suitable for public release, of factors that contributed to reported changes in wholesale acquisition cost during the previous five calendar years; and

(4) Any other information that the manufacturer wishes to provide to the commission.

Based on the records furnished under subsection (b) and available information from the center for health information and analysis or an outside third party, the commission shall identify a proposed value of the drug for a prescribed drug specified in subsection (c). The commission may request additional relevant information that it deems necessary to identify a proposed value of the drug.

(d) A manufacturer of the following prescribed drugs shall comply with the requirements set forth in this section:

(1) a drug identified by the department of public health under subsection (b);

(2) all FDA-approved COVID-19 vaccinations; and

(3) all FDA-approved COVID-19 pharmaceutical drug treatments.

(e) Records disclosed by a manufacturer under this section shall: (i) be accompanied by an attestation that all information provided is true and correct; (ii) not be public records under section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the commission may produce reports summarizing any findings; provided that any such report shall not be in a form that identifies specific prices charged for or rebate amounts associated with drugs by a manufacturer, or in a manner that is likely to compromise the financial, competitive or proprietary nature of the information.

(f) If, after review of any records furnished to the commission under subsection (c), the commission determines that the manufacturer’s pricing of the drug is potentially unreasonable or excessive in relation to the commission’s proposed value under subsection (c), the commission shall, with 30 days’ advance notice to the manufacturer and the public, hold a public hearing at which the drug manufacturer shall be required to appear and testify to provide further information related to the pricing of the prescribed drug and the manufacturer's justification for the pricing. In addition to the drug manufacturer, the commission may identify as witnesses other relevant parties, including patients, providers, provider organizations and payers. Witnesses shall provide testimony under oath and subject to examination by the commission, the secretary of health and human services, and the attorney general or their respective designees, at the public hearing in a manner and form to be determined by the commission.

(g) Any information, analyses or reports regarding a particular drug reviewed or used in identifying the supplemental rebate or assessing the proposed value of the drug shall be provided to the manufacturer for review and input. The commission shall consider any clarifications or data provided by the manufacturer with respect to its drug. The commission may not base its determination on the proposed value or the reasonableness of the drug pricing solely on the analysis or research of an outside third party.

(h) If the commission relies upon a third party to provide cost-effectiveness analysis or research related to the proposed value, such analysis or research shall also provide, but not be limited in scope to, (i) a description of the methodologies and models used in its analysis; (ii) any assumptions and potential limitations of research findings in the context of the results; and (iii) outcomes for affected subpopulations that utilize the drug.

(i) Not later than 60 days after receiving information from the manufacturer, as required under subsection (c) or (f), the commission shall confidentially notify the manufacturer, in writing, of its determination on whether the manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s proposed value of the drug.

(j) Following a determination and notification to the manufacturer that the manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s proposed value of the drug, the commission shall either:

(1) publicly issue a determination that the manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s proposed value of the drug and publicly disclose the proposed value of the drug; or

(2) require the manufacturer to file and implement an improvement plan to address the cost of the drug and improve patient access, consistent with the process to implement a performance improvement plan under section 10 of chapter 6D.

(k) If the commission determines that the manufacturer’s pricing of a drug is not unreasonable or excessive in relation to the commission’s proposed value of the drug but the commission identifies patient access barriers, the commission may require the manufacturer to file and implement an improvement plan to improve patient access, consistent with the process to implement a performance improvement plan under section 10 of chapter 6D.

(l) If the manufacturer fails to timely comply with the commission’s request for records under subsections (c) or (f), or otherwise knowingly obstructs the commission’s ability to issue its determination under subsection (i), including, but not limited to, providing incomplete, false or misleading information, the commission may impose appropriate sanctions against the manufacturer, including reasonable monetary penalties not to exceed $500,000, in each instance. The commission shall seek to promote compliance with this section and shall only impose a civil penalty on the manufacturer as a last resort.

(m) The commission shall adopt any written policies, procedures or regulations the commission determines necessary to implement this section.

(n) Subsection (d)(1) of this Act shall remain in effect for a period of 1 year following the enactment of this law.

(o) Subsections (d)(2) and (3) of this Act shall remain in effect until December 31, 2022.

Additional co-sponsor(s) added to Amendment #11 to H4888

COVID-19 Medication Access Amendment