Sections 46 and 6 of Chapter 41 of the Acts of 2019, An Act Making Appropriations for the Fiscal Year 2020 for the Maintenance of the Departments, Boards, Commissions, Institutions and Certain Activities of the Commonwealth, for Interest, Sinking Fund and Serial Bond Requirements and for Certain Permanent Improvements (the “FY 2020 Budget”) give authority to the Executive Office of Health and Human Services (EOHHS), and specifically to the MassHealth program, to negotiate directly with pharmaceutical drug manufacturers for supplemental rebates, and to the Health Policy Commission (HPC) to investigate the manufacturer’s pricing of the drug if an agreement cannot be reached.
Upon a referral from MassHealth, the law, codified as M.G.L. c. 6D, § 8A, authorizes the HPC to collect information related to the referred manufacturer’s pricing of certain high-cost drugs, including through a standard reporting form developed by HPC with input from manufacturers. Based on the submissions from manufacturers and other information from MassHealth, the HPC may identify a proposed value for the drug and ultimately determine whether the manufacturer’s pricing of the drug is unreasonable or excessive in relation to the HPC’s proposed value for the drug. In addition, the HPC may, in consultation with MassHealth, propose a supplemental rebate for the drug.
The HPC issued a proposed regulation to implement this new statutory authority to collect and review information relative to a pharmaceutical drug manufacturer’s pricing of certain high cost drugs referred by MassHealth and to determine whether the pricing of such drugs is unreasonable or excessive in relation to the HPC’s proposed value for the drug.
As required by statute, the HPC has developed a draft Standard Reporting Form for use in collecting information from a referred manufacturer regarding the manufacturer’s pricing of a drug. The HPC seeks input and comment on the draft form.
On Friday, December 13, 2019 at 1:00 PM, the HPC held a public hearing on the proposed regulation and Standard Reporting Form. Testimony was provided in-person by representatives from Health Care For All, the Greater Boston Interfaith Organization, the Jewish Alliance for Law and Social Action, the Disability Policy Consortium, and the Mental Health Legal Advisors Committee.
Written comments were accepted until December 20, 2019, at 5:00 PM. All submitted testimony is posted at the link below, and may be released in response to a request for public records.
On Wednesday, February 5, 2020, the HPC Board voted to approve and release the final text of the regulation. The slides from that presentation are available below.