Outside Section 6
Chapter 6D of the General Laws, as appearing in the 2016 Official Edition, is hereby amended by inserting after section 8 the following section:-
Section 8A. (a) The commission shall require a manufacturer of a prescribed drug specified in subsection (b) to disclose to the commission within a reasonable time any records that describe or relate to the manufacturer's pricing of that drug.
(b) A manufacturer of the following prescribed drugs must comply with the requirements set forth in this section: a drug for which the executive office of health and human services was unable to successfully conclude supplemental rebate negotiations with the manufacturer of the drug under subsection (a) of section 12A of chapter 118E, and for which the commission has received notice from the secretary of health and human services under subsection (c) of said section 12A of said chapter 118E.
(c) Records disclosed by a manufacturer under subsection (a) shall not be public records under section 7 of chapter 4 and under chapter 66 and shall remain confidential; provided, however, that the commission may produce reports summarizing any findings related to records received under this section to the extent allowable under applicable state and federal laws.
(d) If, after review of any records furnished to the commission under subsection (a), the commission determines that the drug manufacturer's pricing of the drug is potentially unreasonable or excessive in relation to the executive office's final determined value of the drug under subsection (b) of section 12A of chapter 118E or other appropriate metric, the commission shall, with 30 days advance notice to the drug 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, payers and others. 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.
(e) Within 60 days from the date of a public hearing under subsection (d), the commission shall issue a report concerning the reasonableness of the manufacturer's pricing of the drug. In the event the commission concludes that the drug manufacturer's pricing of the drug is unreasonable or excessive in relation to the executive office's final determined value of the drug under subsection (b) of section 12A of chapter 118E or other appropriate metric, the commission may refer the drug manufacturer to the office of attorney general for appropriate action under chapter 93A, or any other applicable provision of the General Laws.
(f) In the event the drug manufacturer does not timely comply with the commission's request for records under subsection (a) or appearance at a public hearing under subsection (c), or otherwise knowingly obstructs the commission's ability to issue the report described in subsection (e), including by providing incomplete, false, or misleading information, the commission may impose appropriate sanctions against the drug manufacturer, including reasonable monetary penalties not to exceed $500,000, and may refer the drug manufacturer to the office of attorney general for appropriate action under chapter 93A, or any other applicable provision of the general laws. The commission shall seek to promote compliance with this section and shall only impose a civil penalty on the drug manufacturer as a last resort.
(g) The commission shall, in consultation with the executive office of health and human services, adopt any written policies, procedures or regulations the commission determines necessary to implement this section.
This section gives the Health Policy Commission the authority to hold public hearings and to require drug manufacturers to disclose information and documents related to the pricing of high-cost prescription drugs. It would also allow the Commission to impose appropriate sanctions for noncompliance.
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