Code of Massachusetts Regulations
958 CMR - HEALTH POLICY COMMISSION
Title 958 CMR 12.00 - Drug Pricing Review
Section 12.13 - Penalties

Universal Citation: 958 MA Code of Regs 958.12

Current through Register 1531, September 27, 2024

(1) The Commission may assess a civil penalty to a Referred Manufacturer of not more than $500,000 in each instance if it finds that the Referred Manufacturer has:

(a) Failed to timely provide information to the Commission.

(b) Knowingly obstructed the Commission's ability to issue a determination, including providing incomplete, false or misleading information to the Commission.

(2) The Commission shall determine whether to assess a penalty by vote of the Board.

(3) The Commission shall seek to promote compliance with 958 CMR 12.00 and shall only impose a civil penalty as a last resort.

(4) The Commission shall provide written notice to a Referred Manufacturer of the amount of the penalty, the reason(s) for assessing the penalty, and the right to request a hearing.

(5) The Commission shall not assess a penalty unless the Commission, through the Executive Director, has first afforded the Referred Manufacturer an opportunity for a hearing in accordance with M.G.L. c. 30A, § 10.

(6) After the hearing, the Commission shall render a written decision and may assess a civil penalty pursuant to 958 CMR 12.13(1).

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