Code of Massachusetts Regulations
958 CMR - HEALTH POLICY COMMISSION
Title 958 CMR 12.00 - Drug Pricing Review
Section 12.03 - Notice of Identification by the Executive Office
Universal Citation: 958 MA Code of Regs 958.12
Current through Register 1531, September 27, 2024
(1) The Commission shall provide written notice to each Referred Manufacturer. Such notice shall state that:
(a) the Commission has received notice from the Executive Office identifying the Referred Manufacturer as a Manufacturer of a Drug for which
1. negotiations with the Executive Office for a Supplemental Rebate have been unsuccessful and
2. the Executive Office has determined to be a High-cost Drug pursuant to 101 CMR 801.00;
(b) the Referred Manufacturer must provide the information specified in 958 CMR 12.04(1);
(c) any information disclosed by the Referred Manufacturer under M.G.L. c. 6D, § 8A or 958 CMR 12.00 shall be accompanied by a signed Attestation Form as specified in 958 CMR 12.04(6); and
(d) information disclosed by the Referred Manufacturer under M.G.L. c. 6D, § 8A or 958 CMR 12.00 shall not be a public record under M.G.L. c. 4, § 7 or M.G.L. c. 66 and shall remain confidential; provided, however, that the Commission may disclose the narrative submitted by a Referred Manufacturer pursuant to 12.04(3)(g) and may produce reports summarizing findings based on such records consistent with its responsibilities under M.G.L. c. 6D, § 8A. Such reports shall not identify specific prices charged for or rebate amounts associated with drugs of a Referred Manufacturer and shall not be presented in a manner that is likely to compromise the financial, competitive or proprietary nature of the information.
(2) The Commission shall include with the written notice the Standard Reporting Form, the Attestation Form and additional requests for information pursuant to 958 CMR 12.04(4).
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