Code of Massachusetts Regulations
958 CMR - HEALTH POLICY COMMISSION
Title 958 CMR 12.00 - Drug Pricing Review
Section 12.02 - Definitions

Universal Citation: 958 MA Code of Regs 958.12
Current through Register 1531, September 27, 2024

As used in 958 CMR 12.00, these terms have the following meaning:

Attestation Form. A form, prescribed by the Commission, to be signed by a Referred Manufacturer, attesting that all information reported or provided is true and correct under pains and penalties of perjury.

Board. The governing board of the Commission established in M.G.L. c. 6D, § 2(b).

Commission. The Health Policy Commission established in M.G.L. c. 6D.

Drug. A pharmaceutical product manufactured by a Manufacturer.

Executive Director. The Executive Director of the Commission.

Executive Office. The Executive Office of Health and Human Services established under M.G.L. c. 6A.

Manufacturer. An entity that manufactures a pharmaceutical product for which coverage is, or is reasonably anticipated to become, available from MassHealth for eligible members.

MassHealth. The medical assistance and benefit programs administered by the Executive Office pursuant to Title XIX of the Social Security Act (42 U.S.C. § 1396 et seq.), Title XXI of the Social Security Act (42 U.S.C. § 1397aa et seq.), M.G.L. c. 118E, and other applicable laws and waivers to provide and pay for medical services to eligible members.

Referred Manufacturer. A Manufacturer for which the Commission has received notice from the Executive Office pursuant to M.G.L. c. 118E, § 12A(g) identifying the Manufacturer as a Manufacturer of a Drug for which (i) negotiations with the Executive Office for a Supplemental Rebate have been unsuccessful and (ii) the Executive Office has determined to be a High-cost Drug pursuant to 101 CMR 801.00.

Standard Reporting Form. The form, as prescribed by the Commission, pursuant to 958 CMR 12.04.

Supplemental Rebate. As authorized by the Social Security Act, § 1927 (42 U.S.C. § 1396r-8 et seq.), the value of payments by a Manufacturer for covered Drugs dispensed or administered for use by MassHealth members and included on claims paid by the Executive Office or a participating MassHealth managed care entity, which may be the result of a traditional or value-based arrangement, and which is in addition to the Manufacturer's mandated rebate under the Medicaid Drug Rebate Program as authorized by the Social Security Act, § 1927 (42 U.S.C. § 1396r-8 et seq.)

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