Code of Massachusetts Regulations
101 CMR - EXECUTIVE OFFICE FOR HEALTH AND HUMAN SERVICES
Title 101 CMR 801.00 - Drug Manufacturer Negotiations and Accountability
Section 801.02 - Definitions

As used in 101 CMR 801.00, terms will have the meanings set forth in 101 CMR 801.02, except where the context clearly indicates otherwise.

Covered Drug. A pharmaceutical product for which coverage is, or is reasonably anticipated to become, available from MassHealth for eligible members.

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

Health Policy Commission (HPC). The commission established under M.G.L. c. 6D.

High-cost Drug. A covered drug projected by EOHHS to exceed a post-rebate cost per utilizer of $25,000 annually or an aggregate annual post-rebate cost to MassHealth of $10,000,000, based on factors including actual or expected utilization, prevalence of the disease or condition that is treated by the coved drug, dosing information, duration of therapy, and price of the covered drug after application of the manufacturer's mandated rebate under the MDRP.

Manufacturer. An entity that manufactures a covered drug.

MassHealth. The medical assistance and benefit programs administered by EOHHS 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.

Medicaid Drug Rebate Program (MDRP). The program authorized by Section 1927 of the Social Security Act ( 42 U.S.C. §§ 1396r-8 et seq.) under which participating manufacturers are required to enter and have in place a national rebate agreement with the Secretary of the federal Department of Health and Human Services in exchange for state Medicaid coverage of most of the manufacturer's drugs, and under which such manufacturers are required to pay a rebate to states for such drugs paid for by the state's Medicaid program pursuant to a statutory formula.

Secretary. The Secretary of the Massachusetts Executive Office of Health and Human Services.

Supplemental Rebate Agreement (SRA). An agreement authorized by Section 1927 of the Social Security Act ( 42 U.S.C. §§ 1396r-8 et seq.) and in a format approved by the federal Centers for Medicare & Medicaid Services between EOHHS and a manufacturer memorializing the terms and conditions for payments by the manufacturer for covered drugs dispensed or administered for use by MassHealth members and included on claims paid by EOHHS or a participating MassHealth managed care entity, as applicable. The payment is in addition to the manufacturer's mandated rebate under the MDRP and may be structured as a traditional or value-based arrangement, as appropriate.

Third-party. An entity that is not:

(a) a manufacturer;

(b) EOHHS;

(c) another state department, agency, subdivision, office, board, commission, or institution of the executive, judicial, or legislative branches of the Commonwealth; or

(d) an individual employed by an entity described in 101 CMR 801.02: Third-party(a) through (c).