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

Current through Register 1525, July 5, 2024
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).