Code of Massachusetts Regulations › 101 CMR - EXECUTIVE OFFICE FOR HEALTH AND HUMAN SERVICES › Title 101 CMR 331.00 - Prescribed Drugs › Section 331.02 - General Definitions

Current through Register 1525, July 5, 2024
340B Actual Acquisition Cost (340B
				AAC)
. The amount a 340B covered entity pays for a drug purchased
				through the 340B Drug Pricing Program, net of discounts, rebates, chargebacks,
				and other adjustments to the price of the drug.
340B Ceiling Price
. The maximum amount
				that a manufacturer can charge a 340B covered entity for a drug purchased
				through the 340B Drug Pricing Program pursuant to Section 340B of Public Health
				Law 102-585, the Veterans Health Act of 1992.
340B Covered Entities
. Facilities and
				programs eligible to purchase discounted drugs through a program established by
				Section 340B of Public Health Law 102-585, the Veterans Health Act of
				1992.
340B Drug Pricing Program
. A program
				established by Section 340B of Public Health Law 102-585, the Veterans Health
				Act of 1992.
Actual Acquisition Cost (AAC)
. The
				lowest price for the drug available from one or more surveys of pharmacy costs
				designated by EOHHS
via
administrative bulletin or other
				written issuance, or if EOHHS has not so designated one or more surveys, the
				drug's National Average Drug Acquisition Cost (NADAC). For a given drug, if no
				price is available from a survey of pharmacy costs designated by EOHHS
via
administrative bulletin or other written issuance, or, if
				EOHHS has not so designated one or more surveys and no NADAC is available for
				the drug, the drug's AAC is the drug's wholesale acquisition cost (WAC).
Brand Name Preferred
. A multiple
				source drug that is designated pursuant to
				130 CMR
				406.413(A)(3).
Center
. The Center for Health
				Information and Analysis established under M.G.L. c. 12C.
Compounded Drug
. Any drug, excluding
				cough preparations, in which two or more ingredients are extemporaneously mixed
				by a registered pharmacist.
Dispensing Fee
. The fee paid, over and
				above the ingredient cost of the drug, to providers by governmental units and
				purchasers under M.G.L. c. 152 for dispensing drugs to publicly aided
				individuals and/or industrial accident patients.
Drug
. A substance containing one or
				more active ingredients in a specified dosage form and strength and authorized
				by the purchasing governmental unit or purchaser under M.G.L. c. 152. Each
				dosage form and strength is a separate drug.
EOHHS
. The Executive Office of Health
				and Human Services established under M.G.L. c. 6A.
Federal Upper Limit
. The Federal Upper
				Limit as established by the Centers for Medicare and Medicaid Services (CMS) by
				regulation or otherwise.
Fiscal Year
. The annual accounting
				period adopted by a provider.
Governmental Unit
. The Commonwealth,
				any department, agency, board or commission of the Commonwealth, and any
				political subdivision of the Commonwealth.
Industrial Accident Patient
. A person
				who receives medical services for which persons, corporations or other entities
				are in whole or part liable under M.G.L. c. 152.
Massachusetts Maximum Allowable Cost
				(MMAC)
. For multiple source drugs not designated as Brand Name
				Preferred and not certified as medically necessary (
i.e
.,
				drugs for which the prescriber has not designated "no substitution" and "brand
				name medically necessary" on the prescription form), an amount equal to 100% of
				the lowest price for a therapeutic equivalent of the drug available from one or
				more surveys of pharmacy costs designated by EOHHS
via
administrative bulletin or other written issuance, or if EOHHS has not
				so designated one or more surveys, the lowest National Average Drug Acquisition
				Cost (NADAC) for a therapeutic equivalent of the drug, for the most frequently
				purchased package size.
For multiple source drugs designated as Brand Name Preferred,
				the MMAC is an amount equal to the drug's AAC.
Most Frequently Purchased Package
				Size
. The package size of a drug most frequently purchased by
				providers based on utilization data compiled by the MassHealth agency. Thus,
				that NDC number which is most often paid by the MassHealth agency, and verified
				by audit, if necessary, will be considered the most frequently purchased
				package size.
Multiple Source Drug
. A drug marketed
				or sold by two or more manufacturers or labelers or a drug marketed or sold by
				the same manufacturer or labeler under two or more different names.
National Average Drug Acquisition Cost
				(NADAC)
. The National Average Drug Acquisition Cost as published
				by CMS.
National Drug Code (NDC) Number
. A
				unique number issued by the United States Food and Drug Administration to
				identify drug products. The NDC number has three components: the first
				component identifies the drug manufacturer (Labeler No.); the second component
				identifies the product (Product No.); and the third component identifies the
				package size (Pkg.).
Over-the-counter Drug
. Any drug for
				which no prescription is required by federal or state law. These drugs are
				sometimes referred to as non-legend drugs. The MassHealth agency requires a
				prescription for both prescription drugs and over-the-counter drugs
				(
see
130 CMR
				406.411(A):
Legal
				Prescription Requirements
).
Prescription Drug
. Any drug for which
				a prescription is required by applicable federal and/or state laws or
				regulations other than MassHealth regulations. These drugs are sometimes
				referred to as legend drugs.
Provider
. A pharmacy that is licensed
				by the Board of Registration in Pharmacy in accordance with the provisions of
				M.G.L. c. 112 or by the Department of Public Health in accordance with the
				provisions
				105 CMR
				700.004:
Registration
				Requirements
, and which also meets the current conditions of
				participation of the purchasing governmental unit, purchaser under M.G.L. c.
				152, or the 340B Program, as applicable and out of state pharmacies described
				in
				130 CMR
				406.404(C):
Out-of-state Providers
.
Publicly-aided Individual
. A person
				for whose medical or other services a governmental unit is in whole or in part
				liable under a statutory public program.
Purchaser under M.G.L. c. 152
. An
				insurance company, self insurer, or worker's compensation agent of a department
				of the Commonwealth, county, city or district which purchases medical services
				subject to M.G.L. c. 152, § 1.
Single Source Drug
. A drug marketed or
				sold by only one manufacturer or labeler under one proprietary name.
Usual and Customary Charge
. The lowest
				price that a provider charges or accepts from any payer for the same quantity
				of a drug on the same date of service, in Massachusetts, including but not
				limited to the shelf price, sale price, or advertised price for any drug
				including an over-the-counter drug. If an insurer and the provider have a
				contract that specifies that the insurer will pay an average or similarly
				computed fixed amount for multiple therapeutic categories of drugs with
				different acquisition costs, the fixed amount will not be the provider's usual
				and customary charge.
Wholesale Acquisition Cost (WAC)
. A
				manufacturer's price published in a national price compendium or other publicly
				available source or an adjusted list price.