Code of Maryland Regulations › Title 14 - INDEPENDENT AGENCIES › Subtitle 01 - PRESCRIPTION DRUG AFFORDABILITY BOARD › Chapter 14.01.01 - General Provisions › Section 14.01.01.01 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this
				subtitle, the following terms have the meanings indicated.
B. Terms Defined.
(1) "Abbreviated new drug application (ANDA)"
				means a submission to the FDA for the review and potential approval for
				marketing of a generic drug product, including bioequivalence data, as defined
				in 21 CFR §
											314.3 and described under
				21 CFR §
											314.50.
(2) "Accelerated approval" means the FDA drug
				approval process defined in 21 U.S.C. §
											356(c)(1)(A).
(3) "Active ingredient" means a component of
				a drug that is intended to provide pharmacological activity or other direct
				effect in the diagnosis, cure, mitigation, treatment, or prevention of disease,
				or to affect the structure or any function of the body, as defined in
				21 CFR §
											314.3.
(4) "Active moiety" means the molecule or ion
				responsible for the physiological or pharmacological action of the drug
				substance, excluding those appended portions of the molecule that cause the
				drug to be an ester, salt, or other noncovalent derivative of the molecule, as
				defined in 21 CFR §
											314.3.
(5) "Average cost share" means the sum of the
				cost share of a prescription drug product for each patient, divided by the
				number of patients.
(6) "Average
				payor cost per patient" means the sum of the total dollars paid by all payors
				over the most recent calendar year, divided by the number of
				patients.
(7) "Average sales price
				(ASP)" has the meaning stated in
				42 U.S.C §
											1395w-3a(c)(1).
(8) "Average total out-of-pocket cost" means
				the sum of all patient total out-of-pocket costs, divided by the number of
				patients.
(9) "Average wholesale
				price (AWP)" means the average suggested price paid by a retailer to buy a drug
				from a wholesaler, excluding price concessions, discounts, and
				rebates.
(10) "Biologic" means a
				biological product, as defined in
				42 U.S.C. §
											262(i)(1).
(11) "Biologics license application (BLA)"
				means a request to the FDA to introduce, or deliver for introduction, a
				biological product, as defined in
				21 CFR §
											600.3(h), into interstate
				commerce, as regulated under 21 CFR § 600-680.
(12) "Biosimilar" means a biological product,
				as defined in 42 U.S.C.
				§
											262(i)(2), that is
				produced or distributed in accordance with a biologics license application
				approved under 42 U.S.C.
				§
											262(k)(3).
(13) "Board" has the meaning stated in
				Health-General Article, §21-2C-01, Annotated Code of Maryland.
(14) "Board staff" means an employee of the
				Board or a qualified independent third party that has contracted with the Board
				and is subject to a nondisclosure or confidentiality agreement.
(15) "Brand name drug" has the meaning stated
				in Health-General Article, §21-2C-01, Annotated Code of
				Maryland.
(16) "Carrier" has the
				meaning stated in Health-General Article, §19-132, Annotated Code of
				Maryland.
(17) "Chair" means the
				chair of the Board, as provided in Health-General Article, §21-2C-03,
				Annotated Code of Maryland.
(18)
				"Coinsurance" means the percentage of costs paid by the patient after meeting
				the deductible.
(19) "Consumer
				Price Index for All Urban Consumers (CPI-U)" means the measure of the average
				change over time in the prices paid by urban consumers for a defined market
				basket of consumer goods and services.
(20) "Copayment" means the set dollar amount
				that a patient pays for prescriptions or services covered by the patient's
				health insurance, separate from the deductible.
(21) "Cost share" means the patient total
				out-of-pocket costs divided by gross spending.
(22) "Deductible" means the set amount a
				patient pays for health and medical services and products each calendar year
				before a health insurance plan begins to provide coverage, usually expressed in
				dollars.
(23) "Discount" means a
				monetary adjustment that reduces the price paid or dollar amount received by an
				entity engaging in a prescription drug transaction that occurs during the
				prescription drug transaction as reflected on the invoice.
(24) "Disease burden" means the impact of a
				health condition measured by financial cost, mortality, morbidity, severity,
				and epidemiological indicators.
(25) "Drug class" means the grouping of
				medications based on a common active ingredient, or ingredients, or by
				pharmacologic or therapeutic class.
(26) "Drug-specific patient access program"
				means a program designed to provide a patient with assistance in affording a
				prescription drug or paying for a prescription drug, including but not limited
				to the provision of a drug to a patient, coupons supplied by the manufacturer,
				donations to a nonprofit or foundation associated with the manufacturer, and
				donations to an independent nonprofit that are earmarked expressly for the
				manufacturer's drugs.
(27) "Federal
				Supply Schedule (FSS)" means the drug pricing program under the collection of
				multiple award contracts used by federal agencies, U.S. territories, Indian
				tribes, and other specified entities to purchase supplies and services from
				outside vendors.
(28) "Food and
				Drug Administration (FDA)" means the federal agency of the U.S. Department of
				Health and Human Services tasked with protecting and promoting public health
				through the control and supervision of food safety, tobacco products, dietary
				supplements, prescription and over-the-counter pharmaceutical drugs, vaccines,
				biopharmaceuticals, medical devices, and certain other consumer
				products.
(29) "Formulary" has the
				meaning stated in Insurance Article, §
										15-1601, Annotated Code of
				Maryland.
(30) "Fund" means the
				Prescription Drug Affordability Fund, as provided for in Health-General
				Article, §21-2C-11, Annotated Code of Maryland.
(31) "Generic drug" has the meaning stated in
				Health-General Article, §21-2C-01, Annotated Code of Maryland.
(32) "Gross spending" means the sum of all
				monies paid for a prescription drug product for an individual patient in a
				calendar year.
(33) "Health
				economics and outcomes research" means the form of economic analysis that
				compares the relative costs and outcomes of different treatments, such as cost
				effectiveness analysis, comparative effectiveness research, health economic
				information analysis, and health technology assessments.
(34) "Health maintenance organization (HMO)"
				has the meaning stated in Health-General Article, §19-701, Annotated Code
				of Maryland.
(35) "Indication"
				means labeling that discusses the disease or condition the drug product is
				intended to diagnose, treat, prevent, cure, or mitigate, including a
				description of the patient population.
(36) "Insurance benefit design" means the
				rules that determine the services covered by the plan and any other
				cost-sharing measures.
(37)
				"Managed care organization (MCO)" has the meaning stated in Health-General
				Article, §15-102.4, Annotated Code of Maryland.
(38) "Manufacturer" has the meaning stated in
				Health-General Article, §21-2C-01, Annotated Code of Maryland.
(39) "Maryland Medical Care Database (MCDB)"
				means the database established and maintained by the Maryland Health Care
				Commission pursuant to Health-General Article, §19-133, Annotated Code of
				Maryland.
(40) "Medicaid" means the
				public health program jointly administered by the federal government and states
				that primarily serves low-income people (children, parents, and, in certain
				states, other adults) and some medically needy patients.
(41) "Medicare" means the health insurance
				program administered by the federal government for people 65 years old or older
				or with certain disabilities.
(42)
				"National average drug acquisition cost (NADAC)" means the pricing benchmark
				calculated from the Centers for Medicare & Medicaid Services' (CMS) monthly
				surveys of retail pharmacies that reflects the average price pharmacies pay to
				acquire a drug from a wholesaler or manufacturer, excluding subsequent
				discounts or rebates from manufacturers to wholesalers or pharmacies.
(43) "National Drug Code (NDC)" means the
				unique three-segment number used for identification and reporting as set forth
				in 21 CFR §
											207.33.
(44) "Net cost" means the per-unit cost paid
				by payors of a drug after accounting for all price concessions, discounts, and
				rebates.
(45) "Net price" means the
				per-unit amount received by manufacturers of a drug after accounting for price
				concessions, discounts, and rebates.
(46) "New drug application (NDA)" means a
				submission to the FDA for the review and potential approval for marketing of a
				drug product, which includes chemical, pharmacological, medical,
				biopharmaceutical, and statistical data, as defined in
				21 CFR §
											314.3 and described under
				21 CFR §
											314.50.
(47) "Other cost-sharing" means a program,
				benefit design, or other mechanism that determines a patient's responsibility
				for a prescription drug product, such as a copayment, coinsurance, deductible,
				formulary, or other management tool.
(48) "Out-of-pocket costs" means the expenses
				for medical care, including prescription drug therapy, that are not reimbursed
				by insurance and are paid by a patient, including copayments, coinsurance, and
				deductibles for covered services, and the costs for all non-covered
				services.
(49) "Patient total
				out-of-pocket costs" means the sum of a patient's out-of-pocket costs,
				including items such as copayments, coinsurance, and deductibles, in a calendar
				year.
(50) "Payor" means the entity
				other than the patient that is responsible for paying for health care costs,
				including health insurance carriers, health plan sponsors, PBMs, Medicare,
				Medicaid, MCOs, and HMOs.
(51)
				"Person" means an individual, limited liability company, partnership,
				corporation, association, county, and public or private organization of any
				character other than an agency.
(52) "Pharmacy benefit manager (PBM)" means a
				third-party administrator of prescription drug programs as stated in Insurance
				Article, §
										15-1601, Annotated Code of
				Maryland.
(53) "Prescription drug
				product" has the meaning stated in Health-General Article, §21-2C-01,
				Annotated Code of Maryland.
(54)
				"Price concession" means a mechanism other than a rebate or discount that
				reduces the price paid by a payor.
(55) "Proprietary" means something that is
				used, produced, or marketed under the exclusive legal right of the inventor,
				maker, or owner.
(56) "Rebate"
				means a monetary adjustment that reduces the price paid or dollar amount
				received by an entity engaging in a prescription drug transaction that occurs
				after the prescription drug transaction.
(57) "Regulatory exclusivity" means any
				exclusive marketing rights or data exclusivity rights conferred by the FDA with
				respect to a pharmaceutical product other than patents, including but not
				limited to 180-day exclusivity, orphan drug exclusivity, new chemical entity
				exclusivity, data exclusivity, and pediatric exclusivity.
(58) "Stakeholder Council" means the
				Prescription Drug Affordability Stakeholder Council, as provided for in
				Health-General Article, §21-2C-04, Annotated Code of Maryland.
(59) "Standard medical practice" means the
				customary treatment by medical professionals:
(a) Based on credible scientific evidence
				published in peer reviewed medical literature generally recognized by the
				relevant medical community;
(b)
				Consistent with physician specialty society recommendations; or
(c) Consistent with the views of physicians
				practicing in the relevant clinical areas.
(60) "State actual acquisition cost (SAAC)"
				has the meaning stated in COMAR
				10.09.03.01B(42).
(61) "Therapeutic alternative" means a drug
				product that has the same or similar indications for use as a particular drug
				but is not a therapeutic equivalent to that drug.
(62) "Therapeutic class" means a group of
				drugs containing active moieties that share scientifically documented
				properties and are defined on the basis of any combination of three attributes:
				mechanism of action, physiologic effect, and chemical structure.
(63) "Therapeutic equivalent" has the meaning
				stated in 21 CFR §
											314.3.
(64) "Total gross spending" means the sum of
				all monies paid for a prescription drug product in a calendar year.
(65) "Total patient out-of-pocket cost" means
				the sum of all patient out-of-pocket costs in a calendar year, including items
				such as copayments, coinsurance, and deductibles.
(66) "Trade secret" has the meaning stated in
				Commercial Law Article, §
										11-1201, Annotated
				Code of Maryland.
(67) "Wholesale
				acquisition cost (WAC)" means the manufacturer's list price for a prescription
				drug product to wholesalers or direct purchasers in the United States, not
				including prompt pay or other discounts, rebates, or reductions in price, as
				reported in a wholesale price guide or other publication of prescription drug
				product pricing data.
(68)
				"Wholesale distributor" has the meaning stated in Health Occupations Article,
				§
										12-6C-01,
				Annotated Code of Maryland.