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
Universal Citation: MD Code Reg 14.01.01.01
Current through Register Vol. 51, No. 19, September 20, 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.
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