Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 2 › Subtitle 09 - MEDICAL CARE PROGRAMS › Chapter 10.09.03 - Pharmacy Services › Section 10.09.03.01 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "340B price" means the price at which
				  drugs are purchased as authorized under Section 340B of the Public Health
				  Service Act.
(2) "Actual acquisition cost (AAC)" means the amount
				  paid by a provider for a drug or product less all discounts, rebates, refunds,
				  chargebacks, incentives, and price reductions.
(3) "Allowable cost" means the maximum amount
				  which the Program will reimburse for the drug or product portion of the
				  prescription.
(4) "Approved unit
				  dose system" means a drug distribution system approved by the Department that
				  is used to prepare and distribute an individual, properly labeled dose of
				  medication for a patient in a nursing facility.
(5) "Brand name drug" means:
(a) A single source drug;
(b) An innovator multiple source drug;
				  or
(c) A drug submitted for payment
				  as brand medically necessary.
(6) "Compounded prescription for intravenous
				  therapy" means a prescription that:
(a)
				  Combines two or more ingredients;
(b) Is prepared by using aseptic technique
				  under a laminar flow clean bench; and
(c) Is administered to a patient
				  intravenously.
(7)
				  "Controlled substance" means a drug as defined under
				  21 U.S.C. §
												802.
(8) "Convenience package" means a smaller or
				  specially packaged quantity of a product prepared for the convenience of a
				  patient or provider as opposed to the regular packaging.
(9) "Copayment" means the amount a
				  participant is liable to pay for prescriptions, when applicable, which is
				  deducted from provider reimbursement.
(10) "Department" means the State Department
				  of Health and Mental Hygiene, the single State agency designated to administer
				  the Medical Assistance Program under Title XIX, Social Security Act,
				  42 U.S.C. §
												1396 et seq.
(11) "Diluent component" means a liquid used
				  for reconstitution or dilution of an active ingredient in compounded
				  prescription intravenous therapy.
(12) "Direct price" means,
(a) The price charged by a pharmaceutical
				  manufacturer to a dispensing pharmacy for a product supplied to the pharmacy
				  without intermediate distribution charges; or
(b) For specialty for drugs identified by the
				  Program, the price charged by a pharmaceutical manufacturer to a dispensing
				  pharmacy for a product supplied to the pharmacy without intermediate
				  distribution charges, less any rebates, discounts, refunds, chargebacks,
				  incentives, and price reductions.
(13) "Drugs" means legend drugs (those
				  requiring a prescription under federal or State law) or over-the-counter (OTC)
				  drugs (those not requiring a prescription under federal or State
				  law).
(14) "Early and periodic
				  screening, diagnosis, and treatment (EPSDT)" means a program of preventive
				  health care services for Medical Assistance individuals younger than 21 years
				  old.
(15) "EPSDT-related service"
				  means diagnosis and treatment necessary to correct or manage health problems
				  detected by a screening performed by a certified EPSDT provider. EPSDT-related
				  services are rendered by a certified EPSDT provider or an appropriate Medical
				  Assistance provider.
(16) "Family
				  planning services" means providing individuals with the information and means
				  to prevent unwanted pregnancy and maintain reproductive health.
(17) "Federally qualified health center
				  (FQHC) " means an entity as defined by Health-General Article, §24-1301,
				  Annotated Code of Maryland, and § 1905(l)(2)(B) of the Social Security
				  Act.
(18) "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.
(19) "Federal upper limit (FUL)" means the upper limit
				  of payment for multiple source drugs for which a specific maximum allowable
				  cost has been established by the Centers for Medicare & Medicaid Services
				  (CMS) of the Department of Health and Human Services pursuant to
				  42 CFR §
												447.514.
(20) "Freestanding clinics" means those
				  clinics, not associated with a hospital, which are under the direction of
				  physicians as further defined in COMAR
				  10.09.08.01A.
(21) "Generic drug" means a drug
				  that is:
(a) Available to pharmacy providers
				  from at least one manufacturer;
(b)
				  Rated as therapeutically equivalent by the U.S. Food and Drug Administration;
				  and
(c) Not a brand name
				  drug.
(22) "Innovator
				  multiple source drug" means a multiple source drug that was originally marketed
				  under an original new drug application approved by the U.S. Food and Drug
				  Administration.
(23) "Institutional
				  pharmacy" means a pharmacy owned and operated by a hospital, nursing facility,
				  or clinic.
(24) "Invoice" means:
(a) A form issued or approved by the
				  Department for use by providers in submitting bills for payment; or
(b) A bill issued by a manufacturer or
				  wholesaler to a provider which indicates proof of purchase and the:
(i) Actual acquisition cost paid by the
				  provider; or
(ii) The direct price
				  charged to the provider by the manufacturer.
(25) "Maintenance medication" means
				  medication in chronic therapeutic categories corresponding to the following
				  American Hospital Formulary Service (AHFS) classification numbers:
(a) Cardiac drugs (24:04);
(b) Antilipemic agents (24:06);
(c) Hypotensive agents (24:08);
(d) Vasodilating agents (24:12);
(e) Sclerosing agents (24:16);
(f) Alpha-adrenergic blocking agents
				  (24:20);
(g) Beta-adrenergic
				  blocking agents (24:24);
(h)
				  Calcium-channel blocking agents (24:28);
(i) Renin-angiotensin-aldosterone system
				  inhibitors (24:32);
(j) Hydantoins
				  (28:12:12);
(k) Oxazolidinediones
				  (28:12:16);
(l) Succinimides
				  (28:12:20);
(m) Anticonvulsants,
				  miscellaneous (28:12:92);
(n)
				  Replacement solutions (40:12) (potassium supplements only);
(o) Diuretics (40:28);
(p) Lipotropic agents (56:24);
(q) Contraceptives (68:12);
(r) Estrogens and antiestrogens
				  (68:16);
(s) Antidiabetic agents
				  (68:20);
(t) Antihypoglycemic
				  agents (68:22);
(u) Parathyroid
				  (68:24);
(v) Progestins
				  (68:32);
(w) Thyroid and
				  antithyroid agents (68:36);
(x)
				  Vitamins (88:00);
(y) Sodium
				  fluoride (92:00); and
(z) Iron
				  preparations, oral (20.04.04) (oral products in which ferrous sulfate is the
				  only active ingredient and chewable tablets of any ferrous salt if combined
				  with vitamin C, multivitamins, multivitamins and minerals, or other minerals in
				  the formulation).
(26)
				  "Medical Assistance Program" means a program of comprehensive medical and other
				  health-related care for indigent and medically indigent persons.
(27) "National average drug acquisition cost
				  (NADAC)" means the average price paid by retail community pharmacies to acquire
				  a prescription or over-the-counter covered out-patient drug as calculated by
				  the Centers for Medicare and Medicaid Services.
(28) "Nominal price" means a price that is
				  less than 10 percent of the average manufacturer price (AMP) in the same
				  quarter for which AMP is computed.
(29) "Nursing facility" means an institution
				  as further defined in COMAR
				  10.09.10.01B(30),
				  and classified as a long-term care facility.
(30) "Participant" means a person who is
				  certified as eligible for and is receiving Medical Assistance benefits.
(31) "Pharmacist" means an
				  individual licensed in good standing to practice pharmacy in the state where
				  the service is provided.
(32)
				  "Pharmacy" means an establishment or institution licensed in good standing that
				  is required to obtain a permit in accordance with Health Occupations Article,
				  Title 12, Annotated Code of Maryland, or a similar entity legally authorized to
				  dispense legend drugs to the public in the state in which the establishment or
				  institution is located.
(33)
				  "Pharmacy and Therapeutics Committee" means a committee established by the
				  Department to develop recommendations for pharmacy practices including but not
				  limited to development of a preferred drug list according to Regulation .12 of
				  this chapter.
(34)
				  "Preauthorization" means an approval required from the Department or its
				  designee before a drug is dispensed.
(35) "Preferred drug list" means a list of
				  recommended drugs developed by the Department that is based on the
				  recommendations of the Pharmacy and Therapeutics Committee.
(36) "Prescriber" means a physician, dentist,
				  podiatrist, or other professional licensed in good standing to prescribe legend
				  drugs in the state in which the service is provided.
(37) "Prescription" means an order by a
				  prescriber, or a prescriber's order transferred from one pharmacist to another,
				  for Program covered pharmacy services in accordance with applicable federal and
				  State laws conveyed in one of the following forms:
(a) An original order signed by the
				  prescriber and written on tamper-resistant paper which shall contain
				  industry-recognized features designed to prevent:
(i) Unauthorized copying of a prescription
				  form;
(ii) Erasure or modification
				  of information written on the prescription by the prescriber; and
(iii) Use of counterfeit prescription
				  forms;
(b) A fax of an
				  original order signed by the prescriber sent directly from the prescriber to
				  the pharmacy provider;
(c) An
				  electronic order; or
(d) An oral
				  order from the prescriber to the pharmacist if the:
(i) Pharmacist promptly writes or prints out
				  and files the prescription;
(ii)
				  Prescription is not for a Schedule II controlled dangerous substance;
				  and
(iii) Prescription is not for
				  certain drugs that have been determined by the Secretary to present an emerging
				  threat in the State because of increasing abuse and diversion.
(38) "Professional dispensing fee" means the
				  professional fee as defined in
				  42 CFR §
												447.502.
(39) "Program" means the Maryland Medical
				  Assistance Program.
(40) "Provider"
				  means an individual, association, partnership, or incorporated or
				  unincorporated group of individuals duly licensed or certified to provide
				  services for recipients and who, through appropriate agreement with the
				  Department, has been identified as a Program provider by issuance of an
				  individual account number.
(41)
				  "Single source drug" means a covered drug which is produced or distributed
				  under an original new drug application approved by the Food and Drug
				  Administration, including a drug product marketed by any cross-licensed
				  producers or distributors operating under the new drug application.
(42) "State actual acquisition cost (SAAC)"
				  means, for those drugs or products identified by the Program, the Program's or
				  its designee's calculation of AAC, based on a survey of providers' actual
				  prices paid to acquire drugs or products marketed or sold by specific
				  manufacturers, when NADAC is unavailable.
(43) "State Formulary" means drug products
				  listed in the United States Food and Drug Administration's Current List of
				  Approved Drug Products with Therapeutic Equivalence Evaluations unless
				  disqualified by the Department in conformity with Health Occupations Article,
				  §
											12-504, Annotated
				  Code of Maryland.
(44) "State-only participants" means those
				  participants in the Program administered and financed by the State who do not
				  meet the technical requirements of Title XIX of the Social Security Act and for
				  whom the State does not claim federal financial participation.
(45) "Usual source of supply" means a
				  wholesaler, distributor, or manufacturer from whom pharmacy providers within
				  the State most frequently obtain their pharmaceuticals.
(46) "Wholesale acquisition cost (WAC)" means
				  the price pharmaceutical manufacturers and distributors charge to wholesale
				  distributors who provide retail and institutional pharmacies with products used
				  to fill prescriptions.