Md. Code Regs. 10.09.03.01

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.09.03.01 - Definitions

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.

Md. Code Regs. 10.09.03.01

Regulation .01 amended effective June 1, 1985 (12:10 Md. R. 961); April 30, 1988 (15:8 Md. R. 1009); March 14, 1989 (16:4 Md. R. 497)
Regulations .01 amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1203); expired November 10, 1979
Regulations .01 amended as an emergency provision effective November 15, 1988 (15:23 Md. R. 2654); emergency status expired March 13, 1989
Regulations .01 amended as an emergency provision effective October 1, 1982 (10:1 Md. R. 19); adopted permanently effective January 30, 1983 (10:1 Md. R. 29)
Regulations .01 amended as an emergency provision effective December 31, 1987 (15:2 Md. R. 117) (Emergency provisions are temporary and not printed in COMAR)
Regulations .01 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1113); amended permanently effective October 23, 1995 (22:21 Md. R. 1615)
Regulations .01 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective December 30, 1996 (23:26 Md. R. 1860)
Regulations .01B amended as an emergency provision effective April 1, 1991 (18:8 Md. R. 861); amended permanently effective July 8, 1991 (18:13 Md. R. 1482)
Regulation .01B amended effective July 1, 1992 (19:11 Md. R. 1015)
Regulations .01C, N, S; .07F, H; amended effective November 11, 1979 (6:22 Md. R. 1779)
Regulation .01E-1_E-3 adopted effective December 26, 1980 (7:26 Md. R. 2422)
Regulation .01H-1 amended effective May 5, 1986 (13:9 Md. R. 1029) Regulations .01B amended as an emergency provision effective July 9, 1998 (25:16 Md. R. 1261); amended permanently effective October 19, 1998 (25:21 Md. R. 1574)
Regulation .01B amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)
Regulation .01B amended effective March 3, 2003 (30:4 Md. R. 316)
Regulation .01B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired effective January 1, 2004
Regulation .01B amended effective February 16, 2004 (31:3 Md. R. 207); November 23, 2006 (33:23 Md. R. 1794); April 21, 2008 (35:8 Md. R. 805); November 28, 2011 (38:24 Md., R. 1502)
Regulations .01C, N, S amended effective November 11, 1979 (6:22 Md. R. 1779)
Regulation .01P amended effective February 8, 1980 (7:3 Md. R. 263); amended effective 44:19 Md. R. 896, eff. 9/25/2017; amended effective 45:26 Md. R. 1242, eff. 12/31/2018