In this chapter, the following terms have the meanings indicated. Terms Defined. "340B price" means the price at which drugs are purchased as authorized under Section 340B of the Public Health Service Act. “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. “Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription. “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. “Brand name drug” means: A single source drug; An innovator multiple source drug; or A drug submitted for payment as brand medically necessary. “Compounded prescription for intravenous therapy” means a prescription that: Combines two or more ingredients; Is prepared by using aseptic technique under a laminar flow clean bench; and Is administered to a patient intravenously. “Controlled substance” means a drug as defined under 21 U.S.C. §802. “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. “Copayment” means the amount a participant is liable to pay for prescriptions, when applicable, which is deducted from provider reimbursement. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX, Social Security Act, 42 U.S.C. §1396 et seq. “Diluent component” means a liquid used for reconstitution or dilution of an active ingredient in compounded prescription intravenous therapy. “Direct price” means, 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. “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). “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. “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. “Family planning services” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. “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. “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. “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. “Freestanding clinics” means those clinics, not associated with a hospital, which are under the direction of physicians as further defined in COMAR 10.09.08.01. “Generic drug” means a drug that is: Available to pharmacy providers from at least one manufacturer; Rated as therapeutically equivalent by the U.S. Food and Drug Administration; and Not a brand name drug. “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. “Institutional pharmacy” means a pharmacy owned and operated by a hospital, nursing facility, or clinic. “Invoice” means: A form issued or approved by the Department for use by providers in submitting bills for payment; or A bill issued by a manufacturer or wholesaler to a provider which indicates proof of purchase and the: Actual acquisition cost paid by the provider; or The direct price charged to the provider by the manufacturer. “Maintenance medication” means medication in chronic therapeutic categories corresponding to the following American Hospital Formulary Service (AHFS) classification numbers: Cardiac drugs (24:04); Antilipemic agents (24:06); Hypotensive agents (24:08); Vasodilating agents (24:12); Sclerosing agents (24:16); Alpha-adrenergic blocking agents (24:20); Beta-adrenergic blocking agents (24:24); Calcium-channel blocking agents (24:28); Renin-angiotensin-aldosterone system inhibitors (24:32); Hydantoins (28:12:12); Oxazolidinediones (28:12:16); Succinimides (28:12:20); Anticonvulsants, miscellaneous (28:12:92); Replacement solutions (40:12) (potassium supplements only); Diuretics (40:28); Lipotropic agents (56:24); Contraceptives (68:12); Estrogens and antiestrogens (68:16); Antidiabetic agents (68:20); Antihypoglycemic agents (68:22); Parathyroid (68:24); Progestins (68:32); Thyroid and antithyroid agents (68:36); Vitamins (88:00); Sodium fluoride (92:00); and 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). “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “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. “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. “Nursing facility” means an institution as further defined in COMAR 10.09.10.01B(30), and classified as a long-term care facility. “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. “Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided. “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. “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. “Preauthorization” means an approval required from the Department or its designee before a drug is dispensed. “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. “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. “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: An original order signed by the prescriber and written on tamper-resistant paper which shall contain industry-recognized features designed to prevent: Unauthorized copying of a prescription form; Erasure or modification of information written on the prescription by the prescriber; and Use of counterfeit prescription forms; A fax of an original order signed by the prescriber sent directly from the prescriber to the pharmacy provider; An electronic order; or An oral order from the prescriber to the pharmacist if the: Pharmacist promptly writes or prints out and files the prescription; Prescription is not for a Schedule II controlled dangerous substance; and 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. “Professional dispensing fee” means the professional fee as defined in 42 CFR §447.502. “Program” means the Maryland Medical Assistance Program. “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. “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. “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. “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. “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. “Usual source of supply” means a wholesaler, distributor, or manufacturer from whom pharmacy providers within the State most frequently obtain their pharmaceuticals. “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. A pharmacy may not qualify as a provider without first having obtained a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery and to dispense drugs in the state in which the service is provided. To participate in the Program, the provider shall: Meet the licensure requirements in Regulation .02 of this chapter; Apply for participation in the Program using the application form designated by the Department; Be approved for participation by the Department; Accept, as payment in full, the amounts paid by the Program plus any copayment required by Regulation .05C(5) of this chapter; Maintain adequate records and prescriptions for a minimum of 6 years, and make them available for inspection, upon request, to the Department or its designee; Ensure that all prescriptions contain sufficient information to justify the invoice charges; Provide services without regard to race, creed, color, age, sex, national origin, marital status, physical or mental handicap; Agree that the provider may not employ knowingly a person who has been disqualified from the Program to compound or dispense Medical Assistance prescriptions, unless prior written approval has been received from the Department; Verify the participant’s eligibility before dispensing covered drugs; Place no restriction on the participant’s right to select providers of the participant’s choice; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant; Maintain a record of the individual who picks up a prescription that includes: The prescription number; The name of the individual picking up the prescription; The signature of the individual picking up the prescription; and The date the prescription was picked up; Reverse invoice charges for any prescription not picked up by the participant or their designee within 14 days; Maintain a record of a participant or designee’s written authorization for automatic refill, if automatic refills are provided; Agree that the provider may not deny services to any participant because of the individual’s inability to pay the copayment; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant; On the Department’s request, provide within 15 days all invoices, as defined in Regulation .01B(24)(b) of this chapter, to assess the AAC; and Participate in the cost of dispensing survey and, on the Department’s request and within the Department’s timeline, provide to the Department all documentation that the Department or its designee determines is necessary. The Department shall cover: Legend drugs except certain drugs for which federal financial participation is prohibited pursuant to 42 CFR §441.25; Schedule V cough preparations; Contraceptives; Hypodermic needles and syringes; Supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home; Enteric coated aspirin when prescribed for: The treatment of arthritic conditions as certified on the prescription in the prescriber's own handwriting or by the dispenser after consultation with the prescriber; and At least 250 tablets of 325 milligrams each, whether for initial prescriptions or refills. Nonlegend ferrous sulfate oral preparations in the following strengths, dosage forms, and quantities only: Drops (125 milligrams per milliliter) in units of 50 milliliter dropper bottles; Elixir (220 milligrams per 5 milliliters) in quantities of at least 473 milliliters; Syrup (90 milligrams per 5 milliliters) in quantities of at least 473 milliliters; and Tablets (300 milligrams to 325 milligrams) in quantities of at least 100 tablets; Nonlegend chewable tablets of any ferrous salt if: The tables are combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals; The participant is under 12 years old; and The quantity dispensed is at least 60 tablets and not more than a 100-day supply; Nonlegend ergocalciferol liquid (8,000 international units per milliliter); and Any nonlegend drug determined by the Program to be cost effective. Prescription Requirement. Except as provided in §B(2) of this regulation, a prescription is required for all items to be covered under this regulation even if the item is not a legend drug or otherwise does not require a prescription under federal or State pharmacy law. A prescription is not required for various forms of latex condoms or other drugs or products identified by the Program, each within the limits established by the Program. The Department may cover legend drugs not otherwise covered by §A of this regulation when: The drugs are identified as necessary to address a drug shortage as identified by the United States Food and Drug Administration; and The Department determines the coverage of the drugs medically necessary. Except as specifically identified as being covered under Regulation .04 of this chapter, the following are not covered: Nonlegend drugs; Medical supplies and durable equipment; Any original prescription for a controlled substance dispensed more than 30 days after the date it was ordered; Drugs supplied to hospital inpatients; Drugs and supplies dispensed by the provider with an actual acquisition cost of $0; Experimental or investigational drugs; Except where authorized by the Department to be covered under this Regulation, injectables dispensed by a provider for administration by the prescriber; Food supplements or infant formulas, including supplemental vitamin and mineral products when administered orally; Sugar or salt substitutes; Cosmetics, medicine chest supplies, and sundries including all soaps, all body powders, all body oils or body lotions, cotton balls, adhesive strip bandages, cotton-tipped applicators, suntan products, deodorants, dentifrices, tissues, convenience packages of covered items, hot water bottles, ice caps, heating pads, soft cervical collars; Alcoholic beverages; Ostomy supplies; Those services authorized for payment to a prescriber, hospital, nursing facility, hospital outpatient department, or freestanding clinic; Oral drugs or injections for central nervous system stimulants, anorexigenics, and any other agents when used for weight control; Drug products for which federal financial participation is prohibited pursuant to 42 CFR §441.25; Ovulation stimulants unless used to treat an iatrogenic infertility; Effective January 1, 2006, any Part D drug for individuals who are eligible for Medicare Part D benefits; Drugs or products used for hair growth or other cosmetic purposes; Any drug or supply that is covered and reimbursed by the Department under any other chapter of this subtitle; and Any drug or product the Department determines is not medically necessary. Prescriptions requiring preauthorization according to Regulation .06 of this chapter are not covered unless the required preauthorization has been obtained from the Department or its designee. Limitations on Covered Services. The allowable cost of ingredients dispensed pursuant to a prescription may not exceed an upper limit as established in Regulation .07, of this chapter. Refills. The prescriber shall authorize refills only on the original prescription if the prescriber determines a refill is necessary and appropriate. The Program may authorize no more than 11 refills, not to exceed other applicable federal and State limitations. The pharmacy may not automatically refill a prescription unless authorized in writing by the recipient or their designee. Days Supply. The total amount dispensed under one prescription order, including refills, is limited to a 360 days supply, not to exceed other applicable federal and State limitations. Unless otherwise specified, prescriptions shall be limited to a 34 day supply at one time. Unless otherwise specified, maintenance medication shall be limited to: A 34-day supply for the initial prescription; and Up to a 100-day supply at one time for all subsequent prescriptions. Prescriptions shall be dispensed at the lower of the quantity prescribed or the maximum days supply allowed at one time unless: The Program authorizes a reduction of the quantity; or The prescription is the final refill for the balance remaining on the total prescription order. Providers may partially fill a prescription for Schedule II controlled dangerous substances, but the remaining portion of the prescription may not be later filled. Oral sodium fluoride products used in the prevention of dental caries are limited to an original prescription of up to a 120-day supply with up to two refills, not to exceed a total of a 360-day supply. Prescriptions for drugs packaged by the manufacturer as an unbreakable unit may be dispensed in increments of appropriate package size. Whether for an initial or subsequent prescription, contraceptive prescriptions may be dispensed in up to a 12 months supply at one time. Generic Drugs. Except as limited by §C(4)(b) and (c) of this regulation, when a drug product is prescribed by its nonproprietary or generic name, a provider shall substitute as follows: A drug product in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, therapeutically equivalent to the drug as prescribed; or A drug product with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, bioequivalent to the drug as prescribed as rated by the U.S. Food and Drug Administration. A provider may not substitute a generic drug for a brand name drug under §C(4)(a) of this regulation if: The prescriber specifically directs otherwise; and The prescriber requests and received approval from the Program. The Department shall only authorize a provider to substitute a drug product under this regulation when there will be a savings in or no increase in cost to the Department. Copayment for Services Rendered on or after July 1, 2005. There will be no pharmacy copayment for prescriptions for the following: Individuals younger than 21 years old; Pregnant women; Institutionalized individuals who are inpatients in long-term care facilities or other institutions requiring spending all but a minimal amount of income for medical costs; Family planning drugs and devices; and Individuals who are American Indians or Alaskan Natives. The copayments for prescriptions not excluded from a copayment under §C(5)(a) of this regulation are: $3 for prescriptions for brand name drugs not on the preferred drug list; $1 for prescriptions for generic drugs and brand name drugs on the preferred drug list; and $1 for prescriptions for antiretroviral drugs in American Hospital Formulary Service therapeutic class 8:18:08. Reimbursement may not be made: For nonlegend enteric coated aspirin tablets in strengths other than 300 to 325 milligrams; For any other nonlegend aspirin products such as sustained release capsules, buffered tablets, compressed tablets, liquid preparations or combination products in which aspirin is only one of the active ingredients; For nonlegend ferrous sulfate products in strengths or dosage forms not listed in Regulation .04A(8) of this chapter; For nonlegend iron products combined with other active ingredients, except for chewable tablets as described in Regulation .04A(9) of this chapter; or At a reimbursement level which exceeds the maximum allowable cost established by the Program. Condoms dispensed by pharmacy providers are subject to the following limitations: The recipient shall present a Medical Assistance card with a current eligibility period; Only 12 condoms may be dispensed to an individual at one time; The provider may dispense condoms only to the individual named on the Medical Assistance card; Natural membrane condoms are not covered; and Both the recipient receiving the condoms and the provider shall sign the dispensing documentation. A compounded prescription for intravenous therapy is subject to the following limitations: The Program may not cover a compounded prescription for intravenous therapy if a premixed, therapeutically equivalent commercial intravenous therapy is available from a commercial source; The Program may not cover the diluent component of a compounded prescription for intravenous therapy; and All claims submitted require new prescription numbers. Prescriptions dispensed to participants residing in nursing facilities are subject to the following limitations: Claims shall be identified as nursing facilities prescriptions by coding mechanisms determined by the Program; Credits for unused unit dose medication and any other medication which may legally be returned to pharmacy stock: Shall be made within 60 days of Program payment; May not take into account any professional fee paid by the Program; and Shall adjust for leave of absence prescriptions; and Multiple prescriptions dispensed to a recipient residing in a nursing facility for the same drug product or compounded prescription shall receive only one professional fee per calendar month except for: Leave of absence prescriptions; Prescriptions for intravenous therapy; and Prescriptions for Schedule II-V controlled substances. Tamper Resistant Prescriptions. Prescriptions written on or after April 1, 2008, that do not contain at least one of the tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered. Prescriptions written on or after October 1, 2008, that do not contain all three tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered. No covered drug or supply identified under Regulation .04 of this chapter shall be reimbursed under Regulation .07 of this chapter if: Federal financial participation from the Centers for Medicare & Medicaid Services is not available for the drug or supply; or Prior authorization for the drug or supply is required under Regulation .06 of this chapter but was not obtained. A drug is not covered for State-only participants if: The manufacturer has not provided the same rebate to the State for State-only participants’ purchases of drugs as is required under Section 1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)); The Program has provided notice to the manufacturer of the manufacturer's failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and The manufacturer has failed to demonstrate to the Secretary that the drug’s availability is essential to State-Only participants. A manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation or under 42 U.S.C. §1396r-8(c) more than 3 years after the date the rebate was paid. The provider shall obtain preauthorization from the Department or its designee for any prescription for: Antibiotic liquids requiring reconstitution for amounts exceeding a 14-day supply; Nonmaintenance drugs for more than a 34 day supply; A usual and customary charge exceeding $2,500; Female hormones for biologic males when used for treating sexual aggression; Vitamin and mineral products when given by nasogastric, jejunostomy, or gastrostomy tube in the home; Drugs rejected by the point-of-sale system because of edits established by the Program to ensure appropriate utilization of medication before the prescription is dispensed, if the Department does not allow provider level overrides; Where a prescriber has filed an official report of an adverse event or product problem with the Program or the United States Food and Drug Administration regarding a generic drug, the brand name drug used as an alternative to that generic drug; Drugs identified by the Program that are subject to fraud or abuse; or Drugs not on the preferred drug list developed under Regulation .12 of this chapter except for: Antiretrovirals; or Any other drugs or classes of drugs as determined by the Department. Off-Label Uses of Drugs. The Department may require preauthorization for an off-label use of a drug. Except as provided in §B(3) of this regulation, the Department or its designee may not grant preauthorization for an off-label use of the drug if: The off-label use is inconsistent with generally accepted standards of care; The drug is prescribed for a non-medically accepted indication; The drug is prescribed in a manner not approved by the U.S. Food and Drug Administration; or The off-label use is not documented in and supported by the latest edition of: The American Hospital Formulary Service Drug Information (AHFS-DI); The Thompson Micromedex Drugdex; or The United States Pharmacopeia. The Department or its designee may grant preauthorization for the off-label use of mental health drugs for individuals 18 years old and younger within the limits established by the Program. Preauthorization is not required for: Prescriptions for oral contraceptive drug products; Drugs dispensed in unit dose form to patients in a nursing facility by a provider using an approved unit dose system. Preauthorization Process. The provider or the prescriber, if appropriate, ordering a drug subject to preauthorization, shall: Contact the Department or its designee through an established 24-hour hot-line to request preauthorization; and Provide required information and documentation. The Department or its designee shall respond to a request for preauthorization by telephone or facsimile request within 24 hours of receipt of a request for preauthorization. A 72-hour supply of the prescribed drug shall be allowed: In an emergency as determined by the prescriber; In an emergency as determined by the pharmacist, if possible in consultation with the prescriber; or If the Department does not provide a response to a preauthorization request within 24 hours. A preauthorization granted by the Department or its designee under this Regulation may not be used by any person as indicating that the individual for whom the prescription was ordered is eligible for Program benefits on the day the prescription is filled or that the Department will guarantee reimbursement for the prescription. All Program restrictions and requirements on eligibility, covered services, and limitations on reimbursement remain in effect. A 30-day emergency supply of atypical antipsychotic drugs not on the preferred drug list shall be: Immediately authorized by the Department or its designee in an emergency as determined by the: Prescriber; or Pharmacist, if unable to contact the prescriber; and Limited to a one-time 30-day period. Reconsideration of Adverse Decisions. The Department or its designee shall respond within 48 hours of receiving all necessary documentation of a written request from a participant or provider for reconsideration of an adverse decision on a preauthorization request. The Department or its designee shall ensure that all adverse decisions of reconsiderations are reviewed and issued by a physician. Appeals of adverse decisions of reconsideration requests shall be filed in accordance with Regulation .10 of this chapter. The Department or its designee may: Require preauthorization for more than ten prescriptions including refills per 30-day period per noninstitutionalized participant; and May exclude certain drugs such as antibiotics from the limit as appropriate. The provider shall produce records to verify any charge to the Program upon request. The provider shall bill all appropriate insurance carriers before requesting payment from the Department. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The provider shall submit a request for payment on a form designated by the Department. The Department may return to the provider all invoices not properly completed. The pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for similar prescriptions. The physician or osteopath shall charge the Program his actual acquisition cost for the drugs dispensed. Determination of Allowable Cost. For covered legend drugs and nonlegend drugs, allowable cost shall be: The NADAC; or When the NADAC is unavailable, the lowest of the: WAC plus 0 percent; FUL; and SAAC. For covered legend brand name drugs for which the prescriber files an official report of an adverse event or product problem regarding a generic drug with the Program or the United States Food and Drug Administration, or when the Department requires the brand name drugs to be dispensed, the allowable cost shall be: The NADAC of the branded product; or When the NADAC of the branded product is unavailable, the lower of the: WAC plus 0 percent; or SAAC. For condoms dispensed by pharmacy providers, the allowable cost shall be as described in §H(1) of this regulation. For covered over-the-counter products, and covered medical supplies, the allowable cost shall be as described in §H(1) of this regulation. For covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail, the allowable cost shall be: The NADAC; or When the NADAC is unavailable, the lowest of the: WAC plus 0 percent; FUL; or SAAC. Except when purchased at the 340B price by a provider, the allowable cost for covered clotting factors shall be the lower of the: WAC plus 0 percent; or AAC plus 8 percent. For 340B covered entities or FQHCs that fill Program participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act, the allowable cost shall be the provider’s AAC. For facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS, the allowable cost shall be the provider’s AAC. For facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, the allowable cost shall be the provider’s AAC. Payment for Covered Services to a Pharmacy. Payment for covered legend and nonlegend drugs, over-the-counter products, and covered medical supplies is the lower of: The provider's charge according to §F of this regulation, less any applicable co-payment according to Regulation .05C(5) of this chapter; or The amount that is: The allowable cost of the item in §H(1) of this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for covered legend brand name drugs as indicated in §H(2) of this regulation shall be the lower of: The provider’s charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or The total of: The allowable cost of the item in §H(2) of this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for condoms will be the lower of the: The provider's charge according to §F of this regulation; or Allowable cost according to §H(3) of this regulation. Copayment is not required for condom orders. Payment for covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail shall be the lower of the: Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or The total of: The allowable cost of the item in §H(5) of this regulation; Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for clotting factor shall be lower of the: Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or Amount that is: The allowable cost of the item in §H(6) of this regulation; Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for providers that fill Medicaid participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act shall be the total of: The allowable cost of the item in §H(7) of this regulation; Plus the applicable professional dispensing fee indicated in §I(12) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS shall be the total of: The allowable cost of item in §H(8) this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, shall be the total of: The allowable cost of item in §H(9) this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for participants residing in nursing facilities shall be $11.67. The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for individuals other than residents in nursing facilities shall be $10.67. The professional dispensing fee for covered services rendered on or after April 1, 2017 to a pharmacy for medication purchased at the prices authorized under Section 340B of the Public Health Services Act shall be $12.12. The Department may pay a pharmacy using an approved unit dose system on the basis of a monthly dispensing fee per nursing home resident. The value of the fee may not be higher than the pharmacy’s usual and customary charge to non-Medicaid patients for similar services. Payment for Covered Services to a Physician or Osteopath. Except as provided in §J(2) of this regulation, the Program shall reimburse a physician or osteopath for covered drugs dispensed at the lower of: The physician's or osteopath's actual acquisition cost, less any applicable copayment according to Regulation .05C(5) of this chapter; or The allowable cost of the item in §H of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter. The Program shall reimburse a physician or osteopath for covered drugs dispensed to Medicaid participants on the same basis as reimbursement to a registered pharmacist if: The physician or osteopath dispenses the covered drugs on a regular basis in the physician's or osteopath’s office; The physician's or osteopath’s office is not located within a 10-mile radius of a Medicaid participating pharmacy; and The Program, after consultation with the Board of Pharmacy, has verified that the physician or osteopath is dispensing drugs in accordance with accepted pharmacy standards. In order to determine whether the current professional dispensing fee is appropriate, the Department will periodically conduct surveys to determine the actual costs involved in filling a prescription in the State. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or third-party source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, pharmacist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department may consult with the State Pharmaceutical Association, the State Board of Pharmacy, and the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The findings and recommendations of these groups will be given consideration. The Department will give the provider reasonable notice of its intentions to impose sanctions. In the written notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. Any provider voluntarily withdrawing from the Program or removed or suspended from the Program according to this section shall notify recipients that he no longer honors Medical Assistance cards before rendering additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. The Department may establish a Pharmacy and Therapeutics Committee (Committee). The Committee shall consist of the following 12 members: Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs; Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and Two members of the Committee shall be consumer representatives residing in the State. Consideration for membership on the Committee shall be given to appointing physicians and pharmacists participating in the Program or with experience in developing or practicing under a preferred drug list. The Committee members shall: Be appointed by the Secretary; Have 3 year terms; Be allowed to serve more than one term; and Elect a chairman and vice chairman. The Committee shall: Meet at least twice a year; To the extent feasible, review all drug classes included on the list at least once every 12 months; Develop recommendations for a preferred drug list for the Program by considering the: Clinical efficacy of the drug; Cost effectiveness of the drug, including any supplemental rebates from manufacturers; and Needs of Program recipients, such as the ease of drug therapy administration, rate of compliance with drug therapy instructions, and frequency of prior authorization; Recommend: The addition or deletion of existing drugs as necessary; Preauthorization criteria; and Conditions or illnesses to be exempted from prior authorization based on clinical data; and Consider medically accepted off-label use of U.S. Food and Drug Administration (FDA) approved drugs. The Department shall: Inform the Committee of any decisions regarding the preferred drug list; Annually publish the preferred drug list; Maintain an updated preferred drug list that is available electronically; Ensure, based upon timely notice from the manufacturer, that any new products are reviewed at the next regularly scheduled meeting of the committee; Provide an expedited review process for newly approved drugs designated as priority by the FDA; and Provide manufacturers and the public an opportunity to submit written material to the committee. The preferred drug list developed by the Department based on the recommendations of the Pharmacy and Therapeutics Committee: May not include certain therapeutic classes including antiretroviral medications used to treat the AIDS virus, which are exempt from preauthorization as indicated in Regulation .06A(12) of this chapter; Shall, for therapeutic classes other than those described in §G(1) of this regulation, include at least one drug approved by the FDA for use in the specific therapeutic class, in every therapeutic class for which the FDA has approved three or fewer drugs for use; and Shall, in every therapeutic class other than those described in §G(1) of this regulation, offer a choice of at least two pharmaceutical or biological entities without an administrative preference for each therapeutic class in which there are four or more pharmaceutical or biological entities approved by the FDA. The Department may negotiate and collect supplemental rebates from manufacturers. Health-General Article, §§2-104(b), 15-103, 15-103.1, 15-105, 15-118, and 15-148, Annotated Code of Maryland Effective date: February 16, 1966 Amended effective March 15, 1967; July 1, 1967; December 1, 1969; July 1, 1971; January 22, 1975 (2:2 Md. R. 86); March 18, 1975 (2:9 Md. R. 659); July 1, 1975 (2:15 Md. R. 1066); January 1, 1976 (2:29 Md. R. 1739) Existing regulations repealed and new regulations adopted effective September 1, 1976 (3:18 Md. R. 981) 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, .02, .04, .05A, .06, .07H, and .09A—C amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1203); expired November 10, 1979 Regulations .01, .03, .05 and .07 amended as an emergency provision effective November 15, 1988 (15:23 Md. R. 2654); emergency status expired March 13, 1989 Regulations .01, .05C, .07H, H-1 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 and .07 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—.05 and .07 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, .05, and .07 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, .05C, and .07C, H—J 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 .01B, .05C, and .07I 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); September 25, 2017 (44:19 Md. R. 896); December 31, 2018 (45:26 Md. R. 1242) Regulations .01C, N, S; .07F, H; and .09A—C 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) Regulation .01P amended effective February 8, 1980 (7:3 Md. R. 263) Regulations .02B; .04F (recodified from §H); .05B; .07F-1, H-1 (recodified from §§G and J, respectively) adopted effective November 11, 1979 (6:22 Md. R. 1779) Regulation .03 amended effective March 14, 1989 (16:4 Md. R. 497); November 28, 2011 (38:24 Md., R. 1502); March 31, 2014 (41:6 Md. R. 378); September 25, 2017 (44:19 Md. R. 896) Regulation .03K adopted effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03L adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04 amended effective May 1, 1979 (6:7 Md. R. 576); February 8, 1980 (7:3 Md. R. 263); July 11, 1988 (15:14 Md. R. 1654); November 28, 2011 (38:24 Md., R. 1502); June 14, 2021 (48:12 Md. R. 470) Regulation .04A amended effective October 17, 1980 (7:21 Md. R. 1994); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637); July 1, 1992 (19:12 Md. R. 1134) Regulation .04A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707) Regulation .04A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822) Regulation .04A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .04A amended effective March 3, 2003 (30:4 Md. R. 316); February 16, 2004 (31:3 Md. R. 207); September 25, 2017 (44:19 Md. R. 896) Regulation .04C adopted effective March 31, 2025 (52:6 Md. R. 267) Regulation .04E amended effective October 29, 1984 (11:21 Md. R. 1811) Regulation .04G adopted effective March 9, 1987 (14:5 Md. R. 579) Regulation .05 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .05 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) Regulation .05A amended effective May 1, 1979 (6:7 Md. R. 576); November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); October 17, 1980 (7:21 Md. R. 1994); October 29, 1984 (11:21 Md. R. 1811); March 9, 1987 (14:5 Md. R. 579); July 11, 1988 (15:14 Md. R. 1654); July 1, 1992 (19:12 Md. R. 1134) Regulations .05A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707) Regulation .05A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822) Regulation .05A amended effective February 16, 2004 (31:3 Md. R. 207); March 13, 2006 (33:5 Md. R. 520); June 14, 2021 (48:12 Md. R. 470); March 31, 2025 (52:6 Md. R. 267) Regulation .05A, C amended effective October 22, 2018 (45:21 Md. R. 973) Regulation .05B amended effective July 1, 1992 (19:12 Md. R. 1134) Regulation .05C amended effective December 26, 1980 (7:26 Md. R. 2422); March 9, 1987 (14:5 Md. R. 579); September 7, 1987 (14:18 Md. R. 1966); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:24 Md. R. 2769); March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637) Regulation .05C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861) Regulation .05C amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707) Regulation .05C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); amended permanently effective November 10, 2003 (30:22 Md. R. 1579) Regulation .05C amended effective September 27, 2004 (31:19 Md. R. 1432); August 1, 2005 (32:15 Md. R. 1320); December 6, 2007 (34:24 Md. R. 2157); March 31, 2014 (41:6 Md. R. 378) Regulation .05D and E adopted as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769) Regulation .05F and G adopted effective April 21, 2008 (35:8 Md. R. 805) Regulation .05-1 adopted as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); adopted permanently effective December 1, 1992 (19:23 Md. R. 2040) Regulation .05-1 amended effective November 28, 2011 (38:24 Md., R. 1502) Regulation .05-1A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .05-1A amended effective March 3, 2003 (30:4 Md. R. 316); September 25, 2017 (44:19 Md. R. 896) Regulation .06 amended effective November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); November 8, 1981 (8:21 Md. R. 1707); August 30, 1982 (9:17 Md. R. 1708); December 19, 1983 (10:25 Md. R. 2268); October 29, 1984 (11:21 Md. R. 1811); September 7, 1987 (14:18 Md. R. 1966); December 12, 1988 (15:24 Md. R. 2769) Regulation .06 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .06 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) Regulation .06A amended effective July 1, 1992 (19:12 Md. R. 1134); October 10, 2016 (43:20 Md. R. 1109); June 14, 2021 (48:12 Md. R. 470) Regulation .06A, C amended effective December 6, 2007 (34:24 Md. R. 2157) Regulation .07 amended effective March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) Regulation .07C amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07C amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861) Regulation .07G amended effective June 1, 1985 (12:10 Md. R. 961); May 5, 1986 (13:9 Md. R. 1029); May 4, 1987 (14:9 Md. R. 1080); October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009); July 11, 1988 (15:14 Md. R. 1654) Regulation .07G amended as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769) Regulation .07H amended as an emergency provision effective July 1, 1977 (4:14 Md. R. 1080); emergency status extended at 4:23 Md. R. 1728; adopted permanently effective November 4, 1977 (4:23 Md. R. 1734) Regulation .07H amended effective July 1, 1978 (5:12 Md. R. 967); May 1, 1979 (6:7 Md. R. 576); July 1, 1980 (7:13 Md. R. 1278); March 9, 1987 (14:5 Md. R. 579); July 1, 1987 (14:13 Md. R. 1473); July 11, 1988 (15:14 Md. R. 1654) Regulation .07H amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1204); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) Regulation .07H amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1122); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) Regulation .07H amended as an emergency provision effective July 1, 1984 (11:14 Md. R. 1246); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) Regulation .07H-1 amended effective March 9, 1987 (14:5 Md. R. 579) Regulation .07H, I amended effective September 27, 2004 (31:19 Md. R. 1432) Regulation .07I amended effective March 19, 1990 (17:5 Md. R. 637) Regulation .07I amended as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); amended permanently effective October 15, 1991 (18:19 Md. R 2099) Regulation .07I amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707) Regulation .07I amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .07I amended effective March 3, 2003 (30:4 Md. R. 316); June 14, 2021 (48:12 Md. R. 470) Regulation .07J adopted as an emergency provision effective July 1, 1980 (7:13 Md. R. 1266); adopted permanently effective October 17, 1980 (7:21 Md. R. 1995) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulation .12 adopted effective March 3, 2003 (30:4 Md. R. 316) Regulation .12 amended as an emergency provision effective September 18, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .12E amended effective November 23, 2006 (33:23 Md. R. 1794) Regulation .12G amended effective December 6, 2007 (34:24 Md. R. 2157) Table I adopted effective June 1, 1985 (12:10 Md. R. 961) Table I repealed and new Table I adopted effective May 5, 1986 (13:9 Md. R. 1029); amended effective October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009)