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10.09.03.00.htm 10.09.03.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 09 MEDICAL CARE PROGRAMS Chapter 03 Pharmacy Services Authority: Health-General Article, §2-104(b) 15-103, 15-103.1, 15-105, and 15-118, Annotated Code of Maryland
10.09.03.01.htm 10.09.03.01. 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 reimbur
10.09.03.02.htm 10.09.03.02. 02 License Requirements.. A. 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.B. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19.C. A doctor of medicine or osteopathy shall be lic
10.09.03.03.htm 10.09.03.03. 03 Conditions for Participation.. To participate in the Program, the provider shall:. A. Meet the licensure requirements in Regulation .02 of this chapter;. B. Apply for participation in the Program using the application form designated by the Department;. C. Be approved for participation by the Department;. D. Accept, as payment in full, the amounts paid by the Program plus any copayment required by Regulation .05C(5) of this chapter;E. Maintain adequate reco
10.09.03.04.htm 10.09.03.04. 04 Covered Services.. A. The Department shall cover:. 1) Legend drugs except certain drugs for which federal financial participation is prohibited pursuant to 42 CFR §441.25;2) Schedule V cough preparations;. 3) Contraceptives;. 4) Hypodermic needles and syringes;. 5) Enteral nutritional and supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home;6) Enteric coated aspirin when prescribed for:. a) The treatment of arthr
10.09.03.05.htm 10.09.03.05. 05 Limitations.. A. Except as specifically identified as being covered under Regulation .04 of this chapter, the following are not covered:1) Nonlegend drugs;. 2) Medical supplies and durable equipment;. 3) Any original prescription for a controlled substance dispensed more than 30 days after the date it was ordered;4) Drugs supplied to hospital inpatients;. 5) Drugs and supplies dispensed by the provider with an actual acquisition cost of $0;.
10.09.03.05-1.htm 10.09.03.05-1. 05-1 Expanded Limitations.. A. A drug is not covered for State-only participants if:. 1) 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)2) 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 requir
10.09.03.06.htm 10.09.03.06. 06 Preauthorization Requirements.. A. The provider shall obtain preauthorization from the Department or its designee for any prescription for:1) Antibiotic liquids requiring reconstitution for amounts exceeding a 14-day supply;. 2) Nonmaintenance drugs for more than a 34 day supply;. 3) A usual and customary charge exceeding $2,500;. 4) Female hormones for biologic males when used for treating sexual aggression;. 5) Enteral nutritional products and vitamin and mi
10.09.03.07.htm 10.09.03.07. 07 Payment Procedures.. A. The provider shall produce records to verify any charge to the Program upon request.. B. The provider shall bill all appropriate insurance carriers before requesting payment from the Department.C. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.D. The provider shall submit a request for payment on a form designated by the Department..
10.09.03.08.htm 10.09.03.08. 08 Recovery and Reimbursement.. A. 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 c
10.09.03.09.htm 10.09.03.09. 09 Cause for Suspension or Removal and Imposition of Sanctions.. A. 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:1) Suspension from Program;. 2) Withholding of payment by the Program;.
10.09.03.10.htm 10.09.03.10. 10 Appeal Procedures.. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.
10.09.03.11.htm 10.09.03.11. 11 Interpretive Regulation.. 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.
10.09.03.12.htm 10.09.03.12. 12 Preferred Drug Program.. A. The Department may establish a Pharmacy and Therapeutics Committee (Committee). B. The Committee shall consist of the following 12 members:. 1) Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs;2) Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and
10.09.03.9999.htm 10.09.03.9999. Administrative History 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) M
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