Sec. 10.14.02.08. Pharmacy Services

A. To be considered a participating pharmacy in the Program, the provider shall:

(1) Obtain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland;

(2) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;

(3) Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient's health insurer, if applicable;

(4) Agree not to bill an eligible patient for an additional charge for the reimbursed pharmacy services provided; and

(5) Maintain adequate prescription and administrative records for a minimum of 5 years and, upon request, allow the Department access to the records.

B. Reimbursed pharmacy services include but are not limited to the following:

(1) A prescription, when ordered and signed by a prescriber for an eligible patient, within the limits established by the Program which includes:

(a) A legend drug, including but not limited to the following drug classifications:

(i) Analgesic;

(ii) Antidepressant;

(iii) Antiemetic;

(iv) Anti-infective;

(v) Antineoplastic agent;

(vi) Benzodiazepine;

(vii) Colony stimulating factor;

(viii) Hormone; and

(ix) Individual vitamin; and

(b) An especially formulated enteral or parenteral nutritional preparation required for a patient with a documented pathologic condition, when treatment is medically necessary and life sustaining;

(2) Hypodermic needle and syringe;

(3) Over-the-counter iron preparation;

(4) Durable medical equipment as specified in Regulation .10B of this chapter; and

(5) A disposable medical supply as specified in Regulation .10B of this chapter.

C. Non-reimbursed pharmacy services include but are not limited to:

(1) An over-the-counter drug, excluding iron preparations;

(2) A legend drug for which federal finance participation is prohibited pursuant to 42 CFR §441.25;

(3) An experimental drug; and

(4) A drug not directly related to the diagnosis and treatment of breast or cervical cancer or a complication of treatment for breast or cervical cancer.

D. The participating pharmacy responsibilities are as follows:

(1) Monitoring an eligible patient’s file for contraindications and toxicity; and

(2) Submitting a bill on the designated Departmental form for the reimbursed:

(a) Medication;

(b) Durable medical equipment; and

(c) Disposable medical supply.

E. The Department shall reimburse the participating pharmacy:

(1) Pursuant to COMAR 10.09.03.07A-G, H(1)-(3), and (5)-(6); and

(2) For the deductible or patient contribution amount, or both.

F. The participating pharmacy shall obtain recovery pursuant to COMAR 10.09.03.08.

G. Periodic peer review may be performed by the Department or its designee.

H. Except as provided in §I of this regulation, a drug manufacturer shall pay drug rebates to the Department for reimbursable pharmacy services in the same manner and amount that rebates are provided to the State for State-Only and Pharmacy Assistance recipients' purchases of drugs in accordance with §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)) which is incorporated by reference.

I. Limitations.

(1) The Department shall provide notice to a drug manufacturer who fails to provide adequate rebates in accordance with this chapter indicating that the manufacturer shall pay the drug rebate unless:

(a) The manufacturer submits a written request to the Secretary for a waiver of the rebate requirement; and

(b) The Secretary grants a waiver under §I(2) of this regulation.

(2) The Secretary shall grant a waiver to the requirement set forth in §H of this regulation only if the Secretary determines that the drug manufacturer has demonstrated that:

(a) The drug is a single source drug or an innovator multiple source drug;

(b) The Department has determined that the drug is essential to the health of the eligible patient;

(c) The drug has been given a rating of I-A by the Food and Drug Administration; and

(d) The physician has obtained the Department's authorization for use of the drug before prescribing the drug to the eligible patient.

(3) No manufacturer or its designee may dispute or request repayment of any rebate paid under §H of this regulation more than 3 years after the date the rebate was paid.

J. Except when a manufacturer has been granted a waiver to the rebate requirement under §I of this regulation, the Program may not pay for a drug under this chapter if the manufacturer has not provided a rebate to the Program in accordance with §H of this regulation.