Current through Register Vol. 51, No. 19, September 20, 2024
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
and 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.
