PARRIS N. GLENDENING, Governor

Ch. 102

Article - Health - General

15-118.

(a) [The forms that are used in prescribing and billing for drugs under the
Program shall include the following statement, if applicable: This prescription shall be
filled with a generic equivalent as authorized by State law, unless the prescriber directs
otherwise in writing.] A PRESCRIPTION, FORM, OR AN ELECTRONIC COMMUNICATION
THROUGH THE POINT-OF-SALE SYSTEM THAT IS USED TO PRESCRIBE OR BILL FOR
DRUGS SHALL SPECIFY CONSPICUOUSLY ON ITS FACE THAT THE GENERIC
EQUIVALENT OF A PRESCRIPTION DRUG IS REQUIRED UNLESS OTHERWISE
DIRECTED IN WRITING BY THE PRESCRIBER.

(b) (1) Unless the prescriber directs otherwise AND INCLUDES A MEDICAL
REASON WHY THE GENERIC CANNOT BE USED on the form or on an attached signed
certification of need, the generic form of the drug authorized under § 12-508 of the
Health Occupations Article shall be used to fill the prescription[, except for drugs
generally not available in the State, drugs that have low utilization, or drugs lacking
significant cost differential between the interchangeable products].

(2) IF THE APPROPRIATE GENERIC DRUG IS NOT GENERALLY
AVAILABLE, THE DEPARTMENT MAY WAIVE THE REQUIREMENT FOR GENERIC
SUBSTITUTION UNDER PARAGRAPH (1) OF THIS SUBSECTION.

(c) (B) (1) [The Program shall publish a list of drugs with therapeutic
equivalence as defined in § 12-508 of the Health Occupations Article that are generally
available within the State, have sufficient utilization, are packaged for administration or
patient use in a manner that avoids any potential adverse impact on efficacy of treatment,
and have sufficient cost differential between products.

(2) The] EXCEPT AS PROVIDED UNDER PARAGRAPH (2) OF THIS
SUBSECTION, THE Program shall establish maximum reimbursement levels for the drug
products [listed under paragraph (1) of this subsection based on the cost of the available
generic products] FOR WHICH THERE IS A GENERIC EQUIVALENT AUTHORIZED
UNDER § 12-508 OF THE HEALTH OCCUPATIONS ARTICLE, BASED ON THE COST OF
THE GENERIC PRODUCT.

(2) IF A PRESCRIBER DIRECTS A SPECIFIC BRAND NAME DRUG, THE
REIMBURSEMENT LEVEL SHALL BE BASED ON THE COST OF THE BRAND NAME
PRODUCT.

[(3) Additions to the Program list of interchangeable drugs shall be effective
60 days after the publication of the Program list or supplements to the Program list
including the changes.

(4) Drug products disqualified from being used as a generic substitute in
accordance with § 12-508 of the Health Occupations Article shall be deleted from the
Program list of interchangeable drugs concurrently and without further action by the
Department.]

(d) (C) (1) [Unless] EXCEPT AS PROVIDED UNDER PARAGRAPH (4) OF
THIS SUBSECTION AND UNLESS the change is made by an emergency regulation, the

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