Ch. 647

1994 LAWS OF MARYLAND

and requires Medicaid agencies to pay for off-label use of drugs prescribed for Medicaid
patients if the use is stated in any of these sources; and the Omnibus Budget
Reconciliation Act of 1993 applies the same criteria and coverage to Medicare patients;
and

WHEREAS, Ten states have passed legislation similar to this Act; and

WHEREAS, Use of FDA approved drugs for off-label indications provides
efficacious drugs at a lower cost; to require that all appropriate uses of a drug undergo
approval by the FDA would substantially increase the cost of drugs, and delay or even
deny patients' ability to obtain medically effective treatment;. FDA approval for- each use
would require substantial expenditure and time to undergo the clinical trials necessary to
obtain FDA approval, particularly when a drug is off patent and in generic production,
and consequently is available at a lower price; once a drug is in generic production by
multiple manufacturers, it is not economically feasible for a manufacturer to incur the
cost of FDA approval; and

WHEREAS, Reimbursement for off-label indications of FDA approved drugs is
necessary to conform to the way in which appropriate medical' treatment is provided, to
make needed drugs available to patients, and to contain health care costs; now, therefore,

SECTION -1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF
MARYLAND, That the Laws of Maryland read as follows:

Article 48A - Insurance Code

490W.

(A)     (1) IN THIS SECTION THE FOLLOWING WORDS HAVE THE MEANINGS
INDICATED.

(2) "MEDICAL LITERATURE" MEANS SCIENTIFIC STUDIES PUBLISHED IN
A PEER-REVIEWED NATIONAL PROFESSIONAL MEDICAL JOURNAL.

(3)      "OFF-LABEL USE OF DRUGS" MEANS WHEN DRUGS ARE
PRESCRIBED FOR TREATMENTS OTHER THAN THOSE STATED IN THE LABELING
APPROVED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION.

(4)      "STANDARD REFERENCE COMPENDIA" MEANS:

(I)       THE UNITED STATES PHARMACOPEIA DRUG INFORMATION;

(II)     THE AMERICAN MEDICAL ASSOCIATION DRUG EVALUATIONS;
OR

(III)    THE AMERICAN HOSPITAL FORMULARY SERVICE DRUG
INFORMATION.

(B)      (1) EACH CONTRACT OR POLICY OF HEALTH INSURANCE DELIVERED
OR ISSUED FOR DELIVERY WITHIN THE STATE TO AN EMPLOYER OR AN
INDIVIDUAL ON A GROUP OR INDIVIDUAL BASIS THAT PROVIDES COVERAGE FOR
DRUGS MAY NOT EXCLUDE COVERAGE OF A DRUG FOR A PARTICULAR INDICATION
ON THE GROUND THAT THE DRUG HAS NOT BEEN APPROVED BY THE FEDERAL

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