PARRIS N. GLENDENING, Governor

Ch. 35

(4) "STANDARD REFERENCE COMPENDIA" MEANS:

(I) THE UNITED STATES PHARMACOPEIA DRUG INFORMATION;

(II) THE AMERICAN MEDICAL ASSOCIATION DRUG EVALUATIONS;

AND

(III) THE AMERICAN HOSPITAL FORMULARY SERVICE DRUG

INFORMATION.

(B) EFFECT OF SECTION.
THIS SECTION DOES NOT:

(1) ALTER ANY LAW THAT LIMITS THE COVERAGE OF DRUGS THAT
HAVE NOT BEEN APPROVED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION;

(2) REQUIRE COVERAGE OF A DRUG IF THE FEDERAL FOOD AND DRUG
ADMINISTRATION HAS DETERMINED USE OF THE DRUG TO BE CONTRAINDICATED;
OR

(3) REQUIRE COVERAGE OF EXPERIMENTAL DRUGS NOT APPROVED
FOR ANY INDICATION BY THE FEDERAL FOOD AND DRUG ADMINISTRATION.

(C) EXCLUSION OF COVERAGE PROHIBITED.

(1) THIS SUBSECTION APPLIES TO EACH HEALTH INSURANCE POLICY
OR CONTRACT THAT IS DELIVERED OR ISSUED FOR DELIVERY IN THE STATE TO AN
EMPLOYER OR INDIVIDUAL ON A GROUP OR INDIVIDUAL BASIS, INCLUDING A
CONTRACT ISSUED BY A HEALTH MAINTENANCE ORGANIZATION.

(2) A POLICY OR CONTRACT SUBJECT TO THIS SUBSECTION THAT
PROVIDES COVERAGE FOR DRUGS MAY NOT EXCLUDE COVERAGE OF A DRUG FOR
AN OFF-LABEL USE OF THE DRUG IF THE DRUG IS RECOGNIZED FOR TREATMENT IN
ANY OF THE STANDARD REFERENCE COMPENDIA OR IN THE MEDICAL
LITERATURE.

(3) COVERAGE OF A DRUG REQUIRED BY THIS SUBSECTION ALSO
INCLUDES MEDICALLY NECESSARY SERVICES ASSOCIATED WITH THE
ADMINISTRATION OF THE DRUG.

(D) AUTHORITY OF COMMISSIONER TO REQUIRE PAYMENTS.

THE COMMISSIONER MAY DIRECT A PERSON, INCLUDING A HEALTH
MAINTENANCE ORGANIZATION, THAT ISSUES A HEALTH INSURANCE POLICY OR
CONTRACT TO MAKE PAYMENTS REQUIRED BY THIS SECTION.

(E) REVIEW OF OFF-LABEL USE.

(1) THE SECRETARY OF HEALTH AND MENTAL HYGIENE SHALL
APPOINT A PANEL OF MEDICAL EXPERTS TO REVIEW THE OFF-LABEL USE OF DRUGS
NOT INCLUDED IN ANY OF THE STANDARD REFERENCE COMPENDIA OR IN THE
MEDICAL LITERATURE AND TO ADVISE THE SECRETARY WHETHER A PARTICULAR
OFF-LABEL USE OF A DRUG IS MEDICALLY APPROPRIATE.

- 1073 -