H.B. 351

VETOES

(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, INCLUDING A HEALTH MAINTENANCE ORGANIZATION,
may not exclude coverage of a drug for a particular indication on the ground that the drug
has not been approved by the federal Food and Drug Administration for that indication
if the drug is recognized for treatment of the indication in one of the standard reference
compendia or in the medical literature.

(2) Coverage of a drug required by this subsection also includes medically
necessary services associated with the administration of the drug.

(c)     The Secretary of Health and Mental Hygiene COMMISSIONER has the
authority to direct a person that issues a contract or policy of health insurance,
INCLUDING A HEALTH MAINTENANCE ORGANIZATION, to make payments required by
this section.

(d)     (1) The Secretary of Health and Mental Hygiene shall appoint a panel of
medical experts to review off-label uses 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 is medically appropriate.

(2)     The panel shall consist of:

(i) Three medical oncologists chosen by the State Medical Oncology
Association;

(ii) Two specialists in the management of AIDS patients chosen by the
State AIDS Medical Provider Organizations;

(iii) One specialist in heart disease appointed by the University of
Maryland Medical System; and

(iv) One physician chosen by the State Medical Association.

(3)     The panel shall make recommendations from time to time and whenever
a particular dispute about payment for off-label use is brought to the Secretary of Health
and Mental Hygiene.

(4) WITHIN 30 DAYS OF THE PANEL'S DECISION, THE SECRETARY SHALL
SUBMIT A WRITTEN REPORT ON THE RECOMMENDATIONS TO THE COMMISSIONER.

(e)     This section may not be construed to:

(1)     Alter existing law with regard to provisions limiting the coverage of
drugs that have not been approved by the federal Food and Drug Administration;

(2)     Require coverage for any drug when the federal Food and Drug
Administration has determined its use to be contra-indicated; or

(3)     Require coverage for experimental drugs not otherwise approved for any
indication by the federal Food and Drug Administration.

Article - Health - General

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