| (a) An issuer of a health benefit plan that provides coverage
for drugs shall provide coverage for any drug prescribed to treat an enrollee
for a covered chronic, disabling, or life-threatening illness if the drug:
(1) has been approved by the Food and Drug Administration for
at least one indication; and
(2) is recognized for treatment of the indication for which
the drug is prescribed in:
(A) a standard drug reference compendium; or
(B) substantially accepted peer-reviewed medical literature.
(b) Coverage of a drug required under subsection (a) of this
section:
(1) shall include services medically necessary to administer
the drug, including any supply medically necessary to administer the drug,
if the supply is a covered benefit under the health benefit plan;
(2) may be denied based on a finding that the use of the drug
is not medically necessary to treat the enrollee's disease, syndrome, or condition,
so long as the finding is not based on the fact that the drug is being prescribed
for an off-label use;
(3) may not be denied solely on the basis that the drug does
not appear on the formulary. If the issuer of a health benefit plan refuses
to provide an off-label drug that is not included in a drug formulary, and
the enrollee's physician or provider has determined is medically necessary
for an off-label use, the refusal constitutes an adverse determination for
purposes of Insurance Code Article 21.58A, §2. An enrollee may appeal
the adverse determination under §§6 and 6A of Article 21.58A;
(4) may be denied for a drug prescribed to treat any disease
or condition that is excluded from coverage under the health benefit plan;
(5) may be denied for a drug prescribed for outpatient use
if coverage of drugs under that particular health benefit plan is limited
to the hospitalization of the enrollee; or
(6) may be denied for a drug that the Food and Drug Administration
has determined to be a contraindication for treatment of the current disease
or condition.
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