Texas Administrative Code
Title 28 - INSURANCE
Part 1 - TEXAS DEPARTMENT OF INSURANCE
Chapter 21 - TRADE PRACTICES
Subchapter V - PHARMACY BENEFITS
Division 3 - OFF-LABEL DRUGS
Section 21.3011 - Minimum Standards of Coverage for Off-Label Drug Use
Universal Citation: 28 TX Admin Code § 21.3011
Current through Reg. 50, No. 13; March 28, 2025
(a) An issuer of a health benefit plan that provides coverage for drugs must 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) must
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 §
4201.002(1).
An enrollee may appeal the adverse determination under Insurance Code Chapter
4201, Subchapters H and I;
(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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