28 TAC § 21.3011. Minimum Standards of Coverage for Off-Label Drug Use, DIVISION 3. OFF-LABEL DRUGS

(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 it 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.