Off-label Uses of Prescription Drugs

SECTION 27-55-2

§ 27-55-2. Prescription drug coverage.

(a) No health insurer issuing a policy which provides coverage for prescription drugs shall exclude coverage of any drug used for the treatment of cancer or disabling or life-threatening chronic disease on the grounds that the drug has not been approved by the FDA for that indication; provided that the drug is recognized for treatment of that indication in one of the standard reference compendia, or in the medical literature. It is the responsibility of the prescribing physician to submit to the insurer documentation supporting the proposed off-label use or uses, if requested by the issuer.

(b) Any coverage of a drug which serves as the primary treatment required by this chapter shall also include medically necessary services associated with the administration of the drug.

(c) No coverage is required under this chapter: (1) For any drug which has not been fully licensed or approved by the FDA; (2) For the use of any drug when the FDA has determined that use to be contraindicated; or (3) For any experimental drug not approved for any indication by the FDA. The provisions of this section apply to drugs used in the treatment for cancer or disabling or life-threatening chronic disease only and nothing in this section is construed to create, impair, alter, limit, modify, enlarge, abrogate, or prohibit reimbursement for medications used in the treatment of any other disease or condition.

(d) Nothing in this section is construed to prevent the application of contractual deductibles or co-payment provisions or managed-care review.

History of Section.
(P.L. 1994, ch. 339, § 1; P.L. 2016, ch. 95, § 1; P.L. 2016, ch. 105, § 1.)