§1060.8. Coverage of drugs approved by the United States Food and Drug Administration; exclusions; definitions

            A. No health coverage plan delivered or issued for delivery in this state shall limit or exclude coverage involving a minor for a drug on the basis that the drug is prescribed for a use that is different from the use for which that drug has been approved by the United States Food and Drug Administration and all of the following apply:

            (1) The drug has been approved by the United States Food and Drug Administration.

            (2) The drug is prescribed by a licensed healthcare provider for the treatment of a life threatening, chronic, or seriously debilitating disease or condition in a minor; the drug has been approved by the United States Food and Drug Administration for the same condition or disease in an adult; and the drug is medically necessary to treat the disease or condition.

            (3) The drug has been recognized for the treatment of the disease or condition in pediatric application by one of the following:

            (a) The American Medical Association Drug Evaluations.

            (b) The American Hospital Formulary Service Drug Information.

            (c) The United States Pharmacopeia Dispensing Information, Volume 1, "Drug Information for the Health Care Professional".

            (d) Recognized in two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed journal.

            (4) The drug is on the insurer's formulary or preferred drug list, if any.

            B. If requested by the health insurance insurer, the prescriber shall be responsible for submitting to the health insurance insurer documentation supporting compliance with the provision of this Section.

            C. Any coverage required by this Section shall include medically necessary services associated with the administration of a drug that is subject to the conditions of the health coverage plan.

            D. The provisions of this Section shall not require coverage for any of the following:

            (1) The treatment of a condition or disease that is excluded under the terms of the health coverage plan.

            (2) An experimental drug not approved by the United States Food and Drug Administration.

            (3) A drug not listed on the health coverage plan's formulary or preferred drug list, if any.

            E. The coverage provided in this Section may be subject to annual deductibles, coinsurance, and copayment provisions as are consistent with those established under the health coverage plan and may be subject to prior authorization.

            F. For purposes of this Section, "health coverage plan" means any hospital or medical expense insurance policy, hospital or medical service contract, employee welfare benefit plan, contract, or other agreement with a health maintenance organization or a preferred provider organization, health and accident insurance policy, or any other insurance contract of this insurance plan, and the office of group benefits programs. "Health coverage plan" does not include a plan providing coverage for excepted benefits defined in R.S. 22:1061, limited benefit health insurance plans, and short-term policies that have a term of less than twelve months.

            Acts 2022, No. 703, §1, eff. Jan. 1, 2023.