North Dakota Code 26.1-36-06.1 – Coverage for off-label uses of drugs
1. In this section:
Terms Used In North Dakota Code 26.1-36-06.1
- Contract: A legal written agreement that becomes binding when signed.
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- Individual: means a human being. See North Dakota Code 1-01-49
- Organization: includes a foreign or domestic association, business trust, corporation, enterprise, estate, joint venture, limited liability company, limited liability partnership, limited partnership, partnership, trust, or any legal or commercial entity. See North Dakota Code 1-01-49
- State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See North Dakota Code 1-01-49
- United States: includes the District of Columbia and the territories. See North Dakota Code 1-01-49
a. “Coverage of a drug” includes medically necessary services associated with the administration of the drug.
b. “Medical literature” means scientific studies published in a peer review national medical journal.
c. “Off-label use of drugs” means prescribing drugs for treatments other than those stated in the labeling approved by the federal food and drug administration.
d. “Standard reference compendia” means the United States pharmacopeia drug information or American hospital formulary service drug information.
2. An insurance company, nonprofit health service corporation, or health maintenance organization that provides coverage for drugs may not issue, deliver, execute, or renew any health insurance policy or health service contract on an individual, group, blanket, franchise, or association basis which excludes coverage of a drug for a particular indication on the grounds the drug has not been approved by the federal food and drug administration for that indication if the drug is recognized for treatment of the indication in one of the standard reference compendia or medical literature.
3. The insurance commissioner may direct an insurer or contractor regulated by this section to make payments as required by this section.
4. The state health officer may appoint a panel of up to eight qualified medical experts to review off-label uses of drugs not included in the standard reference compendia or medical literature. This panel shall advise the insurance commissioner whether a particular off-label use is medically appropriate and shall make recommendations regarding payment of off-label use.
5. This section does not alter existing law regarding provisions limiting the coverage of drugs that have not been approved by the federal food and drug administration; does not require coverage for any drug when the federal food and drug administration has determined its use to be contraindicated; and does not require coverage for experimental drugs not otherwise approved for any indication by the federal food and drug administration.