North Dakota Code § 26.1-36-06.1

Coverage for off-label uses of drugs
Open in Lexace · Ask the AI about this section
1. In this section:
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.

‹ Prev All North Dakota sections Next ›


Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.