N.D. Cent. Code § 26.1-36-06.1
26.1-36-06.1. Coverage for off-label uses of drugs
26.1-36-06.1. Coverage for off-label uses of drugs
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.