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Section: Findings, declarations, "off-label" drugs

Statute: 26:1A-36.9

1. The Legislature finds and declares that: a. Many citizens of this State rely upon health insurance to cover the cost of obtaining health care. b. It is essential that the citizens' expectation that their health care costs will be paid by their insurance policies is not disappointed and that they obtain the coverage necessary and appropriate for their care within the terms of their insurance policies. c. Currently, some insurers deny payment for drugs that have been approved by the Federal Food and Drug Administration (FDA) when the drugs are prescribed for treatments other than those stated in the labelling approved by the FDA ("off-label" use) while other insurers providing similar coverage terms do pay for "off-label" use. d. Denial of payment for "off-label" use can interrupt or effectively deny access to necessary and appropriate treatment for a person being treated for a life-threatening illness. e. "Off-label" use of an FDA-approved drug is legal when prescribed in a medically appropriate way and is often necessary to provide needed care. Approximately 50 percent of cancer patients receive some type of "off label" drug in their treatment. The FDA and the federal Department of Health and Human Services recognize the wide variety of effective "off-label" uses of FDA-approved drugs. Information on the appropriate "off-label" use of FDA-approved drugs is obtained from compendia published by the United States Pharmacopoeial Convention, the American Medical Association, and the American Society of Hospital Pharmacists. In addition, scientific studies of "off-label" use of drugs published in recognized peer-reviewed professional journals provide information on appropriate uses of "off-label" drugs. f. The "Omnibus Budget Reconciliation Act of 1990," Pub. L. 101-508, requires Medicaid agencies to pay for "off-label" use of drugs prescribed for Medicaid patients if the use is stated in any of the three compendia or peer-reviewed literature; thereby providing recognition of the three compendia and peer-reviewed literature as appropriate sources for reimbursement. g. "Off-label" use of FDA-approved drugs provides efficacious drugs at a lower cost. To require that all appropriate uses of a drug undergo approval by the FDA may substantially increase the cost of drugs and delay or even deny patients' ability to obtain medically effective treatment. FDA approval for each use would require substantial expenditure and time to undergo the clinical trials necessary to obtain FDA approval. h. Reimbursement for "off-label" uses of FDA-approved drugs is necessary to conform to the way in which appropriate medical treatment is provided, to make needed drugs available to patients, and may help to contain health care costs. L.1993,c.321,s.1.

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