New Jersey § 26:1a-36

§ 26:1a-36.

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 , 1 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. 1

See U.S.C.A. Tables for classification.