26:2J-4.5. Health maintenance organization, benefits for "off-label" drugs required

7. a. Notwithstanding any provision of law to the contrary, and except as otherwise provided in P.L.1992, c.161 (C.17B:27A-2 et al.) or P.L.1992, c.162 (C.17B:27A-17 et seq.), a certificate of authority to establish and operate a health maintenance organization in this State shall not be issued or continued on or after the effective date of this act for a health maintenance organization which provides health care services for prescribed drugs approved by the federal Food and Drug Administration unless the health maintenance organization provides health care services to any enrollee for a drug prescribed for a treatment for which it has not been approved by the Food and Drug Administration if it is recognized to be medically appropriate for the specific treatment for which the drug has been prescribed in one of the following established reference compendia:

(1) the American Medical Association Drug Evaluations;

(2) the American Hospital Formulary Service Drug Information;

(3) the United States Pharmacopoeia Drug Information;

or, it is recommended by a clinical study or review article in a major-peer reviewed professional journal.

b. Notwithstanding the provisions of this section, coverage shall not be required for any experimental or investigational drug or any drug which the Food and Drug Administration has determined to be contraindicated for the specific treatment for which the drug has been prescribed. Health care services provided pursuant to this section shall be determined and provided to the same extent as other services under the enrollee plan for drugs prescribed for treatments which have been approved by the Food and Drug Administration.

c. This section shall apply to health maintenance organization plans in which the right to change the enrollee charge has been reserved.

d. Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.

L.1993,c.321,s.7.