It is enacted by the General Assembly as follows:

SECTION 1. Title 27 of the General Laws entitled "Insurance" is hereby amended by adding thereto the following chapter:

{ADD 27-55-1. Definitions. -- ADD} {ADD For the purpose of this chapter, the following words and terms shall have the following meanings:

(a) "FDA" means the Federal Food and Drug Administration.

(b) "Health insurer" means all persons, firms, corporations or other organizations offering and assuring health services on a prepaid or primarily expense incurred basis, including but not limited to policies of accident or sickness insurance, as defined in chapter 18 of this title, nonprofit hospital or medical service plans, whether organized under chapter 19 or 20 of this title or under any public law or by special act of the general assembly, health maintenance organizations, and any other entity, which insures or reimburses for diagnostic, therapeutic or preventive services to a determined population on the basis of a periodic premium.

(c) "Medical literature" means published scientific studies published in at least two (2) articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.

(d) "Standard reference compendia" means (i) the United States Pharmacopeia Drug Information, (ii) the American Medical Association Drug Evaluations, or (iii) the American Hospital Formulary Service Drug Information.

(e) "Drug" shall mean the primary anti-cancer or antineoplastic agent or agents. ADD}

{ADD 27-55-2. Prescription drug coverage. -- ADD} {ADD (a) No health insurer issuing a policy which provides coverage for prescription drugs shall exclude coverage of any such drug used for the treatment of cancer on the grounds that the drug has not been approved by the FDA for that indication, provided that such drug is recognized for treatment of such indication in one of the standard reference compendia, or in the medical literature. It shall be the responsibility of the prescribing physician to submit to the insurer documentation supporting the proposed off-label use or uses, if requested by the insurer.

(b) Any coverage of a drug which serves as the primary treatment required by this chapter shall also include medically necessary services associated with the administration of the drug.

(c) No coverage shall be required under this chapter (i) for any drug which has not been fully licensed or approved by the FDA, (ii) for the use of any drug when the FDA has determined that use to be contraindicated, or (iii) for any experimental drug not otherwise approved for any indication by the FDA. The provisions of this section shall apply to drugs used in the treatment for cancer only and nothing herein shall be construed to create, impair, alter, limit, modify, enlarge, abrogate or prohibit reimbursement for medications used in the treatment of any other disease or condition.

(d) Nothing in this section shall be construed to prevent the application of contractual deductibles or co-payment provisions or managed care review. ADD}

{ADD 27-55-3. Advisory panel on off-label uses of prescription drugs. -- ADD} {ADD The director of the department of health shall appoint an advisory panel of seven (7) medical experts. The purpose of the advisory panel shall be to make recommendations to the director regarding whether a particular off-label use is medically appropriate, whenever a particular dispute about payment for such off-label use is referred to the director of the department of health. Parties seeking to refer a dispute to the director shall do so in writing within thirty (30) days of the denial of coverage of the drug. The members of such panel shall include seven (7) licensed Rhode Island physicians, included (a) a physician appointed by a hospital and medical services corporation and (b) a physician appointed by the Rhode Island medical society and (c) three (3) medical oncologists appointed by the Society of Rhode Island Clinical Oncologists and (d) a physician appointed by the Rhode Island Association of health maintenance organizations from a member plan and (e) a Rhode Island physician appointed by the health insurance association of America. The members of the advisory panel shall serve at the pleasure of the director of the department of health and shall receive no compensation for their service on such advisory panel. ADD}

SECTION 2. This act shall take effect upon passage.