2016 -- S 2499 SUBSTITUTE A

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LC004543/SUB A

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO INSURANCE -- OFF-LABEL USES OF PRESCRIPTION DRUGS

     Introduced By: Senators Walaska, Nesselbush, Sosnowski, Goldin, and Algiere

     Date Introduced: February 25, 2016

     Referred To: Senate Health & Human Services

     (Attorney General)

It is enacted by the General Assembly as follows:

     SECTION 1. Section 27-55-2 of the General Laws in Chapter 27-55 entitled "Off-label

Uses of Prescription Drugs" is hereby amended to read as follows:

     27-55-2. Prescription drug coverage. -- (a) No health insurer issuing a policy which

provides coverage for prescription drugs shall exclude coverage of any drug used for the

treatment of cancer or disabling or life-threatening chronic disease on the grounds that the drug

has not been approved by the FDA for that indication, provided that the drug is recognized for

treatment of that indication in one of the standard reference compendia, or in the medical

literature. It is the responsibility of the prescribing physician to submit to the insurer

documentation supporting the proposed off-label use or uses, if requested by the issuer.

      (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 is required under this chapter: (1) for any drug which has not been fully

licensed or approved by the FDA, (2) for the use of any drug when the FDA has determined that

use to be contraindicated, or (3) for any experimental drug not approved for any indication by the

FDA. The provisions of this section apply to drugs used in the treatment for cancer or disabling or

life-threatening chronic disease only and nothing in this section is 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 is construed to prevent the application of contractual

deductibles or co-payment provisions or managed care review.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE -- OFF-LABEL USES OF PRESCRIPTION DRUGS

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     This act would provide that no health insurer issuing a policy which provides coverage

for prescription drugs shall exclude coverage of any drug used for the treatment of disabling or

life-threatening chronic disease on the grounds that the drug is considered "off-label" in that the

drug has not been approved by the FDA for that indication, provided that the drug is recognized

for treatment of that indication in one of the standard reference compendia, or in the medical

literature.

     This act would take effect upon passage.

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