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:

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

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

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

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

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

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

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

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

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

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      (b) Any coverage of a drug which serves as the primary treatment required by this

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chapter shall also include medically necessary services associated with the administration of the

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drug.

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      (c) No coverage is required under this chapter: (1) for any drug which has not been fully

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

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

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

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life-threatening chronic disease only and nothing in this section is construed to create, impair,

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alter, limit, modify, enlarge, abrogate or prohibit reimbursement for medications used in the

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treatment of any other disease or condition.

 

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      (d) Nothing in this section is construed to prevent the application of contractual

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deductibles or co-payment provisions or managed care review.

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     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

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

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

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

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

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literature.

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     This act would take effect upon passage.

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