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S.22

AN ACT RELATING TO OFF-LABEL USE OF PRESCRIPTION DRUGS FOR CANCER

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1.  8 V.S.A. chapter 107, subchapter 9 is added to read:

Subchapter 9.  Off-Label Use of Prescription Drugs for Cancer

§ 4100e.  REQUIRED COVERAGE FOR OFF-LABEL USE

(a)  A health insurance plan that provides coverage for prescription drugs shall provide coverage for off-label use in accordance with the following:

(1)  A health insurance plan contract may not exclude coverage for any drug used for the treatment of cancer on grounds that the drug has not been approved by the federal Food and Drug Administration, provided the use of the drug is a medically accepted indication for the treatment of cancer.

(2)  Coverage of a drug required by this section also includes medically necessary services associated with the administration of the drug.

(3)  This section shall not be construed to require coverage for a drug when the federal Food and Drug Administration has determined its use to be contraindicated for treatment of the current indication.

(4)  A drug use that is covered under subdivision (1) of this subsection may not be denied coverage based on a “medical necessity” requirement except for a reason unrelated to the legal status of the drug use.

(5)  A health insurance plan contract that provides coverage of a drug as required by this section may contain provisions for maximum benefits and coinsurance and reasonable limitations, deductibles, and exclusions to the same extent these provisions are applicable to coverage of all prescription drugs and are not inconsistent with the requirements of this section.

(b)  As used in this section, the following terms have the following meanings:

(1)  “Health insurance plan” means a health benefit plan offered, administered, or issued by a health insurer doing business in Vermont.

(2)  “Health insurer” is defined by subdivision 9402(9) of Title 18.  As used in this subchapter, the term includes the state of Vermont and any agent or instrumentality of the state that offers, administers, or provides financial support to state government, including Medicaid, the Vermont health access plan, the VScript pharmaceutical assistance program, or any other public health care assistance program.

(3)  “Medically accepted indication” includes any use of a drug that has been approved by the federal Food and Drug Administration and includes another use of the drug if that use is prescribed by the insured’s treating oncologist and supported by medical or scientific evidence.  For purposes of this subchapter, “medical or scientific evidence” means one or more of the following sources:

(A)  peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff.

(B)  peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the National Institutes of Health’s National Library of Medicine for indexing in Index Medicus, Excerpta Medicus (EMBASE), Medline, and MEDLARS database Health Services Technology Assessment Research (HSTAR).

(C)  medical journals recognized by the federal Secretary of Health and Human Services, under Section 1861(t)(2) of the federal Social Security Act.

(D)  the following standard reference compendia:  the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluation, and the United States Pharmacopoeia-Drug Information.

(E)  findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including the Agency for Health Care Policy and Research, National Institutes of Health, National Cancer Institute, National Academy of Sciences, Center for Medicare and Medicaid Services, and any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health services.

(F)  peer-reviewed abstracts accepted for presentation at major medical association meetings.

(G)  clinical evidence in peer-reviewed medical literature that is consistent with the guidance provided by the federal Department of Health and Human Services Medicare program under 42 U.S.C. § 1395x(t).

(4)  “Off-label use” means the prescription and use of drugs for medically accepted indications other than those stated in the labeling approved by the federal Food and Drug Administration.

Sec. 2.  APPLICATION

Sec. 1 of this act shall apply to all health insurance plans issued or offered on and after October 1, 2005 and to all other health insurance plans on and after October 1, 2005 upon renewal or their anniversary date, whichever is sooner, but in no event later than October 31, 2006.



Published by:

The Vermont General Assembly
115 State Street
Montpelier, Vermont


www.leg.state.vt.us