Senate Bill No. 588

(By Senators Wooton, Kessler, Mitchell, Facemyer,

Rowe, Redd, Sprouse, Burnette, Jackson, Unger,

Prezioso, Craigo, Love, Plymale and McCabe)


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[Introduced February 14, 2002; referred to the Committee

on Banking and Insurance.]

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A BILL to amend article twenty-four, chapter thirty-three of the code of West Virginia, one thousand nine hundred thirty-one, as amended, by adding thereto a new section, designated section seven-g, relating to mandating insurance coverage for clinical trials for patients suffering serious physical disease; setting forth criteria prescribing when coverage is mandated; setting forth definitions; and requiring the insurance commissioner in collaboration with the board of medicine to propose legislative rules designed to effectuate the provisions of this section.

Be it enacted by the Legislature of West Virginia:
That article twenty-four, chapter thirty-three of the code of West Virginia, one thousand nine hundred thirty-one, as amended, be amended by adding thereto a new section, designated section seven-g, to read as follows:
 ARTICLE 24. HOSPITAL SERVICE CORPORATIONS, MEDICAL SERVICE CORPORATIONS, DENTAL SERVICE CORPORATIONS AND HEALTH SERVICE CORPORATIONS.
§33-24-7g. Third-party reimbursement for clinical trials.

(a) Notwithstanding any provision of any policy, provision, contract, plan or agreement applicable to this article, reimbursement or indemnification for clinical trials offering treatment for any life threatening condition may not be denied for any symptomatic person when the drugs and devices to be used have been approved for sale by the Food and Drug Administration (FDA) whether or not the approval includes treating the patient's particular condition, to the extent the drugs or devices are not paid for by the manufacturer, distributor, or provider of the drug or device and are recommended for use by and administered at, the direction of a person licensed to practice medicine and surgery by the board of medicine: Provided, That: (1) The treatment is being provided or the studies are being conducted in a phase I, phase II, phase III, or phase IV clinical trial for cancer; (2) the treatment is being provided in a phase II, phase III, or phase IV clinical trial for any other life-threatening condition or disease; (3) the treatment is being provided in a clinical trial approved by: (A) One of the national institutes of health; (B) the American Medical Association; (C) The Food and Drug Administration in the form of an investigational new drug application; (D) the federal department of veterans affairs; (E) an institutional review board of an institution in the state which has a multiple project assurance contract approved by the office of protection from research risks of the national institutes of health; (F) the facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise; or (G) the available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative.
(b) Definitions. -- For the purposes of this section, the following terms mean:
(1) "Clinical trial" means the systematic investigation of the effects of materials or methods, according to a formal study plan and generally in a human population with a particular disease or class of diseases. In cancer research, a clinical trial generally refers to the evaluation of treatment methods, such as surgery, drugs, or radiation techniques, although methods of prevention, detection, or diagnosis also may be the subject of such studies;
(2) "Investigational new drug" means a drug allowed by the Food and Drug Administration (FDA) to be used in clinical trials but not approved by the FDA for commercial marketing; and
(3) "Symptomatic person" means an individual who exhibits characteristics of a particular disease, whether or not the characteristics are caused by the particular disease.
(c) The same deductibles, coinsurance, network restrictions and other limitations for covered services found in the policy, provision, contract, plan or agreement of the covered person may apply to clinical trials.
 (d) The insurance commissioner in collaboration with the state board of medicine shall propose rules for legislative approval in accordance with the provisions of article three, chapter twenty-nine-a of this code, designed to effectuate the purposes of this section.

NOTE: The purpose of this bill is to require mandatory insurance coverage for clinical tests, under particular circumstances, for patients suffering from life-threatening diseases.

This section is new; therefore, strike-throughs and underscoring have been omitted.