HB 2675 Text

H. B. 2675

(By Delegates Beane, Amores, Campbell,

Craig, Mahan, Michael and Webster)

[Introduced January 27, 2003 ; referred to the

Committee on Banking and Insurance then Finance.]

A BILL to amend chapter thirty-three of the code of West Virginia, one thousand nine hundred thirty-one, as amended, by adding thereto a new article, designated article twenty-five-f, relating to mandating insurance coverage for certain clinical trials for ordinary costs of covered services.

Be it enacted by the Legislature of West Virginia:
That chapter thirty-three of the code of West Virginia, one thousand nine hundred thirty-one, as amended, be amended by adding thereto a new article, designated article twenty-five-f, to read as follows:
ARTICLE 25F. COVERAGE FOR PATIENT COST OF CLINICAL TRIALS.
§33-25F-1. Definitions.

For purposes of this article:

(a) "Cooperative group" means a formal network of facilities that collaborate on research projects and have an established NIH-approved peer review program operating within the group.

(b) "Cooperative group" includes:

(1) The national cancer institute clinical cooperative group;

(2) The national cancer institute community clinical oncology program;

(3) The AIDS clinical trial group; and

(4) The community programs for clinical research in AIDS.

(d) "Member" means a policyholder, subscriber, insured or certificate holder or a covered dependent of a policyholder, subscriber, insured or certificate holder.

(e) "Multiple project assurance contract" means a contract between an institution and the federal department of health and human services that defines the relationship of the institution to the federal department of health and human services and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects.

(f) "NIH" means the national institutes of health.

(g) "Patient cost" means the routine costs of a medically necessary health care service that is incurred as a result of the treatment being provided to the member for purposes of the clinical trial. Routine costs of a clinical trial include all items or services that are otherwise generally available to beneficiaries of the insurance policies. "Patient cost" does not include:

(1) The cost of the investigational drug or device;

(2) The cost of nonhealth care services that a patient may be required to receive as a result of the treatment being provided to the member for purposes of the clinical trial;

(3) Costs associated with managing the research associated with the clinical trial: or

(4) Costs that would not be covered under the patient's policy, plan, or contract for noninvestigational treatments.
§33-25F-2. Coverage applicable under this article.

(a) This section applies to:

(1) Insurers and nonprofit health service plans that provide hospital, medical, surgical or pharmaceutical benefits to individuals or groups on an expense-incurred basis under a health insurance policy or contract issued or delivered in the state;

(2) Health maintenance organizations that provide hospital, medical, surgical or pharmaceutical benefits to individuals or groups under contracts that are issued or delivered in the state: and

(3) Public employees insurance agency, the medicaid agency and the children's health insurance program.

(b) This section does not apply to a policy, plan or contract paid for under Title XVIII or Title XIX of the Social Security Act.

(c) A policy, plan or contract subject to this section shall provide coverage for patient cost to a member in a clinical trial, as a result of:

(1) Treatment provided for a life-threatening condition: or

(2) Prevention, early detection and treatment studies on cancer.

(d) The coverage under subsection (d) of this section is required if :

(1)(A) 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; or

(B) The treatment is being provided in a Phase 1, Phase II, Phase III or Phase IV clinical trial for any other life-threatening condition:

(2) The treatment is being provided in a clinical trial approved by:

(A) One of the national institutes of health;

(B) An NIH cooperative group or an NIH center;

(D) The federal department of veterans affairs; and

(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;

(3) 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;

(4) There is no clearly superior, noninvestigational treatment alternative; and

(5) The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the noninvestigational treatment alternative.

NOTE:
The purpose of the bill is to require insurance companies to cover the ordinary costs associated with clinical trials in certain circumstances.

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

Print On Demand