Senate Bill No. 218
(By Senators Minard, Oliverio, Minear, Rowe and Jenkins)
[Introduced January 23, 2003; referred to the Committee on
Banking and Insurance.]
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
ARTICLE 25F. COVERAGE FOR PATIENT COST OF CLINICAL TRIALS.
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
(3) The AIDS clinical trial group; and
(4) The community programs for clinical research in AIDS.
(c) "FDA means the federal food and drug administration.
(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:
(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
(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
(2) The treatment is being provided in a clinical trial
(A) One of the national institutes of health;
(B) An NIH cooperative group or an NIH center;
(C) The FDA in the form of an investigational new drug
(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
(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.