CODE OF VIRGINIA

COVERAGE FOR CLINICAL TRIALS FOR TREATMENT STUDIES ON CANCER (§ 38.2-3418.8)

A. Notwithstanding the provisions of § 38.2-3419, each insurer proposing to
issue individual or group accident and sickness insurance policies providing
hospital, medical and surgical, or major medical coverage on an expense-incurred
basis; each corporation providing individual or group accident and sickness
subscription contracts; and each health maintenance organization providing a
health care plan for health care services shall provide coverage for patient
costs incurred during participation in clinical trials for treatment studies on
cancer, including ovarian cancer trials, under any such policy, contract or plan
delivered, issued for delivery, or renewed in this Commonwealth on and after
July 1, 1999.

B. The reimbursement for patient costs incurred during participation in clinical
trials for treatment studies on cancer shall be determined in the same manner as
reimbursement is determined for other medical and surgical procedures. Such
coverage shall have durational limits, dollar limits, deductibles, copayments
and coinsurance factors that are no less favorable than for physical illness
generally.

C. For purposes of this section:”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.
“Cooperative group” includes (i) the National Cancer Institute
Clinical Cooperative Group and (ii) the National Cancer Institute Community
Clinical Oncology Program.”FDA” means the Federal Food and Drug
Administration.”Member” means a policyholder, subscriber, insured,
or certificate holder or a covered dependent of a policyholder, subscriber,
insured or certificate holder.”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.”NCI” means the National Cancer
Institute.”NIH” means the National Institutes of
Health.”Patient cost” means the cost of a medically necessary health
care service that is incurred as a result of the treatment being provided to the
member for purposes of a clinical trial. “Patient cost” does not
include (i) the cost of nonhealth care services that a patient may be required
to receive as a result of the treatment being provided for purposes of a
clinical trial, (ii) costs associated with managing the research associated with
the clinical trial, or (iii) the cost of the investigational drug or device.

D. Coverage for patient costs incurred during clinical trials for treatment
studies on cancer shall be provided if the treatment is being conducted in a
Phase II, Phase III, or Phase IV clinical trial. Such treatment may, however, be
provided on a case-by-case basis if the treatment is being provided in a Phase I
clinical trial.

E. The treatment described in subsection D shall be provided by a clinical trial
approved by:

   1.  The National Cancer Institute;

   2.  An NCI cooperative group or an NCI center;

   3.  The FDA in the form of an investigational new drug application;

   4.  The federal Department of Veterans Affairs; or

   5.  An institutional review board of an institution in the Commonwealth that
   has a multiple project assurance contract approved by the Office of Protection
   from Research Risks of the NCI.

F. The facility and personnel providing the treatment shall be capable of doing
so by virtue of their experience, training, and expertise.

G. Coverage under this section shall apply only if:

   1.  There is no clearly superior, noninvestigational treatment alternative;

   2.  The available clinical or preclinical data provides a reasonable
   expectation that the treatment will be at least as effective as the
   noninvestigational alternative; and

   3.  The member and the physician or health care provider who provides services
   to the member under the insurance policy, subscription contract or health care
   plan conclude that the member’s participation in the clinical trial
   would be appropriate, pursuant to procedures established by the insurer,
   corporation or health maintenance organization and as disclosed in the policy
   and evidence of coverage.

H. The provisions of this section shall not apply to short-term travel,
accident-only, limited or specified disease policies or contracts designed for
issuance to persons eligible for coverage under Title XVIII of the Social
Security Act, known as Medicare, or any other similar coverage under state or
governmental plans or to short-term nonrenewable policies of not more than six
months’ duration.

I. The provisions of this section shall not apply in any instance in which the
provisions of this section are inconsistent or in conflict with a provision of
Article 6 (§ 38.2-3438 et seq.) of Chapter 34.

HISTORY: 1999, cc. 643, 649; 2013, c. 751.