38.2-3418.8 - Coverage for clinical trials for treatment studies on cancer.
§ 38.2-3418.8. Coverage for clinical trials for treatment studies on cancer.
A. Notwithstanding the provisions of § 38.2-3419, each insurer proposing toissue individual or group accident and sickness insurance policies providinghospital, medical and surgical, or major medical coverage on anexpense-incurred basis; each corporation providing individual or groupaccident and sickness subscription contracts; and each health maintenanceorganization providing a health care plan for health care services shallprovide coverage for patient costs incurred during participation in clinicaltrials for treatment studies on cancer, including ovarian cancer trials,under any such policy, contract or plan delivered, issued for delivery, orrenewed in this Commonwealth on and after July 1, 1999.
B. The reimbursement for patient costs incurred during participation inclinical trials for treatment studies on cancer shall be determined in thesame manner as reimbursement is determined for other medical and surgicalprocedures. Such coverage shall have durational limits, dollar limits,deductibles, copayments and coinsurance factors that are no less favorablethan for physical illness generally.
C. For purposes of this section:
"Cooperative group" means a formal network of facilities that collaborateon research projects and have an established NIH-approved peer review programoperating within the group. "Cooperative group" includes (i) the NationalCancer Institute Clinical Cooperative Group and (ii) the National CancerInstitute Community Clinical Oncology Program.
"FDA" means the Federal Food and Drug Administration.
"Member" means a policyholder, subscriber, insured, or certificate holderor a covered dependent of a policyholder, subscriber, insured or certificateholder.
"Multiple project assurance contract" means a contract between aninstitution and the federal Department of Health and Human Services thatdefines the relationship of the institution to the federal Department ofHealth and Human Services and sets out the responsibilities of theinstitution and the procedures that will be used by the institution toprotect 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 servicethat is incurred as a result of the treatment being provided to the memberfor purposes of a clinical trial. "Patient cost" does not include (i) thecost of nonhealth care services that a patient may be required to receive asa result of the treatment being provided for purposes of a clinical trial,(ii) costs associated with managing the research associated with the clinicaltrial, or (iii) the cost of the investigational drug or device.
D. Coverage for patient costs incurred during clinical trials for treatmentstudies on cancer shall be provided if the treatment is being conducted in aPhase 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 aPhase I clinical trial.
E. The treatment described in subsection D shall be provided by a clinicaltrial 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 thathas a multiple project assurance contract approved by the Office ofProtection from Research Risks of the NCI.
F. The facility and personnel providing the treatment shall be capable ofdoing 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 reasonableexpectation that the treatment will be at least as effective as thenoninvestigatonal alternative; and
3. The member and the physician or health care provider who provides servicesto the member under the insurance policy, subscription contract or healthcare plan conclude that the member's participation in the clinical trialwould be appropriate, pursuant to procedures established by the insurer,corporation or health maintenance organization and as disclosed in the policyand 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 designedfor issuance to persons eligible for coverage under Title XVIII of the SocialSecurity Act, known as Medicare, or any other similar coverage under state orgovernmental plans or to short-term nonrenewable policies of not more thansix months' duration.
(1999, cc. 643, 649.)