For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

Legislation: House Bill 2675

Effective: June 2003

What clinical trials are covered?

Phase II, III, or IV clinical trials for the prevention, early detection, or treatment of cancer, or for the treatment of any other life-threatening condition.

The clinical trial must be approved by one of the following:

• National Institutes of Health (NIH)
• NIH-sponsored cooperative group or center
• U.S. Food and Drug Administration (FDA)
• U.S. Department of Veterans Affairs
• The Institutional Review Board (IRB) of an institution in West Virginia that has a multiple project assurance contract approved by the NIH Office of Protection from Research Risks

Who is required to pay?

Private insurers, managed care plans, Medicaid or state medical assistance, public employee health plans.

Other key provisions:

• The treatment must have therapeutic intent.
• There is no clearly superior noninvestigational alternative.
• The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be more effective than the noninvestigational treatment alternative.
• Does not require reimbursement for clinical trials intended to:
  • Extend the patent of any existing drug.
  • Gain approval of or coverage for a metabolite of an existing drug.
  • Gain approval or coverage relating to additional clinical indications for an existing drug.
  • Keep a generic version of a drug from coming to market.
  • Gain approval of or coverage for reformulated or repackaged version of an existing drug.