MN SF2983

Health plans must cover routine patient care costs for enrollees participating in qualified clinical trials related to cancer prevention, early detection, treatment, or palliation in Phase I, II, III, or IV investigations.

Qualified clinical trials must be approved by the National Institutes of Health, FDA, Department of Veterans Affairs, Department of Defense, or an institutional review board with a multiple project assurance contract.

Coverage applies only when no clearly superior noninvestigational treatment alternative exists, clinical or preclinical data shows reasonable expectation of effectiveness, and the enrollee's treating physician provides written opinion that treatment will provide medical benefit commensurate with risks.

"Routine patient care costs" are medically necessary services that would be covered under the health plan if the enrollee were not in a clinical trial, excluding investigational drugs, trial management costs, travel expenses, and other nonroutine costs.

Effective August 1, 2010, for health plans offered, sold, issued, renewed, or continued on or after that date; providers may not balance-bill beyond standard cost-sharing if they have a provider agreement with the health plan.