2010-06-17

An ASH-supported provision of the health reform bill, which requires coverage of routine patient costs associated with clinical trial participation, has been included among the benefits deemed to be not applicable to certain health plans in existence prior to enactment of the health reform law.

Under the terms of the provision contained in the health reform law, insurers would be prohibited from dropping coverage because an individual chooses to participate in a clinical trial and from denying coverage for routine care that they would otherwise provide just because an individual is enrolled in a clinical trial. It would apply to all insurance products, including those offered in the Federal Employees Health Benefits Program, and to all clinical trials that treat cancer or other life-threatening diseases. States that have enacted laws and policies that go above and beyond the federal standard laid out in the provision would not be preempted.

However, certain health plans in existence as of March 23, 2010, when the health reform bill became law, were deemed to be "grandfathered" plans, and thus were exempted from many of the new law’s provisions. Included in a proposed federal regulation issued June 14 among the benefits that are not applicable to grandfathered plans is coverage or routine patient costs associated with participation in approved clinical trials. Only when a plan loses its grandfathered status will it be required to abide by the provisions of the health reform law that were not mandated on grandfathered plans, including coverage of clinical trials.

There will be a 60-day comment period on the proposed regulation. ASH is continuing to work with physician organizations and patient groups to ensure adequate coverage for those enrolled in clinical trials.

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