2010-08-17
ASH has joined with a number of organizations to submit comments in response to a proposed
regulation that includes coverage of routine patient costs associated with
clinical trial participation 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 an ASH-supported
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 among the benefits that are not applicable to grandfathered
plans in a proposed
federal regulation issued June 14 is coverage of 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.
The comments submitted by ASH and other cancer research,
cancer care, and patient groups, express concern over grandfathered health
plans and ask that the federal agencies involved in drafting the final
regulation clarify and emphasize that a health plan may add coverage of routine
patient costs for clinical trial participants without losing its grandfathered
status. Similarly, the Society’s comments also seek clarification that
elimination of coverage for routine patient costs associated with clinical
trial participation would, in fact, result in the immediate loss of
grandfathered status of the plan. The comments also encourage the Department of
Health and Human Services (HHS) to provide information on this topic in written
communications to consumers and by including “Coverage of Clinical Trials” as a
point of health plan comparison when consumers utilize the HHS health-care website.
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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