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Medicare's Coverage With Study Participation Policy: Clinical Trials or Tribulations?

45 Pages Posted: 21 Nov 2007  

Sandra J. Carnahan

South Texas College of Law


Under a new coverage policy recently announced by the Centers for Medicare and Medicaid Services (CMS) called Coverage with Study Participation (CSP), CMS has conditioned coverage of certain new items or services upon beneficiary enrollment in a prospective clinical trial. According to CMS, the new policy is directed at interventions for which the available scientific evidence is insufficient to merit a national coverage decision, even though the new intervention is FDA approved, and the existing evidence is promising.

The CSP policy substantially alters the manner in which CMS has historically made its national coverage decisions, and raises significant legal and ethical questions.While CMS has the legal authority to determine whether an intervention is "reasonable and necessary" for coverage purposes, it may have neither the statutory nor the administrative authority to restrict coverage to beneficiaries who agree to participate in post-marketing clinical trials, and doing so may violate federal regulations designed for the protection of human subjects participating in medical research.

Although CMS insists that the goal of CSP is to enhance access to new medical technology that improves health outcomes for Medicare beneficiaries, CSP appears, in the larger context, to be a thinly-veiled effort to control the high cost of new technology by limiting present coverage, and delaying, perhaps for years, full and equal access to the technology. This Article posits that if CMS deems an item or service to be sufficiently reasonable and necessary for the Medicare population to be approved for CSP, then it ought to be covered for all Medicare patients who need the intervention, without coerced participation in clinical trials. Ultimately, Congress, and not CMS, must make the hard decisions to control costs and ration care.

Keywords: Medicaid, Medicare, Clinical Trials

Suggested Citation

Carnahan, Sandra J., Medicare's Coverage With Study Participation Policy: Clinical Trials or Tribulations?. Yale Journal of Health Policy, Law, and Ethics, Vol. 7, 2007. Available at SSRN:

Sandra J. Carnahan (Contact Author)

South Texas College of Law ( email )

1303 San Jacinto Street
Houston, TX 77002
United States

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