On April 10, 2007, the Centers for Medicare and Medicaid Services (CMS) issued a draft of a revised policy for coverage of clinical trials.1 The draft national coverage determination (NCD) sets forth the circumstances under which Medicare would cover routine and/or investigational clinical services in “approved” research studies. The NCD could affect all protocols for trials involving Medicare beneficiaries and raises significant questions about what items and services Medicare will cover and how it will determine whether a trial is an approved research study. CMS will accept comments on the draft NCD until May 10, 2007.

  • The draft NCD would make several changes to the clinical trials policy, including: 
  • renaming the policy, “the Clinical Research Policy;” 
  • adding definitions of “clinical research,” “routine clinical services,” “administrative services,” and “investigational clinical services;” 
  • providing coverage of items and services that are the subject of a trial; and 
  • establishing eight general standards and five Medicare-specific standards for determining when a research study is considered approved.

Although CMS stated that it intends to “provide access to services for beneficiaries by facilitating participation in the full range of qualified, scientifically sound research projects,”2 the draft NCD creates confusion about what items and services will be covered. For example, why did CMS abandon the recommendation it made to the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) to establish a clear policy for coverage of humanitarian use devices (HUDs) that have received humanitarian device exemption status from the Food and Drug Administration (FDA)? How will CMS and its contractors determine whether a trial’s protocol meets the Medicare-specific standards? What will be covered when the definition of “investigational clinical services” appears to conflict with the definition of “routine clinical services?” Will access to on-label uses of drugs be affected by the provisions regarding coverage of post-approval studies?

CMS refers to coverage with evidence development (CED) throughout the draft NCD, which could indicate the agency’s intent to apply CED more frequently in future coverage determinations. The draft NCD would not effect coverage of category A or category B investigation device exemptions, which are covered by regulation. With regard to HUDs, CMS proposes to not include a separate provision for such devices, meaning that coverage of HUDs would be the same as for other items and services in a study.

CMS will accept comments on the draft NCD until May 10, 2007. The final policy is expected to be issued by July 9, 2007