Medicare to Reconsider Clinical Trial Policy

July 10, 2006

On July 10, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Analysis (NCA) tracking document to reconsider its Clinical Trial Policy (to be renamed Clinical Research Policy), originally issued in 2000. The reconsideration is open for public comment through August 9, 2006.

Medicare’s Clinical Trial Policy was implemented under section 1862(a)(1)(E) of the Social Security Act (the Act), which prohibits payment for items and services that are not reasonable and necessary for research. CMS has interpreted this authority to permit payment for research on the effectiveness and appropriateness of clinical care. Under the current policy, Medicare pays for the routine cost of items and services used in clinical trials that meet certain requirements. The overarching goals of the policy are to encourage Medicare beneficiaries to participate in clinical research, which may add to the body of knowledge regarding the efficient, effective and appropriate use of medical products that may improve the quality of care for Medicare beneficiaries. CMS also intends to allow Medicare beneficiaries to receive care that may provide a health benefit, but for which there is inadequate evidence of effectiveness for unrestricted Medicare coverage.

CMS is reconsidering a number of issues in this policy, including the following issues that may be of particular interest:

  • clarification of payment criteria for clinical costs in research studies other than clinical trials;
  • implementation of a strategy to ensure that Medicare covered clinical studies are enrolled in the National Institute of Health (NIH) clinical trials registry website;
  • development of criteria to assure that any Medicare covered clinical research study includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics;
  • clarification of the definitions of routine clinical care costs and investigational costs in clinical research studies;
  • removal of the self-certification process, which has never been implemented;
  • clarification of how items/services that do not meet the requirements of 1862(a)(1)(A) but are of potential benefit can be covered in clinical research studies as an outcome of the National Coverage Determination process; and
  • discussion of Medicare policy for payment of humanitarian use device costs.

Additional information available here.