On October 17, 2007, CMS announced that it will not be implementing any of its proposed revisions to the Medicare National Coverage Decision related to Clinical Trials (the “Clinical Trial Policy”) at this time. The proposed revisions were the second attempt by CMS to address ongoing questions and confusion related to clinical research and Medicare coverage. In April of this year, CMS issued a proposed decision memorandum to further clarify and revise the Clinical Trial Policy. However, rather than adopting the proposed decision memorandum, CMS decided in July only to make a couple of revisions to the policy and opted instead to issue a second proposed decision memorandum so that CMS could further consider the comments and other issues related to the policy. In response to the second proposed decision memorandum, CMS has now reported that due to comments questioning certain authority of CMS with respect to the policy, as well as the passing of the Food and Drug Administration Amendments Act of 2007, the agency will not be making additional changes to the Clinical Trial Policy at this time.
CMS has indicated that it is continuing to review the policy. Accordingly, we can expect more discussion and proposed clarifications in the future. However, until CMS takes further action to clarify and revise the policy and address certain issues, much of the confusion and uncertainty surrounding the policy will remain unanswered.