Clinical Trial Policy

The Centers for Medicare & Medicaid Services is opening a reconsideration of its national coverage determination (NCD) on clinical trials (NCD Manual 310.1).

In July 2006, CMS began a reconsideration of the 2000 Clinical Trial Policy (CTP). CMS convened a Medicare Evidence Development & Coverage Advisory Committee (MedCAC) to obtain public input and provide recommendations to CMS; asked the Agency for Healthcare Research and Quality (AHRQ) to provide recommended changes; and received public comments on the proposed decision. After the publication of our proposed decision memorandum on April 10, 2007, we received several comments from hospitals and advocates suggesting that Medicare contractors had been paying claims for hospital services involving patients in various types of clinical research outside the terms of the clinical trial policy. Hospitals may not have always identified these services as clinical trial services. The hospitals and others sought an assurance that funding will continue for the usual patient care associated with research in a hospital.

In addition, commenters identified additional Medicare policies and statements that are not identical to the coverage provided under that version of the clinical trial policy and the existence of these policies may have been confusing or ambiguous. Due to this confusion and ambiguity, the final NCD maintained the status quo with minor changes.

We are reopening this NCD to allow the public input on proposed changes to clarify the ambiguities. We are simultaneously posting our proposed decision and requesting public comment.

July 19, 2007

October 17, 2007