National Coverage Analysis (NCA) Tracking Sheet

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.

National Coverage Determinations

Benefit Category

No Benefit Category

Requestor Information

Requestor NameRequestor Letter
Internally generated N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
10/17/2007 - 10/17/2007
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
07/19/2007 - 08/18/2007
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Leslye K. Fitterman, Ph.D.

Actions Taken

July 19, 2007

CMS is posting today its proposed clinical research policy decision memorandum. The 30-day comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in the comments on the proposed process to allow study sponsors/principle investigators to certify to CMS that their study meets the standards described in this policy. CMS will release a final decision 60 days following the close of the comment period.

Instructions on submitting public comments can be found at We strongly urge that all public comments be submitted through this website.

The public is invited to participate in an Open Door Forum on this reconsideration being held on August 7, 2007 from 2:00 to 4:00 PM in the CMS auditorium. Details on the Open Door Forum may be found at

October 17, 2007

CMS is posting today its final clinical trial policy decision memorandum along with questions and answers [PDF, 18KB] about the policy