CMS Decision Memo - Clinical Trial Policy
Decision Memo for Clinical Trial Policy (CAG-00071R)
TO: Administrative File: CAG-00071R
Clinical Trial Policy
FROM: Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Leslye K. Fitterman, PhD
DATE: July 9, 2007
SUBJECT: Decision Memorandum for the Clinical Trial Policy
In 2000, CMS published the Clinical Trial Policy (CTP) National Coverage Determination (NCD) in response to a Presidential Executive Memorandum concerning payment for routine costs incurred by Medicare beneficiaries participating in clinical trials. That policy was based on the statutory authority of Section 1862(a)(1)(E) of the Social Security Act.
In July 2006, CMS began a reconsideration of that 2000 NCD to address several issues about the policy. 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 trials outside the terms of the 2000 CTP. While hospitals may not have always identified these services as clinical trial services and these trials may have included comparative trials of products or drugs that had already been approved for one indication, the hospitals and others have sought assurances that coverage will continue for the usual patient care associated with research in a hospital.
The commenters have identified additional Medicare policies and statements that are not identical to the coverage provided under the proposed April 10, 2007 CTP and the existence of these policies may have been confusing or ambiguous. We intend to amend our policies so that they are clear and consistent in terms of our coverage. We recognize, however, that the public has not had an adequate opportunity to comment on those changes. Given the confusion about the 2000 CTP and some contractors’ practice of paying claims of certain providers that did not meet those standards, we are issuing this national coverage determination in order to preserve the status quo with the exception of the two changes described below.