The current Clinical Trial Policy can be found by clicking the link below (under Related Links Inside CMS) labeled "Current Policy - July 2007 NCD". Qs and As for that policy are posted at the link in that same section labeled "October 17, 2007 Qs & As".

Clinical trials are research studies designed to evaluate the safety and effectiveness of medical care. They are key to understanding the appropriate use of medical interventions of all types and informing payers about what services to cover. Only a very small percentage of American seniors participate in clinical trials, although the elderly bear a disproportionate burden of disease in the United States.

On June 7, 2000, the President of the United States issued an executive memorandum directing the Secretary of Health and Human Services to "explicitly authorize [Medicare] payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials." The Health Care Financing Administration (now the Centers for Medicare & Medicaid Services, or CMS) responded to the executive order with the clinical trial policy national coverage determination (NCD) issued on September 19, 2000  The 2000 policy may be found through the link below labeled, "2000 Clinical Trial Policy".

CMS began a reconsideration of that 2000 NCD to address several issues about the policy on July 10, 2006. We issued a final decision memorandum on July 9, 2007 that preserves the status quo of the 2000 CTP with the exception of the following changes:

1. Clarification that items that are covered outside the trial are covered inside the trial
2. Addition of Coverage with Evidence Development (CED)

On July 19, 2007, CMS began a reconsideration of the 2000 CTP which proposes that the CTP be renamed the Clinical Research Policy and that a process be established that clinical research study sponsors/principal investigators must use to certify to CMS that their study meets the scientific and technical standards described in the proposed policy.

Based on a thorough review and consideration of comments from the public and the recent enactment of the Food and Drug Administration Amendments Act of 2007 (FDA AA 2007), the Agency decided that no change to the July 9, 2007 policy was appropriate at the time. On October 17, 2007, CMS closed the reconsideration with a final decision memorandum that retained the July 9, 2007 policy.

Downloads
Clarification of Medicare Payment for Routine Costs in a Clinical Trial [PDF, 77KB] October 17, 2007 Qs and As [PDF, 17KB] September 20, 2007 Town Hall Meeting [PDF, 20KB] Presentations from September 20 Town Hall Meeting [ZIP, 18MB] Transcript from September 20 Town Hall Meeting [PDF, 253KB] August 7, 2007 CRP Open Door Forum - Slides [ZIP, 19KB] March 2005 Medicare Claims Processing Manual [PDF, 47KB] September 2002 Carriers Manual [PDF, 62KB] May 2001 Carriers Manual [PDF, 175KB] September 2000 Final National Coverage Decision [PDF, 31KB] September 2000 Program Memorandum [PDF, 46KB]
Related Links Inside CMS
Current Policy - July 2007 NCD October 17, 2007 Decision Memorandum October 17, 2007 Tracking Sheet 2006 Tracking Sheet Public Comments on this NCA 2000 Clinical Trial NCD National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development Coverage Center Medicare Coverage Database
Related Links Outside CMS
There are no Related Links Outside CMS

Page Last Modified: 09/30/2008 6:43:07 AM
Help with File Formats and Plug-Ins