Clinical trials 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.
CMS began a reconsideration of the 2000 NCD to address several issues about the policy in July 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:
- Clarification that items that are covered outside the trial are covered inside the trial
- Addition of coverage of clinical trials under an NCD (Coverage with Evidence Development).
On July 19, 2007, CMS began a reconsideration of the 2000 CTP which proposed 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.
- 2000-09-19 Clinical Trial Policy (Legacy with 2007 Redline Revisions)
- 2001-05-25 Carriers Manual
- 2002-09-18 Carriers Manual
- 2007-07-09 Clinical Trial Policy (Final – Current)
- 2007-08-07 CRP Open Door Forum – Slides (ZIP)
- 2007-09-20 Town Hall Meeting Agenda
- 2007-09-20 Town Hall Meeting Transcript
- 2007-09-20 Town Hall Meeting Presentations (ZIP)
- 2021-06-01 Clarification of Medicare Payment for Routine Costs in a Clinical Trial
- 2019-02-08 Chapter 32 – Billing Requirements for Special Services