National Coverage Analysis (NCA) Tracking Sheet

Clinical Trial Policy



The Centers for Medicare & Medicaid Services is reconsidering its national coverage decision on the Clinical Trial Policy.

On September 19, 2000, the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services (CMS)) implemented a Clinical Trial Policy through the NCD process. The Clinical Trial Policy was developed in response to a June 7, 2000 executive memorandum, issued by President Clinton, directing Medicare to pay for routine patient costs in certain clinical trials. The 2000 Clinical Trial Policy requires trials to be "qualified" prior to payment of routine costs. The policy provides for certain trials to be deemed qualified; i.e., those that are approved and funded by a Federal agency or have an IND approval from FDA or are IND exempt. An additional option, the self-certification option, was never implemented.

CMS is reconsidering the current Clinical Trial Policy (to be renamed the Clinical Research Policy) to address several issues that have surfaced since its implementation including the need to:

  1. Clarify payment criteria for clinical costs in research studies other than clinical trials;
  2. Devise a strategy to ensure that Medicare covered clinical studies are enrolled in the National Institute of Health (NIH) clinical trials registry website;
  3. Develop criteria to assure that any Medicare covered clinical research study includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics;
  4. Clarify the definitions of routine clinical care costs and investigational costs in clinical research studies including clinical trials;
  5. Remove the self-certification process that was never implemented;
  6. Clarify the scientific and technical roles of Federal agencies in overseeing IND Exempt trials;
  7. Determine if coverage of routine clinical care costs is warranted for studies beyond those covered by the current policy.
  8. Clarify how items/services that do not meet the requirements of 1862(a)(1)(A) but are of potential benefit can be covered in clinical research studies as an outcome of the National Coverage Determination process;
  9. Clarify whether and under what conditions an item/service non-covered nationally may be covered in the context of clinical research to elucidate the impact of the item or service on health outcomes in Medicare beneficiaries; and
  10. Discuss Medicare policy for payment of humanitarian use device (HUD) costs.

In CMS' reconsideration of this NCD, we believe there are three overarching goals of the proposed Clinical Research Policy:

1) to allow Medicare beneficiaries to participate in research studies;
2) to encourage the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive; and,
3) to allow Medicare beneficiaries to receive care that may have a health benefit, but for which evidence for the effectiveness of the treatment or service is insufficient to allow for full, unrestricted coverage.

Meeting these goals will require some clarifications to the current Clinical Trial Policy and may require additional regulatory changes.

The Clinical Trial Policy was developed under the authority of section 1862(a)(1)(E) of the Act. This paragraph prohibits payment for items and services that are not reasonable and necessary to carry out the research purposes of section 1142. In other words, it broadens the limitations on the scope of permissible Medicare payments (in section 1862(a)(1)(A) of the Act) to include making payments for what is reasonable and necessary for the Secretary, acting through AHRQ, to carry out research under section 1142. It permits payment for clinical care that is being studied under section 1142 for its effectiveness and appropriateness.

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
07/10/2006 - 08/09/2006
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
04/10/2007 - 05/10/2007
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Leslye K. Fitterman, Ph.D.

Actions Taken

July 10, 2006

CMS initiates this reconsideration for review of the clinical trial policy. The initial 30-day public 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 and suggestions on resolutions to the 10 issues identified above, as well as any others of concern to the public. Following this initial 30-day comment period, CMS will release a proposed decision memorandum and again solicit public comment.

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

August 24, 2006

October 30, 2006

The Federal Register Notice [PDF, 105KB] publication announced that CMS is convening a Medicare Coverage Advisory Committee (MCAC) meeting on December 13, 2006, to address this topic. Since CMS has decided to convene the MCAC, the due date for this proposed decision memorandum and the NCA expected completion date per Section 1862 (l)(2)(B) of the Social Security Act have been amended.

November 9, 2006

CMS is extending the deadline for presentations and written comments for the December 13, 2006 MCAC meeting. The new deadline is 5PM EST November 24, 2006.

November 22, 2006

CMS posted the roster and the questions [PDF, 130KB] to be discussed at the December 13 MCAC meeting. The questions may be further refined before the date of the meeting. Any updates will be posted.

CMS is extending the deadline for presentations and written comments for the December 13, 2006 MCAC meeting. The new deadline is 5PM EST November 30, 2006.

April 10, 2007

CMS posts the Proposed Decision Memorandum and opens a 30 day public comment period on the proposed decision.

May 30, 2007

Posted comments [PDF, 3MB] received.

View comments received through the website.

July 9, 2007