MEDCAC Meeting

Clinical Trial Policy


Expand All | Collapse All


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.

Actions Taken

October 30, 2006

Posted FR notice [PDF, 104KB] announcing December 13, 2006 meeting.

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 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.

November 29, 2006

Posted agenda.

December 5, 2006

Posted clinical trial background paper [PDF, 90KB].

December 19, 2006

Posted CMS presentation [PDF, 209KB] and score sheet [PDF, 662KB].

February 21, 2007

Posted minutes [PDF, 4MB] and transcript [PDF, 1MB].


Medicare Evidence Development & Coverage Advisory Committee
December 13, 2006
7:30 AM – 4:30 PM
CMS Multi-Purpose Room

Alan M. Garber, MD, PhD, Chairperson
Alex Krist, MD, Vice-Chairperson
Barry Straube, MD- Director, Office of Clinical Standards and Quality
Steve Phurrough, MD, MPA, Director, Coverage and Analysis Group
Janet Brock and Kimberly Long , Executive Secretaries

7:30 – 8:00 AM


8:00 – 8:30 AM

Opening Remarks—B. Straube MD/J.Brock / S. Phurrough, MD, MPA/A.Garber, MD, PhD

8:30 9:15 AM

CMS Presentation and Presentation of Voting Questions:
S. Phurrough MD, MPA

9:15 – 10:15 AM

Scheduled Presentations

10:15 – 10:30 AM


10:30 – 10:45 AM

Open Public Comments
Public Attendees who wish to address the panel will be given that opportunity

10:45 – 11:00 AM

Panel Questions to Presenters

11:00 – 11:15 PM

Charge to the Committee- A. Garber, MD, PhD

11:15 – 12:00 PM

Open Panel Deliberations

* * * * * * * * * * *

12:00 – 1:00PM

LUNCH (on your own)

* * * * * * * * * * *

1:00 – 2:30 AM

Open Panel Deliberations (cont): Dr. Garber

2:30 – 2:45 PM


2:45 – 4:15 PM

Formal Remarks and Vote
The Chairperson will ask each panel member to state his or her position on the questions

4:15 – 4:30 PM

Closing Remarks / Adjournment: S. Phurrough MD, MPA/A. Garber MD, PhD

4:30 PM



Download meeting minutes [PDF, 4MB].

Panel Voting Questions

Download Questions[PDF, 129KB].

Download scoresheet [PDF, 716KB]

Contact Information


Medicare Coverage Advisory Committee
Clinical Trial Policy
December 13, 2006

Alan M. Garber, M.D, Ph.D.
Director, Center for Primary Care and Outcomes Research
Stanford University

Alexander H. Krist, MD
Family Physician
Fairfax Family Practice Center

Voting Member/Patient Advocate:
Nancy Davenport-Ennis, BA
Patient Advocate Foundation

Voting Members:
Wade M. Aubry, M.D.
Senior Advisor
Health Technology Center

Marc L. Berger, M.D.
Vice President
Outcomes Research & Management
Merck & Co. Inc.

Mark D. Grant, MD, MPH
Senior Scientist
BlueCross BlueShield Association
Technology Evaluation Center

Mark A. Hlatky, MD
Professor, Health Research and Policy and Cardiovascular Medicine
Stanford University School of Medicine

Nora A. Janjan, MD
Professor, Dept of Radiation Oncology
University of Texas
M.D. Anderson Cancer Center

Bernard Lo, MD
Professor of Medicine
University of California San Francisco

Sanford J. Schwartz, MD
Professor of Medicine, Health Management & Economics
University of Pennsylvania

Jeremy Sugarman, M.D., M.P.H., M.A.
Harvey M. Meyerhoff Professor of Bioethics and Medicine
Phoebe R. Berman Bioethics Institute and Department of Medicine
Johns Hopkins University

Consumer Representative:
Linda A. Bergthold, PhD
Healthcare Consultant

Industry Representative:
Michael L. Ryan, PharmD
Vice President, Corporate Affairs
Amgen, Inc.

Guest Expert Panelists:

Barbara Alving, MD
Director, NHLBI

Steven N. Goodman, MD, MHS,PhD
Division of Biostatistics
John Hopkins School of Medicine

Cary Gross, MD
Yale University School of Medicine

Steven A. Wartman, MD, PhD
Association of Academic Health Centers

Deborah Zarin, MD

CMS Liaison:
Steve E. Phurrough, MD, MPA
Coverage and Analysis Group

Executive Secretaries:
Janet Brock
Kimberly Long

Associated Technology Assessment