Steven A. Wartman, MD, PhD August 16, 2007 President/CEO …

Steven A. Wartman, MD, PhD             August 16, 2007
President/CEO

Board of Directors
                                       Steve Phurrough, MD, MPA
Michael V. Drake, MD
Chancellor                             Director Coverage & Analysis Group
University of California, Irvine       Centers for Medicare & Medicaid Services
Chair
                                       Office of Clinical Standards & Quality
Arthur Rubenstein, MBBCh
Executive Vice President for the
                                       Director, Coverage & Analysis Group
Health System                          ATTN: Clinical Study Certification
Dean, School of Medicine
University of Pennsylvania             Mailstop: C1-09-26
Chair-Elect                            7500 Security Blvd
Frank B. Cerra, MD                     Baltimore, MD 21244
Senior Vice President
for Health Sciences
University of Minnesota                Re: Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2)
Immediate Past Chair

John Fernandes, DO, MBA                Dear Dr. Phurrough:
President
Oklahoma State University
Center for Health Sciences             On behalf of the Association of Academic Health Centers (AAHC), I
Antonio M. Gotto, Jr., MD, DPhil       would like to thank the Centers for Medicare & Medicaid Services
Stephen and Suzanne Weiss Dean         (CMS) for providing the opportunity to discuss the proposed clinical
and Provost, Medical Affairs
Weill Medical College and Graduate     research policy (CRP) and hear the perspectives from agency
School of Medical Sciences
Cornell University                     administrators at the August 7, 2007 Special Open Door Forum. In
                                       light of those discussions, we would like to emphasize and expand on a
Jane E. Henney, MD
Senior Vice President and              number of issues raised in our earlier comment letter, dated August 6,
Provost for Health Affairs             2007.
University of Cincinnati

Philip A. Pizzo, MD
Dean, School of Medicine
                                       The AAHC, a national, non-profit association representing more than
Stanford University                    100 academic health centers nationwide, is dedicated to improving the
Sheldon M. Retchin, MD, MSPH           nation's health care system by mobilizing and enhancing the strengths
Chief Executive Officer VCU Health
System, Vice President for Health
                                       and resources of the academic health center enterprise in health
Sciences                               professions education, patient care, and research.
Virginia Commonwealth University

Fred Sanfilippo, MD, PhD               As stated in our earlier letter, the AAHC strongly recommends that the
Senior Vice President and
Executive Dean for Health Sciences     policy implementation date be decided upon based on the date of
Chief Executive Officer, OSU Medical   initial IRB approval rather than the date of patient enrollment. The
Center
The Ohio State University              date of the first enrollment is not the milestone event in clinical trial
Larry J. Shapiro, MD                   administrative and billing processes. Using this marker may mean that
President, Washington University       studies that already have IRB approval will need to be re-reviewed and
Medical Center, Executive Vice
Chancellor for Medical Affairs and     approved again by the IRB. All institutions track IRB approvals; few
Dean, School of Medicine               track enrollment dates. Thus, all studies with an initial IRB approval on
Washington University
                                       or before the effective implementation date should be covered under
Andrew A. Sorensen, PhD                the old Clinical Trial Policy and any studies without initial IRB approval
President
University of South Carolina           should be subject to the new Clinical Research Policy.



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www.aahcdc.org
Dr. Steve Phurrough
Page 2
August 16, 2007

The AAHC would now additionally recommend that to provide clarity and consistency
throughout the policy, CMS use "date of initial Institutional Review Board
approval" in several sections of the proposed CRP. These sections are:

   1. The first sentence of the NCD Manual 310.1: Clinical Research Policy, which
      would then read: "Medicare covers usual patient care in a clinical research
      study initially approved by an Institutional Review Board as of October 17,
      2007." [Presuming the final policy is issued on this date.]
   2. Under the approval process section of the proposed policy: the description of
      the information that should be included in the certification letter should be
      changed to read the "date of initial IRB approval" rather than "study start
      date."
   3. Proposed standard bullet #10 should be changed to read: "The clinical
      research study is registered on the ClinicalTrials.gov web site by the study
      sponsor/principal investigator, or designee of the principal investigator, after
      initial IRB approval."

Finally, to ameliorate the administrative burden during the transition from the
current Clinical Trial Policy to the new Clinical Research Policy, the AAHC suggests
CMS consider a process that would permit, at the institution's discretion, clinical
research studies begun prior to the effective date of the final CRP to be brought
under the new policy. This would occur by fulfilling the requirements of
ClinicalTrials.gov registration and submission of the certification letter to CMS.

Thank you for considering these recommendations which were developed by
members of the AAHC's Forum on Regulation, comprising chief compliance officers
from academic health centers nationwide. The AAHC looks forward to continuing to
work with CMS and stands ready to assist in any capacity.

Sincerely,



Steven A. Wartman, MD, PhD, MACP
President/CEO


CC: Leslye K. Fitterman