National Coverage Analysis (NCA) View Public Comments

Clinical Trial Policy

Public Comments

Commenter Comment Information
Osborne, Kent Title: Cancer Center Director
Organization: Baylor college of Medicine
Date: 08/19/2007
Comment:

I think the proposed changes are good.

amatruda, thomas Title: physician
Organization: Hubert H. Humphrey Cancer Center, Netro-MN CCOP
Date: 08/18/2007
Comment:

to CMS:

I am writing in regards to the proposed revisions in CMS policy regarding coverage of routine healthcare expenses in Medicare patients who are participating in clinical trials. This is Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2), at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210

These changes will have an adverse effect on the care of Medicare patients. Therefore, I urge you to rescind or delay these proposed regulations.

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Weinberg, Armin Date: 08/18/2007
Comment:

Introduction

We, at the Eliminating Disparities in Clinical Trials (EDICT) Project, appreciate the opportunity to respond to the revised NCD and applaud CMS efforts to revisit the benefit issues related to clinical trials. The EDICT Project, launched in 2005, is a research study designed to address the problems and find workable solutions to recruiting and retaining populations that are underrepresented in clinical trials such as low income, elderly, racial-ethnic minorities or those

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Quirk, James Title: Executive Director
Organization: Alliance of Dedicated Cancer Centers
Date: 08/18/2007
Comment:

The Alliance of Dedicated Cancer Centers: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
City of Hope National Medical Center
Dana-Farber Cancer Institute
Fox Chase Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Roswell Park Cancer Institute
Seattle Cancer Care Alliance
Sylvester Comprehensive Cancer Center

August 18, 2007

By Electronic

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Clausen, Sue Title: Associate Vice President/Chief Compliance Officer
Organization: UW Medicine - University of Washington
Date: 08/18/2007
Comment:

August 17, 2007

RE: Medicare’s Proposed Clinical Research Policy

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the July 19th proposed Clinical Research Policy (CRP). We appreciate the efforts of the Center for Medicare and Medicaid (CMS) to clarify coverage of services for Medicare beneficiaries enrolled in clinical research. We also appreciate CMS’ clarification of its intent as articulated at the August 7, 2007 Open Forum. We look forward to

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sprague, evie Date: 08/18/2007
Comment:

This is very unfair to those who will want to participate in clinical trials. This proposal is illegal. It denies a patient the right to receive care that should be available to all.

Walker, Susan Title: Senior Director, Health Policy and Reimbursement
Organization: St. Jude Medical, Inc.
Date: 08/17/2007
Comment:

Submitted Electronically on CMS Website

August 17, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health & Human Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2)

Dear Dr. Phurrough:

St. Jude Medical, Inc. appreciates this opportunity to comment on the Centers for Medicare and Medicaid

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Duffy, Barbara Title: Executive Director of AACI and EVP & CEO of ASCO
Organization: Association of American Cancer Institutes (AACI) with the American Society of Clinical Oncology (ASCO)
Date: 08/17/2007
Comment:

The American Society of Clinical Oncology (ASCO) is the leading medical society for physicians involved in cancer treatment and clinical research. The Association of American Cancer Institutes (AACI) is comprised of 89 of the nation’s leading academic and freestanding cancer research centers that are the nexus of both basic cancer research and clinical investigations. Members of ASCO and AACI conduct the overwhelming majority of cancer clinical trials in the United States. We regard the

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Korn, Allan Title: Senior Vice President and Chief Medical Officer
Organization: Blue Cross and Blue Shield Association
Date: 08/17/2007
Comment:

Centers for Medicare & Medicaid Services
Via e-mail

Re: Comments on Clinical Trial Policy (CAG-00071R2)

The Blue Cross and Blue Shield Association (BCBSA), an association of 39 independent Blue Cross and Blue Shield Plans that collectively provide health insurance benefits to 99 million Americans, appreciates the opportunity to provide comments on the Proposed Decision Memo for Clinical Trial Policy. BCBSA supports the efforts of CMS to clarify this policy and

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Patel, Parashar Title: Vice President
Organization: Boston Scientific Corporation
Date: 08/17/2007
Comment:

August 17, 2007

BY ELECTRONIC DELIVERY

Steve Phurrough, M.D., MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services Department of Health and Human Services
Mail Stop C1-12-28
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG -00071R2)

Dear Dr. Phurrough:

Boston Scientific

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Bernard, Gordon Title: Assistant Vice Chancellor for Research
Organization: Vanderbilt University
Date: 08/17/2007
Comment:

August 17, 2007

Leslye K. Fitterman, Ph.D.,
Lead Analyst
Centers for Medicare & Medicaid Services
Mail Stop C1-10-23
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Comments to the Proposed CMS Clinical Research Policy

Dear Dr. Fitterman:

On behalf of Vanderbilt University, I would like to express our appreciation to the Centers for Medicare & Medicaid Services (CMS) for the opportunity to submit Comments on the Second Reconsideration of the

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Michalski, Jeff Title: Medical Director of Clinical Trials Office
Organization: Siteman Cancer Center
Date: 08/17/2007
Comment:

I am pleased to see CMS taking a positive step in the coverage of patients that are enrolled in peer reviewed clinical trials. I would like to make sure that consideration is given to expand currently approved treatments to new indications. These treatments are currently considered as a standard of care to established indications but may show promise in other similar diseases. When these treatments are being tested in for these new indications the treatments should be considered as "Usual

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Lynch, Ann-Marie Title: Executive Vice President
Organization: AdvaMed
Date: 08/17/2007
Comment:

August 17, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health & Human Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, Maryland 21244-1850

Re: Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2)

Dear Dr. Phurrough:

I am writing on behalf of the Advanced Medical Technology Association (AdvaMed) regarding the Centers for

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Herberman, Ronald Title: Director
Organization: University of Pittsburgh Cancer Institute
Date: 08/17/2007
Comment:

August 17, 2007

Steve E. Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, MD 21244

Dear Dr. Phurrough:

UPMC Cancer Centers and the University of Pittsburgh Cancer Institute (UPCI) appreciate the opportunity to provide comments addressing the proposed Clinical Trial Policy (CAG-00071R2), renamed the Clinical Research Policy. UPMC

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Zwolak, Robert Title: Executive Director
Organization: Society for Vascular Surgery
Date: 08/17/2007
Comment:

August 19, 2007

Steve Phurrough, M.D.
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

RE: Proposed Decision Memo for Clinical Trials Policy (CAG-00071R2)

Dear Dr. Phurrough:

On behalf of the 2,300 members of the Society for Vascular Surgery (SVS), we offer the following comments on the Centers for Medicare & Medicaid Services’ (“CMS”)

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Parker, George Title: General Manager
Organization: Cyberonics
Date: 08/17/2007
Comment:

August 17, 2007

Steve Phurrough, M.D., M.P.A.
Director of Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG -00071R2)

Dear Dr. Phurrough:

On behalf of Cyberonics, Inc., thank you for this opportunity to comment on CMS’ July 19, 2007, Proposed Decision Memo for Second

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Moore, Walter Title: Vice President, Government Affairs
Organization: Genentech, Inc.
Date: 08/17/2007
Comment:

Genentech, Inc.
Government Affairs
1399 New York Ave, NW, Suite 300
Washington, DC 20005
Phone: (202) 296-7272
Fax: (202) 296-7290

August 17, 2007

By Electronic Submission

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Mailstop: C1-12-28
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Second Reconsideration of the

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Smith, Richard Date: 08/17/2007
Comment:

Conclusion

PhRMA appreciates the opportunity to submit comments on this proposed decision memorandum. We look forward to working with CMS to ensure that Medicare’s clinical research policy supports the goal of encouraging broad beneficiary access to promising health care innovations.

Sincerely,
Richard I. Smith
Senior Vice President
Policy, Research and Strategic Planning

Diane E. Bieri
Senior Vice President and General Counsel

cc: Barry Straube, M.D.
Steve Phurrough, M.D., M.P.H.
Tamara Syrek Jensen, J.D.
Patricia Graves
Rosemarie Hakim, Ph.D.

Less

August 17, 2007

VIA E-MAIL AND U.S. MAIL

Leslye K. Fitterman, Ph.D.
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

Re: Second Reconsideration of Clinical Trial Policy (CAG-00071R2)

Dear Dr. Fitterman:

The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates this opportunity to comment on the proposed decision

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Harder, Joel Title: Director, Quality Improvement and Outcomes
Organization: Heart Rhythm Society
Date: 08/17/2007
Comment:

August 17, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mail Stop C1-12-28
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG-00071R2)

Dear Dr. Phurrough:

The Heart Rhythm Society (HRS) appreciates this

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Clyde, Alexandra Title: Vice President, Health Policy & Payment
Organization: Medtronic, Inc.
Date: 08/17/2007
Comment:

August 17, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

ELECTRONICALLY SUBMITTED

Re: Clinical Research Policy CAG-00071R2

Dear Dr. Phurrough:

Medtronic, Inc. is one of the world’s leading medical technology companies specializing in implantable and interventional therapies that alleviate pain,

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Mathias, Ann Title: Director, Ethics and Compliance
Organization: University of Pittsburgh Medical Center
Date: 08/17/2007
Comment:

I am pleased to submit comments on the Proposed Decision Memorandum for Second Reconsideration of the Clinical Trail Policy, renamed the Clinical Research Policy (CAG-00071R2). My comments are provided on behalf of the University of Pittsburgh Medical Center (UPMC).

On June 7, 2000 the President issued an executive order directing Health and Human Services to explicitly authorize Medicare payment of routine patient care costs and costs due to medical complications associated with

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American Medical Association, . Organization: American Medical Association
Date: 08/17/2007
Comment:

The American Medical Association (AMA) appreciates the opportunity to comment on the Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (the Policy) (CAG – 00071R2). In general, the AMA welcomes clarification of the Policy that governs National Coverage Determinations for Medicare beneficiaries participating in clinical trials, but has a number of concerns with the proposed changes and the process utilized to revise

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Henschel, Laurel Title: RN, Medical Auditor, Research Coverage Analyst
Organization: Aurora Healthcare
Date: 08/17/2007
Comment:

CAG-00071R2
I very much appreciate the opportunity to comment on the proposed clinical research policy. As a member of the provider community working with research coverage issues, I want to be sure that I am providing correct claim information to CMS for Medicare beneficiaries in clinical research studies.

USUAL and ROUTINEDoes CMS consider "usual and routine" within a clinical trial to mean an individual physician''s usual and routine testing practices outside of a trial? How

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DeWilde, Leticia Title: Senior Policy Analyst
Organization: American Cancer Society
Date: 08/17/2007
Comment:

August 17, 2007

Steve Phurrough, MD, MPA
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG-00071R2)

Dear Dr. Phurrough:

On behalf of the American Cancer Society we appreciate the opportunity to submit comments regarding

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Grousky, Ronald Title: Director, Medicare Strategy
Organization: Mayo Clinic
Date: 08/17/2007
Comment:

August 17, 2007

We appreciate the opportunity to comment on the National Coverage Analysis for Clinical Research Policy (CAG-00071R2) issued July 19, 2007 regarding changes to the National Coverage Decision (NCD) for Clinical Trial Policy established by a June 7, 2000 Executive Memorandum. Mayo Clinic has reviewed the National Coverage Analysis (NCA) and respectfully submits the following comments.

Timing of NCA issuance

We are concerned that CMS is proposing a

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Schwartzberg, MD, Lee Title: President
Organization: Accelerated Community Oncology Research Network
Date: 08/17/2007
Comment:

The Accelerated Community Oncology Research Network, Inc. (ACORN) is a network of over 30 community oncology sites that conduct clinical research trials collaboratively with the aim of achieving a higher quality, more effective, and efficient research process. Our goal is to advance the science of oncology care in order to bring needed improvements in treatment options to our patients. On behalf of ACORN and our member sites, I am submitting these comments regarding the changes proposed

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Stovall, Ellen Organization: Cancer Leadership Council
Date: 08/17/2007
Comment:

August 17, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Mail Stop C10-9-06
Baltimore, Maryland 21244-1850

RE: Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2)

Dear Dr. Phurrough:

The undersigned cancer organizations, representing cancer patients, researchers, and caregivers, are writing to express their strong objections to the proposed decision memo for clinical

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Seferian, Suzanne Title: Senior Counsel
Organization: Johnson & Johnson
Date: 08/17/2007
Comment:
Steve Phurrough, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG-00071R2)

Dear Dr. Phurrough:

These comments are submitted on behalf of the Johnson & Johnson Family of Companies in response to the proposed decision memorandum that would revise the Medicare

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McKay, Paul Title: Co-Chair
Organization: North American Brain Tumor Coalition
Date: 08/17/2007
Comment:

August 17, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Mail Stop C10-9-06
Baltimore, Maryland 21244-1850

RE: Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2)

Dear Dr. Phurrough:

The North American Brain Tumor Coalition (NABTC), a network of brain tumor organizations dedicated to improving the treatments for brain tumors, appreciates the

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Washington, Bonnie Title: Vice President Health Policy
Organization: Novartis Pharmaceuticals Corporation
Date: 08/17/2007
Comment:

Summary

Novartis appreciates the opportunity to submit comments on CMS Clinical Research Policy. We hope that the CMS finds these comments useful in producing a final set of clear regulations that provides Medicare beneficiaries with increased access to clinical research trials that further the development of innovative pharmaceutical products. In review, Novartis:

  • Opposes the deletion deeming process of IND and federally funded trials and request that CMS reinstate the pathway for

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  • Berger, Edward Title: Principal
    Organization: Larchmont Strategic Advisors
    Date: 08/17/2007
    Comment:

    I would like to thank the Agency for the opportunity to comment on the Proposed Decision Memorandum for the Clinical Research Policy (CAG-00071R2). My comments will address three distinct subjects:

  • The overall merit of the proposal and thesubstantial improvement it represents as comparedto the current Clinical Trial Policy;
  • A suggestion for clarification of one of thestandards that research must meet in order toqualify under the proposed policy; and
  • Identification of

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  • Marcot, Carole Title: Vice President Quality and Regulatory Affairs
    Organization: SynCardia Systems, Inc.
    Date: 08/16/2007
    Comment:

    SynCardia Systems, Inc. (“SynCardia”) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (“CMS”) proposed national coverage determination regarding Medicare’s clinical research policy (“Proposed NCD”). As the developer of biomechanical cardiac replacement and assist devices that are approved by the Food and Drug Administration (“FDA”) and devices for which we are seeking FDA approval, we have a strong interest in ensuring that Medicare’s clinical trial

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    Baer, Ivy Title: Director and Regulatory Counsel
    Organization: Association of American Medical Colleges
    Date: 08/16/2007
    Comment:

    I am submitting the following comments on behalf of the Association of American Medical Colleges:

    The Association of American Medical colleges represents all 125 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs medical centers; and 94 academic and scientific societies. Through these institutions and organizations, the AAMC represents 109,000 faculty members, 67,000 medical

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    Tolcher, Anthony Title: Director, Clinical Research
    Organization: South Texas Accelerated Research Therapeutics
    Date: 08/16/2007
    Comment:

    August 16, 2007

    Centers for Medicare and Medicare

    Re: Changes in CMS coverage for clinical trials

    To Whom It May Concern:

    I want to register with you my deep concern about your proposed decision to alter Medicare coverage for participation in clinical trials. After the last few decades spending significant money to develop new agents for the treatment of cancer, a disease that primarily affects the age groups that are covered by Medicare, this

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    Holt, Lawrence Title: MD
    Date: 08/16/2007
    Comment:

    Thank you for the opportunity to comment on the Clinical Trial Policy.

    In review of the policy, there is a clear overlap with other government agencies that also have a supervisory and regulatory role. The duplication of oversite is excessive, not necessary and inhibitory to trial function. The "qualifications for trial endorsemement are vague and potentially arbitrary. The net result will be an inhibitory influence to trial availability such that patients/beneficiaries will suffer

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    Becker, Tracy Title: Research Advocacy Manager
    Organization: American Society of Hematology
    Date: 08/16/2007
    Comment:

    The American Society of Hematology (ASH) represents over 11,000 hematologists in the United States who are committed to the treatment of blood and blood-related diseases. ASH members include hematologists and hematologist/oncologists who regularly render services to Medicare beneficiaries. The Society appreciates this opportunity to provide comments to the Center for Medicare and Medicaid Services (CMS) on the proposed revisions to the Medicare National Clinical Research Policy

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    Cantor-Weinberg, Julie Title: Vice President, Public Policy
    Organization: American College of Gastroenterology
    Date: 08/16/2007
    Comment:

    August 16, 2007

    Steve Phurrough, MD, MPA
    Director, Coverage & Analysis Group
    Office of Clinical Standards & Quality
    Centers for Medicare & Medicaid Services
    ATTN: Clinical Study Certification
    Mailstop: C1-09-26
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: Proposed Decision Memo for Clinical Trials Policy (CAG-00071R2)

    Dear Dr. Phurrough:

    On behalf of the American College of Gastroenterology (ACG), we want to commend CMS for

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    Dreyer, MD, Stephen Date: 08/15/2007
    Comment:

    The development of a Medicare policy to assure better representation of recognized minorities in the cancer clinical trial process should be encouraged.

    To adequately assess the efficacy and safety of a particular therapy the study popualtion should accurately represent the cancer prone popuation in this country. This populaton includes the elderly as well as ethnic minorities and rural residents.

    This policy would offer an opportunity to define and eliminate barriers to clinical trial

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    Evans, Gina Date: 08/15/2007
    Comment:

    I would prefer to see greater clarification of what is considered to be a malformed body member. This can be subjective and open for dispute.

    Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services—which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a

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    Schlicht, James P. Title: Executive Vice President, Government Affairs & Adv
    Organization: American Diabetes Association
    Date: 08/15/2007
    Comment:

    Diabetes is a disease which disproportionately affects racial and ethnic minorities. According to the Agency for Healthcare Research and Quality (AHRQ), diabetes prevalence rates for most minority groups are two to six times greater than that for non-Hispanic Whites. In addition, CDC estimates that 18.5 percent of Americans 65 – 74 years of age have diabetes. On behalf of all minority Medicare beneficiaries with diabetes, the American Diabetes Association (ADA) submits for your

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    Spencer, Crystal E. Title: Director of Research Administration/IRB
    Organization: St. Lukes Health System
    Date: 08/15/2007
    Comment:

    Thank you for allowing us the opportunity for comment on this important proposal. We are pleased with the overall recommendations but do have some comments. One area of concern is definition of "enrollment" as it relates to the transition period. We would appreciate clarification for the term Enrollment Date:

    The use of the term “enrollment date” creates confusion because it can have several different definitions such as: date the consent form was signed date the

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    Reinhard, Robert Title: Member
    Organization: Community Advisory Group, San Francisco Dept of Publich Health, Research Section
    Date: 08/15/2007
    Comment:

    a copy of these comments preserving endnote formatting and references and contact information is also submitted to CAGinquiries

    TO: Steve Phurrough, MD, MPA
    Director, Coverage and Analysis Group

    Leslye K. Fitterman, PhD
    Lead Analyst

    Office of Clinical Standards and Quality
    Centers for Medicare and Medicaid Services (CMS)
    Mail Stop C1-09-06
    7500 Security Boulevard
    Baltimore, Maryland 21244-1850

    RE: Proposed Decision Memo for Clinical Trial

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    Biggs, Deborah Title: Chair, Clinical Research Billing Lead Team
    Organization: University of Michigan
    Date: 08/14/2007
    Comment:

    August 14, 2007

    Steve Phurrough, M.D., M.P.A.
    Director, Coverage and Analysis Group
    Centers for Medicare and Medicaid Services
    Hubert H. Humphrey Building room 445-G
    200 Independence Avenue, SW
    Washington, DC 20201

    RE: Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG -00071R2)

    Dear Dr. Phurrough:

    On behalf of The University of Michigan Health System (UMHS), we would like

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    Kaplan, Barry Title: Director, Division of Hematoloy/Medical Oncolgy
    Organization: New York Hospital Queens
    Date: 08/14/2007
    Comment:

    I am a hematologist/medical oncologist and have been involved in clinical trials for many years. I have also been a member of IRBs and currently serve on the Biologic Research Association of NY IRB as a reviewer. Frankly, I cannot understand why this new policy has been set up. Almost all the issues you raise are covered in excruciating detail by an IRB and I have no idea why you think you are more fit to make these determinations than a qualified IRA.

    I think Medicare should pay for

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    Bryant, Donna Title: Oncology Nurse Practitioner
    Organization: Mary Bird Perkins Cancer Center
    Date: 08/13/2007
    Comment:
    Access to clinical research trials is fundamental to cancer prevention and treatment. Improving access to cutting-edge therapies is just one part of cancer care. Studying new ways to better understand lifestyle issues that affect cancer risk could pay dividends for many diseases by implementing approaches proven effective through screening, diagnostics, and cancer prevention research trials. Please do not burden the system more than it already is by asking providers to do more paperwork in

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    Spurgin, Elizabeth Title: Vice President
    Organization: B&D Consulting
    Date: 08/13/2007
    Comment:

    Dear Dr. Phurrough:

    Thank you for the opportunity to comment on the proposed Clinical Research Policy. We appreciate CMS' efforts to consider additional comments from stakeholders.

    B&D Consulting's Health & Life Sciences Practice group offers advisory and advocacy services to health care providers, pharmaceutical companies, medical device manufacturers, industry groups and voluntary health associations. We respectfully submit the following comments for your review.

    We commend the

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    Sleckman, Bethany Title: Principal Investigator
    Organization: St. Louis-Cape Girardeau CCOP
    Date: 08/10/2007
    Comment:

    I agree with the ASCO evaluation of this policy. I am concerned about the increased regulatory burden it will require, as well as decreased participation by Medicare recipients. Please don't change a policy that is working quite well as it stands.

    Godwin, John Title: Professor
    Organization: Southern Illinois University
    Date: 08/10/2007
    Comment:

    Dear Sirs:
    The proposed policy change in CMS coverage for clinical trials is a serious blow to the progress we have made in fighting cancer. Just as the public is seeing the benefit of decades of research that has resulted in a decrease in cancer death rates, your office is proposing to halt the progress by restricting clinical trial participation. This is also at a time when our population is aging and thus will be more likely challenged by a cancer diagnosis. This would qualify as a

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    barrera, ermilo Date: 08/10/2007
    Comment:

    I completely support mandating that every effort be made to include subpopulations, particularly diadvantaged subpopulations, in clinical trials.

    pohlmeyer, robert Title: MD
    Organization: Pinehurst Medical Clinic section Hem/Onc
    Date: 08/10/2007
    Comment:
    In private practice it is hard enough to enroll patients in clinical trials. Both from a personell and logistical point of view. Not to mention the extra time it takes to explain the trial and make sure the patient is willing to participate. Any increase in the amount of paperwork and/or requirements is certainly going to limit my group's ability to participate in clinical trials.
    Glode, Michael Organization: uchsc
    Date: 08/09/2007
    Comment:

    As a clinical trialist in prostate cancer, I can assure you that any policy which impairs the ability of my patients to participate in clinical trials would have an extremely negative effect on our ability to advance the fight against prostate cancer. This

    mendez, pedro Date: 08/09/2007
    Comment:

    the sad reality is that too much of medical research is an instrument of advertaisement of drug companies, this is also the case with medical schools, in this setting the benefit of the so called research is very much questionable.

    the same drug companies will charge as much as $6000 or more for the monthy supply of just every new cancer drug.

    Rathbun, Jill Organization: Society of Gynecologic Oncologists
    Date: 08/09/2007
    Comment:
    August 10, 2007

    Steve Phurrough, M.D.
    Coverage and Analysis Group
    Centers for Medicare and Medicaid Services
    Department of Health and Human Services
    Mailstop: C1-09-06
    7500 Security Blvd.
    Baltimore, MD 21244

    RE: Proposed Decision Memo for Clinical Trials Policy (CAG-00071R2)

    Dear Dr. Phurrough:

    On behalf of the 1,100 members of the Society for Gynecologic Oncologists (SGO), we offer the following comments on the Centers for Medicare & Medicaid Services' (CMS')

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    Reid, Erin Title: Assistant Professor of Medicine
    Organization: University of California, San Diego
    Date: 08/09/2007
    Comment:

    I am absolutely opposed to the proposed changes in clinical trial policy to the Medicare program. These changes would result in limited access of Medicare patients to clinical research and set a precedent that quite likely would be followed by private insurance agencies. The effects would go beyond limiting access to clinical trials for Medicare patients; this would further strain the medical research community in general, where funding is already severely restricted resulting.

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    Carling, Shelly Date: 08/09/2007
    Comment:

    Thank you for the opportunity to comment on CMS' Proposed Clinical Research Policy. We would like to offer three comments/questions for further clarification.

    1. During the Special Open Door Forum on the Proposed CRP National Coverage Determination (CRP NCD)held Tuesday, August 7, 2007, Dr. Phurrough made two remarks about the CRP NCD and clinical trials of IDE devices. First, he stated that the CRP NCD would have "minimal" effect on IDE device studies. Later in the Open Door Forum,

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    Lager, Joanne Title: Discovery Medicine Oncology
    Organization: GlaxoSmithKline
    Date: 08/09/2007
    Comment:
    I am very concerned that this policy will have a chilling effect on patient's ability to access novel therapies and on our ability to develop better therapies for patients with cancer. This policy should be reconsidered.
    Gines, Venus Title: CEO
    Organization: Dia de la Mujer Latina, Inc
    Date: 08/09/2007
    Comment:

    Please refrain from using the term "subpopulations" - the politically correct term is "vulnerable populations" - many advocates have taken offense to the term subpopulation b/c the word sub - denotes lower than, which always reflect negatively on communities of color.

    Kahl, Brad Date: 08/09/2007
    Comment:
    Ask any termainlly ill patient or family member of an afflicted patient and they will affirm that progress in the war on cancer is too slow. As a physician dedicated to clinical cancer research, I can attest that the barriers to conducting this research are formidible and contibute to the slow pace of progress. The CMS decision would only add to these barriers. I ask that you continue to policy set forth in 2000. Our federal government should be actively working to speed clinical cancer

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    Dizon, Don Title: Director of Medical Oncology and Integrative Care
    Organization: Program in Women's Oncology of Women & Infants Hospital of Rhode Island
    Date: 08/09/2007
    Comment:

    I am urging CMS to reconsider its policy. The access to clinical trials is the only way we are going to make progress in the fight against cancer and this policy, which strips away a patient's ability to afford treatment on protocols while going even further to make them not eligible for protocols is impractical and will do more to discourage BOTH investigators and patients from participation in trials. I urge withdrawl of what will be a burdensome and unethical policy, which will

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    Wojtaszek, Cynthia Date: 08/09/2007
    Comment:

    I commend Dr. Bailes on his comprehensive assessment of the proposed policy and potential implications. I have a few additional comments/concerns which I would like to address.

    Although I understand the effective date of the revised policy will be the day it is posted (October 17, 2007). I would graciously ask CMS to add parameters around this date. Specifically, those studies that have already begun the IRB process (at atleast 1 site, not all sites) prior to the effective date

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    Bailes, MD, Joseph S. Title: Chair, Government Relations Council
    Organization: American Society of Clinical Oncology
    Date: 08/08/2007
    Comment:

    As the leading medical society for physiciansinvolved in cancer treatment and research, theAmerican Society of Clinical Oncology (ASCO) submits these comments in strong opposition to theproposed changes in the clinical trial policy ofthe Medicare program, now renamed the Clinical Research Policy. If adopted as proposed, the newpolicy will impose substantial impediments toresearch as well as needless additional expensefor the research enterprise, in both the publicand private sectors. The

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    Sanchez Silver, Eve Title: Founder, Executive Director
    Organization: Cinta Latina Research
    Date: 08/08/2007
    Comment:

    Latino groups must be included in clinical trials and also seperately identified. Though we share one language our cultures vary as much as our diets and locations. Do not include our numbers as one group. This will serve no one. There are other underrepresented and disadvantaged members of our society who have never gained any benefit from clinical trials which did not include them. Programs must be tailored to appeal, not to the clinician, but to the study patient, with guidance

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    Hudson, Linda Date: 08/08/2007
    Comment:
    I agree with this proposed policy revision. It is important that we make every effort to include underrepreseted populations in the clinical trials process and that we make every effort to insure a clear and full understandng of the benefits of participation
    Wartman, MD, PhD, Steven Title: President/CEO
    Organization: Association of Academic Health Centers
    Date: 08/03/2007
    Comment:

    Re: Proposed Decision Memo for Clinical Trial Policy (CAG-00071R2)

    Dear Dr. Phurrough:

    On behalf of the Association of Academic Health Centers (AAHC ), I am pleased to provide comments on the Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy, Renamed the Clinical Research Policy (CAG-00071R2) issued by the Centers for Medicare & Medicaid Services (CMS) on July 19, 2007. I wish to applaud the agency for seeking to improve and clarify issues and for

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    Meyers, Abbey Title: President
    Organization: National Organization for Rare Disorders (NORD)
    Date: 07/26/2007
    Comment:

    To: Centers for Medicare & Medicaid Services

    From: Abbey S. Meyers, President
    National Organization for Rare Disorders NORD)
    P.O. Box 1968
    Danbury, CT 06813-1968
    Phone: (203) 744-0111
    Fax: (203) 798-2757
    www.rarediseases.org

    Cc: Maria Hardin, NORD Vice President Patient Services
    Diane Dorman, NORD Vice President Public Policy

    Date: July 25, 2007

    RE: Comments on Proposed Decision Memo for Clinical Trial Policy

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    wojtaszek, cynthia Date: 07/23/2007
    Comment:

    Thank you for taking the time to readdress this policy. The current NCD defines 1 requirement for medicare coverage of routine costs that I do not believe is adequately addressed in the proposed decision. Specifically, the current NCD states that the "The trial must not be designed exclusively to test toxicity or disease pathology. It must have therapeutic intent."

    This language, are you are aware, has very imporant implications for Phase I research studies in cancer patients.

    In

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    Price, Patrick Date: 07/22/2007
    Comment:

    The clinical trial policy and the clincal research policy both state the following:
    The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the following desirable characteristics; however, some trials, as described below, are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage:
    4. The trial design is appropriate to answer the

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