National Coverage Analysis (NCA) View Public Comments

Clinical Trial Policy

Public Comments

Commenter Comment Information
Pillon, Luana Title: Director, Dialysis VANYHHCS
Date: 05/10/2007
Comment:

Dear Dr Phurough,
Please consider supporting noninvasive objective technologies to guide volume optimization in dialysis patients.Non invasive technologies to assess and guide fluid management in the dialysis population are necessary to prevent cardiovascular and cerebrovascular morbidity and mortality.

Methods that have demonstrated clinical validation in observational studies should be expanded to large well designed randomized clinical trials. Examples of these technologies are

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Haynie, Matthew Date: 05/10/2007
Comment:

To Whom it May Concern:

Re: Clinical Trial Policy

May 10, 2007

I am writing to lend my support for CMS to provide a clinical trial for the validation of blood volume monitoring to identify ideal dry weights in hemodialysis patients.

Studies have shown that 90% of dialysis patients could be normotensive by lowering dry weight. Experts in the renal community have admitted that we need to focus on dry weights and that we have do a better job of establishing and maintaining dry

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Pillon, Luana Title: Assistant Professor
Organization: New York University School of Medicine
Date: 05/10/2007
Comment:

It is clear that many of the established KDOQI guidelines have improved the adequacy of dialysis in terms of delivered urea clearance Kt/V >1.2, URR >65%, Hgb 11g/dl -12 g/dl.

What is needed are guidelines for the component of adequacy that have been to date overlooked- VOLUME ASSESSMENT AND MANAGEMENT.

The mortality rate of patients receiving chronic hemodialysis (HD) therapy in the United States remains unacceptably high at 15 - 20% per year. [USRDS, 2001]

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Garcia, Maria Date: 05/10/2007
Comment:

Please find evidence below why particular focus should be given to our dialysis patients. In particular the focus should be targeted on volume and its management. Data from the 2006 USRDS reveals the following.

The number of hospital stay for those on hemodialysis, has not improved since 1999.

Cardiovascular admissions, in contrast, while increasing 8 percent overall, are now 20 percent higher in blacks, 27 percent higher in patients age 20-44, and 53 percent greater in pediatric

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Brennan, Michael Date: 05/10/2007
Comment:
You need to focus on cardiovascular death that isrelated to volume on dialysis. You need toresearch and evaluate the fluid volumes inpatients to help assess and guide fluid status sopatients will experience less symptoms and have abetter quality of life and be at a less risk forheart attack or stroke.
Weinberg, Armin Title: Professor
Organization: Baylor College of Medicine
Date: 05/10/2007
Comment:

We are writing to 1) express our concern regarding the proposed standard related to health disparities and 2) request that any new guidelines include education of beneficiaries regarding clinical trials coverage.

HEALTH DISPARITIES

The CMS standard as stated does not improve upon the existing NIH Revitalization Act of 1993 and the FDA Modernization Act of 1997, which have proven ineffective in bolstering the representation of underrepresented populations to date. Current research

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Patel, Parashar Title: Vice President
Organization: Boston Scientific Corp.
Date: 05/10/2007
Comment:

May 10, 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: NCA Tracking Sheet for Clinical Trial Policy (CAG-00071R)

Dear Dr. Phurrough:

Boston Scientific Corporation (Boston Scientific)

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Rathbun, Jill Title: Director of Government Relations
Organization: Society of Gynecologic Oncologists
Date: 05/10/2007
Comment:

The Society of Gynecologic Oncologists (SGO) is a national medical specialty society of physicians who are trained in the comprehensive management of women with malignancies of the reproductive tract. Our purpose is to improve the care of women with gynecologic cancer by encouraging research, disseminating knowledge which will raise the standards of practice in the prevention and treatment of gynecologic malignancies and cooperating with other organizations interested in women's health

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Slurzberg, Jo Ellen Title: VP Reimbursement and Health Policy
Organization: Almyra, Inc.
Date: 05/10/2007
Comment:

May 10, 2007

BY ELECTRONIC DELIVERY

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 TrialPolicy (CAG-00071R)
Dear Dr. Phurrough:

On behalf of the Almyra, IncI am submitting thefollowing comments to the Centers for Medicare andMedicaid Services’ (CMS) Proposed

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Lynch, Ann-Marie Title: Executive Vice President
Organization: Advanced Medical Technology Association (AdvaMed)
Date: 05/10/2007
Comment:

I am writing on behalf of the Advanced Medical Technology Association (AdvaMed) regarding the Centers for Medicare and Medicaid (CMS) proposed decision memorandum revising the national coverage decision on the “Clinical Trial Policy” (hereinafter referred to as the “Clinical Research Policy”). AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection,

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Rodriguez, Denise Date: 05/10/2007
Comment:

We need more focus on cardiovascular death related to volume on dialysis.

Goffena, Don Title: Coverage, Coding and Reimbursement
Organization: W.L. Gore & Associates, Inc.
Date: 05/10/2007
Comment:

May 10, 2007

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

Dear Dr. Phurrough:

Re: NCD – Clinical Research Policy CAG-0071R

We commend CMS for providing revisions that help clarify the proposed Clinical Trial Policy, now titled the Clinical Research Policy (CRP). This policy has broad implications for both beneficiaries and the health care industry and deserves thoughtful evaluation by all affected parties.

W.L. Gore & Associates, Inc. (Gore), has designed,

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Leahey, Mark Title: Executive Director
Organization: Medical Device Manufacturers Association
Date: 05/10/2007
Comment:
May 9, 2007

BY ELECTRONIC DELIVERY

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 Trial Policy (CAG-00071R)

Dear Dr. Phurrough:

On behalf of the Medical Device Manufacturers Association (MDMA), a national trade association representing the innovative sector of the

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Seferian, Suzanne Title: Senior Counsel
Organization: Johnson & Johnson
Date: 05/10/2007
Comment:

Leslye K. Fitterman, Ph.D.
Centers for Medicare & Medicaid Services
Leslye.fitterman@cms.hhs.gov

Re: NCA for Clinical Trial Policy (CAG-00071R)

Dear Dr. Fitterman:

These comments are submitted on behalf of the Johnson & Johnson Family of Companies in response to the proposed decision memorandum for the Medicare National Clinical Trial Policy. The proposed decision memorandum would revise the national coverage determination (NCD) under which Medicare currently covers the

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Walker, Susan Title: Sr. Director, Health Policy and Reimbursement
Organization: St. Jude Medical, Inc.
Date: 05/10/2007
Comment:
May 10, 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-00071R)

Dear Dr. Phurrough:

St. Jude Medical, Inc. appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS) proposed decision memorandum revising the

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Quirk, James Title: Executive Director
Organization: The Alliance of Dedicated Cancer Centers
Date: 05/10/2007
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

May 10, 2007

By

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Clyde, Alex Title: Vice President , Health Policy & Payment
Organization: Medtronic, Inc.
Date: 05/10/2007
Comment:

May 10, 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-00071R

Dear Dr. Phurrough:

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

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Keener, A. Paige Title: Director, Medicare & Medicaid Policy
Organization: Novo Nordisk Inc.
Date: 05/10/2007
Comment:

Dear Drs. Fitterman and Phurrough:

Novo Nordisk Inc. (Novo Nordisk) appreciates the opportunity to comment on the Medicare Clinical Research Policy contained in the Proposed Decision Memorandum issued April 10, 2007 (CAG- 00071R). We applaud CMS in reconsidering this policy that affects a wide range of vital clinical research. As Medicare is the largest purchaser of healthcare in the United States, and Medicare coverage and payment policy is often a guidepost for private payers, we

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Smith, Richard Title: Senior Vice President, Policy & Research
Organization: PhRMA
Date: 05/10/2007
Comment:
DeCrappeo, Anthony Title: President
Organization: Council on Governmental Relations
Date: 05/10/2007
Comment:

Steve Phurrough
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services

Subject: CAG-00071R: Proposed Decision Memorandum for Medicare National Clinical Trial Policy

Dear Dr. Phurrough:

The Council on Governmental Relations (COGR) is an association of more that 170 research universities and their affiliated academic medical centers and research institutes. COGR concerns itself with the influence of government regulations, policies, and

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quinn, bruce Title: Contractor Medical Director
Organization: NHIC; conveying opinion of New Tech Workgroup CMDs
Date: 05/10/2007
Comment:
Comment from Contractor CMD Workgroup for New Technology. The May 10, 2007 CMD Workgroup for New Technology discussed the draft NCD for clinical trials. Comments included these two:(1) Since the final NCD will probably take effect immediately, it will be important to have operational guidance to the Medicare Specific Criteria, especially the fourth and fifth ones.(2) We note that the current manuals have no reference or virtually no reference at all to HUDs. The proposed NCA/NCD presents

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Munoz, Santiago Title: Associate Vice President
Organization: University of California, Office of the President
Date: 05/10/2007
Comment:

May 10, 2007

Leslie Norwalk
Interim Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building, Room 443-G
200 Independence Ave, SW
Washington, DC 20201

SUBJECT: CAG-00071R - Proposed Rule Relating to Medicare Payments for Clinical Trials

Dear Interim Administrator Norwalk:

On behalf of the University of California (UC), Office of the President, and the UC’s five academic medical centers (AMCs) located in Davis, Los

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Mayes, Gwen Title: Director of Government Relations/Reimbursement
Organization: Abiomed, Inc.
Date: 05/10/2007
Comment:

May 10, 2007
VIA FedEx and Electronic-Mail to
CAGinquiries@cms.hhs.gov
Steve Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850
RE: Proposed Decision Memo for Clinical
Trial Policy (CAG-00071R)
Coverage Pathway for Humanitarian Use Devices under Humanitarian Device Exemption
Dear Dr. Phurrough:

On behalf of ABIOMED, the

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Herberman, Ronald Title: Director
Organization: University of Pittsburgh Cancer Institute and UPMC Cancer Centers
Date: 05/10/2007
Comment:

UPMC Cancer Centers and the University of Pittsburgh Cancer Institute (UPCI) appreciate the opportunity to provide comments addressing the proposed Clinical Trial Policy (CAG-00071R). UPMC Cancer Centers and UPCI strongly support Medicare’s actions, including the National Coverage Decision (NCD), which work to reduce barriers and improve access for Medicare beneficiaries to qualified research. In an effort to further improve clinical research access by Medicare beneficiaries we would

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Whitman, Andrew Title: Vice President, Medical Products
Organization: Medical Imaging and Technology Alliance
Date: 05/10/2007
Comment:

May 10, 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: [CAG-00071R] Proposed Decision Memo for Clinical Trial Policy

Dear Dr. Phurrough:

The Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturer’s

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Hill,, Catherine Jeakle Title: AANS/CNS Senior Manager, Regulatory Affairs
Organization: submitted for AANS, CNS, and ASITN
Date: 05/10/2007
Comment:

May 10, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00071R: Proposed National Coverage Decision for Clinical Trial Policy

Dear Dr. Phurrough:

The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the American Society of Interventional and Therapeutic Neuroradiology appreciate the opportunity

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Soiffer, Robert Title: President
Organization: American Society for Blood and Marrow Transplantation (together with the National Marrow Donor Program)
Date: 05/10/2007
Comment:

Thank you for the opportunity to provide comments to the Center for Medicare and Medicaid Services (CMS) on the proposed revisions to the Medicare National Clinical Research Policy (CRP). I am submitting comments on behalf of ASBMT and the NMDP.

ASBMT is the American Society for Blood and Marrow Transplantation, an association of 1,500 clinicians and investigators promoting research, education and clinical practice in the field of blood and marrow transplantation and related cellular

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DeMille, Jeannette Title: RN, Dialysis Nurse
Date: 05/10/2007
Comment:

End stage renal disease has been a funded, supported, and monitored for over 40 years. As the guardian of the patients being served by this benefit, it is important to bring to your attention the lack of forward direction being required and applied by our health care system in America. European patients have been monitored and successfully achieved a higher level of well being and physical wellness by concentrating not only on the clearance of the toxins (urea) but by focusing on the

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PAK, THOMAS Date: 05/09/2007
Comment:

I support research in cardiovascular death and stroke and quality of life on dialysis as it relates to fluid management.

brennan, dennis Date: 05/09/2007
Comment:

PLease focus on fluid managetment in HD patients. Stroke,MI,poor quality life and death is much to high in these patients.

pillon, renzo Organization: pillon architect inc
Date: 05/09/2007
Comment:
cardiovascular death is a raising issue that has affected us all. Specifically with pateients on Dialysis. The quality of life for a patient on dialysis is also in need of improvement. I understand that both of these issues can be adressed and are interrelated.
Sweeting, Raeshell Date: 05/09/2007
Comment:

Hemodialysis patients frequently die of cardiac death which is related to poor fluid assement and management, there is a need for randomized controlled trials addressing aspects of volume related cardiac morbidity and mortality

Hahn, Cynthia Title: Administrator, Research Compliance
Date: 05/09/2007
Comment:

We thank the Center for Medicare Services (CMS) for providing the research community with the opportunity to comment on Proposed Decision Memo for Clinical Trial Policy (CAG-00071R) and recognize the need for CMS to develop consistent and operationally effective standards for determining when a clinical research study is qualified to be reimbursed by CMS. We welcome a number of the proposed revisions, however we caution against implementation of the decision as currently written without

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Vaughan, William Title: Senior Policy Analyst
Organization: Consumers Union
Date: 05/09/2007
Comment:

Consumers Union, the independent, non-profit publisher of Consumer Reports, congratulates and strongly supports CMS’s proposal to require the registration of all clinical trials prior to the enrollment of the first study subject, and that the research protocol specifies and provides for the public release of all pre-specified outcomes to be measured, including release of outcomes if outcomes are negative or the study is terminated early.

Thousands of Americans have suffered, and many have

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Schwartzberg, MD, FACP, Lee S. Title: Lee S. Schwartzberg, MD, FACP, President
Organization: Accelerated Community Oncology Research Network, Inc.
Date: 05/09/2007
Comment:
May 7, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd., Room C1-12-04
Mail Stop C1-09-06
Baltimore, MD 21244

Re: CAG-0071R – Proposed Decision Memorandum for National Clinical Trial Policy

Dear Dr. Phurrough:

The Accelerated Community Oncology Research Network (ACORN) is a network of 30 community oncology sites who conduct research trials collaboratively with the aim of achieving a more

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Moore, Walter Title: Vice President, Government Affairs
Organization: Genentech, Inc.
Date: 05/09/2007
Comment:

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

May 9, 2007

By Electronic Submission

Steve Phurrough, MD
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 Medicare National Clinical

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Sleckman, Bethany Title: Director of Oncology Research
Organization: St. John's Mercy Medical Center
Date: 05/09/2007
Comment:

I run the clinical cancer research program at a tertiary care community hospital and also serve as PI for the St. Louis-Cape Girardeau CCOP. I speak for all of my colleagues when I say that I wholeheartedly agree with the comments submitted by ASCO. The IND exempt trials need to be covered by Medicare, and CMS needs to work closely with the FDA to refine this policy. These trials are large part of our cancer research program and we need to make them available to Medicare patients.

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Bishop, Robert Title: Vice Chancellor for Institutional Compliance
Organization: University of Arkansas for Medical Sciences
Date: 05/09/2007
Comment:

On behalf of the University of Arkansas for Medical Sciences (UAMS), please find our comments in response to the April 10, 2007 request by CMS for public comments regarding the Proposed Decision Memo for Clinical Trial Policy (CAG-00071R). UAMS is a state institution with a large clinical research program involving both industry-sponsored and investigator-initiated research.

The Proposed Decision Memo for Clinical Trial Policy provides clarification in a number of areas. However, as

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Becker, Tracy Title: Research Advocacy Manager
Organization: American Society of Hematology
Date: 05/09/2007
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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Black, Michael Title: Vice President
Organization: Hema Metrics
Date: 05/09/2007
Comment:

PLEASE MAKE VOLUME MANAGMENT A POINT OF FOCUS: Below I have outlined evidence that suggest the need to focus on volume and the managment of Volume;

2006 Annual Data Report - Chapter 6 The number of hospital days has decreased somewhat steadily over time for those on peritoneal dialysis; for those on hemodialysis, the number has varied little since 1999. Cardiovascular admissions, in contrast, while increasing only 8 percent overall, are now 20 percent higher in blacks, 27 percent

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Washington, Barbara Title: Vice President Health Policy
Organization: Novartis Pharmaceuticals Corporation
Date: 05/09/2007
Comment:

6. Summary

Novartis appreciates the opportunity to submit comments on CMS Clinical Trial Policy and we hope that the CMS finds our comments helpful in producing a final set of clear regulations that provides Medicare beneficiaries with increased access to clinical studies. In review, Novartis:

  • Has concerns regarding the breadth of the proposed “clinical research” definition and has proposed an alternative definition in alignment with the FDA’s definition of clinical trial.
  • Opposes

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  • Pillon, Luana Title: Assistant Professor
    Organization: VA NYHHCS and New York University School of Medicine
    Date: 05/09/2007
    Comment:

    1. We need a focus on preventing cardiovascular morbidity and mortality in the hemodialysis(HD) population. a. Specifically, we need more objective measures to help the clinician assess and guide fluid status in these patients. The sensitivity and specificity of the physical exam in these patients is poor. There exist validated, FDA approved technologies, for example, that that can help assess and guide management. More than 20 million Americans have chronic kidney disease (CKD) - a

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    Dowling, Robert Title: Professor of Surgery
    Organization: University or Louisville School of Medicine
    Date: 05/09/2007
    Comment:

    My name is Dr. Robert Dowling and I am a Professor of Surgery at the University of Louisville, Louisville, Kentucky, and the Director of Mechanical Circulatory Support. Along with Dr. Laman Gray, I served as the Principal Investigator for the AbioCor total replacement heart clinical trial between 2001 and 2004, performing 7 of the 14 implants at Jewish Hospital. During this time, we feel we have become one of the most experienced surgical and medical team for the replacement of the human

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    Biggs, Deborah Title: Chief Compliance Officer, UM Medical School
    Organization: University of Michigan Health System
    Date: 05/09/2007
    Comment:

    Dear Dr. Phurrough:

    On behalf of The University of Michigan Health System (UMHS), we would like to thank the Centers for Medicare and Medicaid Services for the opportunity to provide feedback on the proposed revisions to the Medicare National Clinical Research Policy (CRP). As an academic institution active in clinical research, we are pleased to be able to provide our perspective on the CRP, which we believe will continue to have a profound impact on academic health centers around the

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    Wiegmann, Theresa Title: Director, Public Policy
    Organization: jAABB
    Date: 05/09/2007
    Comment:
    May 9, 2007

    Steve Phurrough, MD, MPA
    Director
    Coverage and Analysis Group
    Center for Medicare and Medicaid Services
    Hubert H. Humphrey Building, Room 445-G
    200 Independence Avenue, SW
    Washington, DC 20201

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

    Dear Dr. Phurrough:

    AABB (formerly known as the American Association of Blood Banks) appreciates the opportunity to comment on the Center for Medicare and Medicaid

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    Stovall, Ellen Organization: Cancer Leadership Council
    Date: 05/09/2007
    Comment:

    May 9, 2007

    CLC COMMENTS RE CMS PROPOSED DECISION MEMORANDUM ON MEDICARE NATIONAL CLINICAL TRIAL POLICY

    RE: CAG-00071R

    The undersigned members of the Cancer Leadership Council (CLC) represent cancer patients, providers and researchers throughout the nation. We are writing to express our deep concern over the proposal to change the “deemed status” of IND exempt trials, eliminating their automatic coverage by Medicare under the 2000 National Coverage

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    Hanus, James Title: RN, BSN, OCN, MHA
    Date: 05/09/2007
    Comment:

    As an Oncology nurse that has been involved in clinic resaerch for the past 5 years there are several issues with the "proposed decision memo" that I would like to bring to your attention.

    First, the requirement that a study by listed on ClinicalTrials.gov before a Medicare patient can be enrolled. There are many studies that I am involved with where the sponsoring drug company does not want others to know what they are doing. By requiring to place the study on the government web site,

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    Bocchino, RN, MBA, Carmella Title: Exec. V.P., Clinical Affairs & Strategic Planning
    Organization: America's Health Insurance Plans
    Date: 05/09/2007
    Comment:

    May 9, 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

    Dear Dr. Phurrough,

    Thank you for the opportunity to comment on the proposed changes to the national coverage decision (NCD) governing the Centers for Medicare and Medicaid Services’ (CMS) Clinical Trial Policy (to be renamed Clinical Research Policy). America’s

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    Schnell, MD, Frederick Title: Frederick M. Schnell, MD, President
    Organization: Community Oncology Alliance
    Date: 05/08/2007
    Comment:
    May 7, 2007

    Steve Phurrough, MD, MPA
    Director, Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Blvd., Room C1-12-04
    Mail Stop C1-09-06
    Baltimore, MD 21244

    Re: CAG-0071R – Proposed Decision Memorandum for National Clinical Trial Policy

    Dear Dr. Phurrough:

    The Community Oncology Alliance (COA), a non-profit organization whose mission is to foster and protect high quality, affordable and accessible cancer care, would like to offer

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    Podolsky, M.D., Daniel K. Title: Chief Academic Officer
    Organization: Partners HealthCare System, Inc.
    Date: 05/08/2007
    Comment:

    Steve Phurrough, M.D., M.P.A.
    Director
    Coverage and Analysis Group

    May 8, 2007

    RE: Proposed Decision Memorandum for Medicare National Clinical Trial Policy

    Dear Dr. Phurrough:

    On behalf of Partners HealthCare System, Inc. (Partners), I appreciate the opportunity to comment upon the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision Memorandum for Medicare National Clinical Trial Policy.

    Partners HealthCare is an integrated health system founded in

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    Wartman, MD, PhD, Steven Title: President/CEO
    Organization: Association of Academic Health Centers
    Date: 05/08/2007
    Comment:

    On behalf of the Association of Academic Health Centers (AAHC), I wish to comment on the proposed clinical research policy (CRP) of the Centers for Medicare & Medicaid Services (CMS). The AAHC, representing 100 academic health centers nationwide, is dedicated to improving the nation’s health and well-being by mobilizing and enhancing the strengths and resources of the academic health center enterprise in health professions education, patient care, and research.

    I would like to take

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    Harris, Jean Title: Assoc Dir, Div of Advocacy and Health Policy
    Organization: American College of Surgeons
    Date: 05/08/2007
    Comment:

    May 8, 2007
    Steve Phurrough, MD, MPH
    Centers for Medicare & Medicaid Services
    Office of Clinical Standards and Quality
    Director, Coverage and Analysis Group
    C1-09-06
    7500 Security Boulevard
    Baltimore, MD 21244-1850

    Re: Comments on National Clinical Trial Policy, CAG-0071R

    Dear Dr. Phurrough:

    On behalf of the more than 71,000 Fellows who are members of the American College of Surgeons (College), I am pleased to comment on the

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    Baer, Ivy Title: Regulatory Counsel
    Organization: Association of American Medical Colleges
    Date: 05/08/2007
    Comment:

    The following comments are submitted on behalf of the Association of American Medical Colleges:

    RE: Proposed Decision Memo for Clinical Trail Policy (CAG-0071R)

    The Association of American Medical Colleges is a nonprofit association representing 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

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    michaels, margo Title: Executive Director
    Organization: Education Network to Advance Cancer Clinical Trials (ENACCT)
    Date: 05/05/2007
    Comment:
    On behalf of the Education Network to Advance Cancer Clinical Trials, we urge CMS to require that all patients diagnosed with cancer are notified of all their treatment options, which includes clinical trials. We note that education is sorely lacking in this policy, yet lack of knowledge on the part of the patient, the primary care provider, or even the oncologist about the availability of trials is a serious barrier to accrual. Therefore CMS should require appropriate notification of

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    Ruggieri, Alexander Title: Senior Director of Safety Solutions
    Organization: Cerner Corporation
    Date: 05/02/2007
    Comment:

    This policy is unfortunately watered down with respect to acheiving its stated goals of gaining knowledge of how medical products and therapeutics impact the medicare population as a whole.

    Many Phase IV studies, post marketing commmittment studies and registries are designed with a safety focus in mind. Excluding Medicare patients from these only because they have a safety objective in mind seems futile as there are potential learnings about safety that may beneifit the entire Medicare

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    Bailes, MD, Joseph S. Title: Co-Chair, Government Relations Council
    Organization: American Society of Clinical Oncology
    Date: 04/27/2007
    Comment:

    The American Society of Clinical Oncology (ASCO), with more than 24,000 members worldwide, is the leading medical society for physicians involved in cancer treatment and research. ASCO has a longstanding interest in cancer clinical research and was heavily involved in the negotiation of terms for the National Coverage Determination that is now under review.

    When the current clinical trial policy was finalized in September 2000, it reflected the contributions not just of ASCO and

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    Schroeder, Wendy Title: RN, CCRC, Research Finance Coverage Analyst
    Organization: Banner Health Research Institute
    Date: 04/26/2007
    Comment:

    Please consider the case study application of the current proposed policy that follows in reference to these questions:

  • Who should pay for the investigational treatment for Medicare subjects who are geographically challenged by local contractor denial of this service?

  • Does the treatment described in this case study meet the definition of a billable clinical trial service if it is only available to “some” Medicare beneficiaries based on local contractor coverage

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  • Miranda, George Title: Assistant Director
    Organization: Cancer Center
    Date: 04/25/2007
    Comment:

    I am generally in favor and enthusiastic about theproposed amendments to the Clinical Research NCD.I am especially glad that CMS proposes to coveritems/drugs, etc. being researched if they areALREADY a covered benefit outside of the trial.

    My main concern, however, is the proposal tocontinue refusing payment for scans, labs, etc.,that are required by the trial but not of discretetherapeutic benefit. The reason is oppose this isthat such information gained from these"research-only"

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    Costello, Keitha Title: Practice Manager
    Organization: Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
    Date: 04/24/2007
    Comment:
    I am confused about your new definition of investigational clinical services. If the clinical trial is looking at a new use for a drug and the drug is available to Medicare beneficiaries for colon cancer but not breast cancer and the clinical trial is testing it's efficacy in breast cancer, is the drug now approved in the clinical trial under investigational clinical services?
    quinn, bruce Date: 04/23/2007
    Comment:
    The draft policy states:"This policy is not applicable to, and does not propose to change Medicare coverage according to the regulations on category A and category B investigational device exemptions (IDE) found in 42 CFR 405.201-405.215, 411.15, and 411.406 (Should have known)." S. 405 is indeed the IDE section and is appropriate to reference. This statement in fact over-arches the whole policy and might be better placed in the preamble.

    Now, 411.15 is CFR location of most of the

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    Simonsen, Dee Date: 04/20/2007
    Comment:
    Aetna has multiple Medicare Advantage contracts with CMS. We are hopeful the next release of this policy will expand on payment guidance to all parties - Medicare beneficiaries, carriers, FI's and MA Plans. It's clear that all Medicare beneficiaries (including those enrolled in managed care plans) may opt to participate in a qualified clinical trial. However, it's very confusing as to who is responsible for reimbursing the provider of the trial.
    quinn, bruce Title: physician
    Date: 04/19/2007
    Comment:

    The proposed NCD is an improvement in clarity. There are two ways in which the implementation would be made easier for both investigators and contractors.

    (1) Be crystal clear regarding the exclusion of Category B related trials and registries. Although the authors probably feel point #8 regarding IDE is clear, I suggest the policy explicitly say that Cat A&B rules entirely "override" the Clinical Trials NCD, even when many parts of the NCD seem to apply (e.g. an NIH funded trial). In

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    Goozner, Merrill Title: Director, Integrity in Science Project
    Organization: Center for Science in the Public Interest
    Date: 04/17/2007
    Comment:

    According to the proposal, on page 3, the current policy:

    ". . . limits the payment for items and services provided to Medicare beneficiaries in qualified trials to routine costs. In general, the policy defines 'routine costs' as those items and services that would generally be available to Medicare beneficiaries outside the trial. Among other things, it also excludes items and services that are the subject of the investigation even if they are covered outside the trial."

    The new policy

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    Hubert, Christine Date: 04/13/2007
    Comment:

    What about Device trials? On the decision memo dated 4/10/2007, #9)General Standards, third standard, "Studies conducted under an Investigational New Drug (IND)where the protocol has been reviewed by the FDA". Does this statement also apply to studies conducted under an Investigational Device Exemption (IDE)?

    Duvall, Daniel Title: Contractor Medical Director
    Organization: Riverbend
    Date: 04/11/2007
    Comment:

    Excellent policy, 2 small points:
    1. There are some Cat B IDE Trials in which an existing device is being used for a new indication as opposed to the classic device of an improved existing device for an existing indication. Trial for a new indication in which it may or may not work is fundamentally a clinical trial. Cat B IDE may be NONCOVERED by the local contractor and often are if the unproven indication creates a lack of medical necessity ("investigational"). Recommend adding to

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