National Coverage Analysis (NCA) View Public Comments

Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

Public Comments

Commenter Comment Information
Brady, Art Date: 08/02/2013
Comment:
Pet does not include measuring cerebral spinal fluid rate of flow and volume of flow.It does not include measuring Intercranial pressure.Current studies are incomplete because they are missing these markers. We consider amyloid protein a residue form by the combination of 9 protein antagonists found in CSF. The Fonar Upright MRI now has the ability to measure CSF and ICP.
McConathy, Jonathan Title: Assistant Professor of Radiology
Organization: Washington University School of Medicine
Date: 08/02/2013
Comment:

I am writing as a radiologist and nuclear medicine physician active in neuroimaging in clinical and research settings.

I believe that the restrictive coverage decision for amyloid PET poorly serves many patients suffering from cognitive impairment as well as their families. Accurate and early diagnosis of serious medical conditions such as dementia is fundamental to making informed clinical decisions even in the absence of disease-modifying treatments. It is also critical to

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Pandya DO, Siddharth Title: Neuroariologist, Clinical Assistant Professor
Organization: Nova Southeastern University College of Osteopathic Medicine
Date: 08/02/2013
Comment:

I believe that proving more tools to the physicians to make a more accurate diagnosis will in the long run be cost effective. In the case for beta amyloid imaging, weighing the probability of AD or non-AD causes of MCI should allow the physician, family and social services to better plan for the management of the patient.

With the current trend of increasing longevity and the baby-boomers reaching the ages where MCI is more prevalent as is the prevalence of chronic disease such as

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Halliday, Sue Organization: Northern California PET Imaging Cen
Date: 08/02/2013
Comment:

Re: CAG-00431N - National Coverage Analysis for Beta Amyloid PET in Dementia and Neurodegenerative Disease

The proposal by CMS to cover one amyloid PET scan through coverage with evidence development (CED) in clinical studies that meet certain clinical endpoints is not reasonable given the recent recommendations by the SNMMI and Alzheimer's Association. Covering one PET scan under the appropriate use criteria (AUC) guidelines IS reasonable and will allow patients to be triaged

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Dickerson, Brad Title: Director, MGH FTD Unit
Organization: Massachusetts General Hospital/Harvard Medical School
Date: 08/02/2013
Comment:

I am a practicing behavioral neurologist in a specialty dementia center, and a researcher using neuroimaging as a tool in my studies. In my role as a clinician, I am often in the position of providing highly specialized expert opinion about the cause of a patient's cognitive impairment or dementia. In many cases that are referred to my program, the clinical presentation is unusual. In the cases in which the presentation is commonplace, I can often be highly confident in my diagnostic

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Silverman, Dan Organization: University of California, Los Angeles
Date: 08/02/2013
Comment:

Today, CMS posted a comment submitted on behalf of the American Academy of Neurology (AAN). The AAN stands out among professional organizations submitting their comments in this forum, as having done an admirable job of responsibly sticking (nearly) exclusively to the facts in the face of an intimidating field of public comments asserted by many professional organizations or collaborative groups and displayed here, which have strayed far into the territory of largely opinion-based rather

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Wahl, Richard Title: Professor and Director, Nuclear Medicine and PET C
Organization: Johns Hopkins University School of Medicine
Date: 08/02/2013
Comment:

Dear Dr. Jacques:

I am a practicing nuclear medicine physician in an academic health care center. My practice includes all aspects of nuclear medicine including brain imaging. We have had FDG PET available to our patients for many years to help sort out the challenging cases of fronto-temporal dementia vs. Alzheimer’s disease. While we do these studies occasionally, they are certainly used infrequently. Thus, I am quite puzzled by CMS very restrictive proposed coverage

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Tesar, Ruth Title: CEO
Organization: Northern California PET Imaging Center
Date: 08/02/2013
Comment:

I have read most of the comments for this proposed decision memorandum. After digesting many of the well thought out data driven comments, I would like to propose a way to move forward that could be more cost effective in the long run and, one that could provide patients appropriate access to this important procedure.

The draft decision memo recommends one PET scan. “ Therefore, we propose to cover one PET Aß scan per patient through coverage with evidence development (CED)”, if

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Peterson, Todd Title: Associate Professor of Radiology
Organization: Vanderbilt University
Date: 08/02/2013
Comment:

As President of SNMMI's Center for Molecular Imaging Innovation and Translation and a molecular imaging researcher, I appreciate the opportunity to comment on the Proposed Decision Memo for Beta Amyloid PET in Dementia and Neurodegenerative Disease. In issuing its approval, the FDA noted the clinical utility of Amyvid, and I believe that sufficient evidence exists to support immediate coverage by Medicare. The proposed coverage with evidence development is overly burdensome, as it would

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Kuhlmann, MD, D. ABPN, David Title: Medical Director, Sleep Medicine
Organization: Bothwell Regional Health Center
Date: 08/02/2013
Comment:

I applaud CMS in its decision to allow for the coverage of one Beta Amyloid PET scan per patient in approved clinical studies that focus on health outcomes. By allowing for reimbursement for PET scans, Alzheimer’s research will not be stifled. As CMS correctly determined, the field is not ready to handle the logistics of widespread testing. Many of Medicare’s beneficiaries will have a positive result, which could unnecessarily devastate one of our country’s most vulnerable

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Reiman, Eric Title: Executive Director
Organization: Banner Alzheimer's Institute
Date: 08/02/2013
Comment:

August 2, 2013

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques,

As an Alzheimer’s disease brain imaging researcher, psychiatrist and executive director of an organization that serves the needs of patients and families with Alzheimer’s and related diseases, I urge CMS to reconsider its draft decision and approve reimbursement

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Sha, Sharon Title: Clinical Assistant Professor
Organization: Stanford University
Date: 08/02/2013
Comment:

Dear Dr. Jacques,

I am a neurologist at an academic dementia center and care for patients with cognitive impairment and dementia. In practice and research, the utility of amyloid PET has proven useful in diagnosis and management of these patients. Cases in which I have found particular use is distinguishing between frontotemporal dementia and Alzheimer's disease. I believe the knowledge of having Alzheimer's disease pathology can also help quality of life for people who want to

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Bocchino, Carmella Title: Executive Vice President
Organization: America's Health Insurance Plans
Date: 08/02/2013
Comment:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Decision (NCD) Tracking Sheet for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market

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Wells, Janet Date: 08/02/2013
Comment:

I strongly support CMS in its decision to take a measured, informed and responsible position regarding Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.

The U.S. government should not succumb to pressure from pharmaceutical manufacturers who prey upon the public’s fear of Alzheimer’s disease to rush to diagnosis of Alzheimer's and to treat it with drugs of unknown efficacy or safety in individuals who may or may not have the disease. The industry

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Sperling, Reisa Title: Professor of Neurology
Organization: Harvard Medical School, Brigham and Women's Hospital
Date: 08/02/2013
Comment:

Thank you for the opportunity to comment on the CMS draft decision. I am a neurologist and a clinical researcher who has been working in Alzheimer’s disease (AD) for the past 20 years. I specifically remember the first presentation of PET amyloid imaging data at the International Conference on Alzheimer’s Disease in 2002 and the strong sense that this technology would greatly aid our field in bringing accurate diagnosis to our patients and ultimately in finding a successful

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McGlothlin, Anita Title: Health Policy Analyst
Organization: American College of Radiology
Date: 08/02/2013
Comment:

August 2, 2013

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

VIA ELECTRONNIC SUBMISSION

Re: CAG- 00431N Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

Dear Dr. Jacques:

The American College of Radiology (ACR), representing more than 34,000

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Egge, Robert Title: Vice President, Public Policy
Organization: Alzheimer's Association
Date: 08/02/2013
Comment:

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Bhujwalla, Zaver Title: President
Organization: World Molecular Imaging Society
Date: 08/02/2013
Comment:

The World Molecular Imaging Society (WMIS) appreciates the opportunity to comment on the Proposed Decision Memorandum on Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N).

WMIS recognizes that the Proposed Decision proposes an option for providing a limited number of Medicare beneficiaries with beta amyloid PET through coverage with evidence development (CED). However, WMIS is concerned that the Proposed Decision reflects unwarranted

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Steinberg, Carol Date: 08/02/2013
Comment:

August 2, 2013
Louis Jacques, M.D.
Coverage and Analysis Group, Director
Centers for Medicare & Medicaid Services
Department of Health and Human Services
2500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

On behalf of the Alzheimer’s Foundation of America (AFA), a national nonprofit organization that

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kipper, michael Date: 08/02/2013
Comment:
This comment is in support of the use of Amyvid PET in the evaluation of dementia. I feel this agent can be efficacious in selected patients, and recommend approval. I have full confidence in my neurology and medical colleagues to use this agent judiciously, reserving testing for those patients who remain undiagnosed and/or problematic. My experience in nuclear medicine/PET for >30 years has convinced me that all radiopharmaceuticals and diagnostic tests are ultimately utilized based upon

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Nagy, Mark J. Title: Vice President, Global Patient Outcomes
Organization: Eli Lilly and Company
Date: 08/02/2013
Comment:

August 2, 2013

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Draft Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

On behalf of Lilly USA, LLC (Lilly), we are providing our

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Lopez, Alfredo Date: 08/02/2013
Comment:
CMS should reverse its proposed decision memo and cover the three indications of the AUC without inappropriate coverage with evidence development. I disagree with CMS that an Aß scan does not lead to better health outcomes for appropriately selected patients, particularly in the case of a differential diagnosis which can prevent patients from being subjected to inappropriate medications and costs.
Morris, John Title: Friedman Distinguished Professor of Neurology
Organization: Washington University School of Medicine
Date: 08/02/2013
Comment:
For 25 years, I have directed the faculty outpatient Memory Diagnostic Center at an academic medical center. The opportunity to now detect the amyloid molecular pathology of Alzheimer disease in living patients by using beta-amyloid positron emission tomography (PET) is the most valuable clinical advance that has occurred during my years of practice. Although much remains to be refined with this technology in clinical settings (eg, sensitivity, specificity, reliability, reproducibility,

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Kremer, Ian Title: Executive Director
Organization: LEAD Coalition (Leaders Engaged on Alzheimer's Disease)
Date: 08/02/2013
Comment:

August 2, 2013

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard?Baltimore, MD 21244-1850

RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dr. Jacques:

We thank the Centers for Medicare & Medicaid Services (CMS) for the

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Everman, Lynda Date: 08/02/2013
Comment:

I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology.

While there is not yet a cure, early and proper diagnosis can extend the quality of life for the patient and their loved ones. [PHI Redacted] was diagnosed w Mild Cognitive Impairment in 1997 @ the Institute for Memory Impairments and

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Jorgensen, Jenny Date: 08/02/2013
Comment:
Allowing this diagnostic tool will provide more clear diagnosis and treatment whether the Alzheimers is present or not. Please keep it as a tool without limits.
Thank you.
Iagaru, Andrei Organization: Stanford University Medical Center
Date: 08/02/2013
Comment:

August 2, 2013

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00431N Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

Dear Dr. Jacques:

Firstly I would like to thank you for the opportunity to provide comments on the Proposed Decision Memo for Beta

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Ruckert, Nancy Date: 08/02/2013
Comment:

I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

Over 5 years ago [PHI Redacted] began showing signs of something going wrong. He had behavioral

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Vaadia, Kim Date: 08/02/2013
Comment:
I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care.
Price, Julie Title: Professor of Radiology and Biostatistics
Organization: University of Pittsburgh
Date: 08/02/2013
Comment:

I too urge CMS to adopt broader coverage consistent with the carefully defined Appropriate Use Criteria (AUC, Johnson et al., 2013) that reflect substantial evidence and expertise. The AUC are consistent with health care and cost benefits that result from more informed, efficient and effective patient care and management. Given that there are areas where sufficient evidence is clear, I urge CMS to allow this technology to be more accessible to all who could benefit from its responsible

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Morgan, David Title: Co-Founder
Organization: ResearchersAgainstAlzheimer's
Date: 08/02/2013
Comment:

ResearchersAgainstAlzheimer's

August 2, 2013

Louis B. Jacques, M.D.
Director
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

VIA ELECTRONIC DELIVERY

Re: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

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Egge, Robert Title: Vice President, Public Policy
Organization: Alzheimer's Association
Date: 08/02/2013
Comment:

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 1, 2013

Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

The Alzheimer’s Association appreciates the opportunity to comment on the Center for Medicare & Medicaid Services (CMS) draft

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Vradenburg, George Title: Chairman
Organization: USAgainstAlzheimer's
Date: 08/02/2013
Comment:

usagainstalzheimersnetwork.org

VIA ELECTRONIC DELIVERY

August 02, 2013

Louis B. Jacques, M.D.
Director
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

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Tulip, PhD, Thomas Title: President & Chief Business Officer
Organization: Navidea Biopharmaceuticals
Date: 08/02/2013
Comment:
August 2, 2013
Via Electronic Delivery

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

Navidea Biopharmaceuticals, Inc. is pleased to submit comments on the Centers

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Olson, Tiffany Title: President, Nuclear Pharmacy Services
Organization: Cardinal Health
Date: 08/02/2013
Comment:

August 2, 2013

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques –

Cardinal Health is pleased to respond to the Centers for Medicaid and Medicare Services (CMS) request for comments on the reconsideration request of Section 220.6 of the National Coverage Determinations (NCD) Manual,

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Burkholder, Randy Organization: PhRMA
Date: 08/02/2013
Comment:

August 2, 2013

BY ELECTRONIC DELIVERY

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dr. Jacques:

The

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Nasrallah, Ilya Date: 08/02/2013
Comment:

I urge CMS to reconsider the Proposed Decision Memo for Beta Amyloid PET in Dementia and Neurodegenerative Disease. There has been to date much experience with PET amyloid imaging agents, and with FDA approval of florbetapir there is opportunity to use this experience to benefit patients. The Society for Nuclear Medicine and Molecular Imaging and the Alzheimer’s Association have thoroughly evaluated the available research and have identified three scenarios where there is already strong

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Molchan, M.D., Susan Title: Former Program Director, Alzheimer’s Disease N
Date: 08/02/2013
Comment:

As a geriatric psychiatrist (with neither industry nor academic strings attached), I appreciate the thoughtful and reasonable draft coverage decision on florbetapir. Although presentations at the Alzheimer’s Association’s International Conference last month didn’t change my mind, I was struck by the consistency on the merits of broader coverage: sponsorship by Lilly.

The amyloid imaging agents, including florbetapir are wonderful research tools. The CMS allowance of covering

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Hillner, Bruce Title: Chair
Organization: National Oncologic PET Registry
Date: 08/02/2013
Comment:

As the Co-chairs of the National Oncologic PET Registry (NOPR) Working Group, we appreciate the opportunity to comment on the Proposed Decision Memorandum on Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-0431N).

Because our expertise relates principally to the uses of PET in oncology, NOPR takes no position on the substantive merits of the Proposed Decision. However, we note that the Centers for Medicare & Medicaid Services (CMS) has

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Bens, Cynthia Title: Vice President, Public Policy
Organization: Alliance for Aging Research
Date: 08/02/2013
Comment:

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop S3-02-01
Baltimore, Maryland 21244

RE: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

On behalf of the Alliance for Aging Research, thank you for the opportunity to

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Serafini, Anton Title: Nuclear Radiologist
Organization: Lake Medical Imaging & Vascular Institute
Date: 08/02/2013
Comment:

As a board certified Radiologist/Nuclear Medicine Physician with a group that encompasses four large outpatient imaging centers in Florida servicing a patient base predominantly of Medicare patients, I have extensive experience with PET for cancer imaging and for assisting in the differential diagnosis of dementia. I work with my medical community in assisting in the care of patients with various degrees of memory loss and in aiding in the diagnosis of dementia. As you are aware, CMS

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rehm, patrice Date: 08/02/2013
Comment:

Proposed Decision Memo for Beta Amyloid PET in Dementia and Neurodegenerative Disease. Sufficient evidence exists to support immediate coverage,according to the appropriate use criteria (AUC) devleoped by the Alzheimer’s Association and SNMMI jointly.

All Medicare eligible patients, and not just those in limited clinical trials, should have access to a valuable new tool that can assist physicians in better diagnosing patients with cognitive impairment.

CMS should

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Esposito, Giuseppe Date: 08/02/2013
Comment:
In a selected patient population, patients with documented cognitive impairment where AD is in the differential diagnosis, amyloid imaging has demonstrated its value to increase diagnostic accuracy and alter patient management. The importance or confirming or excluding amyloid deposition with PET in patients where diagnosis is otherwise uncertain is absolutely crucial for patients and their relatives, to better direct patient care. It remains a mistery to me why CMS has overlooked the

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Seibyl, John Title: President and Senior Scientist
Organization: Molecular Neuroimaging and Instit. for Neurodegen. Disorders
Date: 08/02/2013
Comment:

I appreciate the thoughtful and measured review of the existing literature regarding the clinical utility, efficacy, and safety of florbetapir amyloid PET imaging by CMS in drafting proposed coverage guidelines. In addition, I'm grateful for the opportunity for public comment where consideration of additional viewpoints may further illumine the final coverage decision for amyloid PET imaging in the diagnosis of Alzheimer's dementia.

In this regard, it strikes me that the

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Devous, Sr., Ph.D., Michael D. Title: Professor of Radiology
Organization: University of Texas Southwestern Medical Center
Date: 08/02/2013
Comment:

Drs. Conway, Jacques and Ms. Tavenner

Centers for Medicare and Medicaid Services

We write this comment in opposition to the draft decision to use Coverage with Evidence Development as a way to consider amyloid imaging in the assessment of Medicare Beneficiaries with neurodegenerative disorders. We and our colleagues have previously submitted a letter to you detailing the value of amyloid PET imaging, and indeed it is widely endorsed by many scientists and clinicians

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Smith, Ashley Date: 08/02/2013
Comment:

August 02, 2013

Louis B. Jacques, M.D.
Director
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

USAgainstAlzheimer’s advocates appreciate this opportunity to

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Pandya, Naushira Title: Professor and Chair
Organization: Nova Southeastern University College of Osteopathic Medicine
Date: 08/01/2013
Comment:

Dear Dr. Hutter

As a clinical and academic geriatrician with thirty years of experience in caring for frail elders, I would like to strongly recommend that amyloid PET be approved for patients who meet accepted criteria for this imaging modality without Coverage with Evidence development (CED). In addition to clinical and laboratory evaluation, and MRI, patients in whom the cause of dementia is unclear, need to undergo neuropsychological testing. Many cannot undergo these tests

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Bae, K. Ty Title: Professor and Chairman, Dept of Radiology
Organization: University of Pittsburgh
Date: 08/01/2013
Comment:
I urge CMS to approve the use of beta-amyloid PET agents for use by qualified clinicians as recommended by the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer’s Association Appropriate Use Criteria (AUC) guidelines. These AUC guidelines identified subjects who likely would benefit from this technology, as well as subjects who likely would not benefit. The use of this technology in the differential diagnosis of dementias will have a positive effect on patient outcomes,

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Quon, Andrew Title: Associate Professor
Organization: Stanford University School of Medicine
Date: 08/01/2013
Comment:

A strong connection between Aß PET/CT imaging and the post-mortem diagnosis of Alzheimer's Disease has already been established by Clark et al. (Lancet Neurology 2012), Choi et al. (Alzheimer Disease and Associated Disorders 2012), and others (Ikonomovic et al., Brain 2008). The U.S. Food and Drug Administration (FDA) fully vetted this data and approved Florbetapir PET/CT imaging for clinical use. Yet despite the rigorous review and approval by the FDA, the decision by CMS to not

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Stephenson, Diane Date: 08/01/2013
Comment:

Re: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques:

I urge CMS reconsider the recent decision regarding coverage of Amyvid for AD diagnosis and use in clinical trials. Having spent my entire career dedicated to development treatments for AD, I have witnessed the revolutionary developments in our understanding of AD based on molecular imaging. Innovative technologies should pave

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Duara, Ranjan Title: Medical Director and Prof of Neurology
Organization: University of Florida College of Medicine
Date: 08/01/2013
Comment:

I am a neurologist with over 30 years of experience in diagnosisng and treating patients with memory and cognitive disorders and am particlualry interested in the use of imaging technology in guiding the diagnostic process adn making treatment decisions. While I appreciate the careful review provided by CMS in making its draft decision regarding reimbursement of amyloid PET imaging

I am concerned that the decision was driven primarily by the perception that approval would result in

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Serafini, Aldo Title: Professor of Radiology and Medicine
Organization: Univ. of Miami Sch. of Med./SCCC/Jackson Memorial Medical Center
Date: 08/01/2013
Comment:
To
Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr Jacques,

As a practising physician in South Florida, I am only to aware of the great need for safe and reliable test to assist in medical diagnosis. This is especially true in the case of patients suspected of having Alzheimer's disease who are particularly at risk for bein

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Price, Bruce Title: Chief, Department of Neurology, McLean Hospital
Organization: Harvard Medical School
Date: 08/01/2013
Comment:
If the recently released CMS proposed decision memo for amyloid PET coverage holds, and therefore only patients priviledged enough to be enrolled in an approved clinical trial have access, the epidemiology and health care disparities of AD in this country will continue their exponential increases. It will, indeed, be regretable and preventable.
Jackson, Tatianie Title: Resident Physician
Organization: Stanford University Medical Center
Date: 08/01/2013
Comment:
During my time at Stanford I have seen Beta Amyloid PET help many of our neurologist treat patient with very complicated and unclear forms of dementia by differentiated whether beta amyloid was involved. This is an important to study to the inflected patients and their families.
Gomez, Camilo Title: Director
Organization: Neurological Institute of Alabama
Date: 08/01/2013
Comment:

July 31, 2013

Dear Dr. Hutler, Ms. Burton and Mr. Caplan:

I would like to comment on the coverage decision made by the Centers for Medicare and Medicaid Services (CMS) regarding the use of beta amyloid positron emission tomography (PET) in dementia and neurodegenerative diseases. Currently, I am the Director of the Neurological Institute of Alabama (NIA), and have over 30 years of experience in clinical neurology and neuroimaging. Throughout my career, I have had the

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Walsh, Travis Title: Program Director of Nuclear Medicine
Organization: SAVAHCS
Date: 08/01/2013
Comment:
I agree with you current proposal not to cover Amyoid PET due to insufficient data on the effects on health care. Those that object clearly have potential financial bias. I am a nuclear medicine physician at a VA medical center and I do not have this bias. I also believe that the VA should follow the investigate and result of CMS or they they should conduct their own. This is not the current plan.
Sabbagh, Marwan Title: Director
Organization: Banner Sun Health Research Institute
Date: 08/01/2013
Comment:

As an investigator for the amyloid imaging compounds that hold such potential with Alzheimer’s disease, I have participated in the development of these products from an early stage of testing to completion of the clinical pathological correlations. However, my comments here are offered as a clinical neurologist who cares exclusively for dementia patients.

Until now, clinical assessment, management of patients with cognitive decline, memory loss and dementia has been mired in

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RUCKSTIHL, RICHARD Organization: Aadd, LLC
Date: 08/01/2013
Comment:
Please reconsider your proposed decision to make more obstacles before allowing an Amyloid PET imaging available to people who may have Alzheimer's.The FDA has approved this procedure. I am a full time caregiver for [PHI Redacted] and need all the diagnostic help I can get to find out what to do with the rest of our lives and our family's lives also This is a problem with many of our friends also.
RUCKSTUHL, PATRICIA Date: 08/01/2013
Comment:
[PHI Redacted] The FDA has approved this technology, but Medicare has proposed obstacles to prevent this test. Please consider requiring Medicare to not impose their proposed obstacles, and instead to encourage use of this test.
NALIVAIKA, LEO Title: SPEAKER OF NCOR SNMMITS,TECHNOLOGIST
Organization: SNMMI
Date: 08/01/2013
Comment:

As Speaker of the National Council of Representatives of the SNMMI Technologists section, as a technologist, as a professional and patient advocate I submit this letter in regards to Beta Amyloid Imaging. The importance of this material in the diagnosis in demetia and neurogenerative disease is paramount. The following points though provided by the society I belong to and believe in make this case. I apprecaite your review of this as well as hopefully changing ones ruling on this

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Grooms, Daneen Date: 08/01/2013
Comment:

August 1, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Submitted via email: CAGinquiries@cms.hhs.gov

RE: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease (CAG-00431N)

Dear Dr. Jacques,

The American Academy of

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McDonald, Elaine Title: Director of Imaging Services
Organization: Rocky Mountain Cancer Centers / USOncology
Date: 08/01/2013
Comment:

I reiterate the comments made by the SNMMI and could not state the case better. See below. However I can add that as someone approaching the age where early or confirmative diagnosis of AD, I do not agree with the current coverage plan. CMS should not take this valuable tool from patients. Let's move forward in imaging, not backward!

  • SNMMI appreciates the opportunity to comment on the Proposed Decision Memo for Beta Amyloid PET in Dementia and Neurodegenerative Disease.

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  • Hardin, Cynthia Date: 08/01/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] was diagnosed with Parkinson's disease due to a tremor in her hand. For ten

    More

    Bunning, Sue Title: Director, Health Policy and Regulatory Affairs
    Organization: Society of Nuclear Medicine and Molecular Imaging
    Date: 08/01/2013
    Comment:

    August 1, 2013

    Louis Jacques, M.D.
    Director, Coverage and Analysis Group
    Office of Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: CAG-00431N Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

    Dear Dr. Jacques:

    The Society of Nuclear Medicine and Molecular Imaging (SNMMI) appreciates the opportunity to comment on the

    More

    Tran, Ho Title: President and CEO
    Organization: National Council of Asian Pacific Islander Physicians
    Date: 08/01/2013
    Comment:

    The Centers for Medicare and Medicaid Services (CMS) announced in September 15, 2004 that the evidence was adequate to conclude that a 2-deoxy-2- [F-18] fluoro-D-glucose Positron Emission Tomography (FDG-PET) scan was reasonable and necessary in patients with documented cognitive decline of at least six months and a recently established diagnosis of dementia who meet diagnostic criteria for both Alzheimer's disease (AD) and fronto-temporal dementia (FTD). The test was approved by FDA,

    More

    polonsky, richard Title: private citizen
    Date: 08/01/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] was 83 when she was diagnosed with Alzheimer's. She refused to accept that

    More

    McDade, Eric Title: Assistant Professor
    Organization: University of Pittsburgh School of Medicine.
    Date: 08/01/2013
    Comment:

    In response to the Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N), I would first like to thank the member of the committee for what appears to be a well thought-out and comprehensive evaluation of the topic of CMS coverage of amyloid-base PET imaging. That being said I would like to provide the perspective of practicing Behavioral Neurologist faced with the often-difficult task of accurately identifying the cause

    More

    Johnson, Keith Date: 08/01/2013
    Comment:

    Louis B. Jacques, M.D.
    Director, CMS Coverage and Analysis Group
    Office of Clinical Standards and Quality (CMS/OCSQ)
    Centers for Medicare & Medicaid Services
    Louis.Jacques@cms.hhs.gov

    Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N) Submitted on behalf of The Amyloid Imaging Taskforce

    Dear Dr. Jacques:

    President Obama signed the National Alzheimer’s

    More

    Todd, Laurel L. Title: Managing Director, Reimbursement and Health Policy
    Organization: The Biotechnology Industry Organization (BIO)
    Date: 08/01/2013
    Comment:

    August 1, 2013

    BY ELECTRONIC DELIVERY

    Louis Jacques, M.D.
    Director, Coverage and Analysis Group
    Centers for Medicare and Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Jacques:

    The Biotechnology Industry Organization (BIO)

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    goodman md, ira Title: director- Compass Clinic
    Organization: Compass Clinic
    Date: 07/31/2013
    Comment:

    I have been a practicing adult neurologist for 30 years with my practice limited to the evaluation and treatment of people with memory disorders. I have seen our evaluation and treatment of these people evolve over the years and have shared with them and their loved ones the frustration and sadness from our inability to confirm specific diagnosis which if we could would very likely allow us to develop effective disease targeted treatments rather than the very limited symptomatic treatments

    More

    Naasan, Georges Title: Assistant Clinical Professor
    Organization: UCSF
    Date: 07/31/2013
    Comment:
    Amyloid scans have really improved clinicians ability to differentiate between Alzheimer's dsiease and other types of diseases, especially in atypica lpresentation such as logopenic aphasia, posterior cortical atrophy, early-onset Alzheimer's dsiease and differentiating from FTD. I think there needs to be a braod coverage of Amyloid scans as it is an invaluable tool for clinicians diagnostic accuracy. In my practice so far, I have had to rely on research obtained amyloid scan to verify

    More

    Shapiro, Garry Date: 07/31/2013
    Comment:

    I write in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] was a dynamic individual. A salesman all his life, he started a small electronic

    More

    Jadvar, Hossein Title: Associate Professor of Radiology; President, ACNM
    Organization: University of Southern California
    Date: 07/31/2013
    Comment:

    August 1, 2013

    Louis Jacques, M.D.
    Director, Coverage and Analysis Group
    Office of Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: CAG-00431N Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

    Dear Dr. Jacques:

    The American College of Nuclear Medicine (ACNM) appreciates the opportunity to comment on the Proposed Decision

    More

    Baker, Ronald Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    My family and I moved in with [PHI Redacted] when she was diagnosed with this horrofic disease

    More

    Mocherla, Bobby Title: MD
    Organization: Las Vegas Radiology
    Date: 07/31/2013
    Comment:

    I am the director of Nuclear Medicine at Las Vegas Radiology which is an outpatient imaging facility. Our imaging site works with the local physicians providing health care to some of the underprivilaged communities. We had the privilege to offer amyvid PET scans to some of our patients under a clinical trial. In my opinion which is based on the input I received from the referring physicians, a negative Beta amyloid PET scan has a powerful impact on patient management, most often leadi

    More

    Cohen, Daniel Title: Physician
    Organization: Sentara Healthcare/Eastern Virginia Medical School
    Date: 07/31/2013
    Comment:
    I am a neurologist with sub-speciatly board certification in Behavioral Neurology. I mostly see patients with cognitive disorders. In patients that are rapidly progressive or have other atypical features, the diagnostic question of whether their impairment is related to neurodegenerative pathology versus non-degenerative pathology is a pressing clinical matter, generally more so than defining which neurodegenerative disease a patient has. Autoimmune/paraneoplastic limbic encephalitis is in the

    More

    Press, Daniel Title: Staff neurologist
    Organization: Beth Israel Deaconess Medical Center
    Date: 07/31/2013
    Comment:
    I am a cognitive neurologist at Beth Israel Deaconess Medical Center and an Assistant Professor of Neurology at Harvard Medical School. I run an active memory disorders group and can attest to how useful amyloid scanning would be in specific circumstances. For instance, patients who develop early onset memory impairment with some degree of behavioral symptoms pose a real challenge. I am often forced to do lumbar punctures to measure CSF Tau/Abeta to help distinguish between frontotemporal

    More

    Majcher, Jane Organization: GE Healthcare
    Date: 07/31/2013
    Comment:

    July 31, 2013

    Louis Jacques, MD,
    Director
    Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: Request for Public Comment for Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Jacques:

    GE Healthcare (GEHC) appreciates this opportunity to comment on the proposed decision memo

    More

    Cook, Claire Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    I knew something wasn't right with [PHI Redacted] over 10 years ago. We went through expensive

    More

    Crane, Donna Organization: none
    Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    PET imaging isn't the same as a CT Scan, it shows different things, it can give a clearer picture, it measures

    More

    Kasper, Ronald Title: Retired
    Organization: Retirred
    Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] suffered from dementia the last years of her life. She was not prepared for

    More

    Kindred, Sandra Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] had Dementia. At first one doctor said she had "sundowner's syndrome". T

    More

    Caplan, David Date: 07/31/2013
    Comment:

    Beta amyloid scanning will help enormously in early diagnosis of AD. This will provide guidabce to families in planning that will have important economic benefits to families and government agencies tha support AD patients. I suggest that this canning be made available now

    David Caplan, MD, PhD
    Director,
    Behavioral/Cognitive Neurology
    Massachusetts General Hospital
    Professor of Neurology
    Harvard Medical School

    Rayborne, Scott Organization: AmConDev
    Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] had Alzheimers before she passed away. But figuring that out was was ridiculously

    More

    Ellison MD MPH, James Title: Director, Geriatric Psychiatry
    Organization: McLean Hospital
    Date: 07/31/2013
    Comment:
    As we strive toward earlier and more secure diagnosis of cognitive impairment, amyloid imaging is one of the most promising tools developed to date. I support greater availability of this tool to our patients for appropriate clinical use.
    osburn, gina Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted]
    She has always been physically active and an amazing teacher. In the past 3

    More

    stegelman, jan Date: 07/31/2013
    Comment:
    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story: [PHI Redacted] has dementia or alzheimers - we don't know which- but is being treated for the alzheimers

    More

    Kuo, Phillip Date: 07/31/2013
    Comment:
    Our multi-disciplinary dementia team has had excellent experience with amyloid imaging in the clinical setting. The scans have been useful in confirming amyloid deposition in patients with MCI. Just as importantly or more so, we have ruled out AD with negative amyloid imaging in patients in their 80's who were thought almost certainly to have AD. This imaging can have great impact on patient care when used properly.
    Rizzo, Melba Date: 07/31/2013
    Comment:

    [PHI Redacted] has been diagnosed with early Dementia. He has a pacemaker, ruling out an MRI. Does this also prevent his from availing the use of PET scan? Also, would this procedure benefit a positive diagnosis?

    Melba Rizzo
    Marks, Donald Title: Clinical Neurologist
    Organization: Donald S. Marks, M.D., P.C.
    Date: 07/31/2013
    Comment:

    The current CMS decision, while presented under the banner of "more clinical trials needed" is at odds with recommendations made by the Amyloid Imaging Task Force, a collaborative effort by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI). I am not a member of this task force, but a community-based clinical neurologist who has spent 25 years in a practice focused on dementia patients. Out of the several hundred probable AD patients currently

    More

    Axelson, David Title: citizen
    Date: 07/31/2013
    Comment:
    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story: Alzheimer's medications are still very expensive and probably ineffective for other types of dementia (i.e. Lewy Body,

    More

    DePalma, Brenda Date: 07/31/2013
    Comment:

    This is a response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here are my comments:

    Delaying the more definite diagnosis of Alzheimer's versus another condition by requiring more evidence seems odd

    More

    Billie, Catherine Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] has attained the age of 100 years...about 6 years ago she began having

    More

    Duffield, Amy Title: N/A
    Organization: N/A
    Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] primary care physician kept telling her that her first signs of memory loss were

    More

    Gresh, Kathleen Date: 07/31/2013
    Comment:
    I am writing to urge the Centers for Medicare and Medicaid not to delay in coering the cost of the Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease. [PHI Redacted] suffered from progressive dementia for over 12 years. Her doctors could not tell us if the dementia was caused by Alzheimer's disease or another form of neurodegenerative disease. With new research and discovery in the causes of dementia, I believe it is important to diagnose and

    More

    Trenner, Anita Date: 07/31/2013
    Comment:
    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story: [PHI Redacted], a genius and a very talented artist, was gripped by Alzheimer's disease a full ten years

    More

    Savell, Sandra Date: 07/31/2013
    Comment:
    First I watched [PHI Redacted] die of Alzheimer's. Then [PHI Redacted]. Then an [PHI Redacted]. When I began going to the doctor with [PHI Redacted], they would not say the words "Alzheimer's" but they would prescribe drugs to combat it. [PHI Redacted] thought the doctors were crazy and refused to take the drugs. I was [PHI Redacted] caregiver for 8 years before she died of Alzheimer's. I have

    More

    Lura, Chris Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    The side-effects of drugs to treat [PHI Redacted] cognitive condition are devastating and

    More

    Anderson, Carolyn Title: Professor of Radiology
    Organization: University of Pittsburgh
    Date: 07/31/2013
    Comment:
    As current Past-President of the Center for Molecular Imaging Innovation and Translation of the SNMMI and a molecular imaging researcher, I am very concerned regarding the decision by CMS to restrict the use use of florbetapir for positron emission tomography imaging of Alzheimer's disease (AD). Florbetapir has been FDA approved and shown in several clinical trials to validate the presence of beta amyloid plaques, allowing for the appropriate diagnosis and treatment options for patients with

    More

    Jones, Judy Date: 07/31/2013
    Comment:

    I am writing in supprt of making diagnostic testing available quickly to families that may have members with Alzheimer's.

    [PHI Redacted] had Alzheimer's. For the first years, her friends and family thought she was a secret alcoholic. She got a lot of criticism from all of us, instead of getting support in helping her deal with her disease.

    Prior to that, [PHI Redacted] also had Alzheimer's. This took a long time to diagnose as it was

    More

    Carey, William Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] Medicare needs to cover this procedure. It is beyond the means of most

    More

    Kofford, Todd Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    [PHI Redacted] was diagnosed with Alzheimer's several years ago. He went from being the vice

    More

    Auer, Jeanne Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    Both [PHI Redacted] suffer/ed from dementia related diseases. We still aren't sure that

    More

    Cardillo, Beth Title: Executive Director
    Organization: Armbrook Village (551 North Road, Westfield, Ma) n
    Date: 07/31/2013
    Comment:
    I understand Medicare is declining to offer coverage for an FDA approved PET imaging technique that could potentially help seniors with Mild Cognitive Impairment. I am distressed about this as many people with MCI can get help faster if they were properly diagnosed which would 1. Improve the quality of life for those affected and 2. Lessen the cost for families, insurance, state insurance in the long run if proper diagnosis and treatment were determined earlier. Please make sure that medicare

    More

    Higgins, Susan Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story:

    I am a Dementia Care Giver Survivor. [PHI Redacted] was diagnosed with Parkinson's with

    More

    Benzinger, Tammie Title: Radiologist
    Organization: Washington University School of Medicine
    Date: 07/31/2013
    Comment:
    I am a clinical neuroradiologist and Alzheimer's disease (AD) researcher. The ability to perform Amyvid scans in the setting of complex dementia would offer an important improvement in the care of my patients. I am dismayed that the current CMS proposal will limit the use of this test to my patients who are wealthy or those who are willing to join particular clinical trials. In my clinical practice, I receive daily consultations for the workup of patients with complex dementias. Sadly, the

    More

    Rosing, Lisa Joy Date: 07/31/2013
    Comment:

    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is.

    My very close relative is suffering. Her dementia is worsening and I am slowly loosing her. Amyloid PET imaging would have

    More

    Christian, Michele Date: 07/31/2013
    Comment:
    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care. I want to tell you how difficult this is here is my story: [PHI Redacted] was a smart, energetic nurse practitioner, one of the first in the state of Massachusetts

    More

    Bhatia, MD, Manoj Organization: Lake Medical Imaging & Vascular Institute
    Date: 07/31/2013
    Comment:

    July 31, 2013

    Joseph Hutter, MD, MA
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Hutter:

    As a board certified Radiologist with Lake Medical Imaging, which serves a patient base comprised primarily of Medicare patients, I have extensive experience with

    More

    Kainz, MD, George E. Organization: Lake Medical Imaging & Vascular Institute
    Date: 07/31/2013
    Comment:

    July 31, 2013

    Joseph Hutter, MD, MA
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Hutter:

    I am writing to ask you to support the request that CMS revise Section 220.6 of the National Coverage Determination (NCD) Manual and potentially cover PET tracers that image

    More

    Keller, MD, Cathrine E. Organization: Lake Medical Imaging & Vascular Institute
    Date: 07/31/2013
    Comment:

    July 31, 2013

    Joseph Hutter, MD, MA
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Hutter:

    As a board certified Radiologist with Lake Medical Imaging, which serves a patient base predominantly comprised of Medicare patients, I am writing to ask you to

    More

    Patel, MD, Romil Y. Organization: Lake Medical Imaging & Vascular Institute
    Date: 07/31/2013
    Comment:

    July 30, 2013

    Joseph Hutter, MD, MA
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Hutter:

    I am writing to ask you to support the request that CMS revise Section 220.6 of the National Coverage Detennination (NCD) Manual and potentially cover PET tracers that image

    More

    Silverman, MD, PhD, Dan Title: Head, Neuronuclear Imaging Section/Professor, Depa
    Organization: Ahmanson Translational Imaging Division/Executive Committee, UCLA Alzheimer's Disease Research Center
    Date: 07/31/2013
    Comment:

    As several comments posted here have implied or asserted that Amyvid (florbetapir) and other amyloid imaging radiotracers have diagnostic specificity that can be used to assess whether a patient's cognitive symptoms are due to Alzheimer's disease, it is worthwhile to examine what the peer-reviewed published literature actually has reported concerning this assertion.

    It turns out despite explicit statements made in this forum claiming that amyloid imaging "can provide sensitive and

    More

    Larkin, Robert Title: President
    Organization: Senior Living Residences / Compass Memory Support Asst'd. Living
    Date: 07/30/2013
    Comment:

    As a 20-year, non-medical,provider of assisted living care to many hundreds of seniors with both diagnosed and undiagnosed forms of dementia, and as one who lost [PHI Redacted] to Alzheimer's disease, I am writing to urge your most thorough reconsideration of the draft CMS decision to withhold Medicare coverage for florbetapir F18 PET in dementia and other neurodegenerative diseases.

    The waste and tragedy of dementia is compounded by the failure to diagnose it,

    More

    Vassey, Elizabeth Title: Associate Director
    Organization: Boston Center for Memory
    Date: 07/30/2013
    Comment:
    This scan is critical for the health of these patients. As a diagnostician in a memory center who has considerable experience with the Avid scan, it is my impression it is enormously helpful in reaching a diagnosis and in developing an efficacious treatment plan. With all do respect, I urge CMS to reconsider their decision.
    Clelland, Tadd Date: 07/30/2013
    Comment:
    I support Medicare reimbursement for F18 PET scans.
    Moreno, Monica Organization: The Alzheimer’s Association National Early-Stage Advisory Group
    Date: 07/30/2013
    Comment:

    Louis Jacques, M.D.
    Director, Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Jacques:

    Thank you for the opportunity to comment on the Center for Medicare & Medicaid

    More

    Noto, Richard Date: 07/30/2013
    Comment:
    As a physician who has utilized beta amyloid PET imaging as part of multiple research projects, I am writing to ask CMS to reconsider the Coverage with Evidence Development (CED) requirements in the Proposed Decision Memo for Beta Amyloid PET in Dementia and Neurodegenerative Disease. It has already been clearly established that this exciting technology can make a significant impact on patient management decisions in the correct clinical settings and it is not appropriate to limit the

    More

    Dubroff, Jacob Title: Assistant Professor of Radiology
    Organization: University of Pennsylvania
    Date: 07/30/2013
    Comment:

    Alzheimer’s Disease (AD) is an increasingly important health problem in the US. Amyloid beta is the most widely recognized marker of Alzheimer Disease (AD), and many even believe it is a causal factor. Amyloid plaques are associated with neuronal damage that can eventually lead to profound dementia in a subset of patients. Positron Emission Tomography (PET) using imaging agents designed to measure amyloid plaque deposition has been shown to be an accurate, safe, and effective method for

    More

    Agarwal, Rajan Title: Radiologist
    Organization: Radiology Group Of Abington
    Date: 07/30/2013
    Comment:
    As a board certified diagnostic and nuclear radiologist who practices in the community setting, I was very disappointed by the recent CMS decision on PET Amyloid Imaging. My patients, and possibly loved ones in the future, will be denied access to this ground breaking technology that for the first time can non-invasively diagnose the presence of Amyloid plaques in the brain. Currently the diagnosis of Alzheimer's disease is made incorrectly about 20% of the time; and this new test would

    More

    Weisman, David Date: 07/30/2013
    Comment:

    As a front line neurologist with sub-specialty training and interest in AD, I'd like to write a letter in support of your decision on PET imaging.

    1. Many academics seemingly have no clue how tests in general are over-utilized, and seem particularly blind to the potential over-utilization of amyloid molecular imaging. Once this test is paid for by society at large, it will be massively overused and will not be tethered to clinical trials. Instead it will be pushed by those in the

    More

    Armstrong, Evan Title: PET/CT Technologist
    Organization: VRI-Radnet Inc
    Date: 07/30/2013
    Comment:

    The medical community in my area finds it beneficial, but the price prevents them from ordering the exam

    More accurate diagnosis and decreasing unnecessary tests.

    Can be used in the management of the patient

    Weiner, Michael Title: Professor
    Organization: University of California, San Francisco
    Date: 07/30/2013
    Comment:

    I provide public comment as a Professor of Radiology at the University of California, San Francisco who has been performing clinical research concerning Alzheimer’s disease for the past 25 years, as the Principle Investigator of the NIH funded Alzheimer’s Disease Neuroimaging Initiative, and as [PHI Redacted] with advanced dementia probably due to Alzheimer’s disease.

    I’m extremely disappointed that “The Centers for Medicare & Medicaid Services (CMS) proposes that

    More

    Brown, Francis Date: 07/30/2013
    Comment:
    I am writing in response to your proposed decision to require more evidence development before you make PET imaging available to people who may have Alzheimer's. This is the wrong decision. The FDA has approved this technology. People who face a diagnosis of Alzheimer's deserve to have it brought to their care.
    Frank, MD, PhD, Richard Title: Chief Medical Officer
    Organization: Siemens Medical Solutions, USA Inc.
    Date: 07/29/2013
    Comment:

    July 30, 2013

    Louis B. Jacques, MD
    Director, Coverage & Analysis Group
    Centers for Medicare and Medicaid Services
    Mail Stop S3-02-01 7500 Security Boulevard
    Baltimore, MD 21244-1850

    RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dr. Jacques:

    On behalf of Siemens Medical Solutions USA, Inc. and Siemens’ PETNET Solutions, thank

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    Stephens, MD, Ph.D., Andrew Title: VP, Clinical Research and Development
    Organization: Piramal Imaging
    Date: 07/29/2013
    Comment:

    July 29, 2013

    Louis Jacques, MD
    Director, Coverage and Analysis Group
    Centers for Medicare and Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: Piramal Imaging Provides Comments to the Proposed Decision Memo for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Jacques:

    Piramal Imaging thanks the Centers for Medicare and Medicaid Services (CMS) for releasing a

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    Critelli, Michael Date: 07/29/2013
    Comment:
    I believe strongly that, since this is now an FDA approved treatment, it should be a covered service under CMS. CMS ultimately sets the pace for private insurance, so the CMS decision will have profound consequences.
    Cummings, Jeffrey Title: Director, Cleveland Clinic Lou Ruvo Center for Bra
    Organization: Cleveland Clinic
    Date: 07/29/2013
    Comment:

    CMS reviewers:

    I support the Appropriate Use Criteria for amyloid PET developed by the Soc for Nuclear Medicine and Molecular Imaging, Alzheimer's Association, and many informed scientists and clinicians working in Alzheimer's disease (AD) research and care.

    The availability of a diagnostic-support test for symptomatic patients is critically important. Autopsy and clinical studies show a high rate of misdiagnosis of AD with resulting improper management decisions.

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    Lanata, Serggio Date: 07/29/2013
    Comment:
    PET amyloid imaging represents a stepping stone in the field of neurodegenerative disease biomarker tools. Although it's diagnostic utility in the clinical setting has bot been fully determined yet, there is clear anecdotal evidence of it's value in diagnosing atypical or mixed cases of suspected neurodegenerative disease. More work needs to be done in this field, and for this reason I strongly support CMS approving coverage for amyloid PET imaging in appropriate patients with dementia.
    Gardner, Raquel Title: Clinical Instructor
    Organization: University of California, San Francisco
    Date: 07/29/2013
    Comment:
    As a behavioral neurologist and dementia clinical researcher, I appreciate this opportunity to encourage the Centers for Medicaid and Medicare Services (CMS) to reconsider their decision regarding coverage for beta-amyloid PET scans. Despite the lack of effective disease modifying therapy for Alzheimer's disease at this time, beta-amyloid PET scans still have significant clinical importance for diagnosis, management (choice of medications), and, perhaps most importantly, for family, estate,

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    Djekidel, Mehdi Date: 07/29/2013
    Comment:

    I thank CMS for the opportunity to comment on this memo decision related to Amyvid clinical coverage. I respectfully disagree with the decision. As pointed out in the memo and AIT report, poor quality of care is achieved from high levels of uncertainty in the clinical diagnosis of AD as is the current practice. The AIT report pointed out also that the survey from Harvard found that more than half of dementia patients have no established diagnosis (quite unacceptable). Amyvid would improve

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    Lah, James Title: Associate Professor
    Organization: Emory University
    Date: 07/29/2013
    Comment:

    As a neurologist caring for patients with dementias and as a researcher in the field, I have considerable interest in evolving biomarker tools, including brain amyloid imaging. As a taxpayer and citizen, I have concerns about the financial impact that may come from making new imaging tools broadly available. Amyloid PET ligands are indeed useful, but must be applied thoughtfully and judiciously. A test of comparable or greater diagnostic utility is already available through CSF examination

    More

    Saba, Najib Title: Medical Director
    Organization: Broward PET Imaging Center
    Date: 07/29/2013
    Comment:
    I strongly support the SNMMI position regarding the beta amyloid PET in dementia and neurodegenerative disease . I beleive that Medicare eligible patients under the Alzheimer's association and SNMMI guidlines should have a covered access to the imaging test without the CED limitations .
    Messer, Guy Title: Principal/CFO
    Organization: Trident Medical Imaging
    Date: 07/29/2013
    Comment:
    The recent proposed CMS decision to cover Amyloid Plaque brain imaging under CED should be reversed and the coverage for Ab imaging should be similar to the already approved coverage guidelines that exist for FDG. CMS has already approved FDG imaging for the evaluating dementia that mat be caused by AD vs. Frontaltemporal Dementia. Ab imaging is much easier to interpret and will provide better patient care and outcomes for the patients involved. Given the already approved use of FDG in

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    Perkins, Larry Date: 07/29/2013
    Comment:
    [PHI Redacted] effected by Alzheimers, I urge the panel to reconsider its decision to not allow Medicare coverage of FDA approved florbetapir F18 PET for patients with cognitive impairment. This is a very important diognostic tool!
    Pryma, Daniel Date: 07/29/2013
    Comment:

    Alzheimer’s Disease (AD) is an increasingly important health problem in the US. Prevention and treatment of this disease depends critically on our ability to make an early and specific diagnosis. Because the neurodegeneration that occurs in AD is irreversible, early diagnosis is absolutely critical. Positron Emission Tomography (PET) using imaging agents designed to measure amyloid plaque deposition, an early indicator of AD pathology, has been shown to be an accurate, safe, and

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    Mandell, MD, Alan Title: Assistant Professor of Neurology and Psychiatry
    Organization: Boston University School of Medicine
    Date: 07/29/2013
    Comment:

    I am a behavioral neurologist with over 30 years clinical experience, in both VA Medical Centers and in academic institutions, in evaluating and, when possible, treating patients with a variety of dementia syndromes. Treating patients also means, in most cases, treating their families.

     Most patients over 70 years of age harboring a degenerative dementing disease present symptomatically with the clinical syndrome of "Dementia of the Alzheimer type (DAT)," and a large

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    Charney m.d., A.S. Date: 07/29/2013
    Comment:
    Having been involved with amyloid imaging for several years-I think it is a mistake not to include coverage to help with the diagnosis of AD verses other dementia-just being able to make early diagnosis or to differentiate the dementia can potentially save CMS millions of dollars each year- if we can potentially slow the progress with early intervention- -A.S.Charney m.d.
    Barton, Cynthia Title: Nurse Practitioner III
    Organization: UCSF Memory and Aging Center
    Date: 07/28/2013
    Comment:
    As a nurse practitioner providing care to patients at an academic medical center in both research and clinical venues, I appreciate the need for evidence-based practice and the careful evaluation of re-imbursement for new technology. Our center is involved in the evaluation of patients with more atypical dementias, especially FTD and the clinical diagnosis can be challenging. The road to accurate diagnosis is often a long and frustrating one for patients and families, leading them to multiple

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    Gandy, Sam Title: Professor of Neurology and Psychiatry
    Organization: Icahn School of Med & Alzheimer Dis Rsrch Ctr at Mount Sinai
    Date: 07/28/2013
    Comment:

    I have and continue to experience the tragedy of Alzheimer's disease as a caregiver, as a physician, and as a laboratory scientist. Given the emotional and economical impact of dementia, the notion that reimbursement of the breakthrough technology of amyloid imaging will be denied is, frankly, stultifying.

    The role of the physician as diagnostician is just as important as the role as healer. Amyloid scanning enables diagnostic precision and accuracy heretofore not available to

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    Vossel, Keith Title: Assistant Professor of Neurology
    Organization: University of California, San Francisco
    Date: 07/28/2013
    Comment:

    As a behavioral neurologist who cares for patients suffering from dementia, I greatly value the information provided by beta amyloid-PET imaging. I see patients who are diagnostically challenging and need amyloid-PET imaging to determine if their dementia is most likely due to Alzheimer's disease or a non-Alzheimer's dementia. Patients are much more likely to agree to PET imaging than a lumbar puncture. Amyloid-PET imaging results help me to decide on the most appropriate therapy for my

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    Solomon, Paul Title: Clincal Director
    Organization: Boston Center for Memory
    Date: 07/28/2013
    Comment:
    We have had the opportunity to use amyloid imaging in a research setting for the past 5 years. During this time we have had the opportunity to scan more than 100 patients. This experience had led us to the conclusion that amyloid imaging is a very important part of the diagnostic process. amyloid imaging leads not only to more accurate diagnosis, but to earlier diagnosis. Early and accurate diagnosis leads to significantly better management and treatment of patients with Alzheimer's

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    Wallack, Max Date: 07/28/2013
    Comment:
    As an Alzheimer's researcher and aspiring physician, I urge the panel to reconsider this decision. Beta-amyloid PET imaging could lead to earlier diagnosis and treatment of this disease at an earlier stage. In addition, it would be beneficial in many cases where AD might be ruled out, avoiding extensive, costly, and potentially harmful treatments and encouraging physicians to seek alternate diagnoses.
    Mankoff, David Title: Professor of Radiology; Nuclear Medicine Chief
    Organization: University of Pennsylvania
    Date: 07/28/2013
    Comment:

    Alzheimer’s Disease (AD) is an increasingly important health problem in the US. Prevention and treatment of this disease depends critically on our ability to make an early and specific diagnosis. Positron Emission Tomography (PET) using imaging agents designed to measure amyloid placque deposition, an early indicator of AD pathology, has been shown to be an accurate, safe, and effective method for early diagnosis of Alzheimer’s disease (Clark, J Am Med Assoc. 2011, 305: 275) and has

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    DeKosky, Steven Title: Vice President and Dean
    Organization: University of Virginia School of Medicine
    Date: 07/27/2013
    Comment:
    I have been a researcher in dementia and Alzheimer's Disease for over 30 years. I've been involved in the development of clinical trials, and neuropathological validation of the first amyloid imaging agent Pittsburgh Compound B (PiB), and have had extensive experience using such compounds in research, in particular for difficult cases. I strongly urge an approval for use of these agents for use by clinicians, with appropriate restrictions to assure appropriate use, but not so strict as to make

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    Jagust, William Date: 07/27/2013
    Comment:

    I understand that the CMS has issued a negative decision about coverage of amyloid PET imaging. I am a neurologist who has been caring for patients with dementia and studying dementia for over 25 years. While I am sure that the CMS decision was well reasoned, there are a few points I would like to bring to your attention.

    1. FDG-PET is now approved by CMS for the differentiation of Alzheimer’s disease and Frontotemporal lobe dementia. However, FDG-PET has no biochemical

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    Wagner, Robert Date: 07/27/2013
    Comment:

    I am a physician located at an academic medical center and have had significant experience with interpretation of this study.

    The greatest benefit of this study is to provide additional data to support an earlier diagnosis of AD or to exclude the presence of AD. Exclusion of AD is particularly important since it allows the clinician to pursue other avenues of treatment, some of which may result in improved performance. When significant amyloid plaque is found AND the symptoms of

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    Littlejohn, Diane Date: 07/26/2013
    Comment:
    Beta Amyloid PET should continue to be covered, to aid in the diagnosis of Alzheimer's disease and early-onset dementias. Early detection is key in the patient starting medication to slow the progression of the disease. In my case, my loved one was misdiagnosed with Alzheimer's disease, when his actual problem is frontotemporal dementia. PET imaging would have been helpful in obtaining a proper diagnosis, and in turn, selecting appropriate medication, behavior modifications (e.g. driving

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    Robinson, Gale Title: Averag citizen
    Date: 07/26/2013
    Comment:
    As one of millions who will surely need the care (Some sooner than others) provided by results found through this testing and use, please do not remove these tests and programs from Medicare and any other possible support system.
    Ham, Peter Date: 07/26/2013
    Comment:
    I urgently support the use of Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative disease. For the last 9 years, I have facilitated and early stage support group for the Alzheimer's Association. The participants strongly advocate for research which will aid in the better detection of a dementing illness to provide for better care and support for those diagnosed. The use of the beta amyloid marker for PET scans with thoughtful consent will advance the care and support

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    Simmons-Stern, Nicholas Title: Research Assistant
    Organization: The Center for Translational Cognitive Neuroscience
    Date: 07/26/2013
    Comment:

    To whom it may concern:

    As an Alzheimer's researcher and family member of patients suffering from Alzheimer's disease, I STRONGLY urge you to reconsider your non-coverage decision for florbetapir F18 PET (Amyvid). This biomarker product has the potential to reinvigorate an Alzheimer's community that is distraught after the failures of bapinuzimab, solenuzemab, and other promising drugs last year. It has the potential to stimulate the crippled AD pipeline. It has the potential to

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    Vellante, Beth Title: Executive Director
    Organization: Stonebridge at Burlington
    Date: 07/26/2013
    Comment:
    As a professional who has worked with individuals and family members battling Alzheimer's disease for the past 35 years, I strongly urge the panel to reverse its decision. We can not afford to waste valuable time by taking a giant step backward. These are critically important diagnostic tools. To deny most patients access to them would be unreasonable and unfair. We need this now!
    Holbrook, Alan Title: Volunteer Advocate and Care Giver
    Date: 07/26/2013
    Comment:
    Many professionals in the field of dementia care and dementia research have already provided learned arguments for coverage of this technology as a diagnostic tool. As a caregiver and a volunteer advocate with the Alzheimer's Association, I would like to give you the layman's perspective. Any procedure that adds to the ability of the physician and caregiver to more knowledgeably intervene and participate earlier in the treatment of a loved one's disease will provide incalculable benefit in

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    Morin, Kristen Organization: Northbridge Companies
    Date: 07/26/2013
    Comment:
    We are professionals working in the field directly with individuals and families battling Alzheimer’s Disease. It is imperative for these families to continue to receive all of the help that can possibly be provided. We need to continue to care for those who are already impacted by this devastating disease, learn more about it, expedite potential improvements from a treatment standpoint, and hopefully more effectively help prevent others from the same suffering. We need this now.
    Dickinson, Susan Title: Executive Director
    Organization: The Association for Frontotemporal Degeneration
    Date: 07/26/2013
    Comment:

    July 26, 2013

    Louis Jacques, MD
    Director, Coverage and Analysis Group
    Center for Medicaid and Medicare Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: Proposed Decision Memorandum for : CAG-00431N
    Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

    Dear Dr. Jacques,

    On behalf of the Association for Frontotemporal Degeneration, we are writing in response to the preliminary decision on

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    Robinson, Diane Date: 07/26/2013
    Comment:
    I am a professional working in the field directly with individuals and families battling Alzheimer’s Disease. It is imperative for these families to continue to receive all of the help that can possibly be provided. We need to continue to care for those who are already impacted by this devastating disease, learn more about it, expedite potential improvements from a treatment standpoint, and hopefully more effectively help prevent others from the same suffering. We need this now.
    Kopits, Ilona Date: 07/26/2013
    Comment:
    It is important to continue to have these types of tests/imaging available (and covered) for the continued work in prevention and treatment of various dementias. I support the coverage of this test by Medicare.
    Wint, Dylan Title: Director, Education in Neurodegeneration
    Organization: Cleveland Clinic
    Date: 07/26/2013
    Comment:
    A massive amount of money is wasted on patients who are diagnosed with Alzheimer disease but do not have it. I would suggest that, instead of a blanket refusal to cover, CMS develops criteria for which exams should be covered. For example, an 80 year-old presenting with an amnestic disorder does not need amyloid imaging; the likelihood of positive imaging (which is nonspecific) is absurdly high. However, a 55 year-old presenting with cognitive disturbance and no conclusive diagnosis after MRI,

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    Bernick, Charles Organization: Cleveland Clinic
    Date: 07/26/2013
    Comment:
    As a clinician at a very busy memory disorders clinic, I strongly support CMS coverage of PET amyloid imaging, particularly in certain clinical circumstances. As it is pointed out in your Decision Summary, there is sufficient evidence that PET amyloid imaging can be very useful in the differential diagnostic process. In line with other comments, patients with young onset dementia, atypical presentations or comorbid conditions such as cerebrovascular disease present difficult diagnostic

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    Mercier, Gustavo Title: Chief, Molecular Imaging and Nuclear Medicine
    Organization: Boston Medical Center
    Date: 07/26/2013
    Comment:

    Thank you for the opportunity to comment on the recent decision of CMS not to cover Beta Amyloid PET Imaging.

    I support the response from the Society of Nuclear Medicine and Molecular Imaging, but I would like to add to their statement.

    Given the need to distribute limited financial resources across a group of beneficiaries, it would behoove CMS to review procedures that are approved for reimbursement but may not warrant it in light of new evidence.

    To

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    Cook, Sandra Date: 07/26/2013
    Comment:

    The decision to drastically limit amyloid imaging is in direct conflict with what President Obama's Administration called its “historic effort to fight Alzheimer’s disease”.

    In the preliminary determination, the CMS discussion sadly revolves around a very simplistic and one-sided point - no data exists to support that a positive scan may change a physician’s algorithm of treatment. It may be true that a confirmatory study may not dramatically change the course of treatment, but

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    Rodriguez, Ph.D., Gail M. Title: Executive Director
    Organization: Medical Imaging & Technology Alliance
    Date: 07/26/2013
    Comment:

    July 26, 2013

    By electronic mail

    Louis Jacques, MD
    Director
    Coverage and Analysis Group
    Centers for Medicare and Medicaid Services
    Mail Stop S3-02-01
    7500 Security Blvd.
    Baltimore, MD 21244

    Re: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Jacques:

    The Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on

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    Forester, Brent Date: 07/25/2013
    Comment:

    I am a practicing geriatric psychiatrist, medical educator and clinical researcher. The technology of amyloid PET imaging will allow for the identiation of beta amyloid pathology for individuals showing signs of memory decline. This technology is not approriate for widespread clinical use at this time. However, for those individuas meeting The Society of Nuclear Medicine and Molecular Imaging and the Alzheimer’s Association Amyloid Imaging Taskforce's (AIT) recently published appropriate

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    Sadowsky, Carl Title: Prof. of Clinincal Neurology, Nova SE University
    Organization: Palm Beach Neurology
    Date: 07/25/2013
    Comment:

    I am a clinician who has had extensive experience with amyloid PET scan imaging of the brain. Amyloid imaging clearly has a significant impact on differential diagnosis and treatment decisions.

    I think this technology is extremely helpful in patients with mild cognitive impairment and clearly affects treatment. Patients with a negative amyloid scan have a very low risk for developing Alzheimer's disease and do not require treatment. Patients with a positive scan have high risk for

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    Pascual-Leone, Alvaro Date: 07/25/2013
    Comment:
    There are definitely scenarios (fopr example MCI to determine who might be at great risk of AD and who not, posterior cortical atrophy patients to sort between CBD and AD, PPA patients to sort out if its AD vs. Tau/TDP, etc) where this scan would be extremely helpful and even save patients LP's and other more invasive testing and del;ayed diagnosis
    Galaburda, Albert Title: Professor of Neurology
    Organization: Beth Israel Deaconess Medical Center/Harvard Medical School
    Date: 07/25/2013
    Comment:
    Scientists have worked very hard to develop a clinical marker of amyloid deposition, which can help tell apart disorders with markedly different treatments and prognosis. It is imperative that the government and private health insurance payers agree to pay for this important clinical test and thus serve patients properly.
    Whelihan, William Title: Clin. Associate Professor
    Organization: Brown University
    Date: 07/25/2013
    Comment:
    As a board-certified clinical neuropsychologist who specializes in care of the elderly, I urge the panel to reconsider its decision to not provide coverage for diagnostic PET imaging for patients who may have an early-stage neurodegenerative disorder. The Alzheimer’s Association and Society for Nuclear Medicine and Molecular imaging have already provided appropriate use criteria for amyloid imaging that would establish reasonable guidelines for use of this procedure. These include: 1)

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    Silverman, Dan Title: Head, Neuronuclear Imaging Section; Professor
    Organization: University of California, Los Angeles
    Date: 07/25/2013
    Comment:

    "If fifty million people say a foolish thing, it is still a foolish thing."

    —Anatole France, Nobel Prize Laureate, 1921
    Basso, Danny Date: 07/25/2013
    Comment:
    As a health care provider and someone with family members suffering from dementia, I can assure you that Beta Amyloid PET imaging will affect outcomes and treatment. CMS should broaden it's approved coverage. Please reconsider your proposed coverage.
    Budson, Andrew Title: Associate Director
    Organization: Boston University Alzheimer's Disease Center
    Date: 07/25/2013
    Comment:
    To refuse to pay for a test that can diagnose Alzheimer's disease non-invasively with high accuracy makes no sense, and brings up the question of agism. We wouldn't hesitate to pay for such a test if the population in question was younger. The beta amyloid PET scan should be paid for.
    O'Donnell, James Title: Director, Nuclear Medicine
    Organization: Case Medical Center, University Hospitals of Cleveland
    Date: 07/25/2013
    Comment:
    Having experienced Alzheimer's dementia in unfortunate family members and friends, and having participated in ADNI F-18 florbetapir clinical imaging trials as a Nuclear Medicine physician, I attest that this PET-CT imaging procedure is extremely helpful and relevant in appropriate populations as determined by a referring Neurologist. Although certainly not a screening test, it clearly adds incremental differential clinical information and changes patient management often as documented in the

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    Karvelis, Kastytis Title: Director of Nuclear Medicine
    Organization: Henry Frod Health System
    Date: 07/25/2013
    Comment:

    I appreciate the opportunity to comment on the Proposed Decision Memo for Beta Amyloid PET in Dementia and Neurodegenerative Disease. I believe that ample evidence exists to support immediate coverage, which would change patient management, lead to better health outcomes for patients and assist families making care decisions. The following are some items you should consider carefully:

    Coverage with evidence development (CED), as proposed, is not appropriate for Aß imaging, which

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    Pounds, Thomas Date: 07/25/2013
    Comment:
    Amyvid is very useful to help differentiate causes of dementia which leads to treatment of patients with appropriate medications which differ depending on the underlying causes. Science has already proved this.
    Villemagne, Victor Date: 07/24/2013
    Comment:

    Dear Dr. Hutter:

    I have worked in the area of amyloid imaging with PET for the last 10 years, with extensive experience using 11C-PiB and four of the 18F labelled amyloid tracers. The introduction of amyloid imaging was a revolutionary step that allowed not only the non invasive assessment of brain pathology in vivo, but also the assessment of changes in amyloid burden over time.
    The approval of Amyvid for clinical use by the FDA was a pivotal step in translating several years

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    Rowe, Christopher Title: Professor of Medicine
    Organization: Austin Health and University of Melbourne
    Date: 07/24/2013
    Comment:

    I am writing as a neurologist and nuclear medicine physician who is very active in clinical management of patients with cognitive decline and in Alzheimer’s disease research.

    The decision to severely restrict funding for amyloid PET imaging is of grave concern for many reasons. Firstly, it is based on the assumption that correct diagnosis and prognosis is not important when there is no proven treatment to slow disease progression. Correct diagnosis is the core of good medicine.

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    Rafii, Michael Title: Director, Memory Disorders Clinic
    Date: 07/24/2013
    Comment:

    Dr. Hutter and Ms. Barton,

    As a clinical researcher, it is clear from the published data that amyloid PET imaging is invaluable as an adjunct to cognitive testing, volumetric MRI, and a comprehensive clinical assessment to further support a diagnosis of MCI due to AD, so called 'prodromal AD'. A positive amyloid scan will greatly strengthen a diagnosis of prodromal AD, whereas a negative scan will encourage deeper consideration of a whole host of other, less common

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    Price, Grant Title: Associated Radiologists
    Organization: Associated Radiologists
    Date: 07/24/2013
    Comment:

    1. We have had training in indications and interpretation, and have been reading this for about a year. We are excluded by this policy.

    2. Indications for scans are very clear, and the test is being ordered appropriately. We screen them carefully in any event.

    3. The NOPR is a longstanding and successful way to collect data on new indications for PET scanning. It should be used here.

    Pressman, Peter Title: Clinical Instructor
    Organization: UCSF Memory and Aging Center
    Date: 07/24/2013
    Comment:
    A decision against reimbursing amyloid PET could stunt a promising diagnostic tool not just for distinguishing Alzheimer's from frontotemporal dementia, but other diagnoses such as chronic traumatic encephalopathy. Please reconsider.
    Nelson, Alexandra Organization: University of California, San Francisco, Neurology Department
    Date: 07/24/2013
    Comment:
    I am a neurologist specializing in the diagnosis and treatment of neurodegenerative diseases, and have been following the research related to PIB scans for some years now. I have not had cause to use PIB scans for diagnosis of most patients I see with cognitive impairment, but I think it can be useful in a very limited set of circumstances, most prominently in patients with atypical presentations that make one concerned for frontotemporal dementia versus Alzheimer's disease. Since these two

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    Karageorgiou, Elissaios Title: Behavioral Neurology Fellow
    Organization: Memory and Aging Center, UCSF
    Date: 07/24/2013
    Comment:

    To all responsible parties:

    I write to argue against the recent draft on not reimbursing PET imaging in dementia workup and to urge you to reconsider your decision.

    I am a young neurologist who completed residency a month ago and who is currently pursuing a Behavioral Neurology Fellowship at UCSF. Reviewing the several comments already posted by leaders in the field, I am not the most experienced person in the field, but I have a passion for what I do and want to

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    Jaffe, Robert Title: MD
    Organization: Associated Radiologists
    Date: 07/24/2013
    Comment:

    In my own practice we have been doing Amyvid studies since they were publicly available. I was in the first group of trainees at the SNMMI in 2012. The study when negative is extremely useful to clinicians. The exam is straightforward in its interpretation. I have never had to give an ambiguous report. The impact of a negative exam on the patient workup is great. Other, perhaps more treatable causes of dementia can be searched for and much patient anxiety can be allayed. This exam has not

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    Fotuhi, Majid Date: 07/24/2013
    Comment:

    As a neurologist with more than 25 years of experience in neuroscience research and dementia care, I believe that the Amyloid imaging should not be covered by Medicare. My two main reasons are:

    1. The results of the test do not change managment of patients. It may add anxiety and confusion, for patients and their doctors.

    2. Up to 30% of elderly have amyloid deposits in their brain and yet they have no symptoms. There is still no convincing evidence that Amyloid is the

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    Silverman, Daniel Title: (Please see signature block.)
    Organization: University of California, Los Angeles
    Date: 07/24/2013
    Comment:

    24 July 2013

    Coverage and Analysis Group (CAG)
    Centers for Medicare & Medicaid Services (CMS)
    United States Department of Health and Human Services
    7500 Security Boulevard, Baltimore, MD 21244
    CAGinquiries@cms.hhs.gov

    re: National Coverage Analysis (NCA) for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease” (CAG-00431N)

    Please consider the following as responsive to your solicitation of comments to the above

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    Rabinovici, Gil Title: Assistant Professor
    Organization: UCSF Memory & Aging Center
    Date: 07/23/2013
    Comment:

    July 24, 2013

    Louis B. Jacques, MD
    Director, Coverage & Analysis Group
    Centers for Medicare and Medicaid Services
    Mail Stop S3-02-01
    7500 Security Boulevard Baltimore, MD 21244-1850

    Dear Dr. Jacques,

    I am a neurologist who cares for cognitively impaired patients in an academic dementia center. For the past eight years I have also conducted clinical research evaluating the diagnostic utility of amyloid PET. I am writing to urge CMS to

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    Carome, Michael Title: Director, Health Research Group
    Organization: Public Citizen
    Date: 07/23/2013
    Comment:

    July 23, 2013

    Louis B. Jacques, M.D.
    Director, Coverage and Analysis Group
    Office of Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard, Mail Stop S3-02-01
    Baltimore, Maryland 21244

    Submitted via email to: CAGinquiries@cms.hhs.gov

    RE: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr.

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    Grundman, MD, MPH, Michael Title: Neurologist
    Organization: Global R&D Partners, LLC, University of California San Diego
    Date: 07/23/2013
    Comment:

    July 23, 2013

    Louis Jacques, M.D.
    Director, Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    Re: National Coverage Analysis (NCA) Tracking Sheet for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dear Dr. Jacques:

    I am a neurologist who has been studying Alzheimer’s disease for over 25 years. I am surprised and dismayed by the

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    Silverman, Daniel Title: (Please see signature block.)
    Organization: University of California, Los Angeles
    Date: 07/22/2013
    Comment:

    With regards to the prognosis argument…

    …many proponents for broadening the decision for CMS coverage of amyloid imaging are arguing for CMS to cover for indications that follow the guidelines suggested by SNMMI-AA “appropriate use” criteria and the FDA-approved language for amyloid imaging; some amyloid imaging proponents are concomitantly arguing that CMS should provide coverage for use in establishing “prognosis of MCI.”

    So what are the guidelines laid out by the

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    Applebaum, MD, Jeffrey Title: MD (assistant clinical prof of family practice)
    Organization: U C Davis Medical Group, Sacramento area
    Date: 07/21/2013
    Comment:
    I performed an Amyvid scan recently on one of my 81yo male patients with Parkinson's Disease and cognitive impairment ( possible early Alzheimer's disease). Family and I are concerned about this patient since his wife is dying of hepatocellular carcinoma ( life expectancy 6-12months). Pt and wife living alone, in remote location, and in a large home. Entire family concerned about patient's increasing disability, especially if Parkinson's combined with Alzheimer's dementia in the near future.

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    Lyketsos, Constantine Title: Elizabeth Plank Althouse Professor
    Organization: Johns Hopkins Bayview and Johns Hopkins Medicine
    Date: 07/21/2013
    Comment:

    I write primarily as a clinician but I am also an active investigator and teacher in the field and I was a non-voting member of the CMS panel that evaluated the utility of this new technology. I am also director of the Johns Hopkins Memory and Alzheimer's Treatment Center and Associate DIrector of the Johns Hopkins Alzheimer's Disease Research Center.

    My main point is that the DRAFT proposal to limit payment for this test to the research setting is too limited and must be revised.

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    Stern, Robert Title: Professor of Neurology and Neurosurgery
    Organization: Boston University School of Medicine
    Date: 07/19/2013
    Comment:

    To whom it may concern:

    I applaud the exhaustive and comprehensive review conducted by the Panel that resulted in the current decision to limit coverage to a single beta amyloid PET in select clinical research studies. Although I am in agreement with much of the panel's interpretation of the existing literature,I strongly disagree with the interpretation of the existing data on the current impact beta amyloid PET (specifically florbetapir)tests have on clinical practice and

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    Asay, Derek Title: Senior Director, Govt Strategy, Fed Accts and Qual
    Organization: Lilly USA LLC
    Date: 07/18/2013
    Comment:

    July 18, 2013

    Louis B. Jacques, MD
    Director, Coverage & Analysis Group
    Centers for Medicare and Medicaid Services
    Mail Stop S3-02-01
    7500 Security Boulevard
    Baltimore, MD 21244-1850

    RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

    Dr. Jacques:

    On behalf of Lilly USA, LLC (Lilly), we are providing our first set of

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    Masdeu, Joseph Date: 07/17/2013
    Comment:
    As CMS is recommending that coverage be in the context of evidence development, the requirement that the compound tested be FDA approved should extend to compounds for which the investigator could obtain an IND. For instance, it would be foolish not to cover PIB, the amyloid compound that provides the best quality images and for which there is the most experience. There are already in the pipeline compounds likely as good as PIB, but for which there is still very little experience. Covering

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    Elliott, Christian Date: 07/16/2013
    Comment:

    Full text of the comment is also available at: http://www.mybraintest.org/2013/07/should-medicare-cover-the-cost-of-brain-imaging-tests-for-alzheimers-diagnosis/

    Positron Emission Tomography (PET) imaging tests can identify amyloid beta deposits in the brain by using imaging agents that are introduced into the brain through the bloodstream. These imaging agents bind to amyloid beta plaques in the brain, allowing for a sensitive and generally accurate measure of amyloid beta “load”

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    Foster, Norman Title: M.D.
    Date: 07/16/2013
    Comment:

    I am a physician who frequently evaluates patients with cognitive impairment. I have reviewed the CMS draft decision on amyloid PET in detail. I concur with the broad agreement within the community knowledgeable about Alzheimer’s disease and related dementias that amyloid PET is a valuable clinical tool that are patients need today. I support the published Appropriate Use Criteria for amyloid PET.

    I strongly disagree with the proposed draft decision. It should be reconsidered.

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    DeCarli, Charles Title: Director, Alzheimer's Disease Center
    Organization: University of California at Davis
    Date: 07/16/2013
    Comment:

    Speaking as a clinician, I would strongly encourage CMS to consider covering amyloid imaging under two important conditions.

    The first is early onset dementia

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    Silverman, Daniel Title: (Please see signature block.)
    Organization: University of California, Los Angeles
    Date: 07/15/2013
    Comment:

    With respect to the relationship between decisions made by the U.S. Food and Drug Administration (FDA) and CMS...

    ...it may be "clear" (at least to some) that approval of a "diagnostic tool" by the FDA for a given indication should be regarded as equivalent to an obligation on the part of CMS to pay for the use of that tool for that indication, at least for those Medicare beneficiaries in whom that use would be "appropriate" (i.e., whose health would benefit from doing so)

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    Fleisher, Adam Organization: Banner Alzheimer's Institute
    Date: 07/14/2013
    Comment:
    It is clear that the CMS decision to Cover with Evidence Development will relegate this important diagnostic tool to only those that can afford it in this country, given current FDA approval of Amyvid PET. It is in direct contradiction to this administrations current efforts through the affordable care act and NAPA. This decision points to the lack of direct expertise in dementia care of the voting CMS panel and conflicts with a basic tenant in medicine regarding making the proper diagnosis

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    Silverman, Daniel Title: (Please see signature block.)
    Organization: University of California, Los Angeles
    Date: 07/12/2013
    Comment:

    Since it has been suggested, among comments made here and in other forums, that the "consensus of expert opinion" reported by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the Alzheimer’s Association (AA) joint taskforce (J. Nucl. Med., 2013; 54:476-490) are in support of CMS coverage for amyloid imaging scans, unencumbered by the need to collect additional data via the opportunity provided by CMS through Coverage with Evidence Development (CED), it is worthwhile to look

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    Bodeau, Geoffrey Organization: Consulting Radiologists, Ltd.
    Date: 07/10/2013
    Comment:

    I am disappointed by the Centers for Medicare & Medicaid Services (CMS) draft coverage decision on brain amyloid imaging, particularly given the clear, scientific consensus recommendations provided to CMS by the Alzheimer’s Association and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) regarding appropriate, limited coverage, only in specific populations.

    As a nuclear medicine physician familiar with and currently providing beta-amyloid brain PET imaging, with

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    Carr, John Date: 07/10/2013
    Comment:
    I have a [PHI Redacted] with some memory and cognative impariment. I would like to be able to have this test covered and run through his medicaid insurance. The ability to have a better undestanding of his symptoms being caused by alzheimers or some other cause woudl be beneficial to [PHI Redacted] and to our entire family. Please select to have these test covered.
    Silverman, Daniel Title: (Please see signature block.)
    Organization: University of California, Los Angeles
    Date: 07/09/2013
    Comment:

    This proposed decision follows the recommendation of the January 2013 MEDCAC, whose members ultimately addressed the question posed by the Chair, "How confident are you that there is adequate evidence to determine whether or not PET imaging of brain beta amyloid changes health outcomes [for either better or worse] in patients who display early symptoms or signs of cognitive dysfunction? One is low confidence and five is high confidence, you can vote anywhere from one to five." Result:

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    Vance, Richard Date: 07/07/2013
    Comment:
    In general the CMS is far too restrictive on use of PET for a multitude of conditions, lacking any real evidence that the PET is harmful. Given the alternatives, CAT and MRI, or worse some surgeon, tools such as PET and Protons are by definition far superior. IF YOU DON'T HAVE EVIDENCE OF WIDESPREAD CONSISTENT HARM the technology should be approved for all purposes, period.
    Simon, Jay Date: 07/04/2013
    Comment:
    Given the evidence, it is the right decision. It is unfortunate because PET needs Amyvid to be successful and with this new set-back, this products chance for success is doubtful. There are other promising PET drugs in various stages of development and hopefully the clincial evidence of those products will be stronger to gain CMS approval.