National Coverage Analysis (NCA) View Public Comments

Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

Public Comments

Commenter Comment Information
Heidebrink, Judy Title: MD
Organization: University of Michigan
Date: 08/16/2023
Comment:
With the advent of Alzheimer's disease therapies whose appropriateness and duration are guided by the results of an amyloid PET scan, it is imperative that this tool be available as a covered CMS benefit. Beyond treatment implications, an amyloid PET scan can provide tremendous value to patients and families in knowing whether Alzheimer's changes are indeed present and not just someone's "best guess."
Lasser, Adina Title: Public Policy Manager
Organization: Alliance for Aging Research
Date: 08/16/2023
Comment:

August 16, 2023

Joseph Chin, M.D.
Medical Officer for Coverage and Analysis
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services, mailstop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

RE: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG00431R)

Dear Dr. Chin:

The 35 undersigned organizations resolutely support the Centers for Medicare & Medicaid Services

More

Bellinger, Julia Title: Director, Health Policy and Regulatory Affairs
Organization: Society of Nuclear Medicine and Molecular Imaging
Date: 08/16/2023
Comment:

VIA ELECTRONIC DELIVERY

David Dolan and Joseph Hutter, M.D.
Center for Clinical Standards and Quality
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attention: CAG-00431R
P.O. Box 8013
Baltimore, MD 21244–1850

Re: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease Proposed Decision Memorandum and National Coverage Analysis

More

Bagel, Michael Title: AVP Public Policy
Organization: Alliance of Community Health Plans
Date: 08/16/2023
Comment:

Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: NCD Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

Dear Administrator Brooks-LaSure:

The Alliance of Community Health Plans (ACHP) applauds the Centers for Medicare & Medicaid Services (CMS) for its commitment to establish

More

Neves, Lauren Title: Deputy Vice President, Policy and Research
Organization: PhRMA
Date: 08/16/2023
Comment:

August 16, 2023

VIA ELECTRONIC FILING

Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Blvd.
Baltimore, Maryland 21244

Re: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the Centers for Medicare &

More

Bens, Cynthia Title: Senior Vice President, Public Policy
Organization: Personalized Medicine Coalition
Date: 08/16/2023
Comment:

August 16, 2023

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

BY ELECTRONIC DELIVERY

Re: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Dr. Chin:

The Personalized Medicine Coalition (PMC), a multi-stakeholder

More

Cooper, Josie Title: Executive Director
Organization: Alliance for Patient Access
Date: 08/16/2023
Comment:

August 16, 2023

Joseph Chin, M.D.
Director, Coverage and Analysis Group
Center for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Dr. Chin:

On behalf of the Alliance for Patient Access (AfPA), thank you for the opportunity to offer comment

More

Quinn, Bruce Title: Consultant
Organization: Bruce Quinn Associates LLC
Date: 08/16/2023
Comment:

I support the removal of the NCD and the shift to local decisions rather than an NCD. By way of background, I am an MD PhD and the first part of my career was as a full time Alzheimer research in two medical schools as a faculty member.

There is one concern that could arise at the MAC level, however. All three tracers approved for Amyloid PET studies contain FDA language - from their approval, some years ago - "not shown to be safe and effective for therapeutic monitoring."

More

Spurgin, Elizabeth Title: Head, Reimbursement & Policy
Organization: GE HealthCare
Date: 08/16/2023
Comment:

Submitted Electronically

August 16, 2023

Ms. Tamara Syrek-Jensen
Director, Coverage and Analysis
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: Beta Amyloid Positron Emission Tomography in Dementia and Neurogenerative Disease (CAG-00431R)

Dear Ms. Syrek-Jensen:

On behalf of GE HealthCare, thank you for the opportunity to comment on the Centers for

More

Dennison, Hayley Organization: Minneapolis Clinic of Neurology
Date: 08/16/2023
Comment:
Amyloid PET scans are an essential tool that enable physicians to identify appropriate candidates for Lecanemab. There is a considerable amount of public evidence that the use of beta amyloid imaging positively impacts patient management and leads to better outcomes. Pet scans, one of the most widely used methods for patient selection in clinical trials, help confirm whether brain amyloid exists and can guide treatment. Once in a lifetime limit on amyloid pet is outdated and not clinically

More

Lee MD, Roland Title: Professor of Radiology/Neuroradiology
Organization: VA San Diego and University of California San Diego
Date: 08/16/2023
Comment:
Alzheimer’s disease (AD) is an increasing problem with our aging population. It’s important to make an accurate diagnosis, especially with the approval of lecanemab to treat AD. As a practicing academic neuroradiologist, I commonly perform CT scans and MRI scans to diagnose AD, but they are almost useless in establishing the diagnosis. In contrast, beta amyloid PET is the Gold standard to assess Amyloid burden in the brain, which much more definitively establishes this crucial diagnosis. It

More

Cosgrove, Andrew Organization: BIO
Date: 08/16/2023
Comment:

VIA ELECTRONIC DELIVERY TO: https://www.cms.gov/medicare-coverage-database/view/national-submit-public-comment.aspx?DocID=308&commentDocType=nca&fromPage=pmemo&proposed=Y&fromTracking=Y&=

August 16, 2023
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00431R
P.O. Box 8013
Baltimore, MD 21244–18

RE: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron

More

Fedewa, Anna Title: Manager of Federal Government Relations
Organization: National Down Syndrome Society
Date: 08/16/2023
Comment:

National Down Syndrome Society Comments to the Centers for Medicare & Medicaid Services (CMS)
Re: Proposed Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease
(CAG-00431R)

August 16, 2023

The National Down Syndrome Society (NDSS) empowers individuals with Down syndrome and their families by driving policy change, providing resources, engaging with local communities, and shifting public perceptions. In

More

Guastella, Michael Title: Executive Director
Organization: Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR)
Date: 08/16/2023
Comment:

The Council on Radionuclides and Radiopharmaceuticals, Inc.

500 North Capitol Street, NW
Suite 210
Washington, DC 20001-7407
(202) 547-6582

VIA ELECTRONIC SUBMISSION

Ms. Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
Attention: CAG-00431R
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

More

Berry, Kate Organization: AHIP
Date: 08/16/2023
Comment:

August 16, 2023

SUBMITTED ELECTRONICALLY

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Ms. Syrek Jensen:

AHIP appreciates the opportunity to provide input on the Centers for

More

Bartelme, Amanda Title: Executive Director, Policy
Organization: Eisai Inc.
Date: 08/16/2023
Comment:

August 16, 2023

VIA ELECTRONIC SUBMISSION

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: Proposed Decision Memorandum on the Reconsideration of National Coverage Decision for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative

More

Lakhani, Ali Title: Head of Public Policy
Organization: Biogen
Date: 08/16/2023
Comment:

BIOGEN
225 Binney Street
Cambridge MA 02142
Phone: 781-464-2000
www.biogen.com

August 16, 2023

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00431R
Mail Stop C4–26–05
7500 Security Boulevard
Baltimore, MD 21244–1850

Re: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

More

DeMatteis, Candace Title: Policy Director
Organization: Partnership to Fight Chronic Disease
Date: 08/16/2023
Comment:

August 16, 2023

Joseph Chin, M.D.
Medical Officer for Coverage and Analysis
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services, mailstop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

SUBMITTED VIA ONLINE COMMENT PORTAL

Re: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease – CAG-00431R

Dear Dr. Chin:

More

Mueller, Daniel Title: Director of Corp. Accts - Family Member
Organization: SOFIE
Date: 08/16/2023
Comment:
It is critical that Amyloid Plaque Imaging and the tracers to image Amyloid Plaque in the brain be paid for! My family has been affected by Alzheimer's in a significant way. I currently have 2 [PHI Redacted] that have been affected and have not received the care they should have over the past few years. If there was a separate payment for the scan and the tracer, I believe they would have been better cared for and possibly received therapy to slow the progression. The cost

More

Kremer, Ian Title: Executive Director
Organization: LEAD Coalition (Leaders Engaged on Alzheimer's Disease)
Date: 08/16/2023
Comment:

August 16, 2023

Joseph Chin, M.D.
Medical Officer for Coverage and Analysis
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services, mailstop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Re: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Dr. Chin:

Thank you for the Centers for Medicare & Medicaid Services (CMS) July 17 proposal (CAG-00431R) [1] to remove the

More

Wildburger, Norelle Organization: SynapsDx
Date: 08/15/2023
Comment:

Response to CMS Proposed Decision on PET Beta Amyloid Imaging Coverage:
Should CMS remove the current NCD for beta amyloid PET in dementia and neurodegenerative disease?

Daniel L. Alkon1, David Morgan2, Giulio Taglialatela3, and Alberto J. Espay4

1 Chief Scientific Advisor of SynapsDx, Rockville, Maryland
2 Department of Translational Neuroscience, Michigan State University, Grand Rapids, Michigan
3 Mitchell Center

More

Bernstetter, Steve Title: Compliance Director
Organization: BJC HealthCare
Date: 08/15/2023
Comment:

Submitted electronically to the Medicare Coverage Database via CMS.gov.

August 16, 2023

Coverage and Analysis Group
Center for Medicare and Medicaid Services
Department of Health and Human Services
Administrative File CAG-00431R

RE: Proposed National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease

Dear members of the Coverage and Analysis Group,

We

More

March, Andrew Organization: The New IDEAS Study
Date: 08/15/2023
Comment:

August 15, 2023

Joseph Chin, M.D.
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD

Electronically Submitted: CMS_caginquiries@cms.hhs.gov

Re: Public Comment on NCA for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Dr. Chin:

The New Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study

More

Paulsen, Russ Title: Chief Operating Officer
Organization: UsAgainstAlzheimer's
Date: 08/15/2023
Comment:

We are immensely grateful for the opportunity to comment on the Center for Medicare and Medicaid Services' (CMS) proposed National Coverage Determination (NCD) reconsideration for Beta Amyloid Positron Emission Tomography(PET) in Dementia and Neurodegenerative Disease.

At UsAgainstAlzheimer's, we welcome CMS's proposal to eliminate the highly-restrictive NCD at § 220.6.20, effectively ending coverage with evidence development (CED) for PET beta amyloid imaging.

The

More

Taylor, James Title: President
Organization: Voices of Alzheimer's
Date: 08/15/2023
Comment:

Voices of Alzheimer's, an advocacy organization led by people living with Alzheimer's Disease and caretakers, supports action by the Centers for Medicare & Medicaid Services (CMS) to end Coverage with Evidence Development (CED) requirements for beta-amyloid PET in Dementia and Neurodegenerative Disease. We also support the CMS proposal to lift PET scan coverage limits, which currently cover virtually no scans, as patients are only eligible for one scan in their lifetime if participating in

More

Blakey, MS, Alicia Title: Principal Economic Policy Analyst
Organization: American College of Radiology
Date: 08/15/2023
Comment:

August 15, 2023

Joseph Hutter, M.D.
Lead Medical Officer
Centers for Medicare and Medicaid Services

Electronically Submitted: CMS_caginquiries@cms.hhs.gov

Re: Public Comment on NCA for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Dr. Hutter:

The American College of Radiology (ACR) representing more than 41,000 diagnostic radiologists, radiation oncologists,

More

White, Anne E. Title: President, Neuroscience Business Unit
Organization: Eli Lilly and Company
Date: 08/15/2023
Comment:

August 16, 2023

BY ELECTRONIC DELIVERY (CAGinquiries@cms.hhs.gov)

Dr. Joseph Chin
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Determination (NCD) for Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease (220.6.20) (CAG-00431R)

Dear Dr. Chin:

Eli Lilly and Company

More

Thornhill, Laura Organization: Alzheimer's Association
Date: 08/14/2023
Comment:

The Alzheimer’s Association appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum on Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease for the diagnosis of Alzheimer’s disease. The proposed new policy will remove the Coverage with Evidence Development (CED) data collection requirements and lifetime one scan limit which create unnecessary barriers to this important diagnostic and

More

Halzack, Nicholas Title: Director, Health Policy
Organization: Roche Diagnostics
Date: 08/13/2023
Comment:

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

14 August 2023

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

Dear Ms. Syrek Jensen:

On behalf of the Roche Diagnostics Corporation (“Roche”), I am pleased to submit comments in response to the above-captioned proposed

More

Proskeyy, Malia Date: 08/11/2023
Comment:
Finally! Some movement on providing patients and patient's famlies with answers! Cognitive impairment is more than a disease, it steals all aspects of life from it's victim and their loved ones. Can you imagine being the patient that is diagnosed based solely off of symptom and MOCA score,etc. only to be placed on a treatment that is doing more harm than good? We have had the means to provide real answers that lead to precision treatment plans, and yet, the issue is lack of coverage.

More

Keszler, Peter Title: DO
Organization: Johns Hopkins Community Physicians
Date: 08/11/2023
Comment:
As a neurologist I see many patient's with cognitive problems. It is often very difficult to determine which patient's with cognitive impairment will progress to dementia. Amyloid PET scan will allow us to help identify those who are at risk for progression to alzheimer's and intervene early as possible. By allowing more access to Amyloid PET scans we will have a non-invasive way to help determine which patients would benefit from the new disease modifying medications that are hitting the

More

Stephens, MD, Andrew Title: Chief Medical Officer
Organization: Life Molecular Imaging
Date: 08/11/2023
Comment:

August 11, 2023

Chiquita Brooks-LaSure, Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Diseases (CAG-00431R)

Dear Administrator Brooks-LaSure:

Life Molecular Imaging (LMI) appreciates the opportunity to submit comments on the above-referenced proposed decision memo of the National Coverage Determination

More

Brennan, Ann Title: Nonprofit Professional and Elder Advocate
Date: 08/09/2023
Comment:
I strongly endorse the CMS proposal to cover PET scan imaging for Alzheimer's disease detection. The historical cost burden of these scans has hindered access, despite their critical role in understanding the disease process, monitoring brain changes, and facilitating accurate diagnoses—especially given the emergence of new drugs targeting amyloid. The recent decision to lift the coverage with evidence development (CED) on PET scans is a pivotal stride forward, and I urge active support for

More

Kramp, Joseph Date: 08/09/2023
Comment:
Patients need Amyloid imaging. Please cover this service.
Bunning, Susan Title: Managing Director, Positron Emission Tomography
Organization: Medical Imaging & Technology Alliance
Date: 08/08/2023
Comment:

August 8, 2023

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00431R
Mail Stop C4–26–05
7500 Security Boulevard
Baltimore, MD 21244–1850

Re: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431R)

Dear Administrator Brooks-LaSure:

The Medical Imaging

More

Kerschner, Matt Title: Director, Regulator Affairs and Policy
Organization: American Academy of Neurology
Date: 08/08/2023
Comment:

The American Academy of Neurology (AAN) is the world’s largest neurology specialty society representing more than 40,000 neurologists and clinical neuroscience professionals. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a physician with specialized training in diagnosing, treating, and managing disorders of the brain and nervous system. These disorders affect one in six people and include conditions such as multiple sclerosis (MS),

More

ALLEN, YOLANDE Title: SOCIAL WORKER
Organization: DEPARTMENT OF VETERANS AFFAIRS
Date: 08/07/2023
Comment:
I WOULD LIKE TO SUBMIT THIS IN SUPPORT OF THE PETITION FOR THE BETA AMYLOID POSITRON SCAN TO BE COVERED BY CMS. THIS IS A CRUCIAL STEP TOWARDS DIAGNOSIS AND TREATMENT OF ALZHEIMERS DEMENTIA AND A SCAN OF THIS NATURE SHOULD BE AVAILABLE TO ALL PATIENTS WHO NEED IT, NOT JUST THOSE WHO CAN AFFORD IT. MY UNDERSTANDING IS THAT THE SCAN AS AN OUT OF POCKET EXPENSE IS EXTREMELY EXPENSIVE. COST SHOULD NOT BE A BARRIER TO NECESSARY CARE.
Pesticci, Wendy Date: 08/05/2023
Comment:
This approval is a much needed to not only help with this diagnosis of these approved indications but absolutely a necessary tool to determine if the treatment they are receiving is effective. If we can slow the progression of these diseases, in the long run the cost to everyone would be much less. The cost to care for these patients is much greater if their diseases are in the later stages. People could live more independent lives with a higher quality of life for much longer in many

More

Paulin, Jon Date: 08/04/2023
Comment:
Patients need Amyloid imaging. Please cover this service.
Scanga, Daniel Title: MD
Organization: Mecklenburg Radiology Associates
Date: 08/04/2023
Comment:
Need to cover the drug (radiotracer) in addition to covering the scan in order to properly expand access to all patients who need amyloid imaging for dementia.
BHATIA, PERMINDER Title: MD
Organization: NEURO-PAIN MEDICAL CENTER
Date: 08/03/2023
Comment:
AMYLOID SCAN IS A REQUIRED PILLER IN THE DIAGNOSIS AND TREATMENT OF ALZHEIMER'S DISEASE. AMYLOID PRESENCE CAN BE DETEMINED BY EITHER SPINAL TAP OR AMYLOID SCAN. SPINAL TAP IS MORE CUMBERSOME, NEED PATIENT TO GO TO HOSPITAL, TO BE DONE UNDER FLUROSCOPY, AND PATIENT CAN SUFFER FOR 5 DAYS OF POST SPINAL HEADACHE. WHERE AS AMYLOID SCAN LESS BURDENSOME, OUT PATIENT PROCEDURE.
WITH NEW MEDICATIONS FOR ALZHEIMER'S REQUIRING CONFIRMATION OF DIAGNOSIS, BY SHOWING PRESENCE OF AMYLOID PLAQUES IN

More

Bayas, Angel Title: MD
Organization: First Choice Neurology
Date: 08/03/2023
Comment:
It is imperative that as Life expectancy continues to increase and more and more people develop dementia that we have access to novel diagnostic modalities and therapies to treat dementia and neurodegenerative diseases. As a neurology resident, I am advocating for my patients and future patients for the coverage for beta amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease accessibility. Often times I have to have difficult conversations with patients and their

More

Sotelo, Renato Title: Registered Nurse
Organization: First Choice Neurology
Date: 08/03/2023
Comment:
It is imperative that as life expectancy continues to increase and more and more people develop dementia that we have access to novel diagnostic modalities and therapies to treat dementia and neurodegenerative diseases. As a neuroscience nurse, I am advocating for my patients and future patients for the coverage for beta amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease accessibility. Often times I have to have difficult conversations with patients and their

More

Miranda-Pasqualini, Sofia Title: Nurse Practitioner
Organization: First Choice Neurology
Date: 08/03/2023
Comment:
It is imperative that as Life expectancy continues to increase and more and more people develop dementia that we have access to novel diagnostic modalities and therapies to treat dementia and neurodegenerative diseases. As a neuroscience nurse practitioner, I am advocating for my patients and future patients for the coverage for beta amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease accessibility. Often times I have to have difficult conversations with patients

More

Espinosa, Patricio Title: Board certified Neurologist
Organization: Espinosa Neuroscience Institute
Date: 08/03/2023
Comment:
I have been treating and managing patients with neurodegenerative diseases for over 15 years. It is imperative that as Life expectancy continues to increase and more and more people develop dementia that we have access to novel diagnostic modalities and therapies to treat dementia and neurodegenerative diseases. As a Board Certified Neurologist, I am advocating for my patients and future patients for the coverage for beta amyloid Positron Emission Tomography in Dementia and Neurodegenerative

More

Alusma-Hibbert, Kettia Title: Neuroscience Nurse Practitioner
Organization: First Choice Neurology
Date: 08/03/2023
Comment:
It is imperative that as Life expectancy continues to increase and more and more people develop dementia that we have access to novel diagnostic modalities and therapies to treat dementia and neurodegenerative diseases. As a neuroscience nurse practitioner, I am advocating for my patients and future patients for the coverage for beta amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease accessibility. Often times I have to have difficult conversations with patients

More

Newhouse, MD, Paul Title: Clinical Core Director, Vanderbilt ADRC
Organization: Vanderbilt University Medical Center
Date: 08/03/2023
Comment:
In my role as Clinical Core Director for the Vanderbilt Alzheimer's disease research center and Alzheimer's disease clinical trialist, I have come to appreciate the importance of beta amyloid positron emission tomography imaging for the diagnosis and follow up of Alzheimer's disease. PET imaging has become a critical tool in our ability to be confident of the diagnosis of patients prior to the initiation of investigational anti-amyloid therapies and the assessment of their impact on brain

More

Allison, Michelle Title: Clinical Supervisor
Organization: Johns Hopkins Hospital
Date: 08/03/2023
Comment:
As a medical professional who works closely with PET patients as well as a layman with a [PHI Redacted] suffering from Alzheimer's the extension of coverage by Medicare for Beta Amyloid would be beneficial. The devastation that Alzheimer's and FTD causes to families and society as a whole cannot be cured at this time but having testing that could detect it earlier is essential to slowing the progression of the disease. We have spent years collecting proper data to expand

More

Lacroix, Sheila Title: Nuclear Medicine Director
Organization: Clermont Radiology
Date: 08/03/2023
Comment:
I support the opportunity for all to have access to this incredible medical advancement in slowly down the progression of Alzheimer’s Disease. Do not allow for those who are not financially privileged to be left out of this amazing opportunity.
Esposito, Giuseppe Title: Nuclear Medicine Physician
Organization: Medstar Georgetown University Hospital
Date: 08/03/2023
Comment:
I support removal of the NCD and ending the CED for beta amyloid PET imaging, to allow for coverage determinations to be made by local Medicare Administrative Contractors. With the approval of new effective anti-amyloid treatments, amyloid PET imaging is critical to select patients that will likely benefit from treatment, to avoid unnecessary side effects in patients that do not have amyloid deposition, and to save the financial cost of unnecessary treatments. I am in favor of approving at

More

Dean, James Title: M.D.
Organization: Warren Clinic— Neurology
Date: 08/03/2023
Comment:

As one of a small number of U.S. neurologists solely dedicating his “New Patient” appointment slots to
1) MCI
or
2) Mild Dementia, (likely of Alzheimer’s type)

I can tell you w/o doubt that amyloid PET is the only current appropriate choice for diagnosing “highly likely Alzheimer’s” (ie., MCI/mild dementia “w/ an amyloid basis”). Spinal fluid is not a clinically reasonable choice not sufficiently accurate for using LEQEMBI(or similar agent) given the risks. Blood

More

crowley, james Title: Imaging Administrator
Organization: Carilion
Date: 08/03/2023
Comment:

Amyloid PET is an effective non invasive tool to determine the presence and burden of amyloid in the brain. The PET amyloid study was utilized in the trials for the approved agents and is vital to the succesful utilization of amyloid reduction therapy. We need to know about amyloid deposition.

In addition to removing the Non coverage determination and need CED with development AND coverage for the isotope. Only changing the coverage for the scan does not support the procedure.

More

Malone, Melody Organization: Individual
Date: 08/03/2023
Comment:
As a Physical Therapist, for over 40 years, and having had treated many patients with cognitive impairment, I support the use of Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease. If we can KNOW someone’s diagnosis and/or ‘staging’ of their illness then we can better implement interventions tailored to their specific needs. Currently, the broad brush of the diagnosis is limiting at best.
In addition, this will allow physicians and researchers with more

More

Deville, Brad Date: 08/02/2023
Comment:
In the interest of better patient care, I firmly support the removal of the limiting criteria in place at this time by CMS.
Duffy, Erin Date: 08/01/2023
Comment:
Please allow for additional PET scans as needed for therapeutic drugs that require it to begin treatment with that drug.
Hirsch, Ronald Date: 07/31/2023
Comment:
You can delete my first comment- I now realize that 200.6.13 is for FDG PET not amyloid.
But my question is - in 200.6.13, there is a very prescriptive list of requirements for coverage of the scan, including a min-mental state exam, documentation of medications, prior imaging, etc. Will these requirements be applicable to this new NCD?

It is a terrible idea to retire the current NCD without any guidelines for coverage in place to replace it other than the proposed "decision by the

More

D, Marissa Title: Billing and Revenue Management
Organization: Perigon Imaging
Date: 07/28/2023
Comment:
As a [PHI Redacted] of an early onset Alzheimer’s patient, whom of which my [PHI Redacted] passed after a 7 yr battle at the age of 69, this scan would have been amazing. Now, being in this industry 25+ years, being on the imaging side we are on the edge of our seats waiting for this to come to fruition. I think more than one scan should be allowed for updates for those patients taking Leqembi. Can’t wait to hear the announcement it is finally covered.
Nasrallah, Ilya Date: 07/28/2023
Comment:
Covering amyloid PET scans is imperative; this is an important diagnostic test for appropriate diagnosis of Alzheimer's disease and critical to use of anti-amyloid therapies. In order to allow access to this test, CMS must also allow radiopharmaceutical pass-through; reimbursement rates without pass through do not account for the realities of radiopharmaceutical production and scan acquisition and interpretation. Without pass through, this test (and associated treatments) will be limited from

More

AGRAWAL, BRAJESH Date: 07/27/2023
Comment:
I fully support the decision to remove the coverage limitations currently imposed on Beta Amyloid PET scans for Dementia/Alzheimer's Disease detection. Anyone suffering from symptoms of Dementia/Alzheimer's disease deserves access to anything that has been proven effective in diagnosing and treating the progression of this devastating disease. Everyday people watch their loved ones turn into someone they don't know as well as someone that doesn't know them. I'm sure if you asked anyone of

More

Abdelmalik, Amir Title: Radiologist
Date: 07/27/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. There should be a broader coverage and more than one scan allowed if needed.
BOGGANS, LATOYA Title: AR SPECIALIST
Organization: INTEGRATED ONCOLOGY NETWORK
Date: 07/27/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. There should be a broader coverage and more than one scan allowed if needed
Hulse, Matthew Title: Director of Nuclear Medicine and PET
Organization: SimonMed Imaging
Date: 07/26/2023
Comment:

In an age where we appreciate preventative care and early detection to save costs and more importantly lives, it should be understood offering these PET exams in conjunction with the treatment needs to be standard of care. From the Alzheimer's Association: "1 in 3 seniors dies with Alzheimer's or another dementia. It kills more than breast cancer and prostate cancer combined."

I fully support CMS coverage of these FDA approved and proven drugs. The debate of efficacy is settled

More

Cohen, Jason Title: Lead Nuclear Medicine/PET technologist
Organization: SimonMed Imaging
Date: 07/26/2023
Comment:
I support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans.
Beta amyloid PET imaging is an important exam in the diagnosis and maintenance of the dementia patient. Without this important tool, many patients may not have their dementia properly diagnosed, and many others may not have opportunity to track their treatment progress.
Schuster, David Title: MD
Organization: Emory University
Date: 07/26/2023
Comment:
I am supportive but since the radiotracers are beyond pass-through does this mean that the radiotracer would not be separately reimbursed, but bundled into reimbursement of the PET scan itself? In that case, patients would be scanned at a significant revenue loss.
Strosser, Lanette Title: Operations Manager
Organization: Cancer Care of North Florida
Date: 07/26/2023
Comment:
We strongly support CMS’ decision and the opportunity for broader coverage of PET beta amyloid imaging by removing CED and the limit of one scan per patient. This change in coverage will allow patients greater access to amyloid PET scans for diagnosis, management, and evaluation for newly approved therapies.
Collins, David Title: MD
Organization: Sutter East Bay Medical Group
Date: 07/26/2023
Comment:
Availability of amyloid-PET in standard clinical practice is necessary to establish the presence or absence of Alzheimer's disease, in light of new approved monoclonal antibody therapies that must only be used in cases of definite Alzheimer's disease. Without the availability of amyloid-PET, these expensive and potentially dangerous treatments are likely to be used inappropriately.
GROVES, TIFFANY Title: PATIENT CARE COORDINATOR
Organization: PET/CT IMAGING OF HAGERSTOWN, MD
Date: 07/26/2023
Comment:
I fully support the decision to remove the coverage limitations currently imposed on Beta Amyloid PET scans for Dementia/Alzheimer's Disease detection. Anyone suffering from symptoms of Dementia/Alzheimer's disease deserves access to anything that has been proven effective in diagnosing and treating the progression of this devastating disease. Everyday people watch their loved ones turn into someone they don't know as well as somone that doesn't know them. I'm sure if you asked anyone of those

More

Marlowe, Ashley Title: Authorization/Insurance Specialist
Organization: PET Imaging of Dallas NE
Date: 07/26/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. There should be a broader coverage and more then 1 scan allowed if needed.
Ehret, Eileen Title: Remove the Amyloid PET/CT One Scan Limitation
Organization: ION
Date: 07/26/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. One scan is not enough to determine a baseline and whether treatment such as Leqembi is effective. There should be a broader coverage and more than one scan allowed.
Richmond, William Title: ARRT, (N), (CT) | CNMT
Organization: Integrated Oncology Network
Date: 07/26/2023
Comment:
Alzheimer's Disease is tragic not only to the individuals suffering with it, it radiates to the loved ones caring for those who are inflicted.
I strongly support the removal of the Medicare limitations on amyloid PET/CT scans because I believe that broader coverage allowing for multiple scans can provide valuable data for a early detection in the future. By mining data, as done with pancreatic cancer, diagnostic imaging can provide the information needed to help preventative measures

More

Arya, Kathy Title: PET/CT Specialist
Organization: ION LLC DBA PET Imaging
Date: 07/26/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans.  There should be a broader coverage and more than one scan allowed if needed.
Regan, Jean Date: 07/26/2023
Comment:

My [PHI Redacted] died at 84 after 15 years of non-diagnosed dementia. My [PHI Redacted] died at 81 with vascular dementia and Alzheimer’s diagnosed at autopsy. My [PHI Redacted] is 96 and is in a dementia nursing home unit. Her dementia began around 2010. It’s assumed that she has Alzheimer’s but she’s never had a PET scan.

I had a PET scan during a research project that I was in. [PHI

More

Portillo, Monica Title: patient concierge/patient scheduler for pet/ct
Organization: PET IMAGING OF DALLAS NE
Date: 07/26/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on Amyloid pet/ct scans. There should be Broader coverage for these types of scans and there should be broader coverage for more than one scan allowed if needed.
Spreiter, Natalie Title: nuclear medicine technologist
Organization: PET Imaging of Tulsa
Date: 07/26/2023
Comment:
As the [PHI Redacted] of a patient battling Alzheimer's disease, I strongly support any efforts to bring care and hope to this patient demographic. This disease is about timing (and the lack of) for the people. As we continue to wait for these decisions, the patients continue to decline cognitively, possibly excluding them from treatments. As a nuclear medicine technologist I recommend the PET/CT Amyloid scan over lumbar puncture. The PET/CT is basically non invasive

More

ROBASON, RONLEY Title: Nuclear Medicine Technologist
Organization: PET IMAGING OF TULSA
Date: 07/26/2023
Comment:
"I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. There should be a broader coverage and more than one scan allowed if needed”.
Mellema, Amber Title: Senior Regional Director of Operations
Organization: Rocky Mountain Oncology
Date: 07/26/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. There should be a broader coverage and more than one scan allowed if needed.
Simon, Stacey Title: Director of Imaging
Organization: ION
Date: 07/26/2023
Comment:
I fully support the decision to remove the Medicare limitations currently placed on amyloid PET/CT scans. There should be a broader coverage and more than one scan allowed if needed.
Intenzo, MD, Charles Date: 07/26/2023
Comment:
I read amyloid brain PET scans. it is absolutely essential that follow -up scans are performed to assess objective therapeutic response.
Menendez, Isabel C Date: 07/25/2023
Comment:
The best current way to confirm clinical suspicion of Alzheimer, the most common dementia, and to follow patient's course and response to treatment is with the use of Beta-Amyloid Positron Emission Tomography (PET). It is imperative that CMS recognizes the importance of this diagnostic tool so that Medicare and medical insurances will cover the cost. A single Beta-Amyloid PET may help in initial diagnosis, but subsequent Beta-Amyloid PET would be necessary to monitor patient's disease

More

Faradji, Victor Title: MD
Organization: VIN
Date: 07/25/2023
Comment:

We really need the amyloid PET scans approved for clinical practice. Many patients require the PET scans before they can be consider for antiamyloid therapy.

I would recommend that the PET scans go through an authorization process that verifies need. This should include previous neurological consult and work-up that is required before ordering the PET scan.

The protocol would be similar to what clinical research companies and the new ideas clinical trial follows as

More

scullin, corissa Date: 07/25/2023
Comment:
Encouraging CMS to remove barriers in obtaining PET scans for patients.
Goldstein, Alanna Title: Senior Director, Public Affairs and Advocacy
Organization: American Geriatrics Society
Date: 07/25/2023
Comment:

The American Geriatrics Society (AGS) supports the Centers for Medicare & Medicaid Services (CMS) proposal to remove the national coverage determination (NCD) at § 220.6.20, ending coverage with evidence development (CED) for positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors (MACs) under § 1862(a)(1)(A) of the Social Security Act. We urge CMS to finalize

More

Tanner, Jeremy Title: Assistant Professor of Neurology
Organization: UT Health San Antonio
Date: 07/23/2023
Comment:
I strongly support coverage for amyloid PET scans. For some patients, it is the only available clinical Alzheimer's disease biomarker testing (particularly those unable to undergo lumbar puncture) and guides their diagnosis, management, and prognosis for cognitive symptoms and guides decision-making for other medical concerns. Additionally, for patients started on anti-amyloid therapy, it will be important to monitor for amyloid reduction and to assess when to consider stopping the therapies.
SMITH, RICHARD Date: 07/22/2023
Comment:
[PHI Redacted] I encourage coverage for PET scans.
Swaters, Cherie Title: RN, BSN
Date: 07/22/2023
Comment:
Having the PET Scan covered by Medicare (and therefore more available to the majority of consumers) would make the ability to diagnose Alzheimer's available earlier in the disease so that the current medications could be started when they would do the most good. Please, please lift the prohibition against coverage of this very important test. We need that test available to all now! [PHI Redacted] died of Alzheimer's in 1995 at the age of 77. Since then, I have lived with the

More

Lavely, William Title: Nuclear Medicine Physician
Organization: Northside Radiology Associates
Date: 07/20/2023
Comment:
Beta-Amyloid imaging has been available and approved for some time now, but unfortunately, because there was not therapy available, it was not covered by Medicare or other insurance since there was no way to objective determine response to therapy and therefor was deemed unnecessary. With the recent approval of a new anti-amyloid therapy, and potentially more to come, we now have need to conclusively prove the presence of amyloid plaques so that the starting position and subsequent response to

More

Rhodes, Thera Title: Financial Systems Analyst II
Date: 07/20/2023
Comment:

I just read the AD article and it had me thinking. Why are we not running these tests at regular intervals like we do for vaccinations, colon screening, prostate screening, mammograms, and PAP smears. You would think our neurological health is vital and should have a schedule automatically approved by all insurance companies. Cognitive function is critical to life and we should be in the business of ensuring that everyone lives well. When restrictions and limitations are placed on

More

Hazen, Lisa Title: Nuclear Medicine Technologist/Patient Advocate
Date: 07/19/2023
Comment:
Dear Sirs-
We have been waiting for PET brain imaging to become the gold standard in helping diagnosis and manage neurogenerative disease for many years. The roadblock for patients has been the lack of reimbursement from CMS rules. When we look at the landscape of the patient population that we are assessing for disease, it is only right that CMS covers these scans for not only initial diagnosis but continued care and progression of disease. Our patients on Medicare deserve to have the

More

T, Fred Title: Physician
Organization: UMASS School of Medicine
Date: 07/18/2023
Comment:
I am concerned that approving a very expensive test with limited clinical value will not be a cost effective use of the healthcare budget. There are other priorities which warrant attention first such as universal Medicare for all.
Hirsch, Ronald Date: 07/17/2023
Comment:
I would suggest a provision in the NCD that once the presence of amyloid is established in the patient with dementia, no further PET scans will be covered unless part of a clinical trial that specifically is studying amyloid burden in realtionship to treatment. It is conceivable that patients and physicians will use repeated PET scans, as they currently do with cancer, as a surrogate measure of efficacy of the treatment. But without data suggesting that a reduction in amlyoid directly

More