National Alzheimer's Project Act: Public Comments from Advisory Council Meeting, January 2021

Thank you to the Advisory Council on Alzheimer's Research, Care, and Services, and for the opportunity to comment on this important issue of the direction of dementia research. At Positive Approach to Care, we'd especially like to thank Ron Peterson for his presentation on nomenclature in dementia research, as our statement is specifically in support of need for a major change in nomenclature, and as such, the direction of the research focus on the cure for dementia, to broader dementia health services research focus.

When we, as scientists and policy makers, were in the mode to cure cancer, we were looking for the magic drug. The magic chemical combination. Then we started saying "Oooh, we can prevent it!" Then we said, "But wait! Some cancer is genetic!"
"Ooh, but some of it is about exposure!"
"Ooh! But some of it is actually manageable because it is chronic!"
"And some of it is intractable!"
We moved away from researching for a singular cure for cancer, to the place we are now, with incredible gains in the 200 different forms, types, and causes of cancer.

To make these gains, we had to acknowledge that our original approach of finding the cure was too limited in scope. It was only when we stopped only talking about the cure that the public and policy makers started understanding that, WOW, this is bigger. We needed more seats at the table, especially including those receiving treatment, and we began to make true advances in morbidity and mortality for all forms, types, and causes of cancer.

Enter Alzheimers. It is only one type of dementia. It has been 114 years since Alzheimers was first diagnosed, and somehow, we're still talking about finding a cure, and finding a treatment for Alzheimers. Further, we are still funding research and making policy largely without people living with these diseases in on the conversation.

NAPA has a goal to Prevent and Effectively Treat Alzheimer's disease by 2025. We believe that goals such as this not only perpetuate this inaccurate narrative around dementia, but also holds us back in funding and policy. For advancement in the quality of care and quality of life for people living with dementia, this goal should address not just prevention and effective treatment of Alzheimers, but a five-fold, balanced goal to address:

1. Prevention
2. Cure
3. Restoration and Rehabilitation
4. Compensation and augmentation of skill loss (the occupational approach)
5. Comfort and Palliative Care

By creating a goal in all five areas of research, we can craft a robust care plan for each person and their care team that aligns with the latest scientific evidence on neurodegenerative disorders, addresses the complexity and uniqueness of each situation our health services community faces, and delivers the care that the public deserves.

I am a Project Director at Education Development Center. Thank you for the opportunity to make these public comments. I prepared these comments with Dr. Epstein-Lubow of Brown University and Dr. Reuben of UCLA. These comments are our own.

We are making these comments to urge the Assistant Secretary for Planning and Evaluation (ASPE) and this Advisory Council to improve access to comprehensive dementia care through payment reform.

As this Council is aware, in November 2020, Senators Stabenow (D-MI) and Toomey (R-PA) sent a letter[1] to HHS Secretary Azar to recommend that HHS review a series of important policy recommendations which the Senators collected from national experts. One recommendation is that the CMS Innovations Center (CMMI) create and test an alternative payment and care model for people with dementia. Subsequently, the Alzheimer's Association led the development of two letters: a letter[2] in appreciation of the senators' bipartisan support and a letter (see attachment) to Amy Bassano, Deputy Director of CMMI, encouraging CMMI to move forward on the development and testing of such a model.

Relatedly, we would like to call this Advisory Council's attention to a recent report by the Alzheimer's Impact Movement and Alzheimer's Association, titled Dementia Care Management: A Proposed Framework for an Alternative Payment Model[3], to which Dr. Reuben and Dr. Epstein-Lubow contributed. The report lays the groundwork for an alternative payment model for dementia care focusing on key elements of coordinated care management to support people living with dementia as well as family caregivers, including measurable outcomes and flexibility to support widespread adoption.

Too often, health care systems and medical groups are unable to implement evidence-based dementia care programs because the costs of administering the program are inadequately covered by the existing payment mechanisms. The development of an alternative payment model for dementia care would dramatically increase access to effective comprehensive dementia care. We encourage ASPE and the Advisory Council to plan multiple strategies to advance this work.

In the meantime, recent changes to billing code structure may help providers narrow the coverage gap for dementia care. We applaud the Administration for Community Living for publishing a Guide to Billing Codes for Dementia Services[4] available through the National Alzheimer's and Dementia Resource Center. We are appreciative of the additional webinar guidance which accompanies this guide, and we recommend additional guidance be made available along with educational efforts to encourage clinicians to deliver these services.

All of these efforts are consistent with a report we published in the Journal of the American Geriatrics Society in September 2020 entitled, "Recommendations to Improve Payment Policies for Comprehensive Dementia Care."[5]

In addition, we urge ASPE to address three actions we recommended in prior public comments, including:

1. Continue work previously conducted by ASPE and included in its report Examining Models of Dementia Care.
2. Convene at least one work group addressing payment reform for comprehensive dementia care.
3. Monitor and report on how the inclusion of dementia as a risk adjustment modifier in the CMS HCC coding affects the definitions of populations of people living with dementia, the quality and types of care received, and the health outcomes of those individuals.

These recommended actions are in alignment with the National Plan to Address Alzheimer's Disease's Strategy 1.E and all Strategies under Goal 2: Enhance Care Quality and Efficiency. The recommended actions are also in alignment with the 2020 Recommendations from the Public Members of the Advisory Council, including Cross-Cutting Recommendations 1 and 3; Clinical Care Recommendations 3, 4 and 5; and all five of the Recommendations regarding Long-Term Services and Supports.

Thank you for considering these comments.

NOTES:

1. https://www.toomey.senate.gov/newsroom/press-releases/toomey-and-stabenow-continue-fight-against-alzheimers-disease
2. https://alzimpact.org/media/serve/id/5fd38e932de8a?utm_medium=email&utm_campaign=Weekly%20Round-Up%20December%2011%202020&utm_content=Weekly%20Round-Up%20December%2011%202020+CID_a1709f4632b68ebd314e677274218722&utm_source=Campaign%20Monitor%20Email%20Marketing&utm_term=sent%20a%20letter
3. https://alzimpact.org/media/serve/id/5f1b511b98110
4. https://acl.gov/news-and-events/announcements/new-nadrc-guide-billing-codes-dementia-services
5. https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/jgs.16807

December 9, 2020

Deputy Director
Center for Medicare and Medicaid Innovation (CMMI)
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

Re: Letter from Senators Toomey and Stabenow and Alternative Payment Models for Persons with Alzheimer's and Dementia

Dear Deputy Director Bassano,

We the undersigned thank you and your staff for all you do for Medicare and Medicaid beneficiaries, and particularly those living with Alzheimer's and dementia and their health care providers. We write today to bring to your attention to a recent letter from Senator Pat Toomey and Senator Debbie Stabenow to Secretary Azar offering recommendations on how to strengthen care and services for persons with dementia as well as foster innovation in Alzheimer's and dementia research.

We were particularly encouraged by their specific recommendation that CMMI create and test alternative payment and coordinated care models targeted toward Medicare and/or Medicaid beneficiaries with Alzheimer's disease. In light of these policymakers' interest and the growing demand for comprehensive care for these vulnerable beneficiaries and appropriate reimbursement for their clinicians, we urge you to develop and test a dementia-specific alternative payment model.

We deeply appreciate all of your efforts to improve the care of beneficiaries with Alzheimer's and dementia and we look forward to working with you.

Sincerely,

Alzheimer's Association
Alzheimer's Impact Movement
Alzheimer's Los Angeles
American Association for Geriatric Psychiatry
American Geriatrics Society
Benjamin Rose Institute on Aging
Biogen
Bright Focus Foundation
Center to Advance Palliative Care
Gerontological Society of America
Hackensack Meridian Health
Hackensack University Medical Center
Jewish Family Services of Delaware
John A. Hartford Foundation
Justice in Aging
Lewy Body Dementia Association
LiveWell Institute
Milken Institute Alliance to Improve Dementia Care
National Association of Area Agencies on Aging
National Caucus and Center on Black Aging
National Hispanic Council on Aging
National PACE Association
Rush University Medical Center, Center for Excellence in Aging
Wright Center for Community Health
Wright Center for Graduate Medical Education
Transitions LifeCare
USAgainst Alzheimer's

D. Reuben, M.D., UCLA
G. Epstein-Lubow, M.D., Brown University
S. Borson, M.D., University of Washington (emeritus)
K. Possin, Ph.D., University of California, San Francisco
E. Tangalos, M.D., Mayo Clinic College of Medicine
B. Forester M.D., McLean Hospital/Harvard Medical School
L. Gitlin, Ph.D., Drexel University
M. Boustani, M.D., Indiana University
O. Bell, Benjamin Rose Institute
K. Brandt
C. Callahan, M.D.
S. Dulaney, R.N., University of California, San Francisco
M. Ellenbogen
L. Evertson, D.N.P., UCLA
M. Lepore, Ph.D, LiveWell Institute
S. Stearns, Ph.D., University of North Carolina at Chapel Hill
M. Sterling, Caregiver Experience, Livpact
C. Walsh, Ph.D, University of California, San Francisco
J. Merrilees, R.N., Ph.D., University of California, San Francisco
A. Kao, M.D., Ph.D, University of California, San Francisco
E. Tsoy, Ph.D., University of California, San Francisco
S. Lee, M.D., University of California, San Francisco
K. Casaletto, Ph.D., University of California, San Francisco
A. Staffaroni, Ph.D, University of California, San Francisco
V. Valcour, M.D., Ph.D., University of California, San Francisco
R. VandeVrede, M.D. Ph.D., University of California, San Francisco
D. Chen, M.D., University of California, San Francisco
S. Lanata, M.D., University of California, San Francisco
C. Alagappan, R.N., University of California, San Francisco
R. Gearhart, R.N., M.S., University of California, San Francisco
C. Lindbergh, Ph.D., University of California, San Francisco
A. Ehrenberg, University of California, San Francisco
J. Brown, Ph.D., University of California, San Francisco
L. Grinberg, M.D., Ph.D., University of California, San Francisco
A. Tuqan, M.D., University of California, Davis
L. Gibbs, M.D., University of California, Irvine
M. Hess, M.D., Harbor-UCLA Medical Center
S. Lindau, M.D., University of Chicago
H. Lum, M.D., Ph.D., University of Colorado
B. Parnes, M.D., University of Colorado
S. Tietz, M.D., University of Colorado
L. Jennings, M.D., University of Oklahoma
J. Karlawish, M.D., University of Pennsylvania
L. Edelman, R.N., Ph.D., University of Utah
M. Sorweid, D.O., M.P.H., University of Utah
R. Samper-Ternent, M.D., Ph.D., University of Texas
Z. Tan, M.D., Cedars-Sinai Medical Center
S. Alan Gale, M.D., Harvard
L. Hanson, Ph.D., HealthPartners
M. Rosenbloom, M.D., HealthPartners
N. Fowler, Ph.D., Indiana University
M. D'Souza, M.D., MPH, Jewish Family Services of Delaware
L. Kleinman, M.D., John Muir Health
A. Greenstein, M.D., McLean Hospital
H. Wierman, M.D., Maine Medical Center
T. Uhde, M.D., Medical University of South Carolina
N. Olney, M.D., Providence Medical System
S. Tee, M.D., Stanford
E. Dzielak, D.O., Wright Center for Graduate Medical Education
J. Marquardt, Wright Center for Community Health & Wright Center for Graduate Medical Education
B. Salzman, M.D., Thomas Jefferson University
J. Williamson, M.D., M.H.S., Wake Forest School of Medicine
M. Yang, M.D., M.S., Wake Forest School of Medicine
T. Gill, M.D., Yale University

*Signatures current as of December 9, 2020

COVID-19 and Continuity of Home and Community Based Dementia Care

I am here on behalf of RTI International an independent, nonprofit research institute serving public, private, state and federal entities. I have worked in the field of dementia care policy for the last 20 years.

Administration for Community Living's Alzheimer's Disease Initiative

RTI thanks the Council for its work to maintain and gradually increase funding of the Administration for Community Living's (ACL) Alzheimer's Disease Initiative and its associated National Alzheimer's and Dementia Resource Center (NADRC) https://nadrc.acl.gov/.

As of July 2020, the ACL dementia grants have served 190,000 persons living with dementia, caregivers, and professionals.

RTI has provided expert technical assistance to ACL's dementia initiatives since 2004, covering 215 grantees in 45 states, Washington D.C., and Puerto Rico. Through our contract with ACL, we manage the National Alzheimer's and Dementia Resource Center where our activities include:

• Dementia-focused webinar series, reports, toolkits, and other resources
• Data analyses and reporting on progress of ACL grants
• Site visits with ACL dementia grantees

RTI echoes the challenges identified by today's speakers and would like to share examples of how ACL's portfolio of 90 grantees rapidly pivoted to provide services during the pandemic.

United Community Center's (UCC) Mobile Memory Clinic

United Community Center in Milwaukee, WI addresses health disparities as an inner-city memory disorders clinic serving Latinos with dementia.

Prior to COVID, they developed a mobile clinic team to conduct in-home assessments and to educate caregivers.

To protect the safety of their clients and staff, UCC adopted HIPAA compliant telemedicine platforms using ACL funds. Wi-Fi-enabled laptops are delivered clients for program use. Since May, 49 families have received this virtual service.

Ventura County Area Agency on Aging Wellness Checks

The Ventura County Area Agency on Aging (CA) offers specialized case management to persons with dementia, including 119 people who live alone.

During COVID, this program is providing regular wellness checks via phone and in-person porch visits, which ensures a physical wellness check and may be the client's only social connection.

Amazing Place Savvy Caregiver

ACL supports the community implementation of evidence-based interventions developed through NIA-funded research, such as Savvy Caregiver -- an in-person, group program.

ACL grantees worked with the intervention developers and created protocols to ensure fidelity to the intervention as they moved to virtual platforms.

Amazing Place in Houston, TX, was the first ACL grantee to offer Savvy Caregiver virtually. Initial evaluation data show participants receiving equal benefit.

Closing

As we emerge from a year of exposure to social isolation and other factors that can increase the risk of dementia, this program remains essential to fill gaps in supports for caregivers and people with dementia.

RTI again thanks the Council for its continued support.

RTI welcomes additional collaborations and funding from public and private entities:

1. to assess effectiveness of virtual programming for caregivers and people living with dementia;
2. to train professionals to use and disseminate dementia-specific tools; and
3. to research services that assist older adults to age in place and reduce premature institutionalization.

RTI's work focuses on disparities and social determinants of health and supports communities, caregivers, and the aging network as they build their dementia capability. Our work helps people understand the impact of dementia and provides policymakers with information about the prevalence, costs, and effective approaches to diagnosing, treating, and providing services for people with dementia. RTI staff include researchers, economists, and epidemiologists who have in-depth knowledge of Alzheimer's and related dementia and aging.

The International Association for Indigenous Aging (IA²), a small but highly-accomplished Native nonprofit, has contributed substantially to legislation, policy, and practice affecting the well-being of American Indian and Alaska Native (AIAN) elders over the years. Founded in 2002, IA² is led a member of the Cherokee Nation, and a majority AIAN board.

We would like to call your attention to the disparities facing AIAN elders and their caregivers in addressing Alzheimer's Disease and Related Dementias (ADRD) and the role of IA² in addressing them.

IA² has significant experience in working with the disparities of ADRD in Indian Country. Through both our oral and this written testimony, we'd like to acquaint you with our work and foster collaborations with Council member agencies. We would also like to highlight the disproportionate impact of the COVID-19 pandemic on AIAN populations and the need to address this crisis. We advocate prioritization of efforts to identify and address the urgent needs of patients and caregivers in Indian country affected by ADRD during the pandemic and beyond.

To raise awareness of ADRD in Indian Country IA² worked with the Association of State and Territorial Health Officials (ASTHO) to create a suite of materials for health agencies and organizations across Indian country. These materials, released in 2019, include flyers, posters, a provider guide, radio PSAs, videos, and national newspaper articles. These materials begin to fill a gap in outreach materials.

We were recently awarded a five-year Healthy Brain Initiative cooperative agreement by the Centers for Disease Control and Prevention (CDC) . Through it, we will serve as a national information hub on ADRD for the nation's 574 federally-recognized tribes, as well as urban Indian populations. We'd like to recognize Dr. Lisa McGuire, from the CDC, for her leadership role in developing the Healthy Brain Initiative and her acknowledgement of the unique needs of AIAN people, including support and development of the Road Map for Indian Country.

Recent outreach to our project's Native Healthy Brain Advisory Group Members, composed of experts, providers, tribal leadership, elders, and caregivers from across Indian country, underscores that the COVID-19 pandemic has created significant issues for tribes and tribal elders.

These issues range from access to basic resources such as food and water, to more complex issues such as access to comprehensive health care. Several members of the Native Healthy Brain Advisory Group have themselves been infected with COVID-19 and continue to experience effects from the disease, which impacts their work and family life. Others in this small group shared stories of family and close friends in their tribe who have died as a result of COVID-19.

In our discussions we have found that meeting the needs of Native people with ADRD, and other nonpandemic related work, has been forced to be put on hold by most tribes as they address the crisis of COVID-19.

We also would like to share our concern for the nation's urban Indian population. Approximately 70% of people who identify as AIAN live in urban areas. However, most do not have local access to an Urban Indian Health Center, Indian Health Service, or tribal health care. This lack of access greatly affects their current health status, including limited and in some cases no access to care to identify and address ADRD.

The primary goal of our CDC-funded project is the creation and promotion of information resources on ADRD, such as those previously mentioned. To be effective, AIAN elders and providers need culturally relevant and appropriate, locally tailored ADRD materials and support for best practices. We encourage the Advisory Council to address the specific needs of this population within its work and recommendations.

IA² is also serving as the evaluator for two Administration for Community Living's (ACL) Alzheimer's Disease Program Initiative grants--one with the Great Lakes Intertribal Council in Wisconsin and the other with the Absentee Shawnee Tribal Health Center in Oklahoma. The effects of COVID-19 on tribal communities served by these programs have dramatically affected the work of these two entities.

In September 2020, our principal investigator for these projects, Dr. Jolie Crowder, submitted an article for publication on COVID-19 and health care workers. At the time, only 21 articles on COVID-19 and Native Americans existed. None focused on the impact on elders specifically; none discussed health impacts for AIAN people; and none discussed COVID-19's impact on Native ADRD patients or their caregivers.

Native elders are disproportionately impacted by the pandemic, with many dying from it. Existing research indicates that younger Native elders are dying from COVID-19 at higher rates than their white counterparts. The pandemic not only impacts their current care, including delay of care due to fear of becoming infected, but also has unknown impact on future challenges. The mental health implications for Native elders are significant and interventions are scarce. We urge the Council to ensure that research, outreach, and interventions are developed and implemented immediately that specifically address and include AIAN elders and caregivers, both during the COVID-19 pandemic and afterwards.

AIANs, including elders, face higher COVID-19 infection rates, are more likely to be hospitalized, and are more likely to die than other non-Native cohorts. Similarly, AIANs are more likely to be diagnosed with ADRD but face significant barriers to health care. Both crises evidence the disparities impacting Indian country and urban Indian elders. Already-challenged access to care for ADRD has been made more difficult by pandemic precautions, fears, and related shifts in resources. We call on the Council to ensure that AIAN elders and caregivers, as well as other minority and underserved populations, are prioritized in its forthcoming actions and recommendations.

Our organization is deeply committed and stands ready to partner across multiple sectors to identify and address the needs of tribal and urban elders and caregivers affected by ADRD.

In 2019, the Association of State and Territorial Health Officials and the International Association for Indigenous Aging developed and disseminated a series of materials for outreach to AIAN elders, caregivers, and providers on Alzheimer's Diseases and Related Dementias. All materials are available electronically.

• International Association for Indigenous Aging: National Healthy Brain Initiative http://iasquared.org/wordpress2/what-we-do/current-projects/healthy-brain-initiative/
• Two-Page Flyer for AIAN serving programs https://www.astho.org/generickey/GenericKeyDetails.aspx?contentid=20888&folderid=5150&catid=7184
• Horizontal and Vertical Posters for AIAN serving programs https://www.astho.org/generickey/GenericKeyDetails.aspx?contentid=20888&folderid=5150&catid=7184
• Provider Guide for Healthcare Providers and Administrators https://www.astho.org/Programs/Prevention/Healthy-Aging/Documents/Healthy-Heart-Healthy-Brain-Provider-Guide/
• Radio PSAs:
  • PSA #1: A Healthy Heart is A Healthy Mind (30 seconds) https://www.astho.org/uploadedFiles/Programs/Prevention/Healthy_Aging/IA²-ASTHO_PSA_no1.mp3
  • PSA #2: Older Minds Matter in Indian Country (30 seconds) https://www.astho.org/uploadedFiles/Programs/Prevention/Healthy_Aging/IA²-ASTHO_PSA_no2.mp3
  • PSA #3: Take Action to Care for Your Heart and Mind (60 seconds) https://www.astho.org/uploadedFiles/Programs/Prevention/Healthy_Aging/IA²-ASTHO_PSA_no3.mp3
  • PSA #4: Talk with Your Doctor About Aging and Brain Health (60 seconds) https://www.astho.org/uploadedFiles/Programs/Prevention/Healthy_Aging/IA²-ASTHO_PSA_no4.mp3
• Consumer and Caregiver Videos https://www.astho.org/generickey/GenericKeyDetails.aspx?contentid=20972&folderid=5161&catid=7220:
  • I Can't Remember: A Native Family's Story of Dementia
  • One Day at a Time: Supporting Tribal Caregivers and Elders with Dementia
• Editable Flyers https://www.astho.org/healthy-aging/healthy-heart-healthy-brain/

Good afternoon. I am the Industry Director for Positron Emission Tomography, for the Medical Imaging and Technology Alliance--or MITA.

As we heard, clinical assessments alone are limited in their ability to accurately diagnose patients, but FDA-approved amyloid and tau imaging PET agents are available today to detect the hallmark pathologies of Alzheimer's disease. These precision radiopharmaceuticals have consistently shown high impact on patient diagnosis and management. Additionally, they are powerful and precise enough to detect Alzheimer's disease pathological changes very early. Unfortunately, current Medicare policies compromise covered outpatient beneficiary access to these precision diagnostics.

There are multiple barriers to patient access to these precision neurological diagnostic radiopharmaceuticals -- both in coverage and payment. At CMS, there is an automatic non-coverage policy for non-oncologic PET. Because of this, CMS required a very lengthy coverage with evidence development Study (IDEAS) of 18,000 patients which resulted in patient management changing in over 60% of the time. These findings strongly support the idea that CMS change the automatic non-coverage for non-oncologic PET Alzheimer's diagnostic drugs.

With regard to Medicare payment, the current inequitable "packaged" payment methodology makes these new, targeted diagnostic radiopharmaceuticals a financial liability to hospitals. Specifically, hospitals are only reimbursed a small percentage of the costs to provide the services to Medicare beneficiaries in the outpatient setting. While other payers have found innovative ways to reimburse these diagnostics, Medicare remains tethered to a "packaged payment policy" established more than a decade ago. Industry and Specialty societies have worked with CMS to attempt to resolve both the coverage and payment issues, however lack of access still exists. We ask for your support with CMS to address these issues.

• I am the Director of the Memory Disorders Program at Georgetown University in Washington D.C.
• I want to thank the Council for the opportunity to speak today about the innovations in the diagnostic pathway of Alzheimer's disease.
• There are currently 3 companies with an FDA-approved diagnostic radiopharmaceutical indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. These 3 diagnostic radiopharmaceuticals have been FDA approved since 2013.
• There are multiple barriers to access of beta-amyloid PET imaging due to The Centers for Medicare & Medicaid Services (CMS) decision to cover these imaging techniques to detect the earliest stages of Alzheimer's disease but only under Coverage with Evidence Development (CED).
• In 2016, CMS approved the first CED study to be conducted for Medicare beneficiaries known as the "IDEAS" study. The IDEAS study, of more than 18,000 Medicare beneficiaries, provided evidence that beta amyloid PET imaging can change medical management in 60.2% of mild cognitive impairment patients and 63.5% of dementia patients of uncertain etiology.
• Results of IDEAS also concluded that diagnosis changed in 35.6% of patients, including an increase in diagnostic confidence and a decrease in utilization of alternative diagnostics.
• A second study, and maybe the final study, was approved by CMS in April 2020 and has just started known as New IDEAS.
• New IDEAS will require 7,000 patients and is intended to seek more evidence from African American and Hispanic Medicare-eligible patients. This is an important group as there are estimates that more than 20 percent of Americans with Alzheimer's disease are African American, and 13 percent of U.S. Latinos age 65 or older are thought to have Alzheimer's disease or a related dementia.
• In the first study IDEAS, many academic and large hospitals including Georgetown participated. Unfortunately, in New IDEAS these same hospitals and physicians will not have the ability to participate due to the payment issue whereas Medicare payment to hospitals is packaged for all these services. Payment for diagnostic tools, such as amyloid PET imaging, are currently a financial liability to hospitals.
• While there may be no cure for Alzheimer's disease today, having the correct diagnosis can not only help patient and caregivers make appropriate plans, but can also influence proper management of the patient as seen in IDEAS.
• Further, researchers who are focused on finding viable, novel therapeutics also rely on PET Imaging to determine treatment potential and efficacy of new compounds. This reliance on PET imaging is seen with the various treatments in the clinical trial pipeline and will likely continue for future compounds.
• We encourage the Advisory Council to support the effort to obtain coverage and appropriate payment for all Medicare beneficiaries that need to be tested with FDA approved diagnostic products that can assist physicians in diagnosing Alzheimer's' disease.
• Thank the Council for the opportunity to provide comments at this meeting.