National Alzheimer's Project Act: Public Comments from Advisory Council Meeting, July 2020

I am the Medical Research Program Director for the Physicians Committee for Responsible Medicine. We are a non-profit health advocacy group based in Washington D.C. with over 12,000 physician members. The COVID-19 pandemic has exposed issues that we as the Alzheimer's Disease and Related Dementias (ADRD) community have known for some time. Although it has been encouraging to see the presentations on how we may address emergency preparedness and advance health equity, these are not sufficient. Disparities in care and in research have clearly widened due to the global pandemic. The cracks in our ADRD systems of care have now become fissures.

Although the Advisory Council had already recognized that diversity and health disparities were major issues prior to COVID-19, fundamental issues were not addressed. Roadmaps and research implementation areas were being developed, but in practice the National Plan largely conceptualizes these issues as being addressed in clinical trials and care services. We call on the Advisory Council to recommend immediate action by the National Institutes of Health (NIH) to integrate diversity and health disparities factors throughout the entirety of the therapeutic development process. Relegation of the study of these factors to "the population studies and precision medicine" implementation areas or cross-cutting themes of the National Plan are insufficient. Integration of diversity must be foundational and start with human-based research in the therapeutic discovery phase within "disease mechanism and translational tools".

Thanks to substantial commitments from the public, the NIH has resources to immediately carve out new priorities to address these gaps in ADRD preclinical research. Without these human-based approaches that factor in diversity we hold back our understanding of ADRD and we prevent potential therapies from being developed and effectively applied in a highly heterogeneous society.

To be clear: Understanding human diversity will require human-based approaches. We cannot and should not reduce highly complex risk factors and human diversity factors into narrow subsets of features in animal models.

Fortunately, there are multitudes of modern ways to study the impact of human diversity on ADRD throughout many scales of biological and environmental interaction. We urge the national leadership to rebuild the framework of scientific practice. Research of diversity factors in ADRD must be clearly indivisible from research of the mechanisms and phenomenology of the disease. This should start by the creation of a new action plan for diversity factors in preclinical research.

Our six specific calls to action include:

1. REPORTING & REPRIORITIZATION: Report the number of animal model grants. Shift this funding towards human-based methods of human diversity.

2. CREATE NEW FUNDING: Create new dedicated human-based neuroscience research funding and other resources for high-quality basic neuroscience and preclinical ADRD research. These new projects must explicitly address human diversity factors. These opportunities may take the form of new Concept Clearances and RFPs that specifically stimulate research areas for human diversity using exclusively human-based methods.

3. CHANGE THE REVIEW PROCESS: Overhaul the scientific review process so that (a) human-based research and (b) diversity are major factors in the scientific criteria and numerical "impact scores". It is inadequate to consider these only as "non-numerical scores".

4. DIVERSE BIOSPECIMENS & NEW PARTNERSHIPS: Coordinate new partnerships that increase the availability of diverse human biospecimenrepositories. Set a timeline to ensure that resources are developed to represent disproportionally affected groups, such as ethnic and rural populations.

5. HUMAN-BASED TRAINING: Create (a) new training programs for early career scientists where human-based diversity factors are foundational to their research and (b) new retraining requirements for established researchers to replace outdated approaches with modern human-based approaches that address diversity. The training should advance human-based methods and theoretic frameworks. It will be important to strongly partner -- equally and ethically -- with the communities experiencing health disparities.

6. DIVERSITY & HUMAN-BASED RESEARCH TASK FORCE: Given the urgency of the matter and the disparities intensified by the pandemic, a taskforce should be created as soon as possible to implement the above recommendations. The action plan should be enacted by the next National ADRD Research Summit. The task force should include representation from all stakeholders.

We have no time to waste. As others have spoken today, we can emerge from this crisis more inclusive and equitable. The positions that the committee takes can make all the difference. You can help rally broad support for these most needed priorities of diversity and addressing health disparities in preclinical research, leading to better care and wellness for all. The Physicians Committee stands ready to help the Council and NIH in the next bold stages of the research priorities in the National Alzheimer's Plan.

• Good afternoon! I am Nora Super, Senior Director of the Milken Institute's Center for the Future of Aging. Today, I'm happy to announce the creation of the Alliance to Improve Dementia Care, of which I will serve as Executive Director. [https://milkeninstitute.org/centers/center-for-the-future-of-aging/alliance-to-improve-dementia-care]

• Last November, the Milken Institute released a comprehensive report to examine the evidence and put forward 25 actionable recommendations to reduce the cost and risk of dementia. We believe these recommendations align well with the goals of the Advisory Council on Alzheimer's Research, Care, and Services -- especially those that were presented today as cross-cutting recommendations. [https://milkeninstitute.org/reports/reducing-cost-and-risk-dementia]

• After consulting with a broad network of stakeholders, we identified the need to establish an Alliance focused on improving dementia care to move these recommendations forward.

• Using the convening experience and expansive network of the Milken Institute, the Alliance will bring together partners from health systems, industry, research, advocacy, philanthropy, and government to better communicate, collaborate, and advance recommendations to improve dementia care. [https://milkeninstitute.org/new-about]

• We believe the Alliance comes at a critical moment to ensure we build workforce capacity and implement comprehensive dementia-care models to effectively identify people at risk for or living with dementia, tailor services to meet their needs and those of their caregivers, and ensure they get the right care at the right time.

• With support from founding members AARP, the Alzheimer's Association, Bank of America, Biogen, and The John A. Hartford Foundation, we seek to partner with leaders across multiple sectors to create solutions to optimize the workforce, build system capacity, and integrate services and support.

• We are also deeply committed to developing and promoting policies that reduce disparities in prevalence and access to services for populations at the highest risk for dementia, including women and communities of color.

• The Alliance to Improve Dementia Care is accepting new members and supporters. For more information on the Alliance to Improve Dementia Care, please visit the Milken Institute website https://milkeninstitute.org/centers/center-for-the-future-of-aging/alliance-to-improve-dementia-care.

I am Project Director at Education Development Center, a non-profit research and development organization. I prepared these public comments with Dr. Epstein-Lubow, a geriatric psychiatrist at Butler Hospital and Associate Professor at Brown University and Dr. Reuben, Professor of Medicine and Chief of the Division of Geriatrics at the David Geffen School of Medicine at UCLA. These comments are our own.

In an public comment at the January 27, 2020 meeting, we stated that the Assistant Secretary for Planning and Evaluation (ASPE) and this Advisory Council must address payment reform for dementia care and treatments. There are at least six working models in the US for dementia care that improve quality, achieve better clinical outcomes for persons living with dementia and caregivers, and some lower costs; but, dementia care using these models is not widely available.

ASPE should be aware that on Nov 7, 2019 a one-day meeting focused on "Payment Models for Comprehensive Dementia Care" convened over fifty clinicians, researchers, advocates, payers and other leaders with expertise in dementia care and healthcare payment. The conference was heldin Washington, D.C. with support from The John A. Hartford Foundation, Hebrew Senior Life, and Education Development Center. During the conference, these experts reviewed short-term solutions for payment reform and discussed next steps for accelerating the use of current and new payment models. A manuscript describing conference outcomes has been accepted for publication in the Journal of the American Geriatrics Society. The manuscript includes recommendations for improving access to comprehensive dementia care through payment reform, research, education and advancement of a population health approach to coverage based on risk and need. HHS should consider the expert recommendations in this manuscript when it becomes available.

In addition, HHS should act now to advance payment reform efforts through three activities:

1. Continue work previously conducted by ASPE regarding Examining Models of Dementia Care, and how they have been modified during the COVID-19 pandemic;

2. Convene at least one work group to address payment reform for comprehensive dementia care; and,

3. Begin immediately to monitor how the inclusion of dementia as a risk adjustment modifier in the CMS Hierarchical Condition Category (HCC) coding affects the definitions of populations of people living with dementia, the quality of care, the types of care received, and the health outcomes of those individuals.

These recommendations are in alignment with the National Plan to Address Alzheimer's Disease's Strategy 1.E (Facilitate translation of findings into medical practice and public health programs) and all Strategies under Goal 2: Enhance Care Quality and Efficiency.

Thank you for considering these comments.

Attached is my speech for the NAPA meeting. There is nothing wrong with the format as this is what I need to do in order to read it. It would be great if you can leave it that way so others can see what I must do to continue to be able to function as it may help another person with dementia who also has trouble reading any more.

Please let me know the next steps or if I need to do anything else. I may also add to my comments once I see the agenda and hear the discussion for that day.

My name is Michael Ellenbogen.          Some of you          may remember me          as I live with dementia;          but I am living life to the fullest          and making huge changes          in how people with dementia          should be treated,          wherever they live.         Although my request to speak          over the internet          for so many years was originally denied          a higher-level power          ensured that I had my chance to be heard here today          and I now understand          that all of those with dementia          can now be heard         no matter where they are in the US.          I remember          about 5-6 years ago          when I stood on the floor          and insisted you include people with dementia          as part of the process.          To my surprise          you rose to the top           and did exactly that          the following year.         For that I am extremely grateful.

I now want to commend you          for taking this action of listening to them         over the internet          which will make everyone          so much more knowledgable          as they are the true experts          when it comes to knowing what itsreally like  to live with this disease          and what it truly needs to improve our lives. 

But we still need a little more tweaking.          As part of this program,          you need to add one more person          living with dementia          to the NAPA board.         I have done this for a very long time          and it is my time to move on.          I do hope          that others will step up to the plate          and take over          where I left off.          So much more needs to be done;          but it will only happen          if others          with dementia         continue to fight          for our civil rights          and be heard         and included in the process          of all decisions being made.

It is important          for them to also understand         things do not happen by just saying it          once or twice.          But we must continue to repeat it          as many times as necessary          until it finally becomes part of the process.          I personally know         it is not easy          but we can not give up          as some things have taken 5 years          to finally happen.         Don'tbecome discouraged          if you are not successful;          but think outside the box          for a new method         to get your points across.

Thank you again          as we continue to make progress towards         "Nothing About Us Without Us".

P.S.         I would also like to thank          Arnold & Porter law firm          for standing up for all those          with dementia because if it were not for their assistance          our voices would have been kept silent.

Thanks so much for the opportunity to update but I have no Idea on what I sad because I only though about it an hour before my speech and I had no notes. I tend to live in the moment. Please use what you already have. Hope you show it the way I sent it in and let other know why I do that. Even that is becoming hard for me to read as I was really struggling this time. Butit worked great for about 8-10 year. Reading and writing is really become a big issue. Even following TV as the way people speak it'stoo fast to possess. Have a great day