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

I am the 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.

Too often, health care systems and medical groups are unable to implement evidence-based dementia care programs because the costs of providing services in the program are inadequately covered by the existing payment mechanisms. 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.

During the last Advisory Council meeting we called attention to a report by the Alzheimer's Impact Movement and Alzheimer's Association, titled Dementia Care Management: A Proposed Framework for an Alternative Payment Model. [https://alzimpact.org/media/serve/id/5f1b511b98110]

Today, we are making this public comment to support the Comprehensive Care for Alzheimer's Act which was introduced with bipartisan support on April 15, 2021. If enacted, this legislation would require the Center for Medicare and Medicaid Innovation (CMMI) to test an improved payment structure for dementia management, including a capitated payment model and incentives based on performance to support care planning and coordination, management of chronic conditions, interdisciplinary approaches to care, and caregiver education and support. Importantly, this payment structure would aim to expand access to comprehensive dementia care to "as many Medicare beneficiaries as possible, especially individuals from diverse communities and rural and medically underserved areas". [https://alzimpact.org/press/press_release/id/193]

We are also 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 by addressing 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; and,
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.

I am a producer and co-host of a weekly podcast called Remember Me, which focuses on Frontotemporal Degeneration, otherwise known as FTD.

Remember Me spreads awareness of FTD through the beautiful art of storytelling, and one of the first stories told was my own.

My mother, Amalia had the Primary Progressive Aphasia variant of FTD. She was diagnosed with both FTD and ALS in Boston in 2016, after my family noticed changes in her ability to communicate with us.

Four years later, in December 2020, she died at the age of 56.

My precious, vibrant mother -- a talented artist with followers from all over the world, a woman who humbly changed the lives of so many, was gone in what felt like a blink of the eye. In the last years of her life she was unable to speak, make art or even communicate in any way what was happening to her -- and there was nothing any of us could do to stop it.

In the middle of the pandemic, and in the thick of her illness, I created Remember Me podcast with Rachael Martinez, a friend I met online who was going through the same experience -- across the country -- with her father Frank.

Over the last 9 months, we have interviewed over 30 FTD caregivers from all over the United States. In each interview we ask the caregiver to tell us about the road to diagnosis, the caregiving experience, and most importantly, to remember and share who their loved one was before FTD.

Many symptoms and stories are different, however, one part of every story is always the same. When I ask about receiving the FTD diagnosis, without fail, we hear some variation of "The doctor said: They have FTD, there is nothing we can do, Good Luck"

We've heard caveats of "I hope you have a lot of money", "You can come back and check-in, if you want", "They have 7-10 years to live" or even "You should put them in a nursing home and move on with your life"

Today, I ask you all to imagine this scenario -- your loved one is in the prime of their life, and they receive a dementia diagnosis -- and the doctor says "There's nothing we can do, good luck"

Just because FTD has no cure, does not mean we can just give up on care. In those moments of delivering the diagnosis, a doctor can has a choice and they can choose to the time to listen, comfort, and provide insight.

I always find inspiration in this excerpt from my mother's art blog, in 2007 she wrote, "Everyone has a light. Everyone has the power and ability to inspire."

Each medical professional that deals with FTD or related illnesses has the ability to be a light in the darkest moment for a family. Today I ask that you consider what tools and education we can provide so they can be that light.

Thank you for the presentations today and especially to Laura for sharing her experiences. I am with the Association for Frontotemporal Degeneration. AFTD uses the term Degeneration as an umbrella that covers several different clinical diagnoses including behavioral variant frontotemporal dementia or bvFTD, primary progressive aphasia and the movement disorders Corticobasal syndrome, progressive supra nuclear palsy as well as ALS and FTD. FTD is the most common cause of dementia in people under 60, but most people have still never heard of it before.

As the most common form of dementia in people under the age of retirement, the 24 month waiting period for Medicare coverage hits people with FTD and their families particularly hard. The behavioral symptoms of FTD combined with the general scarcity of diagnostic expertise often results in people getting fired before they are even diagnosed with FTD. For many, the first challenge FTD poses is figuring out how to get a diagnosis and care after losing employer provided health benefits. Once diagnosed, people with FTD can qualify for an expedited disability determination under the compassionate allowances program but many people never even get that far. For those that do, having to wait an additional 2 years for Medicare eligibility can feel like treading water after running a marathon. I can't imagine what it would feel like if there were treatments or therapies for FTD available.

Another complication that has arisen since the waiver of the waiting period for people with ALS was passed is the discovery of the gene C9orf72. The C9 gene is associated with familial ALS and FTD. Some people with C9 mutations will present with FTD while other family members will present with ALS. How the waiting period waiver for Medicare coverage would apply in a situation like that is not entirely clear.

From the perspective of people living with FTD and their families the 2 year wait for Medicare just doesn't make sense. The cynic in me wants to say that it doesn't really matter since there are no drugs or treatments for FTD anyway, but the optimist in me sees real reasons for hope that those treatments will become available in my lifetime. AS it is now, it is possible that a person with FTD could be prevented from accessing a disease modifying therapy because they were waiting for Medicare coverage. Even hypothetically that seems cruel.

The most obvious way to prevent that possibility is to simply waive the 2 year wait for people with FTD, or anyone under the age of retirement with a permanently disabling condition like those on the Social Security Compassionate Allowances list. AFTD welcomes the chance to work with anyone to make that happen.

Good afternoon and thank you for your time today. I am Director for Strategic Alliances for The Gerontological Society of America (GSA).

GSA is the oldest and largest interdisciplinary organization devoted to research, education, and practice in the field of aging, with 5500 members. Our mission is to cultivate excellence in interdisciplinary aging research and education to advance innovations in practice and policy. Many GSA members are devoted to clinical practice and research on ADRD and some are current or past members of the Council.

On behalf of GSA, I'd like to highlight two areas in which we can better support individuals with dementia and their care partners:

1. Earlier detection; and
2. Improved recognition of and care for behavioral and psychological symptoms of dementia (BPSD).

To address the first area, GSA released the 2020 Edition of The GSA KAER Toolkit (available at https://www.geron.org/publications/kaer-toolkit) -- as an update to the 2017 version. The toolkit aims support primary care teams in implementing a comprehensive approach to dementia care - from initiating conversations about cognitive health, detecting, diagnosing through providing referrals to community-based supports and clinical trials. The new edition is digital, summarizes the latest evidence in the field, and provides tips on coding and reimbursement.

To address the second area, we released a new report about dementia-related psychosis (DRP) with a multidisciplinary clinical workgroup. DRP consists of delusions (false beliefs) and hallucinations (seeing or hearing things that others do not see or hear). Symptoms can be frequent, severe, and persistent, and are among the factors that may lead to long-term care placement for loved ones with dementia. Our report examines the challenges that persons with DRP and their care partners encounter as they move through different health care settings. We offer recommendations on how to mitigate risks and improve healthcare outcomes and would invite the Council Members to review our full report on the GSA website (https://www.geron.org/programs-services/alliances-and-multi-stakeholder-collaborations/dementia-related-psychosis).

Thank you for your commitment and service on the Council and to people living with dementia and their care partners.

Everyone agrees the U.S. and the world urgently need an FDA-approved therapy for Alzheimer's disease. One or more potential treatments are under review by the agency. But it is crucial to ensure bias-free consideration of these candidate drugs.

There have been some disturbing omissions in several letters (publicly available) from Alzheimer's advocacy groups to the FDA supporting a current drug candidate.

In particular, possible conflicts of interest were not disclosed in the letters, even as a footnote. Online findings indicated that significant monies have been previously paid, in various forms, by the drug's corporate sponsor to these major advocacy groups.

This is not necessarily bad or wrong, but such clear potential conflicts of interest should be revealed to the FDA, to aid its experts in weighing the value of the support letters. If a compound were approved based on biased support, it could tarnish all Alzheimer's drug development.

There is already in place a strict "disclosure" policy for scientists submitting papers to the major Alzheimer's journals.  Why should advocacy groups be exempted from disclosure in support letters they write to FDA?

I hope the Council will address this issue by providing a formal suggestion to disclose potential conflicts of interest when any advocacy group urges FDA approval of any Alzheimer's therapy.

Thank you for your consideration.