List of Comments
Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.
PLEASE NOTE: The Public Comments included here are not an endorsement of the views or information by National Alzheimer's Project Act, its Advisory Council members, the Administration or the federal agencies involved in this project.
N. Lundebjerg | 8-11-2023
The American Geriatrics Society (AGS), a nationwide, not-for-profit society of more than 6,000 geriatrics healthcare professionals, including geriatricians, geriatrics nurse practitioners, social workers, family practitioners, physician assistants, pharmacists, and internists, appreciated the opportunity to participate in the July 31st meeting of the Advisory Council on Alzheimer's Research, Care, and Services. I am the CEO of the American Geriatrics Society. I am also a care partner who has lived experience caring for someone with dementia.
On behalf of the Society, we were pleased to hear about the various ways that federal agencies are addressing Alzheimer’s Disease and related dementias in their work. We were also excited to learn that the Centers for Medicare and Medicaid Services (CMS) will be testing a new dementia care model. Our main comment as the Center for Medicare and Medicaid Innovation (CMMI) roles out this demonstration is that there needs to be attention to workforce skills and competence in the criteria.
We believe that providing optimal care for people living with AD or dementia requires access to an interprofessional primary care team that has expertise in both geriatrics and dementia. The reality is that people living with dementia often have co-morbidity that contributes to the complexity of their care. Ideally, they will have access to an interprofessional team that includes geriatricians, nurses, social workers, and pharmacists who will support them in accessing the services and supports that they will need. The clinicians involved would be familiar with the person living with dementia and involved in their routine health care and social support needs. They will have expertise in person-centered planning that has at its center what matters to the person.
Unfortunately, there is a current shortage of healthcare professionals that specialize in older adult care and care of those living with AD and other dementias. This shortage is compounded by the lack of attention to older adults across healthcare professional training. The only federal programs that seek to address this gap are the Geriatrics Workforce Enhancement Program and the Geriatrics Academic Career Awards that are overseen by the Health Resources and Services Administration (HRSA). These programs are having a real impact on the knowledge and skills of the primary care clinicians that they reach but are underfunded and but a drop in the bucket in terms of meeting our country’s needs.
For these reasons, we encourage NAPA to include a consideration of the significant gaps in workforce knowledge and skills when it comes to caring for people living with dementia. We believe that this issue should be front and center on every agenda and one of the major areas of focus for the Advisory Committee on AD Research, Care, and Services.
J. Cigliana | 8-7-2023
Members of the NAPA Advisory Council, thank you for opening this meeting for public participation and comment. The work of this Council is crucial as our nation looks to respond to the complex challenges faced by people living with dementia and their families.
It has been a privilege to be here in person on such a monumental day. I want to thank each of you for your countless individual contributions to this work and for collectively serving as champions for the millions of people impacted by dementia.
I serve as the executive director of Memory Care Home Solutions, a community-based organization in St. Louis, Missouri. We’ve been delivering evidence-informed, non-drug dementia services for families for 20 years. Our community has directly benefited from your work, and you have inspired and motivated us. Thanks to funding from the ACL Alzheimer’s Disease Project Initiative, we have translated the evidence-based interventions COPE, which is an Occupational Therapy intervention, and Care Ecosystem for delivery in our community. The Guide model announced today by Administrator Brooks-Lasure and the recommendations of this council will work toward filling enormous voids in healthcare for people living with dementia and their family caregivers. I was working as an Occupational Therapist for a large health system, when I began observing the lack of treatment provided through traditional healthcare settings for people living with dementia and their families. Not only are caregivers largely ignored in care settings, they are often blamed and even criticized for their poor management of their loved one’s other chronic conditions. Patient’s acute issues are addressed in healthcare, but dementia and the long-term management of dementia symptoms and functional decline are largely ignored. At Memory Care Home Solutions, we still see hundreds of families each year who share their painful healthcare interactions with us.
I applaud you all for recommendations that would have a transformational impact on the lives and healthcare experiences of people living with dementia and their caregivers. I am most encouraged to see that the Guide Model and codes proposed for the 2024 Physician Fee Schedule highlight and validate the contributions of informal caregivers. I also lead a community of practice on dementia care for the American Occupational Therapy Association. In a recent poll of our members, concerns about providing and billing for caregiver education were the concerns weighing most heavily on OTs’ minds. Caregiver education from OTs is generally focused on hands-on strategies that directly support the daily function of people with dementia and the management of behavioral and psychological symptoms. We need coverage of caregiver education to reimburse therapists for the time spent with families on these issues which are so central to quality of life. There are few disciplines within healthcare that focus specifically on safety in the home environment, performance of activities of daily living, and meaningful engagement in activities to reduce behavioral and psychological symptoms. Occupational Therapy can and should be an important part of the interdisciplinary team for comprehensive dementia care.
In our navigation model based on Care Ecosystem, we utilize non-licensed navigators who are supported by a clinical team of occupational therapists, social workers and pharmacists. Services are provided in coordination of care with patients’ established primary and specialty care providers. Without philanthropic support and ACL funding, our services would not be possible. The Guide Model and these recommendations would allow for dementia to be managed and covered within healthcare benefits, similar to other chronic health conditions. This level of access is a gift to celebrate.
It's important to acknowledge that community-based organizations, like Memory Care Home Solutions, are deeply entrenched in our communities. We represent and reflect the voices of the people we serve, and we have deep knowledge of the resources available in our regions. Many community-based organizations are billing services through Medicare, are already delivering evidence-based programs and are poised to participate in these models and recommendations.
We look forward to the bridges that will continue to be built across communities, providers, state and local governments and federal agencies to make these recommendations a reality. Thank you for your historic contributions to the field of dementia research and care.
J. Butler | 8-1-2023
Good afternoon. I was diagnosed with Alzheimer's disease seven years ago, and today, I am speaking with you as an advocate with Voices of Alzheimer's.
While we in the Alzheimer's community have much to celebrate recently, I'm here today with one simple message: our work is far from over.
After decades of hard work and sacrifice by so many people here and countless others, I'm extraordinarily grateful for our progress in finally getting treatments and diagnostics for people living with Alzheimer's disease. But these treatments are not a cure, and not everyone needing treatment can access it.
I urge this committee to continue the push to improve rates of early, accurate diagnosis. Existing medicines for Alzheimer's are only effective in the early stages of the disease, meaning that once a person progresses beyond early Alzheimer's, they are out of treatment options. The U.S. government must continue to invest in and drive research that allows for early detection of Alzheimer's at stages of the disease where treatments are still effective.
It's also crucial that we prioritize identifying as many candidates for treatment as possible and continue eliminating treatment barriers. The stigma surrounding the disease, the cost of treatments, unreliable transportation to distant treatment centers, lack of nearby providers, and more are all real barriers preventing people from getting diagnosed and treated every single day and reaping the benefits of delays in the progression of this devastating condition. I urge this committee to do all it can to help dismantle these barriers to care.
Every day, thousands of people progress past the early stage of Alzheimer's to the point when existing treatments may no longer help them. We have a lot to celebrate but also a lot left to do. I urge this committee to keep up the good fight to make sure that the six million Americans living with Alzheimer's like me receive the care and treatment we deserve.
T. Walter | 7-31-2023
Good afternoon. Thank you for letting me speak with you today. It is an honor for me to share with you the Walter family story, my story, of FTD & ALS. This journey will be one of the hardest journeys a patient and their family will ever take. FTD is a brain disease, not a memory disease, affecting one’s behavior, personality, speech, and movement, most commonly occurring in ages 45-64, however it can reach from ages 20-80.
Our family journey started in 1981, with a mother being diagnosed with ALS and finished in 2007 with my husband passing from FTD/ALS. (a 26 year journey). Today, there are 8 children and 15 grandchildren that are at risk in developing the genetic form of FTD/ALS. This is why I am so passionate about FTD and finding a lifelong cure.
Because my husband and his brothers were diagnosed in the very early stages of FTD/ALS and the fact of Sacramento’s closeness to San Francisco, they were able to participate in research as often as possible. Because of their participation in research, the C9orf72 gene was discovered.
The positive outcome has been, since 2007 the Walter family has come together to bring awareness and hope to find a cure for FTD/ALS. Today, I’m super excited about the HEALTHY BRAIN INITATIVE. As with most diseases, early detection is critically important. Unfortunately, the genetic form of FTD/ALS, affects individuals that have the disease prior to the start of symptoms, which is why starting early treatment is critically important.
This is why I believe, FTD/ALS and all other neurological dementias should be included in the Healthy Brain Initiative, not just Alzheimer.
Thank you for taking the time to learn more about this Life altering disease and how it effects our families.
H. Hillerstrom | 7-31-2023
I have a 9-year-old son Oskar with Down syndrome and I am also the President & CEO of LuMind IDSC Foundation. LuMind IDSC is a leading national non-profit organization accelerating Down syndrome research and empowering 300,000 families in our online community.
Adults with Down syndrome are genetically predisposed to early onset of Alzheimer’s disease with a lifetime risk of 90%. Ironically, I am not worried that my son Oskar will get Alzheimer’s disease, because of the exciting disease-modifying drugs that are approved or nearing approval by the FDA for early Alzheimer’s disease. However, the clock is ticking for adults with DS in their 40s and 50s, so we are working with urgency to stop progression of the disease in that generation of adults with DS.
As mentioned in a public comment at the May NAPA Council meeting, LuMind IDSC, the NTG and a group of 20 experts in Alzheimer’s and DS, have been working on equivalency criteria for treatment access to the class of anti-amyloid Alzheimer’s drugs to people with DS. The expert panel concluded on four key adaptations needed for the DS community:
- Age
- Adults with DS-AD are symptomatic at an average age of 54 years, but some get dementia in their early 40s. Access needs to account for the earlier onset.
- Assessment scales
- Cognitive, behavioral and functional assessments are not sensitive enough for use in in individuals with Down syndrome;
- Thankfully, assessment scales have been adapted for people with DS and the expert panel recommends their use.
- Contra-indications
- Seizures, certain immunological diseases, and hypothyroidism are very common in adults with DS, whereas severe mental health issues are very uncommon;
- The expert panel recommended adaptations for our population regarding these possible contra-indications.
- Safety data in our population
- Our query of clinicaltrials.gov showed that in 30 clinical trials with 17,000 participants with Aduhelm, Leqembi and Donanemab no one with DS was included.
- The expert panel recommended the conduct of safety trials in adults with DS, so clinicians feel more comfortable prescribing these drugs to our high need population.
To conclude, Alzheimer’s disease is the leading cause of death in adults with DS, accounting for 75% of deaths. We ask that the NAPA Council, the pharmaceutical companies and all other stakeholders have the DS population on your mind in everything you do, so that barriers to equitable access to the latest Alzheimer’s therapies are removed, and that safety trials are conducted as soon as possible with these promising drugs.
L. Norins | 7-28-2023
Recently there has been much progress in canine detection of the scent of Parkinson's disease. This has been followed by the development of a sebum test analyzed by mass spectrometry. The patient sample required is a non-invasive cotton swab of the patient's back. I hope the NIA can issue an RFP to conduct a large-scale test to determine if canines, with their sensitive noses, can also detect unique aromas from Alzheimer's patients, including skin and urine samples.
Thank you for your consideration.
K. Brandt | 7-27-2023
Good afternoon members of the Advisory Council, presenters and guests. Today I am speaking with two hats; the first is as a former FTD caregiver for my late husband who lost his life to FTD at the age of 33 and the second is as Director of the ALLFTD Participant and Family Engagement Board.
ALLFTD is a comprehensive study targeting most varieties of frontotemporal lobar degeneration, also known as FTLD or FTD. Funded in 2019 with a five-year grant through the NIH’s National Institute on Aging and National Institute of Neurological Disorders and Stroke, ALLFTD has more than 20 study sites across North America and aims to prepare the FTLD community for treatment trials in FTLD.
Our Engagement Board is made up of enrolled study participants and their caregivers whose lives have been touched by FTLD. Board members can provide feedback on the ALLFTD research experience and advise on participant and family priorities for research. It is important that these priorities are known to ALLFTD study staff as well as the larger community of scientists, clinicians, funders, and policy makers because this is an atypical, young-onset dementia which robs individuals and families of a future together while also bestowing a devastating financial burden to shoulder the cost of care.
Today we ask that NIH funding continue, not only for the ALLFTD study, but for FTLD and related dementia research in general. We also ask that expanded education is offered to healthcare professionals in many different settings about how to accurately diagnose FTLD as many individuals living with FTLD experience one or more misdiagnoses because too often clinicians do not have exposure to young-onset and atypical dementias. This steals precious time during the early stage of the disease when individuals and families can connect with a community of support, participate in research and discuss values and wishes for future healthcare.
I would like to thank the NAPA Advisory Council for their continued advocacy for research, care and services for all dementias, building hope that the cure of tomorrow is not so far from the care of today. Our call to action is for continued funding from the NIH for the ALLFTD study beyond 2024 and for expanded research funding for young-onset, rare, atypical and related dementias.
K. McKeon | 7-18-2023
Hello. I am the Manager of Grassroots Advocacy at the National Down Syndrome Society. I am also the first registered lobbyist with Down syndrome.
When I was born 35 years ago, the life expectancy for a person was Down syndrome was only 30 years. Now the life expectancy is about 60 years. Thankfully, medical science has advanced and allowed me the opportunity to live a long and productive life.
However, as you may know, the vast majority of individuals with Down syndrome will experience the brain changes associated with early onset Alzheimer’s disease. Many of these individuals will lose the skills and abilities they worked so hard to achieve and will require increasing assistance from others to care for themselves.
I have a friend who is currently experiencing early onset Alzheimer's disease and deteriorating quickly, and it is a scary reminder of what could happen in the future to me and others if we don’t make discovering a treatment and cure for Alzheimer’s disease for those with Down syndrome a priority. I was thrilled to hear drugs that slow the progression of Alzheimer’s disease have begun to be approved by the FDA. However, it is also discouraging to hear that no individuals with Down syndrome were included in the safety trials. Because of that, physicians will not be able to confidently prescribe this potentially life-extending medication to individuals with Down syndrome despite it being approved for the general population.
It is vital that individuals with Down syndrome are given the chance to be included in clinical trials for Alzheimer's disease so they too can have safe access to the newest and most effective drug treatments for Alzheimer’s disease.
Thank you for your continued support as we work to improve our community’s access to accurate and timely diagnosis, care, and inclusion in research. Let’s continue working to make healthcare equitable for everyone.