ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES
Public Comments on Advisory Council Meeting, February 2017
List of Comments
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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.
S. Peschin | 01-31-2017
Good afternoon. My name is Sue Peschin and I serve as President and CEO of the Alliance for Aging Research. Thank you for the opportunity to provide a public comment.
I have a few thoughts for the council to please consider today:
Last, I have one more comment. To the federal members and staff that serve this counsel, and to your thousands of colleagues back at your agencies: The Alliance for Aging Research believes that the work you do is important, and worth defending. We have hope that this new Administration and Congress will share our sentiment on several of the research funding, clinical development, and healthcare issues that matter to us, and we look forward to working with them on those issues. They may also disagree with us on other issues. But, nothing will prevent us from speaking out and standing up for what we know is right.
Thank you for the work you do, and please know that we support you.
Thank you for the opportunity to comment!
M. Sterling | 01-29-2017
It's increasingly difficult for many families, struggling to care for someone with dementia, to focus. The first week of the new administration has left us wondering what an uncertain future will bring. As I'm writing this, the Affordable Care Act is in serious jeopardy.
When you ask most Americans, "what impact will the repeal of the Affordable Care Act have on people with dementia and their families?", most have never even considered that it WOULD have an impact. People need to know.
My colleagues at the LEAD Coalition did a wonderful job of outlining the "actual facts" in a concise, must-read issue brief. We have copies for each of you. This is important information because repeal of the ACA could very well impact the goals and recommendations of this Council for years to come.
Here are the important provisions hanging in the balance that EVERYONE needs to be aware of and those that are most important to my family:
So in this new era of "alternative facts", let's not leave Alzheimer's families in the dark, only to find the rug has been pulled out from under them and they never saw it coming.
F-Y. Li | 01-27-2017
I am here on behalf of the Physicians Committee for Responsible Medicine, a Washington DC-based nonprofit organization working to advance medical research. Thank you to the NAPA Advisory Council and to all those working tirelessly on the National Alzheimer's Plan to lead the growing efforts to halt the devastating effects of dementia on individuals and our communities.
Although evolution of the Alzheimer's disease and related dementias (AD/ADRD) clinical trials play a central role in achieving the goal of preventing and effectively treating AD/ADRD by 2025, we urge the Council to recognize a number of major caveats and gaps with the current approaches. In particular, there are four major factors in the current drug development pipeline that have and will continue to impede the development of effective disease-modifying treatments:
As the NAPA advisory council works to address the important challenges in clinical trial recruitment, it is essential that the efforts of thousands of patients, caregivers, clinicians and researcher be focused on the most promising targets. Support for future trials based on data derived from humans, preclinical investigation in human-based models, greater prioritization of targeting lifestyle risk factors such as diet will greatly improve our development pipeline for effective interventions to prevent or reverse AD/ADRD in our nation by 2025.
I. Kremer | 01-27-2017
Thank you again to the Advisory Council for your deep engagement in, and strong support for, the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers. We look forward to delivering findings and recommendations that will inform your Nation Plan Update, improve research, and ultimately deliver tangible, transformative results for tens of millions people across this country.
In today's meeting, the Advisory Council is focusing its vision on clinical trials, on how to adopt new and better approaches. That is laudable, appropriate and evidently necessary. I would encourage the Advisory Council also to focus on other assets we have now, assets that work well and hold potential to work even better if properly sustained and strengthened. Two of those assets are dementia-relevant provisions with the Affordable Care Act (ACA) and our federal workforce.
Reasonable people can and do hold a variety of views about the ACA as a whole. But there is widespread agreement that repeal or reform of the ACA would have significant and potentially dangerous implications for people with dementia and their families. The LEAD Coalition recently released an ACA issue brief ( http://bit.ly/LEADCoalitionACA and attached as a PDF) providing an overview of nine elements of the ACA vital to the dementia community. I would encourage the Advisory Council to review the issue brief and to be vocal about the importance of sustaining and strengthening these and other elements of current law that benefit people facing dementia.
I would encourage the Advisory Council also to be vocal about the harmful consequences of a federal hiring freeze or, worse yet, outright reductions in agency bandwidth. It is imperative that the ACL, CMS, CDC, the VA and other agencies are at full capacity to deliver better care, support and quality of life for those facing dementia today. And for all who look forward to a time when science liberates us all from the shadows of dementia, we know it is imperative that the NIH and FDA have the staff necessary to deliver breakthroughs.
Thank you for your leadership.
M. Hogan | 01-27-2017
Once again I appreciate the opportunity to address the Council this morning. In anticipation of the discussion of Clinical Trials, as I write these comments in advance, I am hopeful that issues related to those with Down Syndrome have been included in the morning discussion.
I understand that there are ethical considerations around consent and capacity for those with DS and other intellectual disabilities in regards to participation in clinical trials. However, I am hopeful that participation in the current DS Biomarker research is robust and that the outcome of these studies will provide very useful information for those with DS as well as the general population. I am also hopeful that there will be further efforts to include people with DS in preclinical medication trials in an attempt to delay the onset of AD.
Attached you will find an NIA/NIH document produced by the Alzheimer's Disease Education and Referral Center called: Researchers seek Alzheimer's clues in people with Down Syndrome, dated August 25, 2013 and updated in 2015 [https://www.nia.nih.gov/alzheimers/features/researchers-seek-alzheimers-clues-people-down-syndrome]. This may shed some light on the issue of DS and AD for those on the Council who remain under-informed about this topic.
5 years after the release of the first National Plan we continue to face many challenges for our family members with DS and other forms of ID. These include:
In an effort to provide medical information for this population, Dr. Seth Keller, NTG Co-Chair and Drs. Ira Lott, UC Irvine and Nicole Baumer of Boston Children's Hospital will address an upcoming 2017 Annual Conference for Neurologists on Neurologic Complications in Adults with IDD. Dr. Keller has reached out to Medical Schools to determine the curriculum inclusion for this population. He will also address Neurology Residents at Brigham and Women's Hospital in Boston focusing on the ID population. Additionally, it is his hope to have a round table discussion to address issues related to the needs of adults with DS as they transition to adult Neurology Departments. In the meantime a coterie of trainers from the NTG is providing seminars and webinars to Agencies and Professionals, including Direct Support Professionals, across the US in an effort to expand knowledge, improve care and facilitate further development of local trainers. We are a small group taking on Herculean tasks.
In an effort to provide much needed information to families and other caregivers, including Direct Support Professionals, the National Down Syndrome Society (NDSS), in conjunction with the NTG and Alzheimer's Association, is in the process of preparing a companion document to Aging and DS. This new publication will focus on DS and Alzheimer's disease and will be released at the UN on 3/21, World DS Day.
As Dr. Janicki has noted in his public comments, the NTG and colleagues in US, Canada, UK and Europe are involved in the writing of a number of articles related to ID and Dementia, with the focus on expanding the knowledge base and improving care outcomes for those with ID and Dementia. This effort, resulting from public and private support in Scotland, is to be noted and commended with the sharing of rich ideas and significant efforts across borders.
The NTG has begun a fledging peer support group for Family Caregivers. We are grateful to the NDSS and Cure PSP who assisted us in our efforts. Response to this monthly group has been most positive with a growing number of participants from across the US. Included in this group is a number of parents of young adults facing extraordinary decline in function with no clearly defined cause.
Today we face looming issues with the Federal Budget and changes to the affordable Care Act that could potentially have a disastrous impact on individuals with dementia as well as their caregivers. These concerns will be further noted by Ian Kremer, our colleague from the LEAD Coalition, but demand the attention of all of us at this table and well beyond.
These noted activities reflect a dogged commitment to increasing attention to this special population. I assure you we will persist in our tireless effort to see that people with DS and other forms of ID will remain an integral part of the national discussion of Alzheimer's disease and other dementias. We look to you for continued support as we work to expand our public/private efforts.
Thanks, once again, for the opportunity to be here.
S. DeSanti | 01-27-2017
Piramal Imaging is pleased to provide the following comments to the National Advisory Council on Alzheimer's Research, Care, and Services. Piramal Imaging markets Neuraceq™, a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.1
Today, AD is usually diagnosed after a patient with a cognitive impairment undergoes an extensive clinical examination which typically includes family and medical history, physical and neurological examinations, psychiatric screen, laboratory tests (i.e. thyroid blood tests) and imaging procedures such as computed tomography (CT) or magnetic resonance imaging (MRI) scans. However, a definitive diagnosis of AD can be made only after death where an autopsy can reveal the presence of beta-amyloid plaques and neurofibrillary tangles. Post-mortem studies looking for accumulations of neuritic plaque densities and Braak neurofibrillary stages in the brain have shown that 10 to 30 percent of diagnoses based on clinical examinations are incorrect.2 Our company is working to improve the true positive and true negative rates of detection. When used with PET imaging, Neuraceq holds the promise to detect beta-amyloid plaques in live patients.
Neuraceq may be used to assist in the differential diagnosis of Alzheimer's disease or other dementia types. In a pivotal phase 3 clinical trial, Neuraceq was shown to have a high affinity to beta-amyloid plaques in the brain, a hallmark of Alzheimer's disease.3 A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.4
In clinical practice, a patient suffering from cognitive impairment would undergo a clinical assessment by his or her clinician. If after the clinical assessment there is still some uncertainty regarding the cause of cognitive impairment, the clinician will then refer the patient to an imaging center for a beta-amyloid PET scan, using Neuraceq as the diagnostic agent. A radiologist/nuclear medicine specialist reads and interprets the scan and sends a report back to the patient's referring physician. The report includes the reader's findings about the presence of beta-amyloid plaques in the patient's brain. The referring physician can use the clinical findings with the results of the Neuraceq PET scan, including the presence or absence of beta-amyloid plaques, in their differential diagnosis of the patient. Both clinical and Neuraceq findings are important to consider when constructing the patient's treatment plan. Studies have shown that physician confidence in diagnosis is increased when results from betaamyloid scans are used.5
Currently, beta-amyloid PET imaging is covered under Medicare's Coverage with Evidence Development (CED) program. Per program requirements, Medicare beneficiaries are eligible for one beta-amyloid PET imaging scan per lifetime, as long as the beneficiary is enrolled in a CMS-approved clinical trial.6 Since finalizing the CED decision in September 2013, CMS has approved only three clinical trials with a total estimated beneficiary enrollment of 18,788. The bulk of patient enrollment is expected to occur through the Imaging Dementia -- Evidence for Amyloid Scanning (IDEAS) Study, which anticipates Medicare beneficiary enrollment of 18,488.7
To our knowledge, CMS has not provided a public update on this CED program at an advisory council meeting. We hope to hear an update from Dr. Shari Ling as part of the Federal Workgroups Update at the next meeting on February 3, 2017. Considering that the theme of this advisory council meeting is clinical trials for Alzheimer's disease and related dementias and recruitment challenges, we urge the advisory council to request regular updates from CMS outlining the agency's progress on reviewing and approving new trials under the beta-amyloid PET imaging CED at the Council's public meetings.
Beta-amyloid PET imaging is intended to be used according to Appropriate Use Criteria developed by the Amyloid Imaging Task Force, Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association, as an adjunct to other diagnostic evaluations in the following instances:
Between 15-20% of Americans aged 65 or older are estimated to suffer from Mild Cognitive Impairment (MCI).9 However, fewer than 19,000 Medicare beneficiaries have access to beta-amyloid PET imaging as a covered Medicare benefit, due to the lack of clinical trial approvals by CMS. This means that less than 1% of the estimated 8 million to 11 million Medicare beneficiaries with MCI have access to beta-amyloid PET imaging. This coverage ratio is lower than other Medicare CED programs, such as the National Oncologic PET Registry (NOPR), which enrolled over 100,000 Medicare beneficiaries10 and the Transcatheter Aortic Valve Replacement (TAVR) registry, which had registered almost 55,000 procedures by the end of 2015.11
While we recognize that CMS has the authority to institute CED decisions, Medicare is an entitlement program. All beneficiaries are supposed to have access to covered services and benefits. CMS is arbitrarily limiting coverage by refusing to approve additional clinical trials under the beta-amyloid PET imaging CED. This is blocking beneficiary access to this important diagnostic tool, a benefit to which the beneficiaries are entitled.
Furthermore, we are concerned that CMS has not approved clinical trials that will generate the evidence that the agency itself claims is required in order to determine whether or not beta-amyloid PET imaging meets Medicare's "reasonable and necessary" standards for coverage. In the CED decision memo, the agency stated that approved studies must address one of more aspects of the following questions:
For Medicare beneficiaries with cognitive impairment suspicious for AD, who may be at risk for developing AD:
In talks with the IDEAS trial steering committee, agency staff have indicated that the flagship beta-amyloid CED trial that has been approved is not expected to generate enough evidence to reconsider the coverage decision. This is troubling, especially since CMS has not approved additional trials with a significant number of beneficiaries that would be expected to generate enough evidence to reconsider the coverage decision.
The Advisory Council should ask CMS to explain how the current trials that have been approved under the existing CED will generate the evidence the agency needs to reconsider the coverage determination and efforts by the agency to develop or recruit investigators to develop new clinical trials that will generate the evidence necessary to reconsider the coverage determination. Such an update provided in a public forum will inform stakeholders as to the current status of the CED determination, as well as publicize the types of research that the agency would like to see proposed in the near future.
We appreciate the opportunity to provide these comments, and we look forward to working with the Advisory Council to change the trajectory of Alzheimer's disease and related dementias. If you have any additional questions, please do not hesitate to contact me.
M. Janicki | 01-26-2017
I and Dr. Seth Keller are the co-chairs of the National Task Group on Intellectual Disabilities and Dementia Practices (NTG), a group formed in 2010 with a mission to advocate for people with intellectual disability and their families and other caregivers when an adult with intellectual disability is affected by dementia (http://www.aadmd.org/ntg). The NTG is an affiliate of the American Academy of Developmental Medicine and Dentistry and is associated with the Rehabilitation Research and Training Center on Developmental Disabilities and Health at the University of Illinois at Chicago.
Subject: NTG Activities on Information Development and Dissemination
The notion we wish to raise today concerns our efforts to create and disseminate transformative information related to dementia and intellectual disabilities. We recognize, as does the Council, that much of the general public, health care professionals, and even workers in the field of intellectual disability, are relatively uninformed about the nuances of dementia and how it affects adults with intellectual disability, as well as their spouses, friends, and caregivers. In concert with colleagues within the Alzheimer's and other dementias, intellectual disability, and university educational community, the NTG continues to develop materials in various media to inform and disseminate such information.
The basis for this notion is that many families have difficulties obtaining reliable information on recognizing dementia and how to best provide care and supports, in particular when their relative with intellectual disability is in the late or advanced stage of dementia and needing end-of-life specialized care. Further, we recognized that there are many nuanced issues that at time mirror those affecting adults with dementia in general, but also there are recognizable differences posed by lifelong intellectual disability. These differences can pose barriers to acceptance into generic services or add to confusion about how to provide specialized services. It is our hope at the NTG, as it is among our international colleagues in the intellectual disability and aging community, that this information will provide a basis for increased understanding of how dementia affects people with intellectual disability (as it might among other recognized 'special populations') and constructively influence and affect state and local planning, public policies, and clinical and service practices.
This past October, the NTG partnered with colleagues at the University of the West of Scotland and the University of Stirling (near Glasgow, Scotland) and held an International Summit on Intellectual Disability and Dementia. Invitees from numerous countries within Europe and from the USA and Canada attended and discussed a number of topical issues and deliberated on the state of knowledge. From these discussions, a number of working groups were charged to produce background materials summarizing the issues and producing publishable reports. These reports encapsulate the key aspects of the issues and contain information and recommendations that can help expand knowledge, influence policy, and enhance services affecting adults with dementia and intellectual disability. The NTG's goal in this effort is to complement the activities of the Council and the various federal and organizational partners, and continue to make such information available and help transform policies and services so as to be more helpful to families and adults affected by dementia.
Thus, we are pleased to report that since October the participants of the Summit and their host organizations and associations have been busy on developing a series of summative reports. To date, one of the prepared reports, "Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to Nomenclature" has been accepted for publication by the American Association on Intellectual and Developmental Disabilities' journal, Intellectual and Developmental Disabilities. Another, "Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to End-of-life Care in Advanced Dementia" has been reviewed and is pending acceptance for a special issue on end-of-care topics, in the British journal, the Journal of Applied Research in Intellectual Disability. A third, "International Summit Consensus Statement: Intellectual Disability Inclusion in National Dementia Plans" has been submitted to the American Journal of Alzheimer's Disease and other Dementias and is pending review. A fourth, "Defining Advanced Dementia in People with Down Syndrome and other Intellectual Disabilities: Consensus Statement of the International Summit on Intellectual Disability and Dementia" has been submitted to the Journal of Intellectual Disability Research, a British publication, and is also pending review.
Another grouping of reports and summative statements are in various states of preparation. These will attend to a variety of additional topics, including the needs of family caregivers, the perspectives toward dementia of people with intellectual disability, quality of life and dementia, post-diagnostic approaches to care, and dementia-capable services design for providers.
It is our hope that the Council will consider the substance and recommendations of these reports when constructing future updates of the National Plan to Address Alzheimer's Disease.
These reports and publications are available from us and also posted on the NTG website -- http://www.aadmd.org/ntg.
M. Ellenbogen | 01-25-2017
By way of this speech I am making a formally request that the NAPA committee takes this issue to the top level of the HHS management as I believe what you are doing is not complying with the law.
On Friday, January 6, 2017 1:07 PM I sent a email for the February 3 Meeting Attendance as you can see below. I was denied this access and I am not being treated fairly under the disability guidelines. For two years now I have been ignored and so many others with dementia are not being heard. This must change.
I am requesting to speak at the next meeting public comments for the February 3 for NAPA. I am specifically requesting: reasonable accommodation under section 504 of ADA (Americans with Disability Act) to present my portion of the speech presentation by computer-link with video, or a telephone link-up such as conference call.
Thanks so much for your consideration."
W. Mansbach | 01-24-2017
My name is Dr. William Mansbach, and I am the CEO of Mansbach Health Tools and CounterPoint Health Services. Many of you on the Council are familiar with our BCAT - Brief Cognitive Assessment Tools. I am honored to sit on the Maryland Governor's Alzheimer's Disease Council.
I ask this Council to include scientifically validated brain health programs as part of its comprehensive recommendations.
Our new ENRICH® program is one example:
There are four "steps" to ENRICH®:
We developed this program to address the needs of family caregivers, adult children of those with dementia, and others who are concerned about their risk for developing dementia. Modifying risk factors, increasing brain health, and screening are important factors in early detection and perhaps in delaying the onset of cognitive impairment.
We'd be happy to assist the Council in developing programs to promote brain health, to screen for cognitive impairment, and to provide non-pharmacological interventions for those who are cognitively impaired.
For more information, please visit our new website, http://www.enrichvisits.com.
J. Lyons | 01-23-2017
My name is Jodi Lyons, and I am an author and care consultant who helps older adults find the care they need throughout the country.
Today, I'll discuss challenges that arise due to the behavioral and psychological symptoms of dementia. These often cause people to become combative and dangerous to themselves and others. They can't always be calmed or redirected. Sometimes, the police become involved because the situation is too volatile for EMTs.
Situations like this necessitate our: identifying triggers, identifying causes of delirium, and determining both pharmacological and non-pharmacological tools for dealing with the behaviors.
Unfortunately, the system isn't designed to deal with behavioral crises in those with dementia.
Short stay evaluation for medication adjustment in specialized non-rehab communities is private pay only.
Medication adjustment can be done in short term rehab but Medicare only pays after a 3 day qualifying hospital stay plus a demonstrated need for PT, OT, or Speech Therapy.
Or, medication adjustment can be done in a hospital. But, many hospitals aren't equipped to handle people who wander or are aggressive. Those with that capacity are few and far between and often don't have beds available.
We need a more streamlined system to obtain and pay for care in a dementia crisis. Requiring qualifying hospital stays raises costs to Medicare. Using observation beds to avoid the appearance of unnecessary hospital readmissions prevents patients from qualifying for rehab.
I ask the Council to identify a way to allow Medicare to pay for medication adjustment and behavioral health in qualified facilities without requiring that the patient first be admitted to the hospital for three days.
N. Tatton | 01-19-2017
Frontotemporal Degeneration Disorders -- the Rare Disease of the AD Related Dementias
Frontotemporal Degeneration (FTD) is the most common dementia in people under the age of 60. It is a rare disease affecting at best estimate approximately 60,000 people in the United States. As such, it presents unique challenges when recruiting for clinical trials compared to Alzheimer's Disease which currently affects more than 5 million people in the US.
FTD is a diverse group of disorders that can present with behavioral, cognitive, language and motor dysfunction. Clinically these disorders are grouped as behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, corticobasal degeneration and FTD with ALS. Diagnosis is challenging because it is a rare disease and most health care providers have no or limited experience with FTD disorders. Less than 30% of the FTD disorders are caused by a known gene mutation. FTD disorders also progress fairly rapidly, patients live on average 6-11 years after diagnosis. And for behavioral variant FTD, published studies have reported that it may take as much as 3.5 years before an accurate diagnosis is made.
Persons with FTD can display clinical symptoms that overlap between the disorder subtypes and this can complicate obtaining an accurate diagnosis. And some of the symptoms of FTD can be confused with psychiatric disorders. Currently there is no simple test to distinguish if someone has FTD versus another dementia or psychiatric disorder.