[Senate Hearing 114-683]
[From the U.S. Government Publishing Office]






                                                        S. Hrg. 114-683
 
 ALZHEIMER'S DISEASE: THE STRUGGLE FOR FAMILIES, A LOOMING CRISIS FOR 
                                MEDICARE

=======================================================================

                                HEARING

                               before the

                      SUBCOMMITTEE ON HEALTH CARE

                                 of the

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 13, 2016

                               __________
                               
                               
                               
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                  


                                     
                                     

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                          COMMITTEE ON FINANCE

                     ORRIN G. HATCH, Utah, Chairman

CHUCK GRASSLEY, Iowa                 RON WYDEN, Oregon
MIKE CRAPO, Idaho                    CHARLES E. SCHUMER, New York
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   BILL NELSON, Florida
JOHN THUNE, South Dakota             ROBERT MENENDEZ, New Jersey
RICHARD BURR, North Carolina         THOMAS R. CARPER, Delaware
JOHNNY ISAKSON, Georgia              BENJAMIN L. CARDIN, Maryland
ROB PORTMAN, Ohio                    SHERROD BROWN, Ohio
PATRICK J. TOOMEY, Pennsylvania      MICHAEL F. BENNET, Colorado
DANIEL COATS, Indiana                ROBERT P. CASEY, Jr., Pennsylvania
DEAN HELLER, Nevada                  MARK R. WARNER, Virginia
TIM SCOTT, South Carolina

                     Chris Campbell, Staff Director

              Joshua Sheinkman, Democratic Staff Director

                                 ______

                      Subcommittee on Health Care

               PATRICK J. TOOMEY, Pennsylvania, Chairman

CHUCK GRASSLEY, Iowa                 DEBBIE STABENOW, Michigan
PAT ROBERTS, Kansas                  MARIA CANTWELL, Washington
MICHAEL B. ENZI, Wyoming             ROBERT MENENDEZ, New Jersey
RICHARD BURR, North Carolina         BENJAMIN L. CARDIN, Maryland
DANIEL COATS, Indiana                SHERROD BROWN, Ohio
DEAN HELLER, Nevada                  MARK R. WARNER, Virginia
TIM SCOTT, South Carolina

                                  (ii)


                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Toomey, Hon. Patrick J., a U.S. Senator from Pennsylvania, 
  chairman, 
  Subcommittee on Health Care, Committee on Finance..............     1
Stabenow, Hon. Debbie, a U.S. Senator from Michigan..............     3

                               WITNESSES

Petersen, Ronald C., Ph.D., M.D., chair, Advisory Council on 
  Research, Care, and Services, National Alzheimer's Project Act, 
  Rochester, MN..................................................     5
Paulson, Henry L., M.D., Ph.D., director, Michigan Alzheimer's 
  Disease 
  Center, University of Michigan, Ann Arbor, MI..................     7
Karasow, Connie B., caregiver, Levittown, PA.....................     9

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Karasow, Connie B.:
    Testimony....................................................     9
    Prepared statement...........................................    25
Paulson, Henry L.:
    Testimony....................................................     7
    Prepared statement...........................................    27
Petersen, Ronald C.:
    Testimony....................................................     5
    Prepared statement with attachments..........................    29
Stabenow, Hon. Debbie:
    Opening statement............................................     3
Toomey, Hon. Patrick J.:
    Opening statement............................................     1
    Prepared statement of George Vradenburg, chairman and 
      founder, UsAgainstAlzheimer's, Chevy Chase, MD.............    34

                             Communications

Aging Institute..................................................    37
Ellenbogen, Michael..............................................    39
Jewish Association on Aging......................................    40
Eli Lilly and Company............................................    42
National Association of Psychiatric Health Systems (NAPHS).......    43
National PACE Association........................................    45
Shih, Regina A...................................................    48
University of Pittsburgh Alzheimer Disease Research Center (ADRC)    53
WomenAgainstAlzheimer's Network..................................    56

                                 (iii)


                          ALZHEIMER'S DISEASE:



                       THE STRUGGLE FOR FAMILIES,



                     A LOOMING CRISIS FOR MEDICARE

                              ----------                              


                        WEDNESDAY, JULY 13, 2016

                               U.S. Senate,
                       Subcommittee on Health Care,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 2:47 p.m., 
in room SD-215, Dirksen Senate Office Building, Hon. Patrick J. 
Toomey (chairman of the subcommittee) presiding.
    Present: Senators Grassley, Burr, Heller, Stabenow, 
Menendez, and Carper.
    Also present: Republican Staff: Brad Grantz, Staff 
Director, Subcommittee on Health Care. Democratic Staff: Kim 
Corbin, Minority Staff Director, Subcommittee on Health Care.

  OPENING STATEMENT OF HON. PATRICK J. TOOMEY, A U.S. SENATOR 
   FROM PENNSYLVANIA, CHAIRMAN, SUBCOMMITTEE ON HEALTH CARE, 
                      COMMITTEE ON FINANCE

    Senator Toomey. The Subcommittee on Health Care hearing 
will come to order.
    Alzheimer's is in a category of its own in terms of its 
breadth, its lethality, the severity of this disease. We 
estimate that there are 5.2 million Americans with Alzheimer's. 
It is 100-percent fatal. It is the sixth leading cause of 
death, and the number of fatalities is likely to be 
underreported.
    There is no cure. There is not even a treatment. The cause 
is still unknown. The toll on the lives lost, of course, is 
devastating, but the financial and emotional toll on caregivers 
is devastating as well, and there is a huge financial burden 
that the public pays.
    The research by the Alzheimer's Association concluded that 
Alzheimer's disease is the costliest chronic condition in 
America, more expensive than any other disease. Medicare and 
Medicaid together will spend over $160 billion a year, and 
while approximately 10 percent of Medicare beneficiaries have 
Alzheimer's, they consume about 20 percent of all Medicare 
dollars. This is a significant cost to Medicaid as well, as 
Medicaid provides long-term institutional care, and about half 
of nursing home residents have some form of dementia, many of 
them, of course, from Alzheimer's.
    For many of us, this issue is very personal. My father was 
diagnosed 4 years ago. I had a grandmother who died of the 
disease. I can say firsthand how devastating it is to families.
    I have been pleased to be able to work with a great 
bipartisan group of Senators and House members on advancing a 
Federal response to this. I am the co-chair of the bipartisan 
Congressional Task Force on Alzheimer's Disease, with Senators 
Markey, Collins, and Warner, and I have convened this hearing 
to explore further ways to strengthen Medicare and Medicaid, 
especially to support caregivers.
    There are four big topics that I hope we will be able to 
pursue in some detail today. First is the fact that a lack of 
diagnosis hurts families. There is a report by the Alzheimer's 
Association that suggests that only about 45 percent of people 
with Alzheimer's disease or their caregivers are told their 
diagnosis by their doctor.
    We need to ensure that physicians are aware of the value in 
communicating a diagnosis to the families. There are incredible 
advances in medical imaging technology that now allow a 
definitive diagnosis to be made prior to death. In 2013, 
Senator Hatch led several members of this committee, including 
myself, in writing to CMS in support of a national study on 
using PET imaging to diagnosis Alzheimer's. CMS agreed, and we 
will hear today how that technology has helped families with 
loved ones who have Alzheimer's disease.
    The second point that I want to address today is the 
importance of caregivers being fully engaged in the treatment 
plan. Caregivers face tremendous stress, and a care planning 
session can help connect the caregiver and the patient with 
resources and support. CMS has proposed a new billing code for 
2017 for a care planning session, similar to the approach that 
Senator Stabenow's HOPE for Alzheimer's Act takes. I am pleased 
to announce today I will be a cosponsor of your legislation.
    The third point is the huge long-term care costs for 
families. There are few viable long-term care options for many 
middle-class families, and it places a huge strain on 
caregivers, as well as on family finances. Many families end up 
spending down their assets and eventually qualify for Medicaid. 
In 2010, Congress reduced the value of the medical expense 
deduction, that is, the threshold above which medical expenses 
can be deducted. It was moved from 7.5 percent of income to 10 
percent of income. I am grateful to Senator Coats for working 
with me to restore that deductibility at the lower level. The 
IRS determined that 86 percent of taxpayers claiming this 
deduction for extraordinary medical expenses earn less than 
$100,000. This is an important deduction for them. I also hope 
we will get a chance to talk about long-term care insurance. It 
can be enormously helpful, but very few people really have 
long-term care insurance.
    Finally, and maybe most importantly, we need a cure. One 
hundred and ninety Alzheimer's drugs have been tried, and they 
have failed in human trials. Companies have invested billions 
of dollars in searching for an effective treatment. About $3 
billion a year is spent, but none of that money changes the 
course of this disease. With the number of Alzheimer's patients 
projected to grow from over 5 million to nearly 14 million 
people in the foreseeable future, an effective therapy could 
yield enormous savings--most importantly, the immeasurable 
benefit of saving so many lives, but in addition, it could have 
huge financial benefit for those families that would otherwise 
be afflicted, and for Medicare and Medicaid.
    There are other Federal issues outside the Finance 
Committee's jurisdiction that I think need to be addressed. One 
is the NIH allocation. I have sat down and met with NIH 
Director Francis Collins. The NIH budget is about $32 billion a 
year. Alzheimer's research receives less than 3 percent of the 
funding. The fact is, there are other non-fatal and treatable 
diseases that receive far more resources in their research. I 
think we need to increase our Alzheimer's research, and we need 
to do it in a fiscally responsible way.
    But I want to thank everyone for joining us today, 
including, especially, the Alzheimer's Association from the 
Delaware Valley chapter of southeastern Pennsylvania. I know 
you are very well represented here today. I appreciate that.
    Now, let me recognize our ranking member, Senator Stabenow.

          OPENING STATEMENT OF HON. DEBBIE STABENOW, 
                  A U.S. SENATOR FROM MICHIGAN

    Senator Stabenow. Thank you very much, Mr. Chairman. It is 
my pleasure to join with you in this hearing which is so 
important and, as we know, impacts so many people. I want to 
thank the three witnesses whom we have testifying before the 
subcommittee today, including Dr. Paulson from Michigan. We are 
glad to have you with us. Improving care for people with 
Alzheimer's is critically important to all of us, and it 
touches all of us in some way. So I am really looking forward 
to this hearing.
    We do know the statistics. There are a lot of statistics 
that we could look at. But let me just mention a couple. The 
sixth leading cause of death in the United States is 
Alzheimer's disease. More than 5 million people are living with 
this disease in our country. Important for us on the Finance 
Committee is that 1 out of 5 Medicare dollars, all of Medicare, 
1 out of 5 Medicare dollars goes to caring for those with 
Alzheimer's and related dementias. By 2050, it is estimated 
that 1 in 3 Medicare dollars will go toward Alzheimer's 
patients.
    Alzheimer's is particularly devastating for women and for 
people of color. Women are two times more likely to face an 
Alzheimer's diagnosis than men. African-Americans are twice as 
likely to have Alzheimer's, and Hispanics are 1.5 times more 
likely.
    We also know how critically important research is, because 
there is no known cure, and no cure for Alzheimer's disease 
means we have a lot of work to do on research. Right now, we 
have 1 in 3 seniors who are dying as a result of this disease. 
With this bleak outlook, it is no wonder that doctors delay 
diagnosis and begin some treatment without fully discussing the 
Alzheimer's diagnosis with individuals and families.
    All of this is taking its toll on caregivers, the men and 
women, young and old, who love and care for a person with this 
awful disease. Nearly 16 million family members and friends 
care for those with Alzheimer's or a related dementia. These 
caregivers do this work out of love, but also at a significant 
financial and emotional cost to themselves.
    In short, we need to do more. If we care about people with 
Alzheimer's disease and their loved ones, we need to do more. 
If we care about making sure Medicare is financially 
sustainable in the future, we need to do more.
    There is good news. Since 2010, Senator Collins and I have 
sponsored a bill called the HOPE for Alzheimer's Act, which 
would empower those with Alzheimer's and their caregivers to 
take control of this diagnosis. With this bill, Medicare would 
reimburse for a comprehensive care planning service so that a 
person with Alzheimer's and their family can learn about the 
disease, gain access to much-needed support services in the 
community, learn about treatment and clinical trial options, 
and generally be better armed to face the diagnosis.
    Six years later, we now have 57--with Senator Toomey, 58--
cosponsors. I want to thank Senator Menendez, a long-time 
cosponsor of this legislation, for his advocacy. Not only has 
the Finance Committee been discussing this in its chronic care 
effort, the Appropriations Committee has included language to 
create a HOPE-like benefit in the current Labor, Health, and 
Human Services bill. So we are moving. And now the best news is 
that CMS has proposed creating a new Alzheimer's care planning 
code that could essentially implement the benefit that we have 
been working on in the HOPE Act.
    So with that, as well as the additional dollars going into 
research, which is absolutely critical, we are seeing some 
things happen. But there is still a long way to go.
    I am also very pleased to be the lead Democrat on a bill 
with Senator Capito, who has been very active with HOPE for 
Alzheimer's. I appreciate her partnership and working with me 
to place this language in the Appropriations bill. The new bill 
is called the Alzheimer's Beneficiary and Caregiver Support 
Act. This bill, which came together because of the advocacy of 
UsAgainstAlzheimer's, would create a 3-year Medicare pilot 
program to test the benefits, both financially and the health 
outcome for Medicare beneficiaries, of providing support 
services directly to caregivers of Alzheimer's patients.
    So there is a lot happening. There needs to be a lot 
happening. We need to redouble our efforts, both in supporting 
families and caregivers and doing everything humanly possible 
to create the right kind of medications and a cure.
    So I am pleased to be here today. I am looking forward to 
this hearing and what our witnesses have to say, Mr. Chairman.
    Senator Toomey. Thank you, Senator Stabenow.
    Senator Menendez, would you like to make an opening 
statement?
    Senator Menendez. Mr. Chairman, I will do it before my 
questions so we can get to the witnesses.
    Senator Toomey. Senator Burr, likewise? Very well.
    Then I will begin with the introduction of the witnesses. 
Senator Stabenow will introduce Dr. Paulson, but I will begin 
with an introduction of Dr. Ronald Petersen, director of the 
Mayo Clinic Alzheimer's Disease Research Center and the 
chairman of the Federal Advisory Council on Alzheimer's 
Research, Care, and Services.
    Also joining us is Connie Bastek Karasow. Ms. Karasow is 
the wife and caregiver of Mark Karasow, both of Levittown, PA. 
She is also the executive director of a halfway house for 20 
women recovering from chemical dependency.
    Senator Stabenow, would you like to introduce Dr. Paulson?
    Senator Stabenow. Thank you very much.
    It is my great pleasure to introduce Dr. Henry L. Paulson, 
who is director of the Michigan Alzheimer's Disease Center and 
the Lucile Groff Professor of Neurology for Alzheimer's Disease 
and Related Disorders at the University of Michigan. Dr. 
Paulson received his medical and doctorate degrees from Yale 
University. After completing his residency and fellowships, he 
joined the University of Iowa in 1997 and joined the faculty at 
the University of Michigan in 2007.
    In addition to his own research, since 2011 Dr. Paulson has 
served as the director of the Michigan Alzheimer's Disease 
Center. As director, he coordinates efforts between three major 
research universities in Michigan--the University of Michigan, 
Wayne State University, and Michigan State University--in order 
to better understand Alzheimer's disease. In addition to 
Alzheimer's research, the center promotes education and 
awareness about dementia and provides state-of-the-art clinical 
care.
    We so appreciate your being here.
    Senator Toomey. I would like to formally introduce into the 
record testimony from the Alzheimer's Association and also from 
UsAgainstAlzheimer's chairman George Vradenburg. Thank you to 
both groups in helping on this hearing.
    [The statement appears in the appendix on p. 34.]
    Senator Toomey. Dr. Petersen, you have 5 minutes for your 
testimony.

 STATEMENT OF RONALD C. PETERSEN, Ph.D., M.D., CHAIR, ADVISORY 
 COUNCIL ON RESEARCH, CARE, AND SERVICES, NATIONAL ALZHEIMER'S 
                   PROJECT ACT, ROCHESTER, MN

    Dr. Petersen. Thank you. Good afternoon, Chairman Toomey, 
Ranking Member Stabenow, and distinguished members of the 
Health Subcommittee.
    My name is Ron Petersen, and as Senator Toomey indicated, I 
chair the Advisory Council for the National Alzheimer's Project 
Act. I am also a professor of neurology at Mayo Clinic and 
direct the Alzheimer's Disease Research Center there. I sit on 
the World Dementia Council as well.
    Alzheimer's disease is the most devastating disorder of our 
generation. It is estimated, as we have heard, that 
approximately 5.1 million people in the United States currently 
have the disease, and that is projected to rise to over 13 
million by 2050. The Rand Corporation recently said that 
Alzheimer's disease is, in fact, the most costly chronic 
disease in this country, ranging around, from 2010 data, about 
$200 billion a year at that point in time, as compared to heart 
disease, which was $102 billion, and cancer $77 billion. So in 
that comparison, staggering figures.
    In 2011, President Obama signed the National Alzheimer's 
Project Act into law, and this required the Secretary of Health 
and Human Services to develop a national plan for addressing 
Alzheimer's disease. The first plan was published in 2012 and 
has been revised annually. There was also an advisory council 
appointed as part of the law, and the advisory council's 
charge, in addition to advising the Secretary, has been to 
generate a list of recommendations each year that are sort of 
unencumbered by fiscal restrictions and make recommendations to 
the Secretary and to Congress directly as to what it is going 
to take to fight this disease.
    The primary goal of the national plan is to develop an 
effective treatment and perhaps prevention of the disease by 
2025. One of the corresponding recommendations of the advisory 
council has been that the Federal Government should be spending 
at least $2 billion a year to combat this disease. Currently, 
with the recent increase--thank you very much--in 2016 for 
Alzheimer's disease of $350 million, we are now at $991 
million. But that is still not quite halfway to the $2-billion 
goal recommended by the advisory council.
    According to a recent report by the Alzheimer's 
Association, caring for persons, as of 2015, costs this country 
$226 billion, two-thirds of which comes from Federal Government 
and State government dollars. By 2050, we will be spending $1.1 
trillion caring for individuals, unless something is done about 
this disease. The cumulative costs of caring for individuals 
between now and 2050 will approach $20 trillion--so this almost 
becomes unsustainable--again, almost 70 percent of that coming 
from Medicaid and Medicare. So these numbers need to be 
addressed immediately, because this scenario is untenable for 
the country.
    So putting this in the context of the primary goal of the 
national plan to effectively treat the disease by 2025, it has 
been estimated that if we develop a disease-modifying therapy, 
say, something that delays the onset of the disease by 5 years, 
we will reduce the number of people projected to have the 
disease in 5 years from 8.2 million down to 5.8 million. This 
will result in a savings of $83 billion for that time frame. 
Projecting that out to 2050, where we are anticipating to spend 
$1.1 trillion, that will be reduced to $734 billion. So having 
a therapy that delays the onset of the disease by 5 years will 
have a tremendous impact on individuals, families, and on the 
health-care budget.
    The research community is poised to make the necessary 
progress to make these treatment projections a reality with a 
disease-modifying therapy. The academic field is working on the 
notion of prevention of the disease, because, clearly, from a 
public health perspective, that is what we need.
    So with recent advances, largely funded by the National 
Institutes of Health, such as the Alzheimer's Disease 
Neuroimaging Initiative, our work at Mayo in the Mayo Clinic 
Study of Aging, we are now able to identify individuals who 
have the underlying biologic causes of the disease earlier in 
life, even when they are asymptomatic.
    The advantage of that is it affords us an opportunity then 
to develop treatments that are designed to have impact on those 
particular biologic characterizations. As we move toward 
earlier identification, it becomes imperative to take into 
account the impressions of not only the individual with the 
disease, but their caregivers as well. Recently, the Patient-
Centered Outcome Research Institute, PCORI, has funded an 
Alzheimer's effort designed to, again, assess the impact on 
individuals with the disease and caregivers.
    So in closing, I would like to thank Congress for their 
proactive stance in funding research for Alzheimer's disease, 
but we are only halfway there. The time is now to act and to 
continue to increase the budget for NIH so that these therapies 
can, in fact, be developed, keeping in mind that this is the 
most costly disease with which we deal and small impacts on the 
disease will have enormous impacts on the health-care economy.
    I would also like to commend both my Federal and non-
Federal colleagues on the advisory council, individuals at the 
National Institutes of Health, and individuals at the 
Department of Health and Human Services, for working tirelessly 
on the execution of the national plan and its revision.
    I appreciate this opportunity, and would be happy to answer 
any questions.
    [The prepared statement of Dr. Petersen appears in the 
appendix.]
    Senator Toomey. Thank you, Dr. Petersen.
    Dr. Paulson?

STATEMENT OF HENRY L. PAULSON, M.D., Ph.D., DIRECTOR, MICHIGAN 
ALZHEIMER'S DISEASE CENTER, UNIVERSITY OF MICHIGAN, ANN ARBOR, 
                               MI

    Dr. Paulson. Good afternoon, Chairman Toomey, Ranking 
Member Stabenow, and members of the committee.
    I am here today to express my support for the HOPE for 
Alzheimer's Act. I am a professor at the University of 
Michigan, where I direct the Michigan Alzheimer's Disease 
Center. I am honored to speak on behalf of my colleagues and 
our patients and their families to express a united vision for 
comprehensive care for those living with dementia. As director 
of our center, I speak for countless colleagues who care for 
those with dementia. Collectively, we recognize that the 
comprehensive care planning services provided by the HOPE Act 
will improve the lives of millions of American families 
confronting dementia.
    This health impact is principally what drives our support. 
But by helping dementia patients and their families navigate 
the difficult road ahead, the HOPE Act also will reduce Federal 
health-care costs by nearly $700 million over the next decade. 
It is no wonder this measure has garnered broad bipartisan 
support, and I applaud my Senator, Debbie Stabenow, and her 
colleagues for their vision in crafting and supporting this 
act.
    Each day, over 1,000 Americans receive a diagnosis of 
dementia. Most often, the specific diagnosis is Alzheimer's, 
but other common dementias include Lewy body disease, 
frontotemporal dementia, and vascular dementia. As a doctor, I 
have seen the deep fear and uncertainty that can accompany this 
diagnosis. Busy, overworked health-care providers might only 
offer a simple fact sheet about the disease.
    Too often, the future brought on by this progressive 
disease remains uncharted and frightening. And to someone 
receiving the diagnosis, the questions come fast and furious. 
What changes in my life do I need to make now? What kind of 
medical care do I need and when? How do I connect with others 
who understand? To someone caring for a loved one, these same 
questions and others surface. How can I possibly cope with the 
new demands and stresses I am facing? What can we do to stay 
healthy and close as a family?
    Sadly, too often patients and their families never get the 
chance to consider these questions, because the diagnosis is 
not provided to them. Astonishingly, two-thirds of seniors 
diagnosed with Alzheimer's are unaware of their diagnosis. We 
must do a better job of diagnosing dementia earlier in the 
course. Why? Earlier knowledge about the disease improves long-
term outcomes for those with cognitive impairment.
    The HOPE for Alzheimer's Act will ensure that patients' 
families receive the diagnosis and receive answers to these 
questions, allowing them to work with providers to optimize a 
plan for their future health and security. I cannot think of 
anything more pressing for our patients right now. Yes, many of 
us in the world are working hard to develop better therapies 
and ultimately a cure for Alzheimer's, and Senators Toomey and 
Stabenow and Dr. Petersen eloquently made the point that we are 
working toward that cure.
    But we are not there yet. The HOPE Act makes a difference 
now. A few years ago, at Michigan, we realized that newly 
diagnosed patients and their families sometimes fail to receive 
all the information they need in a timely manner. So we piloted 
a new multidisciplinary program, a team approach to dementia 
that gives patients and caregivers the opportunity to meet with 
a neurologist, neuropsychologist, nurse practitioner, and 
social worker for an appointment during which we discuss test 
results, the diagnosis, and care planning.
    This program has worked exceptionally well. Patients and 
caregivers overwhelmingly support our comprehensive approach, 
because they learn more about their disease sooner and have a 
greater awareness of community support and services. And in the 
process, we are continually reminded that each patient is 
unique. Care planning must be customized, taking into account 
the type of dementia, the stage of the disease, other chronic 
medical problems, and family dynamics, among other factors.
    Unfortunately, few people who receive their diagnosis do it 
through a major research center like ours, where we can pilot a 
multidisciplinary approach. That is why the HOPE Act is so 
important. It will ensure comprehensive care planning for 
dementia across the country at all types of medical facilities.
    Most of us, when we think of treatment, we think of 
medicines. But for dementia, the components that go into state-
of-the-art care extend far beyond medicines. For example, 
recent studies show that exercise improves brain function. 
Careful attention to chronic illnesses, such as depression or 
diabetes, improves the lives of those encountering dementia. 
And access to support groups for patients and caregivers can be 
a lifesaver. Care planning through the HOPE Act will ensure 
that these and other vital components are offered to our 
patients.
    I close on a personal note. When given the opportunity to 
direct our Alzheimer's Center 5 years ago, I jumped at the 
chance. Why? Partly because it is an exciting time. We are now 
testing potential disease-modifying therapies. And partly 
because there is so much we still do not know and we need to 
figure out. But mostly, it is because this disease touches us 
all. I ask everyone in this room now to think of someone you 
know who has confronted dementia. I am thinking of a colleague, 
a brilliant physician, loved by his patients, who retired this 
year when he faced the earliest signs of Alzheimer's.
    Like you, I want to make a difference in the lives of those 
with dementia. Until we have cures for the dementias, we need 
to provide patients and families with the means to cope and 
reasons to hope for a better future. This is precisely what the 
HOPE Act will do.
    I thank you for this opportunity.
    [The prepared statement of Dr. Paulson appears in the 
appendix.]
    Senator Toomey. Thank you, Dr. Paulson.
    Ms. Karasow?

    STATEMENT OF CONNIE B. KARASOW, CAREGIVER, LEVITTOWN, PA

    Ms. Karasow. Mr. Chairman and members of the subcommittee, 
thank you for this opportunity to address the issues associated 
with being a care partner for individuals living with 
Alzheimer's disease and other dementias. It is an honor to 
represent the over 5 million Americans living with the disease 
and more than 15 million care partners who love them. 
Alzheimer's disease is not a respecter of role, rank, or 
relationship.
    Those afflicted with Alzheimer's disease are adept at 
concealing their confusion, their embarrassment, frustrations, 
and fears, often before their partners begin to realize that 
there is a problem. That was certainly true in our case. The 
cues were subtle at first, and I had a demanding career. It was 
not until the notes were piling up, including cues written on 
his hands, that I suggested we see someone, half-jokingly 
saying, to eliminate the big ``A'' fear.
    On November 11, 2010, after some seemingly simplistic 
tests, we were told by Dr. Weisman that my Mark, a 70-year-old 
proud man, devoted husband, and father, had Alzheimer's 
disease, a progressive, fatal disease of the brain. Based on 
these seemingly simplistic tests, we were told that Mark was on 
the bunny slope: we could expect a gradual decline. No direct 
diagnostic tests were available, and we were often told by 
others that no one really knows until they are dead and you can 
see it in the brain--painfully glib, but true at the time. Mark 
was prescribed medication to try to extend his memory, and we 
were sent on our way, stunned, reeling, and projecting 
scenarios we could never really fully appreciate.
    Following Dr. Weisman's diagnosis, Mark experienced 
depression, anxiety, and obsessive-compulsive behaviors that 
led me to look for a geriatric psychiatrist, not an easy 
specialist to find. I found someone who was compassionate and 
intelligent, but untrained in dementia. She prescribed 
medication for Mark's symptoms, and at each session, she would 
give Mark a pep talk by saying ``You are not typically 
Alzheimer's,'' an oxymoron that reinforced our hope and our 
denial.
    If Mark was not typically Alzheimer's, what typically was 
he? And was he receiving the right protocols? We were 
recommended to another neurologist, who sent us to a clinical 
neuropsychologist for further testing. Mark endured 6 grueling 
hours of testing, including assessments that covered 12 
functioning parts of the brain. Following this battery of 
tests, Mark's driver's license was revoked, and Mark left the 
session feeling traumatized, frustrated, and, not typically, 
angry.
    The results indicated subcortical features; dementia 
appeared to be present, mild to moderate in severity. However, 
the precise nature of Mark's dementia was unclear from the test 
data alone. We went back to the referring neurologist, who, 
with a dismissive wave of his hand, declared that he did not 
agree with the diagnosis and that was all he could do. He never 
once asked me to meet with him separately from my husband so I 
could give him my input.
    We went back to Dr. Weisman, who was clearly disturbed with 
what Mark went through. Knowing Mark's scientific curiosity, he 
suggested a clinical trial, the Imaging Dementia--Evidence for 
Amyloid Scanning, or IDEAS, study. The IDEAS study will 
determine the clinical usefulness on patient-oriented outcomes 
of a brain PET scan that detects amyloid plaques, a core 
feature of Alzheimer's disease. This study is particularly 
helpful at determining a diagnosis for people like my Mark who 
do not present with typical dementia or cognitive decline.
    After our previous experience, it was so reassuring to know 
that there are doctors who care enough to help us pursue a firm 
diagnosis and understand how important it really is. When Mark 
had the PET scan that confirmed his diagnosis, all the debate, 
searching, and uncertainty were put to rest and the real work 
of living with the disease began.
    Mark is willing to engage in other trials and wants to 
donate his body when he dies. It is his desire to establish 
something good from the nightmare of watching the 
disintegration of his mind and his life.
    We joined an Alzheimer's Association support group, where 
we shared survival knowledge and survival skills. Issues for 
care partners have included our children's distrust based on 
fear; how to get rid of guns; stealth banking; thermostat wars; 
repetition, the date, family information, media, et cetera; 
hunger strikes; isolation; support; grieving; and survivor 
guilt. We had the opportunity to establish a durable power of 
attorney, medical directives, will, financial planning, medical 
equipment, shoes for his gait, bathing, diet, weight loss, 
family, and friends engagement.
    For me, coping means trying to stay present with him in his 
space, as long as his mind allows me. The rate of stress and 
depression has been described as unique to caregivers. Everyone 
says it is hard, and that is the simple truth. The awareness 
that self-care of my mind, body, and spirit is critical to 
survival is growing faster than the resources that make that a 
reality for me.
    Adult day care 2 days a week for my husband and me is 
expensive, and I know the costs will increase over time. My 
husband thought he was preparing to leave his family some 
financial security that will melt like the snow in spring. 
However, I am also concerned for the homeless poor and working 
poor who lack transportation and child care, let alone elder 
care. Without knowledge, health care, and case management 
resources, families living in the margins of our society cannot 
hope to manage the daily demands of those afflicted with 
Alzheimer's disease. Investment in Alzheimer's services can 
prevent the terrible social and fiscal costs in social services 
due to the dissolution of families.
    Before Mark enrolled in the IDEAS study and was able to get 
an accurate diagnosis, I was asked, ``What difference does a 
precise diagnosis make?'' A fair question, since we know at 
that moment there is no cure.
    Trying to express this is not easy. I looked up the quote, 
``Better the devil you know than the devil you don't.'' This is 
said when you think it is wiser to deal with someone, something 
familiar, although you do not like him, her, or it, than to 
deal with someone or something you do not know and might be 
worse. I believe there is power in naming. How can we cure 
something if we cannot even give it a name?
    On a practical level, an early and accurate diagnosis of 
Alzheimer's disease affords the individual the opportunity, 
dignity, and respect of participation and involvement in 
financial and legal decisions with his or her family. 
Legislation like the HOPE for Alzheimer's Act, which allows 
individuals newly diagnosed with Alzheimer's or related 
dementias to have a care planning session with a health-care 
provider, would do just that. If HOPE had been around at the 
time of Mark's diagnosis, I am sure we would have felt much 
less alone in this fight.
    Thank you again for the honor and the opportunity to 
testify today. I hope that I have been able to address the 
issues of caregivers and their loved ones with the respect and 
recognition they deserve. More importantly, I hope my message 
conveyed to you the exact nature of the problems through our 
eyes and perhaps has given you some insights on how your 
leadership can be instrumental in the current and future needs 
of our families and our communities.
    [The prepared statement of Ms. Karasow appears in the 
appendix.]
    Senator Toomey. Thank you, Ms. Karasow. And let me thank 
you for having the courage to share your personal experience. I 
know that must be a very difficult thing to do.
    I would like to start the questions by directing one to Ms. 
Karasow. In your testimony, you indicated that the PET scan 
that Mark received detected the amyloid plaques, and that led 
to the definitive diagnosis of Alzheimer's. Is it fair to say 
that without that scan, your family would not have had the 
ability to properly chart the course of treatment and plan 
accordingly?
    Ms. Karasow. I would say yes, because I wasted an awful lot 
of time--I wasted 5 years after the original diagnosis then 
very quickly got the pieces of what we needed to do in place, 
as I testified.
    Senator Toomey. Were there decisions that your family made 
that might have been easier or that you might have decided 
differently had you had the definitive, accurate diagnosis 
immediately?
    Ms. Karasow. One of the things that I would not have 
thought of--I have a good friend, who is our solicitor and our 
lawyer, and she recommended that we very quickly revise our 
wills, update our wills, so Mark could have participation in 
that on behalf of his family, and that was very much 
appreciated.
    Senator Toomey. Sure. Thank you.
    Dr. Paulson, we all understand that we do not have a cure 
for the disease and the pharmacological treatments that are 
administered do not really fundamentally change the course of 
the disease. But nevertheless, you mentioned that there are 
important and effective treatments. Could you elaborate a 
little bit on what can be done in the absence of a curative 
treatment?
    Dr. Paulson. Absolutely; I would be happy to do that. I did 
mention a few things. I think we all know that exercise is good 
for the heart, and it is increasingly clear that aerobic 
exercise several times a week improves brain function in people 
who are beyond the age of 65, whether they have cognitive 
impairment or not. So it is one of the first things that I tell 
anyone who comes into my clinic who has dementia.
    Adequate sleep makes all the difference in the world. The 
right kind of sleep can make a difference. We believe that 
maybe we rid the toxic proteins in the dementias by sleeping 
enough.
    Being socially and mentally engaged in the world around 
you, the absolute opposite of a couch potato, is a very good 
thing to help brain function as we go forward.
    Finally, diet probably makes a difference, although that is 
not as clearly worked out.
    I think we need to, as we wait, as we work hard for those 
disease-modifying therapies--and I believe we will get there--
we need to emphasize to people who have dementia that there are 
plenty of things that can be done proactively, non-medically, 
to help.
    Cognitive training is another thing that makes a 
difference, as well. I am sure Dr. Petersen would have other 
things he would add to that.
    Senator Toomey. Thank you very much.
    Dr. Petersen, I would like to just explore with you a 
little bit some recent research into the underlying cause of 
Alzheimer's. In May, in fact, researchers from Harvard 
theorized, in an article that was published in the journal 
Science Translational Medicine, that some kind of pathogen and, 
specifically, maybe a virus, may be responsible for triggering 
Alzheimer's disease, and, specifically, that it may pass 
through the blood-brain barrier.
    Here is a brief quote from a New York Times article on this 
research. ``The brain's defense system rushes in to stop the 
pathogen by making a sticky cage out of proteins, called beta 
amyloid. The microbe, like a fly in a spider web, becomes 
trapped in the cage and dies. What is left behind is the cage, 
a plaque that is the hallmark of Alzheimer's.''
    The idea that is elaborated on in the article is that the 
plaque then sets off a formulation of the tau tangles, which 
then kill the nerve cells, inflame the brain, and hasten the 
death of more brain cells.
    I guess my question is, could you comment on your opinion 
as to whether there is a consensus and, if so, the nature of 
the consensus about the initial first causes? Is it considered 
plausible that there is some kind of pathogen that triggers the 
plaques that we associate with Alzheimer's, or are there other 
theories that you think are more widely accepted?
    Dr. Petersen. It is a very intriguing hypothesis, and I 
think those investigators at Harvard have been working on this 
theory for quite a number of years, with some credible evidence 
that there is a role for either a precise pathogen like a virus 
or at least the role of the immunological system in the brain 
to combat it, and then the secondary inflammation that may 
arise and cause subsequent damage.
    Unfortunately, it throws the whole picture of the role of 
amyloid in the brain, amyloid being the key protein in the 
brain, into question. What is its function? What does it do? We 
still do not know what the normal role of amyloid is in the 
brain.
    So they are postulating that it may actually have a 
protective effect, and these plaques that we see on the PET 
scans that you mentioned actually may be sequestering some of 
the pathogenic material away. So that raises the question, if 
you have a drug then that goes after that plaque, removes the 
plaque or destroys the plaque, is that good or bad? And I think 
it throws a lot of things up in the air and makes us reevaluate 
what we are doing. I think we still think that the amyloid 
protein, and the tau protein that forms the tangles, are 
critical elements; in fact, they are the defining 
characteristics of the disease, as we heard, with regard to 
pathologics.
    But I think we need to learn more about the disease, and 
clearly, as the NIH has expanded its research program, getting 
at some of these basic underlying mechanisms remains a high 
priority.
    Senator Toomey. Thank you, Dr. Petersen.
    Senator Stabenow?
    Senator Stabenow. Thank you very much. Again, thank you to 
all of you for your testimony.
    First, Dr. Paulson, as one of Michigan's top scientists 
working on Alzheimer's, you certainly know as much about the 
disease as anyone, and I know the University of Michigan's 
Alzheimer's Disease Center takes a multidisciplinary approach, 
as you were talking about. But most people in Michigan and 
certainly around the country who have Alzheimer's disease are 
probably unable to visit such a specialized facility.
    So when we look at the fact that, according to the 
Alzheimer's Association, somewhere between 40 percent and 50 
percent of people with Alzheimer's do not get early diagnosis 
and we hear from physicians that they are not sure it makes a 
difference diagnosing it, because they are not sure what they 
would do, that was one of the reasons that we put together HOPE 
for Alzheimer's, so that there would actually be a message to 
physicians that it would be something you could do in terms of 
care-giving sessions and working with families in developing a 
plan and so on.
    But it is concerning to me that I do not know of any other 
top cause of death that is so severely undiagnosed as this. So 
I am just wondering if you might talk a little bit more about 
early and formal diagnosis of Alzheimer's and how important it 
is.
    I know in talking to researchers in Michigan, they all 
indicate that the kinds of things they are working on, if they 
are going to work, actual medications and so on, they involve 
early diagnosis. So it seems like being able to get that is a 
very important thing for a number of reasons, whether it is new 
drugs, whether it is supporting families and caregiver plans, 
or whatever.
    But if you could talk a little bit more about that, early 
formal diagnosis----
    Dr. Paulson. Absolutely. It is a new era in Alzheimer's and 
related dementias. I think if you go back 20 years, it may have 
been fair to say there was nothing we could do. But at this 
point, that is clearly not the case. Connie eloquently 
described the difficulties of making a diagnosis and some of 
the ways that we can actually achieve now an earlier diagnosis.
    Let me comment about why Alzheimer's, unlike heart disease 
or diabetes or depression, is less commonly a diagnosis that 
the family and the patient learn about. I think there are 
really two things driving it. One is that doctors are busy and 
they are moving from patient to patient, and they do not want 
to or have the time to sit down and discuss with a family and a 
patient what this means. That would change, I think, with the 
HOPE Act.
    The second reason is, it is a difficult thing for a doctor 
to say to someone, ``You have a disease that is progressive, 
that currently we cannot stop, and that is fatal.'' As Senator 
Toomey said, this is 100-percent fatal. It is hard to say that.
    We need to change that sort of dynamic for doctors, and 
most of the diagnoses are not given by a specialist like me or 
Dr. Petersen; they are given by primary care doctors. So I 
think it is absolutely vital that we educate more primary care 
providers about how to achieve an earlier diagnosis and provide 
that information.
    In terms of the therapies, yes, symptomatic therapies are 
modest, at best, right now, and the disease-modifying therapies 
are not there now. But I really believe that a sit-down with 
the family and with the patient--where you mention the 
diagnosis and say, these are the things we have to be thinking 
about, we have to plan for in the future; these are the things 
that will be an issue in 4 or 5 years, let us discuss them now; 
these are some things you can do to make your quality of life 
better now--is as important as any medication, frankly.
    Senator Stabenow. Thank you.
    Ms. Karasow, thank you for coming and sharing your story. 
There are so many people who share your story and need to have 
your voice here today speaking for them. I wonder if you might 
talk a little bit more about your husband's path with the 
disease and your experience as a family and a little bit more 
about what having an early, clear diagnosis would mean.
    What could have happened differently for you?
    Ms. Karasow. Thank you for the question. Good question.
    What happened was, we were very fearful and we relied on 
each other and we did not talk about it. We did not talk about 
it to the children, because we did not have anything definitive 
to tell them, and who wants to scare them, and everything that 
that implies?
    If we had known sooner, we probably would have gotten into 
a family session and started planning as a family together. 
This way, we are doing everything catch-up and going back and 
doing things that perhaps we could have put in place sooner.
    What it means is isolation. I have three sons--one is in 
Alaska and two are local--and they say, ``Oh, sure, Mom, we 
will come by and we will stay with Dad anytime you want.'' I 
hate to impose. And in the Alzheimer's support group, it is 
hard to ask for help. It is hard to accept help when you and 
your husband are in a war against this big, ugly, 5,000-pound 
gorilla. It would be very helpful to have the kind of model 
that Dr. Paulson noted. And I understand there is another one 
in Pennsylvania, in Lancaster.
    If there was a one-stop shop where you could have family 
sessions--here is the medication--if I had been able to compare 
with my sisters and brothers in the Alzheimer's support group 
where they have gone--and we have helped each other enormously, 
and that is the wonderfulness of the support group--we would 
have been down the road a piece.
    Maybe we would have taken vacations together while Mark was 
still able. He cannot walk. He is having neurological problems 
now. He is having delusions. Leaving him for an hour in the 
morning for a commitment is very difficult. It is very 
isolating. And you cannot get your family to come 24/7.
    So them understanding that and knowing what you are going 
through and finding other ways to meet the needs and find a 
balance within all of the craziness of the disease is very, 
very useful.
    Senator Stabenow. Thank you very much.
    Thank you, Mr. Chairman.
    Senator Toomey. Senator Menendez?
    Senator Menendez. Thank you, Mr. Chairman and Senator 
Stabenow, for holding this really important hearing today. I 
have many issues in the Senate, but this is an issue that is 
supremely personal to me, since my late mother suffered from 
Alzheimer's for 18 long, difficult years, years when we watched 
her drift further and further away.
    She was a courageous woman, a woman who saw her country in 
the midst of revolution and decided, against my father's wishes 
at the time, to uproot her family and come to the United States 
in search of freedom and a better life for her children, which, 
at that time, meant my brother and sister, coming to a country 
where she had no one waiting for her, did not know the 
language, and had no real understanding of the risks she was 
taking. Courageous woman.
    So when it first happened, I, of course, hoped for the best 
but, of course, expected the worst. And there were days at the 
beginning when my mother seemed just fine, when the lost 
moments became more pronounced, and when they began to last 
longer.
    Now, there were times I wondered if she would recognize me 
the next time I walked into the room, and I wondered if all the 
memories of my youth and her life were in there somewhere or 
whether they were lost forever. For a while, it seemed she was 
as she was before, but then, as you know, it gets worse. She 
lost her cognitive powers, and then the time came when I 
realized she was really no longer with us, and then, 
mercifully, the long goodbye came to an end.
    Now, the grand irony of it all is that often the toll 
Alzheimer's takes on the family, on loved ones, and on 
caregivers can be worse even than on the person suffering with 
the disease.
    I appreciate Ms. Karasow's personal testimony, and I 
appreciate her willingness to share it with us. I think about 
it in the case of my own sister. Her name is Caridad, which in 
Spanish means ``charity.'' And she had an enormous amount of 
charity to give. She was a legal secretary who, during the day, 
worked as I paid for a home health-care aide because of our 
cultural belief that you just do not put Mom in a nursing home, 
and then would come back at the end of a long day--no 
vacations, no time off--and the only time she had off is the 
time that I could ultimately come and give to her.
    And I think about the intergenerational challenges that we 
have with this disease, trying to give mom the dignity she 
deserves in the twilight of her life, taking care of the 
education of our children, trying to get them through college, 
and thinking about our own lives in the future, and I think of 
how many families across this country face that 
intergenerational challenge as a result of this disease.
    So that is why I believe that we must ensure that, in 
addition to proper diagnosis, treatments, and eventually a 
cure, we support and give planning, supporting care to help 
families prepare for life with Alzheimer's.
    I think Congress needs to aggressively fund the research 
for causes and cures, because if not, the long goodbye will be 
even longer for the Nation in costs and in heartache. So that 
is why I am a proud cosponsor of Senator Stabenow's HOPE for 
Alzheimer's Act, because I think it expressly provides for 
these planning services. And I am pleased to see that CMS has 
recently announced new billing codes to allow physicians to 
provide care planning to Medicare beneficiaries. I think that 
is incredibly important.
    But one of the statistics that was mentioned in testimony 
today is that fully two-thirds of those with Alzheimer's 
disease do not know it. To me, that is a tragedy and a failure 
of our health-care system. Not only is it a failure to properly 
treat people, but it causes an undue and unnecessary burden on 
the health-care system, which is a good part of what this 
committee focuses on--certainly the human part of this 
particular disease, as with other diseases that we face, but 
the costs to the Nation collectively.
    Since we know that early diagnosis leads to better long-
term outcomes, which in turn lead to lower costs, it seems to 
me that any investment that we make in providing physicians 
with the time, with the resources, with the knowledge they need 
to better care for those with Alzheimer's will ultimately pay 
for itself many times over.
    I want to follow up with one question I have for both Dr. 
Paulson and Dr. Petersen. I heard part of your response to 
Senator Stabenow, but from the perspective of a clinician, what 
is the root cause of this under-diagnosis? Is it simply, as you 
said, that doctors do not want to necessarily share a very 
difficult diagnosis with patients? There are many diseases, 
some of which are horrible, like certain forms of cancer, which 
I assume doctors would not want to give that diagnosis for, but 
nonetheless do, even though the results at the end of the day 
may not be what that family hoped for.
    Is it that there is not one definitive test for Alzheimer's 
which can account for this major lack of timely diagnosis? Is 
it simply because of a lack of time and resources--which, of 
course, the HOPE Act and CMS's new benefit would help address--
or is it a larger misunderstanding and lack of knowledge about 
the disease more generally beyond specialists like yourselves?
    Dr. Petersen. It is an excellent question, Senator 
Menendez.
    Senator Menendez. I only ask excellent questions. 
[Laughter.] I am just kidding. Just kidding.
    Dr. Petersen. I wish I could give an excellent answer.
    Senator Menendez. None of my colleagues would say I always 
ask excellent questions, I can tell you that. [Laughter.]
    Dr. Petersen. It is very important, and I think many of the 
issues you mentioned are all playing a part. I think there is 
the physician training part, how comfortable they are with 
making the diagnosis, because it is not a simple blood test; it 
is not a simple x-ray. It is a clinical judgment, but I think 
with some of the new techniques we have now, we can be more 
confident that, in fact, this person who meets the clinical 
syndrome of, say, dementia now has Alzheimer's disease as the 
underlying cause.
    So I think we are getting there, and I think the IDEAS 
study that Connie mentioned is going to help us to convince CMS 
that, in fact, we should support the amyloid imaging component 
of the diagnostic process. So I think that is part of it.
    I think there still is some therapeutic nihilism: there is 
nothing we can do about this disease, so why burden this 
patient with this kind of knowledge? And as Dr. Paulson has 
indicated, there are many things we can do about it.
    But most of all, the patient and the family deserve to know 
what is going on. It is going to impact their decision-making 
process; it is going to impact what they do the rest of their 
life. And it is important, I think, for the physician--and we 
have been trying to bring this message home to physicians--that 
these individuals are often aging and they rarely have just 
Alzheimer's disease as a diagnosis. They may have diabetes, 
they may have hypertension, they may have heart failure.
    The management of these other medical problems is 
complicated and compounded by the fact that they have 
Alzheimer's disease. So a person managing his or her own blood 
sugar--diabetes management becomes much more difficult when the 
person is having memory and thinking problems.
    So I think for all of those reasons, it is important that 
we implore the physicians and the medical community out there 
to really get up to speed on what this diagnosis takes, what it 
means for the individuals, and what we can do about it.
    Dr. Paulson. I will follow up. The excellent question was 
followed by an excellent answer, and I will not reiterate what 
Dr. Petersen said, but let me make a couple of comments.
    One, about the difficulty of diagnosis, Connie mentioned a 
doctor saying this is atypical; this is not typical. The 
reality is that with Alzheimer's and actually the whole range 
of dementias, it is a spectrum, and not everything is cookie-
cutter. It is not at all that way.
    Alzheimer's itself can take on many different flavors. It 
can involve the frontal lobe, it can involve the back of the 
brain, it often involves the memory, but it can involve the 
other areas as well. So there can be ways in which the diseases 
can trick us as well.
    So, yes, in addition to this particular point, I think the 
fact that it is a complicated disease, the dynamic changes over 
time, contributes also to the failure of early diagnosis.
    I just want to say I commend you for your comments about 
your mother. But the point you raised about your sister's 
involvement: the emotional and physical toll that occurs on 
families is huge, and that is a dynamic process too over time, 
and you eloquently described that.
    Senator Toomey. Thank you.
    Senator Heller?
    Senator Heller. Thank you, Mr. Chairman and Senator 
Stabenow, for holding this particular hearing. I certainly 
appreciate it.
    I am grateful to our witnesses for being here today and for 
your background and understanding and for the messages that you 
are sending to us.
    I believe that talking about degenerative neurological 
diseases--Dr. Paulson, you talked about how it affects 
everybody. Everybody has a story. Everybody in this room has a 
story. I certainly do appreciate Senator Menendez's story about 
his mother.
    My mother-in-law happens to have late stages of 
Parkinson's. Dr. Paulson, is that considered a degenerative 
neurological disease?
    Dr. Paulson. Yes, Senator Heller. Parkinson's disease is a 
degenerative brain disease, and, in fact, there is an overlap 
between Parkinson's disease and the dementias. In fact, over 
half of individuals who have Parkinson's disease in the late 
stages have dementia. So there is a Parkinson's disease 
dementia.
    And I specifically mentioned the condition called Lewy body 
dementia or diffuse Lewy body disease, which is related to 
Parkinson's disease, because the same kind of protein 
abnormally accumulates. It is not the amyloid that Dr. Petersen 
spoke about. It is a different protein, but it has 
similarities, and in the same way that we are moving forward 
with new technologies and new ideas about therapies for 
Alzheimer's, we are doing the same for Parkinson's disease and, 
by extension, Parkinson's disease dementia and Lewy body 
disease.
    Senator Heller. The reason that I raise that issue is that 
she is in the late stages, and she was at a doctor's 
appointment last week. I went in with her, with my father-in-
law, her husband, and the doctor asked, ``Who are you with?'' 
and she said, ``My friend.'' So you can imagine the impact that 
that has on the family when she is at that stage and she does 
not realize and recognize her own husband of 60-plus years.
    So having mentioned that, I want to talk a little bit to 
Dr. Petersen. You mentioned your organization, your work with 
the National Alzheimer's Project Act in Minnesota. How have you 
been able to expand this to telemedicine?
    I come from the rural State of Nevada. We have the Lou Ruvo 
Clinic that is now working with the Cleveland Clinic. In fact, 
they had a fundraiser last week. They have raised over $250 
million for this specific purpose of these brain diseases and 
trying to find cures and help people who are moving down that 
road.
    But the problem is, it is in Las Vegas, and telemedicine 
has become so important for a large State like Nevada that 
has--two-thirds of it is very rural.
    How do you get to these rural towns? How do you get to the 
Elkos, the Winnemuccas, the Elys and try to make sure that 
those who are diagnosed in these stages and find it so 
difficult to travel are able to get the help and services that 
they need?
    Dr. Petersen. Thank you for that question, because I think 
telemedicine is the wave of the future as to how to deal with a 
disease as widely prevalent as Alzheimer's disease, where 
everybody is not going to be able to make it to a specialty 
clinic, not make it to the Lou Ruvo Brain Institute, but is 
going to have to be seen by their primary care physician.
    The telemedicine offers an opportunity for those physicians 
then to communicate with some of the specialists, to also deal 
with the problems of patients in their homes, and we have been 
dealing with that in Minnesota. Wisconsin has a program. I was 
recently in Texas; Texas is developing a program for 
telemedicine, same principal, with large spaces to deal with.
    So I think that developing systems where we can communicate 
with the primary care physicians for specialist 
recommendations, but also then with the patients and families 
themselves in their home, will help a great deal at reducing 
the anxiety, reducing the co-morbidity that goes with it, and 
actually help the quality of life for individuals with the 
disease.
    Senator Heller. Dr. Petersen, thank you.
    Ms. Karasow, thank you for your message to all of us. Like 
I said, it does make a difference. We need to hear these 
stories. My wife's family is going through similar 
circumstances, as I just mentioned. So it hits home.
    Did you have Medicare services initially when your husband 
was diagnosed?
    Ms. Karasow. We had private insurance, Blue Cross/Blue 
Shield, and he had Medicare. He was on Social Security by the 
time he was diagnosed. Yes.
    Senator Heller. What services were available to you?
    Ms. Karasow. We were referred to the Alzheimer's 
Foundation. I am trying to think of where I found that out. 
Through Dr. Weisman, and that was it.
    Senator Heller. That was it. Okay. Thank you.
    Mr. Chairman, thank you.
    Senator Toomey. Thank you.
    Senator Carper?
    Senator Carper. Thank you. I thank you, Mr. Chairman.
    Welcome. It is good to see all of you. Thank you for being 
here and helping us with an issue that we struggle with as 
families and as States in this Nation.
    My staff and I met earlier this week with some folks from 
the pharmaceutical industry. We probably spent, in a half-hour 
visit, at least half that time talking about Alzheimer's 
research, and several of the companies represented there are 
involved in projects with compounds or biologics trying to find 
the road to a cure. I was encouraged by the numbers of them 
that have paired up, so that you have several companies that 
are working in tandem with others--more sharing of information.
    I do not know if any of you are up to date with what is 
going on on that front, but when we were facing the crisis with 
Ebola, one of the ways we really focused on Ebola was coming up 
with a vaccine, coming up with some kind of medicines that 
could prevent it, that would help people get better. We are 
doing a similar kind of thing with Zika, the Zika virus.
    Just give us an update, somebody, any of you, on what is 
going on on that front with respect to Alzheimer's.
    Dr. Petersen. Thank you for the opportunity to chat on 
that, because that is a very important aspect of developing 
treatments for this disease. Academic medicine can identify the 
molecules, the targets, take it to a certain level. Small 
biotechs can introduce certain techniques. But ultimately, it 
is going to take major pharma to carry out these huge global 
phase 3 trials, and that is really what it is going to take.
    I think almost all of the major pharmaceutical companies 
out there have a program in Alzheimer's disease and dementia 
right now, because the need is so great. Of course, the market 
is also great, but, in fact, I believe that they are actually 
dedicated to trying to help with this particular disease.
    So much of the attention right now is focused on these 
proteins that we have identified and discussed a little bit 
this afternoon: the amyloid protein that is the component of 
the plaque, the tau protein that is the component of the 
tangles. So immunological approaches actually--antibodies, 
either active or passive, approaches to dealing with those two 
proteins--are actively being pursued.
    The interesting feature of those is that, if successful, 
they afford an opportunity for prevention of the disease, 
because many times, these proteins appear in the brain before a 
person becomes symptomatic. That gives us a window of 
opportunity to intervene to try to prevent the clinical 
symptoms down the road.
    There are several trials underway right now at various 
early stages in the disease process aimed at real prevention. 
But I must say, a major obstacle right now to the development 
of therapeutics is in clinical trial recruitment; that is, 
getting individuals to participate in these studies.
    Senator Carper. Really?
    Dr. Petersen. It is a major, major problem right now, and I 
think it goes back to some of the issues we were discussing 
about physician awareness, family awareness, and patient 
awareness that clinical trials are available and are very 
effective at trying to combat this disease.
    Senator Carper. For my colleagues and I, that is actually 
something that is especially interesting. We all work--we have 
our own messaging operations, communication operations, some of 
which are old-fashioned: radio, TV, print. A lot of it is not 
old-fashioned. And the idea of using our collective resources 
to reach out and better inform our constituents across the 
country that there is this need, that could be very helpful.
    Thank you. Please, go ahead.
    Dr. Petersen. I just have one final comment.
    Senator Carper. Please, go ahead. And then I have another 
question.
    Dr. Petersen. I mention in my testimony comments about 
PCORI, and I think PCORI is active in that area. The project 
they are funding now in dementia is exactly that, how we can 
bring in particularly underrepresented groups to participate in 
clinical trials. So I think that this is a major effort. There 
is a large grant right now called the GAP that is at NIH being 
entertained to try to help recruitment in clinical trials.
    This is a global issue as well. It is not just in the 
United States.
    Dr. Paulson. Senator, let me add a few things to what Dr. 
Petersen had to say. You talked about the partnership of 
industry, pharmaceutical companies working together.
    I think it is important to recognize--and this is a very 
good thing--that there have been sort of public-private 
partnerships in the Alzheimer's realm, and there have been real 
collaborations among centers across the country to move forward 
here.
    The point I really want to make is, it gets back to this 
issue of nihilism and whether, in fact, we can get health-care 
providers to recognize that if you diagnose people earlier and 
you let them know about clinical trial opportunities, there is 
a chance to make a difference.
    Why has cancer led to new therapies in cancer? It is 
because so often people who have been diagnosed with cancer are 
put into clinical trials. They sign up quickly. Doctors 
recognize the importance of that.
    We need to change, again, the dynamic, and I think we are 
beginning to for Alzheimer's.
    Senator Carper. Mr. Chairman, my time has expired. Could I 
ask unanimous consent for an extra 20 minutes? [Laughter.]
    Senator Toomey. Objection is heard. But we are going to 
begin a second round.
    Senator Carper. That is great. I will come back.
    Senator Toomey. I just have a brief question I am going to 
direct to Dr. Petersen, and then I know Senator Stabenow has a 
question.
    I would like to touch on something that is a little bit 
disturbing. There is a natural tendency, I think, when faced 
with what seems to some to be a hopeless diagnosis to cling to 
a false hope, and there have been false cures that have been 
suggested.
    I think we have heard that cookware can cause Alzheimer's, 
that cinnamon can cure it, and some are suggesting marijuana is 
a cure, or there are certain games you can play on your iPhone. 
This must be extremely frustrating to the scientists who are 
with us, in particular, but it is terribly unfair to families 
and patients to have a false hope that has absolutely no basis 
in reality.
    Do you have any advice for patients or for families, 
caregivers, about this notion of these false hopes?
    Dr. Petersen. It is a huge industry out there to put out 
nutraceuticals, various supplements, medical foods, or ``my 
brain game is better than your grain game''--huge industry out 
there.
    I do some work with the Federal Trade Commission actually 
on products that are put on the market and are making egregious 
claims about what they might do for aging and memory and all 
that. So it is an active process. I am sure Dr. Paulson spends 
a good part of his practice as well sort of debunking some of 
these, because people will come in with printouts of these 
types of--there are websites out there that are credible. The 
Alzheimer's Association, alz.org, is one of them that provides 
reliable information: what is good, what is not good, and what 
can be done.
    So I think that, again, this is an educational activity 
that we can all participate in, trying to educate the 
physicians as well as the families and caregivers.
    Senator Toomey. Senator Stabenow?
    Senator Stabenow. Thank you very much. I just had one 
question, a follow-up with Dr. Petersen.
    At the Finance Committee, as we look at some of the 
financial pieces of this, when we look at the health costs--you 
said that by 2050, we could face a 420-percent increase, 
basically top over $1 trillion in costs for Alzheimer's 
disease. That is a big number.
    So I am wondering, because we have jurisdiction over 
Medicare and Medicaid on this committee, what more should we be 
doing to combat the disease? What should we, from a Medicare 
and Medicaid standpoint, be looking at?
    Dr. Petersen. Well, as we discussed earlier, I think the 
HOPE Act, if it is translated into its real promises of aiding 
people with a care plan going forward--so it is not just stop 
paying the physician at the time of diagnosis but there is an 
actual care plan that is compensated afterward--that will 
reduce costs down the road.
    So the more knowledge, the more care planning--there have 
been a variety of studies, some done at the University of 
Pennsylvania actually, documenting that if you follow people 
when they get discharged from the hospital with dementia--they 
have other medical problems, get discharged from the hospital--
if you follow up with them, you deal with them at home, you 
have a lifeline for them so that they can contact people about, 
``Is this part of my disease or is this something I need to be 
concerned about,'' you can reduce the subsequent 
hospitalizations that can occur in people with Alzheimer's 
disease--not that we refuse their care, by any means, but we 
are dealing with it in a more educated fashion.
    But I think the HOPE Act is one real tangible way that we 
will actually have a chance to remediate some of those costs 
with Medicare and Medicaid.
    Senator Stabenow. Dr. Paulson, do you have anything to add 
to that in terms of anything else we should be specifically 
looking at in Medicare and Medicaid at this point?
    Dr. Paulson. I agree completely with Dr. Petersen. I love 
the fact that there would be comprehensive care planning. I 
actually would love to see that more than once. And the reality 
is, this disease changes over time. It is not the same disease 
in year 1 versus year 5.
    I do not know the specifics of how Medicare and Medicaid 
should be involved in this, but I do believe that we need to 
look beyond that initial diagnostic period and the planning 
period and recognize that this is a progressive disease that 
lasts for years, if not decades, in every individual who has 
it, and we need to be thinking about the long-term approach.
    Senator Stabenow. Thank you.
    Senator Toomey. I want to thank our witnesses for joining 
us.
    Dr. Petersen, do you have one last comment?
    Dr. Petersen. Just one short comment on that. With Medicare 
and Medicaid, CMS is already funding the IDEAS study that 
Connie mentioned, and that is tremendously important, because 
if we demonstrated, in fact, that amyloid imaging helps the 
outcome of the patient, we may, in fact, reduce costs down the 
road.
    So I think that investment is incredibly important. So 
thank you for that.
    Senator Toomey. Thank you. Members of the committee will 
have 5 business days to revise and extend their remarks.
    I want to thank our witnesses for their very, very helpful 
and valuable testimony. I want to thank Senator Stabenow for 
the really great work that she has been doing in this field.
    I want to recognize Senator Carper.
    Senator Carper. Is this when I get my 20 minutes?
    Senator Toomey. The clock is ticking.
    Senator Carper. I will be uncharacteristically brief. I 
would like to ask one question about cognitive screenings in 
Medicare annual wellness checkups.
    One of the pieces of legislation I worked on in the 
Affordable Care Act, I think along with Senator Stabenow, was 
one to include cognitive screenings in Medicare annual wellness 
checkups. I think sometimes months, maybe even years can go by 
between the first signs of dementia and a medical diagnosis, 
even though early detection and treatment might mean better 
outcomes for the patients and better health outcomes, better 
experiences.
    I just want to ask you this question. Do you know how 
often--do you have any idea how often Medicare beneficiaries 
receive these cognitive screenings as part of their annual 
wellness checkups? Do you have a feel for that? What can we do 
in Congress to help increase the rate of annual wellness 
checkups and cognitive screenings being provided to seniors?
    What other approaches can physicians take to identify 
cognitive impairment and reduce the likelihood of a delayed 
diagnosis of dementia?
    Dr. Petersen. Thank you. I think that was an incredibly 
important move forward with regard to the annual screenings.
    Senator Carper. Would you say that again? [Laughter.]
    Dr. Petersen. I think it was very, very important, because 
it now puts cognitive evaluation on the radar screen like 
another vital sign. So in addition to knowing the heart rate, 
the blood pressure, the blood sugar, we now have an index of 
cognitive function. That is the good news, and I think that is 
a major step forward.
    Where we are not as satisfied is in the uptake of visits. 
Dr. Shari Ling is a Federal member from CMS on the advisory 
council, and she has informed us on numerous occasions that the 
uptake has been disappointingly low, and I think that, again, 
this is another service that we can provide with education, and 
perhaps maybe the HOPE Act now is going to give the physicians 
a rationale for why they might want to identify cognitive 
problems sooner rather than later.
    We can now do something. We can help the family and the 
patient. On our side, I must say that the legislation said 
there should be a cognitive assessment, and that is great, but 
now we have to let the primary care physicians know what is an 
adequate cognitive screen. Is it just saying, ``Hey, how is 
your memory?'' or do we do test A or test B?
    So we have to demonstrate our best recommendations for the 
primary care physicians as to what tools to use and then, what 
do you do with the results of the tool?
    So that is underway right now, and there are several 
exercises addressing that.
    Senator Carper. Does anyone else want to comment on that?
    Dr. Paulson. I completely agree with Dr. Petersen. I think 
you need to recognize that Dr. Petersen is one of the 
individuals who is primarily responsible for recognizing that 
you can find early cognitive changes, well before dementia, and 
that makes a difference.
    So this kind of an effort, this kind of screening, must be 
implemented, and we are moving in that direction.
    Senator Carper. Mr. Chairman, thank you for those extra 
minutes.
    Thank you all, again.
    Senator Toomey. Thank you, Senator Carper.
    Thank you all for your participation, and thanks to the 
many guests who came in attendance.
    The hearing is adjourned.
    [Whereupon, at 4:02 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


           Prepared Statement of Connie B. Karasow, Caregiver
    Good afternoon, Chairman Toomey, Ranking Member Stabenow, and 
members of the subcommittee. Thank you for this opportunity to address 
the issues associated with being a care partner for individuals living 
with Alzheimer's disease and other dementias.

    More than 5 million Americans are living with Alzheimer's, and 
without significant action, as many as 16 million Americans will have 
Alzheimer's disease by 2050. More than 10,000 baby boomers a day will 
turn 65 and as these baby boomers age, one in eight will develop 
Alzheimer's. This explosive growth will cause Alzheimer's costs to 
Medicare and Medicaid to increase from $160 billion today to $735 
billion in 2050 (in today's dollars) and threatens to bankrupt 
families, businesses, and our health-care system. Unfortunately, our 
work is only growing more urgent.

    It is an honor to represent the over 5 million Americans living 
with the disease and more than 15 million care partners who love them. 
Alzheimer's disease is not a respecter of role, rank, or relationship.

    Those afflicted with Alzheimer's disease are adept at concealing 
their confusion, embarrassment, frustrations, and fears, often before 
their partners begin to realize that there is a problem. This was 
certainly true in our case. The cues were subtle, and I had a demanding 
career. It wasn't until the notes were piling up, including cues on his 
hands, that I suggested we see someone to eliminate the big ``A'' fear.

    On November 11, 2010, after some seemingly simplistic tests, we 
were told by Dr. Weisman that my Mark, a 70-year-old proud man, devoted 
husband, and father, had Alzheimer's disease, a progressive, fatal 
disease of the brain. Based on those ``simplistic'' tests, we were told 
Mark was on the ``bunny slope''--we could expect a gradual decline. No 
direct diagnostic tests were available, and we were often told, ``no 
one ever really knows until they are dead and you can see it in the 
brain.'' Painfully glib, but true. Mark was prescribed medication to 
try to extend his memory, and we were sent on our way stunned, reeling, 
and projecting scenarios we could never fully appreciate.

    Following Dr. Weisman's diagnosis, Mark experienced depression, 
anxiety, and obsessive-compulsive behaviors that led me to look for a 
geriatric psychiatrist, not an easy specialist to find. I found someone 
who was compassionate and intelligent but untrained in dementia. She 
prescribed medication for Mark's symptoms, and at each session she give 
Mark a pep talk by saying ``you are not typical Alzheimer's,'' an 
oxymoron that reinforced our hope and denial.

    If Mark was not typical Alzheimer's, what typically was he, and was 
he receiving the right protocols? Another neurologist was recommended. 
In August 2015, we met with a clinical neuropsychologist for further 
testing. Mark endured six grueling hours of testing, including 
assessments of intellectual functioning, behavioral observations, 
visual and verbal capabilities, memory orientation, concentration and 
working memory, verbal learning, language skills, motor and emotional 
functioning, and executive functioning. Following this battery of 
tests, Mark's driver's license was revoked, and Mark left the session 
feeling traumatized, frustrated, and ``not typically'' angry. The 
results indicated subcortical features, dementia appears to be present, 
mild-to-moderate in severity. However, the ``precise nature'' of Mark's 
dementia was ``unclear'' from the test data alone. We went back to the 
referring neurologist who, with a dismissive wave of his hand, declared 
that he didn't agree with the diagnosis and that was all he could do.

    We went back to Dr. Weisman, who was clearly disturbed with what 
Mark went through. Knowing Mark's scientific curiosity, he suggested a 
clinical trial--the Imaging Dementia--Evidence for Amyloid Scanning 
(IDEAS) study. The IDEAS study will determine the clinical usefulness 
on patient-oriented outcomes of a brain PET scan that detects amyloid 
plaques, a core feature of Alzheimer's disease. This study is 
particularly helpful in determining a diagnosis for people like Mark 
who do not present with typical dementia or cognitive decline. After 
our previous experience, it was so reassuring to know that there are 
doctors who care enough to help us pursue a confirmed diagnosis and 
understand how important this really is.

    When Mark had the PET scan that confirmed his diagnosis, all of the 
debate, searching, and uncertainty was put to rest and the real work of 
living with the disease began. Mark is willing to engage in other 
trials and wants to donate his body when he dies. It is his desire to 
salvage something good from the nightmare of watching the 
disintegration of his mind and life.

    We joined an Alzheimer's Association support group where we shared 
knowledge and survival skills. Issues for care partners have included: 
our children's distrust based on fear; how to get rid of guns; stealth 
banking; thermostat wars; repetition, the date, family information, 
media, etc.; hunger strikes; isolation; support; grieving; and survivor 
guilt. We established a Durable Power of Attorney, Medical Directives, 
wills, financial planning, medical equipment, shoes for his gait, 
bathing, diet, weight loss, and family/friends engagement.

    For me, coping means trying to stay present, with him, in his space 
as long as his mind allows me. The rate of stress and depression has 
been described as ``unique'' to caregivers. Everyone says ``it's hard'' 
and that is the simple truth. The awareness that self care of my mind, 
body, and spirit is critical to survival is growing faster than the 
resources to make it a reality.

    Adult day care two days a week for my husband, and me, is 
expensive, and I know the costs will increase over time. My husband 
thought he was preparing to leave his family some financial security 
that will melt like the snow in spring. However, I am also concerned 
for those homeless, poor and working poor, who lack transportation and 
childcare let alone eldercare. Without knowledge, health care, and case 
management resources, families living in the margins of our society 
cannot hope to manage the daily demands of those afflicted with 
Alzheimer's disease. Investment in Alzheimer services can prevent the 
terrible social and fiscal costs in social services due to the 
dissolution of families.

    Before Mark enrolled in the IDEAS study and was able to get an 
accurate diagnosis, I was asked, ``what difference would a precise 
diagnosis make?'' A fair question since we know at this moment there is 
no cure. Trying to express this isn't easy.

    I looked up the quote ``Better the devil you know (than the devil 
you don't).'' This is said when you think it is wiser to deal with 
someone or something familiar, although you do not like him, her, or 
it, than to deal with someone or something you do not know that might 
be worse.

    I believe there is power in naming; how can we cure something if we 
don't even know its name?

    On a practical level, an early and accurate diagnosis of 
Alzheimer's disease affords the individual the opportunity, dignity, 
and respect of participation and involvement in financial and legal 
decisions with his or her family. Legislation like the HOPE for 
Alzheimer's Act, which allows individuals newly diagnosed with 
Alzheimer's disease or a related dementia to have a care planning 
session with a health-care provider, would do just that. If HOPE had 
been around at the time of Mark's diagnosis, I am certain that we would 
have felt much less alone in this fight.

    Of the more than 5 million American seniors currently living with 
Alzheimer's disease or another dementia, only 33 percent are aware of 
the diagnosis. Studies show that one of the reasons doctors do not 
disclose an Alzheimer's diagnosis is insufficient time and resources to 
provide support to patients and caregivers at the time of diagnosis. 
The HOPE for Alzheimer's Act works by incentivizing health-care 
practitioners to: (1) dedicate time and resources to fully inform a 
beneficiary about the diagnosis; (2) have a meaningful discussion of 
treatment and support options; (3) develop a care plan specific to the 
beneficiary, accounting for all other conditions; and (4) document the 
diagnosis and care plan in the patient's medical record that is shared 
with all providers treating the individual.

    Following a diagnosis, care planning is crucial to improving 
outcomes, maintaining quality of life, controlling costs, and planning 
appropriately for the future. The HOPE for Alzheimer's Act builds on 
existing Medicare coverage of a diagnosis to provide individuals with 
Alzheimer's and their caregivers comprehensive care planning services, 
including information on medical and non-medical options for ongoing 
treatment, services, and supports. The HOPE for Alzheimer's Act would 
also allow the care planning discussion to occur with or without the 
beneficiary present, allowing for the facilitation of more effective 
communication between the health-care provider and the beneficiary's 
family, caregivers, or personal representative.

    Additionally, the HOPE for Alzheimer's Act ensures documentation of 
a diagnosis and the care plan in the beneficiary's medical record. 
Although Medicare requires documentation of a diagnosis for purposes of 
reimbursement, there is no requirement for a diagnosis to be documented 
within an individual's medical record. Documentation is critical to 
ensuring effective management of comorbidities (such as heart disease 
and diabetes) by an individual's care team and allows for care 
coordination among treating physicians.

    Finally, by requiring a provider outreach campaign upon 
implementation, the HOPE for Alzheimer's Act also helps ensure 
beneficiaries have access to these services by educating appropriate 
providers about the benefit and its elements. The HOPE for Alzheimer's 
Act is also consistent with the National Plan to Address Alzheimer's 
Disease, which calls for educating health-care providers as well as 
supporting individuals and families upon diagnosis to prepare for care 
needs.

    The HOPE for Alzheimer's Act may also work to reduce the disparity 
between costs for Medicare beneficiaries with Alzheimer's disease and 
those without. More than 85 percent of people with Alzheimer's and 
other dementias have other comorbid chronic conditions, and they are 
about 4 times more likely to have six or more chronic conditions, 
adding to the complexity of their care. Consequently, hospitalization 
rates are twice as high and costs are nearly three times as high for 
Medicare beneficiaries with Alzheimer's compared with other 
beneficiaries. A recent analysis of the HOPE for Alzheimer's Act by 
Healthsperien, which is comprised of former CBO staff, revealed that 
this legislation would lead to reductions in hospitalizations and 
emergency room use as well as improved management of comorbid chronic 
conditions and better management of medications for those receiving the 
benefit. As a result of the legislation, net federal health spending 
would decrease by $692 million over a 10-year period.

    Until a scientific breakthrough leads to an effective treatment or 
cure for Alzheimer's disease, we must work to improve the Medicare 
system to provide better care for American families facing this 
diagnosis. The HOPE for Alzheimer's Act is a win-win: it will improve 
the quality of care and quality of life for Medicare beneficiaries and 
families facing Alzheimer's disease, while reducing Medicare 
utilization and spending for those who receive the benefit.

    Thank you again for the honor and opportunity to testify today. I 
hope that I have been able to address the issues of caregivers and 
their loved ones with the respect and recognition they deserve. More 
importantly, I hope my message conveyed to you the exact nature of the 
problem through our eyes and perhaps has given you some insights on how 
your leadership could be instrumental in the current and future needs 
of our families and communities.

                                 ______
                                 
    Prepared Statement of Henry L. Paulson, M.D., Ph.D., Director, 
      Michigan Alzheimer's Disease Center, University of Michigan
    Good afternoon, Mr. Chairman, ranking member, and members of the 
committee. I flew here today from Michigan to express my support for 
the Health Outcomes, Planning, and Education for Alzheimer's Act, also 
known as the HOPE for Alzheimer's Act, that was introduced by my 
Senator Debbie Stabenow. I am currently the director of the Michigan 
Alzheimer's Disease Center at the University of Michigan where I am 
also the Lucile Groff Professor of Neurology and co-director of the 
U.M. Protein Folding Diseases Initiative. I am honored to speak on 
behalf of my colleagues, our patients, and their families to express a 
united vision for comprehensive care and compassion for those who are 
living with dementia.

    As director of the Michigan Alzheimer's Disease Center, a Center 
that links the three major research universities in Michigan, I bring 
with me the support of countless colleagues across our State who 
provide care for those with Alzheimer's and other forms of dementia. 
Collectively, we recognize that the comprehensive care planning 
services provided by the HOPE for Alzheimer's Act will improve the 
lives of millions of American families confronting dementia. This 
impact is principally what drives our support: through the HOPE Act, we 
will provide better care that makes a real difference in the lives of 
many. By addressing this critical medical need and helping dementia 
patients and their families navigate the difficult road ahead, the HOPE 
Act also will reduce Federal health care costs associated with this 
devastating disease by nearly $700 million over the next decade. It's 
no wonder that this measure has garnered broad bipartisan support. It's 
the kind of legislation that will inspire a new generation of hope, and 
I applaud Senators Stabenow and her colleagues for having the vision to 
craft and support this act.

    Each day, over a thousand Americans receive the diagnosis of 
dementia. Most often, the specific diagnosis is Alzheimer's, which 
currently affects more than 5 million Americans. Other related 
dementias, including Lewy body dementia, frontotemporal dementia, and 
vascular dementia, affect millions more. As a neurologist who cares for 
persons with dementia, I have seen the deep fear, anxiety, and 
uncertainty that can accompany this diagnosis. Busy and overworked 
health care providers may only be able to offer a simple fact sheet 
about the disease or provide a prescription for a medication. The 
future brought on by this slowly progressive disease too often remains 
uncharted and frightening.

    To someone newly receiving the diagnosis, the questions come fast 
and furious:

       What does my future hold?
       What changes in my life do I need to make now?
       How do I prepare for these inevitable changes as my disease 
progresses?
       What kind of medical care do I need and when?
       Who will help my family?
       How do I connect with others who understand?

    To someone caring for a loved one, these same questions, and 
others, surface:

       Where can I turn for help?
       How will I be able to provide care while also working or 
managing the household?
       How can I possibly cope with the new demands and stresses I'm 
facing?
       What can we do to stay as healthy as possible and close as a 
family?

    Sadly, too often patients and their families never get the chance 
to consider these questions because the diagnosis is not provided to 
them. Astonishingly, approximately two thirds of seniors diagnosed with 
Alzheimer's are unaware of their diagnosis. In no other common disease 
affecting seniors--cancer, heart disease, hypertension--are so many 
unaware of their disease. We must do a better job of diagnosing 
dementia earlier in the course, and making our patients and their 
family caregivers aware of the diagnosis. Recent evidence shows that 
early knowledge about the disease improves long-term outcomes for those 
with cognitive impairment.

    The HOPE for Alzheimer's Act will ensure that patients and families 
receive answers to these questions, allowing them to work with health-
care providers to develop a proactive plan to optimize their health and 
security as they deal with the changes wrought by dementia. I cannot 
think of anything more pressing for our patients right now. While we in 
the field are working hard to develop better therapies and ultimately a 
cure for Alzheimer's, we are not there yet. The HOPE Act will make a 
difference now.

    A few years ago we at the University of Michigan realized that, 
even at a major research university like ours, newly diagnosed patients 
and their families sometimes fail to receive all the information they 
need in a timely manner. Thus, we piloted a new program, the 
Multidisciplinary Diagnostic Medical Visit--a ``team'' approach to 
dementia that gives patients and caregivers the opportunity to meet 
with a neurologist, neuropsychologist, nurse practitioner and social 
worker for a comprehensive appointment during which we discuss test 
results, diagnosis, and care planning. Our pilot program also shortens 
the time from first contact to disclosure of a diagnosis. In short, the 
program has worked very well: patients and caregivers overwhelmingly 
support our comprehensive approach, and feel they have a much greater 
awareness of community support and services as a result. Care planning 
also allows us to address critical issues that families might not 
otherwise raise--for example, is it safe for my loved one to keep 
driving? Or to live alone? In the process, we are continually reminded 
that each patient is unique. Comprehensive care planning must be 
customized, taking into account the specific type of dementia, stage of 
disease, other chronic medical disorders, and family dynamics, among 
other factors.

    Unfortunately, only a small percentage of persons with dementia 
receive their diagnosis through a major research center such as ours, 
where we have the privilege to pilot a multidisciplinary approach. That 
is why the HOPE Act is so important: it will ensure comprehensive care 
planning for dementia across the country at all types of medical 
facilities, small and large.

    When we think of disease treatment most of us think, first, of 
medicines. But for dementia, the various components that go into state-
of-the-art care extend far beyond medicines. We now know, for example, 
that non-pharmacologic interventions play a vital role in brain health. 
Recent studies show that regular aerobic exercise improves cognitive 
function. Adequate sleep, and the right kind of sleep, may help rid us 
of the toxic proteins that accumulate in dementia. Cognitive training 
can make a difference. Careful attention to other chronic illnesses, 
such as depression, diabetes or heart disease, improves the lives of 
those encountering dementia. Finally, access to support groups, for 
patients and caregivers alike, can be a life saver. Access to 
comprehensive care planning will ensure that these vital components are 
offered broadly to all of our patients.

    I close on a personal note. Throughout my career, I have sought to 
understand the mechanisms underlying brain diseases so that we might 
develop cures. When given the opportunity to direct the Michigan 
Alzheimer's Disease Center 5 years ago, I jumped at the opportunity. 
Why? Partly because it's an exciting time in the field; our 
understanding of dementia has advanced to the point where we are now 
testing promising, potential disease-modifying treatments. Partly 
because there's so much we still don't know, and need to figure out. 
But mostly because this disease, by affecting millions of Americans, 
touches us all--whether through a family member, a friend, a neighbor, 
a colleague. There are so many faces to this disease. I ask you now to 
think about someone you know who has confronted dementia. I am thinking 
of a colleague, a brilliant physician loved by his patients, who 
retired this year when he faced the earliest signs of Alzheimer's. Like 
you, I want to make a difference in the lives of those with dementia. 
Until we have a cure for Alzheimer's and other dementias, we need to 
provide patients and families with the means to cope and the reasons to 
hope for a better future. This is precisely what the HOPE Act will do.

    Thank you for the opportunity to speak to you today. I am deeply 
encouraged by the HOPE Act, and personally, I have great hope for the 
future of those with Alzheimer's and other dementias. I look forward to 
getting back to Michigan to continue our work toward that better future 
and would be happy to answer any questions that the committee has for 
me.

                                 ______
                                 
Prepared Statement of Ronald C. Petersen, Ph.D., M.D., Chair, Advisory 
 Council on Research, Care, and Services, National Alzheimer's Project 
                                  Act
    Good afternoon, Chairman Toomey and Ranking Member Stabenow. My 
name is Ronald C. Petersen, Ph.D., M.D., and I serve as the chair of 
the Advisory Council on Research, Care, and Services for the National 
Alzheimer's Project Act. I am also a Professor of Neurology and 
Director of the Mayo Alzheimer's Disease Research Center at the Mayo 
Clinic in Rochester, Minnesota. Recently, I was appointed to the World 
Dementia Council by United Kingdom Prime Minister David Cameron.

    Alzheimer's disease is the most devastating disorder of our 
generation. We are all familiar with persons who suffer from the 
disease, as well as families and caregivers of those individuals who 
are keenly aware of the urgency in addressing this disease now.

    It is estimated that there are over 5.1 million people currently in 
the United States with Alzheimer's disease, and that number is 
projected to exceed 13 million by 2050. A recent research project from 
the RAND Corporation published in the New England Journal of Medicine 
based on data from 2010 indicated that the cost to the U.S. healthcare 
and long-term care systems for Alzheimer's disease was between $159 
billion and $215 billion. This is in comparison to similar 2010 data 
for heart disease estimated at $102 billion and cancer at $77 billion. 
As such, this was the first documentation that Alzheimer's disease is, 
in fact, the most costly disease to the U.S. health economy.

    In 2011, President Obama signed the National Alzheimer's Project 
Act into law. This law required the Secretary of Health and Human 
Services to develop the first U.S. Plan to Address Alzheimer's Disease. 
The first Plan was published in May of 2012, and it has been revised 
annually. The law also required the appointment of an advisory council 
to advise the Secretary on the development and revision of the Plan, 
and the Advisory Council, which I chair, has been meeting quarterly 
since 2011. The law also required that the Advisory Council generate a 
separate set of recommendations that would go directly to the Secretary 
and to Congress outlining our opinions and necessary steps for treating 
Alzheimer's disease and related dementias. These recommendations are 
not constrained by any current fiscal considerations.

    The primary goal of the National Plan is to effectively treat and 
prevent Alzheimer's disease by 2025. One of the corresponding 
recommendations that the Advisory Council has put forth to the 
Secretary and Congress urges the Federal Government to allocate at 
least $2 billion a year for research in Alzheimer's disease. Currently, 
with the recent increase in the FY 2016 budget, the Federal allocation 
is $991 million. We are making progress, but we have a long way to go.

    According to a report from the Alzheimer's Association, caring for 
persons with Alzheimer's disease in 2015 cost the United States $226 
billion, 70% of which came from Medicare and Medicaid. This means that 
approximately one in five Medicare/Medicaid dollars was spent on 
Alzheimer's disease. By 2050, that annual cost is estimated to be 
greater than $1.1 trillion. This represents a 420% increase over that 
timeframe and indicates that, by 2050, we will be spending one in three 
Medicare and Medicaid dollars on Alzheimer's disease. The cumulative 
costs from now until 2050 will be over $20 trillion, again 70% of which 
will be covered by Federal and State governments. Therefore, if we were 
to be successful at addressing the primary goal of the Plan, to develop 
an effective treatment by 2025, these figures may become modifiable. We 
need to act now to avert this untenable scenario for our country.

    Putting this in the context of the primary goal of the National 
Plan, if we were to develop by 2025 a disease-modifying therapy that 
delayed onset of the disease by 5 years, this would reduce the number 
of individuals with Alzheimer's disease over the succeeding 5 years, 
from 8.2 million to 5.8 million. This would result in a savings of $83 
billion from $451 billion to $368 billion. If you project these numbers 
out to 2050, at which time we indicated that we would be spending $1.1 
trillion without a disease-modifying therapy, that number would be 
reduced to $734 billion.

    Without an effective treatment, cumulatively over the 10 year 
period from 2025 to 2035, Federal and State governments would pay an 
estimated $3.2 trillion. Again, assuming a disease-modifying therapy by 
2025 over the ensuing 10 years, Federal and State governments would 
appreciate a cumulative savings of $535 billion. Even in the first year 
following a disease-modifying therapy, we would be saving $3 billion. I 
do not mean to inundate you with statistics, but the numbers are 
impressive that, for as little of an investment of $2 billion a year 
for Federal research, the impact in savings to the Federal health-care 
system would be enormous.

    So, are we there? As I mentioned, the current Federal budget for 
Alzheimer's disease research is approximately $991 million. In 2014, 
Congress passed the Alzheimer's Accountability Act which required the 
National Institutes of Health to generate an annual Professional 
Judgment Budget, also called a bypass budget, to estimate what the 
annual costs would be to reach the goal of the plan by 2025. Last year, 
Dr. Francis Collins, Director of the National Institutes of Health, 
announced the first bypass budget for FY17 at the Advisory Council's 
summer meeting. He estimated that the recommended increase in the 
budget for FY17 would be $323 million. He and his staff are currently 
working on the 2018 bypass budget.

    The research community is poised to make the necessary progress to 
make these treatment projections a reality with the disease-modifying 
therapy by 2025. The academic field is working on the notion of 
prevention of Alzheimer's disease. By prevention, we mean a delay in 
the onset or the slowing of progression of the disease, which is 
entirely realistic. Through recent research advances funded largely by 
NIH, such as the Alzheimer's Disease Neuroimaging Initiative and our 
Mayo Clinic Study of Aging, we have become able to identify the 
underlying disease process causing Alzheimer's disease in cognitively 
normal individuals. This research opens the door for designing more 
efficient and effective clinical trials.

    As we move toward earlier and earlier identification of the disease 
through the use of clinical tools and biomarkers, we are developing 
better techniques to assess individuals. The Patient Centered Outcome 
Research Institute (PCORI) has focused a recent dementia initiative on 
evaluating clinical measures from the patients and, and very 
importantly, from caregivers, to assist in the development of these new 
therapies.

    In closing, I would like to thank Congress for its proactive stance 
in addressing these issues. The time is now to act at continuing to 
increase the budget for Federal funding of research for Alzheimer's 
disease because the consequences of these projections are otherwise 
unsustainable. Alzheimer's disease is the most costly disease in this 
country and will become increasingly so unless we develop these 
effective therapies.

    I would like to commend both my Federal and nonfederal colleagues 
on the Advisory Council for Research, Care and Services for the 
National Alzheimer's Plan as well as our colleagues in the Department 
of Health and Human Services, most notably in the office of the 
Assistant Secretary for Planning and Evaluation and the National 
Institutes of Health. Our work is just beginning. I appreciate the 
opportunity to share these thoughts with you this afternoon and would 
be happy to entertain questions. Thank you.

                                 ______
                                 
                              Mayo Clinic 
                          College of Medicine
_______________________________________________________________________
                                                200 First Street SW
                                         Rochester, Minnesota 55905
                                                       507-284-2511

                                    Ronald C. Petersen, Ph.D., M.D.
                                            Cora Kanow Professor of
                                       Alzheimer's Disease Research
                                     507-538-0487, Fax 507-538-6012

October 3, 2016

Patrick J. Toomey
U.S. Senator
United States Senate
Washington, DC 20510

Dear Senator Toomey:

I would like to thank you for the opportunity to testify before the 
Senate Finance Subcommittee on Health Care on ``Alzheimer's Disease: 
The Struggle for Families, a Looming Crisis for Medicare'' on July 13, 
2016. I was pleased to share my views with you and the committee and 
greatly appreciate the venue to discuss this looming crisis.

I recently returned from Australia where I toured the country, 
discussing Alzheimer's research and policy issues in the United States. 
Since Australia is developing a national strategy, they were primarily 
interested in our approach to the U.S. Plan to Address Alzheimer's 
Disease. I spoke at the Australian National Press Club on World 
Alzheimer's Day, September 21, and entered into a rich discussion 
following the presentation. I cited many of the statistics for them 
that I had presented to your subcommittee.

I appreciate the opportunity respond to Senators Grassley and Burr that 
you requested. I will address them as enclosures.

Senator Toomey, I again want to express my appreciation to you for my 
opportunity to respond to you and Senators Grassley and Burr. Please do 
not hesitate to contact me at any time.

Sincerely,

Ronald C. Petersen, Ph.D., M.D.
Professor of Neurology
Distinguished Mayo Clinic Investigator
Cora Kanow Professor of Alzheimer's Disease Research
Cadieux Director, Mayo Alzheimer's Disease Research Center
Director, Mayo Clinic Study of Aging

                                 ______
                                 
                              Mayo Clinic 
                          College of Medicine
_______________________________________________________________________
                                                200 First Street SW
                                         Rochester, Minnesota 55905
                                                       507-284-2511

                                    Ronald C. Petersen, Ph.D., M.D.
                                            Cora Kanow Professor of
                                       Alzheimer's Disease Research
                                     507-538-0487, Fax 507-538-6012

October 3, 2016

Charles E. Grassley
U.S. Senator
United States Senate
Washington, DC 20510

Dear Senator Grassley:

I would like to thank you for your insightful comments regarding the 
status of funding for Alzheimer's disease and other dementias. I 
appreciated the opportunity to testify before the Senate Finance 
Subcommittee on Health Care on July 13, 2016, and greatly appreciate 
your interest.

The issues you raise regarding Alzheimer's disease funding and its 
impact on citizens of Iowa and the country are particularly germane. 
With respect to your specific question on the potential of the EUREKA 
prize, I will offer the following.

A substantial prize such as $10 million for Alzheimer's disease would 
be particularly exciting. While there are many endeavors that could be 
addressed, I believe that early recognition of the diagnosis, and most 
importantly, identifying those at risk for developing the disease in 
the future would be most productive. Due to the magnitude of the 
problem, I do not believe we can wait until people become clinically 
symptomatic to institute treatment. Rather, from a public health 
perspective, we need to prevent the disease. As such, there has been a 
great deal of work on identifying early biomarkers of the disease, even 
when people are clinically normal, and I believe that this is an urgent 
need. I would invest in increased development and validation of 
biomarkers for Alzheimer's disease that we could employ in the 
population as early as possible. Preferably, these would be relatively 
inexpensive and noninvasive to be maximally useful, but in the interim, 
we need to validate current sets of biomarkers. When this work is 
completed, intervention with disease modifying therapies could be 
employed at the appropriate time in the disease process.

I realize that this is just one opinion, but I think it reflects a 
great deal of activity currently underway in the field of Alzheimer's 
disease research. Again, I would like to thank you for your keen 
interest in the topic and your proposal to establish a EUREKA prize.

Sincerely,

Ronald C. Petersen, Ph.D., M.D.
Professor of Neurology
Distinguished Mayo Clinic Investigator
Cora Kanow Professor of Alzheimer's Disease Research
Cadieux Director, Mayo Alzheimer's Disease Research Center
Director, Mayo Clinic Study of Aging


                              Mayo Clinic 
                          College of Medicine
_______________________________________________________________________
                                                200 First Street SW
                                         Rochester, Minnesota 55905
                                                       507-284-2511

                                    Ronald C. Petersen, Ph.D., M.D.
                                            Cora Kanow Professor of
                                       Alzheimer's Disease Research
                                     507-538-0487, Fax 507-538-6012

October 3, 2016

Richard Burr
U.S. Senator
United States Senate
Washington, DC 20510

Dear Senator Burr:

I would like to thank you for the opportunity to testify before the 
Senate Finance Subcommittee on Health Care on July 13, 2016, regarding 
Alzheimer's disease. I found the questions and the subsequent exchange 
to be extremely valuable, and I was impressed with the committee's 
commitment to this topic.

With respect to the specific questions that you have raised following 
the hearing, I would like to offer these responses.

Question 1: What is the state of the research in developing more 
effective diagnostic tools for this disease?

I believe the field is advancing very rapidly with respect to the 
development of diagnostic tools for Alzheimer's disease. In particular, 
formerly, one could not make the diagnosis of Alzheimer's disease until 
the individual had passed away and an autopsy on the brain was 
performed. At the time of autopsy, the two signature proteins, amyloid 
comprising the neuritic plaques and tau comprising the neurofibrillary 
tangles, were sought. The field has progressed sufficiently such that 
we can now identify these two proteins, amyloid and tau, in living 
individuals using positron emission tomography (PET) scanning 
techniques. We can also detect their presence during a lumbar puncture 
to obtain cerebrospinal fluid. This is a tremendous advance in the 
field since, as therapeutics are developed, they can be targeted 
specifically toward these proteins and their effect on the proteins can 
be measured using these new detection techniques.

Consequently, as a clinician at the Mayo Clinic, I am much more 
confident in making my diagnoses using these tools to aid in our 
clinical assessment. Biomarkers will become increasingly valuable as 
therapies evolve.

Question 2: What is the timeline for development of a game-changing 
drug for patients with Alzheimer's disease?

At any given time, there are more than 50 potential therapeutic 
candidates under investigation around the world. However, relatively 
few make it to Phase 3 of FDA testing. Currently, one Phase 3 result 
will be reported later this year pertaining to the anti-amyloid 
antibody, solanezumab. This compound produced by Eli Lilly and Company 
has been tested in two previous trials which have not proved 
successful. However, using the new imaging techniques described above 
in response to Question 1, the proponents are now confident that they 
are using the potential therapy in appropriate participants, i.e., 
individuals who have demonstrated the amyloid protein in their brains. 
As such, this will be a realistic test of this particular compound.

On a related note, another anti-amyloid antibody, aducanumab, has 
demonstrated in Phase 1 results that it can, in fact, lower the amyloid 
levels in the brain over the course of treatment for 12 months. These 
data have been reported in a prominent journal just recently and 
indicate that the antibody strategy does, in fact, work at removing the 
amyloid. Since this was only a Phase 1 study, the study was not 
statistically powered to detect clinical effects, but the group of 
subjects who responded to the compound by demonstrating a reduction in 
amyloid over the 12 months also had stabilization of their clinical 
symptoms. This is very encouraging for the field, and two large global 
Phase 3 trials have been launched.

All this is to say that the development of therapeutics is a very 
active area in the field of Alzheimer's disease research, and we are 
increasingly hopeful that a positive result will appear in the next few 
years.

Question 3: What can be done to accelerate these processes in order to 
reach the goals of effective treatments and cures more quickly?

This is a particularly important issue with respect to the development 
of effective therapeutics. A major barrier to the development of 
effective therapeutics revolves around the issue of subject recruitment 
for randomized controlled trials. That is, when a clinical trial for a 
therapy is designed, the recruitment phase is projected. However, 
almost always, the proponents need to extend the recruitment phase 
because the participants are reluctant to join the trial or, more 
likely, are unaware of the trial's existence. As such, there are major 
efforts underway currently to increase enrollment in randomized 
controlled trials. It is not uncommon for a person with a difficult-to-
treat cancer to enroll in a clinical trial, and we need to raise the 
awareness of the general public and practicing physicians. If the 
physicians were more informed on the availability of clinical trials 
for Alzheimer's disease, we would be able to develop effective 
therapies much more efficiently and economically. As such, enrollment 
in clinical trials is a major area of concern.

I need to disclose that I have consulted both for Eli Lilly and Company 
and Biogen, Inc., with respect to the development of therapeutics for 
Alzheimer's disease. The two compounds I mention above are sponsored by 
these two companies. However, since I do a great deal of work in this 
area as a clinical investigator, I do not think these involvements 
alter my perception of the field. Nevertheless, I wanted you to be 
aware.

Again, thank you so much for your interest in the field, and I would be 
happy to expand upon any of these issues at a future point in time.

Sincerely,

Ronald C. Petersen, Ph.D., M.D.
Professor of Neurology
Distinguished Mayo Clinic Investigator
Cora Kanow Professor of Alzheimer's Disease Research
Cadieux Director, Mayo Alzheimer's Disease Research Center
Director, Mayo Clinic Study of Aging

                                 ______
                                 
 Submitted by Hon. Patrick J. Toomey, a U.S. Senator From Pennsylvania
    Prepared Statement of George Vradenburg, Chairman and Founder, 
                          UsAgainstAlzheimer's
Chairman Toomey, Ranking Member Stabenow, and members of the 
subcommittee:

On behalf of UsAgainstAlzheimer's, a relentless patient-centered force 
committed to ending Alzheimer's disease by 2020, I applaud you for 
holding this hearing on this most important issue. While a number of 
congressional committees have held hearings examining Alzheimer's from 
a number of angles, this session is particularly powerful because it 
focuses explicitly on the devastating economic impact this disease has 
on families and our Medicare program.

Multiple studies in recent years have placed the annual total cost of 
our Nation's Alzheimer's epidemic in excess of $200 billion. Notably, a 
2013 report by the RAND Corporation placed the direct medical costs of 
Alzheimer's disease care at $109 billion (compared to cancer at $77 
billion) and at $159 billion to $215 billion annually when the value of 
informal care services is included.\1\
---------------------------------------------------------------------------
    \1\ Michael D. Hurd, Ph.D., Paco Martorell, Ph.D., Adeline 
Delavande, Ph.D., Kathleen J. Mullen, Ph.D., and Kenneth M. Langa, 
M.D., Ph.D., N. Engl. J. Med., 2013, 368: 1326-1334, April 4, 2013.

Furthermore, estimates indicate that 70 percent of the total national 
costs of Alzheimer's disease are shouldered by taxpayers through the 
Medicare and Medicaid programs. For 2016, this would amount to about 
$160 billion. To put this in perspective, $160 billion is about 24 
percent of the estimated $673 billion the chief actuary estimates will 
be spent in 2016 on the entire Medicare program.\2\
---------------------------------------------------------------------------
    \2\ See FY 2016 HHS Budget in Brief: http://www.hhs.gov/about/
budget/budget-in-brief/cms/medicre/index.html.

Beyond the United States, global costs of this disease in 2015 were 
estimated at $800 billion, or over 1 percent of global GDP. As the 
prevalence of the disease triples in the coming decades with its 
attendant rapid increase in global burden, entitlement costs around the 
world will put increasing pressure on global balance sheets and 
sovereign debt quality. A particularly troubling statistic, according 
to Alzheimer's Disease International, is that by 2030 63 percent of the 
global population living with Alzheimer's or other forms of dementia 
will reside in low- and middle-
income countries, a percentage that will rise to 68 percent by 2050.\3\
---------------------------------------------------------------------------
    \3\ Alzheimer's Disease International: World Alzheimer's Report 
2015: The Global Impact of Dementia; An Analysis of Prevalence, 
Incidence, Cost, and Trends, https://www.alz.co.uk/sites/default/files/
pdfs/world-alzheimer-report-2015-executive-summary-english.pdf.

While the primary focus of this hearing is rightfully the impact of 
this disease on American families and on Medicare, a full discussion on 
Alzheimer's and dementia cannot occur without touching on research. In 
recent years, thanks to the leadership of many in this Chamber, 
Congress has allocated increased resources to support Alzheimer's 
research at the National Institutes of Health (NIH). While the recent 
and ongoing efforts must be applauded vigorously, the reality is that 
today we are committing less than $1 billion to Alzheimer's research--
about \1/6\ of 1 percent of what our government programs are spending 
each year in care costs to address this disease. Increasing levels of 
research investment into the broad promising scientific opportunities 
in attacking this disease hold the promise of reducing this burden. We 
have seen time and again, particularly in the fields of cancer, 
cardiovascular disease and HIV/AIDS, that focused and intensive 
commitments to research can crack heretofore vexing scientific 
challenges and lead to breakthroughs in how we treat and manage a 
condition. We need this same commitment, right now, to Alzheimer's 
disease. The fact is that Alzheimer's is a cancer-size or greater 
---------------------------------------------------------------------------
problem demanding a cancer-size or greater solution.

Over the past several years, I have been privileged to serve as an 
inaugural member of the World Dementia Council to help drive forward 
global action to address Alzheimer's and dementia. Over the past few 
years, this panel and other experts have begun to coalesce around the 
notion that a nation should commit at least 1 percent of care costs to 
research efforts aimed at developing therapies and cures.

Of course, many factors play into making such research decisions 
including the state of the science, the opportunities available and the 
quantity of high-quality and meritorious science being proposed. I 
would submit that Congress and the NIH consider the 1 percent market as 
a short-term target to inform research prioritization. If we fail to 
set priorities that are informed by the most significant current and 
looming threats to the physical and financial well-being of our 
families and the Nation overall, our future will be one of lives lost 
and of fiscal ruin.

As the agency that is responsible for covering these costs, the Centers 
for Medicare and Medicaid Services (CMS) needs to play a significant 
role in leading our national efforts to prevent and effectively treat 
Alzheimer's by 2025. Perhaps the most important action the agency can 
take is to provide greater levels of support and services to 
beneficiaries with Alzheimer's through their caregivers. Doing so is 
another short term strategy to equip caregivers to keep their loved 
ones at home and out of residential care homes for longer periods of 
time and also educing emergency room and avoidable hospital admissions 
or readmissions. Such action would reduce the care costs that are 
burdening Medicare and delay or reduce the institutional care costs 
that are challenging Medicaid.

Some significant developments to achieve these goals have occurred 
during the past few weeks and are examples of issues within the Finance 
Committee's jurisdiction.

Last month, the Senate Appropriations Committee advanced a fiscal year 
2017 Labor, HHS Appropriations Act that included the Health Outcomes 
Planning and Education or HOPE For Alzheimer's Act, a piece of 
legislation long-championed by Ranking Member Stabenow and Senator 
Susan Collins, Chair of the Special Committee on Aging. This bill, if 
enacted, would help ensure Medicare beneficiaries with Alzheimer's 
disease receive timely and accurate diagnoses as well as critically 
important guidance and direction to access a range of care planning 
services.

UsAgainstAlzheimer's knows far too many patients and family members who 
struggled for years to obtain an accurate diagnosis as well as those 
who, once diagnosed, were told there is simply nothing that could be 
done for them. While no disease-modifying or slowing drug has been 
approved as of today, we do know that a number of lifestyle 
modifications, co-morbidity management, and supportive services can 
make a difference in helping patients and their families maintain their 
quality of life and plan for the future.

I urge the members of this committee to do everything you can to enact 
the HOPE Act into law this Congress, through the appropriations process 
or as a stand-alone bill.

More recently, just last week Ranking Member Stabenow joined Senator 
Shelley Moore Capito--who lost both of her parents to Alzheimer's 
disease--in introducing S. 3137, the Alzheimer's Beneficiary and 
Caregiver Support Act. This bill would pick up where the HOPE Act 
leaves off by authorizing Medicare to evaluate promising counseling and 
supportive interventions that, when delivered to the informal or non-
paid caregivers of persons with Alzheimer's and dementia have been 
shown to improve the caregiver's health and well-being, thus enabling 
them to care for their loved one for longer periods of time and reduce 
utilization of the health system.

A major driver of the Alzheimer's cost burden is the cost of care, 
particularly institutional care, with Medicaid being the largest payer 
of such care. One such model, developed by a team at New York 
University and evaluated over decades, found that targeted in-person 
and telephonic counseling and supports delivered to family caregivers 
helped delay placement of the person with Alzheimer's in an 
institutional care setting by about 18 months compared to the control 
groups.

Given the cost of nursing home care--1 year in a semi-private room 
costs nearly $75,000 on average according to LongTermCare.gov--such a 
model could realize significant savings to individual families and to 
our Federal healthcare budget. The time is ripe for CMS to conduct such 
an evaluation, and I urge all members of this subcommittee to cosponsor 
S. 3137 today.

I thank you for calling this important hearing, and I urge you and this 
committee to continue the focus on the impact Alzheimer's will have on 
the Medicare program going forward. There is much that CMS can and 
should be doing to blunt this threat, and I look forward to working 
with all of the members on these issues going forward.

                                 ______
                                 

                             Communications

                              ----------                              


                            Aging Institute

        of UPMC Senior Services and the University of Pittsburgh

                       Forbes Tower, Suite 10065

                      3600 Forbes Avenue at Meyran

                          Pittsburgh, PA 15213

                              412-864-2396

                           www.aging.UPMC.com

The Honorable Pat Toomey            The Honorable Debbie Stabenow
Chairman                            Ranking Member
Senate Finance Subcommittee on 
Health Care                         Senate Finance Subcommittee on 
                                    Health Care
248 Russell Senate Office Building  731 Hart Senate Office Building
Washington, DC 20510                Washington, DC 20510

Chairman Toomey, Ranking Member Stabenow, and committee members:

Thank you for the opportunity to speak in support of the needs of 
caregivers. I serve as the Director of the Aging Institute of UPMC 
Senior Services and the University of Pittsburgh where we are fervent 
in our focus on the core needs of the older adult and the very real 
struggle for families and caregivers, particular those providing care 
for an individual with Alzheimer's Disease, or related dementia. We 
have developed programs and initiatives designed to provide one-on-one 
supports and education for both caregivers, as well the health 
professionals that provide additional services.

In short, the needs of caregivers are great. For those providing care 
for an individual with cognitive changes including Alzheimer's Disease 
or related dementia and other memory disorders, there are the 
additional complexities such as wandering, cognitive and functional 
decline, and behavioral disturbances that heighten the demands on 
caregivers. Becoming a caregiver is associated with increased 
depression, poor self-care, and increased chronic illness, and many of 
these caregivers must manage difficult symptoms and problematic 
behaviors in addition to the physical, emotional, and financial 
challenges of caregiving in the home. Moreover, becoming a caregiver is 
also associated with social isolation. Caregivers must deal with 
changes and challenges in their emotions, energy, living patterns, 
finances, and roles. Over time, heavy duty caregivers decline more 
rapidly than non-caregivers, and caregiving itself is a risk factor for 
mortality.

The demands of this group have been a particular concern in 
Pennsylvania, which has the country's fourth oldest population. Older 
adults have a disproportionally higher burden of disease, utilization 
of health care services, and the need for both family caregiving as 
well as professional health care supports. In addition, according to 
the Alzheimer's Association, there are more than 400,000 individuals, 
throughout the state of Pennsylvania, living with Alzheimer's Disease 
and related dementias with approximately 669,000 family caregivers 
providing 760 million hours of unpaid service throughout the state each 
year. The financial burden is also significant where nationally, more 
than $214 billion, which represent one dollar out of every five spent 
by Medicare and Medicaid goes to treat Alzheimer's Disease. Fifteen 
million individuals provided 17.4 billion hours of unpaid care, with 
60% rating the emotional stress of caregiving as high or very high, and 
one-third to two-thirds reporting high levels of depression. In 
response to this growing need, the Pennsylvania Alzheimer's Disease 
Planning Committee and the Pennsylvania Long-Term Care Commission were 
developed, both of which brought together legislators, medical 
professionals, and individuals living with Alzheimer's disease 
throughout the state to create comprehensive reports outlining 
recommendations from the respective committees. Enacted legislation 
such as the Caregiver Advise Record and Enable Act, referred to as the 
CARE Act or Act 20, is a common sense solution--integrating health and 
social services--that supports caregivers when loved one is 
hospitalized by encouraging a more formalized provision of instructions 
for medical tasks upon their loved one's return to home. In addition to 
the CARE Act, recently proposed legislation such as the Alzheimer's 
Beneficiary and Caregiver Support Act underscore the recommendations 
from these committees and outline a strong focus and plan for 
supportive action:

        Recommendation--PA State Plan for ADRD: Enhance support for 
        family and nonprofessional caregivers and those living with 
        ADRD.

        Recommendation--PA Long-Term Care Commission: Enhance services 
        provided to unpaid caregivers.

How can we prevent caregivers from feeling burdened while sustaining 
and assisting them in meaningful and positive aspects of caregiving? 
The approach should include not just the individual and family 
counseling, participation in support groups, and telephone contact 
discussed later in this testimony. It can also include tailoring multi-
component interventions in a more individualized manner. As such, more 
intensive support strategies that combine education, support, and 
respite into a single, extended service offered more long-term have 
proven efficacy. An example of this type of approach is found in the 
Resources for Enhancing Alzheimer Caregiver Help, referred to as the 
REACH and REACH II protocols currently utilized by the Allegheny County 
Department of Aging for their funded program called Caregiver First 
Initiative through Family Links. A somewhat different approach than the 
New York University's Caregiver Intervention, which the Alzheimer's 
Beneficiary and Caregiver Support Act is modeled after, the REACH and 
REACH II protocols merit attention due to emerging results of improving 
caregivers' quality of life and serve as a first-rate example of a 
local effort bringing evidenced-based practice into service delivery. 
Of note, REACH II was designed to address the needs of culturally 
diverse caregivers of persons with dementia, including White, Hispanic, 
and African-American caregivers and has been able to show that it 
improves caregiver quality of life, and was found to show benefits to 
White, Hispanic, and African-American caregivers.

In addition, the following initiatives are offered free of charge to 
those in the community and serve as a bridge to science, education, and 
service to deliver care that is both evidenced-based and efficient. 
They reflect the mission of the Aging Institute by providing 
integrated, comprehensive, and timely access to a full range of 
services for older adults, their friends, caregivers, family members, 
and healthcare professionals without financial restriction.

Education--In 2013, the Aging Institute developed the INSPIRE 
(Inspiring New Solutions and Providing Individualized Resources and 
Education) Advanced Caregiver Series. Through six weekly sessions, 
personalized, comprehensive, and individualized support as well as in-
depth dementia education is provided to long-term caregivers, 
particularly those providing in-home care to older adults. Core course 
content includes:

     Managing the disease's progression;
     Identifying and responding to behavioral issues;
     Dealing with depression; and
     Crisis resolution.

Pre-course and post-course one-on-one sessions are conducted with 
participants to further emphasize the course content.

Help and referral line--The Aging Institute hosts a free call-line that 
serves as a community-benefit with no restrictions on geographical 
location or insurance affiliation. Callers are connected with a health 
professional trained to provide older adults, caregivers, and members 
of the community with supportive resources based upon their needs. 
These call-line supports have been extended into a physical location at 
a nearby community hospital through the Aging Institute at UPMC 
McKeesport Resource Center. This center provides a physical location 
where individuals from the community can walk in and work with a health 
professional to obtain information and connections to community 
resources. The space also houses educational sessions and support group 
sessions of the Alzheimer's Association.

Website (aging.upmc.com)--The Aging Institute seeks to provide helpful 
aging-
related information to health care professionals, students, 
researchers, and the community at large and contains a feature where 
users can submit aging-related questions to be answered either 
virtually or via phone by the call-line staff. A dedicated section 
contains resources for caregivers and important information on topics 
such as advanced care planning, and social and emotional supports.

Employer/Employee Supports--The Aging Institute and UPMC has partnered 
with the United Way of Allegheny County on the United for Caregivers 
Initiative designed to stimulate both employer and employee engagement 
and to increase the supports available to employees who also serve as 
caregivers. American businesses lose $29 billion each year due to 
employees' need to care for loved ones, and many caregivers in the 
workforce are also members of the ``sandwich generation'' characterized 
as providing caregiving needs to both the older adult and younger 
children at home. Through this initiative, a survey was created and 
disseminated to staff at eight companies to better understand the 
distribution of employees that identified themselves as caregivers 
within the workforce and to identify needed resources for this group.

Charles F. Reynolds III, M.D.
Director, Aging Institute of UPMC Senior Services and the University of 
Pittsburgh
UPMC Endowed Professor in Geriatric Psychiatry
Director, NIMH Center of Excellence in Late-Life Depression Prevention 
and Treatment
Director, John A. Hartford Foundation Center of Excellence in Geriatric 
Medicine, School of Medicine, University of Pittsburgh

                                 ______
                                 
               Statement Submitted by Michael Ellenbogen

My name is Michael Ellenbogen, and I live in Jamison, PA 18929. I am 
living with Alzheimer's and have become a world renowned advocate for 
this cause. Below are the issues and actions that need to be addressed 
as I see them if we are going to help people and their families deal 
with this devastating disease. Implementation of the following will 
lead to future savings to government and the public sector. The 
government loses so much money today because of this disease, including 
many things that are not even being considered under the actual cost of 
the disease; i.e., loss of revenue from taxes from the individuals who 
no longer work, and the added cost of SSDI and unemployment 
supplements. To keep it simple I will make this in bullet form. For 
more details look at my other attachment. Keep in mind I have AD so 
don't expect perfection.

        LACK OF FUNDING is one of the biggest issues we face. If we 
        were to fund research for Alzheimer's like we fund other major 
        disease research, we would find ways to slow it down and even a 
        possible cure.

        AWARENESS AND EDUCATION must be increased. Not only do we need 
        to remove the stigma around this disease, most people including 
        medical staff do not understand this disease. Although NAPA was 
        created about 4 years ago there has been no real public 
        awareness on the disease to better educate the public. One way 
        to help with this is to also support and push for involvement 
        for Dementia Friendly America.

        MEDICAL PROFESSIONALS: Through my experience with medical staff 
        and hospitals, I have learned that in order to educate them 
        about this disease we will need to make training mandatory by 
        insisting they take CEU's related to dementia training. Without 
        it I can assure you it will not happen. I have been told this 
        by high level professionals in the field. In my opinion 
        hospitals should play a key role in advancing such training.

        If we want doctors to actually diagnose people with dementia we 
        need to ensure that people's rights are not taken away just 
        because they receive this diagnosis. People lose their drivers' 
        license in some states. Some judges take away the individual's 
        right to maintain control of their own finances and most 
        importantly we do not get the same rights as someone who is 
        disabled--especially at policy forums like the NAPA Advisory 
        Council. If NAPA does not provide appropriate accommodations 
        for people living with dementia, how are we going to set an 
        example for others to follow?

        Given the ever-increasing number of individuals who need to be 
        diagnosed, gerontologists and geriatricians are critically 
        important. Unfortunately we have a serious issue because there 
        are fewer doctors choosing this field due to the lack of 
        financial reimbursement. Doctors need to spend additional time 
        with these patients in order to determine a proper diagnosis. 
        Additional financial incentives are needed for new doctors to 
        get into this field.

        We also need to change the laws so that physicians can oversee, 
        and be paid for, at-home care so people with dementia can live 
        in their homes longer. That will lead to a savings to all and 
        better outcomes for those patients.

        MEANINGFUL ENGAGEMENT: We need to find meaningful things to do 
        for individuals with dementia who no longer can work. The labor 
        laws prohibit our volunteering. If we were able to volunteer, 
        it would delay the progression of the disease and we would 
        function longer before needing care.

        RESOURCE DATABASE: Today there is no system in place to give 
        help to the people who need it when they need it. I believe a 
        database can be created to do just that. It would help people 
        get the answers they need to help them take care of their love 
        one and would delay placement in a residential facility or the 
        need to go to a hospital emergency room. So many caregivers are 
        thrown into the fire of taking care of others without any tools 
        or directions on what to do or where to go.

These are what I consider the critical issues that will lead to the 
most success in helping to deal with the escalating challenges our 
nation faces from an ever-growing aging population living with 
dementia. Thanks.

                                 ______
                                 
                      Jewish Association on Aging

                             200 JHF Drive

                          Pittsburgh, PA 15217

                              412-420-4000

                            Fax 412-521-0932

                         http://www.jaapgh.org/

July 12, 2016

The Honorable Patrick J. Toomey
Chairman
U.S. Senate Committee on Finance
Subcommittee on Health Care
248 Russell Senate Office Building
Washington, DC 20510

The Honorable Debbie Stabenow
Ranking Member
U.S. Senate Committee on Finance
Subcommittee on Health Care
731 Hart Senate Office Building
Washington, DC 20510

Dear Senators Toomey and Stabenow,

Thank you for allowing me to participate in this critical conversation 
on ``Alzheimer's Disease: The Struggle for Families, a Looming Crisis 
for Medicare.'' As the President and CEO of the nonprofit Jewish 
Association on Aging in Pittsburgh, Pennsylvania, I am acutely aware of 
the ravages of this disease and applaud you for bringing this difficult 
and important conversation to the forefront.

The impact of Alzheimer's in both quantitative and qualitative terms on 
the population we serve cannot be overstated. The illness has a 
devastating impact on individuals, their caregivers, families, the 
economy, the healthcare system, and the community at large. In 2015, 
the Alzheimer's Association reported 270,000 individuals living with 
Alzheimer's in the state of Pennsylvania, with the number projected to 
increase by 18.5 percent to 320,000 by 2025. On a national level, an 
astonishing 1 out of 3 people are affected by this disease--either by a 
personal diagnosis or a diagnosis of a family member--in this country.

The mission of the JAA is to honor and enhance the lives of older 
adults by providing a continuum of individualized quality care 
consistent with Jewish values and tradition. For 110 years we have been 
committed to providing long-term care and shelter to the region's 
elderly population. Today the JAA offers a full range of comprehensive 
care programs to keep seniors active, safe, independent, and connected 
to the community through services to seniors of all faiths, 
backgrounds, and financial means, including seniors who no longer have 
the ability to pay for their own care. In fiscal year 2016, we served 
more than 3,000 seniors and their families throughout our continuum and 
provided more than $2.8 million in uncompensated care services and 
charity.

Since 2012 the JAA has embarked upon a culture change journey 
throughout our continuum to enhance the lives of seniors in our 
community with greater opportunities for independence and social 
engagement. We have several Alzheimer's programs across our continuum, 
including 48 skilled nursing and personal care rooms for those 
suffering from Alzheimer's and dementia. Our Anathan Club Adult Day 
Service has a growing registry of more than 45 individuals and we 
recently launched a Nighttime Memory Care Program--the only facility in 
the state--that cares for those suffering from Alzheimer's and dementia 
during the evening hours when they are the most restless, giving 
caregivers a much needed respite. But that just touches the surface as 
we project that approximately 80% of the elderly we serve across our 
entire continuum of health care services have some form of dementia 
with varying degrees of the progression of the illness. Combine these 
compelling statistics with the fact that Western Pennsylvania is home 
to the second largest population of adults over 65 in the country, 
second only to Dade County, Florida, and we need no other motivation 
for our community to prepare for the ``silver tsunami'' and the surge 
of services that we will need to offer best-in-class care for our 
elders, their families and the community at large.

I wanted to take a few moments to tell you what I, our caregivers, and 
volunteers encounter every day with our Alzheimer's patients. There's 
Marialyce, who walks through the halls with her daughter listening to 
an iPod and laughing at silly, sometimes coarse, jokes. There's Edward 
who cannot recall his wife's name or her smile, but knows he loves her. 
And there's Joel, an esteemed former physician who after his diagnosis 
remained uncommunicative for hours but has suddenly found a new passion 
for painting in one of our art classes offered at our Adult Day 
Service. But for every one of the Marialyces, Edwards and Joels, we do, 
sadly, hear of stories of elderly men and women who battle this disease 
alone with no support and without even a sliver of the care they need. 
We also hear stories of the stress of caregivers, who before they 
discovered our services, found themselves alone, abandoned by friends 
when their loved one's diagnosis became public. This is a disease that 
people are terrified of, and this fear of the unknown leads to 
misunderstanding.

We now take it upon ourselves to battle that fear and we hope Congress 
will support patients and families affected by Alzheimer's by 
supporting the types of services the JAA provides.

At the JAA we have a long-range goal of developing creative and cost-
effective solutions to address the escalating number of older adults 
expected to suffer from Alzheimer's and dementia over the next 30 
years. Last year, we launched our commitment to be the premiere memory 
care specialists in Western Pennsylvania. The JAA has begun training 
staff under the Boston, Massachusetts-based Hearthstone Institute's 
``I'm Still Here'' comprehensive transformation training program, which 
offers innovative memory care techniques through agency-wide culture 
change. This is a philosophy of understanding and caring for 
individuals with Alzheimer's disease and other dementias through 
practical application of a proven methodology. This methodology is 
based on the ``I'm Still Here'' approach of Harvard-educated Dr. John 
Zeisel that despite the diagnosis of Alzheimer's, those affected and 
their families can still find meaning and purpose and have excellent 
quality of life for many, many years. The stigma of this disease is so 
pervasive in our community it prevents people seeking treatment and 
living life to the fullest in spite of the disease. We were compelled 
to invest in this groundbreaking socially responsible program that will 
educate family members, staff and the public at large to change the 
conversation about Alzheimer's as a disease of ``disability'' to one 
that emphasizes ``ability.''

Make no mistake. Funding these programs are a challenge for us. But we 
believe it is a priority, not only for us but for our community and 
nation as a whole.

Alzheimer's disease and the stress it places on patients, families and 
society cannot be ignored. As much as we as a small nonprofit in 
Western Pennsylvania can do, we need support from our local, state and 
national representatives to join us in combating this disease by 
funding important programs such as ours and making sure that our 
parents and grandparents have all the tools at their disposal so they 
don't have to feel like they are suffering alone. Together, we can beat 
this disease and its stigmas.

Thank you for your time and dedication.

Sincerely,

Deborah Winn-Horvitz
President and CEO

                                 ______
                                 
                         Eli Lilly and Company
Chairman Toomey, Ranking Member Stabenow, and distinguished members of 
the subcommittee, thank you for the opportunity to submit written 
testimony on the widespread impact of Alzheimer's disease--a condition 
that devastates the lives of millions of Americans and their families 
each year.

Indeed, the growing impact of Alzheimer's disease has led many 
economists, the health-care industry, and communities across the 
country, to sound the alarm about this enormous public health threat--
and rightfully so, as the statistics are as staggering as they are 
daunting.

For example, there are currently 5.4 million Americans who are living 
with Alzheimer's disease. With an aging baby boomer population, coupled 
with longer life spans, that number will nearly triple to 13.8 million 
by 2050.

Alzheimer's disease will cost Americans $236 billion this year alone--
and this is projected to swell to $1.1 trillion by 2050. But the 
disease reaches much further, with an acute burden placed on the 
families of patients as well. It is estimated that more than 15 million 
caregivers provide an estimated 18.1 billion hours of unpaid care to 
patients each year.

On this path, the burden on families will only amplify for generations 
to come, and the disease will inflict serious trauma on the American 
health care system. Yet, as of now, we currently have no means to 
prevent, slow or cure the sixth leading cause of death in the United 
States.

Of course, while a cure for the disease remains elusive, over the 
course of the last 50 years, scientists--including those at Lilly--have 
gained a better understanding of how the disease affects the brain, 
which, in turn, has helped improve care for millions of people. And 
while the statistics currently related to the disease are sobering, 
there remains hope on the horizon.

After decades of research and determination, scientists have moved 
closer to innovative new therapies. The possibility of real 
breakthroughs are within our grasp. For Lilly's part, we have invested 
28 years and $3 billion in research and development on new medicines to 
treat this devastating disease.

Just last month, we were excited to announce the launch of the 
Alzheimer's Readiness Project. The mission of this project is to 
inspire action by fostering a deeper understanding of Alzheimer's, its 
evolving science, and the public health crisis it poses.

The project will combine efforts to advocate on behalf of those with 
the disease, encourage effective and efficient research and ensure a 
regulatory system that reflects the best science and thinking we have. 
With this initiative, we will support policies and laws that recognize 
innovation and investment that will make a real difference for those 
impacted by the disease.

Building off of ongoing partnerships, public education efforts and 
events, we will provide a platform where people come together to 
discuss solutions and raise awareness of the need for and value of 
advancements in the fight against Alzheimer's disease.

Those engaged in the fight against Alzheimer's--from researchers and 
physicians to advocates, business leaders and Congress--have set a goal 
to prevent or effectively treat Alzheimer's by 2025. The fact is: we 
can't meet the goal if we don't act now. Which is why we have ramped up 
our efforts and the intensity of our focus.

However, while we continue our research, there are conclusions we have 
already drawn that should be considered. For example, we need to 
increase emphasis on early detection and diagnosis of Alzheimer's 
disease--diagnosis and treatment in the early stages is paramount to 
stopping the disease before it does irrevocable damage.

We need to encourage the development of innovative treatments. New 
approaches to treating Alzheimer's disease will play a vital role in 
preventing and effectively treating Alzheimer's. However, the path from 
basic research to new medicines is extremely complex with challenges 
along the way. When those new treatments do become available, timely 
and appropriate reimbursement decisions will need to be made.

We also need to improve the efficiency of clinical trials. A limiting 
factor to advancing research is the challenging process of conducting 
clinical trials, including recruitment of participants.

We also would encourage community action strategies. Communities across 
the nation are facing the fiscal and societal impact of Alzheimer's. 
Implementation of the U.S. National Alzheimer's Plan, as well as 
individual state and community-based plans, are critical.

And an often forgotten component is the need to enhance public 
awareness and engagement. Significant misperceptions about diagnosis 
lead to stigmatization and delayed treatment. Since early detection and 
diagnosis is critical, education about the disease is paramount.

We have learned a great deal about Alzheimer's, and a tremendous amount 
of effort by many has occurred. But we can do better, and doing better 
means laying the groundwork today for the change we want to see in the 
future. Of course, scientific breakthroughs often involve years of 
research, trials, errors and, sometimes, setbacks. But armed with a 
united desire to make life better for people in this country and around 
the world, we can--and must--continue the fight.

                                 ______
                                 
       National Association of Psychiatric Health Systems (NAPHS)

                     900 17th Street, NW, Suite 420

                       Washington, DC 20006-2507

                              202-393-6700

                         https://www.naphs.org/

              Statement of Mark Covall, President and CEO

Mr. Chairman and members of the Subcommittee, I want to thank you for 
holding this hearing on ``Alzheimer's Disease: The Struggle for 
Families, a Looming Crisis for Medicare.''

On behalf of our member organizations, we are pleased to provide our 
insights on the need for Medicare modernization that could play a 
critical role in improving the lives of millions of Americans who live 
with symptoms of a serious mental disorder. We are very concerned about 
patients with Alzheimer's disease and would like a Medicare system that 
fits the 21st century.

The National Association of Psychiatric Health Systems (NAPHS), which 
was founded in 1933, advocates for behavioral health and represents 
provider systems that are committed to the delivery of responsive, 
accountable, and clinically effective prevention, treatment, and care 
for children, adolescents, adults, and older adults with mental and 
substance use disorders. NAPHS members are behavioral healthcare 
provider organizations that own or manage more than 800 specialty 
psychiatric hospitals, general hospital psychiatric and addiction 
treatment units and behavioral healthcare divisions, residential 
treatment facilities, youth services organizations, and extensive 
outpatient networks.

Medicare Modernization Is Necessary

As you know, Medicare was established in 1965 when our healthcare 
delivery system and insurance system were very different than today's. 
This was before Alzheimer's disease was declared the most common form 
of dementia and a substantial public health challenge by the 
neurologist Dr. Robert Katzman in a 1976 editorial.

In 1965, most care for people living with mental illnesses was provided 
in state mental hospitals. Inpatient stays were counted in months and 
years, and much of the care was custodial in nature. So when Congress 
was considering establishing the Medicare program, this was the 
framework that Congress had to work within in establishing coverage for 
mental illnesses. This resulted in a very limited benefit for mental 
illnesses under the original Medicare program and a benefit that 
provided much less coverage compared to that for other medical 
disorders. The benefits for mental illnesses included just inpatient 
hospital and outpatient office-based visits, but more importantly these 
benefits had limits in duration, scope, and cost-
sharing. For example, outpatient psychiatric care had a 50% cost-
sharing requirement (compared to an 80% cost-sharing requirement for 
all other Medicare outpatient services). Also, inpatient psychiatric 
care provided in freestanding psychiatric hospitals was limited to 190 
days during the lifetime of a Medicare beneficiary.

These discriminatory benefits for mental illnesses remained in place 
until 2008 when Congress made the first change in mental health 
coverage since 1965. In 2008, Congress changed the cost-sharing for 
outpatient mental health services from 50% to 80% (phased in over 
several years) to make cost-sharing for mental health just like that 
for all other Medicare outpatient services. Yet the Medicare 190-day 
lifetime limit for inpatient psychiatric care in freestanding 
psychiatric hospitals remains unchanged to this day. (However, the 190-
day lifetime limit does not apply to Medicare beneficiaries receiving 
treatment in a psychiatric unit in a general hospital.)

During the 1980s, there was a growth in the number of community private 
psychiatric hospitals that provided short-term, acute, inpatient 
psychiatric care. At the same time, the downsizing and closing of state 
mental hospitals intensified. During this period, diagnosis and 
treatment of mental illnesses dramatically improved, and new 
medications became available. This resulted in briefer inpatient stays 
compared to the longer-term care that was provided in the 1960s when 
Medicare was first established. The 1990s saw a decline (more than 30%) 
of the overall inpatient psychiatric bed capacity. The decline in beds 
was in all settings, including state mental hospitals, community 
private psychiatric hospitals, and general hospitals' psychiatric 
units. Today, many communities do not have enough inpatient psychiatric 
beds--leading to an increase in emergency room visits, longer time 
spent in the emergency departments, and patients needing to travel long 
distances to receive inpatient psychiatric care.

In 2008, Congress passed landmark legislation called the Paul Wellstone 
and Pete Domenici Mental Health Parity and Addiction Equity Act 
(MHPEA). This legislation changed the landscape of coverage for mental 
and addictive disorders by requiring private commercial health plans 
that offered coverage for mental health and addictive services to 
provide that coverage on par with all other medical disorders. However, 
the major governmental health insurance program for seniors and the 
disabled--the Medicare program--still has discriminatory coverage for 
inpatient psychiatric care. It is long past due to bring the Medicare 
program up to the standard of all other insurance plans and to--once 
and for all--eliminate Medicare's 190-day lifetime limit for inpatient 
psychiatric care delivered in community private psychiatric hospitals.

The need to get rid of this long-standing discriminatory provision for 
inpatient psychiatric care is not just about fairness and equity, but 
it is about real people who are dealing with debilitating Alzheimer's 
disease, who so desperately need this care.

Who Are These Medicare Beneficiaries? Why Is Elimination of the 190-Day 
Lifetime Limit Critical?

The Medicare Payment Advisory Commission \1\ has outlined key 
characteristics of Medicare beneficiaries who receive inpatient 
psychiatric care.
---------------------------------------------------------------------------
    \1\ Medicare Payment Advisory Commission (MedPAC). ``Inpatient 
psychiatric care in Medicare: Trends and issues.'' Chapter 6 in Report 
to Congress. June 2010. See http://www.medpac.gov/chapters/
Jun10_Ch06.pdf.

Unlike beneficiaries seen in other types of hospitals, most Medicare 
beneficiaries treated in inpatient psychiatric facilities (known as 
---------------------------------------------------------------------------
``IPFs'') qualify for Medicare because of disability.

As baby boomers have aged, the number of IPF beneficiaries between the 
ages of 45 and 64 has grown, rising 18% between 2002 and 2009.

More than a quarter of Medicare beneficiaries (29%) have a cognitive/
mental impairment.\2\
---------------------------------------------------------------------------
    \2\ Henry J. Kaiser Family Foundation. ``FACT SHEET: Medicare at a 
Glance,'' #1066-12, January 2010. www.kff.org/medicaid/upload/
4091_06.pdf.

Medicare is a critical safety net for those who have long-term mental 
disabilities, but who have the ability to participate in the community 
---------------------------------------------------------------------------
throughout their lives given adequate support.

These demographics provide a picture of Medicare beneficiaries who have 
symptoms of a serious mental illnesses (such as Alzheimer's disease) 
and who are living with these disorders. Alzheimer's is a chronic 
disease and will require ongoing treatment and care over lifetimes, 
including hospitalization when in crisis.

Care for these sickest patients continues to have unnecessary 
complexity and barriers that don't exist for other complex or chronic 
illnesses. These Medicare beneficiaries can easily exceed the 190-day 
lifetime limit because the chronicity of their illness.

The 190-day lifetime limit restricts access to critical, life-saving 
treatment just when it is most needed.

The 190-day lifetime limit also impacts the continuity of care for 
people living with Alzheimer's disease. Just when they need crisis 
stabilization in a hospital setting, they may not be able to go to the 
hospital and doctors who have been treating them for many years because 
of the arbitrary lifetime limit.

Legislation has been introduced in previous Congresses to eliminate the 
190-day lifetime limit, and it has been both bipartisan and supported 
by broad coalition of national organizations.

In closing, the science and expertise about mental illnesses has grown 
exponentially in recent years. These illnesses can be diagnosed and 
treated effectively. People can recover their memory. What we need to 
do as a society is to give people the hope and help they deserve--just 
as we would for someone who has a heart condition or cancer.

Eliminating the 190-day lifetime limit will equalize Medicare mental 
health coverage with private health insurance coverage, expand 
beneficiary choice, increase access for the most seriously ill, improve 
continuity of care, and create a more cost-effective Medicare program.

Mr. Chairman, again, thank you for holding this very important hearing. 
We look forward to working with you and the entire Subcommittee to 
ensure that Medicare beneficiaries living with Alzheimer's disease are 
able to have coverage that is comparable to what is available for all 
other Medicare beneficiaries.

                                 ______
                                 
                       National PACE Association

                  675 N. Washington Street, Suite 300

                          Alexandria, VA 22314

                          Phone: 703-535-1565

                           Fax: 703-535-1566

                       http://www.npaonline.org/

The Program of All-Inclusive Care for the Elderly (PACE) is a proven 
care model that provides high-quality, community-based, integrated care 
to some of our nation's frailest, most vulnerable citizens--those over 
the age of 55 who need a nursing home level of care but seek to remain 
in their own homes. Studies show that people receiving care from PACE 
organizations live longer, are in better health, have fewer 
hospitalizations and spend more time living in their homes than those 
receiving care through other programs. PACE is an evidence-based 
program in which nearly half of the people who receive care and support 
have been diagnosed with dementia. As described in the chart below, 
PACE programs have a long history of serving patients with dementia, 
along with additional complex chronic conditions.

Today, it is possible to enroll only those individuals who meet their 
state's eligibility criteria for nursing home care. Once enrolled, PACE 
programs provide and are responsible for all care needed by enrollees, 
this includes long-term services and supports and acute services. There 
are 119 PACE programs operating in 31 states, serving approximately 
40,000 participants--and this number continues to grow each year.

As a result of bipartisan legislation passed by Congress and signed 
into law by the President last year, the PACE Innovation Act of 2015, 
PACE has additional opportunities to serve those with intellectual 
disabilities, dementia, and Alzheimer's. The Centers for Medicare and 
Medicaid Services (CMS) now has additional authority under the ACT to 
pilot the PACE model with new populations, including people younger 
than 55 and those with complex care and support needs who do not yet 
meet their state Medicaid agency's criteria for needing a nursing home 
level of care. These pilots have the potential to expand the 
availability of PACE and PACE-like services to a greater number of 
people with Alzheimer's, their families and their friends, thereby 
providing them access to a care option that addresses the serious gaps 
in our current health and long term care delivery systems. The pilots 
would enable PACE organizations to offer high-quality, fully-integrated 
care that allows people with Alzheimer's who do not yet meet 
traditional PACE eligibility criteria to maintain their optimal health, 
receive much-needed services, and live independently in the community.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


Not far from where this committee meets, the lives of two individuals 
and their families provide compelling examples of the difference access 
to a PACE program could make through a pilot program.

Serving People Under the Age of 55: Jim G.

Jim G. is a 54 year old Virginia resident who was diagnosed with early-
onset Alzheimer's disease. Although Jim was initially enrolled in 
clinical trials to combat his illness, he recently ceased all treatment 
as his memory--and his health--deteriorated. Jim tried to enroll in the 
local PACE program, but was unable to because he was not yet 55 and 
therefore did not meet the program's current age eligibility 
requirements.

Jim was hospitalized in 2014 for a lung infection caused by ``silent 
aspiration,'' which occurs when the swallowing function is weakened by 
Alzheimer's. A once vibrant athlete, Jim lost almost 40 lbs. Initially, 
Jim stayed home alone during the day, where he was isolated and 
struggled with activities of daily living, such as personal grooming, 
household chores, and child care. Karen, his caregiver, struggled to 
care for Jim and tend to her school-aged children, while also holding 
down a full time job, but eventually had to quit her job to care for 
him full time. Unfortunately, Karen discovered that his needs were more 
than she could handle. Following a psychotic break and a week as a 
psychiatric inpatient, Jim was permanently placed in a memory care unit 
near their home. Karen had to use ``crowd-sourcing'' to raise funds for 
Jim's treatment.

This heartbreaking situation might have been avoided had Jim been able 
to enroll in PACE. Jim could have received day-time support that would 
allow him to continue to live at home with his family. He could have 
received therapies to help him stay physically strong, and primary care 
to help avoid silent aspiration and other health complications. PACE 
has significant experience with dementia, and might have been able to 
avoid or better manage his psychiatric deterioration. And Karen and her 
family would have received much needed respite services, emotional and 
social support, and peace of mind, perhaps helping her maintain her 
employment.

Serving People At-Risk of Nursing Home Placement: Terry B.

In testimony before the District of Columbia's Council, Terry B. 
described her work as an enrollment coordinator at a PACE program as 
``the most rewarding job I ever had in my life. I was able to help 
older adults and their families find a solution to some very 
heartbreaking issues and could substantially see the huge difference 
this program made in their lives--from being totally at the bottom of 
despair to living a full life and thriving in their final years.''

At the age of 56, Terry was diagnosed with younger onset dementia, and 
has now reached the point where she can no longer work. She recently 
completed her term as a member of the national Alzheimer's Association 
Early-Stage Advisory Group, helping the Association provide the most 
appropriate services for people living with early-stage dementia, raise 
awareness about early-stage issues and advocate with legislators to 
increase funding for research and support programs.

Terry observed that she is ``not yet ready nor qualified to need the 
PACE program, but when I do I know they will be there for me and my 
family.'' Through a pilot program, Terry and her family would be able 
to access the PACE program when they determine they need its support 
and integrated care rather than waiting until Terry meets the state's 
nursing home level of care criteria. This earlier access to PACE can 
support Terry's continued quality of life, in a home setting that also 
strengthens the caregivers in her life.

Providing Access to PACE for People With Alzheimer's

The pilots made possible by the PACE Innovation Act of 2015 would help 
Jim, Terry and others like them. These pilots would allow CMS to test 
and adapt the PACE model for individuals under the age of 55 and those 
who are not yet in need of a nursing home level of care but whose care 
delivery systems and supports are being strained as they strive to 
maintain their quality of life.

But providing care to individuals with dementia is nothing new. 
Specifically, the following are benefits that PACE has, and will 
continue to provide, to people with Alzheimer's, their families, and 
policymakers seeking to improve their care options:

      Access to team based, disability competent care for an 
underserved, high cost population.
      Improved care coordination with timely and accessible primary 
care reducing unnecessary emergency, inpatient and long term care 
utilization.
      Reduced nursing home utilization enabling nursing home eligible 
individuals to live independently in the community.
      Competent, consistent and quality attendant care services for 
activities of daily living.
      Social network of care with innovative physical and virtual day 
programs to enhance independence and employability.
      Extensive use of adapted technologies--computing, telehealth, 
social networking, environmental controls, mobility--to increase 
independence, provide enhanced abilities at reduced cost.
      Significant savings to Medicaid and Medicare--payments to PACE 
programs are less than Medicaid would pay for a comparable population 
in its other programs and PACE provides savings to the Medicare 
program.
      Relocation of individuals from nursing homes into community 
settings by partnering with state and local housing organizations to 
fund development of accessible, affordable and safe housing.

Below is an example of a participant who has benefitted from the PACE 
model of care.

Serving People With Dementia: Anna M.

Anna M., or ``Gramma'' as she was affectionately called, was a 103-
year-old Virginia resident who joined PACE once community adult-day 
care support alone was insufficient to address her needs. She suffered 
from dementia, experienced a steady cognitive and functional decline, 
and could no longer converse in English, but rather spoke in her native 
Italian.

When she joined PACE, Gramma was very agitated and combative, often 
hitting or spitting at PACE staff and, to a lesser degree, other 
participants. She was very territorial over her space and her 
possessions and rather inflexible in her routines. At the very 
beginning, the only activity she would engage in when she began with 
PACE was manically cutting up newspapers and magazines.

In PACE, Gramma worked closely with the entire interdisciplinary team 
(IDT) of PACE professionals, particularly with dementia experts to help 
her transition to PACE. The IDT quickly realized that she thrived with 
routines, familiar environments, and caregivers. So, Gramma was set up 
with a very consistent routine, which she followed daily with regular 
and consistent staff.

With some support, Gramma began to participate in a dozen different 
activities that she enjoyed and looked towards each day. The PACE 
program was able to transition her away from using scissors to more 
benign tasks such as folding laundry and sorting cards. Gramma expanded 
beyond her initial sphere of activity and there were even times when 
she would join in during group activities and interact with her peers 
at the PACE center. Beyond group activities, the PACE program developed 
tailored strategies to support Gramma. They used a colored plate during 
meal-time to increase intake (low vision is often a problem with 
dementia and poor visual contrast of, for example, white food on a 
white plate leads to decreased intake because the person can't see the 
food vs. white food on a blue plate). They would also sweeten her food 
with strawberry syrup because people with dementia lose their sense of 
taste and eventually only taste sweet foods, not to mention Gramma 
loved the color red.

The PACE staff were keen to keep the overall distractions and noise 
level low, provided appropriate activities, and provided direct one-on-
one care. The PACE staff ensured that she was actively engaged in a 
meaningful activity to reduce the risk of falls and minimize agitation. 
Additionally, the PACE team provided ample training and education. They 
hosted a caregiver training series focusing on caring for loved ones 
with dementia.

By working with Gramma and her caregivers, her family noted a number of 
improvements in her quality of life, including:

      Decreased agitation and aggression and overall improved mood;
      Increased participation in a large variety of activities;
      Increased intake;
      Decreased caregiver burden and stress; and
      Increased caregiver competence.

Her family was happy that after joining PACE Gramma began eating dinner 
again with the family. She began sleeping at night and she was again 
enjoying her family's company. Gramma passed away in her home, 
surrounded by her family. PACE supported her and her family throughout 
the end of her life.

Without PACE, Gramma's family said, they simply would not have been 
able to achieve so much.

Congress can advance a proven, cost-effective care model that will help 
achieve the goals of better care coordination, and higher quality of 
life by supporting the expansion of PACE programs both through new 
pilots as well through additional legislative and regulatory 
opportunities. In particular, updating the 2006 regulation, currently 
under review by the OMB, would greatly improve access to PACE with the 
potential to support more and faster growth.

Thank you for the opportunity to provide this testimony. We would be 
happy to provide any additional information that would be of use to the 
committee as it considers how to support the care needs of people with 
Alzheimer's and their families. Please contact Peter Fitzgerald, 
Executive Vice President, Policy and Strategy at the National PACE 
Association with any questions or if we can be of assistance. Mr. 
Fitzgerald can be reached at 703-535-1519 or [email protected].

                                 ______
                                 
               Statement Submitted by Regina A. Shih \1\
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    \1\ The opinions and conclusions expressed in this testimony are 
the author's alone and should not be interpreted as representing those 
of the RAND Corporation or any of the sponsors of its research.
---------------------------------------------------------------------------

                        The RAND Corporation \2\
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    \2\ The RAND Corporation is a research organization that develops 
solutions to public policy challenges to help make communities 
throughout the world safer and more secure, healthier, and more 
prosperous. RAND is nonprofit, nonpartisan, and committed to the public 
interest.
---------------------------------------------------------------------------

                          http://www.rand.org/

    In 2013, my colleagues at RAND published an estimate of the cost of 
dementia to millions of families and the United States more broadly, 
reporting it to be the most costly condition in America.\3\ The team 
found that the vast majority of dementia costs are attributable to 
long-term services and supports (LTSS), rather than medical care. The 
number of Americans who will need LTSS is expected to double by the 
year 2050. As the nation's population grows grayer, the costs of 
dementia LTSS will only soar.
---------------------------------------------------------------------------
    \3\ Michael D. Hurd, Paco Martorell, Adeline Delavande, Kathleen J. 
Mullen, and Kenneth M. Langa, ``Monetary Costs of Dementia in the 
United States,'' New England Journal of Medicine, Vol. 369, No. 14, 
2013, pp. 1326-1334.

    Following RAND's landmark research estimating the extraordinary 
monetary costs of dementia, RAND researchers challenged themselves to 
answer the question: ``What can be done about this?'' I led a team that 
interviewed key representatives of national, state, and local 
stakeholder groups. Their views, combined with research on existing 
national dementia and long-term care reports, were evaluated to 
identify policy options that have the greatest impact on improving 
dementia LTSS. This policy evaluation was the first to examine 
promising LTSS policy solutions specifically for those living with 
Alzheimer's and other related dementias (referred to hereafter as 
dementia) and culminated in the RAND report, Improving Dementia Long-
Term Care: A Policy Blueprint.\4\
---------------------------------------------------------------------------
    \4\ Regina A. Shih, Thomas W. Concannon, Jodi L. Liu, and Esther M. 
Friedman, Improving Dementia Long-Term Care: A Policy Blueprint, Santa 
Monica, CA: RAND Corporation, RR-597, 2014.

    To inform today's subcommittee hearing on the impact of Alzheimer's 
disease on families and Medicare, I present the following statement for 
the record that integrates key findings from RAND's dementia LTSS 
policy blueprint and other relevant research publications.

Costs of Dementia

    In a study published in the New England Journal of Medicine, my 
RAND colleagues reported that the costs of care for seniors in the 
United States with dementia are expected to more than double by 
2040.\5\ In that study, the RAND team estimated that about 9.1 million 
people ages 70 and older will be suffering from Alzheimer's disease or 
another dementia by 2040. That study estimated that in 2010, Americans 
spent $109 billion for dementia care purchased in the marketplace, like 
skilled nursing facilities. When informal care provided by family 
members or others outside of institutional settings is factored in, the 
total cost of caring for individuals with dementia in 2010 grew to 
between $159 and $215 billion.
---------------------------------------------------------------------------
    \5\ Hurd et al., 2013.

    As the U.S. population ages in the coming decades, we can expect 
those costs to continue to escalate. Even if dementia's prevalence 
stays at the current rate and the cost of care does not rise, RAND's 
research showed that by 2040, total costs will have soared to as high 
as $511 billion.\6\ The vast majority of costs associated with dementia 
among those ages 70 or older are attributable to LTSS, rather than 
medical services. Unfortunately, the LTSS system has typically not been 
well aligned with the needs of persons with dementia.
---------------------------------------------------------------------------
    \6\ Hurd et al., 2013.
---------------------------------------------------------------------------

The Current State of Dementia Long-Term Services and Supports

    The costs of LTSS for persons with dementia are high, and they 
increase sharply as cognitive impairment worsens. LTSS can be provided 
by formal or informal caregivers. According to RAND estimates, the 
expense of in-home assistance provided by families accounts for 
approximately 50 percent of the total costs of dementia care.\7\
---------------------------------------------------------------------------
    \7\ Hurd et al., 2013.
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The Burden on Family Caregivers is Unsustainable
    Informal care, which we refer to as family care, is unpaid care 
that usually consists of assistance from a relative, partner, friend, 
or neighbor. The vast majority of dementia LTSS are provided by family 
caregivers, as much as 80 percent by one estimate.\8\ More than 15 
million Americans currently provide care to family members or friends 
with dementia.\9\ These family caregivers shoulder a heavy burden; 
nearly 40 percent reported quitting jobs or reducing work hours to care 
for a family member or friend with dementia. Many of these caregivers 
also experience negative physical and mental health effects. At the 
same time, family caregivers often report being inadequately educated 
about the trajectory of dementia and the scope of available respite/
adult day care resources that could alleviate the stressors of 
providing care, even 1 year after a dementia diagnosis has been 
made.\10\
---------------------------------------------------------------------------
    \8\ L. Harris-Kojetin, M. Sengupta, E. Park-Lee, and R. Valverde, 
Long-Term Care Services in the United States: 2013 Overview, 
Hyattsville, MD: National Center for Health Statistics, 2013.
    \9\ Alzheimer's Association, ``2013 Alzheimer's Disease Facts and 
Figures,'' Alzheimer's and Dementia: the Journal of the Alzheimer's 
Association, Vol. 9, No. 2, 2013, pp. 208-245.
    \10\ M.L. Laakkonen, Raivio, M.M., Eloniemi-Sulkava, U., Tilvis, 
R.S., and Pitkala, K.H., ``Disclosure of Dementia Diagnosis and the 
Need for Advance Care Planning in Individuals With Alzheimer's 
Disease,'' Journal of the American Geriatrics Society, Vol. 56, No. 11, 
2008, pp. 2156-2157; and Allison K. Gibson and Keith A. Anderson, 
``Difficult Diagnoses: Family Caregivers' Experiences During and 
Following the Diagnostic Process for Dementia,'' American Journal of 
Alzheimer's Disease and Other Dementias, Vol. 26, No. 3, 2011, pp. 212-
217.

    Demographic trends suggest that the current heavy reliance on 
family caregiving is unsustainable. Our RAND research has shown that 
compared to cognitively normal adults, persons living with dementia or 
cognitive impairment are more likely to receive care from 
daughters.\11\ This is alarming on several fronts: family sizes are 
shrinking, the number of women in the labor force is growing,\12\ and 
women are more likely than men to suffer negative employment and health 
consequences associated with family caregiving for dementia.\13\ As the 
median age of the U.S. population continues to trend upward, there will 
be a growing imbalance between the number of people needing care and 
family caregivers available to deliver it.\14\ These changes suggest 
that in the future, more people living with dementia will need to turn 
to formal care in lieu of or in support of family caregiving.
---------------------------------------------------------------------------
    \11\ Esther M. Friedman, Regina A. Shih, Kenneth M. Langa, and 
Michael D. Hurd, ``U.S. Prevalence and Predictors of Informal 
Caregiving for Dementia,'' Health Affairs, Vol. 34, No. 10, 2015, p. 
1637-1641.
    \12\ Jonathan Vespa, Jamie M. Lewis, and Rose M. Kreider, 
``America's Families and Living Arrangements: 2012,'' in Current 
Population Reports 2013, Washington, DC: U.S. Census Bureau, 2013.
    \13\ Family Caregiver Alliance National Center on Caregiving, 
``Fact Sheet: Caregiver's Guide to Understanding Dementia Behaviors,'' 
web page, 2016; and Erin DeFries Bouldin and Elena Andresen, Caregiving 
Across the United States: Caregivers of Persons With Alzheimer's 
Disease or Dementia in 8 States and the District of Columbia, Data From 
the 2009 and 2010 Behavioral Risk Factor Surveillance System, McLean, 
VA: Alzheimer's Association, 2014.
    \14\ Donald Redfoot, Lynn Feinberg, and Ari Houser, ``The Aging of 
the Baby Boom and the Growing Care Gap: A Look at Future Declines in 
the Availability of Family Caregivers,'' in Insight on the Issues, 
Washington, DC: A.P.P. Institute, 2013.
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Public Programs Cover Some Costs, but the Middle Class is Most 
        Vulnerable
    With respect to formal LTSS, Medicaid is the largest payer.\15\ 
Medicaid can cover skilled nursing facility care and paid care provided 
in the home or community, as well as assistance with personal care. In 
contrast, Medicare covers only hospice costs and a portion of short-
stay, post-acute care for Medicare beneficiaries. Medicaid eligibility 
rules in many states require that individuals have assets no greater 
than $2,000, and this restriction results in significant gaps in risk 
protection from LTSS costs. People with adequate resources who plan 
early enough turn to private long-term care (LTC) insurance or out-of-
pocket resources for financing, while lower-income individuals are 
covered through Medicaid. The middle class is at greatest risk for 
significant and possibly catastrophic LTSS costs, given the lack of 
readily available resources to finance their dementia LTSS.
---------------------------------------------------------------------------
    \15\ Carol V. O'Shaughnessy, The Basics: National Spending for 
Long-Term Services and Supports (LTSS) 2013, Washington, DC: National 
Health Policy Forum at George Washington University, 2013.
---------------------------------------------------------------------------
Medicare Post-Acute and Hospice Benefits Are Limited and Differentially 
        Affect Those With Dementia
    Persons with dementia would benefit from the expansion of several 
Medicare eligibility requirements. First, traditional Medicare covers 
skilled nursing facility care, if needed after a hospital stay, for 
patients who are hospitalized for at least 3 consecutive days. However, 
patients who are placed under observation status are not considered 
hospitalized.\16\ Therefore, individuals who have been hospitalized for 
3 consecutive days but under observation for some or all of their 
hospital stay would not meet the 3-day inpatient hospitalization 
requirement for subsequent skilled nursing facility coverage, thus 
incurring significant out-of-pocket financial costs. Additionally, some 
individuals who require intensive health and therapeutic services after 
a hospitalization may prefer to receive care in their community rather 
than at a skilled nursing facility. Adult day services are emerging as 
a key community-based provider of short-term rehabilitation and 
transitional care following hospital discharge and could provide some 
specialized services for people living with dementia who have been 
discharged from a hospital stay, instead of a skilled nursing facility. 
Under current Medicare policy, however, such community-based care is 
not reimbursable.
---------------------------------------------------------------------------
    \16\ Centers for Medicare and Medicaid Services, ``Chapter 8: 
Coverage of Extended Care (SNF) Services Under Hospital Insurance,'' in 
Medicare Benefit Policy Manual, Baltimore, MD: Centers for Medicare and 
Medicaid Services, 2014.

    Second, Medicare home health benefits currently require a 
beneficiary to be deemed ``homebound'' in order to access covered in-
home care. Yet, while persons living with dementia may not always have 
physical limitations that make them homebound, their mental and other 
functional limitations may still require the same level of in-home 
---------------------------------------------------------------------------
care.

    Third, the lifetime course of dementia symptoms can be 
characterized by long periods of stability punctuated by steep declines 
and occasional recovery. The average length of stay for beneficiaries 
with dementia who are receiving Medicare hospice care in skilled 
nursing facilities has increased over time,\17\ and the per-person 
hospice care payments across all beneficiaries with dementia were 10 
times higher than average per-person hospice payments for other 
Medicare beneficiaries.\18\ At the same time, the ability of physicians 
to predict 6-month mortality for persons with dementia is constrained 
by great variation in decline and recovery.\19\ Medicare currently 
requires a 6-month prognosis in order to qualify for hospice care, but 
this may not be easy to determine for those in the late stages of 
dementia.
---------------------------------------------------------------------------
    \17\ Susan C. Miller, Julie C. Lima, and Susan L. Mitchell, 
``Hospice Care for Persons with Dementia: The Growth of Access in U.S. 
Nursing Homes,'' American Journal of Alzheimer's Disease and Other 
Dementias, Vol. 25, No. 8, December 2010, pp. 666-673; Centers for 
Medicare and Medicaid Services, 2014.
    \18\ Julie Bynum, tabulations based on data from the Medicare 
Current Beneficiary Survey for 2008, Dartmouth Institute for Health 
Policy and Clinical Care, Dartmouth Medical School, November 2011.
    \19\ Susan L. Mitchell, Susan C. Miller, Joan M. Teno, Roger B. 
Davis, and Michele L. Shaffer, ``The Advanced Dementia Prognostic Tool: 
a Risk Score to Estimate Survival in Nursing Home Residents with 
Advanced Dementia,'' Journal of Pain and Symptom Management, Vol. 40, 
No. 5, November 2010, pp. 639-651; Susan L. Mitchell, Joan M. Teno, 
Susan C. Miller, and Vincent Mor, ``A National Study of the Location of 
Death for Older Persons With Dementia,'' Journal of the American 
Geriatrics Society, Vol. 53, No. 2, 2005, pp. 299-305; and Greg A. 
Sachs, Joseph W. Shega, and Deon Cox-Hayley, ``Barriers to Excellent 
End-of-life Care for Patients with Dementia,'' Journal of General 
Internal Medicine, Vol. 19, No. 10, 2004, pp. 1057-1063.
---------------------------------------------------------------------------

Policy Options for LTSS and Dementia

    Given the mounting toll dementia will place on our nation's 
families, LTSS, and health-care systems, RAND interviewed 40 
stakeholders across seven groups (patients/public, providers, 
purchasers, payers, policymakers, product makers, and principal 
investigators), representing multiple perspectives on dementia care, 
research, and policy, to identify potential policy options. The RAND 
dementia blueprint reports the independent evaluation of the policy 
options across 14 feasibility and impact criteria, ultimately arriving 
at 25 high-impact policy options. For the purposes of this hearing, I 
discuss the high-impact policy options in that report related to 
Medicare and those that could aid family caregivers.
Support Family Caregivers
    Family caregivers face a host of challenges caring for loved ones, 
and the federal government could implement new, or improve existing 
programs to assist these caregivers.

    One option could be to offer business and individual tax incentives 
to provide family caregiving. This approach could include tax breaks 
for individuals who are family caregivers, which would provide some 
compensation for their caregiving time. The incentives could also 
target businesses to promote provision of adult day care centers on 
site, expansion of dependent care accounts to incorporate more LTSS 
costs, and more paid time off and/or flexible work hours to allow for 
more and varied caregiving.

    Another option would be to expand financial compensation programs 
to family caregivers. The RAND dementia blueprint report recommends 
increasing the availability of compensation programs for lost wages and 
caregiving work (e.g., through Medicaid programs) and expanding these 
programs to all states. Such programs are often referred to as 
``participant-directed services'' or ``cash and counseling.'' While 
some persons with dementia may already have access to these programs, 
they are not available in all states and are restricted to persons with 
limited assets (primarily those on Medicaid). This solution would 
expand access to such programs to subsets of the population who 
currently cannot access them and increase awareness of existing 
compensation programs among those who are already eligible.

    A third option is to provide dementia-specific training and 
information about resources to family caregivers and volunteer groups. 
Interventions aimed at providing dementia-specific education, skill 
training, support, and counseling to family caregivers have 
successfully deferred skilled nursing facility placement for persons 
with dementia and decreased depression and distress among 
caregivers.\20\ Additional training and information could be provided 
to volunteer groups with access to persons with dementia and family 
caregivers, so that these groups may be better informed about the needs 
of persons with dementia. We also recommend wide dissemination of 
educational materials about providing care, hands-on training, and 
availability of formal LTSS resources available to family caregivers 
(e.g., respite care, community services) that may help make caregiving 
easier and more manageable. Combined, these policy recommendations are 
likely to reduce caregiver burden and potentially lessen or delay 
individuals' reliance on formal care often paid for by the federal and 
state governments. The legal and political feasibility of the option to 
expand financial compensation programs is likely to be higher than the 
option to provide tax incentives because the latter involves high costs 
to the federal government and businesses. Ideally, all three options 
would be packaged together, so that policies to provide monetary 
incentives to provide family care would be coupled with LTSS and 
dementia-specific LTSS training for family caregivers.
---------------------------------------------------------------------------
    \20\ M.S. Mittelman and S.J. Bartels, ``Translating Research Into 
Practice: Case Study of a 
Community-Based Dementia Caregiver Intervention,'' Health Affairs, Vol. 
33, No. 4, 2014, pp. 587-595; K. Hepburn, M. Lewis, J. Tornatore, C.W. 
Sherman, and K.L. Bremer, ``The Savvy Caregiver Program: The 
Demonstrated Effectiveness of a Transportable Dementia Caregiver 
Psychoeducation Program,'' Journal of Gerontological Nursing, Vol. 33, 
No. 6, 2007, pp. 30-36; and S. Belle, L. Burgio, R. Burns, D. Coon, 
S.J. Czaja, D. Gallagher-Thompson, L.N. Gitlin, J. Klinger, K.M. 
Koepke, C.C. Lee, J. Martindale-Adams, L. Nichols, R. Schulz, S. Stahl, 
A. Stevens, L. Winter, S. Zhang, and Resources for Enhancing 
Alzheimer's Caregiver Health II Investigators, ``Resources for 
Enhancing Alzheimer's Caregiver Health (REACH) II Investigators: 
Enhancing the Quality of Life of Dementia Caregivers From Different 
Ethnic or Racial Groups: A Randomized, Controlled Trial,'' Annals of 
Internal Medicine, Vol. 145, No. 10, 2006, pp. 727-738.
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A Comprehensive National Financing Solution Is Needed for LTSS
    As already discussed, the costs posed by dementia are only going to 
increase in the coming years, and many families are ill prepared to 
face those costs. A broad LTC insurance solution is needed to address 
high out-of-pocket costs for LTSS and the high proportion of older 
adults afflicted with dementia, and the federal government could help 
craft a national solution.

    One option would be to create a national, voluntary opt-out LTC 
insurance program through a public-private partnership, which would 
build upon the structure of the private health insurance system, while 
having a public wraparound of secondary insurance. Insurance provided 
by the private LTC insurance industry allows for market competition and 
consumer choice. Making the program opt-out would encourage greater 
uptake, which in turn could encourage more private insurers to enter 
the LTC insurance market. A large insurance pool would limit exposure 
to the insurers and also improve efficiency by reducing overhead and 
underwriting risk.

    Another option would be to adopt a national single-payer LTC 
insurance system that is financed through taxes and provides coverage 
for all citizens. The LTSS benefit could be a basic package or a 
comprehensive coverage built into Medicare or a new program. While LTC 
insurance coverage would be funded through the government, services 
could be provided by private organizations or other contractors.

    While both of these options would increase LTSS access and 
utilization, they also face challenges. Such programs would require 
substantial implementation costs, creating a significant practical as 
well as political barrier. I note that both the Commission on Long-Term 
Care's 2013 report and the alternative report by the dissenting members 
agreed that an element of public financing is needed, but they 
disagreed on the extent to which a social LTSS insurance system should 
be publicly financed.\21\ Future quantitative analyses that examine 
different financing options for public programs, tax credits for saving 
for LTSS costs, and private LTC insurance will inform the development 
of a comprehensive LTC insurance program. This is especially critical 
given the expected rise in dementia prevalence and associated high 
costs of care to the federal government and families.
---------------------------------------------------------------------------
    \21\ Commission on Long-Term Care, Report to the Congress, 
Washington, DC: U.S. General Accounting Office, September 30, 2013; and 
Long-Term Care Commission, A Comprehensive Approach to Long-Term 
Services and Supports, Washington, DC: U.S. General Accounting Office, 
September 23, 2013.
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Refine Medicare Post-Acute Care and Hospice Benefits
    Medicare post-acute and hospice benefits are limited, and persons 
with dementia would benefit from the expansion of eligibility 
requirements. The following options could be considered.

          Refine the three-day hospital stay requirement for skilled 
nursing facility care. This would extend coverage for skilled nursing 
facility care by allowing outpatient observation days to count toward 
the three-day inpatient hospitalization stay required before skilled 
nursing facility care is covered.
          Allow payments for adult day care instead of a skilled 
nursing facility. For beneficiaries who prefer to go home after a 
hospitalization rather than to a skilled nursing facility, Medicare 
could cover some specialized adult day care services at potentially 
lower cost than through a skilled nursing facility.
          Expand eligibility of hospice benefits to include dementia 
as a qualifying event. This change would mean that persons with 
dementia could receive hospice care before they are diagnosed as 
terminally ill with a life expectancy of six months or less. Doing so 
would give persons with dementia more options for palliative care.
          Reconsider the homebound requirement for receiving home 
health services under Medicare. Expanding eligibility to consider 
persons with dementia as homebound would allow persons with dementia to 
have access to in-home care and would help them remain at home longer.

    Expansion of these Medicare eligibility criteria for benefits and 
qualifying events would likely increase LTSS availability and use. 
Patient safety and patient and caregiver satisfaction would also likely 
increase with more access to post-acute care. While these 
recommendations would increase Medicare costs, they may be offset by 
savings to Medicaid and out-of-pocket spending for potential future 
LTSS, such as institutionalized care. Future cost analyses could 
further quantify the implications of these policy options on costs to 
Medicare.

    I appreciate the opportunity to provide a statement for the record 
for today's hearing. I would be happy to answer any follow-up questions 
that may arise in response to this statement.

                                 ______
                                 
   University of Pittsburgh Alzheimer Disease Research Center (ADRC)

                        UPMC Montefiore, 4 West

                           200 Lothrop Street

                       Pittsburgh, PA 15213-2582

                              412-692-2700

                           Fax: 412-692-2710

July 11, 2016

The Honorable Patrick J. Toomey
Chairman
U.S. Senate Committee on Finance
Subcommittee on Health Care
248 Russell Senate Office Building
Washington, DC 20510

The Honorable Debbie Stabenow
Ranking Member
U.S. Senate Committee on Finance
Subcommittee on Health Care
731 Hart Senate Office Building
Washington, DC 20510

Dear Chairman Toomey and Ranking Member Stabenow,

On behalf of our colleagues at the University of Pittsburgh Alzheimer 
Disease Research Center (ADRC), we are pleased to submit this written 
testimony for consideration at this week's aptly titled hearing, 
``Alzheimer's Disease: The Struggle for Families, a Looming Crisis for 
Medicare.''

As researchers at one of the nation's 31 federally funded Alzheimer's 
Disease Centers we interact regularly with scientists from around the 
globe who share our passion and commitment to improving our 
understanding of and discovering new treatments for Alzheimer's disease 
and related disorders (ADRD). Indeed, we are drafting this statement of 
record for your subcommittee just as we are preparing ourselves to 
present our latest research at the upcoming Alzheimer's Association 
International Conference (Toronto, CA, July 24-28). Meeting with and 
hearing from other leading experts from around the world at scientific 
conferences like this is always a highly energizing experience. These 
meetings give us fresh perspectives on the most innovative ideas for 
advancing the diagnosis and treatment of Alzheimer's disease, which in 
turn, fuels our drive to move forward our own research projects as well 
as to support and facilitate the research of other scientists through 
our leadership roles at the ADRC.

Yet, following each of these inspiring meetings, we return to western 
Pennsylvania and are quickly reminded of the sobering realities of the 
current state of clinical care for individuals with dementia. While we 
know firsthand that scientific progress is accelerating and offers 
great hope for future generations of patients, we are faced with 
frustration as we currently have so few treatment options for patients 
and families who are in the throes of the disease today. Patients and 
families come to Centers like ours seeking the most cutting edge 
diagnostic procedures and treatments that experts have to offer. At the 
time of an initial diagnosis of Alzheimer's disease or a related 
disorder, we see patients and their family members struggling to 
understand the illness and its implications for their futures. More 
than anything, they want to know what can be done to slow the course of 
the disease. Sadly, the answer to that question has been unchanged in 
13 years (when the Food and Drug Administration last approved a new 
treatment for AD); and for all practical matters, the answer has been 
the same since each of us encountered our first patient in clinical 
practice, ``We will do everything we can to manage the symptoms of this 
disease, but there is no cure available.''

While the standard of practice for treating Alzheimer's disease has 
been unchanged in years, what has changed dramatically are the record 
numbers of individuals affected by the disease and the soaring costs of 
caring for them. Estimates from the Alzheimer's Association indicate 
that more than 5 million Americans are currently living with 
Alzheimer's disease or a related dementia, making these conditions as 
common as heart failure, which the CDC estimates to affect 5.7 million 
Americans. However, dementia disorders are especially costly (Kelley et 
al., 2015). While the annual costs of heart failure are estimated at 
$32 billion (including healthcare services, medications and lost 
productivity), the care of persons with dementia is projected to cost 
the nation a staggering $236 billion in 2016. The nature of and payers 
for these costs are varied, but there is no question that Medicare 
related expenses are a major contributor to the overall economic impact 
of the disease on our society. Even other diseases become more costly 
to treat on a backdrop of dementia. For example, recent reports 
indicate that when an individual with dementia is hospitalized for an 
acute illness, they are more likely to have complications which, when 
present, cause dementia patients to incur double the costs for a 
hospitalization as compared to patients without dementia who are 
hospitalized for the same condition (Bail et al., 2014).

The high costs of dementia care, relative to other disease, are also 
documented at the level of out-of-pocket spending among families. A 
recent examination of data from the Health and Retirement Study found 
that out-of-pocket costs to families were 81% higher for patients with 
dementia than for those without dementia. Compounding these out-of-
pocket costs to family caregivers are lost wages as caregiving demands 
lead many individuals to reduce the amount of paid work in which they 
can engage, yielding long-lasting negative effects on overall wealth.

Given the immensity of the toll that Alzheimer's disease and related 
disorders are exacting upon the Medicare system and on American 
families, we commend you for taking the important step of holding this 
hearing. It is most promising that this hearing comes on the heels of 
the House and Senate appropriations committee proposals for historic 
and vitally needed increases in federal funding for research on AD.

Our personal commitments to conducting research on Alzheimer's disease 
are strong, unwavering, and all the more encouraged by announcements of 
such progress at the legislative level. In terms of our own work, our 
pioneering research led to the development of the first chemical agent 
to detect, in the brain of a living person, one of the hallmark 
proteins associated with Alzheimer's disease. This agent, known as 
``Pittsburgh Compound-B or PiB'' is now the gold standard for detecting 
this protein, beta-amyloid, in research studies around the world. We 
have authored some of the first reports on what it is like, from the 
patient's perspective, to experience the uncertainty of early cognitive 
changes and come to terms with planning for a likely course of 
progressive cognitive decline (while setting aside other hopes and 
dreams for old age). As leaders at the Pittsburgh ADRC we work with our 
colleagues to maintain the overall infrastructure of the Center as a 
resource for a multitude of research studies ranging from laboratory 
based genetic studies to clinical trials and caregiving studies.

Despite these efforts at our Center and others across the country, we 
must humbly acknowledge that even under the best case scenario of a 
new, course altering treatment for Alzheimer's disease within the next 
5 years, far too many individuals will continue to suffer the direct 
and indirect effects of this disease. We therefore urge your committee 
to identify new strategies for curbing the devastating impact that ADRD 
are having on patients and families who are living with the everyday 
realities of this disease while the world awaits a breakthrough in 
prevention or treatment approaches. The inclusion of the Health 
Outcomes, Planning, and Education (HOPE) for Alzheimer's Act (S. 857/
H.R. 1559) in the Senate Labor, Health, and Human Services 
Appropriations Committee FY 2017 Funding Bill is certainly a welcome 
and positive step. The HOPE Act would increase access to information on 
care and support for newly diagnosed individuals and their families, 
but we must go further. We need not only to increase access to these 
existing forms of care and support; we need to improve the existing 
options and capacity for care and support.

It is widely recognized that hospital based care and long term 
institutionalization are not the answers for providing compassionate 
and dignified care to persons with advanced dementia. Our colleagues in 
health services research indicate that there is much promise in 
innovative approaches to home and community based care. One example is 
the Aging Brain Care (ABC) program, a team based medical home model of 
care for persons with dementia and depression developed at Indiana 
University. This program takes a holistic approach to managing the 
biopsychosocial needs of both patients and their family caregivers 
through community based primary care and has been shown to reduce 
emergency department visits and hospitalizations, yielding annual cost 
savings of thousands of dollars per patient (French et al., 2014).

Similar demonstration projects are needed, but they will require 
financial support. Currently, groups of experienced care-professionals 
are meeting as part of the Alzheimer's Association ``Care and Support 
Operational Task Force.'' In a manner analogous to the process that set 
milestones and a budget for basic and clinical research under NAPA, 
these professionals are developing milestones for the enhancement of 
care and support in our country. A budget will also be eventually 
attached to these care and support milestones and, like the recent 
increases both realized (FY 2016) and proposed (FY 2017) for basic and 
clinical research, this care and support funding will need champions in 
Congress to become reality.

Even in a difficult economic climate, the recent funding increases 
prove that this can happen when our nation and our lawmakers establish 
the struggle our families currently endure as a priority. We hope such 
champions arise from this week's hearing, ``Alzheimer's Disease: The 
Struggle for Families, a Looming Crisis for Medicare.''

Thank you for the opportunity to submit this statement of record.

Sincerely,

Oscar L. Lopez, M.D.
Center Director

William Klunk, M.D., Ph.D.
Center Co-Director

Jennifer Lingler, Ph.D., CRNP
Outreach and Education Core Director

_______________________________________________________________________
Articles cited:

Bail K., Goss J., Draper B., Berry H., Karmel R., and Gibson D. ``The 
Cost of 
Hospital-Acquired Complications for Older People With and Without 
Dementia: a Retrospective Cohort Study. BMC Health Services Research, 
2015;15:91.

French D.D., LaMantia M.A., Livin L.R., Herceg D., Alder C.A., and 
Boustani, M.A. ``Healthy Aging Brain Center Improved Care Coordination 
and Produced Net Savings,'' 2014;33(4):613-8.

Kelley A.S., McGarry K., Gorges R., and Skinner J.S. ``The Burden of 
Health Care Costs for Patients With Dementia in the Last 5 Years of 
Life.'' Annals of Internal Medicine, 2015;163(10):729-36.

                                 ______
                                 
                    WomenAgainstAlzheimer's Network

                  Statement of Jill Lesser, President

Chairman Toomey, Ranking Member Stabenow, and Members of the 
Subcommittee:

On behalf of WomenAgainstAlzheimer's, a network of 
UsAgainstAlzheimer's, I commend you for convening this hearing and for 
your specific focus on the unique and difficult impact of Alzheimer's 
on women and families. Our growing network of women believes that 
Alzheimer's is one of the biggest economic justice issues and a growing 
health crisis for women in America and around the world. Our work is 
driven by passion and we are committed to finding new collaborative and 
innovative approaches to funding, research, and advocacy to bring 
Alzheimer's out of the shadows and into the spotlight.

Approximately 5.4 million Americans have Alzheimer's, and there are 
over 15 million unpaid caregivers of Alzheimer's patients within the 
United States. The number of individuals with Alzheimer's is expected 
to almost triple, approaching 13.5 million, in the next few decades. 
Without a cure, Alzheimer's is expected to cost the United States $2 
trillion by 2020 and have a devastating impact on families who often 
bear the brunt of the disease.

Alzheimer's is the 5th leading cause of death among women in the United 
States. Of the 6.4 million Americans with Alzheimer's disease, 4.2 
million or two-thirds are women. Recent studies suggest that men and 
women may be affected by Alzheimer's differently. Perhaps partially as 
a result of the increased likelihood of women developing Alzheimer's 
and other chronic diseases that increase the risk of developing 
dementia over their longer lifespan, women are much more likely to 
suffer from severe depression. However, recent research suggests there 
may be biological pathways that lead to greater cognitive impairment in 
females. Emerging science indicates that hormonal changes and sex 
differences in gene expression are potential explanations. And, 
WomenAgainstAlzheimer's believes that the time is now for a commitment 
to sex and gender differentiated research--whether in basic, 
translational or clinical research.

Given the rapid increase in the population of older Americans, the 
number of women with dementia and those serving as informal caregivers 
will escalate and cost the economy a cumulative $5.1 trillion (in 2012 
dollars) through 2040. This is according to ``The Price Women Pay for 
Dementia: Strategies to Ease Gender Disparity and Economic Costs,'' a 
new report recently released by the Milken Institute. We are proud to 
be partnering with the Milken Institute on the distribution of their 
groundbreaking report and on future research into the economic impact 
of Alzheimer's disease on women as caregivers and people more likely to 
live with the disease.

A key driver of the devastating impact of Alzheimer's disease on Women 
is our role as caregivers. Women make up the majority of informal 
caregivers, often as family members of dementia patients who need 
around-the-clock assistance with the most basic needs. Significantly, 
approximately 70% of Alzheimer's and dementia caregivers are women. 
Half of women caregivers alter or have to stop working due to the 
demands of caregiving for their loved one. In addition, 75% worry about 
caregiving's toll on their own health.

Due to the time-consuming nature of dementia care, many women drop out 
of the labor market, reduce work hours, or incur lost workdays and 
productivity losses. All of these adversely affect the economy in 
general and women's and families' economic security, in particular. 
With women's participation in the labor force expected to rise in the 
future, the impact on the economy will undoubtedly be magnified. 
Identifying ways to support them is critical.

For these reasons, we support several important Alzheimer's initiatives 
before the Finance Committee and we urge the committee to continue its 
investigation into innovative solutions to relieve the economic burden 
of this disease to American families. Specifically, we urge the Finance 
Committee to explore new programs that support beneficiaries with 
Alzheimer's and their caregivers, the vast majority of whom are women. 
And, we applaud new approaches already being identified. On July 7, 
2016, Ranking Member Stabenow and Senator Capito introduced S. 3137: 
the Alzheimer's Beneficiary and Caregiver Support Act. This bill would 
provide Alzheimer's disease caregiver support services to informal or 
non-paid caregivers to both keep patients in the home setting for 
longer periods of time and improve the quality of life of caregivers, 
ultimately resulting in lower Medicare and Medicaid program costs.

We urge the members of the Senate Finance Committee to cosponsor this 
important legislation and we look forward to working with you to enact 
this bill.

Ultimately, as WomenAgainstAlzheimers--waiting is not an option. In May 
of this year, we officially launched our We Won't Wait Campaign--a 
multi-faceted campaign joining together advocates for women's health 
and economic security to fight for a path to a cure--one that puts 
women front and center as patients and caregivers alike. We look 
forward to working with all of the members of the Committee to 
alleviate the burdens of Alzheimer's disease on a growing number of 
American families.

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