Advisory Council on Alzheimer's Research, Care, and
Services
January 14, 2012
PDF Version:
http://aspe.hhs.gov/daltcp/napa/011413/Mtg7-Slides1.pdf
(65 PDF pages)
Richard J. Hodes, M.D.
Chair, Research
Subcommittee
Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025
- Strategy 1.A: Identify Research Priorities and Milestones
- Strategy 1.B: Expand Research Aimed at Preventing and Treating
Alzheimer’s
- Strategy 1.C: Accelerate Efforts to Identify Early and Presymptomatic
Stages of Alzheimer’s Disease
- Strategy 1.D: Coordinate Research with International Public and
Private Entities
- Strategy 1.E: Facilitate Translation of Findings into Medical
Practice and Public Health Programs
Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025
Strategy 1.A: Identify Research Priorities and Milestones
Alzheimer's Disease Research Summit 2012: Path to Treatment and
Prevention
May 14-15, 2012
National Institutes of Health
U.S. Department of
Health & Human Services
Bethesda, MD
AD Summit Research Timeline
Strategy 1.A.4: Convene a scientific workshop on other dementias in
2013
- Alzheimer’s Disease-Related Dementias: Research Challenges and
Opportunities, Natcher Auditorium, NIH Campus, Bethesda, MD May 1-2, 2013
- The workshop will define the state of the science and identify the
critical opportunities and barriers in each of the dementias, whether basic,
translational, or clinical.
- Open to the public. Register online at
http://www.ninds.nih.gov/ADRelatedDementias2013
Down Syndrome Research Update
- The Global Down Syndrome Foundation, Alzheimer’s Association and
the Linda Crnic Institute for Down Syndrome hosted the workshop from September
13- 14 to bring together key scientists from the fields of Down syndrome and
Alzheimer’s research in Chicago. Attendees included NIA and NICHD staff.
- NIA and NICHD have begun planning for a research workshop on
Down Syndrome and Alzheimer’s disease in 2013.
1.B.2 Expand genetic epidemiologic research to identify risk and
protective factors for Alzheimer's disease.
- Conduct whole genome sequencing to identify areas of genetic
variation that correspond to risk factors of AD.
Alzheimer's Research Highlights -- Gene Discovery
1.B.2. Sequencing -- Update
- Extensive cataloging of individuals from national and international
studies for whom Genome Wide Assay Wide Studies (GWAS) genotyping and
phenotypic data exist, and who have given consent for further research
studies.
- Panels of experts are now studying cases, controls, and families to
determine the priorities for sequencing and determine the most informative
study possible.
- Sequencing to begin early in 2013.
Strategy 1.B.3: Increase enrollment in clinical trials and other
clinical research through community, national, and international outreach
- Organize meetings to identify approaches and coordination points for
these efforts.
- Implement an action plan that incorporates ideas from meeting.
AD Clinical Trial Enrollment Update
- Request for Information (RFI) released November 2012 and disseminated
broadly to interested organizations (ADCs, ADCS, health professional and aging
research organizations, CTSAs, RCMARs, key Federal agencies (VA, FDA), NIH
Institutes and clinical research awareness working group) – responses due
March 15, 2013
- Discussions underway with Federal agencies, grantees, and private
organizations to assess efforts, effective strategies, registries
- Coordinating with NINDS/NIH regarding related upcoming events
- Developing workshop for Spring/Summer 2013
Strategy 1.C: Accelerate Efforts to Identify Early and Presymptomatic
Stages of Alzheimer's Disease
- Identifying imaging and other biomarkers in presymptomatic people
will facilitate earlier diagnoses in clinical settings, as well as aid in the
development of more efficient interventions to slow or delay progression.
Alzheimer's Disease Neuroimaging Initiative (ADNI)
- Continues to collect data and samples to establish a brain imaging,
fluid biomarker, and clinical database in order to identify the best markers or
combinations of markers for following disease progression in the brain.
- Goal: Ability to utilize this information in clinical trials
to monitor response to interventions focused on altering disease progression.
AD Progression
Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025
- Strategy 1.D: Coordinate Research with International, Public and
Private Entities
Common Alzheimer's Disease Research Ontology (CADRO) Structure
- The CADRO is a three-tier classification system created to
capture the complete range of AD research and AD research-related resources.
- The first level of classification consists of seven categories: five
research and two research resources-related:
- Category A – Molecular Pathogenesis and Physiology of
Alzheimer’s Disease
- Category B – Diagnosis, Assessment and Disease
Monitoring
- Category C – Translational Research and Clinical
Interventions
- Category D – Epidemiology
- Category E – Care, Support and Health Economics of
Alzheimer’s Disease
- Category F – Resources for the research community
- Category G – Consortia and Public Private
Partnerships
- Each category is divided into “research topics”; many of
the topics are further divided into “research themes”.
- This detailed classification will enable funders to identify research
gaps, areas of overlap/duplication of effort and opportunities for
collaboration with much greater specificity.
National Institute on Aging/National Institutes of Health -- Alzheimer's
Association Collaboration
Common Alzheimer’s Disease Research Ontology (CADRO) and
International Alzheimer’s Disease Research Portfolio (IADRP)
- The CADRO and IADRP were developed by the National Institute on Aging
at the NIH in collaboration with the Alzheimer’s Association.
- The IADRP database will enable funders of Alzheimer’s research
to coordinate planning, leverage resources, avoid duplication, and identify new
opportunities for collaboration.
- The database will give the public a full picture of the scale of
ongoing research on AD.
- To date, the IADRP database includes funded research from all US
federal agencies and Alzheimer’s Association. Funded grants from the
Alzheimer’s Drug Discovery Foundation and Alzheimer’s Research UK
have been coded and are in the process of being uploaded. Active efforts are
underway to include more domestic and international funders.
- For more information about CADRO and IADRP :
http://www.nia.nih.gov/research/dn/international-alzheimers-disease-research-portfolio
Common Alzheimer’s Disease Research Ontology (CADRO) and
International Alzheimer’s Disease Research Portfolio (IADRP)
EXAMPLE: Comparative Investment Across Research Categories
Category C. Translational Research and Clinical Interventions
Ongoing AD and Dementia Public Private Partnerships
- Alzheimer’s Disease Neuroimaging Initiative (ADNI 2) --
over 27 federal and private partners (FNIH raised $23 million for ADNI1)
- International Alzheimer’s Disease Research Portfolio (IADRP)
and Common Alzheimer’s Disease Research Ontology (CADRO) --
Alzheimer’s Association and NIH/NIA
- AD International Funders-- Alzheimer’s Association and
NIH/NIA
ADNI Public-Private Partnership Structure
WW-ADNI
AD Public Private Partnership (PPP) Development Activities
Alzheimer's Disease Measurement Improvement (AD-MI)
- Alzheimer's Disease Measurement Improvement Conference held in
Baltimore, MD on December 3, 2012
- More activities in planning
- Collaborators include:
- Agency for Health Care Quality (AHRQ)
- Alzheimer’s Foundation of America
- Alzheimer’s Association
- American Medical Association Physician Consortium for Performance
Improvement (AMA-PCPI)
- Leaders Engaged in Alzheimer’s Disease (LEAD)
- Centers for Medicare and Medicaid Services (CMS)
- Food and Drug Administration (FDA), Foundation for NIH, Institute
of Medicine (IOM)
- National Alliance for Caregiving
- National Institutes of Health /(National Institute on Aging (NIA)
- National Quality Forum (NQF), National Pharmaceutical Council and
representatives from the pharmaceutical industry
- NIA will host Public Private Partnership meeting in April 2013
– academia, NIH, Pharma, potential development of a partnership to share
preclinical data, drug targets, and animal models in a precompetitive space to
facilitate new therapies for AD.
- Contact: Dr. Suzana Petanceska (petanceskas@mail.nih.gov)
Strategy 1.E: Facilitate Translation of Findings into Medical Practice
and Public Health Programs
- Promising research and interventions are published in the research
literature and provided in annual report to Congress and public.
National Institutes of Health Annual Report to Congress on
Alzheimer’s Disease Research
2011-2012 Alzheimer's Disease Progress Report: Intensifying the
Research Effort
http://www.nia.nih.gov/alzheimers/publication/2011-2012-alzheimers-disease-progress-report
Shari M. Ling M.D.
Deputy Chief Medical Officer
Centers for
Medicare & Medicaid Services (CMS)
Center for Clinical Standards &
Quality (CCSQ)
Outline
- Overview
- Medicare Coverage
- Measure Improvement
- Training (HRSA)
- Care Models (CMMI)
- Patient and Family Engagement Campaign (CCSQ)
- Community Care Transitions Program
- National Partnership to Improve Dementia Care in Nursing Homes
Implementation Milestones
- June 2012
- Identify and disseminate appropriate assessment tools
- Implement and evaluate new care models to support effective care
transitions for people with AD
- July 2012
- Strengthen the direct-care workforce
- Collect and disseminate dementia-specific guidelines and
curricula for all provider groups across the care spectrum
- Explore programmatically relevant dementia care guidelines and
measures
- December 2012
- Identify and disseminate appropriate assessment tools
- Explore programmatically relevant, dementia care guidelines and
measures
- Monitor, report, and reduce inappropriate use of anti-psychotics
in nursing homes
- February 2013
- Patient and Family Engagement Campaign (PFEC) (12-18 months)
- September 2014
- Implement and evaluate new care models to support effective care
transitions for people with AD
- July 2015
- Evaluate the effectiveness of medical home models for people with
AD
- Evaluate the effectiveness of the Independence at Home
Demonstration
- Explore the effects of new payment models on AD care and costs.
- Consider test of new payment or delivery model to promote the
quality of AD care while reducing costs
Centers for Medicare & Medicaid Services Screen Shot
The Original (Ongoing) Dilemma
- Intense public interest in coverage of certain (usually new)
technologies
- Published evidence base was often
- Suggestive but insufficient to reach a positive R&N decision
- Too immature for confident decision
- In general, clinical trials under-enroll subjects representative of
the beneficiary population
- In general, clinical trials do not focus on clinical utility outcomes
of interest to CMS
The Preferred Road to Coverage
Provide adequate evidence that...
- Diagnostics
- The incremental information obtained by new diagnostic
technology compared to alternatives
- Changes physician recommendations
- Resulting in changes in therapy
- That improve clinically meaningful health outcomes
- Therapeutics
- A treatment strategy using the new therapeutic technology
compared to alternatives
- Leads to improved clinically meaningful health outcomes
In Medicare beneficiaries
Screen Shot
Abstract
Expanding the Coverage with Evidence Development Program to Drive
Innovation: Reimbursement for medical treatments is a powerful driver of
industry investment. Under the Coverage with Evidence Development (CED)
program, Medicare reimburses for promising new technologies that do not
currently meet the standard for full coverage. The CED program requires more
evidence to be collected to determine full potential benefit of new
technologies. The CED authority has existed for more than a decade but has been
applied sparingly. The Centers for Medicare & Medicaid Services (CMS) is
poised to implement the next phase of CED by better defining the parameters and
guidance for CED so it can be used more widely and effectively as a driver of
innovation. CMS believes that the lessons learned during the initial
implementation of CED can inform its more frequent use and create predictable
incentives for innovation while providing greater assurance that new
technologies in fact fulfill their initial claims of benefit.
http://www.whitehouse.gov/sites/default/files/microsites/ostp/national_bioeconomy_blueprint_april_2012.pdf
Alzheimer's Disease Measurement Improvement (AD-MI): Project
Overview
- FNIH convened meeting, Aligning Outcome Measures for Alzheimer's
Disease in May 2011
- Formed the Alzheimer’s Disease Measurement Improvement
(AD-MI) Working Group
- AD-MI Working Group Goal: establish a
“mega-community” around improving quality of care and outcomes by
improving measurement in Alzheimer’s disease (AD)
- Four workgroups
- Draft a conceptual framework and translate the conceptual work
into actions
- Develop a landscape inventory of relevant measures, guidelines,
stakeholders
- Set a research agenda with recommendations from workgroups 1
& 2
- Oversee publication effort and summarize work of AD-MI Working
Group in the 2012 meeting
- 2013 Plans
- Spring summary publication and continue to grow the “mega
community”
- Develop schema of optimal care
- Address heterogeneity of patient population (diagnosis stage)
- Explore cross-cutting themes from other chronic conditions
- Working Group 1 established a conceptual framework
recommending that the group:
- Prioritize AD/dementia and identify optimal systems of care
- Promote quality of care measures that rely on determining disease
stage and components of disease recognition, diagnosis, care management and
treatment
- Identify quality-measurement opportunities to guide the
categorization and prioritization of quality indicators
- Articulate measurement development needs, including early
detection and diagnosis, appropriate use of therapeutics, care management of
co-morbidities and complications
- Working Group 2 conducted an environmental scan, identified
existing measures and guidelines, and discovered:
- Existing measures focus on the time after diagnosis and few
measures relate to detection/screening
- Existing measures are process focused, rather than outcome or
structural measures
- No measures exist for accurate diagnosis or timeliness of
diagnosis
- Medicare’s Annual Wellness Visit includes detection of
cognitive impairment, but no specific tools, process, or reports are required
for evaluation
- Working Group 3 synthesized the AD-MI work and identified gaps
and future research needs:
- Care improvement will require new understanding of the
epidemiology of AD
- Better diagnostics are required, driven by quality measures of
care
- Better measures of disease staging will improve care
- Strategic research focus going forward should include PCP-based
screening assessments and improved diagnostic algorithms
- Working Group 4 will produce a meeting summary and improve the
visibility of AD-MI work through a website, partnerships with other
organizations, and publications in relevant journals
Supplemental Dementia Training
- 45 Geriatric Education Centers received 2 years of supplemental
funding
- $42,222 in FY12; Up to $92,684 in FY13 (depending on availability
of funds)
- Educate healthcare providers to
- Work with people with AD and their families
- Link people to support services
- Identify signs of caregiver burden and depression
- Detect cognitive impairment and assess/diagnose AD
GEC Dementia Trainings
- Between 7/1/12 and 12/31/12 the 45 GECs had:
- 178 interprofessional continuing education programs
- 10,976 trainees
- Each event trained between 2 and 25 professions
- 248 community partners include
- 28 Quality Improvement Organizations
- 15 Alzheimer’s Association chapters
- 8 Area Health Education Centers
- 8 Veterans Administration hospitals
- IHS, AHRQ, AGS, AMDA, AAA
GEC Dementia Training Topics
- AD Guidelines
- Signs & Symptoms
- Assessment
- Caregiver Issues
- Managing AD with co-morbidities
- Referrals
- Understanding and accessing LTSS
- Providers training patients
- Cultural sensitivity
- HIPAA training Transitions of care Clinical trials
Innovation Center
- Awards made May - June, 2012
- Data reporting quarterly
- Metrics programmatic processes, service delivery and outcomes TBD
depending on drivers & goals
- Independent evaluation RFPs or other publically advertised mechanisms
- Anticipated completion date 2015-16
- Data sharing mechanisms TBD
CMMI: Health Care Innovation Award Project (Dementia/Alzheimer's
Relevant)
- Indiana University “Dissemination of the aging brain care
program”
- UCLA “UCLA Alzheimer’s and dementia care: comprehensive,
coordinated, patient-centered”
- University of North Texas Health Science Center “ Brookdale
Senior Living Transitions of Care Program”
- University of Rhode Island “Living Rite--A Disruptive Solutions
for Management of Chronic Care Disease”
Trustees of Indiana University
- Project Title: “Dissemination of the aging brain care
program”
- Plan: to improve care for Medicare beneficiaries with dementia or
late-life depression within a safety net health system in Marion County, IN.
- Will provide individualized and integrated care through a
multidisciplinary care team; will develop patient-specific care plans, deliver
evidence-based protocols, and respond to real-time monitoring and feedback
Regents of the University of California, Los Angeles
- Project Title: “UCLA Alzheimer’s and dementia care:
comprehensive, coordinated, patient-centered”
- Plan: To provide coordinated, comprehensive, patient and
family-centered, and efficient care for approximately 1000 Medicare and
Medicaid beneficiaries with Alzheimer’s disease or other forms of dementia
University of North Texas Health Science Center
- Project Title: “Brookdale Senior Living (BSL) Transitions of
Care Program”
- Goal: Prevent the progress of disease, thereby reducing
complications, improving care, and reducing the rate of avoidable hospital
admissions for older adults
University of Rhode Island
- Project Title: “Living Rite-A Disruptive Solution for Management
of Chronic Care Disease (a focus on adults with disabilities: intellectual and
developmental diagnoses and dementia patients with 2 or more chronic
conditions)”
- Use Interdisciplinary care management teams to teach patients
- how to best manage their chronic diseases
- Provide comprehensive and preventive care for intellectually and
developmental challenged dual eligible beneficiaries
Quality Improvement
- Quality Improvement Organizations
- 10th SOW
- 18th Month products
- Intervention effectiveness tools that outlines communities with
their target populations, interventions and preliminary outcomes based on 4+
months of data
- Anticipate 200+ submissions. This will provide a good gauge
for identifying communities that may be targeting individuals with dementia,
what the interventions are, and can certainly follow up regarding assessment
and other evaluation tools currently being used.
QIO special project in the 10th SOW -- Patient and Family Engagement
Campaign (PFEC)
- Funding to Quality Improvement Organizations (QIOs) who propose fresh
and original models to develop and implement local campaigns to improve
person-centeredness and family engagement .
- This effort will encourage involvement of patients and families in
decisions regarding health and health care to ensure consistency with patient
preferences and priorities, and to empower them to take action for their own
health care that could improve quality of life.
Focus & Aims
- Focus: The QIO shall design its PFEC work to target behaviors
among beneficiaries that will address at least one topic below:
- Care for Individuals Diagnosed with Dementia
- Prevention of Avoidable Readmissions;
- Prevention of Falls;
- Improvement of Cardiac Health
- Aims:
- Improve quality of life for Medicare beneficiaries through
patient-focused care;
- Improve beneficiary awareness of preventive care initiatives;
- Improve caregivers’ knowledge of available resources;
- Improve patients and families full participation in their own
care and health, and encourage them to partner, according to their preference,
with clinicians in fulfilling those expectations.
Centers for Medicare & Medicaid Services Screen Shot
The Community-based Care Transitions Program (CCTP)
- The CCTP, mandated by section 3026 of the Affordable Care Act,
provides funding to test models for improving care transitions for high risk
Medicare beneficiaries.
- CMS is currently accepting applications on a rolling basis and will
continue to award applications on a rolling basis as funding permits (50
programs and counting)
Community-Based Care Transitions Program: It's NOT a Grant --
It's Something Better!
- Community-based organizations partnering with hospitals and other
providers, define and price a new cost-effective care transitions
service for Medicare patients in their communities -- tailored to their own
unique circumstances and capabilities!
- Conduct a thorough Root Cause Analysis and tailor intervention
strategy to directly target your community’s readmissions drivers
- Payment (per eligible discharge rate, no more than 1x / 180 days)
is for direct service costs, not training, overhead, other indirect costs.
- Tell us how services don’t duplicate those already required
through the discharge planning process / CMS Conditions of Participation.
National Partnership to Improve Dementia Care in Nursing Homes: Project
Overview
- Technical Expert Panel convened in April 2012
- Content guided the development of surveyor guidance and work of
state coalitions that followed
- Outreach calls to 50 states
- Coalitions established or strengthened in all 50 states
- Work with CMS regional offices and state agencies to begin surveyor
training
- New guidance development near completion
- Two new mandatory surveyor training videos completed and ready for
launch in January 2013
- Individual outreach calls by CMS core team to various public and
private partners
- Ombudsman, associations, behavioral health, dementia specialists,
psychiatry
- Actively engaged these groups in the national work and state
coalitions
- Major presentations to national, state and local groups around the
country
- Provider education
- Completion of research
- 200 case studies from 25 nursing home in five states
- Focused on how decisions to use or not to use antipsychotic
medications were made
Jane Tilly, Dr.PH
Office of Supportive and Caregiver
Services
Administration on Aging/Administration for Community
Living
Progress
| Action # |
Action Description |
Method of Action |
Lead Agency
(Partner
Agencies) |
Status |
| 3.B.6 |
Share lessons learned
through VA caregiver support strategies with federal partners |
Scheduled informational
meetings |
VA
(Federal
partners) |
VA lead an interagency
call that focused on presentation and discussion of the REACH-VA caregiver
support program. |
| 2.A.3 |
Collect and disseminate
dementia-specific guidelines and curricula for all provider groups across the
care spectrum |
Develop dementia-specific
guidelines and curricula |
HRSA
(VA, CMS, NIH,
IHS) |
HRSA worked with 45
Geriatric Education Center grantees who trained provider groups across the care
spectrum. Grantees have delivered 178 programs to 10,976 providers on dementia
related topics in the past 6 months. |
| |
|
Develop website with
appropriate links and contact info |
HRSA
(VA, CMS, NIH,
IHS) |
HRSA identified and
vetted appropriate links, but the website is not in place. |
| 2.A.5 |
Stengthen the state aging
and public health workforces |
Report on progress
annually |
AoA, CDC |
CDC is developing a new
Healthy Brain Initiative Road Map for public health. Completed concept mapping
process. |
| |
|
|
|
AoA/ACL conducted a
webinar series on legal issues for those with dementia and their caregivers.
|
| |
|
|
|
AoA/ACL developed a new
LTSS workforce competency model addresses cognition. |
| |
|
|
|
AoA/ACL provided training
materials to the National Council of Certified Dementia Practitioners
|
| 2.C.2 |
Enhance assistance for
people with AD and their caregivers to prepare for care needs |
AoA will develop training
materials for Options Counseling which includes best practices for working with
persons with cognitive impairments and their caregivers. |
AoA |
AoA/ACL options
counseling standards now include dementia-capability as a core competency.
|
| |
|
Update tools and
resources to educate caregivers about available programs and
resources |
AoA
(CDC) |
Options counseling
standards include dementia-capability core competency that will be part of a
new options counseling training and certification program.
Tools and
resources for caregivers on Alzheimers.gov have been updated.
AoA/ACL
presented webinar on advance health and financial planning that addresses
caregiver issues. |
| 2.D.1 |
Explore programmatically
relevant, dementia care guidelines and measures |
Identify 3-5 measures
within the first year; submit measures and programmatically relevant guidelines
to National Quality Forum |
CMS
(AHRQ, VA, ASPE,
AoA/ACL) |
CMS developed quality
measures as part of the National Partnership to Improve Dementia Care in
Nursing Homes for potential use in Nursing Home Compare. |
| 2.G.1 |
Review evidence on care
coordination models for people with AD |
Meeting Summary
Report |
ASPE |
ASPE found little
rigorous evidence available to use in defining effective care coordination
models for persons with dementia. Further research is necessary to develop such
models. |
| 3.B.1 |
Identify unmet service
needs |
Release report
summarizing analysis of National Health and Aging Trends Study data |
ASPE |
ASPE reviewed methods for
defining Alzheimer's/ dementia that are possible for the National Health Aging
Trends Study and found major definitional issues that must be resolved before
analyses can begin. |
| 3.B.2 |
Identify and disseminate
best practices for caregiver assessment and referral through the long-term
services and supports system |
Explore public-private
partnership to identify best practices in caregiver assessment / referral.
Examine assessment tools used in states, incl. state Medicaid waiver
programs |
AoA/ACL
(private
partners) |
In partnership with the
National Family Caregiver Alliance, published Selected Caregiver Assessment
Measures (2nd Edition): A Resource Inventory for Practitioners. This
resource provides a compendium of caregiver assessment measures that is
practice-oriented, practical and addresses aspects of the caregiving
experience. |
| 3.C.2 |
Expand long-term care
awareness efforts |
Implement awareness
campaign |
AoA |
Expansion of
Alzheimer’s awareness efforts into long-term care awareness depends upon
availability of additional funds. |
Susan Cooley, Pauline Sieverding, Meg Kabat
This presentation is available at
http://aspe.hhs.gov/daltcp/napa/011413/Mtg7-Slides2.shtml
Research
Clinical Care
LTSS
Research Subcomittee Recommendations
- Voting Members
- Jennifer Manly
- Harry Johns
- Ronald Petersen
- George Vradenburg
- Non-voting Members
- Richard Hodes
- Russell Katz
- Don Moulds
Themes of original research recommendations
- Commit resources with accountability
- Accelerate basic and translational research toward development of
effective treatments
- Add concrete emphasis on process of development of interim
milestones and importance of including these in the next version of the Plan
- Maximizing private investment to develop treatments and improve
disease monitoring technology
- Meaningfully coordinate with global partners
Recommendation 1
We support and applaud the goal of the National Plan -- to prevent and
effectively treat Alzheimer’s Disease by 2025, and recommend that interim
milestones be explicitly stated, through development of a clear roadmap of
research and treatment discovery priorities and timelines, to assure continuing
and successful progress toward achievement of this goal
Notes on Recommendation 1
- The text of the next version of the National Plan should include the
outcome of the process currently underway to specify and prioritize interim
milestones. Data from the International Alzheimer's Disease Research Portfolio
(IADRP), and recommendations from the May 2012 Alzheimer's Disease Research
Summit, private public working groups, and other scientific meetings and
collaborations are being prioritized to set immediate (2013 - 2015), mid-term
(2016 - 2019), and longer term (2020 - 2025) milestones to achieve the goal.
- A model of a grid with interim milestones is attached. These
milestones rely on and relate to the final recommendations from the May 2012
Alzheimer's Disease Research Summit and thus represent a focused subset of
potential milestones for achieving the 2025 goal. This grid is intended to be a
dynamic document that will be continuously improved and refined based on the
process outlined above, including input from nationally and internationally-
based public and private sources. New investment in research must reflect a
critical balance between basic research and the urgency of treatment discovery.
Recommendation 2
There is an urgent need for annual federal research funding to be
increased to the level needed to fund a strategic research plan and to achieve
the breakthroughs required to meet the 2025 goal. Initial estimates of that
level are $2 billion per year but may be more. That investment would be applied
to Alzheimer’s research initiatives spanning basic, translational and
clinical research.
Notes on Recommendation 2
- There has been significant commitment by the Obama Administration in
2012 ($50 million) and promise of $80 million in new Alzheimer’s disease
research funding in fiscal year 2013
- This commitment could represent the initial stages of a ramp-up but
the urgency of getting to $2 billion or more per year is unchanged
Recommendation 3
- We recommend that HHS continue to develop, execute and regularly
update a strategic research plan and priorities to accelerate breakthroughs in
AD research.
Notes on Recommendation 3
- Very productive meetings have occurred, and NIA FOAs have been
released as a result of the recommendations
- A comprehensive strategy of applying these recommendations across
public and private funding sources has not been fully explicated
- The synchronization and coordination between the contents of the
National Plan and a research plan is not yet explicit.
Recommendation 4
To address disparities, we recommend that clinical research studies and
activities aimed at translation of research findings into medical practice and
to the public include specific targets for outreach to specific populations by
racial/ethnic group, sex, and socioeconomic status, as well as to populations
at high risk for AD (e.g., people with Down Syndrome).
Notes on Recommendation 4
- Down syndrome and intellectual disability populations are not yet
specifically mentioned within Goal 1 (but a 2013 Down Syndrome meeting is
planned)
- The National Plan does not yet include language or strategies focused
on leveraging existing resources and engaging private entities
- An emphasis on "translation of research findings" to diverse
populations is not explicit in the Plan.
Recommendation 5
We recommend that HHS, in partnership with experts from the research
community and industry, take steps to accelerate public access to new
therapeutic interventions by compressing the current average time in the
process of identification of therapeutic targets, validation of those targets,
development of behavioral and pharmacologic interventions, testing of efficacy
and safety, and regulatory review.
Notes on Recommendation 5
- Original recommendations 5,6,7 & 8 have been consolidated into
one emphasizing acceleration of discovery and public access to treatments, with
several potential arms and detailed suggestions
- Many details included in this recommendation are relevant to the
implementation plan but are not yet included. This may be at least somewhat
addressed by the interim milestone process described in Recommendation 1.
- The role of PPPs in enhancing scientific innovation and discovery, or
progress in shortening the regulatory process is not yet uniquely emphasized in
the plan
Recommendation 6
- We recommend that the HHS Secretary develop a continuing process by
which research priorities aimed at accelerating the delivery of effective
treatments would be set, including input from scientific experts.
- There are now existing models of joint academic and Industry
Working Groups, which can serve as opportunities to create true partnerships
between government and industry to inform research priorities.
- In order to accelerate the process of discovery, we recommend
that Working Groups identify strategies for increasing the increased
standardization, disclosure, pooling and analysis of pre-clinical, clinical and
electronic health data.
Notes on Recommendation 6
- The next version of the National Plan should include a description of
an overarching process by which both public and private resources will be
coordinated in setting research priorities.
- Multiple ongoing PPP initiatives are already moving forward on this
recommendation and thus specifics could be integrated in future versions of the
plan
Recommendation 7
We recommend that HHS develop accurate and relevant metrics for
assessing the impact of Alzheimer’s on the U.S. economy.
Notes on Recommendation 7
- There is general overlap between this recommendation and Goal 5,
which discusses metrics
- However measurement of economic impact of AD, or the rationale for
doing so, is not specifically discussed in Goal 5 or elsewhere in the Plan
Recommendation 8
We recommend that HHS commit to an effort to maximize private investment
in the development of treatments and improvements in disease monitoring
technology by identifying policies that would encourage private industry to
invest aggressively in disease-modifying interventions, to support technologies
that improve our ability to detect the disease as early as possible, and
monitor the disease accurately so that the effectiveness of interventions can
be tested.
Notes on Recommendation 8
- This revised item has consolidated several recommendations related to
PPPs that were previously spread out across other items
- There is meaningful implementation detail within this recommendation
that is not yet carried though to the Plan
Recommendation 9
We recommend that the Administration continue to expand and enhance
meaningful coordination with global partners and move forward to establish a
Global Alzheimer's Action Plan to respond to the global scope of the problem.
Notes on Recommendation 9
- Promising progress has been made: global partners participated in the
May 2012 meeting, met with HHS at the Vancouver AAIC, and a number of bilateral
efforts have begun
- However the current National Plan does not explicitly discuss a
Global AD Plan, a single high level official whose responsibility it is to
foster international cooperation has not been identified, and thus far there
has been no coordinated discussion internationally of regulatory hurdles.
Recommendation 10
We recommend that the Administration designate specific Offices and
officials within the White House and the Office of the Secretary of HHS with
responsibility and accountability for effective implementation of, and timely,
transparent reporting on, all aspects of the implementation of this National
Alzheimer’s Plan, including responsibility for issuing statutorily
required reports to Congress on behalf of the Secretary, reports to the
Advisory Council, and other reports as warranted.
Notes on Recommendation 10
- Although the current implementation strategy designates specific
offices responsible for Action Items in the Plan, unaddressed aspects of this
item include detail about metrics, milestones, implementation steps, and
accountability.
- No separate, central NAPA office in the White House & HHS is
addressed in the current National Plan.
Discussion
Recommendation 1
Launch a nationwide public awareness campaign to promote early detection
and diagnosis of Alzheimer’s disease.
Recommendation 2
Gather data on the detection of possible cognitive impairment as part of
the Medicare Annual Wellness Visit.
Recommendation 3
Clarify the privacy protections under the Health Insurance Portability
and Accountability Act (HIPAA) to ensure that health care providers can engage
in care planning with family members of those diagnosed with Alzheimer’s
disease or other dementias.
Recommendation 4
Develop a unified curriculum for primary care practitioners to become
more knowledgeable about Alzheimer’s disease and enhance the skills
necessary to deliver dementia capable care.
Recommendation 5
Evaluate models and demonstrations of payment and care delivery reform
on the quality and cost for the subpopulation of participants with
Alzheimer’s disease.
Recommendation 6
Form a blue ribbon panel of experts on advanced dementia to develop
innovations in clinical care practice and quality, including palliative care,
for people with advanced dementia.
Recommendation 7
Expand funding and incentives to encourage individuals to pursue careers
in geriatric specialties.
Discussion
Overview
- Many recommendations same as 2012; Updated and expanded where
appropriate
- Recommendation 1 is primary recommendation from which many others
flow
Recommendation 1
States should assure that they have robust, dementia capable LTSS
systems.
Recommendation 2
HHS should provide federal funds to support a state lead entity in every
state and territory. This entity will facilitate development of the
state’s dementia capable systems, coordinate available public and private
LTSS, conduct service gap analysis, identify opportunities for efficiency, and
enable ongoing stakeholder input to address needs across all sectors and
systems. HHS should use available funds to begin this process in 2013.
Recommendation 3
- HHS should engage all relevant federal agencies to include research
on LTSS that addresses dementia capability in their research agendas. Topics
needing further research include:
- Interventions for persons in the early stages of dementia,
including those that mitigate symptoms of the disease.
- Interventions for persons with Down syndrome and other
intellectual disabilities that are at high risk of acquiring dementia as they
age.
- Impact of caregiving on health and quality of life of caregivers.
- Translation of interventions for persons with dementia and their
caregivers into culturally appropriate programs.
- Translation of interventions for persons with dementia and their
caregivers into community settings.
Recommendation 4
State education and health agencies and others should include key
information about AD in all curricula for any profession or career track
affecting LTSS.
Recommendation 5
State, local and private sector organizations should ensure that
paraprofessional caregivers in every venue are adequately trained and
compensated.
Recommendation 6
Congress and CMS should redesign Medicare coverage and physicians’
and other health care providers’ reimbursement to encourage appropriate
diagnosis of AD and to provide care planning to diagnosed individuals and their
caregivers.
Recommendation 7
LTSS systems should refer people to a healthcare provider for diagnosis
whenever they are admitted to or assessed for eligibility for LTSS and exhibit
signs of cognitive impairment.
Recommendation 8
Providers engaged in diagnosis should consider the National Institute on
Aging’s 2011 guidelines for diagnosis of Alzheimer’s disease and rule
out and treat any conditions that may mimic this disease.
Recommendation 9
The process of diagnosis should include engaging individual and family
in advance care planning (health, legal, estate, and financial).
Recommendation 10
HHS should assure that health and related systems funded with federal
resources should improve chronic disease treatment and related services for
people with AD.
Recommendation 11
HHS should develop quality measures and indicators for the comprehensive
care and treatment of individuals with AD.
Recommendation 12
Practice recommendations for care in every setting should be embedded in
CMS’ federal and state surveillance and quality improvement systems.
Recommendation 13
Recommendations for end-of-life or palliative care should be
incorporated into all CMS surveillance and quality improvement systems at the
earliest possible time.
Recommendation 14
HHS should provide grants through CMS’ Center for Medicare and
Medicaid Innovation (CMMI) for medical home pilot projects specifically
targeted at improving medical and chronic condition management for individuals
with AD, and coordination with family and community care providers in the full
array of settings.
Recommendation 15
HHS should convene a blue ribbon panel of experts to recommend one or
more models of palliative care for people with advanced dementia, including
eligibility criteria and financing mechanisms, and provide grants through CMMI
to implement and evaluate the models.
Recommendation 16
HHS should create a specific grant round of pilot projects through CMMI
to implement and evaluate ways to reduce preventable emergency department
visits, hospitalizations, and length of hospital stays for individuals with AD,
who are living in the full array of settings.
Recommendation 17
HHS and state lead entities should partner to assure access to the full
array of LTSS for specific populations of people with AD including younger
people, non-traditional families, people with intellectual disabilities, such
as Down syndrome, and racial and ethnic minorities who are at increased risk of
acquiring AD.
Recommendation 18
- Recommended use of Federal Funds ($10.5 million) currently proposed
for AoA
- HHS (AoA) should use the $10.5 million for state grants to seed
the development of state action plans and state lead entities that maximize use
of public and private resources to support dementia capable LTSS.
- Governors should designate the state lead entity and commit to
sharing publicly a state plan with recommendations for action.
- State agencies and relevant partners should be included in the
state action plan
- Legislation enacting this program should require matching funds
so as to expand program impact.
- This program should be expanded in future years with additional
resources.
- Additional funding available at HHS or other Operating Divisions
in FFY 2013 and beyond should support this activity.
- Estimated funds necessary to fully fund all states’ action
plans = $85 million.
Recommendation 19
Funding for the Alzheimer’s Disease Supportive Services Program
(ADSSP) should be restored to the FFY 2003 level of $13.4 million.
Recommendation 20
Fully fund caregiver support under AoA
Recommendation 21
HHS, state lead entities, and providers should assure that caregiver
physical health/ behavioral health risk is assessed and addressed regularly.
Caregiver illness and mortality contribute to the enormous personal and
financial cost of AD.
Recommendation 22
The Office of the National Coordinator for Health Information
Technology, in partnership with the private sector, should work to assure that
development of health information technology includes tools that assist
caregivers of persons with AD. Tools could assist caregivers by: helping them
organize the care they provide, educating them about dementia and multiple
chronic conditions, and providing tools to help them maintain their own mental
and physical health.
Recommendation 23
HHS should launch a nationwide public awareness campaign to increase
awareness and to promote early detection of AD.
Discussion
Public Comments
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Last updated: 01/14/2013
