HHS/ASPE. U. S. Department of Health and Human Services.Background

Advisory Council on Alzheimer's Research, Care, and Services

January 14, 2013

PDF Version: http://aspe.hhs.gov/daltcp/napa/011413/Mtg7-Slides1.pdf (65 PDF pages)

NAPA Research Progress Report

Richard J. Hodes, M.D.
Chair, Research Subcommittee

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025

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

Timeline describing research to be done 2012-2025

Strategy 1.A.4: Convene a scientific workshop on other dementias in 2013

Down Syndrome Research Update

1.B.2 Expand genetic epidemiologic research to identify risk and protective factors for Alzheimer's disease.

Alzheimer's Research Highlights -- Gene Discovery

1991 APOEe4 APP, 1995 PS1 PS2, 1996 Transgenic Mouse models, 2005 First published GWAS, 2009 PICALM CLU CR1 GWAS, 2010 BIN 1, 2011 MS4A4/MS4A6E CD2AP SCRL1, 2012 TREM2

1.B.2. Sequencing -- Update

Strategy 1.B.3: Increase enrollment in clinical trials and other clinical research through community, national, and international outreach

AD Clinical Trial Enrollment Update

Strategy 1.C: Accelerate Efforts to Identify Early and Presymptomatic Stages of Alzheimer's Disease

Alzheimer's Disease Neuroimaging Initiative (ADNI)

AD Progression

Line Chart showing Pre-Symptomatic, eMCI, lMCI and Dementia change between: CSF abeta42, Amyloid Imaging, CSF Tau, FDG PET, Cognitive Performance, Function (ADL), MRI Hippocampal Volume

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025

Common Alzheimer's Disease Research Ontology (CADRO) Structure

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)

Common Alzheimer’s Disease Research Ontology (CADRO) and International Alzheimer’s Disease Research Portfolio (IADRP)

EXAMPLE: Comparative Investment Across Research Categories

Bar Chart: DoD -- Category A (5), Category B (4), Category C (1), Category D (2), Category E (3); NIH -- Category A (473), Category B (183), Category C (104), Category D (60), Category E (23); VA -- Category A (19), Category B (5), Category C (4), Category D (0), Category E (0); CDC -- Category A (0), Category B (0), Category C (0), Category D (1), Category E (0); ARUK -- Category A (15), Category B (5), Category C (1), Category D (0), Category E (0); ADDF -- Category A (0), Category B (4), Category C (29), Category D (0), Category E (0); ALZ Assoc. -- Category A (48), Category B (8), Category C (7), Category D (6), Category E (4); AHRQ -- Category A (0), Category B (0), Category C (0), Category D (1), Category E (1); AoA -- Category A (0), Category B (0), Category C (0), Category D (0), Category E (11).

Category C. Translational Research and Clinical Interventions

Line Chart: Drug Discover-Amyloid -- 2008 ($6,266,144), 2009 ($7,364,054), 2010 ($8,833,621), 2011 ($9,887,262); Drug Discovery-NonAmyloid -- 2008 ($10,715,669), 2009 ($9,843,059), 2010 ($11,304,806), 2011 ($9,660,868); Preclinical Therapy Development-Amyloid -- 2008 ($4,146,057), 2009 ($5,326,159), 2010 ($5323,896), 2011 ($6,606,029); Preclinical Therapy Development-NonAmyloid -- 2008 ($5,653,165), 2009 ($8,128,374), 2010 ($8,981,867), 2011 ($9,660,868).

Ongoing AD and Dementia Public Private Partnerships

ADNI Public-Private Partnership Structure

Company/agency logos of those involved in the ADNI Public-Private Partnership


World map with countries circled: NA-ADNI = United States; E-ADNI = Italy; C-ADNI = China; K-ADNI = Korea; J-ADNI = Japan; T-ADNI = Thailand; A-ADNI = Australia.

AD Public Private Partnership (PPP) Development Activities

Alzheimer's Disease Measurement Improvement (AD-MI)

Strategy 1.E: Facilitate Translation of Findings into Medical Practice and Public Health Programs

National Institutes of Health Annual Report to Congress on Alzheimer’s Disease Research

2011-2012 Alzheimer's Disease Progress Report: Intensifying the Research Effort


Clinical Care Progress Report

Shari M. Ling M.D.
Deputy Chief Medical Officer
Centers for Medicare & Medicaid Services (CMS)
Center for Clinical Standards & Quality (CCSQ)


Implementation Milestones

Centers for Medicare & Medicaid Services Screen Shot

Screen shot of CMS.gov.

The Original (Ongoing) Dilemma

The Preferred Road to Coverage

Provide adequate evidence that...

In Medicare beneficiaries

Screen Shot

Screen shot of the article Medicare coverage: engaging on evidence.


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.


Alzheimer's Disease Measurement Improvement (AD-MI): Project Overview

Supplemental Dementia Training

GEC Dementia Trainings

GEC Dementia Training Topics

Innovation Center

CMMI: Health Care Innovation Award Project (Dementia/Alzheimer's Relevant)

Trustees of Indiana University

Regents of the University of California, Los Angeles

University of North Texas Health Science Center

University of Rhode Island

Quality Improvement

QIO special project in the 10th SOW -- Patient and Family Engagement Campaign (PFEC)

Focus & Aims

Centers for Medicare & Medicaid Services Screen Shot

Centers for Medicare & Medicaid Services Screen Shot

The Community-based Care Transitions Program (CCTP)

Community-Based Care Transitions Program: It's NOT a Grant -- It's Something Better!

National Partnership to Improve Dementia Care in Nursing Homes: Project Overview

Long-Term Services and Supports Progress Report

Jane Tilly, Dr.PH
Office of Supportive and Caregiver Services
Administration on Aging/Administration for Community Living


  Action #     Action Description     Method of Action   Lead Agency
  (Partner Agencies)  
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
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
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
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
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.

VA Dementia Initiatives

Susan Cooley, Pauline Sieverding, Meg Kabat

This presentation is available at http://aspe.hhs.gov/daltcp/napa/011413/Mtg7-Slides2.shtml

2013 Recommendations Presentations

Clinical Care

Research Subcommittee Recommendations

Research Subcomittee Recommendations

Themes of original research recommendations

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

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

Recommendation 3

Notes on Recommendation 3

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

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

Recommendation 6

Notes on Recommendation 6

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

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

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

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


Clinical Care Subcommittee Recommendations

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.


Long-Term Services and Supports Subcommittee Recommendations


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

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

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.


Public Comments

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Last updated: 01/14/2013