Advisory Council on Alzheimer's Research, Care, and
Services
PDF Version:
http://aspe.hhs.gov/daltcp/napa/101512/Mtg6-Slides1.pdf
(45 PDF pages)
Richard J. Hodes, M.D.
Chair, Research
Subcommittee
International Alzheimer's Disease Research Portfolio (IADRP)
- Developed by NIA in collaboration with Alzheimers Association
-- http://iadrp.nia.nih.gov/cadro-web/
- Will enable funders of Alzheimers research to coordinate
planning, leverage resources, avoid duplication, and identify new opportunities
for collaboration.
- Will give the public a full picture of the scale of ongoing research
on AD.
- To date, includes only Federally funded and Alzheimers
Association-supported projects. Efforts are underway to include more
domestic and international funders.
- Data Sharing Agreements with Alzheimers Research UK (data to be
uploaded later this month)
Category C. Translational Research and Clinical Interventions
White House Proposal for $80 Million Additional AD Funding in FY
2013
- NIH is using the following process to ensure timely and most
effective spending of the anticipated $80M in additional funding for AD
research for the current fiscal year:
- Representatives from several NIH ICs worked together to identify
areas of highest need/opportunity, informed by the Alzheimers Summit and
other input.
- NIA took the lead on developing FOA concepts for presentation at
NACA in September 2012.
- Extra funding will allow NIH to support more grants through these
or existing FOAs and/or investigator-initiated research.
FY 2013 AD Concept Clearance
- Genetic Analysis
- Target Identification and Validation
- Phase I Clinical Trials for AD Therapeutics
- Prevention Trials
AD Clinical Trial Enrollment Update
- NIA assessing successes, issues, and gaps in Alzheimers
clinical research recruitment/enrollment
- AD Centers, AD Neuroimaging, NACC experience
- Registries -- current landscape
- Strategies to increase enrollment of racial and ethnic
populations -- RCMARs and AD Centers
- Discussions underway with Federal agencies, grantees, and private
organizations
- Request for Information (RFI) under consideration to help in workshop
planning
- Internal planning with NIH, other agencies -- late November 2012
- Workshop to develop action/implementation plan -- early 2013
Alzheimer's Disease-Related Dementias Workshop
May 1-2, 2013, Natcher Auditorium, NIH Campus, Bethesda, MD
- NINDS, together with NIA, is planning a workshop to solicit input and
develop recommendations on research priorities and timelines for AD-Related
dementias.
- Outline of Workshop Topics:
- FTD and AD-Related Tauopathies
- Lewy Body Dementias
- Vascular Contributions to AD-Related Dementias
- Mixed Dementias
- Breakout Groups
- Clinically Important Diagnostic Challenges in Dementias
- Health Disparities in AD-Related Dementias
- 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.
Down Syndrome Research Update
- The Global Down Syndrome Foundation and the Alzheimers
Association hosted the workshop from September 13- 14 to bring together key
scientists from the fields of Down syndrome and Alzheimers research in
Chicago. Widely attended, including NIA and NICHD staff.
- NIA and NICHD have begun planning for a research workshop on
Down Syndrome and Alzheimers disease in 2013.
Shari M. Ling M.D
Deputy Chief Medical Officer
Centers for
Medicare & Medicaid Services (CMS)
Center for Clinical Standards &
Quality (CCSQ)
2.B.2: Identify and disseminate appropriate assessment tools that can be
used in a variety of outpatient settings including the Medicare Annual Wellness
Visit, to assess cognition.
The Seven Instruments
- Ascertain Dementia (AD8)
- Short Blessed Test (SBT)
- Mini-Cog
- Mental Status Questionnaire (MSQ)
- Six-Item Screener (SIS)
- Short Test of Mental Status (STMS)
- Short Portable Mental Status Questionnaire (SPMSQ)
Inclusion Criteria
- Less than or equal to 5 minutes to administer
- Free of charge with simple access
- Applicable to Medicare population
- Designed to assess age-related cognitive impairment
- Must assess memory + at least one other cognitive domain
- Validated in US community-based sample or primary care settings
- Post-validation used in US between 2001 - 2011
Medicare's Annual Wellness Visit (AWV) Components
- Detection of cognitive Impairment
- Health Risk Assessment
- Medical & Family History
- Providers & medications
- Biometric measurements
- Preventive service plan (5-10 yrs)
- Personalized health advice, referrals,
- Other elements determined appropriate by the Secretary and health
education
U.S. Preventive Services Task Force
- Screening for Dementia (2003)
The USPSTF concludes that the
evidence is insufficient to recommend for or against routine screening for
dementia in older adults. Grade: I statement.
- USPSTF Clinical Consideration:
Although current evidence
does not support routine screening of patients in whom cognitive impairment is
not otherwise suspected, clinicians should assess cognitive function whenever
cognitive impairment or deterioration is suspected, based on direct
observation, patient report, or concerns raised by family members, friends, or
caretakers.
- Based on USPSTF recommendations and a general review of the
literature at the time, this element is defined in implementing regulations as:
- assessment of an individuals cognitive function by
direct observation, with due consideration of information obtained by
way of patient report, concerns raised by family members, friends, caretakers,
or others.
2.D.1: Explore programmatically relevant dementia care guidelines and
measures
PQRS # & Title |
Description |
Data Source |
280 --
Dementia: Staging of Dementia |
Percentage of patients,
regardless of age, with a diagnosis of dementia whose severity of dementia was
classified as mild, moderate or severe at least once within a 12 month period
|
Measures
Group |
281 --
Dementia: Cognitive Assessment |
Percentage of patients,
regardless of age, with a diagnosis of dementia for whom an assessment of
cognition is performed and the results reviewed at least within a 12 month
period |
Measures
Group |
282 --
Dementia: Functional Status Assessment |
Percentage of patients,
regardless of age, with a diagnosis of dementia for whom an assessment of
functional status is performed and the results reviewed at least once within a
12 month period |
Measures
Group |
283 --
Dementia: Neuropsychiatric Symptom Assessment |
Percentage of patients,
regardless of age, with a diagnosis of dementia and for whom an assessment of
neuropsychiatric symptoms is performed and results reviewed at least once in a
12 month period |
Measures
Group |
284 --
Dementia: Management of Neuropsychiatric Symptoms |
Percentage of patients,
regardless of age, with a diagnosis of dementia who have one or more
neuropsychiatric symptoms who received or were recommended to receive an
intervention for neuropsychiatric symptoms within a 12 month period
|
Measures
Group |
Physician Quality Reporting System: 2012 Dementia Measures Groups
Measures
PQRS # & Title |
Description |
Data Source |
285 --
Dementia: Screening for Depressive Symptoms |
Percentage of patients,
regardless of age, with a diagnosis of dementia who were screened for
depressive symptoms within a 12 month period |
Measures
Group |
286 --
Dementia: Counseling Regarding Safety Concerns |
Percentage of patients,
regardless of age, with a diagnosis of dementia or their caregiver(s) who were
counseled or referred for counseling regarding safety concerns within in a 12
month period |
Measures
Group |
287 --
Dementia: Counseling Regarding Risks of Driving |
Percentage of patients,
regardless of age, with a diagnosis of dementia or their caregiver(s) who were
counseled regarding the risks of driving and the alternatives to driving at
least once within a 12 month period |
Measures
Group |
288 --
Dementia: Caregiver Education and Support |
Percentage of patients,
regardless of age, with a diagnosis of dementia whose caregiver(s) were
provided with education on dementia disease management and health behavior
changes AND referred to additional resources for support within a 12 month
period |
Measures
Group |
2.A.4: Strengthen the direct-care workforce -- release training
materials for nursing home direct care workforce
- Proactive efforts include collaboration with partner organizations
around:
- provider and prescriber training
- surveyor training, review of surveyor guidance, protocols and
challenges related to assessing compliance in these areas
- research
- quality measurement
- public reporting
- communication strategies such as local and national conference
presentations, press releases
- developing dissemination strategies in states and regions and a
sustainable national plan for ongoing monitoring and evaluation of these issues
Partnership Overview
- Multidimensional approach includes:
- Public Reporting
- First year goal: reduce prevalence rate of antipsychotic drug
use in long-stay nursing home residents by 15% by end of 2012
- Rates of nursing homes antipsychotic drug use available
on Nursing Home Compare (long-stay prevalence; short-stay incidence)
Current Partner Organizations
- AHCA
- AMDA
- LeadingAge
- Advancing Excellence
- ASCP
- Several universities
- Behavioral health management companies
- AAGP
- AGS
- NICHE
- Alzheimers Association
- Consumer Voice, Center for Medicare Advocacy, LTCCC, CANHR, other
advocacy organizations
- IOM
- APNA
- GAPNA
- NaRCAD
- AANAC
- AHFSA and several state survey agencies
Questions
- What should we collectively do to achieve better outcomes?
- What should we know that we might not?
- What quality measures will most meaningfully drive improvement
towards better outcomes?
- Which outcomes are the highest priority to focus on?
The Preferred Road to Diagnostic Coverage
- Provide adequate evidence that
- 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
- In Medicare beneficiaries
The Preferred Road to Therapeutic Coverage
- Provide adequate evidence that
- A treatment strategy using the
new therapeutic technology compared to alternatives
- Leads to improved clinically meaningful
health outcomes
- In Medicare beneficiaries
Jane Tilly, Dr.PH
Office of Supportive and Caregiver
Services
Administration on Aging/
Administration for Community
Living
2013 Recommendation Discussion
- LTSS
- Research
- Clinical Care
States should assure robust, dementia-capable LTSS systems
- Every state should identify a state lead entity
- The system should include a full array of LTSS that are culturally
and linguistically competent and evidence-informed or evidenced-based
- Services include -- outreach; early detection; diagnostic; care and
estate planning; treatment (medical, psychiatric, pharmacological and
social/cognitive interventions e.g.. memory classes); care/treatment advocacy
(e.g.. medication management, benefits counseling and patient navigation);
early stage support services; social support services (such as adult day
services etc) supportive housing; safety services; hospital and community
based end-of-life and palliative care
- Services for families and caregivers include -- outreach; advocacy;
disease and self-care education; caregiver assessment; support groups; supports
for long distance caregivers; dementia care management; legal and financial
(including family care tax relief policies and benefits counseling)
services; respite services; and supportive workplace family care policies.
- Providers should utilize innovative gap filling/financing strategies.
- CMS should provide guidance to all states about how to add adult day
services as a state optional service under Medicaid.
- Services should encourage development and provide LTSS linkages to
state, local; and private supportive housing resources.
- Services should encourage development and implementation of
dementia-capable transportation services.
- Public and private payments for services should reflect a living wage
and recognize any special training for dementia capable service providers
HHS should fund support to a state lead entity in every state and
territory
- The lead entity will be responsible for: facilitating development of
dementia capable systems, coordinating public and private resources and
programs; building capacity for epidemiology; evaluating programs and improving
quality; maximizing the positive impact of services for people with AD and
their caregivers; reducing duplication; coordinating public awareness efforts;
and assuring that evidenced-based, high quality services are available.
- HHS should identify an appropriate office or operating division to
manage funds for the program supporting the state lead entities and convene
representatives of state lead entities regularly.
- HHS should develop standards for state lead entities that should be
met as a condition of funding. Understanding that states are organized
differently, standards should be flexible enough to accommodate various
entities as lead.
- Governors should be enlisted to designate the lead entity for their
state to assure appropriate authority.
- States should draft (or update) a state plan to address AD, in
concert with the National Plan.
- HHS should fully fund the costs of cognitive impairment and caregiver
surveillance through the Behavioral Risk Factor Surveillance System in every
state.
LTSS Research
- HHS should engage all relevant federal agencies to include research
on LTSS that addresses dementia capability in their research agendas
Key information about AD should be in all curricula.
- State education/health agencies, regional accrediting bodies, and
professional organizations should require that current information about AD be
included as a condition of approval of any curriculum or course of study
leading to relevant provider licensure or certification.
- Appropriate organizations should require that current information
about AD be included in all relevant continuing education activity and all
relevant state recertification programs.
- State, local, and private sector first responders, health and human
service personnel, and others who serve the public should receive appropriate
information and training regarding AD and the early warning signs of possible
cognitive impairment to assure they can effectively perform their work.
Adequate training and compensation should be ensured.
- State/Local/Private authorities should require that paraprofessional
caregivers receive at least 10 hours of dementia specific training from a
reliable source.
- States should enact policies that ensure that their hours and pay
reflect a fair and living wage because many of these workers are working
multiple shifts at below subsistence wages, often with few benefits,.
- Public and private sector compensation should reflect the completion
of a prescribed training program.
Medicare coverage should be redesigned to encourage appropriate
diagnosis and care planning for poeple with AD and their caregivers
- Congress should pass legislation to create Medicare coverage for a
package of services that covers the clinical diagnosis of AD as well as care
planning for the individual and their caregivers.
- This Medicare coverage should include care planning with a family
caregiver even if the individual with the disease is not present.
- Medicare reimbursement for this package of services should require
that physicians and other healthcare providers should be required to document
the AD diagnosis and any associated services provided in the individuals
medical record.
- The Health Resources and Services Administration (HRSA) and CMS
should clarify and disseminate information to providers about the procedures
under Health Insurance Portability and Accountability Act with regard to
sharing medical information with caregivers related to dementia, prognosis, and
care planning.
LTSS systems should refer people to a healthcare provider for
diagnosis
- Whenever a person exhibits symptoms of cognitive decline, providers
should consider a diagnosis using the 2011 guidelines.
- The state lead entity should assure that this recommendation is
included in any assessment for eligibility for LTSS.
- Federal agencies should assure that appropriate training resources
are available to health care providers on the use of the guidelines.
Diagnosis should include individual and family in advance care planning
(health, legal, estate, and financial).
- Health and LTSS providers should include advance care planning in the
health and LTSS care plan.
- Health and LTSS providers should have ready access to information for
referral of people diagnosed with AD and their family to community resources
for financial and estate planning.
- The state lead entity should assure that an inventory of community
resources is maintained through appropriate state, local, and private
resources.
HHS should assure that systems improve chronic disease treatment for
people with AD.
- People with AD often have other (multiple) chronic conditions.
Treatment options for persons with AD are limited and prognosis is negatively
affected when individuals have acute flare-ups related to their other
conditions or complications, (e.g., stroke, chronic obstructive pulmonary
disease, coronary heart disease).
- Providers should incorporate training regarding the impact of AD on
care for comorbid conditions in existing pre-service and in-service training
curricula.
- Professional organizations should develop tools and guidance for
clinicians and social service professionals.
- Professional organizations should develop tools for caregivers, which
help them with manage multiple chronic conditions. These tools should link to
the HHS Framework to Address Multiple Chronic Conditions.
HHS should develop quality measures for the comprehensive care and
treatment of individuals with AD.
- AHRQ -- in consultation with the National Quality Forum, the
Institute of Medicine, and various stakeholders -- should develop quality care
measures and indicators for diagnosis, treatment, and care of individuals with
AD.
- Over time, these quality measures and indicators should cover care in
the full array of medical and LTSS settings; care coordination and transitions
among settings.
- The Centers for Medicare and Medicaid Services (CMS) should implement
demonstration projects to study the application of dementia quality care
measures and indicators as they are developed.
- CMS should implement policies for Medicare and Medicaid to embed the
quality measures and indicators in the health and LTSS care system.
Practice recommendations for care in every setting should be embedded
in surveillance and QI systems.
- Stakeholders should develop or update consensus practice
recommendations for the full array of LTSS settings.
- These guidelines should be widely disseminated and embedded in all
federal and state surveillance and quality improvement systems.
- Practice recommendations should include the appropriate management of
AD and common co-morbid physical and behavioral health conditions.
HHS should form a blue ribbon panel of experts
- The Panel should 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.
Recommendations for end-of-life or palliative care should be part of
CMS surveillance and QI systems.
- Because at this time AD is a terminal illness marked by diminishing
capacity, providers should discuss and document use of palliative care and
desires regarding end-of-life care as early as practical in the disease
process.
- Federal and state surveillance and quality improvement systems should
all include measures of whether this communication has taken place in a
meaningful way
HHS should provide grants through CMS CMMI for medical home pilot
projects
- Within one year, CMMI should provide grants for medical home pilot
projects specifically targeted at Medicare beneficiaries with AD.
- Within one year, CMMI should provide grants for medical home pilot
projects specifically targeted at dual eligible individuals (those seniors
eligible for both Medicare and Medicaid) with AD.
- CMS should incorporate those projects that prove successful into the
Medicare and Medicaid programs.
CMMI should implement a new round of grants targeting preventable ED
visits, hospitalizations, and LOS for individuals with AD.
- HHS, states, and the private sector should work together to develop
and evaluate methods of improving hospital care, care coordination, and
transitions of care for people with AD, including training approaches and
proposed quality measures.
- Within one year of formation of this partnership, CMMI should create
a specific grant round focused exclusively on pilot projects and demonstrations
to reduce emergency department visits, preventable hospitalizations and length
of hospital stays among individuals with AD.
- Funded projects should include at least one project that targets
individuals from diverse communities.
HHS and states should partner to assure access for specific populations
including younger people, people with intellectual disabilities, such as Down
syndrome, and racial and ethnic minorities who are at increased risk of
acquiring AD.
- HHS and state lead entities should work with providers to assure that
supports are tailored for caregivers/family members of specific populations
with AD.
- All guidelines and quality improvement efforts should include
specific populations.
- Congress should amend the Older Americans Act Title III to make these
services available to those with younger-onset AD.
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 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.
- Estimated funds necessary to fully fund all states action plans
= $85 million.
Funding for the ADSSP should be restored to $13.4 million.
- ADSSP supports evidenced-based and innovative practices that assist
people with AD and their caregivers in the community.
- HHS, state lead entities and partners can use the lessons learned
from this program to spread the availability of valuable services and should
develop a long-range plan to convert ADSSP from a demonstration program to a
program that provides widely-available services based on the findings from the
demonstrations.
Fully fund caregiver support under AoA
- AoA currently has the National Family Caregiver Support Program, a
component of which can be expanded to better meet the needs of caregivers of
individuals with AD.
- These improvements may result in mitigation of other system costs.
- This program is currently dramatically underfunded and therefore
unable to meet the needs of this growing population of caregivers.
- Fully funding this program can enhance other related efforts to
improve quality of life for people with AD and their caregivers.
- We recommend that program funding be doubled to move toward full
funding.
HHS, states, and providers should assure that caregiver physical
health/ behavioral health risk is assessed and address regularly.
- The health and well-being of a caregiver has a direct impact on the
health and quality of life of a person with AD.
- Whenever a caregiver accompanies a person with AD to a health care
appointment; emergency department visit; or hospitalization, the attending
health care provider should ask if the caregiver is well for the purpose of
information and referral to services, if needed.
- HHS should explore HIT and surveillance systems to determine whether
caregiver risk assessment is occurring.
- Appropriate federal, state, and private sector organizations should
assure that the importance of this action is incorporated into training of
health and LTSS providers and incorporated into education messages for the
public.
- 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.
- Caregivers should have access to reminder tools; communication
methods among caregivers; home monitoring tools; and enhanced decision supports
that help instill confidence and reduce isolation.
HHS should launch a nationwide public awareness campaign to increase
awareness and to promote early detection of AD.
- HHS should coordinate a public awareness campaign with
relevant federal agencies and other stakeholders in a public-private
partnership.
- HRSA should partner with CDC and other HHS agencies, as well as
professional groups to launch a parallel awareness campaign targeted at
physicians and other health care professionals.
- Both campaigns should include promotion of Medicares Annual
Wellness Visit as a vehicle for health care professionals and patients to talk
about memory problems and cognitive function.
- The campaigns should include specific efforts in diverse communities
and populations, including younger-onset individuals and persons with
intellectual disabilities.
- The campaigns should involve appropriate state, county, and local
organizations, including public health departments, and encourage them to
launch public awareness and early detection campaigns of their own.
Themes of original research recommendations
- Commit resources with accountability
- Accelerate basic and translational research toward development of
effective treatments
- 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 Alzheimers Disease by 2025.
- Development of interim milestones, such as a significant
disease-modifying or substantially-enhanced symptom-mitigating behavioral or
pharmacologic intervention by 2020.
- New investment in research must reflect a critical balance
between basic research and the urgency treatment discovery.
Notes on Recommendation 1
- Appendix 4 of the Plan provides implementation milestones for each of
the Goals and Actions
- However the implementation plan is not detailed enough to know if
FACA recommendations are addressed, including 2020 interim goals.
- Explicit timelines, such as one that works backward from 2025 to
sketch out therapy discovery and approval timelines are not incorporated into
the implementation plan.
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 Alzheimers research initiatives spanning basic, translational and
clinical research.
Notes on Recommendation 2
- Introduction of the Plan mentions Obama Administrations
investment of $50 million in new Alzheimers disease research funding in
fiscal year 2012 and $80 million in new Alzheimers disease research
funding in fiscal year 2013
- This could represent the initial stages of a ramp-up but the urgency
of getting to $2 billion is unchanged
Recommendation 3
- We recommend that HHS develop, execute and regularly update a
strategic research plan and priorities to accelerate breakthroughs in AD
research.
Notes on Recommendation 3
- Actions 1.A.1 and 1.A.5 focus on development of the strategic
research plan.
- Very productive meetings have occurred, and NIA RFAs are being
developed as a result of the recommendations
- A comprehensive strategy of applying these recommendations across
public and private funding sources has not been developed
- The synchronization and coordination between the contents of the
National Plan and a research plan is not 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
- Outreach to ethnic groups is mentioned in Strategy 1B and
specifically addressed in 1.B.4
- However the detailed recommendations re: leveraging existing
resources and engaging private entities are not included, and the emphasis on
"translation of research findings" to diverse populations is not explicit in
the Plan.
- Down syndrome and intellectual disability populations are not
specifically mentioned within Goal 1.
Recommendation 5
- We recommend that HHS, in partnership with 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
- There is significant overlap between the broad intent of the
recommendation and the Plan (Action 1.E.1.)
- Many details included in the recommendation are relevant to the
implementation plan but are not included
- We are considering consolidation of recommendations 5,6,7 & 8
Recommendation 6
- We recommend that the Secretary, in consultation with academic
researchers, not-for-profit Alzheimers organizations, and the private
sector, including sponsors of investigational diagnostic and therapy trials, by
year-end 2012 identify and prioritize the action steps needed to reduce the
time for moving therapies from target identification and validation through
clinical development, regulatory review, market approval, and reimbursement
determinations.
Notes on Recommendation 6
- Action 1.E.1 focuses on shortening timeline
- Action 1.E.2 focuses on public private partnerships for
dissemination, translation, and implementation
- The role of PPPs in enhancing scientific innovation and discovery, or
progress in shortening the regulatory process is not uniquely emphasized in the
plan
- Consolidation and revisions of recommendations may result in one for
shortening timeline and one focusing on the broad role of PPPs in research
Recommendation 7
- We recommend that the Secretary examine and include as part of her
annual report to Congress and the Advisory Council:
- How the HHS will reduce barriers and accelerate development of
new therapies
- Immediate steps the HHS will take to address any identified drug
development barriers,
- Additional authorities or other legislative action that may be
needed to accelerate development of therapies and diagnostics
- Immediate steps to shorten time from market approval to coverage
decision
Notes on Recommendation 7
- Action 1.E.1 focuses on compressing timeline of therapy development
- The implementation plan does not currently include the steps detailed
in this recommendation
Recommendation 8
- We recommend that the FDA review and periodically report to the
Advisory Council recommendations to further accelerate FDA review processes
without compromising current standards of safety and efficacy.
Notes on Recommendation 8
- Action 1.E.1 will identify ways to compress the time between target
identification and release of pharmacological treatments
- The implementation plan for 1.E.1 identifies the FDA as a partner
agency in identification of places where timeline could be shortened
- The implementation plan indicates that Sept 2012 is the goal date for
this feedback to be offered to the Advisory Council
Recommendation 9
- 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. In our view,
a joint NIH and industry working group should be established, which can serve
as an opportunity to create a true partnership between government and industry
to inform research priorities.
Notes on Recommendation 9
- Action 1.A.2 is to solicit public and private input on AD research
priorities, and the specific example is to issue an RFI to invite public and
private input
- No specifics are offered on how this will be an ongoing process in
plan development
- Multiple ongoing PPP initiatives are moving forward on this
recommendation and thus specifics could be integrated in future versions of the
plan
Recommendation 10
- We recommend that HHS develop accurate and relevant metrics for
assessing the impact of Alzheimers on the U.S. economy.
Notes on Recommendation 10
- 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 11
- 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 11
- Goal 1.D generally mentions private partners
- However the 1.D actions items appear to focus on Global partners only
- There is tremendous detail in terms of implementation in this
recommendation that is not carried though to the Plan
- There is overlap between this recommendation and other FACA
recommendations that mention the importance of private partners
- We might want to clarify this recommendation or integrate it with
other PPP focus throughout.
Recommendation 34
- We recommend that the Administration 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 34
- Strategy 1.D calls for coordination of research internationally, via
inventory and outreach to international partners
- Global partners participated in the May 2012 meeting, met with HHS at
the Vancouver AAIC, and a number of bilateral efforts have begun
- Early spring 2013 is a target date for an international meeting
- There is no explicit mention of a Global AD Plan.
- A single high level official whose responsibility it is to foster
international cooperation has not been identified
- There has been no coordinated discussion internationally of
regulatory hurdles.
Recommendation 35
- 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
Alzheimers 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 35
- The implementation strategy designates specific offices responsible
for Action Items in the Plan.
- No separate office in the White House is mentioned in the Plan.
- Unaddressed aspects of this item include detail about metrics,
milestones, implementation steps, and accountability.
Workforce
- A prevention or cure is not imminent
- Incentives to work in geriatrics-- lets get specific
- Loan forgiveness (not just for underserved areas)
- Title VII and VII of Public Health Services Act
- Enhance current workforce to be dementia capable
- HRSA and partners to collaborate on health professions
curricula -- disseminate broadly.
- National programs targeted to various health
professionals.
- Even medical sub-specialties -- i.e. Dementia in ER
settings
- Certification/licensure -- varied across states.
Detection and Diagnosis
- Await the workgroup recs on detection tool
- Still favor Medicare comprehensive coverage for diagnosis/care
planning visit.
- Enhanced service with enhanced reimbursement
- Care planning with patient/caregivers
- Reimburse even if patient not present for some of visit
- Include legal, financial, advance care planning
- Enhanced documentation in medical record (required)
- Still need some clarification on HIPAA and dementia
ACA -- Medical Home
- Current plan suggests sub-group analysis of existing programs, but
not new program.
- CMMI should consider specific grant to Medical Home for patients with
dementia.
- This might be more efficient and effective than including
patients with dementia in a mixed medical home model.
Multiple chronic conditions
- Alzheimers Disease as multiplier
- Makes management of other diseases more difficult and costly
- Very little available through Medicare to support providers and
patients with this challenge
- Two CMMI funded projects in our first plan
- Very little research on best practices or cost effective
management -- despite large growth in this population
- Little specific to dementia in area of
transitions/re-hospitalizations despite new data (Callahan)
Care throughout the stages
- Many policy considerations that could make significant differences
for families dealing with Alzheimers/other dementias
- Medicare benefit earlier than 65 w/diagnosis
- Extend Medicare homebound status for people with moderate
dementia so that home supports can be strengthened -- visiting aides, nursing,
etc.
- Tax credits for out of pocket costs for family caregivers
Advanced dementia
- High Priority -- poorly coordinated care that is very costly. Given
rapidly growing numbers this area becomes an urgent need in the next plan.
- Improvements in care can make a difference quickly.
- Many areas already dovetail with current CMS initiatives.
- Management of infections -- antibiotic resistance
- Feeding and nutrition issues
- Transitional care and hospitalizations
- Communication and identification of goals of care
- CMS and other partners to co-sponsor a blue ribbon panel of
experts/researchers in this area.
- Consideration of where research can identify quality innovations
in care delivery or coordination quickly.
- What policy incentives can promote best practices in advanced
dementia care in all settings?
- Address the disconnect between Medicare and Medicaid programs for
this vulnerable group.
Awareness
- Parallel campaign for health professionals -- emphasizing the
importance of early detection and skill development as we manage more people
with dementia.
- Concern that an awareness campaign should provide information about
where to go for specific needs
- Highlight annual Medicare wellness visit
Public Comments
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Last updated: 10/15/2012