Washington,
D.C. –
U.S. Senators Pat Toomey (R-Pa.) and Debbie Stabenow (D-Mich.), the chairman
and ranking member of the Senate Finance Subcommittee on Health Care, are once
again working together to improve care for Alzheimer’s patients and expand
resources for caregivers.
In
a letter to U.S. Secretary of Health and Human Services Alex Azar, the pair
shares a number of recommendations collected from health care providers,
researchers and scientists, patient advocacy groups, states, and other experts.
The
recommendations are derived from a February
request for information issued by Chairman Toomey and Ranking Member
Stabenow seeking input from experts about how to make meaningful improvements
to the detection, education, treatment, and support for patients and families
affected by Alzheimer’s disease and related dementias. To date, more than 200
policy recommendations have been received from over 30 organizations.
In
the letter, Chairman Toomey and Ranking Member Stabenow stated:
“As the Chair and Ranking Member of the
Senate Committee on Finance Subcommittee on Health Care, we are committed to
advancing efforts to meet the goals set forth in NAPA as well as improving care
for existing and future patients. In February, we published a request for
information from experts and stakeholders to inform our regulatory and
legislative efforts. Specifically, we inquired about mechanisms that could
promote care coordination for Alzheimer’s disease patients enrolled in federal
health programs, improve disease detection, enhance the affordability and
accessibility of long-term care, strengthen protections for vulnerable
individuals, and incentivize the development of cures. In response, we received
36 comment letters comprised of more than 200 policy recommendations. Today, we
are asking you to review a subset of these recommendations and take specific
actions to make progress toward these important goals.”
The
letter in its entirety is below. It is available online with footnotes here.
October
21, 2020
The
Honorable Alex M. Azar II
Secretary
U.S.
Department of Health and Human Services (HHS)
200
Independence Avenue, SW
Washington,
DC 20201
Dear
Secretary Azar:
We
write on behalf of the estimated 5.8 million Americans currently living with
Alzheimer’s disease. Beyond the individual cognitive decline and vast
psychological and emotional consequences for families, the costs to society of
Alzheimer’s disease are staggering. For instance, a 2013 study funded by the
National Institute on Aging (NIA) estimated the total annual cost of dementia
in the United States to lie between $159 billion and $215 billion, with that
figure projected to grow to between roughly $379 billion and $511 billion by
2040. Moreover, after adjusting for an individual’s underlying health
conditions and demographics, the same study estimated the annual cost of
informal caregiving attributable to dementia to range between $13,188 and
$27,789 per person. For Medicare, the nation’s largest public health care
payer, dementia-specific costs imposed an additional $2,752 per person on the
program.
Nearly
a decade later, much work remains to address the momentous societal costs of
Alzheimer’s disease and related dementias. Currently, pharmacological
interventions are unable to cure or even effectively treat the relentless
progression of Alzheimer’s disease. Congress has long recognized the
challenges facing Alzheimer’s disease patients and their families, and in 2011,
passed the National Alzheimer’s Project Act (P.L. 111-375; NAPA). This landmark
legislation put forth the laudable goal of finding a cure and treatment by
2025.
As
the Chair and Ranking Member of the Senate Committee on Finance Subcommittee on
Health Care, we are committed to advancing efforts to meet the goals set forth
in NAPA as well as improving care for existing and future patients. In
February, we published a request for information from experts and stakeholders
to inform our regulatory and legislative efforts. Specifically, we inquired
about mechanisms that could promote care coordination for Alzheimer’s disease
patients enrolled in federal health programs, improve disease detection,
enhance the affordability and accessibility of long-term care, strengthen
protections for vulnerable individuals, and incentivize the development of
cures. In response, we received 36 comment letters comprised of more than 200 policy
recommendations. Today, we are asking you to review a subset of these
recommendations and take specific actions to make progress toward these
important goals.
RECOMMENDATIONS
PROMOTE
COORDINATED, QUALITY CARE
- Develop
New Demonstration Projects: We encourage the Centers for Medicare &
Medicaid Services (CMS) or the Center for Medicare & Medicaid Innovation
(CMMI) to create and test alternative payment and coordinated care models
targeted toward Medicare and/or Medicaid beneficiaries with Alzheimer’s disease
that would improve care coordination, reduce duplicative service utilization,
and increase the quality of care.
- Develop
Quality Indicators for Dementia Care Services: To ensure quality of care for
enrollees in federal health programs, we encourage CMS to assess the state of
quality indicators for dementia care services. Alzheimer’s disease patients
often utilize a variety of services such as adult day programs, meal and
transportation services, and memory care centers. Yet, CMS has not produced clear
guidance for state Medicaid programs and Medicare Advantage plans on what
measures are meaningful for Alzheimer’s disease patients’ health outcomes and
quality of care. Similarly, new quality measures for Programs of All-Inclusive
Care for the Elderly (PACE) organizations could allow patients and their
caregivers to make more informed decisions. In a February 2020 report, the
National Quality Forum’s Measure Application Partnership encouraged CMS to
prioritize measure development for this patient population. We urge HHS and CMS
to review existing quality reporting programs and other payment systems in
which quality reporting is lacking within the Medicare and Medicaid programs.
Moreover, we urge HHS to establish a plan to implement specific quality care
indicators for services heavily utilized by Alzheimer’s disease patients.
- Issue
Guidance for Comprehensive Care Practices: In 2019, the NAPA Advisory Council
recommended that HHS form a working group to determine best care practices for
Alzheimer’s disease patients. We urge HHS to quickly implement this
recommendation, and once identified, work with the relevant agencies to issue
guidance to health plans and providers detailing these practices.
- Increase
Coordination of Care Planning: CMS is reviewing comments from stakeholders
regarding wider adoption of interoperable health information technology (IT)
systems across long-term care settings. Inclusion of items, such as a
patient’s care plan, could enhance care coordination of health and social services
that support cognitively impaired individuals. We recommend that CMS continue
to work with providers, patients, and their caregivers to facilitate mobility
of this information across care settings. Encouragement from CMS of documenting
in a patient’s medical record the name of a family member or caregiver, as well
as any advance directives, could also improve care coordination.
- Review
Patient Access to Palliative Care: Palliative care encompasses a set of
services that provide medical, social, emotional, and practical support for
people living with serious illness. Several of our stakeholders expressed
their support for expanding coverage and access to palliative care in federal
health programs, including traditional Medicare, Medicare Advantage, and Medicaid.
We encourage CMS to review current access to palliative care and report to
Congress on areas such as provider prevalence, cost, and quality of care.
- Create
a Nursing Home Staff Database: Nursing home medical directors play an important
role in the coordination and quality of care for patients with Alzheimer’s
disease residing in long-term care facilities. We urge CMS to establish and
operate a publicly available database for nursing home medical directors so
that families and caregivers have a reliable source of contact. Such a database
could be posted to the CMS website in a similar fashion to how CMS posts
Medicare Part D contact information.
LEVERAGE
TELEHEALTH SERVICES
- Revise
the Limit on Billable Telehealth Visits for Nursing Care Facilities: Currently,
CMS allows just one telehealth visit every 30 days in nursing care
facilities. Several of our stakeholders argue that this policy is
arbitrary and limits access to care for patients living with Alzheimer’s
disease in institutional settings. CMS has attempted to address this concern by
revising the limit to once every three days in its proposed physician fee
schedule rule for calendar year 2021. CMS has also noted the potentially
greater acuity and complexity of Medicare beneficiaries in nursing care
facilities, as well as the importance of in-person care in that context.
We find access to telehealth in this setting to be important to the care
provided to Alzheimer’s disease patients, and we support CMS efforts to expand
telehealth access across settings where clinically appropriate and with
adequate beneficiary protections in place.
STRENGTHEN
THE PACE PROGRAM FOR ALZHEIMER’S DISEASE PATIENTS
- Implement
Congressionally-Intended PACE Pilot Demonstrations: In 2015, the PACE
Innovation Act (P.L. 114-85) authorized CMMI to test the PACE model for
new populations with complex and special needs. Rather than test PACE-specific
models, however, CMMI has requested PACE organizations (POs) apply to a
separate Direct Contracting model focused on primary care. In a Senate
Committee on Finance Report, the Committee stated the intent of the
legislation was to test changes to the PACE model, either through an expansion
of eligibility standards and/or changes to administrative requirements that
would enable greater enrollment. Based on stakeholder information we have
received, we believe the existing Direct Contracting model does not provide the
flexibility necessary to test PACE-specific models. We request that CMMI follow
the intent of the statute to create a PACE-specific model.
- Improve
the PACE Application Process: By law, PACE-eligible individuals must reside in
the service area of their applicable PACE program. Moreover, CMS only
reviews service area expansion applications on a quarterly basis and POs are limited
to one pending application under CMS review at a time. , Thus, we request
that CMS review PACE service area expansion applications more frequently and
allow POs to submit more than one service area expansion application at a time.
Furthermore, CMS must prioritize timely review of service expansion
applications and other updates to the program to ensure the federal government
is not a barrier to access for individuals who may benefit from PACE
enrollment.
CONSOLIDATE
RESOURCES FOR CAREGIVERS AND PATIENTS
- Establish
a Centralized, Alzheimer’s Disease-Specific Portal for Patient and Caregiver
Resources: Patients living with Alzheimer’s disease, along with their
caregivers, must often navigate a series of complex decisions involving
long-term care planning and the various institutional or community-based
services available to them. Currently, HHS, its agencies, and state and local
health departments maintain platforms with information about these issues for
patients and caregivers. Our stakeholders believe that Alzheimer’s
disease patients and their caregivers could benefit from a more unified
platform that streamlines all the information and resources available to them.
We urge HHS to undertake a review of its current Alzheimer’s disease-related
resources and consolidate the relevant information for patients and caregivers
into a single online resource portal. This can be done through expansion of an
existing federal resource portal. Information that our stakeholders believe
could be valuable in such a portal include the following:
- Resources
for long-term care planning and clarification on the long-term care benefits,
and eligibility for such benefits, under Medicare fee-for-service, Medicare
Advantage, Medicaid, and other relevant federal health care programs;
- Descriptions
of the types of long-term care facilities and care options available to
Alzheimer’s disease patients, including institutional settings and home- and
community-based services;
- Resources
for federal- and state-sponsored caregiver support and training programs;
- Information
about clinical trial enrollment, including links to existing registries and
support for patients currently enrolled in clinical trials;
- Educational
resources about Alzheimer’s disease and developments in the process toward a
cure and treatment;
- Information
on identifying and preventing elder abuse, neglect, and exploitation;
- Material
on services and devices to improve patient safety, like GPS and web-based home
monitoring services for Alzheimer’s disease patients who suffer from wandering
or navigational issues.
INCREASE
THE USE AND EFFECTIVENESS OF COGNITIVE SCREENS
- Address
Research Gaps for Cognitive Screens: The U.S. Preventive Services Task Force
has concluded that evidence regarding the effectiveness of cognitive impairment
screening is insufficient to support a recommendation for its routine use. As a
result, insurers are not required to cover this service and are also allowed to
apply cost sharing if they do. Ensuring that appropriate wrap-around services
are provided at the right time in a patient’s diagnosis could reduce avoidable
hospital and emergency department visits and as a result, potentially mitigate
federal health care expenditures. , , Thus, it is imperative that
research into the potential benefits of improved cognitive screens and other
means by which providers diagnose Alzheimer’s disease are prioritized by HHS so
that a more robust body of literature surrounding their use can be established.
- Encourage
Use of Evidence-Based Cognitive Assessment Tools: One objective of Medicare’s
annual wellness visit (AWV) is to detect cognitive impairment of an individual,
a clear symptom of Alzheimer’s disease and related dementias. We ask that CMS
recommend the use of an evidence-based cognitive assessment tool during AWVs
rather than direct observation. Ensuring the results of such assessments
be made available in the beneficiary’s electronic health record (EHR) could
also aid in care coordination.
- Encourage
Use of the Health Risk Assessment (HRA) to Assess Cognitive Function: Given the
relatively low uptake in the AWV, we ask that CMS encourage Medicare
Advantage plans to use their HRAs to assess cognitive function and the
potential long-term care needs of seniors. Plans are provided significant
flexibility in what they include in the HRA. While some plans provide for a
cognitive screening, not all plans do. These visits and assessments provide
ample opportunity for the identification of cognitive disorders such as
Alzheimer’s disease, which could lead to more timely coordination of care.
FOSTER
INNOVATION FOR ALZHEIMER’S DISEASE THERAPIES AND DIAGNOSTICS
- Prioritize
Alzheimer’s Disease within the Food and Drug Administration’s (FDA) Complex
Innovative Trial Designs (CID) and Model-Informed Drug Development (MIDD)
Programs: The FDA is currently operating two pilot programs, the CID and MIDD,
which aim to increase the efficiency of the clinical trial process for
innovative therapies and improve the likelihood of their success throughout the
regulatory approval process. In particular, the CID provides opportunities for
enhanced dialogue with FDA officials during the trial design process, and the
MIDD provides sponsors the chance to collaborate with officials on precise
risk-benefit models for the drug. , We urge HHS to consider the merit of
incorporating more Alzheimer’s disease therapeutic sponsors into these pilot
programs.
- Accelerate
Development of Diagnostics: We encourage the National Institutes of Health and
NIA to establish a program akin to the Rapid Acceleration of Diagnostics (RADx)
initiative for COVID-19 with the goal of bringing to market an affordable and
non-invasive point-of-care diagnostic for Alzheimer’s disease. If such an
initiative would require legislation, we urge you to work with us on the
development and passage of such a law.
CLARIFY
AND IMPROVE ACCESS TO CERTAIN SERVICES
- Review
the 2014 Qualified Settings Rule for Home- and Community-Based Services: In
2014, CMS finalized a definition for home- and community-based settings.
Stakeholders expressed concern that parts of the rule intended to promote
community integration or strengthen facility security are not appropriate for
cognitively impaired individuals. One stakeholder expressed concern that the
requirement of locks on doors to strengthen privacy can pose a threat to
patients with dementia. We urge CMS to review the regulation and issue guidance
or best practices to states about how settings that provide services to
individuals with Alzheimer’s disease can best meet the requirements in the
regulation. This can either be achieved through setting-specific policies and
practices or through modifications to person-centered service plans.
- Evaluate
and Expand Access to CPT Code 99483: CPT code 99483 reimburses providers for
undertaking functional assessments and care planning services for individuals
living with cognitive impairment. Unfortunately, the most recent utilization
data suggests that only a small fraction of eligible seniors are receiving the
benefit. We encourage CMS to conduct education and outreach to increase
awareness of and access to the code. Additionally, some stakeholders assert that
the documentation requirements for the code’s billing are too complex and prone
to deficiencies for some providers. We encourage CMS to review the billing
requirements for CPT Code 99483 to ensure such requirements are not uniquely
onerous. Billing requirements should also require proper documentation in the
patient’s medical record or EHR.
We
thank you for your continued engagement on one of the most pressing health care
issues of our time – addressing the scourge of Alzheimer’s disease. As we continue
our efforts to support the Alzheimer’s disease community, we ask that you
transmit any legislative recommendations that the Administration may have in
the aforementioned areas of care coordination, long-term care accessibility,
and the development of a treatment and/or cure for Alzheimer’s disease. We look
forward to your response and a commitment to improve care delivery for this
patient population.