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Antipsychotic Drug Use among

Older Adults with Dementia

Lori Achman
Assistant Director, Health Care
U.S. Government Accountability Office

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Outline
• This presentation is based primarily on report GAO-15-211,
“Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among
Older Adults in Nursing Homes, but Should Expand Efforts to Other
Settings.”

Outline for presentation:


• About the Government Accountability Office (GAO)
• Background information on antipsychotic drug use among older adults
with dementia
• Research objectives
• Methods and Findings
• GAO recommendation and status

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About the GAO

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Background: Dementia

• Dementia affected almost 15 percent of adults aged 71 and over


in 2010, according to an estimate from RAND Corporation.
• RAND estimated that the total monetary cost of caring for
individuals with dementia was between $157 billion and $215
billion – about $11 billion was paid by Medicare.
• Dementia is most commonly associated with a decline in
memory, but can also cause changes in mood or personality,
loss of communication, and, at times, agitation or aggression.
• To manage behavioral symptoms, antipsychotic drugs are
sometimes prescribed.

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Background: Antipsychotic drugs
• Antipsychotic drugs:
• are generally approved for the treatment of schizophrenia and
bipolar disorder.
• are not approved to treat the behavioral symptoms that can be
associated with dementia.
• have been found to increase the risk of death for older adults with a
diagnosis of dementia.
• carry an FDA-required boxed warning that states that they are
associated with an increased risk of death when used to treat older
adults with dementia-related psychosis.
• In 2011, the Department of Health and Human Services (HHS) Office
of Inspector General (OIG) reported that 88 percent of a 2007 sample
of 1.4 million Medicare claims for newer antipsychotic drugs for older
nursing home residents was associated with a dementia diagnosis.

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Background: Caveats
• Physicians are generally not prohibited from prescribing a drug for
uses other than what the Food and Drug Administration (FDA) has
approved. This is called off-label prescribing and is common in the
United States.

• Physicians are not prohibited from prescribing antipsychotic drugs in


the presence of a dementia diagnosis.

• However, clinical guidelines consistently suggest the use of


antipsychotic drugs for the treatment of the behavioral symptoms of
dementia only when other, non-pharmacological attempts to ameliorate
the behaviors have failed, and the individuals pose a threat to
themselves or others.

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Background: National Alzheimer’s Plan

• HHS developed its first National Alzheimer’s Plan in 2012, and it


includes a number of actions to improve systems of care and
service delivery to individuals with dementia.

• The plan has been annually updated since 2012. The latest
update was 2018.

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Research Questions

1. To what extent are antipsychotic drugs prescribed for older


adults with dementia living inside and outside of nursing homes
and what did Medicare Part D pay for these drugs?

2. What is known from selected experts and published research


about factors contributing to the prescribing of antipsychotic
drugs to older adults with dementia?

3. To what extent has HHS taken action to reduce the use of


antipsychotic drugs in older adults with dementia?

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Methods: Extent of older adults prescribed
antipsychotic drugs and Medicare Part D costs
• Analyzed Medicare Part D Prescription Drug Event data for
individuals with dementia in 2012.
• Combined with 2012 data from the Long Term Care Minimum
Data Set to identify individuals living in nursing homes. We
specifically looked at those with a long-stay in a nursing home—
more than 100 days.
• Used other Medicare data to identify whether an individual had a
dementia diagnosis, or a diagnosis for a condition for which FDA
has approved the use of antipsychotic drugs.
• Excluded individuals with an FDA-approved condition.

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Older Nursing Home Residents with Dementia
Who Were Prescribed an Antipsychotic in 2012
Figure 1:

aAresident is considered as having dementia if one of the following diagnoses were present on any of the resident’s assessments in 2012: a general
dementia diagnosis, a diagnosis of Alzheimer’s disease, or a diagnosis of Parkinson’s disease.
Additional notes for this figure are on slide 26.

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Antipsychotic Drug Prescribing among Older
Nursing Home Residents with Dementia, 2012
Table 1:
Percent of residents with an
antipsychotic prescription
All 30%
Length of Stay Short Stay 23
Long Stay 33
Gender Female 29
Male 32
Age 65-74 37
75-84 32
85+ 27
Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) nursing home assessment data. | GAO-15-211
Additional notes for this table are on slide 27.

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Older Medicare Part D Enrollees Outside of the Nursing
Home Diagnosed with Dementia Who Were Prescribed an
Antipsychotic in 2012
Figure 2:

Additional notes for this figure are on slide 28.

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Antipsychotic Drug Prescribing among Older Adult
Medicare Part D Enrollees with Dementia Living Outside
of a Nursing Home, 2012
Table 2:

Percent with an antipsychotic


prescription

All 14%
Gender Female 15
Male 12
Age 66-74 12
75-84 14
85+ 15
Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) Medicare Part D data. | GAO-15-211
Additional notes for this table are on slide 28.

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Medicare Part D Plan Payments for Older Adult Enrollees
With Dementia Who Used an Antipsychotic in 2012, by
Setting
Table 3: In millions
Spending on Spending on
Enrollees with Enrollees Outside
Long-Term Nursing of the Nursing
Home Stay Home Total
All $171 $171 $342
Gender Female 124 122 246
Male 47 49 96
Age 66-74 34 44 78
75-84 69 72 141
85+ 68 55 123
Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) Medicare Part D data. | GAO-15-211
Additional notes for this table are on slide 29.

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Methods: Factors Contributing to the Prescribing of
Antipsychotic Drugs to Older Adults with Dementia
• Literature search in peer-reviewed journals from January 2009
through March 2014, excluding international research.
• 18 articles discussed contributing factors.
• Also interviewed industry, provider, advocacy groups, and
research experts, with experience or work on the subject of
antipsychotic drug use among older adults.

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Patient-specific Factors that Contribute to the
Decision to Prescribe Antipsychotic Drugs
• Behaviors contributing to decision to prescribe antipsychotic
drugs:
• Agitation
• Aggression
• A risk to oneself or others, including frightening delusions or
hallucinations

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Setting-specific Factors that Contribute to the
Decision to Prescribe Antipsychotic Drugs
• Within nursing homes:
• Culture
• Level of staff training and education
• Number of staff
• Leadership
• Entering from the hospital.
• One study looked at variation in antipsychotic drug use in nursing
homes among 16,000 residents in 1,257 nursing homes. The study
found new nursing home residents admitted to facilities with high
antipsychotic prescribing rates were 1.4 times more likely to receive
antipsychotics, even after controlling patient-specific factors.1
Chen, B.A. Briesacher, T.S. Field, J. Tija, D.T. Lau, and J.H. Gurwitz, “Unexplained Variation across US Nursing
1Y.

Homes in Antipsychotic Prescribing Rates,” Archives of Internal Medicine, vol. 170, no. 1 (2010).

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Methods: The extent HHS has taken action to reduce the
use of antipsychotic drugs in older adults with dementia

• Interviewed officials within agencies within HHS:


• CMS
• FDA
• Administration for Community Living (ACL)
• National Institutes of Health’s National Institute on Aging and
National Institute of Mental Health
• Agency for Healthcare Research and Quality (AHRQ)
• Reviewed federal regulations, CMS nursing home guidance,
agency web sites, and other federal documents, such as the
National Alzheimer’s Plan.

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National Plan to Address Alzheimer’s Disease

• Several actions related to monitoring, reporting, and reducing


use of antipsychotic drugs by older adults in nursing homes.
• National Partnership to Improve Dementia Care in Nursing
Homes (National Partnership)
• Focused Dementia Care Surveys, first initiated in 2014, to
assist in determining compliance with areas such as quality
dementia care, the use of non-pharmacological approaches,
and utilization of antipsychotic medications.
• Civil Money Penalty Reinvestment Program, a 3-year effort
to drive improvements in quality of life and quality of care for
nursing home residents. The approach focuses on nursing
homes identified as being slow to reduce antipsychotic
prescribing. CMS will provide technical assistance.
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National Partnership to Improve Dementia Care
in Nursing Homes
• In 2012, CMS launched the National Partnership to Improve
Dementia Care in Nursing Homes (National Partnership) with
federal and state agencies, nursing homes, providers and
advocacy organizations.
• The National Partnership began with an initial goal of reducing
the national prevalence of antipsychotic drug use in long-stay
nursing home residents by at least 15 percent by December 31,
2012.
• Antipsychotic prescribing for long-stay nursing home residents
has been reduced by about 39 percent from 2011 through 2018.

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Prevalence of Antipsychotic Drug Use in Long-
Stay Nursing Home Residents, 2011-2018
Figure 3:
30.0%

25.0% 23.9%
22.3%
19.1%
20.0%
20.3% 17.0% 16.0% 15.1% 14.6%
15.0%

10.0% Initial
Baseline target met
5.0% Rate when GAO
Current Rate
report came out
0.0%
2011

2012

2013

2014

2015

2016

2017

2018
Source: GAO based on CMS Quality Measure, MDS 3.0 data.
Note: Information is from the fourth quarter of each year, except for 2018, which is from the third quarter.

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Other CMS Actions to Reduce Antipsychotic
Drug Use by Older Adults
• Enhanced oversight and enforcement for those nursing homes
that have not improved their antipsychotic prescribing rates
• Provided additional guidance and mandatory training around
behavioral health and dementia care from 2012 through 2013 to
the state surveyors responsible for reviewing and assessing
nursing homes.
• Incorporated measures of long-stay and short-stay nursing
home resident use of antipsychotic drugs into Nursing Home
Compare website.

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Other HHS Actions

• AHRQ funded individual grants for work related to antipsychotic


drug use in nursing homes through its Center for Evidence and
Practice Improvement and Centers for Education & Research on
Therapeutics program.
• National Institute on Aging and the National Institute of Mental
Health have funded related research, including a number of
studies examining the safety of antipsychotic drugs in older
adults.

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Little Action Taken on Antipsychotic Drug Use
Outside of Nursing Homes
• No actions in National Alzheimer’s Plan related to antipsychotic
drug use among older adults living outside of nursing homes.
• Administration on Community Living released a study in 2012
titled “Translating Innovation to Impact” on non-pharmacological
treatments and care practices for individuals with dementia and
their caregivers.
• Stakeholder groups indicated that educational efforts similar to
those provided under the National Partnership should be
expanded to other care settings, such as hospitals, assisted
living facilities, and other settings outside of nursing homes.

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GAO Recommendation

• We recommended that the Secretary of HHS expand its


outreach and educational efforts aimed at reducing antipsychotic
drug use among older adults with dementia to include those
residing outside of nursing homes by updating the National
Alzheimer’s Plan.
• HHS initially concurred with the recommendation, but as of
September 2018, had not updated the National Alzheimer’s Plan
in a manner that addressed our recommendation.

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Notes to Figure 1 on Slide 10
Data on antipsychotic drugs were missing for 204 residents with dementia. Residents in facilities
outside of the 50 states and the District of Columbia were excluded, as were residents who passed
away in the facility in 2012. We included only those that lived through 2012 because antipsychotics
can be used in the hospice or palliative setting to make residents more comfortable at the end of
their lives. We also excluded residents with dementia who were also diagnosed with
schizophrenia, bipolar disorder, Huntington’s disease, and Tourette syndrome because FDA has
approved certain antipsychotics for the treatment of schizophrenia, bipolar disorder, and Tourette
syndrome, and CMS guidance recognizes antipsychotics as an acceptable treatment for
Huntington’s disease. Diagnostic information was identified using all assessments with a target
date in 2012 for a given resident. The initiation of the antipsychotic prescription could have
occurred prior to the nursing home stay or during the nursing home stay.

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Notes to Table 1 on Slide 11
Percentages are rounded to the nearest whole number. The gender of some residents was
unidentified, and those residents are not included in the gender breakdown. Residents in
facilities outside of the 50 states and the District of Columbia were excluded, as were
residents who passed away in the facility in 2012. We included only those that lived through
2012 because antipsychotics can be used in the hospice or palliative setting to make
residents more comfortable at the end of their lives. We also excluded residents with
dementia who were also diagnosed with schizophrenia, bipolar disorder, Huntington’s
disease, and Tourette syndrome because FDA has approved certain antipsychotics for the
treatment of schizophrenia, bipolar disorder, and Tourette syndrome, and CMS guidance
recognizes antipsychotics as an acceptable treatment for Huntington’s disease. Diagnostic
information was identified using all assessments with a target date in 2012 for a given
resident. The initiation of the antipsychotic prescription could have occurred prior to the
nursing home stay or during the nursing home stay.

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Notes to Figure 2 and Table 2 on Slides 12 and
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Enrollees outside of the 50 states and the District of Columbia were excluded, as were
enrollees with less than 12 months of Medicare Part D enrollment, those whose Medicare
coverage began on or after January 1, 2011, and those who passed away in 2012. We
included only those that lived through 2012 because antipsychotics can be used in the
hospice or palliative setting to make patients more comfortable at the end of their lives. We
also excluded enrollees with dementia who were also diagnosed with schizophrenia or
bipolar disorder because FDA has approved certain antipsychotics for the treatment of these
two conditions. Diagnostic information was identified using Medicare Part D Risk File data,
and includes only diagnoses from the previous year.

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Notes to Table 3 on Slide 14
Enrollees in and outside of the nursing home cannot be directly compared because the
severity of dementia—and thus, the level of treatment acuity—needed for enrollees in the
nursing home is much greater than that for enrollees outside of the nursing home. Enrollees
outside of the 50 states and the District of Columbia were excluded, as were enrollees with
less than 12 months of Medicare Part D enrollment, those whose Medicare coverage began
on or after January 1, 2011, and those who passed away in 2012. We included only those
that lived through 2012 because antipsychotics can be used in the hospice or palliative
setting to make patients more comfortable at the end of their lives. Enrollees with stays
greater than 100 days are considered long-stay residents, and all other enrollees are
considered short-stay residents. Diagnostic information was identified using Medicare Part D
Risk File data, and includes only diagnoses from the previous year.

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