ANTIPSYCHOTIC 

DRUG USE

HHS Has Initiatives to 

Reduce Use among 

Older Adults in 

Nursing Homes, but 

Should Expand Efforts 

to Other Settings

Report to Congressional Requesters

January 2015

GAO-15-211

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-15-211, a report to 

congressional requesters

January 2015

ANTIPSYCHOTIC DRUG USE

HHS Has Initiatives to Reduce Use among Older 

Adults in Nursing Homes, but Should Expand Efforts 

to Other Settings

Why GAO Did This Study

Dementia affects millions of older 

adults, causing behavioral symptoms 

such as mood changes, loss of 

communication, and agitation. 

Concerns have been raised about the 

use of antipsychotic drugs to address 

the behavioral symptoms of the 

disease, primarily due to the FDA’s 

boxed warning that these drugs may 

cause an increased risk of death when 

used by older adults with dementia and 

the drugs are not approved for this 

use.

GAO was asked to examine 

psychotropic drug prescribing for older 

adult nursing home residents. In this 

report, GAO examined (1) to what 

extent antipsychotic drugs are 

prescribed for older adults with 

dementia living inside and outside 

nursing homes, (2) what is known from 

selected experts and published 

research about factors contributing to 

the such prescribing, and (3) to what 

extent HHS has taken action to reduce 

the use of antipsychotic drugs by older 

adults with dementia. GAO analyzed 

multiple data sources including 2012 

Medicare Part D drug event claims and 

nursing home assessment data; 

reviewed research and relevant federal 

guidance and regulations; and 

interviewed experts and HHS officials.

What GAO Recommends

GAO recommends that 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 

concurred with this recommendation.

What GAO Found

Antipsychotic drugs are frequently prescribed to older adults with dementia. 

GAO’s analysis found that about one-third of older adults with dementia who 

spent more than 100 days in a nursing home in 2012 were prescribed an 

antipsychotic, according to data from Medicare’s prescription drug program, also 

known as Medicare Part D. Among Medicare Part D enrollees with dementia 

living outside of a nursing home that same year, about 14 percent were 

prescribed an antipsychotic. (See figure.)

Proportion of Older Adult Medicare Part D Enrollees Outside of the Nursing Home Diagnosed 

with Dementia Who Were Prescribed an Antipsychotic in 2012

Note: GAO excluded individuals diagnosed with schizophrenia or bipolar disorder because the Food 

and Drug Administration (FDA) has approved certain antipsychotic drugs for the treatment of these 

conditions.

Experts and research identified patient agitation or delusions, as well as certain 

setting-specific characteristics, as factors contributing to the prescribing of 

antipsychotics to older adults. For example, experts GAO spoke with noted that 

antipsychotic drugs are often initiated in hospital settings and carried over when 

older adults are admitted to a nursing home. In addition, experts and research 

have reported that nursing home staff levels, particularly low staff levels, lead to 

higher antipsychotic drug use.

Agencies within the Department of Health and Human Services (HHS) have 

taken several actions to address antipsychotic drug use by older adults in nursing 

homes, as described in HHS’s National Alzheimer’s Plan; however, none have 

been directed to settings outside of nursing homes, such as assisted living 

facilities or individuals’ homes. While the National Alzheimer’s Plan has a goal to 

improve dementia care for all individuals regardless of residence, HHS officials 

said that efforts to reduce antipsychotic use have not focused on care settings 

outside nursing homes, though HHS has done work to support family caregivers 

in general. Stakeholders GAO spoke to indicated that educational efforts similar 

to those provided for nursing homes should be extended to other settings. 

Extending educational efforts to caregivers and providers outside of the nursing 

home could help lower the use of antipsychotics among older adults with 

dementia living both inside and outside of nursing homes.

View GAO-15-211. For more information, 

contact Katherine M. Iritani, (202) 512-7114, 

iritanik@gao.gov.
Page i GAO-15-211 Antipsychotic Drugs and Older Adults

Letter 1 

Background 7

Approximately 33 Percent of Older Adult Medicare Part D 

Enrollees with Dementia Who Resided in a Nursing Home, and 

14 Percent Outside of a Nursing Home, Were Prescribed 

Antipsychotic Drugs in 2012 10

Experts and Research Commonly Cited Certain Patient and 

Setting-Specific Factors Contributing to the Prescribing of 

Antipsychotic Drugs to Older Adults 21

HHS Agencies’ Actions Focused on Reducing Antipsychotic Drug 

Use by Older Adults with Dementia Target Nursing Home 

Residents, Not Those in Other Settings 26

Conclusion 32

Recommendation for Executive Action 33

Agency Comments 33

Appendix I Scope and Methodology for Data Analyses 34

Appendix II Literature Review 39

Appendix III Comments from the Department of Health and Human Services 42

Appendix IV GAO Contact and Staff Acknowledgments 44

Tables

Table 1: Number and Percent of Older Adult Medicare Part D 

Enrollees Diagnosed with Dementia Who Had a Long 

Stay in a Nursing Home and Were Prescribed an 

Antipsychotic in 2012, by Characteristic 12

Table 2: Antipsychotic Drug Prescribing among Older Adult 

Nursing Home Residents with a Dementia Diagnosis, 

2012 14

Contents
Page ii GAO-15-211 Antipsychotic Drugs and Older Adults

Table 3: Number and Percent of Older Adult Medicare Part D 

Enrollees Diagnosed with Dementia Who Spent No Time 

in a Nursing Home and Were Prescribed an Antipsychotic 

in 2012, by Characteristic 17

Table 4: Medicare Part D Plan Payments for Older Adult Enrollees 

Who Used an Antipsychotic in 2012, by Setting and 

Diagnosis Category 19

Table 5: Number and Percent of Older Adult Medicare Part D 

Enrollees with Dementia and Antipsychotic Drug 

Prescriptions, and Medicare Part D Plan Payments for 

Those Prescriptions in 2012, by Antipsychotic Drug 20

Table 6: Antipsychotic Drugs Included in GAO Analysis, by 

Generation 36

Figures

Figure 1: Proportion of Older Adult Nursing Home Residents 

Diagnosed with Dementia Who Were Prescribed an 

Antipsychotic in 2012 13

Figure 2: Proportion of Older Adult Medicare Part D Enrollees 

Outside of the Nursing Home Diagnosed with Dementia 

Who Were Prescribed an Antipsychotic in 2012 15
Page iii GAO-15-211 Antipsychotic Drugs and Older Adults

Abbreviations

ACL Administration for Community Living

AHRQ Agency for Healthcare Research and Quality

CERT Center for Education & Research on Therapeutics

CMS Centers for Medicare & Medicaid Services

FDA Food and Drug Administration

HHS Department of Health and Human Services

MBSF Master Beneficiary Summary File

MDS Long Term Care Minimum Data Set

NDC national drug code

NIH National Institutes of Health

NPPES National Plan and Provider Enumeration System

OIG Office of Inspector General

PASRR Preadmission Screening and Resident Review

PDE Medicare Part D Prescription Drug Event

QIO Quality Improvement Organization

This is a work of the U.S. government and is not subject to copyright protection in the 

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without further permission from GAO. However, because this work may contain 

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Page 1 GAO-15-211 Antipsychotic Drugs and Older Adults

441 G St. N.W.

Washington, DC 20548

January 30, 2015

The Honorable Ron Johnson

Chairman

The Honorable Thomas R. Carper

Ranking Member

Committee on Homeland Security and Governmental Affairs

United States Senate

The Honorable Susan M. Collins

Chairman

Special Committee on Aging

United States Senate

Dementia affected almost 15 percent of older adults in the United States 

in 2010, according to an estimate from the RAND Corporation.1 RAND 

estimated that the total monetary cost for caring for individuals with 

dementia was between $157 billion and $215 billion, of which the 

Medicare program paid around $11 billion.2

 

1

This estimate applies to adults aged 71 and older. See Michael D. Hurd, et. al, “Monetary 

Costs of Dementia in the United States,” New England Journal of Medicine, vol. 368, 

no. 14 (2013).

Furthermore, RAND 

estimated that dementia costs will more than double by 2040 due to the 

aging of the American population. While dementia is most commonly 

associated with a decline in memory, it can also cause changes in mood 

or personality, loss of communication, and, at times, agitation or 

aggression. These behavioral symptoms can become challenging for 

caregivers, both at home and in institutions such as nursing homes. To 

manage these behaviors, antipsychotic drugs are sometimes prescribed. 

Although experts indicate that an appropriate rate of prescribing of 

antipsychotic drugs cannot be determined given that the clinical decision 

to prescribe antipsychotics is based on individual patient factors, many 

Dementia is not a specific illness, but a term that describes symptoms including memory 

decline. Specific types of dementia, and diseases that can cause dementia, include 

Alzheimer’s disease (the most common type), vascular dementia, and Parkinson’s 

disease dementias.

2

Monetary costs include out-of-pocket spending, Medicare spending, nursing home 

spending, and costs of in-home care. The higher estimate includes forgone wages from 

informal, unpaid care.
 

Page 2 GAO-15-211 Antipsychotic Drugs and Older Adults

believe that prescribing rates for these drugs, particularly for nursing 

home residents with dementia, have been too high.

Concerns have been raised about the use of antipsychotic drugs to 

address behavioral symptoms—such as agitation or aggression—in older 

adults. While a large proportion of prescriptions for antipsychotic drugs in 

this population are used to treat behavioral symptoms, these drugs are 

not approved for this use, and antipsychotic drugs have health risks.3 In 

2011, the Department of Health and Human Services (HHS) Office of 

Inspector General (OIG) reported that a large percentage—88 percent—

of a 2007 sample of 1.4 million Medicare claims for newer antipsychotic 

drugs for older adult nursing home residents was associated with a 

dementia diagnosis. The Food and Drug Administration (FDA)—tasked 

with approving drugs to be marketed in the United States—has not 

approved these drugs to treat the behavioral symptoms of dementia, 

although it has generally approved antipsychotic drugs to treat 

schizophrenia and bipolar disorder.4 Furthermore, these drugs have been 

found to cause falls and other adverse events, including an increased risk 

of death, among older adults with a diagnosis of dementia.5 All 

antipsychotic drugs carry an FDA-required boxed warning stating that 

they are associated with an increased risk of death when used to treat 

older adults with dementia-related psychosis.6

 

3

We define older adults as those around the age of 65 and older.

Physicians are not 

prohibited from prescribing antipsychotic drugs in the presence of 

dementia despite the boxed warning, nor are they prohibited generally 

from prescribing a drug for uses other than what the FDA has approved. 

Otherwise known as off-label prescribing, this practice is common in the 

4

Certain antipsychotic drugs are also FDA-approved for the treatment of Tourette

syndrome and adjunct treatment of major depressive disorder.

5

When the FDA or drug manufacturers determine that a drug may lead to death or serious 

injury when used in certain situations, FDA may require that the product’s label include a 

boxed warning.

6

Psychosis is characterized by a loss of touch with reality and can be expressed through 

delusions and hallucinations. While the boxed warning is specific to dementia-related 

psychosis, antipsychotic drugs are often used to treat other behavioral symptoms of 

dementia. For the purposes of our report, we examine antipsychotic use among older 

adults with dementia, broadly.
 

Page 3 GAO-15-211 Antipsychotic Drugs and Older Adults

United States, and Medicare Part D covers drugs prescribed off-label in 

some cases.7

Less is known about antipsychotic prescribing in settings outside of the 

nursing home, but one study estimated that out of a sample of older 

adults with dementia living outside of a nursing home, close to one in five 

took an antipsychotic between 2002 and 2004.8 The federal government 

has an interest in improving dementia care for individuals living both 

inside and outside nursing homes. The National Alzheimer’s Project Act,

enacted in January 2011, required HHS to establish the National 

Alzheimer’s Project to create and maintain an integrated plan to 

overcome Alzheimer’s disease, including related dementias.9 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.10

You asked us to examine psychotropic drug prescribing for older adult 

nursing home residents. In this report, we examine (1) to what extent 

antipsychotic drugs are prescribed for older adults with dementia living in 

and outside of nursing homes and what Medicare Part D plans paid for 

these drugs; (2) what is known from selected experts and published 

 

7

Medicare Part D is an optional outpatient prescription drug benefit offered by Medicare—

the federally financed health insurance program for persons aged 65 and over, individuals 

under age 65 with certain disabilities, and individuals with end-stage renal disease 

administered by HHS’s Centers for Medicare & Medicaid Services (CMS). CMS contracts 

with private companies—plan sponsors—to provide benefits under Medicare Part D. 

Antipsychotic drugs—a type of psychotropic drug—are also sometimes paid for through 

Medicare Parts A (hospital benefit) and B (physician office benefit).

Medicare Part D reimbursement criteria require that drugs be used for medically accepted 

conditions; this includes FDA-approved conditions as well as conditions, which may or 

may not be off-label, supported by three specific medical compendia: the American 

Hospital Formulary Service Drug Information, the United States Pharmacopaiea-Drug 

Information, and the DrugDEX Information System. 

8

Y. Rhee, J. G. Cernansky, L. L. Emanuel, C. G. Chang, and J. W. Shega, “Psychotropic 

Medication Burden and Factors Associated with Antipsychotic Use: An Analysis of a 

Population-Based Sample of Community-Dwelling Older Persons with Dementia,” Journal 

of the American Geriatrics Society, vol. 59, no. 11 (2011).

9

Pub. L. No. 111-375, § 2(d)(2), 124 Stat. 4100 (Jan. 4, 2011).

10While the National Alzheimer’s Plan specifically mentions Alzheimer’s disease, it also 

addresses related dementias, as required under the act. The National Alzheimer’s Plan is 

updated annually.
 

Page 4 GAO-15-211 Antipsychotic Drugs and Older Adults

research about factors contributing to the prescribing of antipsychotic 

drugs to older adults with dementia; and (3) to what extent HHS has 

taken action to reduce the use of antipsychotic drugs in older adults with 

dementia.

To estimate the extent to which older adults residing inside and outside of 

nursing homes are prescribed antipsychotic drugs, we first analyzed 

Medicare Part D Prescription Drug Event (PDE) data for individuals with 

dementia in 2012.11 We used the Medicare Part D PDE data because 

Medicare is the primary source of insurance coverage for individuals over 

the age of 65, and approximately 63 percent of Medicare beneficiaries 

were enrolled in Medicare Part D in 2012. To identify individuals living in 

nursing homes, we combined the PDE claims data with 2012 data from 

the Long Term Care Minimum Data Set (MDS),12 which includes nursing 

home assessments for all individuals living in nursing homes, regardless 

of insurance coverage. We also used data from the Medicare Master 

Beneficiary Summary File (MBSF),13 as well as the Medicare Part D Risk 

File to identify diagnoses, including dementia diagnoses and diagnoses 

for certain conditions for which FDA has approved the use of 

antipsychotics drugs.14

 

11The PDE data contain pharmacy claims for all prescription drugs dispensed to Medicare 

Part D beneficiaries. 

We excluded from our estimates individuals with 

dementia also diagnosed with one of these FDA-approved conditions for 

antipsychotic drugs—schizophrenia and bipolar disorder. We define an 

individual as having been prescribed an antipsychotic drug if they were 

prescribed at least one prescription for an antipsychotic drug during the 

year, regardless of how many days’ supply are covered by the 

prescription. Within the nursing home population, our analysis of PDE 

claims specifically identified those with a long stay in the nursing home—

We define locations outside of the nursing home as any location an individual may reside 

that it is not a nursing home. This may include assisted living facilities or an individual’s 

home.

12The MDS contains information from nursing-home resident assessments for all 

Medicare or Medicaid certified nursing homes, regardless of payer. In 2012, over 15,600 

nursing homes were Medicare and Medicaid certified and included in the MDS. Medicaid 

is the joint federal-state program that finances health care for low-income individuals.

13MBSF includes data on enrollment, spending, and use of services for all Medicare 

beneficiaries.

14The Medicare Part D Risk File contains enrollee information such as age, gender, and 

diagnoses from the previous year.
 

Page 5 GAO-15-211 Antipsychotic Drugs and Older Adults

defined by the Centers for Medicare & Medicaid Services (CMS) as more 

than 100 days—because drugs for individuals with short stays—100 days 

or less—are generally covered under Medicare Part A, not Part D. We 

identified antipsychotic prescriptions in the PDE claims data by examining 

relevant national drug codes (NDC) using a list of generic names for 

antipsychotic drugs.15

To supplement our analysis of the Medicare Part D data for the nursing 

home population, we also analyzed data on antipsychotic prescribing and 

diagnoses among nursing home residents available in the MDS. This 

allowed us to look at a more comprehensive population of nursing home 

residents—all residents in a Medicare or Medicaid certified nursing 

home—and to examine prescribing rates by length of stay.

We disaggregated the data to examine certain 

characteristics, such as gender, age, and geographic location.

16 For this 

analysis, we determined an individual was prescribed an antipsychotic 

drug if any nursing home assessment during 2012 indicated the resident 

took an antipsychotic drug during the previous 7 days. In addition to 

excluding residents with dementia also diagnosed with schizophrenia and 

bipolar disorder, we also excluded residents with Tourette syndrome, a 

condition for which FDA has approved the use of certain antipsychotics, 

as well as Huntington’s disease, a condition for which CMS guidance has 

recognized antipsychotics as an acceptable treatment.17

To identify what Medicare Part D plans paid for antipsychotic drugs 

prescribed to older adults with dementia in 2012, we identified individuals 

with dementia using the Medicare Part D Risk File, and calculated plan 

payments for those enrollees using the PDE claims data. We also 

calculated plan payments for the most commonly prescribed antipsychotic 

drugs, and used the National Plan and Provider Enumeration System 

(NPPES) to identify the breakdown of prescriber specialties listed on 

Individuals 

with dementia and at least one of these diagnoses accounted for about 

7 percent of nursing home residents with dementia overall.

 

15NDCs uniquely identify specific drug products for a given manufacturer.

16Nearly all of the 15,700 nursing homes providing long term care services in the United 

States participated in the Medicare and Medicaid programs in 2012.

17We were unable to exclude Medicare Part D enrollees with Tourette syndrome and 

Huntington’s disease for the Medicare PDE analysis because the Medicare Part D Risk 

File does not contain information on whether an enrollee has been diagnosed with these 

conditions.
 

Page 6 GAO-15-211 Antipsychotic Drugs and Older Adults

antipsychotic drug claims under Medicare Part D in 2012 to calculate the 

share of plan payments for prescriptions from the specialties with the 

most antipsychotic prescribing for individuals with dementia.18

We ensured the reliability of the MDS data, Medicare PDE claims data, 

Medicare Part D Risk File data, MBSF data, and NPPES data used in this 

report by performing appropriate electronic data checks, reviewing 

relevant documentation, and interviewing officials and representatives 

knowledgeable about the data, where necessary. We found the data were 

sufficiently reliable for the purpose of our analyses.

For more 

details on the data analyses, see appendix I.

To examine what is known from selected experts and published research 

about factors contributing to the prescribing of antipsychotic drugs to 

older adults with dementia, we interviewed experts in the field of dementia 

care and conducted a literature review. We used a snowball sampling 

approach to identify industry, provider, and advocacy groups, as well as 

research experts, with experience or work on the subject of antipsychotic 

drug use among older adults. We interviewed two to five groups within 

each category of expert groups and asked them about contributing 

factors. We also conducted a literature review to identify original research 

on factors associated with prescribing antipsychotic drugs to older adults. 

We searched for relevant articles published in peer-reviewed journals 

from January 2009 through March 2014 and excluded international 

research. We also included articles published within our timeframe that 

were identified through our interviews. We found a total of 42 articles that 

met our inclusion criteria; after reviewing those articles, we found 

contributing factors cited in 18 articles. For more details on the literature 

review and a list of the articles identified, see appendix II.

To identify the extent to which HHS has taken action to reduce 

prescribing of antipsychotic drugs to older adults, we spoke with officials 

from agencies within HHS, including CMS, FDA, the Administration for 

Community Living (ACL),19

 

18NPPES is a list of all Medicare providers, including unique provider identifiers, 

maintained by CMS.

the National Institutes of Health’s (NIH) 

19ACL was created in 2012 to bring together key HHS organizations and offices—the 

Administration on Aging, the Office on Disability, and the Administration on Developmental 

Disabilities—into a single agency to provide support for individuals in the community with 

functional needs, such as seniors with dementia. 
 

Page 7 GAO-15-211 Antipsychotic Drugs and Older Adults

National Institute on Aging and National Institute of Mental Health, and 

the Agency for Healthcare Research and Quality (AHRQ). We also 

reviewed relevant federal regulations, CMS nursing home guidance,

agency Web pages, and other federal documents, such as the National 

Alzheimer’s Plan. 

We conducted this performance audit from January 2014 through January 

2015 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

Antipsychotic drugs are classified into two sub-groups. The first group, or 

generation, of antipsychotic drugs—also known as “conventional” or 

“typical” antipsychotic drugs—was developed in the mid-1950s. Examples 

include haloperidol (Haldol®) and loxapine (Loxitane®). The second 

generation of antipsychotic drugs, known as “atypical” antipsychotics, was 

developed in the 1980s. Examples include aripiprazole (Abilify®) and 

risperidone (Risperdal®). Atypical antipsychotics became more popular 

upon their entry into the market due to the initial belief that these drugs 

caused fewer side effects than the conventional antipsychotics. Each 

antipsychotic drug has its own set of FDA-approved indications.20

 

20FDA-approved indications may include, for example, use of a drug to treat a particular 

diagnosed condition, or symptom, in specific populations and under certain conditions.

The 

vast majority of antipsychotic drugs are FDA-approved for the treatment 

of schizophrenia, and most atypical antipsychotic drugs are FDAapproved for the treatment of bipolar disorder. In addition, some 

antipsychotics are FDA-approved for the treatment of Tourette syndrome. 

CMS guidance to state nursing home surveyors also recognizes 

antipsychotics as an acceptable treatment for conditions for which the 

drugs have not been FDA-approved, such as for the treatment of 

Huntington’s disease.

Background

Antipsychotic Drug 

Classification and FDAApproved Uses
 

Page 8 GAO-15-211 Antipsychotic Drugs and Older Adults

In 2005, FDA recognized the risks associated with atypical antipsychotic 

drugs and required those drugs to have a boxed warning, citing a higher 

risk of death related to use among those with dementia. In 2008, FDA 

recognized similar risks for conventional antipsychotic drugs and required 

the same boxed warning. Besides the risks described in the boxed 

warning, use of antipsychotic drugs carries risks of other side effects, 

such as sedation, hypotension, movement disorders, and metabolic 

syndrome issues. 

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 to others.21 For 

example, AMDA–The Society for Post-Acute and Long-Term Care 

Medicine suggests first assessing the scope and severity of the behavior 

and identifying any environmental triggers for the behavior. A medical 

evaluation may determine whether the behavioral symptoms are 

associated with another medical condition, such as under-treated arthritis 

pain or constipation. In its clinical guideline, AMDA cited conflicting 

evidence surrounding the effectiveness of antipsychotic drugs in treating 

the behavioral symptoms of dementia.22

Other non-pharmacological interventions that can be attempted prior to 

the use of antipsychotic drugs may focus on emotions, sensory 

It noted one evidence review that 

found significant improvement in symptoms with the treatment of certain 

atypical antipsychotic drugs, but also noted that other reviews signaled 

there were no significant differences attributable to atypical antipsychotic 

drugs.

 

21See American Psychiatric Association, Practice Guideline for the Treatment of Patients 

With Alzheimer’s Disease and Other Dementias (October 2007); American Geriatrics 

Society, “Updated Beers Criteria for Potentially Inappropriate Medication Use in Older 

Adults,” Journal of the American Geriatrics Society, vol. 60, no. 4 (2012); and American 

Medical Directors Association, Excerpts from the Dementia in the Long Term Care Setting 

Clinical Practice Guideline: American Medical Directors Association (Columbia, Md.:

2012).

22American Medical Directors Association, Excerpts from the Dementia in the Long Term 

Care Setting Clinical Practice Guideline. 

Treatment Approaches for 

Behavioral Symptoms of 

Dementia
 

Page 9 GAO-15-211 Antipsychotic Drugs and Older Adults

stimulation, behavior management, or other psychosocial factors.23 An 

example of an emotion-oriented approach is Reminiscence Therapy, 

which involves the recollection of past experiences through old materials 

with the intention of enhancing group interaction and reducing 

depression. An example of a sensory stimulation approach is Snoezelen 

Therapy, which typically involves introducing the individual to a room full 

of objects designed to stimulate multiple senses, including sight, hearing, 

touch, taste, and smell. This intervention is based on the theory that 

behavioral symptoms may stem from sensory deprivation. A 2012 white 

paper published by the Alliance for Aging Research and the 

Administration on Aging, a part of the ACL, noted that advancements 

have been made with regards to the evidence base supporting some nonpharmacological interventions, but that evidence-based interventions are 

not widely implemented.24 Experts referenced in the white paper identified 

the need for clearer information about the interventions, such as a system 

to classify what interventions exist and who might benefit from those 

interventions. Experts also noted that additional research is needed to 

develop effective interventions.

Federal law requires nursing homes to meet federal quality and safety 

standards, set by CMS, to participate in the Medicare and Medicaid 

programs. CMS regulations require nursing homes to ensure that 

residents’ drug therapy regimens are free from unnecessary drugs, such 

as medications provided in excessive doses, for excessive durations, or 

without adequate indications for use.25

 

23See Department of Veterans Affairs Health Services Research & Development Service, 

A Systematic Evidence Review of Non-pharmacological Interventions for Behavioral 

Symptoms of Dementia (Washington, D.C.: March 2011).

Nursing facility staff must assess 

each resident’s functional capacity upon admission to the facility and 

24K. Maslow, Translating Innovation to Impact: Evidence-Based Interventions to Support 

People with Alzheimer’s Disease and Their Caregivers at Home and in the Community, a 

report prepared at the request of the Alliance for Aging Research, the Administration on 

Aging, and MetLife Foundation (Washington, D.C.: The Alliance for Aging Research, 

September 2012).

2542 C.F.R. § 483.25(l). Federal law also requires that nursing homes protect and promote 

residents’ rights to be free from chemical restraints, defined as any drug used for 

discipline or convenience and not required to treat the resident’s medical symptoms. 

42 U.S.C. § 1395i-3(c)(1)(A)(ii). 

Federal Nursing Home 

Standards and 

Regulations
 

Page 10 GAO-15-211 Antipsychotic Drugs and Older Adults

periodically thereafter, and provide each resident a written care plan.26

Based on these assessments, nursing homes must ensure that 

antipsychotics are prescribed only when necessary to treat a specific 

condition diagnosed and documented in the patient’s record, and that

residents who use antipsychotic drugs receive gradual dose reductions 

and behavioral interventions, unless clinically contraindicated. Part of the 

nursing home survey process, otherwise known as nursing home 

inspections, involves audits of these care plans and assessments.27

About one-third of older adult Medicare Part D enrollees with dementia 

who spent over 100 days in a nursing home were prescribed an 

antipsychotic drug in 2012. Among those Medicare Part D enrollees with 

dementia who spent no time in a nursing home in 2012, we found that 

about 14 percent were prescribed an antipsychotic. In total, Medicare 

Part D plans paid roughly $363 million in 2012 for antipsychotic drugs 

prescribed for older adult Medicare Part D enrollees with dementia.

 

26In addition to any other requirements a state may have established, it must operate a 

Preadmission Screening and Resident Review (PASRR) program, approved by CMS as 

part of its state Medicaid plan, that provides for the evaluation of all individuals with 

serious mental illness who apply to reside in Medicaid certified nursing homes. According 

to CMS, if PASRR recommends that a nursing home is the appropriate setting, necessary 

treatment, such as antipsychotic drugs, should be specifically listed on the PASRR 

recommendations. If an individual does not have a PASRR recommendation for 

antipsychotic drugs, additional scrutiny may be triggered if an antipsychotic drug is 

prescribed.

27All nursing homes that participate in the Medicare and Medicaid programs are subject to 

periodic surveys to ensure that they are in compliance with federal quality standards. CMS 

contracts with state survey agencies to conduct the surveys. Surveys must include an 

adequate number of residents with dementia who are receiving an antipsychotic drug.

Approximately 

33 Percent of Older 

Adult Medicare Part D 

Enrollees with 

Dementia Who 

Resided in a Nursing 

Home, and 

14 Percent Outside of 

a Nursing Home, 

Were Prescribed 

Antipsychotic Drugs 

in 2012
 

Page 11 GAO-15-211 Antipsychotic Drugs and Older Adults

We found that about 33 percent of Medicare beneficiaries with dementia 

who were enrolled in a Part D plan and had a long stay in a nursing 

home—defined as over 100 cumulative days—were prescribed an 

antipsychotic in 2012.28

• Male enrollees were slightly more likely to have been prescribed 

an antipsychotic drug than female enrollees—about 36 percent and 

32 percent, respectively.

(See table 1.) We also found that prescribing 

rates for Medicare Part D enrollees with dementia who were nursing 

home residents varied somewhat by resident characteristic:

• The prescribing rate declined as Medicare Part D enrollee age 

increased. For example, about 41 percent of those Medicare Part D 

enrollees aged 66 to 74 received an antipsychotic prescription, 

compared to 29 percent of those enrollees aged 85 and older who 

were prescribed an antipsychotic drug.

• The prescribing rate for antipsychotic drugs was highest for enrollees 

in the South, and lowest for enrollees in the West.

 

28Medicare Part D prescriptions for short-stay nursing home enrollees—enrollees with 

100 days or less in the nursing home—may be low because often Medicare Part A covers 

drugs administered during short, post-acute stays in nursing homes.

Roughly One-third of 

Older Adult Nursing Home 

Residents with Dementia 

Were Prescribed an 

Antipsychotic Drug in 2012
 

Page 12 GAO-15-211 Antipsychotic Drugs and Older Adults

Table 1: Number and Percent of Older Adult Medicare Part D Enrollees Diagnosed 

with Dementia Who Had a Long Stay in a Nursing Home and Were Prescribed an 

Antipsychotic in 2012, by Characteristic

Enrollees with dementia in the long-stay 

nursing home settinga

Number without 

antipsychotic 

prescription

Number with 

antipsychotic 

prescription

Percent with 

antipsychotic 

prescription

Total 268,486 131,480 33%

Gender Female 206,215 95,911 32

Male 62,271 35,569 36

Age 66-74 28,888 19,842 41

75-84 89,131 51,014 36

85+ 150,467 60,624 29

Census location Midwest 73,906 33,743 31

Northeast 68,648 31,120 31

South 93,026 52,938 36

West 32,906 13,679 29

Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) Medicare Part D data. | GAO-15-211

Notes: Percentages are rounded to the nearest whole number. 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. Enrollees are considered as having dementia if one of the 

following diagnoses were present in the 2012 Medicare Part D Risk File: a general dementia 

diagnosis, a diagnosis of Alzheimer’s disease, or a diagnosis of Parkinson’s disease.

a

We found slightly lower rates of antipsychotic drug prescribing when we 

restricted our analysis to those enrollees with three or more 30-day 

supply prescriptions during 2012. Specifically, about 28 percent of longstay Medicare Part D enrollees with dementia were given three or more 

30-day supply prescriptions for an antipsychotic drug over the course of 

2012. We also found that the majority of prescriptions given to those longstay Medicare Part D enrollees with dementia—about 68 percent—were 

for seven or more 30-day supplies of the drug, while only 3 percent were 

for less than one 30-day supply.

If a Medicare Part D enrollee had a nursing home stay that was longer than 100 days, they were 

considered a long-stay nursing home enrollee; data on all other enrollees with shorter stays in nursing 

homes are not included in this table.
 

Page 13 GAO-15-211 Antipsychotic Drugs and Older Adults

Consistent with the findings for Medicare Part D enrollees, our analysis of 

MDS data showed that approximately 30 percent of all older adult nursing 

home residents—regardless of enrollment in Medicare Part D—with a 

dementia diagnosis were prescribed an antipsychotic drug at some point 

during their 2012 nursing home stay.29

Figure 1: Proportion of Older Adult Nursing Home Residents Diagnosed with 

Dementia Who Were Prescribed an Antipsychotic in 2012

(See fig. 1.) Residents with 

dementia accounted for a significant proportion of all nursing home 

residents. In 2012, about 38 percent, or almost 1.1 million of the 

2.8 million nursing home residents that year, were diagnosed with 

dementia.

Notes: 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.

a

 

29To examine this more comprehensive population of nursing home residents, we 

identified prescribing rates based on nursing home assessments through the MDS.

A resident 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.
 

Page 14 GAO-15-211 Antipsychotic Drugs and Older Adults

Examining this more comprehensive database of nursing home residents 

also allowed us to compare the antipsychotic drug prescribing rates of 

long-stay residents and short-stay residents—those residents who spent 

100 days or less in the nursing home. The proportion of residents 

diagnosed with dementia who were prescribed an antipsychotic drug 

was greater for long-stay residents than for short-stay residents (about 

33 percent versus 23 percent, respectively). (See table 2.) Variation in 

prescribing rates across resident characteristics was similar to the 

variation found in the Medicare Part D enrollee long-stay nursing home 

population.

Table 2: Antipsychotic Drug Prescribing among Older Adult Nursing Home 

Residents with a Dementia Diagnosis, 2012

Residents with dementiaa

Number without 

antipsychotic 

prescription

Number with 

antipsychotic 

prescription

Percent with 

antipsychotic 

prescription

All 741,926 313,311 30%

Length of stay Short stay b 285,570 86,471 23

Long stay 456,356 226,840 33

Gender Female 520,729 208,516 29

Male 221,145 104,785 32

Age 65-74 75,251 43,080 37

75-84 240,158 115,043 32

85+ 429,247 155,188 27

Census location Midwest 199,391 77,804 28

Northeast 177,365 72,313 29

South 259,121 126,145 33

West 106,049 37,049 26

Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) nursing home assessment data. | GAO-15-211

Notes: 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.

a

A resident 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.
 

Page 15 GAO-15-211 Antipsychotic Drugs and Older Adults

b

If a resident had a nursing home stay that was longer than 100 days, they were considered a longstay resident; all other residents were considered short-stay residents.

Of those Medicare Part D enrollees with dementia in settings outside of 

the nursing home, about one in seven (14 percent) were prescribed an 

antipsychotic. (See fig. 2.) Roughly 1.2 million of the 20.2 million older 

adult Medicare Part D enrollees living outside of a nursing home in 2012 

had a diagnosis of dementia—just above 6 percent.

Figure 2: Proportion of Older Adult Medicare Part D Enrollees Outside of the 

Nursing Home Diagnosed with Dementia Who Were Prescribed an Antipsychotic in 

2012

Notes: 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.

a

Enrollees are considered as having dementia if one of the following diagnoses were present in the 

2012 Medicare Part D Risk File: a general dementia diagnosis, a diagnosis of Alzheimer’s disease, or 

a diagnosis of Parkinson’s disease.

One in Seven Older Adult 

Medicare Part D Enrollees 

with Dementia Living 

Outside of Nursing Homes 

Were Prescribed an 

Antipsychotic Drug in 2012
 

Page 16 GAO-15-211 Antipsychotic Drugs and Older Adults

The rate of antipsychotic drug prescribing among older adult Medicare 

Part D enrollees with dementia was lower for those living outside of 

nursing homes, compared to those living in nursing homes, given that 

residents of nursing homes are generally sicker than those living outside 

of nursing homes. We also found that the pattern of variation in 

antipsychotic drug prescribing for Medicare Part D enrollees outside of a 

nursing home for certain characteristics was different from the pattern of 

variation found in the nursing home population.

• The proportion of Medicare Part D enrollees outside of nursing homes 

diagnosed with dementia who were prescribed an antipsychotic drug 

was higher for older enrollees—the opposite of the pattern found in 

the nursing home setting. (See table 3.)

• The prescribing rate was also higher for female enrollees outside of 

the nursing home than for male enrollees, whereas the opposite was 

true in the nursing home setting.

• The prescribing rate for enrollees with dementia outside of the nursing 

home changed less depending on enrollee location than those in 

nursing homes.
 

Page 17 GAO-15-211 Antipsychotic Drugs and Older Adults

Table 3: Number and Percent of Older Adult Medicare Part D Enrollees Diagnosed 

with Dementia Who Spent No Time in a Nursing Home and Were Prescribed an 

Antipsychotic in 2012, by Characteristic

Enrollees with dementia outside of the nursing 

home setting

Number without 

antipsychotic 

prescription

Number with 

antipsychotic 

prescription

Percent with 

antipsychotic 

prescription

Total 1,056,433 170,286 14%

Gender Female 677,304 119,779 15

Male 379,129 50,507 12

Age 66-74 238,542 33,328 12

75-84 468,323 73,171 14

85+ 349,568 63,787 15

Census location Midwest 225,473 30,913 12

Northeast 204,389 34,316 14

South 384,800 65,196 15

West 241,771 39,861 14

Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) Medicare Part D data. | GAO-15-211

Notes: Percentages are rounded to the nearest whole number. 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. Enrollees are considered as having dementia if one of the 

following diagnoses were present in the 2012 Medicare Part D Risk File: a general dementia 

diagnosis, a diagnosis of Alzheimer’s disease, or a diagnosis of Parkinson’s disease.

We found slightly lower rates of antipsychotic drug prescribing for 

Medicare Part D enrollees outside of the nursing home when we 

restricted our analysis to those enrollees with three or more 30-day 

supply prescriptions. Specifically, about 11 percent of enrollees outside of 

the nursing home received three or more prescriptions for antipsychotic 

drugs over the course of 2012. About 58 percent of antipsychotic 

prescriptions for Medicare Part D enrollees with dementia living outside of 

a nursing home were for seven or more 30-day supplies of the drug, while 

only 3 percent were for less than a 30-day supply.
 

Page 18 GAO-15-211 Antipsychotic Drugs and Older Adults

Medicare Part D plans paid roughly $363 million in 2012 for antipsychotic 

drugs used by Medicare Part D enrollees with dementia aged 66 and 

older.30 (See table 4.) Medicare Part D spending on antipsychotic drugs 

for Medicare Part D enrollees living outside of a nursing home with a 

dementia diagnosis totaled almost $171 million in 2012, the same as 

spending for long-stay nursing home enrollees with dementia. Payments 

for short-stay nursing home enrollees may be low because often 

Medicare Part A covers drugs administered during short, post-acute stays 

in nursing homes. Medicare Part D plans consistently spent more than 

double on antipsychotic prescriptions for female enrollees than for male 

enrollees; as reported in table 1, the number of female Medicare Part D 

enrollees using antipsychotic drugs was also over two times that of 

males.

 

30Medicare Part D plans paid almost $1.2 billion in 2012 for antipsychotic drugs used by 

Medicare Part D enrollees aged 66 and older, regardless of dementia diagnosis. We 

excluded new enrollees, including all 65-year-olds, because the Medicare Part D Risk File 

did not have diagnostic data for these groups.

Medicare Part D Plan 

Payments for 

Antipsychotic Drugs 

Prescribed to Older Adult 

Enrollees with Dementia 

Totaled $363 Million in 

2012
 

Page 19 GAO-15-211 Antipsychotic Drugs and Older Adults

Table 4: Medicare Part D Plan Payments for Older Adult Enrollees Who Used an Antipsychotic in 2012, by Setting and 

Diagnosis Category

In millions

Enrollees in the long-stay 

nursing home settinga Enrollees outside of the nursing home setting

Total, including short-stay 

nursing home

Total spending

on antipsychotic 

drugs

Enrollees 

with 

dementiab

Total spending 

on antipsychotic 

drugs

Enrollees 

with 

dementia

Total spending 

on antipsychotic 

drugs

Enrollees 

with 

dementia

All $367 $171 $748 $171 $1,185 $363

Gender Female 259 124 521 122 830 261

Male 109 47 227 49 356 102

Age 66-74 132 34 446 44 611 83

75-84 138 69 210 72 373 151

85+ 97 68 91 55 201 130

Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) Medicare Part D data. | GAO-15-211

Notes: 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. Diagnostic information was identified using Medicare Part D Risk File data, and 

includes only diagnoses from the previous year.

a

If a Medicare Part D enrollee had a nursing home stay that was longer than 100 days, they were 

considered a long-stay nursing home enrollee; all other enrollees who spent time in a nursing home 

were considered short-stay enrollees.

b

Internal medicine, family medicine, and psychiatry or neurology 

physicians prescribed the greatest proportion of antipsychotic drug 

prescriptions for older adult Medicare Part D enrollees with dementia—

about 82 percent in total. Antipsychotic drugs prescribed by these 

specialties also made up about 82 percent of the Medicare Part D plan 

payments for antipsychotic drugs—almost $298 million in plan payments. 

Antipsychotic prescriptions from internal medicine physicians comprised 

36 percent of Medicare Part D plan payments for antipsychotic drugs, 

while family medicine and psychiatry or neurology prescriptions 

comprised about 30 and 16 percent, respectively. Nurse practitioner and 

Enrollees are considered as having dementia if one of the following diagnoses were present in the 

2012 Medicare Part D Risk File: a general dementia diagnosis, a diagnosis of Alzheimer’s disease, or 

a diagnosis of Parkinson’s disease. For this dementia-specific calculation, we 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.
 

Page 20 GAO-15-211 Antipsychotic Drugs and Older Adults

physician assistant prescriptions collectively accounted for almost 

5 percent of antipsychotic drug claim payments, while the remaining 

13 percent encompassed many specialties.31

Quetiapine Fumarate, Risperidone, and Olanzapine were the most 

commonly prescribed antipsychotic drugs for older adult Medicare Part D 

enrollees with dementia in 2012, comprising approximately $246 million in 

plan payments. (See table 5.) Haloperidol and Aripiprazole were also 

commonly prescribed; these two drugs were prescribed to almost 9 and 

6 percent of Medicare Part D enrollees with dementia, respectively.

Table 5: Number and Percent of Older Adult Medicare Part D Enrollees with 

Dementia and Antipsychotic Drug Prescriptions, and Medicare Part D Plan 

Payments for Those Prescriptions in 2012, by Antipsychotic Drug

Antipsychotic drug Number Percent Payments in millions

Quetiapine Fumarate* 146,868 48.7% $158

Risperidone* 100,108 33.2 24

Olanzapine* 38,458 12.7 64

Haloperidol 26,761 8.9 1 

Aripiprazole* 18,015 6.0 80

Ziprasidone HCL* 5,031 1.7 10

All Other 9,270 3.0 5 

Source: GAO analysis of Centers for Medicare & Medicaid Services (CMS) Medicare Part D data. | GAO-15-211

*denotes atypical antipsychotic drugs

Notes: Percentages are rounded to the nearest tenth of a percent and do not add up to 100, 

suggesting that some enrollees had prescriptions for multiple antipsychotic drugs. Enrollees 

outside of the 50 states and the District of Columbia were excluded, as were enrollees with less than 

12 months of 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. Enrollees are considered as having dementia if 

one of the following diagnoses were present in the 2012 Medicare Part D Risk File: a general 

dementia diagnosis, a diagnosis of Alzheimer’s disease, or a diagnosis of Parkinson’s disease. This 

table does not include prescriptions for enrollees with a short stay in the nursing home because 

prescriptions during a short stay may be covered by Medicare Part A.

 

31About 5 percent of prescriptions contained a provider identifier that did not match with 

the NPPES data, and 1 percent of prescriptions contained a provider identifier for which 

the taxonomy code listed did not match a taxonomy code listed by the Washington 

Publishing Company, the creator of healthcare provider taxonomy codes.
 

Page 21 GAO-15-211 Antipsychotic Drugs and Older Adults

Experts we spoke with and research we reviewed commonly identified 

certain factors that are specific to the patient that contribute to 

antipsychotic prescribing, such as patient agitation or delusions. Experts 

and research also identified certain contributing factors that are specific to 

settings, such as to nursing homes or hospitals.

The majority of experts we spoke with and some research articles we 

reviewed highlighted agitation, aggression, or exhibiting a risk to oneself 

or others as factors that contribute to the decision to prescribe 

antipsychotics. For example, in a study examining the MDS from 1999 to 

2006 in eight states, 51 percent of aggressive nursing home residents 

diagnosed with dementia were prescribed antipsychotic drugs in 2006, as 

opposed to 39 percent of residents with behavioral symptoms but who 

were not aggressive during that same time period.32

Many experts we interviewed identified other situations that may warrant 

the use of antipsychotics despite their risk, such as patients experiencing 

frightening delusions or hallucinations that cause the patient to act out in 

ways that may be violent or harmful. Several experts noted that 

individuals experiencing these psychotic and other behaviors may be 

suffering from distress and are more likely to be prescribed antipsychotic 

The study suggested 

that aggressive residents may have been more likely to be prescribed 

antipsychotics because of the greater risk of injury associated with the 

aggressive behavior. This is consistent with findings from our analysis of 

nursing home assessment data; we found that, of residents diagnosed 

with dementia and documented as being a risk to themselves or others, 

61 percent had an antipsychotic drug prescription in 2012.

 

32S. Crystal, M. Olfson, C. Huang, H. Pincus, and T. Gerhard, “Broadened Use of Atypical 

Antipsychotics: Safety, Effectiveness, and Policy Challenges,” Health Affairs, vol. 28, no. 5 

(2009).

Experts and 

Research Commonly 

Cited Certain Patient 

and Setting-Specific 

Factors Contributing 

to the Prescribing of 

Antipsychotic Drugs 

to Older Adults

Experts and Research 

Identified Patient-Specific 

Factors, Such As Agitation 

or Delusions, That 

Contribute to the Decision 

to Prescribe Antipsychotic 

Drugs
 

Page 22 GAO-15-211 Antipsychotic Drugs and Older Adults

drugs to ease their distress and improve their quality of life.33 For 

example, individuals may injure themselves or strike another resident or 

staff member because of delusions that these people intend to kill them. 

A few research articles identified psychotic behaviors as a contributing 

factor. For instance, one study that examined medical records of more 

than 200 nursing home residents with dementia found that 47 percent of 

residents who were on an antipsychotic also had a diagnosis of 

psychosis.34

The research we reviewed also cited other specific patient characteristics 

associated with higher antipsychotic use in dementia patients. Patient 

characteristics such as age, gender, race or ethnicity, and psychiatric 

diagnoses were associated with higher antipsychotic prescribing in 

several articles. For example, in one study of nursing home assessments 

and Medicaid drug claims from seven states, researchers found that 

nursing home residents with psychiatric co-morbidities, such as anxiety 

and depression without psychosis, were more likely to be prescribed 

antipsychotic drugs.

 

35 Male gender was also mentioned as a patient 

characteristic associated with higher antipsychotic prescribing in three 

research articles.36

 

33Psychotic behaviors may be associated with multiple conditions, including schizophrenia 

or dementia. Antipsychotic drugs are FDA-approved for the treatment of schizophrenia but 

not approved for the treatment of behavioral symptoms of dementia.

In our analyses of 2012 Medicare data, males had a 

higher prescribing rate in the nursing home, while females had a higher 

rate outside of the nursing home. Finally, one article found that black 

nursing home residents were more likely to be prescribed antipsychotic 

34Healthcare Management Solutions, LLC and the Meyers Primary Care Institute at the 

University of Massachusetts Medical School. Antipsychotic Drug Use Project Final Report

(Columbia, Md.: January 2013).

35See J. A. Lucas, S. Chakravarty, J. R. Bowblis, T. Gerhard, E. Kalay, E. K. Paek, and 

S. Crystal, “Antipsychotic Medication Use in Nursing Homes: A Proposed Measure of 

Quality,” International Journal of Geriatric Psychiatry (2014).

36See Lucas, et al, “Antipsychotic Medication Use”; Y. Chen, B. A. Briesacher, T. S. Field, 

J. Tija, D. T. Lau, and J. H. Gurwitz, “Unexplained Variation across US Nursing Homes in 

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

P. Kamble, H. Chen, J. T. Shere, and R. R. Aparasu, “Use of Antipsychotics Among 

Elderly Nursing Home Residents with Dementia in the U.S.: An Analysis of National 

Survey Data,” Drugs & Aging. vol. 26, no. 6 (2009).
 

Page 23 GAO-15-211 Antipsychotic Drugs and Older Adults

drugs, while another article found that black residents were less likely to 

receive them when compared to white residents.37

Experts and research identified factors within the setting that an individual 

visits or resides in, such as nursing homes or hospitals, as contributing to 

the decision to prescribe antipsychotic drugs to older adults. Among 

nursing homes, experts and research cited factors, including the culture 

of the facility, the level of staff training and education, and the number of 

staff at the nursing home, as contributing to the decision to prescribe 

antipsychotic drugs to older adults. Specifically, nursing home 

leadership—such as administrators and medical directors—and culture 

were cited by half of the experts and two of the research articles. An 

expert told us that when the leadership of the nursing home believes it is 

broadly acceptable to provide antipsychotic drugs to residents with 

dementia, this belief spreads throughout the facility. One study examining 

variation in antipsychotic use in nursing homes looked at the pharmacy 

claims and nursing home assessments of more than 16,000 residents in 

1,257 nursing homes.38

In addition to nursing home culture and leadership, many experts and two 

research articles identified staff or prescriber education and training on 

antipsychotic prescribing for individuals with dementia as affecting 

antipsychotic drug prescribing. One industry group we spoke with 

indicated that physician training specifically regarding older adults with 

dementia in nursing homes and knowledge of related federal regulations 

are often lacking. Similarly, a study in 68 nursing homes in Connecticut 

examining knowledge of nursing home leaders and staff, who often set 

the tone for prescribing antipsychotic drugs and observing patients’ 

behavioral symptoms, found most of the certified nursing assistants— 

96 percent—were not aware of the serious risks to residents that can 

The study found that new nursing home residents 

admitted to facilities with high antipsychotic prescribing rates were 

1.4 times more likely to receive antipsychotics, even after controlling for 

patient-specific factors.

 

37See Lucas, et al, “Antipsychotic Medication Use” and Chen, et al, “Unexplained 

Variation Across U.S. Nursing Homes.”

38See Chen, et al, “Unexplained Variation across U.S. Nursing Homes.”

Experts and Research 

Identified Setting-Specific 

Factors That Contribute to 

Antipsychotic Prescribing
 

Page 24 GAO-15-211 Antipsychotic Drugs and Older Adults

result from antipsychotic use.39 The study also found that 56 percent of 

direct-care staff believed medications worked well to manage resident 

behavior. Another article reported that antipsychotic drug prescribing for 

individuals with dementia decreased from 20.3 to 15.4 percent in one 

nursing home after the implementation of an educational in-service 

training designed to reduce the inappropriate use of antipsychotic 

prescribing and increase documentation of non-pharmacological 

interventions.40

Nursing home staffing levels, specifically low staff levels, were also cited 

as a contributing factor to antipsychotic drug use in one research article 

and by a few experts. For example, one study examined more than 5,000 

nursing homes and 561,000 residents by linking 2009 and 2010 

prescription drug claims to the Nursing Home Compare database to 

identify a nationwide pattern of antipsychotic drug use.

In expert interviews, education of staff was identified as a 

factor that can contribute to minimizing unnecessary antipsychotic 

prescribing. One provider group noted that, in order to reduce 

antipsychotic use, a facility would need to invest in professional training 

for staff in a way that provides information about adequate alternatives to 

antipsychotic drugs.

41 The study found 

the nursing homes with the highest quintiles of antipsychotic drug use had 

significantly less staff than those with the lowest quintiles.42

 

39C. A. Lemay, K. M. Mazor, T. S. Field, J. Donovan, A. Kanaan, B. A. Briesacher, S. Foy, 

L. R. Harrold, J. H. Gurwitz, and J. Tjia, “Knowledge of and Perceived Need for Evidencebased Education about Antipsychotic Medications among Nursing Home Leadership and 

Staff,” Journal of the American Medical Directors Association, vol. 14, no.12 (2013).

An expert 

group noted that nursing homes with less staff may not have enough 

activities and oversight for the patients, which in turn may make the 

nursing home residents susceptible to higher antipsychotic drug use.

40K. Watson-Wolfe, E. Galik, J. Klinedinst, and N. Brandt, “Application of the Antipsychotic 

Use in Dementia Assessment Audit Tool to Facilitate Appropriate Antipsychotic Use in 

Long Term Care Residents with Dementia,” Geriatric Nursing, vol. 35 (2014).

41Nursing Home Compare is a consumer tool designed to help individuals choose a 

nursing home for themselves or someone for whom they are caring by displaying 

information related to the quality of specific nursing homes.

42B. A. Briesacher, J. Tjia, T. Field, K. M. Mazor, J. L. Donovan, A. O. Kanaan, and 

J. H. Gurwitz, “Nationwide Variation in Nursing Home Antipsychotic Use, Staffing and 

Quality of Care,” Pharmacoepidemiology and Drug Safety, vol. 21 (2012). 
 

Page 25 GAO-15-211 Antipsychotic Drugs and Older Adults

In addition, the majority of experts we spoke with told us that entering a 

nursing home from a hospital is a factor leading to higher antipsychotic 

prescribing in the nursing home. These experts agreed that antipsychotic 

drugs are often initiated in hospital settings and carried over to nursing 

home settings. One industry group we spoke with noted that individuals 

with dementia go to the hospital frequently and can be prescribed an 

antipsychotic drug if they exhibit disruptive behavior. Another industry 

group attributed the actual prescribing of antipsychotic drugs to hospital 

care culture and stated that the prescribing of antipsychotics is a common 

practice in hospitals for treating individuals with dementia. A research 

study that examined the medical charts of 73 residents in seven nursing 

homes found 84 percent of the residents that had been admitted to the 

nursing home from the hospital were admitted on at least one 

psychoactive medication—including antipsychotics.43

Finally, experts we spoke with indicated that caregivers’ frustration with 

the behavior of individuals with dementia can lead to requests for 

antipsychotic drugs. For example, an advocacy group we spoke with 

mentioned that a caregiver may request an antipsychotic drug for an 

individual with dementia in an effort to keep them in the home. The 

individual with dementia may not recognize their relative, which can 

cause them agitation. To keep the individual calm so that they can stay in 

the home and not be placed in a nursing home, an antipsychotic 

medication may be prescribed. Representatives from another provider 

group explained that when an individual with dementia has an unmet 

need, they may also appear to be in distress, which may cause the 

caregiver to become frustrated because they do not know how to relieve 

this distress.

 

43V. A. Molinari, D. A. Chiriboga, L. G. Branch, J. Schinka, L. Schonfeld, L. Kos, 

W. L. Mills, J. Krok, and K. Hyer, “Reasons for Psychiatric Medication Prescription 

for New Nursing Home Residents,” Aging and Mental Health, vol. 15, no. 7 (2011).
 

Page 26 GAO-15-211 Antipsychotic Drugs and Older Adults

HHS agencies, including CMS, AHRQ, and NIH, have taken actions to 

address antipsychotic drug use by older adults with dementia in nursing 

homes. However, HHS has done little to address antipsychotic drug use 

among older adults with dementia living in settings outside of the nursing 

home.

Under the National Plan to Address Alzheimer’s Disease, HHS has a goal 

to expand support for people with Alzheimer’s disease and their families 

with emphasis on maintaining the dignity, safety, and rights for those 

suffering from this disease.44

In 2012, CMS launched the National Partnership to Improve Dementia 

Care in Nursing Homes with federal and state agencies, nursing homes, 

providers, and advocacy organizations.

To reach this goal, HHS outlined several 

actions, including monitoring, reporting, and reducing the use of 

antipsychotics drugs by older adults in nursing homes. CMS has taken 

the lead in carrying out this work. Other HHS agencies have also done 

work related to reducing antipsychotic drug use in nursing homes.

45

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. CMS used 

publicly reported measures from the Nursing Home Compare website to 

This was in response to several 

reports dating back to 2001 published by the HHS Inspector General and 

advocate concerns about the persistently high rate of antipsychotic drug 

use and quality of care provided to nursing home residents with dementia.

 

44Alzheimer’s disease is the most common type of dementia. While the National 

Alzheimer’s Plan specifically mentions Alzheimer’s disease, it also addresses related 

dementias.

45Throughout this document we use the term “National Partnership” to refer to the 

National Partnership to Improve Dementia Care in Nursing Homes.

HHS Agencies’ 

Actions Focused on 

Reducing 

Antipsychotic Drug 

Use by Older Adults 

with Dementia Target 

Nursing Home 

Residents, Not Those 

in Other Settings

HHS Has Several 

Initiatives Focused on 

Reducing Antipsychotic 

Drug Use by Older Adult 

Nursing Home Residents

CMS Actions
 

Page 27 GAO-15-211 Antipsychotic Drugs and Older Adults

track the progress of the National Partnership and, according to officials, 

to reach out to those states and individual facilities with high prescribing 

rates. In the fourth quarter of 2011, which was deemed the baseline, 

23.8 percent of long-stay nursing home residents nationwide were 

prescribed an antipsychotic drug. While the National Partnership did not 

reach its target reduction in 2012, by the end of 2013 the national use 

rate decreased to 20.2 percent, a 15.1 percent reduction.46

The National Partnership works with state-based coalitions and consumer 

advocates to educate and promote a re-thinking of dementia care in 

nursing homes, with a focus on person-centered care.

The majority 

of states showed some improvements in their rates; however some states 

showed much more improvement than others. For example, Delaware 

showed a 27 percent reduction—from 21.3 to 15.5 percent—in the 

prevalence of antipsychotic drug use from 2011 through 2013, while 

Nevada saw a smaller reduction of 2.7 percent—from 20.3 to 

19.7 percent—during the same period. The National Partnership is 

working with state coalitions, as well as nursing homes to reduce this rate 

even further. In September 2014, CMS established a new set of national 

goals to reduce the use antipsychotic drugs in long-stay nursing home 

residents by 25 percent by the end of 2015 and 30 percent by the end of 

2016, which, assuming a baseline of 23.8 percent, would lead to a 

prescribing rate of 16.7 percent. Beginning in January 2015, CMS’s FiveStar Quality Rating System for nursing homes will be based, in part, on 

this measure of the extent to which antipsychotic drugs are used in the 

nursing home. The Five-Star Quality Rating System provides a way for 

consumers to compare nursing homes on the Medicare Web site. 

Previously, the measure was displayed, but not included in the calculation 

of each nursing home’s overall quality score.

47

 

46The calculations CMS uses to measure antipsychotic drug use in nursing homes are 

somewhat different than the calculations used for the information provided in earlier 

sections of the report. For example, CMS’s measure is not specific to individuals with a 

dementia diagnosis.

In addition to 

state-based coalitions, the National Partnership also includes Quality 

Improvement Organizations (QIO), which are state-based Medicare 

contractors tasked with promoting the delivery of quality services to 

47Person-centered care is an approach to care that focuses on residents as individuals 

and supports caregivers working most closely with them. It involves a continual process of 

listening, testing new approaches, and changing routines and organizational approaches 

in an effort to individualize and de-institutionalize the care environment.
 

Page 28 GAO-15-211 Antipsychotic Drugs and Older Adults

Medicare beneficiaries, and Advancing Excellence in America’s Nursing 

Homes Campaign, a major initiative of the Advancing Excellence in Long 

Term Care Collaborative.

48

In addition, CMS has taken four additional actions that aim to reduce 

antipsychotic drug use among older adults in nursing homes:

The National Partnership includes regular 

conference calls with states, regions, and advocates, and presentations 

by experts in the field, to share best practices and brainstorm ways to 

improve dementia care in their facilities. 

• CMS 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. This was done in order to improve surveyors’ ability to identify

the use of unnecessary drugs, including inappropriate use of 

antipsychotic drugs.

• QIOs have focused some of their efforts on reducing antipsychotic 

drug use in nursing homes. For example, beginning in 2013, the QIOs 

provided training to nearly 5,000 nursing homes on the appropriate 

use of antipsychotic medications.

• CMS recently concluded pilots of a new dementia-focused survey that

examines the use of antipsychotic drugs to older adults with dementia 

living in nursing homes. CMS reported that the focused survey pilot 

results will allow the agency to gain new insight about the current 

survey process, including how the process can be streamlined to 

more efficiently and accurately identify and cite deficient practices as 

well as to recognize successful dementia care programs. The pilot 

consisted of onsite, targeted surveys of dementia care practices in 

five nursing homes in each of five states.

• CMS began reporting the rate of chronic use of atypical antipsychotic 

drugs by older adult Medicare beneficiaries living in nursing homes for 

 

48CMS is required to contract with one QIO for each of the 50 states, the District of 

Columbia, Puerto Rico, and the U.S. Virgin Islands. The statutory mission of the QIO is to 

promote the effectiveness, efficiency, economy, and quality of services delivered to 

Medicare beneficiaries and to ensure that those services are reasonable and necessary. 

42 U.S.C. §§ 1320c-2,1320c-3. 

The mission of the Advancing Excellence in Long Term Care Collaborative is to help 

nursing homes improve residents’ quality of care and quality of life.
 

Page 29 GAO-15-211 Antipsychotic Drugs and Older Adults

Medicare Part D plans in 2013.49

In addition to CMS actions, AHRQ and NIH have awarded research 

grants for work related to antipsychotic drug use by older adults with 

dementia in nursing homes.

This information is publicly available 

on the Medicare Part D Compare Website, which is used by Medicare 

beneficiaries comparing Medicare Part D plans. The measure used for 

Medicare Part D plans differs in a few respects from the measure 

used to assess nursing homes. First, the Medicare Part D measure 

examines chronic use, defined as having at least 3 months or more of 

a prescription for an atypical antipsychotic drug, whereas the nursing 

home measure includes any use. Additionally, the Medicare Part D 

measure only includes atypical antipsychotic drugs, compared to the 

nursing home measure, which includes all antipsychotic drugs. Of the 

421 Medicare Part D plans reporting in 2012, the rate of use among 

Medicare Part D enrollees residing in nursing homes ranged from 0 to 

almost 64 percent. The average among all Medicare Part D plans in 

2012 was approximately 22 percent of enrollees residing in nursing 

homes having at least 3 months or more of a prescription. CMS told 

us that variation in antipsychotic prescribing among Medicare Part D 

plans may be explained by the prescribing practice in the plan’s 

service area, nursing home willingness to allow the use of 

antipsychotic drugs for the behavioral symptoms of dementia, resident 

need, and success in implementing interventions to reduce the 

inappropriate use of antipsychotic drugs.

• AHRQ has funded individual grants for work related to antipsychotic 

drug use in nursing homes through its Center for Evidence and 

Practice Improvement and the Centers for Education & Research on 

Therapeutics (CERT) program. For example, in 2011, CERT funded 

several project centers for a 5-year period to study a broad range of 

health care issues, including Rutgers University, which studied 

patterns of antipsychotic drug use, along with the safety and

effectiveness of antipsychotic drug use for individuals living in nursing 

homes.

 

49This metric specifically measures the percent of Medicare Part D beneficiaries 65 years 

and older who are continuously enrolled in a nursing home and who received an atypical 

antipsychotic medication. Medicare Part D Compare defines chronic use as any 

beneficiary who has received at least a 90-day supply of atypical antipsychotic 

medication(s) during a nursing home stay.

Actions of Other HHS 

Agencies
 

Page 30 GAO-15-211 Antipsychotic Drugs and Older Adults

• Within the NIH, the National Institute on Aging and the National 

Institute of Mental Health have also funded related research, including 

a number of studies examining the safety of antipsychotic drugs in 

older adults.

Some stakeholders and other provider groups we spoke with expressed 

overall support of HHS’s efforts, while others cautioned that the emphasis 

should not curtail access to those individuals who need antipsychotic

drugs. Specifically, stakeholders indicated that the collaboration between 

public and private organizations, as part of the National Partnership, 

along with the sharing of practices aimed at reducing antipsychotic drug 

use, contributed to the campaign’s success. Stakeholders also mentioned 

that the National Partnership allowed nursing homes to pay attention and 

start talking about issues related to antipsychotic drug use. Some 

stakeholders further indicated that HHS’s initiatives have brought focus to 

the issue of antipsychotic drug use in older adults in nursing homes. 

Conversely, other groups and individuals involved in HHS’s efforts 

expressed concern that the emphasis on reducing antipsychotic drug use 

in nursing homes could result in some individuals who need these 

medications not receiving them. One researcher we spoke with noted that 

because nursing homes’ use of antipsychotic drug use is measured and 

publicly reported, these facilities may be worried about their antipsychotic 

drug rate and focus on the bottom-line number instead of what is good for 

the individual. CMS officials told us that they are careful in their 

messaging to acknowledge that antipsychotic drugs have a useful 

prescribing purpose and therefore will never be totally eliminated. They 

are working with providers to develop a comprehensive view of what a 

patient potentially needs, emphasizing that using antipsychotic drugs 

should not be the first-line intervention.

While the National Alzheimer’s Plan was established to improve care for 

all individuals with dementia regardless of the setting where they reside, 

HHS efforts related to reducing antipsychotic drug use among older 

adults have primarily focused on those living in nursing homes with less 

activity geared toward those living outside of nursing homes. HHS 

officials noted that the focus has been on reducing antipsychotic drug use 

rates in nursing homes for a variety of reasons, including the severity of 

dementia among nursing home residents and the agency’s responsibility 

to ensure appropriate training of nursing home staff. However, the risk of 

antipsychotic drugs to older adults is not specific to those in nursing 

homes. Furthermore, we found that 1 in 7 Medicare Part D enrollees with 

HHS Has Taken Little 

Action to Educate and 

Provide Outreach to 

Reduce Antipsychotic 

Drug Use among Older 

Adults Residing Outside of 

Nursing Homes
 

Page 31 GAO-15-211 Antipsychotic Drugs and Older Adults

dementia outside of the nursing home were prescribed an antipsychotic 

drug in 2012.

We identified one activity by HHS’s ACL that examined a topic related to 

the use of antipsychotic drugs, specifically the use of nonpharmacological interventions in the treatment of individuals with 

dementia. In 2012, ACL partnered with a research group to conduct a 

study on non-pharmacological treatments and care practices for 

individuals with dementia and their caregivers.50

While ACL has not focused on reducing antipsychotic drug use among 

older adults outside of nursing homes, ACL is responsible for other parts 

of the National Alzheimer’s Plan related to improving dementia care in the 

community. ACL partners with national groups to share information on 

dementia-related issues such as caring for minority populations with 

dementia and preventing elder abuse and neglect. As part of this work, 

ACL works with organizations, such as the Alliance for Aging Research 

and the National Family Caregiver Alliance, to share research, host 

webinars and presentations, and promote issues through social media. 

ACL also funds grants for state long-term care ombudsmen that are 

responsible for advocating for older adults living in nursing homes, 

assisted living facilities, and other residential settings for older adults.

The study results were 

presented in a white paper and disseminated on the ACL’s Web page. 

ACL also included the study results in a newsletter distributed to state 

organizations on aging. ACL officials also told us that they participate in 

the National Partnership as a stakeholder organization, including 

reviewing the training materials that were distributed to nursing homes. 

However, ACL officials told us that none of their other past activities have 

dealt specifically with reducing antipsychotic drug use among older adults 

outside of nursing homes.

Stakeholder groups we spoke to indicated that educational efforts similar 

to those provided under the National Partnership should be extended to 

those providing care to older adults in other settings, such as hospitals 

and assisted living facilities. Some stakeholders noted that some of the 

same material regarding non-pharmacological interventions could be 

shared with caregivers in these other care settings.

 

50See K. Maslow, “Translating Innovation to Impact.”
 

Page 32 GAO-15-211 Antipsychotic Drugs and Older Adults

Many experts we spoke with said that many nursing home residents 

come to the nursing home already on an antipsychotic drug. Extending 

educational efforts to caregivers and providers outside of the nursing 

home could help lower the use of antipsychotics among older adults with 

dementia living both inside and outside of nursing homes.

The decision to prescribe an antipsychotic drug to an older adult with 

dementia is dependent on a number of factors, according to experts in the 

field, and must take into account the possible benefits of managing 

behavioral symptoms associated with dementia against potential adverse 

health risks. In some cases, the benefits to prescribing the drugs may 

outweigh the risks. HHS has taken important steps to educate and inform 

nursing home providers and staff on the need to reduce unnecessary 

antipsychotic drug use and ways to incorporate non-pharmacological 

practices into their care to address the behavioral symptoms associated 

with dementia. However, similar efforts have not been directed toward 

caregivers of older adults living outside of nursing homes, such as those 

in assisted living facilities and private residences. Targeting this segment 

of the population is equally important given that over 1.2 million Medicare 

Part D enrollees living outside of nursing homes were diagnosed with 

dementia in 2012 and Medicare Part D pays for antipsychotic drugs 

prescribed to these individuals. While the extent of unnecessary 

prescribing of antipsychotic drugs is unknown, older adults with dementia 

living outside of nursing homes are also at risk of the same dangers 

associated with taking antipsychotics drugs as residents of nursing 

homes. In fact, the National Alzheimer’s Project Act was not limited to the 

nursing home setting, but calls upon HHS to develop and implement an 

integrated national plan to address dementia. HHS’s National Alzheimer’s 

Plan addresses antipsychotic drug prescribing in nursing homes only, 

however, and HHS activities to reduce such drug use have primarily 

focused on older adults residing in nursing homes. Given that HHS does 

not specifically target its outreach and education efforts relating to 

antipsychotic drug use to settings other than nursing homes, older adults 

living outside of nursing homes, their caregivers, and their clinicians in 

these settings may not have access to the same resources about

alternative approaches to care. By expanding its outreach and 

educational efforts to settings outside nursing homes, HHS may be able 

to help reduce any unnecessary reliance on antipsychotic drugs for the 

treatment of behavioral symptoms of dementia for all older adults 

regardless of their residential setting.

Conclusion
 

Page 33 GAO-15-211 Antipsychotic Drugs and Older Adults

We recommend 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.

We provided a draft of this report to HHS for comment. In its written 

response, reproduced in appendix III, HHS concurred with our 

recommendation, stating that the agency will support efforts to update the 

National Alzheimer’s Plan through continued participation on the Federal 

National Alzheimer’s Project Act Advisory Council. HHS also provided 

technical comments that we incorporated as appropriate.

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution of it until 30 days from its 

date. At that time, we will send copies to the Secretary of Health and 

Human Services. In addition, the report will be available at no charge on 

the GAO website at http://www.gao.gov. 

If you or your staffs have any questions about this report, please contact 

me at (202) 512-7114 or iritanik@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. GAO staff who made key contributions to this report 

are listed in appendix IV. 

Katherine M. Iritani

Director, Health Care

Recommendation for 

Executive Action

Agency Comments
Appendix I: Scope and Methodology for Data 

Analyses 

Page 34 GAO-15-211 Antipsychotic Drugs and Older Adults

This appendix describes our methodology for analyzing the 2012 

prescribing of antipsychotic drugs for older adults with dementia in 

nursing homes and other settings, as well as for analyzing Medicare 

Part D plan payments for these antipsychotic drug prescriptions. It also 

describes our efforts to ensure the reliability of the data.

We used two primary data sources to examine antipsychotic drug 

prescribing for older adults with dementia: the Medicare Part D 

Prescription Drug Event (PDE) data to identify antipsychotic drug 

prescribing for Medicare Part D enrollees in and outside of the nursing 

home,1 and the Long Term Care Minimum Data Set (MDS) to identify 

antipsychotic drug prescribing for all nursing home residents, regardless 

of Medicare Part D enrollment.2

To estimate the extent to which older adults residing inside and outside of 

nursing homes are prescribed antipsychotic drugs, we first analyzed 2012 

PDE data for individuals with dementia.3 We used the Medicare Part D 

PDE data because Medicare is the primary source of insurance coverage 

for individuals over the age of 65 and approximately 63 percent of 

Medicare beneficiaries were enrolled in Medicare Part D in 2012. To 

identify individuals living in nursing homes, we combined the PDE claims 

data with data from the MDS, which includes nursing home assessments 

for all individuals living in nursing homes, regardless of insurance 

coverage. We also used data from the Medicare Master Beneficiary 

Summary File (MBSF),4 as well as the Medicare Part D Risk File to 

identify diagnoses, including dementia diagnoses and diagnoses for 

certain conditions for which the Food and Drug Administration (FDA) has 

approved the use of antipsychotics drugs.5

 

1

The PDE data contain pharmacy claims for all prescription drugs dispensed to Medicare 

Part D beneficiaries.

We excluded from our 

2

The MDS contains information from nursing home resident assessments for all Medicare 

or Medicaid certified nursing homes, regardless of payer. In 2012, over 15,600 nursing 

homes were Medicare and Medicaid certified and included in the MDS.

3

The 2012 PDE data were the most recent data available at the time of our review.

4

MBSF includes data on enrollment, spending, and use of services for all Medicare 

beneficiaries.

5

The Medicare Part D Risk File contains enrollee information such as age, gender, and 

diagnoses from the previous year.

Appendix I: Scope and Methodology for Data 

Analyses

Analyses of Antipsychotic 

Drug Prescribing for Older 

Adults with Dementia

Medicare Part D Prescription 

Drug Event data analyses
Appendix I: Scope and Methodology for Data 

Analyses

Page 35 GAO-15-211 Antipsychotic Drugs and Older Adults

estimates individuals with dementia also diagnosed with one of these 

FDA-approved conditions for antipsychotic drugs—schizophrenia and 

bipolar disorder. The Medicare Part D Risk File contains diagnoses based 

on claims from the previous year for each enrollee, so our diagnosis 

categories may be conservative estimates as they did not take into 

account longer-standing or newer diagnoses. We also excluded enrollees 

with outlier data, enrollees with less than 12 months of Medicare Part D 

enrollment in 2012, and those enrollees who died in 2012 because they 

did not have complete Medicare Part D data for the entire year. Finally, 

we excluded enrollees who resided outside of the 50 states and the 

District of Columbia.

For these analyses, we define an individual as having been prescribed an 

antipsychotic drug if they were prescribed at least one prescription for an 

antipsychotic drug during the year, regardless of how many days supply 

are covered by the prescription. We identified relevant national drug 

codes (NDC) using a list of generic names for antipsychotic drugs,6 and, 

using those codes, we determined the number and percent of Medicare 

Part D enrollees who were prescribed an antipsychotic drug in 2012.7 The 

specific drugs included are listed in table 6.

 

6

NDCs uniquely identify specific drug products for a given manufacturer.

7

We did so using Red Book, a compendium published by Truven Health Analytics that 

includes information about the characteristics of drug products. Some included drugs have 

been discontinued. We excluded NDCs for drugs with a route of administration that was 

not oral or sublingual. We also excluded drugs that contain antipsychotics but are not 

classified as antipsychotic.
Appendix I: Scope and Methodology for Data 

Analyses

Page 36 GAO-15-211 Antipsychotic Drugs and Older Adults

Table 6: Antipsychotic Drugs Included in GAO Analysis, by Generation

First generation (conventional) Second generation (atypical)

Chlorpromazine Hydrochloride Aripiprazole

Fluphenazine Hydrochloride Asenapine

Haloperidol; Haloperidol Lactate Clozapine

Loxapine Hydrochloride (discontinued); Loxapine 

Succinate

Iloperidone

Mesoridazine Besylate (discontinued) Lurasidone Hydrochloride

Molindone Hydrochloride (discontinued) Olanzapine

Perphenazine Paliperidone

Pimozide Quetiapine Fumarate

Promazine Hydrochloride (discontinued) Risperidone

Thioridazine (discontinued); Thioridazine

Hydrochloride

Ziprasidone Hydrochloride

Thiothixene; Thiothixene Hydrochloride (discontinued)

Trifluoperazine Hydrochloride

Source: GAO summary. | GAO-15-211

Notes: Antipsychotic drugs are classified into two sub-groups. The first generation of antipsychotic 

drugs, also known as “conventional” antipsychotic drugs, was developed in the mid-1950s. The 

second generation of antipsychotic drugs, also known as “atypical” antipsychotics, was developed in 

the 1980s. We excluded NDCs for drugs that are not classified as antipsychotics and do not have an 

oral or sublingual route of administration.

Within the nursing home population, our analysis of PDE data specifically 

identified those with a long stay in the nursing home—defined by the 

Centers for Medicare & Medicaid Services (CMS) as more than 

100 days—because drugs for individuals with short stays—100 days or 

less—are generally covered under Medicare Part A, not Part D. We 

disaggregated the data to examine certain characteristics, such as 

gender, age, and geographic location.

To supplement our analysis of the Medicare Part D data for the nursing 

home population, we also analyzed 2012 data on antipsychotic 

prescribing and diagnoses among nursing home residents available in the 

MDS. This allowed us to look at a more comprehensive population of 

nursing home residents—all residents in a Medicare or Medicaid certified 

nursing home—and to examine prescribing rates by length of stay, using 

steps identified by CMS based on dates reported in the nursing home 

Long Term Care Minimum 

Data Set analysis
Appendix I: Scope and Methodology for Data 

Analyses

Page 37 GAO-15-211 Antipsychotic Drugs and Older Adults

assessments.8 In addition to excluding residents with dementia also 

diagnosed with schizophrenia and bipolar disorder, we excluded residents 

with Tourette syndrome, a condition for which FDA has approved the use 

of certain antipsychotics, as well as Huntington’s disease, a condition for 

which CMS guidance has recognized antipsychotics as an acceptable 

treatment.9 Individuals with both dementia and at least one of these 

diagnoses accounted for about 7 percent of nursing home residents with 

dementia overall. We also excluded residents with outlier identification 

codes or other outlier data, residents under the age of 65, and residents 

in facilities outside of the 50 states and the District of Columbia. We 

included only those residents that lived through 2012 so that there was a 

complete year of data for each resident and because antipsychotic drugs 

can be used in a hospice setting to make residents more comfortable at 

the end of their lives.10 For this analysis, we determined an individual was 

prescribed an antipsychotic drug if any nursing home assessment during 

2012 indicated the resident took an antipsychotic drug during the previous 

7 days, and we include any instance where antipsychotic use is 

documented.11 We disaggregated the data to examine certain 

characteristics, such as gender, age, and geographic location.

To identify what Medicare Part D plans paid for antipsychotic drugs 

prescribed to older adults with dementia in 2012, we identified individuals 

with dementia using the Medicare Part D Risk File, and calculated plan 

 

8

We looked at rates for those residents with a long stay, defined as more than 100 

cumulative days in a facility, and a short stay, defined as all other residents.

9

It was not possible to exclude other conditions on this basis such as nausea and severe 

depression refractory to other therapies without a medical record review. Therefore, these 

conditions are not included in our exclusions. In addition, we were unable to exclude 

Medicare Part D enrollees with Tourette syndrome and Huntington’s disease for the 

Medicare PDE analysis because the Medicare Part D Risk File does not contain 

information on whether an enrollee has been diagnosed with these conditions. Of nursing 

home residents in 2012, approximately 0.06 percent were diagnosed with Huntington’s 

disease and 0.02 percent were diagnosed with Tourette syndrome.

10We conducted a sensitivity analysis to determine whether the prescribing rate changed 

as a result of including residents who died in the facility in 2012, and the prescribing rate 

did not change significantly.

11This differs from the CMS measures of antipsychotic drug use among nursing home 

residents. For example, the CMS measure for residents that spend 100 days or less in a 

nursing home does not include instances of antipsychotic drug use documented on an 

initial assessment.

Medicare Part D Plan 

Payments
Appendix I: Scope and Methodology for Data 

Analyses

Page 38 GAO-15-211 Antipsychotic Drugs and Older Adults

payments for those enrollees using the PDE claims data. We also 

calculated plan payments for the most commonly prescribed antipsychotic 

drugs, and used the National Plan and Provider Enumeration System 

(NPPES) to identify the breakdown of prescriber specialties listed on 

antipsychotic drug claims under Medicare Part D in 2012 to calculate the 

share of plan payments for prescriptions from the specialties with the 

most antipsychotic prescribing for individuals with dementia.12

We ensured the reliability of the MDS data, Medicare PDE data, Medicare 

Part D Risk File data, MBSF data, Red Book data, and NPPES data used 

in this report by performing appropriate electronic data checks, reviewing 

relevant documentation, and interviewing officials and representatives 

knowledgeable about the data, where necessary. We found the data were 

sufficiently reliable for the purpose of our analyses.

We conducted this performance audit from January 2014 through January 

2015 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

 

12NPPES is a list of all Medicare providers, including unique provider identifiers, 

maintained by CMS.

Data Reliability and Audit 

Standards
Appendix II: Literature Review

Page 39 GAO-15-211 Antipsychotic Drugs and Older Adults

To identify what is known from published research about factors 

contributing to the prescribing of antipsychotic drugs to older adults with 

dementia, we conducted a literature search among recently published 

articles; specifically, we searched for relevant articles published from 

January 1, 2009, through March 31, 2014. We conducted a structured 

search of various databases for relevant peer reviewed and industry 

journals including MEDLINE, BIOSIS Previews, and ProQuest. Key terms 

included various combinations of “antipsychotic,” “dementia,” “elderly,” 

“older adults,” “nursing homes,” “community,” “assisted living,” “home 

health,” “medication management,” and “medication monitoring.” From all 

database sources, we identified 386 articles. We first reviewed the 

abstracts for each of these articles for relevancy in identifying contributing 

factors related to the use of antipsychotic drugs both inside and outside of 

nursing homes. For those articles we found relevant, we reviewed the full 

article and excluded those where the research (1) was conducted outside 

the United States; (2) included individuals less than 65 years of age; or 

(3) was an editorial submission. We added one article that could be linked 

to original research outside of the research cited in the article. After 

excluding these articles and including others, 42 articles remained: 22 

focused on nursing homes; 11 focused on settings outside of nursing 

homes; 7 focused on both settings; and in 2 articles, the settings were 

either unclear or undetermined. Articles were then coded by analysts 

according to whether they identified contributing factors for use of 

antipsychotic drugs. We found 18 that contained detailed reasons that 

contribute to antipsychotic drug use among older adults:

Bowblis, J. R., S. Crystal, O. Intrator, and J. A. Lucas. “Response to 

Regulatory Stringency: The Case of Antipsychotic Medication Use in 

Nursing Homes.” Health Economics, vol. 21 (2012).

Briesacher, B. A., J. Tjia, T. Field, K. M. Mazor, J. L. Donovan, 

A. O. Kanaan, L. R. Harrold, C. A. Lemay, and J. H. Gurwitz. “ 

Nationwide Variation in Nursing Home Antipsychotic Use, Staffing 

and Quality of Care.” Abstracts of the 28th ICPE 2012, (2012).

Briesacher, B. A., J. Tjia, T. Field, D. Peterson, and J. H. Gurwitz.

“Antipsychotic use Among Nursing Home Residents.” The Journal of 

American Medical Association, vol. 309, no. 5 (2013).

Chen, Y., B. A. Briesacher, T. S. Field, J. Tjia, D. T. Lau, and 

J. H. Gurwitz. “Unexplained Variation across U.S. Nursing Homes in 

Antipsychotic Prescribing Rates.” Archives of Internal Medicine, vol. 170, 

no. 1 (2010).

Appendix II: Literature Review
Appendix II: Literature Review

Page 40 GAO-15-211 Antipsychotic Drugs and Older Adults

Crystal, S., M. Oflson, C. Huang, H. Pincus, and T. Gerhard. “Broadened 

Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy 

Challenges: Expanded Use of these Medications, Frequently Off-label, 

Has Often Outstripped the Evidence Base for the Diverse Range of 

Patients Who Are Treated with Them.” Health Affairs, vol. 28, no. 5 

(2009).

Department of Health and Human Services – Office of Inspector General, 

Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home 

Residents,” OEI-07-08-00150, May 2011.

Fung, V., M. Price, A. B. Busch, M. B. Landrum, B. Fireman, 

A. Nierenberg, W. H. Dow, R. Hui, R. Frank, J. P. Newhouse, and 

J. Hsu. “Adverse Clinical Events among Medicare Beneficiaries Using 

Antipsychotic Drugs: Linking Health Insurance Benefits and Clinical 

Needs.” Medical Care, vol. 51, no. 7 (2013).

Healthcare Management Solutions, LLC and the Meyers Primary Care 

Institute at the University of Massachusetts Medical School. Antipsychotic 

Drug Use Project Final Report (Columbia, Md.: January 2013).

Kamble, P., J. Sherer, H. Chen, and R. Aparasu. “Off-Label Use of 

Second-Generation Antipsychotic Agents among Elderly Nursing Home 

Residents.” Psychiatric Services, vol. 61, no. 2 (2010).

Kamble, P., H. Chen, J. T. Sherer, and R. R. Aparasu. “Use of 

Antipsychotics among Elderly Nursing Home Residents with Dementia in 

the United States: An Analysis of National Survey Data.” Drugs & Aging, 

vol. 26, no. 6 (2009).

Lemay, C. A., K. M. Mazor, T. S. Field, J. Donovan, A. Kananaan, 

B. A. Briesacher, S. Foy, L. R. Harrold, J. H. Gurwitz, and J. Tjia. 

“Knowledge of and Perceived Need for Evidence-Based Education 

about Antipsychotic Medications among Nursing Home Leadership 

and Staff.” The Journal of American Medical Directors Association, 

vol. 14, no. 12 (2013).

Lucas, J. A., S. Chakravarty, J. R. Bowblis, T. Gerhard, E. Kalay, 

E. K. Paek, and S. Crystal. “Antipsychotic Medication Use in Nursing 

Homes: A Proposed Measure of Quality.” International Journal of 

Geriatric Psychiatry (2014).
Appendix II: Literature Review

Page 41 GAO-15-211 Antipsychotic Drugs and Older Adults

Molinari, V. A., D. A. Chiriboga, L. G. Branch, J. Schinka, L. Shonfeld, 

L. Kos, W. L. Mills, J. Krok, and K. Hyer. “Reasons for Psychiatric 

Medication Prescription for New Nursing Home Residents.” Aging & 

Mental Health, vol. 15, no.7 (2011).

Rhee, Y., J. G. Cernansky, L. L. Emanuel, C. G. Chang, and J. W. Shega. 

“Psychotropic Medication Burden and Factors Associated with 

Antipsychotic Use: An Analysis of a Population-Based Sample of 

Community-Dwelling Older Persons with Dementia.” The Journal of 

American Geriatrics Society, no. 59 (2011).

Saad, M., M. Cassagnol, and E. Ahmed. “The Impact of FDA’s Warning 

on the Use of Antipsychotics in Clinical Practice: A Survey.” The 

Consultant Pharmacist, vol. 25, no. 11 (2010).

Sapra, M., A. Varma, R. Sethi, I. Vahia, M. Chowdhury, K. Kim, and 

R. Herbertson. “Utilization of Antipsychotics in Ambulatory Elderly with 

Dementia in an Outpatient Setting.” Federal Practitioner, (2012).

Tjia, J., T. Field, C. Lemay, K. Mazor, M. Pandolfi, A. Spenard, S. Ho, 

A. Kanaan, J. Donovan, J. H. Gurwitz, and B. Briesacher. “Antipsychotic 

Use in Nursing Homes Varies By Psychiatric Consultant.” Medical Care, 

vol. 52, no. 3. (2014).

Watson-Wolfe, K., E. Galik, J. Klinedinst, and N. Brandt. “Application of 

the Antipsychotic Use in Dementia Assessment Audit Tool to Facilitate 

Appropriate Antipsychotic Use in Long Term Care Residents with 

Dementia.” Geriatric Nursing, vol. 35 (2014).
Appendix III: Comments from the Department 

of Health and Human Services

Page 42 GAO-15-211 Antipsychotic Drugs and Older Adults

Appendix III: Comments from the 

Department of Health and Human Services
Appendix III: Comments from the Department 

of Health and Human Services

Page 43 GAO-15-211 Antipsychotic Drugs and Older Adults
Appendix IV: GAO Contact and Staff 

Acknowledgments

Page 44 GAO-15-211 Antipsychotic Drugs and Older Adults

Katherine M. Iritani, (202) 512-7114 or iritanik@gao.gov

In addition to the contact named above, Lori Achman, Assistant 

Director; Todd D. Anderson; Shaunessye D. Curry; Leia Dickerson; 

Sandra George; Kate Nast Jones; Ashley Nurhussein-Patterson; 

and Laurie Pachter made key contributions to this report.

Appendix IV: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

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