Under-Enforced and OverPrescribed: The Antipsychotic
Drug Epidemic Ravaging
America’s Nursing Homes

Report of the Committee on Ways and Means Majority
U.S. House of Representatives
July 2020

 “The implicit goal of the regulatory system is to ensure that
any person requiring nursing home care be able to enter any
certified nursing home and receive appropriate care, be
treated with courtesy, and enjoy continued civil and legal
rights. This happens in many nursing homes in all parts of the
country. But in many other government-certified nursing
homes, individuals who are admitted receive very inadequate
– sometimes shockingly deficient – care that is likely to hasten
the deterioration of their physical, mental,
and emotional health.”
—Institute of Medicine, 1986

2

 Table of Contents
EXECUTIVE SUMMARY .................................................................................................................... 6
INTRODUCTION.................................................................................................................................... 9
BACKGROUND..................................................................................................................................... 13
RESULTS................................................................................................................................................. 23
DISCUSSION .......................................................................................................................................... 32
CONCLUSION ....................................................................................................................................... 37
APPENDICES ......................................................................................................................................... 38

3

 FOREWORD
In 2018 and 2019, the Committee on Ways and Means began investigating the overuse of
antipsychotics in nursing homes across the country. This was long before COVID-19 came to
American shores – before it descended upon Life Care Center of Kirkland, Washington, and
before the novel virus claimed the lives of thousands of our nation’s long-term care facility
residents and staff. The virus has largely targeted the most vulnerable among us with individuals
over the age of 65 representing almost a third of all COVID-19 cases, nearly half of all
hospitalizations, and 80 percent of all deaths. 1 As of mid-July 2020, the number of known
COVID-19 cases in long-term care facilities reached 316,000 across nearly 14,000 facilities.
Deaths of long-term care residents and staff have likely exceeded 57,000, accounting for more
than 40 percent of COVID-19 deaths nationwide and more than 60 percent in many states. 2
Alarmingly, these numbers are likely an underestimation due to still inadequate testing.
The rampant spread of the virus within and across nursing homes in the United States is
unfortunately not surprising. It reflects persistent challenges known to have plagued nursing
home settings for decades – some attributable to limited state budgets and the low Medicaid
payment rates associated with them, others attributable to low-paying jobs with low retention
rates, or to the lack of alignment between financial decision-making and patient needs. 3 Some
challenges, too, may reflect cultural attitudes toward aging and the stigma Americans have for
years applied to institutional elder care.
Although the story of antipsychotic overuse that the Committee offers in this report is not
specific to current concerns – that of preparedness and infection control in nursing homes across
the country – it is emblematic of the challenges that have been quietly plaguing nursing homes
across the country for years, if not decades. Even in normal times, nursing homes have been
hotspots for infection and disease. In the United States, one to three million serious infections
occur in nursing homes each year, and more than 60 percent of facilities have been cited for
deficiencies related to infection control since the beginning of 2017. 4,5 In addition, sedation, a
common side effect of antipsychotics, could result in nursing home residents being less able to
communicate symptoms, leading to delayed detection of infections. 6

Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) – United States, February 12March 16, 2020, Center for Disease Control and Prevention, (2020). Available at:
https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e2.htm?s_cid=mm6912e2_w
2
More Than 40% of U.S. Coronavirus Deaths Are Linked to Nursing Homes, The New York Times, (2020).
Available at: https://www.nytimes.com/interactive/2020/us/coronavirus-nursing-homes.html
3
Walker, Chas, Poverty Wages in Nursing Homes Have Accelerated the Coronavirus Outbreak, Boston Globe,
(2020). Available at: https://www.bostonglobe.com/2020/04/25/opinion/poverty-wages-nursing-homes-haveaccelerated-coronavirus-outbreak/
4
Nursing Homes and Assisted Living, Center for Disease Control and Prevention, (2019). Available at:
https://www.cdc.gov/longtermcare/index.html
5
Coronavirus Stress Test: Many 5-Star Nursing Homes Have Infection Control Lapses, Kaiser Family Foundation,
(2020). Available at: https://khn.org/news/COVID-19-preparedness-infection-control-lapses-at-top-rated-nursinghomes/
6
Adverse Effects of Antipsychotic Medications, American Family Physician, (2010). Available at:
https://www.aafp.org/afp/2010/0301/p617.html
1

4

 The story of antipsychotics overuse in nursing homes is similar to infection control
lapses. It is one of patient harm, inadequate oversight, and insufficient staffing. And it is one of
often avoidable heartbreak. Addressing the issues in nursing homes begins with considering the
immense vulnerability of our nursing home population and committing to tackling the multitude
of interrelated challenges that persist. The scourge of COVID-19 in nursing facilities
demonstrates the tragic consequences of turning a blind eye to our nation’s seniors and
individuals with disabilities, and it underscores the need for robust emergency preparedness and
oversight of the nursing home industry.
— Ways and Means Committee Majority Staff, July 2020

5

 EXECUTIVE SUMMARY
In the fourth quarter of 2019, approximately 20 percent of all skilled nursing facility
(SNF) residents in the United States (U.S.) – about 298,650 people every week – received some
form of antipsychotic medication, most without any psychosis diagnosis for which the drugs are
indicated. 7, 8, 9 Nursing homes continue to give these powerful drugs to residents despite the
Food and Drug Administration’s (FDA) issuing a black box warning specifically stating that the
use of off-label antipsychotics among seniors with dementia can result in injuries,
hospitalizations, and even death. 10 In fact, individuals over 70 are 3.5 times more likely than
younger individuals to be admitted to the hospital due to adverse drug reactions associated with
psychotropic medications. 11 One recent study found that the inappropriate use of antipsychotic
medication was associated with a 50 percent increased risk of a serious fall-related bone
fracture. 12
A 2011 Department of Health and Human Services (HHS) Office of Inspector General
(OIG) report found that 14 percent of elderly nursing home residents had Medicare claims for
atypical antipsychotic use, shining a national spotlight on this issue. In response, the Obama
Administration took steps to crack down on the high rates of antipsychotics prescribing in SNFs.
In 2016, the Centers for Medicare & Medicaid Services (CMS) published a Final Rule that
strengthened the public enforcement system for SNFs violating federal standards of care, called
Requirements of Participation (RoPs). 13 This Final Rule increased requirements for pharmacists
to report irregularities in antipsychotic overuse, established a 14-day PRN (pro re nata or “as
needed”) limitation on psychotropic drugs, and implemented behavioral health measures targeted
to enhance person-centered care. 14 Finally, CMS directed civil money penalties (CMPs) be
imposed against nursing homes for all deficiencies, including the misuse and overuse of
antipsychotic drugs, on a per-day basis for each day an individual SNF violated these federal
RoPs. By 2016, two-thirds of all CMPs for facility deficiencies were per-day penalties.

Committee calculations of MDS Frequency Report: Fourth Quarter 2019 Antipsychotic Medications Received,
Centers for Medicare and Medicaid Services, (2019). Available at:
https://www.cms.gov/apps/mds/mds_notemp/mds30FreqStart.asp?isSubmitted=mds30Freq3&var=N0410A&date=3
3
8
Mollot, Richard, Despite Promised Crackdown, Citations for Inappropriate Drugging Remain Rare, Long Term
Care Community Coalition, (2018). Available at: https://nursinghome411.org/wp-content/uploads/2018/11/LTCCCAdvisory-Nursing-Home-Drugging-Citations-November-2018.pdf
9
Report to the Congress: Medicare Payment Policy, Medicare Payment Advisory Commission, (2020). Available at:
http://medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf
10
Atypical Antipsychotic Medications: Use in Adults, Centers for Medicare and Medicaid Services, (2015).
Available at: https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-IntegrityEducation/Pharmacy-Education-Materials/Downloads/atyp-antipsych-adult-factsheet11-14.pdf
11
Brooks, Hoblyn, Neurocognitive costs and benefits of psychotropic medications in older adults, Journal of
Geriatric Psychiatry and Neurology, (2007); 20:199–214.
12
Fraser, Lisa-Ann, Falls and Fractures With Atypical Antipsychotic Medication Use, JAMA Network, (2015).
Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2089230
13
Medicare and Medicaid Programs; Reform of Requirements for Long Term Care Facilities, Centers for Medicare
and Medicaid Services, (2016). Available at: https://www.govinfo.gov/content/pkg/FR-2016-10-04/pdf/201623503.pdf
14
Id.
7

6

 As part of the Trump Administration’s broader de-regulation campaign, in 2017 and
2018, the Administration reversed course and rolled back a number of Obama-era regulations
and practices. The Trump Administration granted facilities an 18-month moratorium on the 2016
Obama-era safety regulations, including those that established the 14-day PRN limitation and
CMPs for citations related to inappropriate antipsychotic use. 15
This report provides an overview of antipsychotic citation trends in SNFs from 2015 to
2018. Using data from CMS and the Kaiser Family Foundation (KFF), the Committee conducted
five state-level descriptive analyses.

KEY FINDINGS
Inappropriate Antipsychotic Drug Use Remains High in Skilled
Nursing Facilities
• Approximately 20 percent of all skilled nursing facility residents in the U.S.
– about 298,650 people every week – received some form of antipsychotic
medication in the fourth quarter of 2019, while only about two percent had
qualifying conditions for such drugs.
• Citations for antipsychotic misuse in SNFs increased by 200 percent
between 2015 and 2017 but declined by 22 percent from 2017 to 2018, as
the Trump Administration rolled back Obama-era protections.
• Rates of antipsychotic citations remain high, particularly in the Northwest
and Midwest.
• Ten percent of citations associated with Actual Harm or Immediate Jeopardy
to a resident’s health or safety resulted in no fine from 2017-2018.
Citations for antipsychotic misuse in SNFs increased by 200 percent between 2015
and 2017 but were followed by a 22 percent decline from 2017 to 2018. Nationally, between
2015 and 2018, there was a 124 percent increase in the number of citations SNFs received, from
1116 citations (2015) to 2,497 citations (2018). Data showed a 200 percent increase in the rate of
citations for unnecessary antipsychotic use from 2015 to 2016 under the Obama Administration
(when Obama-era nursing home regulations went into full effect). From 2016 to 2017, the
average national citation rate remained relative stable, decreasing by 3.9 percent (about 130 total
citations) nationwide. This period was followed by a 22 percent decline in citations from 2017 to
2018 under the Trump Administration, which coincided with a period of SNF deregulation.
Rau, Jordan, Trump Administration Cuts the Size of Fines for Health Violations in Nursing Homes. National
Public Radio, (2019). Available at: https://www.npr.org/sections/health-shots/2019/03/15/702645465/trumpadministration-cuts-the-size-of-fines-for-health-violations-in-nursing-hom
15

7

 Some research suggests this national reduction may also be the result of SNFs increasingly
falsifying psychosis diagnoses to avoid inappropriate antipsychotic citations. 16, 17
Overall, rates of antipsychotic citations remain high, particularly in the Northwest
and Midwest. In 2018, state surveyors issued an average of 49 citations for unnecessary
antipsychotic medications in SNFs. About 15 percent of SNFs nationwide (2,327), received at
least one antipsychotic citation that year. States in the Pacific Northwest and Midwest had
relatively higher antipsychotic citation rates.
Ten percent of citations associated with “Actual Harm” or “Immediate Jeopardy”
to a resident’s health or safety resulted in no fine. In 2017-2018, surveyors issued 70 citations
for “Actual Harm” or “Immediate Jeopardy to Resident Health or Safety” across the country.
Only 0.02 percent of all antipsychotic citations (41 of the total 5,704 antipsychotic citations)
within the 2017-2018 dataset documented “Actual Harm” or “Immediate Jeopardy.” Nearly onefourth of these citations were associated with a fine of less than $20,000, and almost 10 percent
of these citations resulted in no penalty whatsoever, despite each of these citations being
associated with actual harm to a resident.
The analysis presented in this report illustrates that, across the nation, antipsychotic
citation rates have decreased dramatically since 2017. Nevertheless, use of antipsychotics
remains high, particularly in the Northwest and Midwest, and the extent to which nursing home
management may have falsified diagnoses to justify the inappropriate use of these drugs as a
chemical restraint is relatively unknown. Regulatory roll-back and a lack of meaningful federal
enforcement may have also played a significant role in permitting the use of antipsychotics to
continue.
The high rate of antipsychotics use across our nation’s nursing homes shows that many
facilities continue to resort to the use of these potentially dangerous drugs as a chemical restraint
– in lieu of proper staffing – which has the potential to harm hundreds of thousands of patients.
As the population continues to age and more Baby Boomers increasingly rely on institutional
care provided in SNFs, it is critical that meaningful steps are taken to reduce the overuse of
antipsychotics and ensure the nation adequately and appropriately addresses the needs of these
vulnerable patient groups.

16
Flamm, Hannah, Why are nursing homes drugging dementia patients without their consent? The Washington Post,
(2018). Available at: https://www.washingtonpost.com/outlook/2018/08/10/8baff64a-9a63-11e8-8d5ec6c594024954_story.html
17
Urick, Kaskie, Carnahan,. Improving antipsychotic prescribing practices in nursing facilities: The role of surveyor
methods and surveying agencies in upholding the Nursing Home Reform Act. Res Social Admin Pharm ,(2016). JanFeb;12(1):91-103.

8

 INTRODCUTION
“I do not mess with no Seroquel [an antipsychotic drug]. I don’t know what the
drug does. But I know it’s dangerous. I was seeing monkeys on the wall… It
knocks you out. It’s a powerful, powerful drug. I sleep all the time. I have to ask
people what the day is... That Seroquel: that’s gonna kill me.”
— Ruth D., a 62-year-old woman who said she was given Seroquel (an antipsychotic medication)
without her knowledge or consent in a nursing facility in Texas
Quotes provided to Committee from Human Rights Watch analysis; US: Nursing Homes Misuse Drugs to Control Residents, Human
Rights Watch, (2018). Available at: https://www.hrw.org/news/2018/02/05/us-nursing-homes-misuse-drugs-control-residents

When the U.S. Congress passed the Omnibus Reconciliation Act (OBRA) of 1987, it
included the Nursing Home Reform Act (NHRA), which outlawed the inhumane use of chemical
and physical restraints for residents of skilled nursing facilities (SNFs), except in cases where
such restraints were necessary to protect a patient from doing physical harm to
himself/herself/themself or to others. 18, 19 Instead of eliminating restraints altogether, passage of
the NHRA shifted focus to another kind of restraint: those induced by medications, often called
“chemical restraints.” 20 For the purposes of this report, the Committee defines “chemical
restraint” as the use of a drug indicated for a psychiatric disorder that is inappropriately
prescribed to a resident to modify behavior or for the purposes of discipline or convenience. 21
Scientists first developed antipsychotic drugs in the 1950s as psychotropic drugs that
could alter the central nervous system. 22 They were originally developed to treat schizophrenia,
but some were later approved to treat other conditions, including Tourette’s Syndrome and
bipolar disorder. 23 Although not clinically indicated for dementia, many patients being treated
for dementia have received these drugs, leading the Food and Drug Administration (FDA) to
issue a black box warning specifically stating that the use of off-label antipsychotics among
seniors without a qualifying diagnosis described on the drug’s label can result in injuries,
hospitalizations, and even death (see Figure 1). 24, 25

Klauber, Martin and Wright, Bernadette, The 1987 Nursing Home Reform Act, American Association of Retired
Persons, (2001). Available at: https://www.aarp.org/home-garden/livable-communities/info2001/the_1987_nursing_home_reform_act.html
19
Subtitle C of the Omnibus Reconciliation Act (OBRA) of 1987, Pub. L. No. 100-203.
20
US: Nursing Homes Misuse Drugs to Control Residents, Human Rights Watch, (2018). Available at:
https://www.hrw.org/news/2018/02/05/us-nursing-homes-misuse-drugs-control-residents
21
Flamm, Hannah, Why are nursing homes drugging dementia patients without their consent? The Washington Post,
(2018). Available at: https://www.washingtonpost.com/outlook/2018/08/10/8baff64a-9a63-11e8-8d5ec6c594024954_story.html
22
Id.
23
Id.
24
Id.
25
Atypical Antipsychotic Medications: Use in Adults, Centers for Medicare and Medicaid Services, (2015).
Available at: https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-IntegrityEducation/Pharmacy-Education-Materials/Downloads/atyp-antipsych-adult-factsheet11-14.pdf
18

9

 Figure 1. Example of FDA Black Box Warning Label for Antipsychotic, Risperdal 26
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. RISPERDAL® is not approved for
use in patients with dementia-related psychosis. (5.1)
Although off-label prescribing of medications is legal and typically used for specific
patient populations in select scenarios, the extensive off-label use of antipsychotic medications in
nursing homes does not fall within scenarios of typical off-label medication use and can be
dangerous to patients. One study found that the inappropriate use of antipsychotic medication
was associated with a 50 percent increased risk patients experiencing a serious fall-related bone
fracture. 27 Furthermore, the Centers for Medicare & Medicaid Services (CMS) requires that
nursing facility staff employ non-pharmacological approaches, prior to dispensing antipsychotic
medications for off-label use, and implement a gradual dose reduction regimen as part of the
CMS Developing a Restful Environment Action Manual (DREAM) Toolkit. 28
The use of antipsychotics in SNFs has increased dramatically since passage of NHRA in
1987. In 2007, the Department of Health and Human Services (HHS) Office of Inspector General
(OIG) found that 14 percent of Medicare nursing home residents had claims for an antipsychotic
drug, and 83 percent of these claims were for off-label use. 29 CMS reported that in 2010, nearly
40 percent of nursing home residents who did not have a psychosis diagnosis were receiving
antipsychotic medications – a pattern that, research shows, persists. 30, 31
In response to the dramatic increase in antipsychotic misuse in SNFs, CMS started a
voluntary program in 2012 to reduce the use of antipsychotics and educate nursing home staff
about using behavioral interventions instead of medication. 32 During the same time period,
consumer advocacy organizations and federal agencies, such as the American Psychiatric
Association (APA) and the Substance Abuse and Mental Health Services Administration

Risperdal Black Box Warning, Seeger Weiss, LLP (2020). Available at:
https://www.drugdangers.com/risperdal/black-box-warning/
27
Fraser, Lisa-Ann, Falls and Fractures With Atypical Antipsychotic Medication Use, JAMA Network, (2015).
Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2089230
28
Civil Money Penalty Reinvestment Program, Centers for Medicare and Medicaid Services, (2020). Available at:
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/LTC-CMPReinvestment
29
Introcaso, David, The Never-Ending Misuse of Antipsychotics in Nursing Homes, Health Affairs, (2018).
Available at: https://www.healthaffairs.org/do/10.1377/hblog20180424.962541/full/
30
Id.
31
Improving antipsychotic prescribing practices in nursing facilities: The role of surveyor methods and surveying
agencies in upholding the Nursing Home Reform Act, Research in Social and Administrative Pharmacy (2016);
12:91–103.
32
Introcaso, David, The Never-Ending Misuse of Antipsychotics in Nursing Homes, Health Affairs, (2018).
Available at: https://www.healthaffairs.org/do/10.1377/hblog20180424.962541/full/
26

10

 (SAMHSA) also released guidelines aimed at reducing inappropriate use of antipsychotics in
SNFs. 33, 34
Between 2011 and 2016, CMS reported that
the rate of antipsychotics prescribed in SNFs
decreased from 24 percent of residents in 2011 to 16
percent in 2016. That rate is still abnormally high,
given that only about two percent of the general
population will ever have a diagnosis of psychosis or
other medical condition for which the FDA has
approved the use of antipsychotic drugs. 35, 36
Moreover, evidence shows that some SNFs may be
falsifying psychosis diagnoses to avoid inappropriate antipsychotic citations. 37 According to a
2016 study, almost 40 percent of state surveyors said they had identified a new but incorrect
diagnosis of psychosis in a nursing home to justify an inappropriate antipsychotic prescription. 38
The onset of bipolar disorder and schizophrenia rarely occur in people over the age of 30, but
data show a 30 percent increase in schizophrenia diagnoses from 2011 to 2017 in the elderly
population. 39
The onset of bipolar disorder and
schizophrenia rarely occur in
people over the age of 30, but
data show a 30 percent increase
in schizophrenia diagnoses from
2011 to 2017 in the elderly
population.

While the Obama Administration took steps to crack down on the high rates of
prescribing in SNFs in 2016, the Trump Administration subsequently rolled back those
protections. 40 By 2018, approximately 20 percent of all nursing home residents in the U.S.,
including 40 percent of those with dementia, were prescribed some form of antipsychotic
APA Releases New Practice Guidelines on the Use of Antipsychotics in Patients with Dementia, American
Psychiatric Association, (2016). Available at: https://www.psychiatry.org/newsroom/news-releases/apa-releasesnew-practice-guidelines-on-the-use-of-antipsychotics-in-patients-with-dementia
34
Guidance on Strategies to Promote Best Practice in Antipsychotic Prescribing for Children and Adolescents,
Substance Abuse and Mental Health Services Administration, (2018). Available at:
https://store.samhsa.gov/system/files/pep19-antipsychotic-bp.pdf
35
Flamm, Hannah, They Want Docile, Human Rights Watch, (2018). Available at:
https://www.hrw.org/report/2018/02/05/they-want-docile/how-nursing-homes-united-states-overmedicate-peopledementia
36
How Common is Psychosis, National Institute of Health, National Institute of Mental Health, (2019). Available
at: https://www.nimh.nih.gov/health/topics/schizophrenia/raise/raise-questions-and-answers.shtml#3
37
Flamm, Hannah, Why are nursing homes drugging dementia patients without their consent? The Washington Post,
(2018). Available at: https://www.washingtonpost.com/outlook/2018/08/10/8baff64a-9a63-11e8-8d5ec6c594024954_story.html
38
Urick, Kaskie, Carnahan,. Improving antipsychotic prescribing practices in nursing facilities: The role of surveyor
methods and surveying agencies in upholding the Nursing Home Reform Act. Res Social Admin Pharm ,(2016). JanFeb;12(1):91-103.
39
Jonathan D. Winter et al., Increased Reporting of Exclusionary Diagnoses Inflate Apparent Reductions in LongStay Antipsychotic Prescribing, 42:3, 297-301, Clinical Gerontologist, (2019). Available at:
https://www.tandfonline.com/doi/abs/10.1080/07317115.2017.1395378; Johns Hopkins Medicine, Study suggests
overdiagnosis of schizophrenia: Reported symptoms of anxiety and hearing voices most common reasons for
misdiagnosis by non-specialty physicians, ScienceDaily, (2019). Available at:
https://www.sciencedaily.com/releases/2019/04/190422090842.htm
40
Rau, Jordan, Trump Administration Cuts the Size of Fines for Health Violations in Nursing Homes, National
Public Radio, (2019). Available at: https://www.npr.org/sections/health-shots/2019/03/15/702645465/trumpadministration-cuts-the-size-of-fines-for-health-violations-in-nursing-hom
33

11

 medication, most without any diagnosis of psychosis. 41, 42 Accordingly, this report provides an
overview of the changes in oversight and regulation of antipsychotic use from 2015 to 2018 and
documenting associated trends in antipsychotic use in SNFs during those years.

Flamm, Hannah, They Want Docile, Human Rights Watch, (2018). Available at:
https://www.hrw.org/report/2018/02/05/they-want-docile/how-nursing-homes-united-states-overmedicate-peopledementia
42
Mollot, Richard, Despite Promised Crackdown, Citations for Inappropriate Drugging Remain Rare, Long Term
Community Coalition, (2018). Available at: https://nursinghome411.org/wp-content/uploads/2018/11/LTCCCAdvisory-Nursing-Home-Drugging-Citations-November-2018.pdf
41

12

 BACKGROUND
In response to the Health Care Financing Administration’s (later renamed CMS) 1982
proposal to ease the annual inspection and certification requirement for SNFs, the Institute of
Medicine (IOM; later renamed the National Academy of Medicine) conducted a comprehensive
two-year study of nursing home regulations, ultimately publishing Improving the Quality of Care
in Nursing Homes in 1986. The report catalogued inadequacies in the nursing home regulatory
system and issued a number of conclusions and recommendations (see Figure 2 below). 43
Figure 2. 1986 IOM Nursing Home Conclusions
1) Quality of care and quality of life in many nursing homes are not satisfactory.
2) More effective government regulation can substantially improve quality in nursing
homes. A stronger federal role is essential.
3) Specific improvements are needed in the regulatory system.
4) There are opportunities to improve quality of care in nursing homes that are independent
of changes in Medicaid payment policy or bed supply.
5) Regulation is necessary but not sufficient for high-quality care.
6) A system to obtain standardized data on residents is essential.
7) The regulatory system should be dynamic and evolutionary in outlook.
These conclusions served as the basis for the NHRA, included in OBRA of 1987, which
established standards of care that facilities had to meet to receive reimbursement under the
Medicare and Medicaid programs. 44 The NHRA also strengthened the survey process to
determine nursing home compliance with federal care standards and implemented an
enforcement system that could respond with meaningful penalties to the noncompliance that
surveyors identified and cited. 45 The law included a lengthy “Residents’ Bill of Rights” and
effectively banned the use of physical and chemical restraints “imposed for purposes of
discipline or convenience and not required to treat the resident’s medical symptoms.” 46
Although the NHRA was successful in reducing physical restraints – which declined
from 21.1 percent in 1991 to less than five percent in 2007 – the decline in physical restraints
gave way to the unintended rise in the use of chemical restraints. 47

Improving the Quality of Care in Nursing Homes, National Academies of Sciences Engineering Medicine,
Institute of Medicine, (1986). Available at: https://www.nap.edu/read/646/chapter/2
44
Id.
45
Id.
46
Nursing Home Reform Act, Nursing Home Abuse Guide, Paul and Perkins PA, (2019). Available at:
https://nursinghomeabuseguide.com/resources/nursing-home-reform-act/
47
A letter to state survey agency directors, Freedom from Unnecessary Physical Restraints: Two Decades of
National Progress in Nursing Home Care, Centers for Medicare and Medicaid Services, (2008). Available at:
https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationGenInfo/downloads/SCLetter09-11.pdf
43

13

 Current State of Affairs: Antipsychotic Overuse is a National Problem
Antipsychotic misuse. Although the 2011 HHS OIG report shined a national spotlight on
antipsychotic overuse in nursing homes, inappropriate use of these medications remains a major
national issue today. In 2018, approximately 20 percent of all nursing home residents continued
to receive antipsychotics, while only about two percent had qualifying conditions that medically
indicate such drugs were appropriate. 48, 49, 50 In the
The Human Rights Watch found
fourth quarter of 2019, approximately 20 percent of
that in 2018, antipsychotic drugs
all skilled nursing facility (SNF) residents in the U.S.
were administered weekly to
– about 298,650 people every week – received some
more than 179,000 nursing home
form of antipsychotic medication, most without any
51, 52
residents who do not have
diagnosis of psychosis.
A 2018 Human Rights
diagnoses for which the drugs are
Watch (HRW) report found similar antipsychotic
approved.
drugging rates and concluded that CMS may be
under-enforcing its own guidance, as less than one
percent of all antipsychotic citations also identified resident harm. 53
Resident harm. The off-label use of antipsychotics can be particularly harmful for frail,
elderly patients, leading to injuries, hospitalizations, and even death. 54 A 2015 literature review
of clinical outcomes related to antipsychotic use showed that antipsychotic medication use in
nursing homes resulted in increased risk of many adverse events for nursing home residents,
including hip fractures, thrombotic events, cardiovascular events, hospitalizations, and death. 55
These drugs carry severe potential side effects, including blood clots, diabetes, dyskinesia, fall
risk, irreversible cognitive decompensation, pneumonia, severe nervous system problems, stroke,
and visual disturbances. 56 One study found that elderly individuals with dementia using
Levinson, Daniel, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,
Department of Health and Human Services, (2011). Available at: https://oig.hhs.gov/oei/reports/oei-07-0800150.pdf
49
Phillips, et al., An observational study of antipsychotic medication use among long‐stay nursing home residents
without qualifying diagnoses, Psychiatric and Mental Health Nursing, (2018). 1-12.
50
MDS 3.0 Frequency Report, Centers for Medicare and Medicaid Services, (2019). Available at:
https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Minimum-Data-Set-3-0Public-Reports/Minimum-Data-Set-3-0-Frequency-Report.html
51
Committee calculations of MDS Frequency Report: Fourth Quarter 2019 Antipsychotic Medications Received,
Centers for Medicare and Medicaid Services, (2019). Available at:
https://www.cms.gov/apps/mds/mds_notemp/mds30FreqStart.asp?isSubmitted=mds30Freq3&var=N0410A&date=3
3
52
Mollot, Richard, Despite Promised Crackdown, Citations for Inappropriate Drugging Remain Rare, Long Term
Care Community Coalition, (2018). Available at: https://nursinghome411.org/wp-content/uploads/2018/11/LTCCCAdvisory-Nursing-Home-Drugging-Citations-November-2018.pdf
53
Id.
54
Atypical Antipsychotic Medications: Use in Adults, Centers for Medicare and Medicaid Services, (2015).
Available at: https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-IntegrityEducation/Pharmacy-Education-Materials/Downloads/atyp-antipsych-adult-factsheet11-14.pdf
55
Chiu, Yunwen et al., A literature review of clinical outcomes associated with antipsychotic medication use in
North American nursing home residents. Science Direct, (2015). Available at:
http://dx.doi.org/10.1016/j.healthpol.2015.02.014
56
Introcaso, David, The Never-Ending Misuse of Antipsychotics in Nursing Homes, Health Affairs, (2018).
Available at: https://www.healthaffairs.org/do/10.1377/hblog20180424.962541/full/
48

14

 antipsychotics were in the hospital nearly 1.5 times as long per year relative to those who were
not using antipsychotic drugs (i.e., 52 days compared to 35 days per year). 57 Another study
found that antipsychotic use increased the mortality risk among elderly individuals with
dementia by as much as 3.8 percent. 58 Furthermore, persons over 70 are 3.5 times more likely
than younger individuals to be admitted to the hospital due to adverse drug reactions associated
with psychotropic medications. 59
The American Geriatrics
Society Beers criteria, a widely
respected reference for safe
prescribing for the elderly, lists
antipsychotic medications in the
category of “strongly recommended
— Texas nursing home social worker
against use” because of these
Quotes provided to Committee from Human Rights Watch analysis; US: Nursing
potential harms. 60 In fact, the 2018
Homes Misuse Drugs to Control Residents, Human Rights Watch, (2018).
HRW study reported that many
Available at: https://www.hrw.org/news/2018/02/05/us-nursing-homes-misusedrugs-control-residents
nursing home residents and their
family members reported sedation,
cognitive decline, fear, and the inability to communicate from the overuse of these medications.
61
The report also found that many nursing facilities often fail to obtain informed consent from
patients or their families, a recommendation provided by the Substance Abuse and Mental Health
Services Administration (SAMHSA) – and some facilities reportedly pressured individuals to
give consent, despite federal law barring these practices and many state laws requiring informed
consent as a predicate to off-label prescribing. 62, 63
“Since you’re taking that medicine, then you get
a diagnosis. That’s how you get a diagnosis. If
we’re treating the symptoms, then you have the
disease.”

Relationship with staffing levels. Research shows that inappropriate use of
antipsychotics is linked to lower registered nurse (RN) staffing levels: For residents with and
without dementia, one additional RN hour per resident-day could reduce the odds of
antipsychotic use by 52 percent and 56 percent, respectively. 64 Another study found that a staff
training intervention focusing on alternatives to drugs for agitation led to a 19.1 percent

Bushak, Lecia, Antipsychotic Drugs Linked to More Hospitalizations Among Dementia Patients, Being Patient,
(2019). Available at: https://www.beingpatient.com/antipsychotics-dementia/
58
Maust, Donovan et al., Antipsychotics, other Psychotropics and the Risk of Death in Patients With Dementia,
JAMA Network, (2015). Available at: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2203833
59
Brooks, Hoblyn, Neurocognitive costs and benefits of psychotropic medications in older adults, Journal of
Geriatric Psychiatry and Neurology, (2007); 20:199–214.
60
American Geriatrics Society 2019 Updated AGS Beers Criteria for Potentially Inappropriate Medication Use in
Older Adults, American Geriatrics Society, (2019). Available at:
https://qioprogram.org/sites/default/files/2019BeersCriteria_JAGS.pdf
61
Flamm, Hannah, They Want Docile, Human Rights Watch, (2018). Available at:
https://www.hrw.org/report/2018/02/05/they-want-docile/how-nursing-homes-united-states-overmedicate-peopledementia
62
Id.
63
Guidance on Inappropriate Use of Antipsychotics, Substance Abuse and Mental Health Services Administration,
(2019). Available at: https://store.samhsa.gov/system/files/pep19-inappuse-br_0.pdf
64
Phillips, et al., An observational study of antipsychotic medication use among long‐stay nursing home residents
without qualifying diagnoses, Psychiatric and Mental Health Nursing, (2018).
57

15

 reduction in neuroleptic prescribing. 65 According to the HRW report, experts interviewed agreed
that many nursing facilities exhibited staffing levels well below what is needed to provide
appropriate care, further confirming the link between staffing levels and the overuse of
antipsychotics as a chemical restraint. 66
Medicare costs. In addition to the harm
For residents with and without
antipsychotic overuse inflicts on patients and
dementia, one additional RN hour
families, it also carries a high public cost. About
per resident-day could reduce the
one-third of older adult Medicare Part D enrollees
odds of antipsychotic use by 52
with dementia who spent more than 100 days in a
percent and 56 percent,
nursing home were prescribed an antipsychotic in
respectively.
2012, constituting roughly $363 million in Part D
plan payments that year. 67 Furthermore, falls – a
type of adverse event associated with inappropriate use of antipsychotics in senior populations –
are particularly expensive, annually costing $50 billion (non-fatal) and $754 million (fatal) for
the 65 and older population, according to the Centers for Disease Control and Prevention. 68 Not
only does the public bear the cost of overprescribing, but inappropriate prescribing also increases
Medicare spending due to increased hospitalizations. 69
Recommendations to Reduce Antipsychotic Use in Skilled Nursing Facilities
Due to the ubiquity of antipsychotic use in nursing homes, federal and private sector
organizations have developed clinical guidelines for their use. The 2016 APA guidance
recommended that patients with dementia be assessed for pain and other potentially modifiable
contributors to symptoms prior to providers prescribing antipsychotics. 70 The organization also
recommended creating a treatment plan that includes nonpharmacological interventions, a
benefit assessment of antipsychotic use, and medication tapering or withdrawal if no clinically
significant response is found after a four-week trial. 71
In 2019, SAMHSA also released guidance, recommending informed consent, side-effect
profiling of antipsychotics that align with patient risk, and employment of nonpharmacological
65

Mattingly, Joseph, A Review Exploring the Relationship Between Nursing Home Staffing and Antipsychotic
Medication Use, National Center for Biotechnology Information, (2015). Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685870/
66
Id.
67
Antipsychotic Drug Use: HHS has Initiatives to Reduce Use among Older Adults in Nursing Homes but Should
Expand Efforts to Other Settings, Government Accountability Office, (2015). Available at:
https://www.gao.gov/assets/670/668221.pdf
68
Falls Data: Cost of Older Adults Falls, Centers for Disease Control and Prevention, (2019). Available at:
https://www.cdc.gov/homeandrecreationalsafety/falls/fallcost.html
69
Lund, Brian et. al., Effect of Hospitalization on Inappropriate Prescribing in Elderly Medicare Beneficiaries,
Journal of the American Geriatrics Society, (2018). Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5844260/
70
American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis
in Patients with Dementia, American Psychiatric Association, (2016). Available at:
https://psychiatryonline.org/doi/pdf/10.1176/appi.books.9780890426807
71
Id.

16

 approaches prior to antipsychotic use. 72 In the event of antipsychotic use, staff should monitor
the patient’s vital signs in the determination for reassessment, SAMHSA said. 73 These
nonpharmaceutical approaches and gradual dose reductions have been required as the standard of
care for decades, since the passage of the NHRA in 1987. 74
Administrative Efforts to Reduce Antipsychotic Use in Skilled Nursing Facilities
In 2011, then-CMS Administrator Donald Berwick met with nursing home advocates
from several organizations, who expressed concerns over the high rate of antipsychotic
medications in nursing homes. 75 The meeting resulted in CMS establishing a 2012 voluntary
program under the Obama Administration, the “National Partnership to Improve Dementia Care
in Nursing Homes,” to reduce antipsychotic overuse with behavioral techniques. 76 The National
Partnership is a public-private coalition that includes CMS, consumers, advocacy organizations,
providers, professional associations, and dementia care leaders in every state with the goal of
encouraging nursing homes to implement non-pharmacologic approaches and person-centered
dementia care practices. 77
Beginning in July of 2012, CMS began publicly reporting data on the prescribing of
antipsychotics to nursing home residents. 78 Additionally, CMS updated its survey process to
improve surveyors’ ability to detect deficient practices related to dementia care and unnecessary
antipsychotic medication use. 79 This process included updating the unnecessary medication
citation to specifically include the unnecessary use of psychopharmacological medications, such
as antipsychotics. 80 CMS began nationwide training programs on this updated guidance for all of
its state surveyors. By 2015, all CMS state surveyors had completed the nationwide training. 81

Guidance on Inappropriate Use of Antipsychotics, Substance Abuse and Mental Health Services Administration,
(2019). Available at: https://store.samhsa.gov/system/files/pep19-inappuse-br_0.pdf
73
Id.
74
Klauber, Martin and Wright, Bernadette, The 1987 Nursing Home Reform Act, American Association of Retired
Persons, (2001). Available at: https://www.aarp.org/home-garden/livable-communities/info2001/the_1987_nursing_home_reform_act.html
75
Interim report on the CMS National Partnership to Improve Dementia Care in Nursing Homes: Q4 2011 – Q1
2014, Centers for Medicare and Medicaid Services, (2014). Available at: https://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-19.pdf
76
Introcaso, David, The Never-Ending Misuse of Antipsychotics in Nursing Homes, Health Affairs, (2018).
Available at: https://www.healthaffairs.org/do/10.1377/hblog20180424.962541/full/
77
National Partnership to Improve Dementia Care exceeds goal to reduce use of antipsychotic medications in
nursing homes: CMS announces new goal. Centers for Medicare and Medicaid Services, (2014). Available at:
https://www.cms.gov/newsroom/press-releases/national-partnership-improve-dementia-care-exceeds-goal-reduceuse-antipsychotic-medications-nursing
78
Id.
79
Id.
80
Id.
81
Id.
72

17

 Surveyors rank citations on a 1 to 4 scale, in which a Level 1 deficiency corresponds to
No Actual Harm with Potential for Minimal Harm to the resident and a Level 4 deficiency
corresponds to Immediate Jeopardy to Resident Health or Safety (see Table 1). According to
CMS, a Level 3 deficiency (Actual Harm that is Not Immediate Jeopardy) represents
“noncompliance with the requirements that results in actual harm to residents that is not
Immediate Jeopardy,” while a Level 4 deficiency (Immediate Jeopardy to resident health or
safety) represents “a situation in which entity noncompliance has placed the health and safety of
recipients in its care at risk for serious injury, serious harm, serious impairment, or death.” 82, 83
Table 1. Interpretation of Scope and Severity of Unnecessary Medication Citations
Severity
Level

Description of Level

Scope is
Isolated

Scope is
Pattern

Scope is
Widespread

1

No Actual Harm with Potential
for Minimal Harm

A

B

C

2

No Actual Harm with Potential
for more than Minimal Harm
that is not Immediate Jeopardy

D

E

F

3

Actual Harm that is Not
Immediate Jeopardy

G

H

I

4

Immediate Jeopardy to
Resident Health or Safety

J

K

L

Source: Table 1. was reproduced from the California Department of Public Health Consumer Guide table on
interpreting the severity of a deficient practice that is cited in a federal recertification survey.

Beyond documenting antipsychotic use, CMS enacted other relevant regulatory measures
from 2012 and 2016. In 2014, CMS started fining nursing homes on a per-day basis, for each day
they were inappropriately prescribing antipsychotic medications. In 2016, CMS published a
Final Rule, “Medicare and Medicaid Programs, Reform of Requirements for Long-Term Care
Facilities” (CMS-3260-F), which strengthened the public enforcement system for SNFs cited
with violating federal standards of care, called Requirements of Participation (RoPs). 84 This
State Operations Manual: Appendix Q – Core Guidelines for Determining Immediate Jeopardy, Centers for
Medicare and Medicaid Services, (2019). Available at: https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/som107ap_q_immedjeopardy.pdf
83
Nursing Home Enforcement – Frequently Asked Questions, Centers for Medicare and Medicaid Services,
Available at: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationEnforcement/Downloads/NH-Enforcement-FAQ.pdf
84
Medicare and Medicaid Programs; Reform of Requirements for Long Term Care Facilities, Centers for Medicare
and Medicaid Services, (2016). Available at: https://www.govinfo.gov/content/pkg/FR-2016-10-04/pdf/201623503.pdf
82

18

 change was part of a five-year initiative to revise the federal RoPs, which included strengthening
the protections against the inappropriate use of antipsychotics in SNFs. 85 This Final Rule
increased requirements for pharmacists to report irregularities in antipsychotic overuse,
established a 14-day PRN (pro re nata or “as needed”) limitation on psychotropic drugs, and
implemented behavioral health measures that were targeted to enhance person-centered care. 86
Finally, CMS directed that civil money penalties (CMPs) be imposed against nursing homes for
all deficiencies, including the misuse and overuse of antipsychotic drugs, on a per-day basis – for
each day an individual SNF violated these federal RoPs. By 2016, two-thirds of all CMPs for
facility deficiencies were per-day penalties. Ultimately, the Obama Administration aimed to
strengthen nursing home regulations, some of which had not been updated since 1991. 87
CMS reported that its efforts
But the nursing homes don’t want behaviors.
reduced antipsychotic use in nursing
They want docile. They want people with no
facilities from 24 percent of residents
cognitive deficits who can take care of
in 2011 to 16 percent in 2016. 88 Still,
themselves. I’ve worked in nursing homes.
the national reduction in
They’d say, ‘Send them to [the psychiatric
antipsychotics use may be misleading
hospital] to get medicated and let them
because data showed a spike in
come back.’”
schizophrenia diagnoses during this
time period, suggesting that some
— Texas behavioral hospital social worker
SNFs may have falsified psychosis
Quotes provided to Committee from Human Rights Watch analysis; US: Nursing
diagnoses to avoid inappropriate
Homes Misuse Drugs to Control Residents, Human Rights Watch, (2018).
Available at: https://www.hrw.org/news/2018/02/05/us-nursing-homes-misuseantipsychotic citations. 89 One study
drugs-control-residents
found that almost 40 percent of state
surveyors reported a new but incorrect
diagnosis of psychosis to justify an inappropriate antipsychotic prescription in a nursing home. 90
There is also some concern among advocates and researchers that nursing homes are replacing
these highly regulated antipsychotics with alternative sedating drugs, which pose similar health
risks. 91

Edelman, Toby, Deregulating Nursing Homes, American Bar Association, (2018). Available at:
https://www.americanbar.org/groups/law_aging/publications/bifocal/vol--39/issue-3--february-2018/DeregulatingNursingHomes/
86
Id.
87
US: Nursing Homes Misuse Drugs to Control Residents, Human Rights Watch, (2018). Available at:
https://www.hrw.org/news/2018/02/05/us-nursing-homes-misuse-drugs-control-residents
88
Introcaso, David, The Never-Ending Misuse of Antipsychotics in Nursing Homes, Health Affairs, (2018).
Available at: https://www.healthaffairs.org/do/10.1377/hblog20180424.962541/full/
89
Flamm, Hannah, Why are nursing homes drugging dementia patients without their consent? The Washington Post,
(2018). Available at: https://www.washingtonpost.com/outlook/2018/08/10/8baff64a-9a63-11e8-8d5ec6c594024954_story.html
90
Urick, Kaskie, Carnahan,. Improving antipsychotic prescribing practices in nursing facilities: The role of surveyor
methods and surveying agencies in upholding the Nursing Home Reform Act. Res Social Admin Pharm ,(2016). JanFeb;12(1):91-103.
91
Flamm, Hannah, Why are nursing homes drugging dementia patients without their consent? The Washington Post,
(2018). Available at: https://www.washingtonpost.com/outlook/2018/08/10/8baff64a-9a63-11e8-8d5ec6c594024954_story.html
85

19

 On the state level, efforts to reduce antipsychotic use have been relatively stagnant. 92
Most state policies that go beyond the federal requirements focus on physical rather than
chemical restraints. 93 Still, a number of states, such as Kansas, Oklahoma, and Ohio, have
broadened the definitions of key terms – SNF, licensed bed, agent, antipsychotic drug, and/or
continuing care retirement facilities – to expand the scope of antipsychotic misuse enforcement.
California, Oklahoma, and Illinois have extended regulations to require that physicians obtain
informed consent from either the resident or resident’s interested family members. 94 Finally,
other states, including Oklahoma, Ohio, and Tennessee, have developed financial incentive
programs that include specific target thresholds for antipsychotic use among SNF long-stay
residents. 95
Trump Administration Reduction in Skilled Nursing Facility Oversight
Despite efforts at both the state and federal levels to reduce the inappropriate use of
antipsychotics, the HRW report found inadequate enforcement of federal nursing home
regulations because surveyors only categorized two percent of all 2017 antipsychotic deficiency
citations as “Actual Harm” (Level Three) or
“Immediate Jeopardy” (Level Four); see Table
Rather than implementing a five1. 96, 97 As explained in the HRW report, the Trump
year initiative to reduce
Administration’s “Patients over Paperwork”
antipsychotic use, CMS imposed
initiative undid much of the progress made under
an 18-month moratorium on these
the Obama Administration by prioritizing
Obama-era regulations.
reductions in provider burden over a number of
consumer protections, including a reduction in fines for the overuse of antipsychotics – even
when the result was the death of a nursing home resident. 98 In November 2018, CMS imposed an
18-month moratorium on eight new Obama-era safety regulations, including the 14-day PRN
limitation on psychotropic drugs and CMPs associated with antipsychotic citations under the
updated survey process. 99
More specifically, the Trump Administration eliminated the Obama-era per-day fining
practices in July of 2017, which resulted in CMS issuing a single fine for two-thirds of all
inappropriate antipsychotic citations that would have previously resulted in a per-day fine. 100
Congressional Research Service, e-mail message to authors, August 23, 2019.
Id.
94
Id.
95
Id.
96
The severity of a deficiency is based on a level of 1 to 4, where a Level 1 deficiency implies no actual harm with
the potential for minimal harm and a Level 4 deficiency implies Immediate Jeopardy to resident health or safety.
97
US: Nursing Homes Misuse Drugs to Control Residents, Human Rights Watch, (2018). Available at:
https://www.hrw.org/news/2018/02/05/us-nursing-homes-misuse-drugs-control-residents
98
Rau, Jordan, Trump Administration Eases Nursing Home Fines in Victory for Industry, (2017). Available at:
https://www.nytimes.com/2017/12/24/business/trump-administration-nursing-home-penalties.html
99
Temporary Enforcement Delays for Certain Phase 2 F-Tags and Changes to Nursing Home Repair, Centers for
Medicare and Medicaid Services, (2017). Available at: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-04.pdf
100
Rau, Jordan, Trump Administration Cuts the Size of Fines for Health Violations in Nursing Homes, National
Public Radio, (2019). Available at: https://www.npr.org/sections/health-shots/2019/03/15/702645465/trumpadministration-cuts-the-size-of-fines-for-health-violations-in-nursing-hom
92
93

20

 According to a Kaiser Health News (KHN) report, average aggregate fines on nursing homes
found to have endangered or injured residents dropped from $41,260 during President Obama’s
last year in office (2016) to $28,405 in the period between April 2017 and March 2018. 101 KHN
also found that CMS issued financial penalties for Immediate Jeopardy citations in fewer cases
under the new Trump-era rules compared to the prior administration, and fines were 18 percent
lower than they were in 2016. 102 Critics of the earlier approach have suggested the Obama-era
regulations led to fines that were based on random timing of an inspection as opposed to the
severity of the infraction. 103 For instance, under the Obama Administration approach, if
surveyors discovered a deficient practice had been occurring for two months, as opposed to one
month, the overall fine would be double, even if the infraction was the same. 104 For a Table
cataloguing major CMS policies and actions related to reducing or eliminating nursing home
protections from May 2017-March 2020, please see Table 5 in Appendix C.
Ways and Means Committee Responses to Trump-Era Deregulation in SNF Setting
In July 2018, House Ways and Means Committee then-Ranking Member Richard E. Neal
(D-MA) wrote a letter to CMS Administrator Seema Verma expressing concern about the
continued overuse of antipsychotics in nursing homes. 105 CMS responded on November 20,
2018, by highlighting the agency’s administrative actions to reduce antipsychotic misuse. On
January 22, 2019, now-Chairman Neal wrote a follow-up letter to CMS, noting that progress had
slowed in reducing inappropriate use of antipsychotics and raising questions about potential
patterns of falsified psychosis diagnoses. 106
“Unfortunately, CMS’s data are still extremely disappointing, showing that progress
reducing inappropriate use of antipsychotic drugs in nursing homes has slowed.
Moreover, I am concerned that the ‘improvement’ is not the result of changed
prescribing behavior but, instead, stems from some nursing homes falsifying
psychosis diagnoses, making incidence of this contra-indicated prescribing appear
improved when it is, in fact, not.”
— Chairman Richard E. Neal
Letter to CMS, January 22, 2019

Rau, Jordan, Nursing Home Fines Drop as Trump Administration Heed Industry Complaints, Kaiser Health
News, (2019). Available at: https://khn.org/news/nursing-home-fines-drop-as-trump-administration-heeds-industrycomplaints/
102
Id.
103
Id.
104
Id.
105
Neal, Richard, Antipsychotics in individuals with dementia-related psychosis, Ways and Means Committee,
(2018). Available at: https://theconsumervoice.org/uploads/files/general/neal-letter-CMS.pdf
106
Neal, Richard, Continued concern with overuse of antipsychotics in nursing homes, Ways and Means Committee,
(2019). Available at:
https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/SNF_Antipsychotics%2
0letter%20to%20CMS_January%202019.pdf
101

21

 Chairman Neal’s letter concluded with a request for information about CMS’s efforts to
mitigate these issues as well as specific nursing home antipsychotic citation data. 107 While CMS
never provided the Ways and Means Committee with a detailed written plan to reduce
inappropriate antipsychotic use or to reduce falsified antipsychotic diagnoses, the agency
provided the Committee with SNF survey data from 2015 to 2018. This report details the
analysis the Committee conducted using these CMS-provided data to identify changes in
antipsychotic misuse over time and geographic variation (see Methodology section in Appendix
A for more information on the data source and analytic approach used in this report).
On November 14, 2019, the Committee on Ways and Means held a hearing entitled,
“Caring for Aging Americans.” In addition to other elderly caregiving issues, witnesses
discussed many of the unique challenges of caring for individuals with Alzheimer’s disease and
other related dementias, including the misuse of antipsychotics in SNFs. During the hearing,
witness Richard Mollot, a nursing home expert representing The Long Term Care Community
Coalition (LTCCC), discussed antipsychotic misuse and provided some recommendations to
alleviate it:
The overuse and inappropriate use of antipsychotic drugs on residents and nursing homes
and in assisted living and in other settings is really disgraceful, frankly, and it harms
hundreds of thousands of people every day. I would say, first of all, a lot of families that
we talk to, they do not even know that their loved one is receiving these drugs, or they are
explicitly told by caregivers not to look up the drug online. It is really important that we
have informed consent, and as part of that, what Congress could do is to pass an
informed consent bill that included written informed consent and that provided for the
resident and the family to periodically review and, again, give informed consent as
necessary if those drugs are to continue because really there are very, very, very limited
circumstances under which someone should be receiving an antipsychotic drug for any
extended period of time unless they have a condition of schizophrenia or another specific
illness. 108

107

Id.
Richard Mollot. Quote from: U.S. Congress. Hearing of the Committee on Ways and Means. “Caring for Aging
Americans.” (2019). Available at: https://waysandmeans.house.gov/legislation/hearings/caring-aging-americans
108

22

 RESULTS
The following section describes the results from a four-part analysis the Committee
conducted to examine trends in antipsychotic use in SNFs across states, using CMS-provided
data. 109 A description of the methodology used to conduct this analysis is included in Appendix
A.
Analysis of Skilled Nursing Facilities’ Antipsychotic Citations, 2015-2018
From 2015 to 2018, the number of antipsychotic citations in SNFs more than doubled.
Nationally, there was a 124 percent increase in the number of citations (1,381 more citations)
between 2015 and 2018. Despite this marked increase, a year-by-year analysis provides more
insight into the trends (see Figure 3): The number of citations peaked in 2016 (3,337 citations)
and then decreased to 2,497 by 2018. For a state-level breakdown of these data, see Table 3 and
Table 4 in Appendix B.
Figure 3. Nursing Home Antipsychotic Citations, 2015-2018
4000
3337

Antipsychotic Citations

3500

3207

3000

2497

2500
2000
1500

1116

1000
500
0

2015

2016

2017

2018

Year
Source: All data provided by CMS.
Notes: The annual number of unnecessary antipsychotic citations by SNFs in the U.S. from 2015 to 2018 includes
all levels of deficiencies cited. Data include all SNFs cited for tags F0222, F0605 (Free from Chemical Restraints),
F0329, and F0758 (Free from Unnecessary Drugs). F0605 and F0758 replaced F0222 and F0329 beginning on
November 28, 2017.

Figure 3 shows the number of antipsychotic citations nearly tripled from 2015 to 2016 – a
199 percent increase in citation rates (2,221 more citations) with nearly every state experiencing
large increases. The largest of these increases was in California, where SNFs received 280 more
citations across all facilities in 2016 than in 2015 – an increase of 191 percent. Ohio, Texas, New

Data includes all nursing facilities cited for tags F0605 (Free from Chemical Restraints) and F0758 (Free from
Unnecessary Psychotropic Drugs). F0605 and F0758 replaced F0222 and F0329 beginning on November 28, 2017.
109

23

 York, Pennsylvania, and Indiana SNFs, on average, received at least 100 more citations in 2016
than in 2015.
From 2016 to 2017, the average national citation rate was relatively stable, decreasing by
3.9 percent (about 130 total citations) nationwide. Over this time, many states experienced
similar citation rate reductions. For instance, Texas SNFs on average received 71 – about 33
percent fewer – citations in 2017 compared to 2016. Kansas, Iowa, and New York SNFs on
average all received fewer citations as well.
In 2018, the number of citations plummeted,
with SNFs receiving 710 – about 22.1 percent fewer –
in 2018 compared to 2017. The largest of these
reductions occurred in California (189 fewer
citations), Ohio (90 fewer citations), Indiana (78
fewer citations), and New York (54 fewer citations).
These are also some of the states with the most nursing facilities; to account for such difference,
the analysis below adjusts for the number of facilities in a given state.
In 2018, the number of citations
plummeted, with SNFs receiving
710 – about 22.1 percent fewer –
in 2018 compared to 2017.

While most states saw large decreases in the number of citations in 2018, some saw
increases, particularly those with relatively lower initial citation rates. For example, Kentucky
SNFs received 17 more citations in 2018 than 2017 and Mississippi SNFs received six more
citations in 2018 compared to 2017.
Analysis of Skilled Nursing Facilities’ Antipsychotic Citations, 2018
In 2018, on average, state surveyors issued 49 citations for unnecessary medications to
SNFs in their respective states. California (273 citations), Illinois (191 citations), Texas (165
citations), and Ohio (167 citations) nursing homes received the most citations – three to six times
more than the national average. On the other hand, 11 states’ nursing facilities (including
Washington, D.C.) received between zero and 10 citations for unnecessary medications (i.e.,
Washington, D.C., Vermont, Rhode Island, North Dakota, New Hampshire, Mississippi, Maine,
Hawaii, Arkansas, Alabama, and Louisiana). Notably, the four states that issued the most
citations were also some of the states with the largest populations of seniors in nursing facilities.
These findings are presented in Figure 4.

24

 Figure 4. Skilled Nursing Facility Antipsychotic Citations, 2018

Source: All data provided by CMS.
Notes: The total number unnecessary antipsychotic citations by SNFs across all 50 states in 2018 in the U.S.
includes all levels of deficiencies cited. Data include all SNFs cited for tags F0222, F0605 (Free from Chemical
Restraints), F0329, and F0758 (Free from Unnecessary Drugs). F0605 and F0758 replaced F0222 and F0329
beginning on November 28, 2017.

Due to variations in results by the size of the state nursing home population, the
Committee conducted an additional analysis that accounted for population and facility size, using
state-level certified nursing facility data from the Kaiser Family Foundation (see Appendix A for
description of data sources and methodology). 110, 111 Figure 5 shows the number of antipsychotic
citations each state issued for every 10,000 nursing home residents in 2018. That year, states
issued an average of 25.1 citations per 10,000 residents in their nursing facilities, equating to
about one citation for every 400 SNF residents. After accounting for nursing home resident
population size, Texas, California, New York, Illinois, and Ohio had relatively lower citation
rates compared to many areas in the Northwest, Southwest, and Mountain regions. Alaska issued
the most citations per population – 148 antipsychotic citations per 10,000 SNF residents in 2018.
Alaska was followed by the Northwest states of Washington, Oregon, and Wyoming, which
issued 65, 56, and 53.5 citations per 10,000 SNF residents, respectively.

Total Number of Residents in Certified Nursing Facilities, Kaiser Family Foundation, (2019). Available at:
https://www.kff.org/other/state-indicator/number-of-nursing-facilityresidents/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
111
Id.
110

25

 Figure 5. Antipsychotic Citations per 10,000 Skilled Nursing Facility Residents, 2018

.Sources: All citation data provided by CMS; data on certified nursing facility resident population by state from
Kaiser Family Foundation, available at: https://www.kff.org/other/state-indicator/number-of-nursingfacilities/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
Notes: The total number of antipsychotic citations per 10,000 SNF residents for unnecessary antipsychotic citations
of all deficiency levels among all SNFs across all 50 states in the U.S. in 2018. Data include all SNFs cited for tags
F0222, F0605 (Free from Chemical Restraints), F0329, and F0758 (Free from Unnecessary Drugs). F0605 and
F0758 replaced F0222 and F0329 beginning on November 28, 2017.

Adjusting for population size tended to overemphasize the citations in states with
particularly low citation rates. For example, Alaska had the highest antipsychotic citation rate per
10,000 residents, but state surveyors issued a third of the citations as surveyors in Massachusetts.
On the other hand, New Hampshire, which has a resident population ten times that of Alaska, did
not issue a single citation for its 6,442 residents. Likewise, Alabama only issued three citations
for its 22,482 nursing home residents, a state SNF population size just below the national
average.
States in the Northwest had the highest citation
In 2018, about one in seven
rates per resident within the continental U.S.
SNFs received at least one
Washington, Oregon, Idaho, Montana, Wyoming, and
antipsychotic citation.
Utah had between two and three times the national
average citation rate per resident for their SNFs.
Midwestern states also had relatively higher antipsychotic citation rates. For example, Kansas
SNFs received 38.2 antipsychotic citations per 10,000 residents and Nebraska SNFs received
31.6 antipsychotic citations per 10,000 residents.

26

 Figure 6 shows the percentage of facilities that received at least one citation in 2018. In
2018, 2,327 SNFs, or about 15 percent of nursing facilities, received at least one antipsychotic
citation. Alaska had the highest citation rate, as half of the state’s 18 nursing facilities received at
least one antipsychotic citation. Washington and Wyoming followed with 42.4 percent and 34.2
percent of nursing facilities receiving citations, respectively.
Figure 6. Percent of Skilled Nursing Facilities that Received One or More Antipsychotic
Citations, 2018

Sources: All data provided by CMS. data on total number of certified nursing facilities by state retrieved from
Kaiser Family Foundation, available at: https://www.kff.org/other/state-indicator/number-of-nursingfacilities/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
Notes: The percent of SNFs that received one or more unnecessary antipsychotic citations of all deficiency levels
across all 50 states in the U.S. in 2018. Data include all SNFs cited for tags F0222, F0605 (Free from Chemical
Restraints), F0329, and F0758 (Free from Unnecessary Drugs). F0605 and F0758 replaced F0222 and F0329
beginning on November 28, 2017.

The Northwest still had a relatively high number of facilities that received at least one
citation, while the rate was lower in Midwestern states. More than 18 percent of facilities in
Kansas and more than 13 percent of facilities in Nebraska received at least one antipsychotic
citation in 2018.

27

 Analysis of Skilled Nursing Facilities Cited for Unnecessary Medications and Resident Harm (G
or Higher Deficiency Level Citation), 2017-2018
Surveyors rank citations on a 1 to 4 scale, in
which a Level 1 deficiency corresponds to no actual
harm with potential for minimal harm to the resident
and a Level 4 deficiency corresponds to Immediate
Jeopardy to resident health or safety (see Table 1).

In 2018, a SNF resident in
Florida was rushed to the
hospital with signs of brain
damage after the staff
accidentally gave the resident 80
times the ordered amount of the
antipsychotic Haldol.

Figure 7 shows the number of SNFs in each
state that were cited for Level 3 (Actual Harm that is
Not Immediate Jeopardy) or Level 4 (Immediate
Source: CMS data; see Table 6 in Appendix D.
Jeopardy to Resident Health or Safety) deficiencies in
2017 and 2018. In 2017-2018, SNFs across the country received 70 Level 3 or 4 citations for
unnecessary medications. Of these Level 3 and 4 unnecessary medication citations, 41 citations
were for the inappropriate use of antipsychotics. In other words, nearly 60 percent of all
deficiencies that culminated in Actual Harm or Immediate Jeopardy to a Resident’s Health or
Safety were the result of inappropriate antipsychotic usage. 112
Only 0.02 percent of all antipsychotic citations
(5,704 antipsychotic citations) within the 2017-2018
dataset documented Actual Harm or Immediate
Jeopardy. While the average fine for all 70 Level 3 or
4 citations was $77,625 over this time period, 23
percent of these citations were associated with a fine
of less than $20,000. Twenty-five percent of these
Level 3 or 4 fines were delivered on a per-instance
basis (as opposed to a per-day basis), and these fines
averaged $12,600 per citation. For context, these fines are relatively small compared to average
annual Medicare payments to SNFs. In 2017, Medicare paid each SNF an average of $1.7
million for their Medicare beneficiaries. 113 Almost 10 percent of all Level 3 or 4 citations did not
result in a fine.
Nearly 60 percent of all
deficiencies that culminated in
Actual Harm or Immediate
Jeopardy to a Resident’s Health
or Safety were the result of
inappropriate antipsychotic
usage in 2017-2018.

Nursing Home Enforcement – Frequently Asked Questions, Centers for Medicare and Medicaid Services,
Available at: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationEnforcement/Downloads/NH-Enforcement-FAQ.pdf
113
Skilled Nursing Facility Services, Medicare Payment Advisory Commission, (2019). Available at:
http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch8_sec.pdf
112

28

 Figure 7. Skilled Nursing Facilities Cited for Unnecessary Medications and Resident Harm
(Level 3 or Higher Deficiency Level Citation), 2017-2018

Source: All data provided by CMS.
Notes: This map includes the total number of SNFs cited for unnecessary medications with a Severity Level 3 or
higher across all 50 states in 2017 and 2018. Data include all nursing facilities cited for unnecessary medications
with a Severity Level G or higher. CMS did not provide specific tags for these citations. The severity of a deficiency
is based on a Level of 1 to 4, where a Level 1 deficiency implies No Actual Harm with the Potential for Minimal
Harm and a Level 4 deficiency implies Immediate Jeopardy to Resident Health or Safety. A Level 3 or higher
deficiency level corresponds to a Level “G” or higher deficiency level.

California and Washington state surveyors issued the largest number of Level 3 or 4
citations, both issuing eight citations from 2017 through 2018. California also has the second
highest nursing home population with over 101,030
In 2018, a SNF resident in Illinois
nursing home residents, while Washington only has
was forcibly injected with Haldol,
about 16,000 nursing home residents – a sixth of the
against the patient’s will, simply
nursing home population size of California and less
because the individual was upset
than the average state nursing home population size
that a nurse had locked the
(about 26,000 residents).
private bathroom door. No
enforcement penalty was
Additionally, SNFs in Ohio, Indiana, Illinois,
imposed on the SNF.
and Michigan, which had above-average citation rates
in 2018, also received relatively more Level 3 or
Source: CMS data; see Table 6 in Appendix D.
higher citations than other states in 2017 and 2018.
29

 SNFs in Michigan, which has an above-average nursing home population size, received seven
resident harm citations. With some exceptions, SNFs in Northwest and Midwest states again
tended to receive more high-level deficiency citations.
Analysis of Skilled Nursing Facilities Cited for Antipsychotic Citations, 2016-2018 114
According to a Kaiser Health News report, average fines on nursing homes found to have
endangered or injured residents significantly decreased between 2016 and the time period
between April 2017 to March 2018. 115 Building on this Kaiser Health News study, the
Committee investigated how the total number of antipsychotic citations issued changed from
Obama’s final year in office (2016) to Trump’s second full year in office (2018).
As depicted in Figure 8, state surveyors nationally issued 840 fewer citations in 2018
compared to 2016 – a decrease of 25.2 percent. Only surveyors in 12 states documented more
citations in 2018 than in 2016. Four states had relatively large percent increases in the citation
rates. Alabama had the largest percent increase – receiving 200 percent more citations in 2018
compared to 2016 – followed by Montana and Missouri, whose nursing homes received 185.7
percent and 157.1 percent more citations, respectively, in 2018 compared to 2016. Still, these 12
states that witnessed an uptick in citation rates were historically lower antipsychotic citation-rate
states.

114
Data include all SNFs cited for tags F0222, F0605 (Free from Chemical Restraints), F0329, and F0758 (Free
from Unnecessary Drugs). F0605 and F0758 replaced F0222 and F0329 beginning on November 28, 2017.
115
Rau, Jordan, Nursing Home Fines Drop as Trump Administration Heed Industry Complaints, Kaiser Health
News, (2019). Available at: https://khn.org/news/nursing-home-fines-drop-as-trump-administration-heeds-industrycomplaints/

30

 Figure 8. Percent Change in Antipsychotic Citations at Skilled Nursing Facilities,
2016- 2018

Source: All data provided by CMS.
Notes: Map shows the percent change from 2016 to 2018 in the total number of unnecessary antipsychotic citations
by all SNFs across all 50 states in the U.S. in 2018. This analysis includes all level of deficiencies cited.

State surveyors in 36 states issued fewer antipsychotic citations to SNFs in 2018
compared to 2016. At the top of this list was California, where SNFs received 154 fewer
citations in 2018 compared to 2016. New York followed with 86 fewer citations; Kansas SNFs,
which received 79 fewer citations; and Ohio SNFs, which received 65 fewer citations. Typically,
states with large SNF populations received fewer citations in 2018 compared to 2016. Overall,
SNFs in 11 states had a 50 percent or greater reduction in the number of citations they received
in 2018 compared to 2016.

31

 DISCUSSION
This analysis shows an increase in the rates of antipsychotics citations for SNFs across
the nation from 2015-2018, with generally higher rates in the Northwest and Midwest.
Examining the data in year-over-year changes is more instructive than looking across the entire
four-year time frame, however. As the results of this study point to two distinct time periods –
one from 2015-2017 and another from 2017 to 2018 – the trends may reflect the external policy
environment rather than internal industry prescribing changes. Antipsychotic citation rates
increased dramatically – by 187 percent – across the nation during 2015-2017, from 1116
citations in 2015 to 3207 citations in 2017. This period was followed by a sharp 22 percent
reduction in citation rates from 2017 to 2018. This citation reduction occurred during the change
in administrations – which also corresponded with policy changes from per-day fines under the
Obama Administration to single fines for two-thirds of antipsychotics infractions under the
Trump Administration. It also corresponded with an 18-month moratorium on eight new Obamaera safety regulations. 116, 117
Given the descriptive nature
of this analysis, it is impossible to
determine the extent to which these
trends in citation rates reflect
internal changes within the SNF
industry with respect to
antipsychotic prescribing patterns or
— Lena D, daughter and power of attorney of Lucinda D.,
the external policy shifts that
an 88-year-old woman in a California nursing facility
occurred between 2015 and 2018.
Quotes provided to Committee from Human Rights Watch analysis; US: Nursing
Examined in isolation, such time
Homes Misuse Drugs to Control Residents, Human Rights Watch, (2018).
trends might reflect an industry
Available at: https://www.hrw.org/news/2018/02/05/us-nursing-homes-misusedrugs-control-residents
responding to external pressures to
curb inappropriate antipsychotic use.
In other words, it is possible that the 22 percent reduction in citations from 2017-2018 reflects a
true decrease in the proportion of SNF patients inappropriately administered antipsychotics
without any behavioral responses to the loosening of administration regulations. More likely
though, antipsychotic use remained more-or-less constant and such trends in citation rates reflect
the underlying policies of two distinct administrations. On the one hand, the Obama
Administration cracked down on antipsychotic overuse by implementing per-day fines,
strengthening federal RoPs, and updating surveyor guidance. On the other, the Trump
“Every little thing, they [the nursing home staff]
want to put you on psych meds… She [my
mother] would be sitting there, slumped over,
mucus everywhere. I would go over and say,
‘She’s sick.’”

116
Rau, Jordan, Nursing Home Fines Drop as Trump Administration Heed Industry Complaints, Kaiser Health
News, (2019). Available at: https://khn.org/news/nursing-home-fines-drop-as-trump-administration-heeds-industrycomplaints/
117
Temporary Enforcement Delays for Certain Phase 2 F-Tags and Changes to Nursing Home Repair, Centers for
Medicare and Medicaid Services, (2017). Available at: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-04.pdf

32

 Administration was focused on industry-wide de-regulation, weakening federal RoPs and
eliminating per-day fining practices.
The findings in this report show an association between federal oversight and
antipsychotic citation rates during the final year of the Obama Administration. Between 2015
and 2016, when Obama-era nursing home regulations issued between 2012-2015 went into full
effect, there was a 199 percent increase in citation rates (2,221 more citations), as nationwide
rates nearly tripled. These rates remained relatively constant from 2016-2017, as these Obamaera regulations remained in place in 2017. The Trump Administration’s “Patients over
Paperwork” deregulatory program, which went into effect in late 2017, coincided with a
reduction in antipsychotic citation rates compared to President Obama’s final years in office.
Between 2016 and 2018, state surveyors issued 840 fewer citations – a drop of 25.2 percent –
with 36 states experiencing fewer antipsychotic citations in 2018 compared to 2016.
Following the implementation of the Obama-era nursing home oversight regulations,
SNFs across the nation may have taken strides to reduce antipsychotic use. In fact, in April of
2019, CMS reported a 39 percent reduction in antipsychotic misuse in SNFs since 2011. 118 Still,
some evidence shows that this national reduction was associated with SNFs increasingly seeking
false psychosis diagnoses to avoid inappropriate antipsychotic citations. 119, 120
Another potential reason for the reduction in antipsychotic citations could be the change
in surveyor guidance. In November 2016, CMS provided new citation tagging methods and
interpretative guidance to state surveyors as a means to implement an updated survey process as
part of the Obama-era 2016 updates to the RoPs in long-term care facilities. The change in
citation tagging, which was implemented in late November 2017, may have led to surveyors
incorrectly tagging inappropriate antipsychotic use and may at least partially explain the 22
percent reduction in citation rates from 2017 to 2018. Still, other elements of this updated survey
process could have led to increased citation rates, including increasing the resident sample size
included in each survey and tripling the interview, observation, and screening time.
Although it is impossible to determine which (if any) external factors affected the rate of
antipsychotic prescribing in SNFs during the period of study, two important points are clear: 1)
the data revealed two distinct time periods (2015-2017 and 2017-2018) of prescribing patterns
that align with a shift in administrations and 2) regardless of the period of prescribing, the rate of
antipsychotic use remains inappropriately high in SNFs across the entire country. Together, these
points indicate that policymakers must continue to implement interventions aimed at reducing
use of antipsychotics as a chemical restraint in lieu of appropriate staffing – and that the right
National Partnership to Improve Dementia Care in Nursing Homes: Antipsychotic Medication Use Data Report,
Centers for Medicare and Medicaid Services, (2019). Available at: https://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Antipsychotic-Medication-Use-DataReport.pdf
119
Flamm, Hannah, Why are nursing homes drugging dementia patients without their consent? The Washington
Post, (2018). Available at: https://www.washingtonpost.com/outlook/2018/08/10/8baff64a-9a63-11e8-8d5ec6c594024954_story.html
120
Improving antipsychotic prescribing practices in nursing facilities: The role of surveyor methods and surveying
agencies in upholding the Nursing Home Reform Act, Research in Social and Administrative Pharmacy (2016);
12:91–103.
118

33

 interventions may have success in changing behavior, given that the findings in this study
suggest external factors may play a large role in influencing behavioral change in SNFs.
Recommendations
Given the ubiquity of antipsychotic use in SNFs, a number of organizations have
provided policy recommendations to CMS and other federal agencies. A sampling of these
recommendations can be found in Table 2.
Table 2. Recommendations to Reduce Inappropriate Antipsychotic Use in SNFs 121, 122, 123
Organization

Long Term Care
Community
Coalition
(LTCCC)

Substance Abuse
and Mental Health
Services
Administration
(SAMHSA)

Human Rights
Watch (HRW)

Year

Recommendations

2020

• Establish minimum nurse staffing levels for facilities or other
effective measures for addressing understaffing, inadequate training,
and high turnover rates.
• Strengthen the enforcement of requirements linked to inappropriate
antipsychotic drug use, such as care planning, as well as transfer and
discharge standards.
• Follow CMS guidance indicating that many inappropriate
antipsychotic drug uses amount to Actual Harm or Immediate
Jeopardy violations.

2019

• Create a clear person-centered care plan with specific behavior
modification strategies.
• SNFs should link caregivers to services, such as respite care,
information and assistance, counseling, and training.
• Informed consent must be used with these drugs, considering side
effect profiles of antipsychotics and balancing them with patient risk.
• Employ nonpharmacological approaches prior to antipsychotic use.

2018

• Use more existing regulatory and enforcement tools to reduce the
inappropriate use of antipsychotics.
• Establish federal regulations on a right to informed consent and
minimum nurse staffing levels for facilities.
• Increase the severity of violations for SNFs that were cited for Level
3 or 4.

Flamm, Hannah, They Want Docile, Human Rights Watch, (2018). Available at:
https://www.hrw.org/report/2018/02/05/they-want-docile/how-nursing-homes-united-states-overmedicate-peopledementia
122
Antipsychotic Drug Use: HHS has Initiatives to Reduce Use among Older Adults in Nursing Homes but Should
Expand Efforts to Other Settings, Government Accountability Office, (2015). Available at:
https://www.gao.gov/assets/670/668221.pdf
123
Levinson, Daniel, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,
Department of Health and Human Services, (2011). Available at: https://oig.hhs.gov/oei/reports/oei-07-0800150.pdf
121

34

 Organization

American
Psychiatric
Association (APA)

Government
Accountability
Office (GAO)

Health and Human
Services Office of
the Inspector
General
(HHS OIG)

Center for
Medicare
Advocacy (CMA)

Year

Recommendations

2016

• Use a comprehensive treatment plan that includes appropriate
person-centered nonpharmacological and pharmacological
interventions, particularly for dementia patients.
• Review clinical response to nonpharmacological interventions prior
to nonemergency use of an antipsychotic medication.
• Before nonemergency treatment with an antipsychotic is initiated in
patients with dementia, a clinician must assess the potential risks and
benefits from antipsychotic medication. Risks must be discussed with
the patient (if clinically feasible) as well as with the patient’s
surrogate decision-maker (if relevant) with input from family or
others involved with the patient.

2015

• HHS officials should focus on reducing antipsychotic use in other
care settings outsides nursing homes, including assisted living
facilities or individuals’ homes.
• Extend educational efforts to caregivers and providers who do not
work in SNFs.

2011

• CMS should facilitate access to information to improve prescription
accuracy.
• CMS must assess whether the survey and certification processes
offer adequate safeguards against unnecessary antipsychotic use.
• CMS should explore alternative methods beyond survey and
certification processes to promote compliance with federal standards
regarding unnecessary drug use in nursing homes.

2011

• CMS should adopt the 1992 proposed rules on chemical restraints,
including providing specific written informed consent for
antipsychotic drug use.
• CMS should conduct trainings on all CMS regulations on
antipsychotic drugs.
• CMS should revise the new Quality Indicator Survey to include
residents using antipsychotic drugs in every resident survey sample

Considerations
The results the Committee presents in this report are meant neither to make a case for a
specific policy proposal nor to highlight the behavior of particular state surveyors relative to
others. Instead, the findings are meant to broadly illustrate the troubling trends in antipsychotic
overuse across the nation – regardless of administration – and the harmful implications for
patients and their families. Given that the “true” rate of antipsychotic misuse remains unknown,
more work needs to be done to understand prescribing patterns, identify solutions, and
implement change across nursing home settings. With the backdrop of the devastation COVID19 has inflicted on nursing homes across the country, focus on all components of patient safety
in these settings is paramount.

35

 In particular, future work could examine the relationship between staffing levels and
antipsychotic use to determine whether or not states with lower average staffing rates tend to
have higher antipsychotic rates. Furthermore, factors such as updated surveyor guidance,
increased enforcement mechanisms, and increases in psychosis diagnoses may have all affected
the change in antipsychotic citation rates from 2015-2018. Additional research could use
adjusted analysis techniques to isolate these variables and examine their relationship with the
change in citation rates.

36

 CONCLUSION
In May, 2011 HHS Inspector General Levinson stated “Too many [nursing homes] fail to
comply with federal regulations designed to prevent overmedication, giving nursing home
patients antipsychotic drugs in ways that violate federal standards for unnecessary drug
use…Government, taxpayers, nursing home residents, as well as their families and caregivers
should be outraged – and seek solutions.” 124
Since the Inspector General’s sharp warning, CMS has initiated a program aimed at
reducing the inappropriate use of antipsychotic drugs for residents in SNFs who do not have
qualifying diagnoses – but more work must be done. Still, several years later in November 2019,
Richard Mollot described similar issues in his testimony before the Ways and Means Committee:
“Over 40 percent of U.S. nursing homes have what we call chronic deficiencies:
repeated violations of the same regulatory requirement year after year after year. Abuse,
neglect, even crimes against residents are persistent and pervasive. Approximately 20
percent of residents are administered antipsychotic drugs every day, despite the FDA's
black box warning not to use these drugs on elderly people due to substantial risk of
harm and even death.” 125
It is reasonable to conclude that the
overuse and misuse of
antipsychotics is pervasive and
continues to occur at unacceptably
high rates. Incremental change is
just that – incremental – and
insufficient for the thousands of
families who have entrusted their
loved ones to nursing homes only
later to face unnecessary
hospitalizations or even death.

Whatever the reason for the changes in
antipsychotics prescribing patterns documented in
this study, it is reasonable to conclude that the
overuse and misuse of antipsychotics is pervasive
and continues to occur at unacceptably high rates.
Incremental change is just that – incremental –
and insufficient for the thousands of families who
have entrusted their loved ones to nursing homes
only later to face unnecessary hospitalizations or
even death.

The NHRA in 1987 was evidence that
policymakers, experts, and advocates believed
there was a better future possible for nursing home residents – one where human dignity and
personalized care trumped all other concerns. The health system’s stagnation in eliminating
chemical restraints in nursing homes reflects an inability to realize the goals of Congress more
than 30 years ago, when Americans hoped for a better future for the system’s most vulnerable.
Today, the stark reality of COVID-19 has brought this fact to the public’s consciousness. As the
population continues to age and more Baby Boomers are relying on SNFs for rehabilitation
services and long-term care, it is critical that policymakers and regulators continue to address
antipsychotic misuse in the nursing home setting and ensure the nation adequately addresses the
124
Levison, Daniel R, et al., Overmedication of Nursing Home Patients Troubling, Department of Health and
Human Services, Office of the Inspector General, (2011). Available at: https://oig.hhs.gov/newsroom/testimony-andspeeches/levinson_051011.asp
125
Richard Mollot. Quote from: U.S. Congress. Hearing of the Committee on Ways and Means. “Caring for Aging
Americans.” (2019). Available at: https://waysandmeans.house.gov/legislation/hearings/caring-aging-americans

37

 needs of these vulnerable patient groups. As the Inspector General stated in 2011, Americans
should continue to be outraged, and those who rely on nursing homes deserve better.

38

 APPENDIX A: METHODOLOGY AND LIMITATIONS
In response to Chairman Neal’s January 22, 2019, letter to CMS on antipsychotic use in
nursing homes, CMS provided the Committee with data on antipsychotic citations for nursing
homes from 2015-2018. For this report, the Committee utilized two specific datasets: 126
1. Skilled Nursing Facilities Cited for Unnecessary Medications in 2015, 2016, 2017, and
2018: Lists all nursing facilities cited for deficiencies in 2015-2018; the dataset specifies
the provider number, name, state, ZIP code, and survey date for each antipsychotic
citation reported. Data include all SNFs cited for tags F0222, F0605 (Free from Chemical
Restraints), F0329, and F0758 (Free from Unnecessary Drugs). F0605 and F0758
replaced F0222 and F0329 beginning on November 28, 2017.
2. Skilled Nursing Facilities Cited for Unnecessary Medication and Resident Harm with
Corresponding Penalties in 2017 and 2018: Lists all nursing facilities cited for
unnecessary medications with a Severity Level 3 or higher deficiency in 2017 and 2018.
The severity of a deficiency is based on a level of 1 to 4, where a Level 1 deficiency
implies no actual harm with the potential for minimal harm and a Level 4 deficiency
implies Immediate Jeopardy to Resident Health or Safety. 127 The CMS-provided data
included any facility that received a Level 3 (Actual Harm that is Not Immediate
Jeopardy) or a Level 4 (Immediate Jeopardy to Resident Health or Safety). See Table 1,
Interpretation of Scope and Severity of Unnecessary Medication Citation.
To account for nursing home population size, the Committee also used two datasets from
the Kaiser Family Foundation. One dataset included the total number of residents in certified
nursing facilities for every state in 2017. 128 The second included the number of certified nursing
facilities for every state in 2017. 129 Using CMS-provided 2015-2018 antipsychotic citation data
and 2017 nursing home facility and population data from the Kaiser Family Foundation, the
Committee conducted five state-level analyses across all 50 states to calculate:
•
•
•
•
•

State and national percent change in citations from 2015-2018
Number of citations per 10,000 residents in 2018
Percent of facilities that had at least one citation in 2018
Number of facilities with a G or higher level citation from 2017-2018
Percent change in citations from 2016-2018

Centers for Medicare & Medicaid Services, e-mail message to authors, June 14, 2019.
Nursing Home Enforcement – Frequently Asked Questions, Centers for Medicare and Medicaid Services,
Available at: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationEnforcement/Downloads/NH-Enforcement-FAQ.pdf
128
Total Number of Certified Nursing Facilities, Kaiser Family Foundation, (2017). Available at:
https://www.kff.org/other/state-indicator/number-of-nursingfacilities/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
129
Id.
126
127

39

 Limitations
This study had several important limitations. First, this report was conducted at the statelevel, which limited the Committee’s ability to analyze the effects of facility-level factors, such
as staffing levels or ownership type, which may impact antipsychotic use in SNFs. To control for
the number of facilities and nursing home residents, the Committee used 2017 Kaiser Family
Foundation data (the latest year of data available at the time of this study) alongside 2018
antipsychotic citation data. Thus, we assumed that nursing home population and the number of
facilities remained stagnant from 2017 to 2018. Prior years of data suggest the number of nursing
facilities have remained relatively constant from year to year. 130 Additionally, the Kaiser data
included both SNFs and nursing facilities (Medicaid-only), yielding a slight overestimation of
the number of nursing homes and nursing home residents nationwide. Still, the Medicare
Payment Advisory Commission estimates approximately 15,000 SNFs operate nationwide, so the
Kaiser total of 15,483 facilities was not too extreme. 131
Second, with the exception of facilities fined for Level G or higher citations, CMS did
not provide the Committee with data on the penalty amounts for facilities cited, which limited
the scope of this study. For the analysis of Severity Level G or higher citations, CMS provided
data on nursing facilities cited for any unnecessary medications, which include any medication
for which there is an excessive dose, duration and/or a drug used without adequate monitoring or
adequate indication for its use. 132 These data also include unnecessary medications other than
antipsychotic drugs, such as opioids, anticoagulants, insulin, and antibiotics.133 Thus Committee
staff used descriptions provided alongside each citation to determine whether the citation related
to antipsychotic misuse.
Third, data were not provided on citation rates in the U.S. territories, which limited the
scope of the analysis to U.S. states.
Finally, variations in state surveying practices may create some of the differences in
citation rates across states, rather than true differences in prescribing patterns; however, the
Committee did not have data to control for this variable in its analysis.

Total Number of Certified Nursing Facilities, Kaiser Family Foundation, (2017). Available at:
https://www.kff.org/other/state-indicator/number-of-nursingfacilities/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
131
Report to Congress: Medicare Payment Policy, Medicare Payment Advisory Commission, (2020). Available at:
http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0
132
Unnecessary Medications, Psychotropic Medications, and Medication Regime Review Critical Element Pathway,
Department of Health and Human Services and Centers for Medicare and Medicaid Services, (2017). Available at:
https://www.nehca.org/wp-content/uploads/CMS-20082-Unnecessary-Medications.pdf
133
Id.
130

40

 APPENDIX B: STATE-LEVEL ANTIPSYCHOTIC CITATION TABLES FOR SKILLED
NURSING FACILITIES
Table 3. Number of State-Level Antipsychotic Citations for Skilled Nursing Facilities,
2015-2018
Number of Citations
2015

2016

2017

2018

AL

6

1

9

3

AK

4

5

4

9

AZ

10

19

21

29

AR

13

34

12

18

CA

147

427

462

273

CO

19

83

62

31

CT

16

71

43

20

DE

7

23

19

21

DC

2

3

5

2

FL

35

119

105

82

GA

5

25

33

46

HI

3

14

19

5

ID

6

25

21

17

IL

44

113

157

191

IN

55

166

196

118

IA

22

73

34

48

KS

57

135

94

56

KY

5

8

3

20

LA

22

35

35

10

ME

2

10

18

7

MD

25

89

88

42

MA

4

17

28

28

MI

52

117

102

105

MN

37

98

87

56

MS

7

5

2

8

MO

23

42

62

108

MT

8

7

18

20

NE

25

56

57

36

NV

4

30

20

11

NH

1

3

2

0

NJ

18

63

36

37

NM

6

22

30

22

NY

36

150

118

64

41

 Number of Citations
2015

2016

2017

2018

NC

15

48

52

37

ND

6

15

13

9

OH

63

232

257

167

OK

35

93

85

83

OR

15

49

51

41

PA

49

156

137

96

RI

1

13

12

6

SC

7

26

37

26

SD

1

9

9

13

TN

7

17

24

25

TX

61

212

141

165

UT

15

39

53

25

VT

4

15

6

5

VA

25

95

70

63

WA

29

109

139

104

WV

9

24

17

14

WI

45

84

90

62

WY

3

13

12

13

3337

3207

2497

TOTAL
1116
Source: All data provided by CMS.
Notes: Table includes any level of deficiencies cited.

42

 Table 4. Change and Percent Change in Number of Antipsychotic Citations for Skilled
Nursing Facilities, 2015-2018
Change in Citations
2015-2016 2016-2017

Percent Change in Citations
2015-2016 2016-2017 2017-2018

2017-2018

AL

-5

8

-6

AL

-83.3%

800.0%

-66.7%

AK

1

-1

5

AK

25.0%

-20.0%

125.0%

AZ

9

2

8

AZ

90.0%

10.5%

38.1%

AR

21

-22

6

AR

161.5%

-64.7%

50.0%

CA

280

35

-189

CA

190.5%

8.2%

-40.9%

CO

64

-21

-31

CO

336.8%

-25.3%

-50.0%

CT

55

-28

-23

CT

343.8%

-39.4%

-53.5%

DE

16

-4

2

DE

228.6%

-17.4%

10.5%

DC

1

2

-3

DC

50.0%

66.7%

-60.0%

FL

84

-14

-23

FL

240.0%

-11.8%

-21.9%

GA

20

8

13

GA

400.0%

32.0%

39.4%

HI

11

5

-14

HI

366.7%

35.7%

-73.7%

ID

19

-4

-4

ID

316.7%

-16.0%

-19.0%

IL

69

44

34

IL

156.8%

38.9%

21.7%

IN

111

30

-78

IN

201.8%

18.1%

-39.8%

IA

51

-39

14

IA

231.8%

-53.4%

41.2%

KS

78

-41

-38

KS

136.8%

-30.4%

-40.4%

KY

3

-5

17

KY

60.0%

-62.5%

566.7%

LA

13

0

-25

LA

59.1%

0.0%

-71.4%

ME

8

8

-11

ME

400.0%

80.0%

-61.1%

MD

64

-1

-46

MD

256.0%

-1.1%

-52.3%

MA

13

11

0

MA

325.0%

64.7%

0.0%

MI

65

-15

3

MI

125.0%

-12.8%

2.9%

MN

61

-11

-31

MN

164.9%

-11.2%

-35.6%

MS

-2

-3

6

MS

-28.6%

-60.0%

300.0%

MO

19

20

46

MO

82.6%

47.6%

74.2%

MT

-1

11

2

MT

-12.5%

157.1%

11.1%

NE

31

1

-21

NE

124.0%

1.8%

-36.8%

NV

26

-10

-9

NV

650.0%

-33.3%

-45.0%

NH

2

-1

-2

NH

200.0%

-33.3%

-100.0%

NJ

45

-27

1

NJ

250.0%

-42.9%

2.8%

NM

16

8

-8

NM

266.7%

36.4%

-26.7%

NY

114

-32

-54

NY

316.7%

-21.3%

-45.8%

NC

33

4

-15

NC

220.0%

8.3%

-28.8%

ND

9

-2

-4

ND

150.0%

-13.3%

-30.8%

OH

169

25

-90

OH

268.3%

10.8%

-35.0%

OK

58

-8

-2

OK

165.7%

-8.6%

-2.4%

43

 Change in Citations
2015-2016 2016-2017

Percent Change in Citations
2015-2016 2016-2017 2017-2018

2017-2018

OR

34

2

-10

OR

226.7%

4.1%

-19.6%

PA

107

-19

-41

PA

218.4%

-12.2%

-29.9%

RI

12

-1

-6

RI

1200.0%

-7.7%

-50.0%

SC

19

11

-11

SC

271.4%

42.3%

-29.7%

SD

8

0

4

SD

800.0%

0.0%

44.4%

TN

10

7

1

TN

142.9%

41.2%

4.2%

TX

151

-71

24

TX

247.5%

-33.5%

17.0%

UT

24

14

-28

UT

160.0%

35.9%

-52.8%

VT

11

-9

-1

VT

275.0%

-60.0%

-16.7%

VA

70

-25

-7

VA

280.0%

-26.3%

-10.0%

WA

80

30

-35

WA

275.9%

27.5%

-25.2%

WV

15

-7

-3

WV

166.7%

-29.2%

-17.6%

WI

39

6

-28

WI

86.7%

7.1%

-31.1%

WY

10

-1

1

WY

333.3%

-7.7%

8.3%

TOTAL

199.0%

-3.9%

-22.1%

TOTAL
2221
-130
-710
Sources: All data provided by CMS.
Notes: Table includes all levels of deficiencies cited.

44

 APPENDIX C: CMS ADMINISTRATIVE ACTIONS TO REDUCE OR ELIMINATE
NURSING HOME PROTECTIONS
Below are summaries of major CMS policies and actions related to reducing or
eliminating nursing home regulations from May 2017-March 2020 (at the beginning of the
COVID-19 pandemic).
Table 5. CMS Administrative Actions to Reduce or Elimination Nursing Home Protections,
2017-2020
CMS Administrative Actions to Reduce or Eliminate Nursing Home Protections

Type of Action

Action Description

Reference

Date

Proposed Rule

CMS solicits comments on three possible areas
where nursing home standards might be eliminated
or reduced:
• Notice to Long-Term Care Ombudsman Program
when nursing home is evicting resident;
• Standards for handling resident grievances; and
• Requirement that facilities develop quality
improvement programs. CMS also seeks “feedback
regarding any additional areas of burden reduction
and cost savings in [nursing homes].”

Proposed
Rules, 82 Fed.
Reg. 21,014,
21,089

May 4,
2017

Proposed Rule

CMS proposes to eliminate ban of arbitration
agreements and, instead, allow nursing homes to
require such agreements as a condition of
admission.

Proposed
Rules, 82 Fed.
Reg.
26,649

June 8,
2017

Moratorium on
Policies

CMS announces that for one year it will
not impose fines or any other meaningful
penalties for violations of certain regulations
scheduled to go into effect November 2017.

CMS Survey
and
Certification
(S&C) Memo
17-36-NH

June 30,
2017

Revision of
CMP Policies

CMS changes its policies to reduce amount
and frequency of nursing home fines. Fines
will be assessed on a per-day basis, rather
than a per-instance basis, when the violation
occurred prior to inspection. In addition,
per-instance fines will be used even for
an ongoing violation considered a “single
isolated incident.”

CMS S&C
Memo, 17-37NH

July 7,
2017

45

 CMS Administrative Actions to Reduce or Eliminate Nursing Home Protections

Type of Action

Action Description

Reference

Date

Revision of
CMP Policies

CMS proposes to repeal previous S&C (survey and
certification) Memo 16-31-NH and reduce
imposition of fines against nursing homes. Proposed
changes include giving nursing homes more
opportunities to delay or potentially avoid
fines and, even in Immediate Jeopardy
situations, allowing fines only in cases of
serious injury or death.

CMS S&C
Memo 18-01NH

Oct. 27,
2017

CMS launches “Patients Over Paperwork”
initiative to eliminate or weaken regulations
governing health care providers.

CMS press
release

Oct. 30,
2017,

Notice of
Proposed
Rulemaking
(NPRM)

CMS indicates intent by June 2018 to issue
proposed nursing home regulations that
would eliminate or revise regulations that
allegedly are excessively burdensome,
unnecessary, or obsolete.

Fall 2017

Notice of
Proposed
Rulemaking
(NPRM)

CMS issues Notice of Proposed Rulemaking
(NPRM) to allow nursing homes to review their
emergency preparedness programs and train
staff to carry out those plans every two years rather
than annually.

Unified
Agenda of
Regulatory
and
Deregulatory
Actions, RIN
0938AT36
Proposed
Rule, 83 Fed.
Reg. 47,686,
47,725-47,727

Sept. 20,
2018

White House
Budgetary
Proposal

The Trump Administration's Fiscal Year 2020
Budget suggests reducing the frequency of SNF
surveys for top-performing nursing homes. CMS
Administrator Seema Verma also indicates that the
agency is interested in the idea; however, studies
indicate that even high-rated nursing homes
continue to violate residents’ rights and protections.
As a July 2019 GAO’s report suggests, more than
20 percent of nursing homes considered “above
average” and “much above average” by CMS have
been cited for abuse in a single year.

The
President's FY
2020 Budget

March,
2019

Program
Launch

46

 CMS Administrative Actions to Reduce or Eliminate Nursing Home Protections

Type of Action

Action Description

Reference

Date

Proposed Rule

CMS proposes reducing the frequency that nursing
facilities are required to conduct facility
assessments, allowing them to streamline their
compliance and ethics programs. The proposal also
considers other de-regulation policies related to
independent dispute resolutions and Quality
Assurance Program Improvement (QAPI).

Proposed
Rules, 84 Fed.
Reg. 34,737

July 18,
2019

Final Rule

CMS finalizes rule amending the Long-Term Care
Requirements of Participation (RoPs). Most notably,
the Final Rule removes the requirement prohibiting
facilities from entering into pre-dispute arbitration
agreements with residents, while
maintaining the 2016 ban on requiring residents to
agree to arbitration as a condition of
admission or as a requirement for continued care.

Final Rule, 84
Fed. Reg.
34,718

July 18,
2019

Payment Model
Implementation

CMS began implementing a new payment system,
called the “Patient Driven Payment Model”
(PDPM), for Medicare-covered nursing home care.
PDPM creates a new set of financial incentives for
nursing homes to consider when admitting and
discharging residents, as well as providing resident
care. While it will take some time to assess PDPM’s
effects on resident care, PDPM also allows 25
percent of a resident’s total therapy regimen, by
discipline, to be provided in group and/or concurrent
therapy settings.

Payment
Driven
Payment
Model
(PDPM)

Oct. 1,
2019

Source: 2017 CMS Administrative Actions were provided by the Long Term Care Community Coalition (LTCCC)
and can be found here: https://nursinghome411.org/how-cms-is-rolling-back-nursing-home-protections-table/. 2018
and 2019 Administrative actions related to nursing home care were provided by the LTCCC through personal
correspondence.

47

 APPENDIX D: SUMMARIES OF SELECT SKILLED NURSING FACILITIES CITATION FOR UNNECESSARY
MEDICATIONS AND RESIDENT HARM (G OR HIGHER LEVEL CITATION), 2017-2018
Below are summaries from select G or higher level (i.e., G, H, I, J, and K) citations SNFs received in 2017 or 2018. To protect
anonymity, the Committee removed facility name and provider number.
Table 6. Summaries of Select Skilled Nursing Facilities Citations for Unnecessary Medications and Resident Harm (G or
Higher Level Citation), 2017-2018 134
Summaries of Nursing Facilities Citation for Unnecessary Medications and Resident Harm (G or Higher Level Citation), 2017-2018
State

California

Date

2/2/2018

Overall Inspection
Star
Survey
Rating
Rating

5

4

Survey
Type

Complaint

Severity
Code

Remedy
Imposed

No
enforcement
imposed
based on
regional
office
review

G

Civil
Money
Penalty

Summary of Citation

N/A

The facility failed to recognize the cumulative side
effects of multiple psychotropic medications and ensure
the prescriber was notified of the resident response and
behavioral assessments. A resident was admitted to the
SNF with diagnoses, which included alcohol dependence
and withdrawal delirium, but the resident’s admission
assessment stated he was alert and able to walk with
assistance. The physician ordered multiple anti-anxiety
and antidepressant medications in combination with
10mg of Haldol a day. Later reports showed this
combination of antipsychotics and anti-anxiety
medication led the patient to lose alertness and even
forgo his meals. Documentations showed that the SNF
staff did not document his behavioral changes or the
resident’s excessive sedation. The resident could no
longer walk, eat, use the bathroom on his own, hold a
phone, or even speak.

The severity of a deficiency is based on a level of 1 to 4, where a Level 1 deficiency implies No Actual Harm with the Potential for Minimal Harm and a
Level 4 deficiency implies Immediate Jeopardy to Resident Health or Safety. A Level 3 or Higher deficiency level corresponds to a Level “G” or higher
deficiency level. See Table 1 for more information.
134

48

 Summaries of Nursing Facilities Citation for Unnecessary Medications and Resident Harm (G or Higher Level Citation), 2017-2018
State

California

Florida

Date

8/22/2017

4/13/2017

Overall Inspection
Star
Survey
Rating
Rating

2

2

1

2

Survey
Type

Complaint

Complaint

Severity
Code

Remedy
Imposed

Civil
Money
Penalty

J

Civil
Money
Penalty

K

49

Civil
Money
Penalty

Summary of Citation

$25,198
(Per-Day)

Based on observation, interview, and record review, the
facility failed to ensure the resident was free of
unnecessary drugs. The resident was receiving excessive
amounts of narcotics and psychotropic medications
without adequate monitoring and indication for its use, in
duplication and without attempting a gradual dose
reduction. The resident’s diagnoses included multiple
sclerosis, major depressive disorder, anxiety disorder,
and insomnia. In May of 2017, following multiple
diagnoses, the resident took Ambien, Xanax, Valium,
and Lexapro nearly 30 times each in one month.

$350,628.20
(Per
Instance)

The facility failed to ensure the resident’s drug regimen
was free of unnecessary drugs. Based on a review of
records, the resident had an order placed in her chart in
error for Coumadin for diagnoses of Cerebrovascular
Accident. The resident did not have this diagnosis and
the order was never signed off by any staff members. The
resident received the drug without monitoring of the
high-risk medication and developed a significant
intracranial hemorrhage (bleeding in the brain) per local
hospital records. The actions of the medical and nursing
staff who failed to order the necessary laboratory tests to
monitor clotting times and identify the transcription error
subsequently resulted in the resident developing a
significant intracranial bleeding and Coumadin toxicity.
This resulted in the resident’s death.

 Summaries of Nursing Facilities Citation for Unnecessary Medications and Resident Harm (G or Higher Level Citation), 2017-2018
State

Florida

Date

1/5/2018

Overall Inspection
Star
Survey
Rating
Rating

1

1

Survey
Type

Complaint

Severity
Code

Remedy
Imposed

Civil
Money
Penalty

J

50

Civil
Money
Penalty

Summary of Citation

$98,455
(Per-Day)

One of the sampled residents received the antipsychotic
medication, Haldol, without documented evidence of an
indication for use and in the absence of any behavioral
symptoms that presented a danger to the resident or
others. The resident received an excessive dose that was
80 times the ordered amount and continued to receive the
excessive doses of Haldol after she began experiencing
adverse consequences. The resident was supposed to
receive a 0.25mg dose of Haldol, but due to an error, the
resident received a 20mg dose of Haldol. The resident
was placed on 24-hour crisis care and was transferred to
the hospital. Her admitting hospital diagnosis was acute
encephalopathy (brain damage), “probably medicationinduced from Haldol from overdose at the nursing
home." The resident needed extensive assistance for bed
mobility transfers, locomotion, dressing, toilet use,
personal hygiene, and bathing.

 Summaries of Nursing Facilities Citation for Unnecessary Medications and Resident Harm (G or Higher Level Citation), 2017-2018
State

Illinois

Kentucky

Date

11/5/2018

11/17/2017

Overall Inspection
Star
Survey
Rating
Rating

1

1

1

1

Survey
Type

Standard

Complaint

Severity
Code

Remedy
Imposed

No
enforcement
imposed
based on
regional
office
review

G

Civil
Money
Penalty

K

51

Civil
Money
Penalty

Summary of Citation

N/A

The facility failed to ensure a resident was offered the
right to refuse an intramuscular psychotropic medication
or provided the least restrictive means of medication
intervention. The resident had been having loose stools
and was instructed to pull the emergency cord in her
room every time she had a bowel movement. However,
when she pulled the emergency cord, one of the nurses
instructed her not to use the cord and locked the
resident’s private bathroom. The resident was incontinent
and had soiled herself. The nursing staff then phoned the
physician and ordered Atvian and Haldol injections. The
physician orders did not have any type of necessary
diagnoses in order to use psychotropic medications. A
member of the nursing staff said the resident should be in
a mental institute and administered the antipsychotic
medication. While omitted from the nurse’s notes, the
resident refused the medication, but was given an
intramuscular injection for these chemical restraints
anyway.

$366,709.85
(Per-Day)

The facility failed to ensure that four different sampled
residents were free from unnecessary medications. The
facility administered an antipsychotic medication to four
residents without adequate monitoring to ensure the
residents were receiving a safe, therapeutic dosage of
medications, resulting in kidney damage and subsequent
death for one resident. An evaluation showed that there
was no evidence that the resident’s clinical condition was
reviewed for the continued need for the medication.

 Summaries of Nursing Facilities Citation for Unnecessary Medications and Resident Harm (G or Higher Level Citation), 2017-2018
State

Date

Overall Inspection
Star
Survey
Rating
Rating

Survey
Type

Severity
Code

Remedy
Imposed

Civil
Money
Penalty

Maryland

1/19/2017

3

1

Standard

K

Civil
Money
Penalty

$884,711.88
(Per-Day)

Michigan

3/31/2017

5

4

Complaint

G

Civil
Money
Penalty

$6,500 (Per
Instance)

New
Mexico

7/19/2018

1

1

Standard

Civil
Money
Penalty

J

52

$224,779
(Per-Day)

Summary of Citation
The facility failed to have a system in place for accurate
documentation of the administration of medications
within physician ordered parameters. Residents were
receiving medications for blood pressure or heart
medications as well as antipsychotics. The facility lacked
documentation that a physician authorized the
administration of a number of these drugs. As a result, a
total of 58 medication errors were evident for five
residents reviewed during the survey.
The facility failed to monitor international normalized
ratio (INR) for anticoagulant monitoring levels during
the use of various medications. The deficient practice
resulted in abnormally high medication level causing
excessive bleeding, which may have contributed to death.
The resident had multiple diagnoses, including anemia
and atrial fibrillation and started on Coumadin. While
Coumadin levels were high, the orders for testing were
missed on the admission orders. No prothrombin time
(PT) or INR tests were ordered. The residents died within
a few days with primary diagnosis of low blood volume
and septic shock.
During the annual survey, it was determined that a nurse
gave a resident the antipsychotic medication Seroquel for
aid with sleep. The resident and his wife reported that on
the next day, he was over-sedated. The resident further
reported that he was anxious about getting his
medication. Based on record review, interview, and
observation, the facility failed to ensure Seroquel was
given for an appropriate indication for the resident. This
deficient practice resulted in unnecessary fear, worry and
anxiety, and over-sedation.

 Summaries of Nursing Facilities Citation for Unnecessary Medications and Resident Harm (G or Higher Level Citation), 2017-2018
State

Ohio

Washington

Date

3/16/2018

5/4/2017

Overall Inspection
Star
Survey
Rating
Rating

1

4

1

3

Survey
Type

Standard

Complaint

Severity
Code

Remedy
Imposed

J

Civil
Money
Penalty

G

No
enforcement
imposed
based on
regional
office
review

Civil
Money
Penalty

Summary of Citation

$13,627.25
(Per
Instance)

The facility failed to ensure one resident had a qualifying
diagnosis for a psychotropic medication. The diagnosis
was based on incorrect information that the resident was
delusional. The resident’s physician prescribed a
psychotropic medication without a supporting diagnoses
or documented rationale for use. The resident was
observed with severe cognitive impairment, lethargy,
decreased oral intake, excessive sleeping, decreased
physical abilities, and decreased participation in
activities. The facility failed to monitor the resident for
effectiveness or adverse effects of the antipsychotic
medication. The facility identified seven residents
residing in the facility who received antipsychotic
medications.

N/A

The facility failed to ensure a resident was treated with
dignity and respect. The staff combined chemical
restraints, in the form of injections of 5mg of Olanazpine,
10mg of Haldol and a sedating anti-histamine (50mg of
injectable Benadryl), for behavioral management.
However, the resident experienced psychosocial harm
and over-sedation as a result of the imposed medications.

Source: Summaries of select unnecessary medication citations with a Severity Level 3 or higher were provided from CMS data on all unnecessary medication
citations with a Severity Level 3 or higher from 2017 and 2018.
Notes: The severity of a deficiency is based on a level of 1 to 4, where a Level 1 deficiency implies No Actual Harm with the Potential for Minimal Harm and a
Level 4 deficiency implies Immediate Jeopardy to Resident Health or Safety. A Level 3 or Higher deficiency level corresponds to a Level “G” or higher
deficiency level. See Table 1 for more information.

53