U.S. Department of  Health  and  Human Services  
Office of Inspector General  
 
Long-Term Trends of  
Psychotropic Drug Use in 
Nursing Homes  
Christi A. Grimm  
Inspector General   
November  2022, OEI-07-20-00500   U.S.  Department of Health and  Human Services  
 
Office  of  Inspector  General  
Report in Brief  
November  2022,  OEI-07-20-00500  
Why  OIG Did This Review   Long-Term  Trends of Psychotropic Drug Use  
Nursing  home residents  and  their  
in Nursing Homes   
families  rely  on  nursing  homes  to 
provide  quality  care  in  a  safe  
CMS has  oversight of nursing homes  
environment,  and  nursing  homes  are  
Key Takeaway   that are responsible for the  health and  
statutorily  required  to protect  
residents rights in  this regard.   OIG  Overall, psychotropic drug   safety of vulnerable residents.   CMS is  
work  in  2011  raised  quality  and   use in  nursing homes was   required to monitor nursing home  
safety  concerns  about  the  high use   relatively constant,   activities, including  compliance with  
of  one category  of  psychotropic   prescribed to  about  80  standards related to nursing homes  
drugantipsychoticsby  nursing   percent of nursing home   use of  drugs to treat residents various  
home residents.   CMS began   residents from 2011 through  conditions.   
monitoring  nursing  home  residents   2019.  Protecting nursing  
Over the past 10 years,  CMS took 
use  of  antipsychotics  in 2012,  and  in 
home residents from the 
May  2021  OIG  published  a  report   important steps to reduce the use of 
potential harms of  
that determined  that  CMS's  existing   one category of psychotropic drug 
psychotropic drugs is  
methods  for  monitoring   antipsychotics.   However, there 
essential yet remains  
antipsychotic  use  by  nursing  home   continues to be  concern about the use  
challenging without the  
residents did not  always provide   of psychotropic drugs  among  nursing  
ability to comprehensively  
complete information.   Additionally,  home  residents.  
determine the scope of  these 
congressional  stakeholders  continue 
to raise concerns  that  nursing  home  drugs use  in nursing homes.   CMS defines psychotropic  drugs as  
residents  may  be  inappropriately   any drug that affects brain activities  
prescribed  other  types  of   associated with mental processes and behavior.   These medications can  
psychotropic drugs and  that   be effective in treating a range of  conditions but  carry  risk and must be  
potentially  inappropriate use of   prescribed appropriately.   CMS guidance acknowledges that medications  
those  drugs may  be  going  beyond antipsychoticssuch as anticonvulsants, mood stabilizers, and  
undetected.    central nervous system agentsmay affect brain activity and therefore 
must only be prescribed with a documented  clinical indication.   For this  
How OIG Did This Review  
report, we refer to all of these medications as psychotropic drugs.  
We  used  Minimum  Data  Set  (MDS)  
assessment  data  from  calendar  years   What OIG Found  
2011  through 2019 to  identify  long-
From 2011 through 2019,  about 80 percent of Medicares long-stay  
stay  nursing  home  residents aged  65 
nursing home residents  were prescribed  a psychotropic  drug.  While CMS 
and  older  and  reviewed  Medicare 
focused its  efforts  on  reducing  the use of one  category of psychotropic  
Part  D  psychotropic drug claims data  
drugantipsychoticsthe  use of another category of psychotropic  
for  these residents.   From  these data,  
druganticonvulsantsincreased.  This increased use of anticonvulsants  
we identified  the number  of  
contributed to the overall use of psychotropics remaining constant.  
residents  who received  a  prescription  
for  any  of  these  drugs.   We  then 
In 2019, higher use of psychotropic drugs was associated with nursing  
searched for  patterns and 
homes that have  certain  characteristics.   Nursing homes  with lower  ratios  
characteristics  in  these  data  
of registered nurse staff  to residents  were associated  with higher use of  
correlated  with  a  higher  use of  
psychotropic drugs.   Nursing homes with higher percentages  of residents  
psychotropic drugs in  nursing 
with low-income subsidies  were  also associated with higher use of 
homes.   Our review  did not  assess  
psychotropic drugs.  
the  administration  of  or  medical 
necessity  of  psychotropic drugs for  
nursing home  residents.    
 
   
Additionally, over time  the  number of unsupported schizophrenia  
diagnoses increased and in 2019 was concentrated in relatively few 
nursing  homes.  Specifically, we found that from 2015  through 2019 the 
number of residents reported in the MDS as having  schizophrenia but  
lacking a corresponding schizophrenia diagnosis in Medicare  claims and  
encounter data increased by 194 percent.   In 2019, the  unsupported  
reporting of schizophrenia  was concentrated in  99 nursing homes in 
which 20 percent or more of the residents  had a report  of schizophrenia 
in  the MDS that was not found in the Medicare  claims history.  
CMSs long-stay quality measure  that tracks antipsychotic use in nursing  
homes excludes residents  who are reported as having  schizophrenia  in  
the MDS.   Thus, nursing homes could misreport  residents  as having  
schizophrenia in the MDS to  falsely impact  CMSs  quality measure.  
By not collecting diagnoses on Medicare Part D claims, CMS  is limited in  
its ability to effectively conduct oversight of psychotropic drugs.   First,  
not having diagnoses on claims limits  CMSs  ability to  detect patient risk  
and patterns of potentially inappropriate drug use.  Second, the lack of 
diagnoses makes it difficult  for CMS to systematically determine whether  
claims meet the payment requirement that drugs be used for medically  
accepted purposes.    
What OIG Recommends and How the Agency Responded  
CMS should: (1)  evaluate the use of psychotropic drugs among nursing  
home residents to determine whether  additional action is needed to  
ensure that use among residents is appropriate, (2)  use data to identify  
nursing homes or nursing home characteristics that  are associated with  a 
higher use of psychotropic drugs and  focus  oversight  on nursing homes  
in which trends may signal inappropriate use, and (3)  expand the  
required data elements on  Medicare Part  D claims to include a diagnosis  
code.   CMS  concurred with the first two recommendations and did not  
concur with the third recommendation in this report.  
 
   
TABLE OF CONTENTS  
 
 
BACKGROUND ................................................................................................................................................  1  
FINDINGS ......................................................................................................................................................... 9  
Overall psychotropic drug use among nursing home residents was  relatively constant from  2011  
through 2019 at  80 percent; antipsychotic use declined while use of another category of  
psychotropic  druganticonvulsantsincreased .........................................................................................................  9  
Higher use of psychotropic drugs was associated with nursing homes that had certain 
characteristics  in 2019 ........................................................................................................................................................... 10  
By not  collecting  a diagnosis on Medicare  Part  D  claims, CMS is limited in its ability to effectively  
conduct oversight of psychotropic drugs ...................................................................................................................... 13  
CONCLUSION AND RECOMMENDATIONS ...........................................................................................  15  
Evaluate the use of psychotropic drugs  among nursing home residents to determine whether  
additional action is needed to ensure that use among residents is appropriate ........................................... 15  
Use data to identify nursing homes or nursing home characteristics that are associated with a  
higher  use of psychotropic drugs and focus  oversight on nursing homes in which trends  
may  signal  inappropriate use ............................................................................................................................................. 16  
Expand the required data elements on Medicare Part D  claims to include a  diagnosis code .................. 16  
AGENCY COMMENTS AND OIG RESPONSE  .........................................................................................  17  
APPENDICES..................................................................................................................................................  19  
Appendix A: CMS  Enforcement Actions  ......................................................................................................................... 19  
Appendix B: Select CMS  Regulatory Requirements ................................................................................................... 20  
Appendix C: Agency  Comments ........................................................................................................................................ 21  
ACKNOWLEDGMENTS AND CONTACT  ................................................................................................  26   
ABOUT THE OFFICE  OF INSPECTOR GENERAL. ....................................................................................2 7   
ENDNOTES  ...................................................................................................................................................  28   
 
 
   
BACKGROUND  
OBJECTIVES  
To examine:  
1.   the trends of psychotropic drugs used in nursing homes over time, and  
2.   how the use of psychotropic drugs  could be monitored using Medicare data. 
 
The  Centers  for  Medicare  &  Medicaid  Services  (CMS)  oversees  nursing  homes, which  
are responsible for the health and safety of vulnerable residents.1   CMS is required to  
monitor nursing home activities including compliance with standards related to  
nursing homes use of drugs to treat residents various conditions.2   Medications can 
be effective in treating  a range of  conditions, but  all drugs carry risk  and must be 
prescribed appropriately.  
Recently, members of  Congress expressed  concerns about the use of psychotropic  
medications  in  nursing  homes  after  reviewing  clinical  research  and  conducting  their  
own investigative research.3   Additionally, the White House announced new measures  
to improve the quality and safety of nursing homes that include a new effort to  
identify  problematic diagnoses and refocus efforts to continue  to bring down the 
inappropriate use of some medications.4  
CMS defines  a psychotropic drug as any drug that affects brain activities associated 
with  mental  processes and  behavior.5,  6, 7   Specifically,  CMS  states that psychotropic  
drugs include,  but  are  not  limited to: antipsychotic, antidepressant,  antianxiety, and 
hypnotic  drugs.8   CMS  guidance  acknowledges that  other medicationssuch as 
anticonvulsants, mood stabilizers, and  central nervous system  agentsmay affect  
brain activity  and therefore must only be prescribed  with a documented  clinical 
indication.9, 10   For this report, we refer to all of these medications as psychotropic  
drugs.11  
The use of psychotropic drugs in nursing homes  can be concerning because of the 
serious side effects and risks associated  with the use of psychotropic drugs such as  
antipsychoticsincluding increased risk of death among  the elderly.  The risk  of  
adverse consequences  varies  based on  both the number of medications being taken 
regularly and  the  specific pharmacological  classes  of medications, such as 
antipsychotics and anticonvulsants, that are taken.12, 13   In 2008, the Food and Drug 
Administration (FDA)  issued a boxed  warning,  stating  that  some  off-label  uses of  
antipsychotic  medications  can  result in severe adverse effects (i.e., antipsychotics are 
associated with an increased risk of mortality in elderly patients treated  for dementia-
related psychosis).14   Several anticonvulsant medications also have boxed  warnings  
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that draw  attention to serious and potentially life-threatening adverse reactions,  
which include vision loss, liver failure, and increased risk of suicidality.15   Similarly,  
antidepressant medications are associated  with several side effects to which elderly  
adults may be more vulnerable.   These  side  effects  range  from  headaches  and  
gastrointestinal  issues  to  cognitive impairment and increased risk for falls that can 
cause serious  injury and  lead to hospitalization.16   
CMSs efforts to  reduce inappropriate use of one category of  
psychotropic drugantipsychoticsin nursing homes  
National  Partnership  
CMS formed the National Partnership to  Improve Dementia Care in Nursing Homes  
(the Partnership) to improve comprehensive dementia care.   The Partnership is a  
public-private collaboration that engaged Federal  and State agencies, nursing homes,  
other providers, advocacy groups,  and caregivers.17   Although its focus has centered  
on reducing the use of antipsychotic medications, the Partnerships larger  mission is  
to enhance the use of nonpharmacologic approaches and person-centered practices  
for  dementia care.18  
In CMSs 2014 interim report about the Partnerships progress, CMS described several  
possible reasons  for the high use of antipsychotics in nursing homes.19   CMS  
developed a targeted survey to supplement annual  nursing home surveys  and provide 
more focused oversight  on the inappropriate prescribing of antipsychotics.   CMS  
identified a lack of staff training and lower registered nurse (RN) staffing levels as  
possible reasons.  Additionally, CMS reported that higher use of these drugs was  
more often found in for-profit nursing homes.   Conversely, decreased use was  
associated with nursing homes with higher  Medicaid payment rates.20   
In 2016, CMS (through the Partnership)  identified an issue of providers  
inappropriately coding residents as being diagnosed with schizophrenia to  artificially  
improve their quality measure and Nursing Home  Five-Star Quality Rating  System  
performance.   As a result, CMS  piloted a targeted  survey to  exclusively  review  this  
issue and inform future actions.21  
In 2017, CMS  (through the Partnership) targeted nursing homes with high rates of  
antipsychotic medication use and little-to-no  change over the years  (i.e., late  
adopters).   Nursing homes identified as late adopters were subject to more severe 
enforcement actions.   CMS  also sent letters to those nursing home chains with a large 
number of facilities identified as late adopters.22    
In 2021, CMSs  targeted  surveys focused exclusively on investigating the 
inappropriate diagnosing and coding of residents  with schizophrenia.    
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Quality  Measures  
CMS uses quality measures as tools to quantify health care processes, outcomes, and  
organizational systems that are associated  with effective, safe, and efficient health 
care.  Since 2012,  CMS has used one such quality  measure to quantify  the percentage 
of long-stay residents  (i.e., those with a nursing home stay of 101 days or longer) who  
received  one category of psychotropic drugantipsychotics.23   The Nursing Home  
Five-Star Quality Rating  System  and CMSs  Care Compare website are key  tools for  
consumers to use when choosing a nursing home.  In 2015, CMS began using the 
long-stay quality measure that tracks antipsychotic use in nursing homes  for one of  
its  Nursing Home Five-Star Quality Rating System  calculations.24   This calculation,  
which excludes beneficiaries who are reported in the Minimum Data Set (MDS)  as  
having schizophrenia, Huntingtons disease or Tourettes syndrome, impacts the 
rating that nursing homes receive on the Care Compare website.25, 26   This exclusion  
applies even when no support for these claims exist anywhere else in a residents  
clinical records.   Importantly, the data used  for the nursing home long-stay quality  
measure calculation is self-reported by nursing homes in the MDS.27      
CMSs oversight  activities to protect nursing home residents  
CMS,  in conjunction with States,  oversees  nearly 16,000 Medicare- and Medicaid-
certified nursing homes to ensure that they meet  Federal requirements.28   Onsite 
nursing home surveys are one important oversight tool to ensure that nursing home 
residents are safe and receive quality  care.   States conduct standard certification  
surveys on behalf of CMS for nursing homes on average every  12 months  but at least  
every 15 months.   Compliance with standards related  to medication management  is  
among hundreds  of regulatory requirements that  surveyors may evaluate during  
surveys.29   Through this onsite survey process, CMS  and States have documented the 
potential for  concerns related to medication management,  and CMS has  increased  
some oversight activities in response.  
These oversight activities include enforcement actions such as citations  and  
impositions of civil monetary penalties (CMPs).   Citations correspond to  a specific  
regulation within the Code of Federal Regulations and can be issued for a variety of  
concerns,  such as the use of unnecessary medications.   In 2018 and  2019,  the number  
of citations issued by CMS related to the unnecessary use of psychotropics in nursing  
homes remained  constant at approximately 3,000  citations  per year.   CMPs  can vary in 
the dollar amount and duration and  can depend  on a variety of factors.   Sometimes,  
large CMPs are a useful tool to incentivize nursing homes to come back into swift  
compliance with Federal rules.   See Appendix A for additional information on  
enforcement actions and CMPs.  
Sufficient and competent staffing in nursing homes  
Nursing homes are required to employ sufficient  staff to provide care and  services in 
assisting residents to attain or maintain their highest levels  of physical, mental, and  
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psycho-social well-being.30   CMS states that nursing homes should have sufficient  
staff members, including  RNs, who possess the basic competencies  and skill sets to  
meet the behavioral health needs of residents.31   CMS  describes sufficient and  
competent staffing more specifically in stating that nursing homes should implement  
person-centered approaches to  care based on comprehensive assessments  and be 
guided by interdisciplinary teams.32   CMS requires  nursing homes to report their daily  
staffing information based on payroll information to the Payroll Based Journal (PBJ).   
This data is used by CMS to calculate the staffing rating used in the Nursing Home 
Five-Star Quality Rating  System.33   See Appendix B for additional information on CMS  
regulatory requirements.  
Medicare Part  D payment for psychotropic drugs  
Comprehensive prescription drug coverage is available to all Medicare beneficiaries  
through Medicare Part D.   Medicare beneficiaries  generally have the option to enroll  
in a stand-alone prescription drug plan and receive all other Medicare benefits on a  
fee-for-service basis, or to enroll in a Medicare Advantage prescription drug plan and  
receive all of their  Medicare benefits, including prescription drug  coverage, through  
managed care.   Long-term care pharmacies contract  with Medicare prescription drug  
plans to provide drugs to their enrollees who  are residents of the nursing homes that  
those pharmacies serve.   Additionally, Medicare Part D helps  cover the cost of  
prescription drugs  and provides for extra help with prescription drug  costs for eligible 
individuals whose income and resources are limited (i.e., low-income subsidy).  
Medicare Part D  claims data include elements that provide patient level information.   
The information included on Medicare Part  D claims provides details  such as  the type 
of medication, dosage,  number of  days  supply, volume of drugs, cost of the drug,  and 
whether the beneficiary  qualifies for a low-income subsidy.  
For drugs to qualify for Medicare  Part D reimbursement, the drugs must  be used for  
medically accepted  indications.34   However, Medicare Part  D claims data include 
information about the drugs dispensed but do not include diagnosis information 
because CMS does not require or collect diagnoses (i.e., the reasons for the drugs) for 
these items.  
Previous OIG work described quality and safety concerns in 
nursing homes related to antipsychotic drug use,  adverse  
events, and staffing levels  
Protecting the health, safety, and  well-being of nursing home residents is a top 
priority for OIG, and  we have a large portfolio of  nursing home oversight  work  
spanning decades.   Some of this prior work, summarized below, is particularly relevant  
to concerns about psychotropic drug use.  
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Previous OIG work found that nursing home residents who  were prescribed  
antipsychotics were at risk for harm.35   Specifically, 83 percent of Medicare claims for  
atypical antipsychotics  were associated with conditions other than those for which 
FDA approved the use of those medications  (i.e.,  off-label use), and  88 percent were 
associated with a  condition specified in the FDA boxed warning.   The boxed warning  
states that elderly patients with dementia-related  psychosis  who are treated with 
these drugs are at an increased risk of death.   OIG recommended that CMS facilitate  
access to information necessary to ensure accurate coverage and reimbursement  
determinations, such as  expanding the required  data elements to include a diagnosis  
code.   CMS did not concur with that recommendation.  
In 2012, OIG used medical record reviews  to evaluate nursing home compliance with 
Federal quality and safety standards on assessment and care plans.36   The study found 
that 59 percent  of care plans did not include evidence of resident, family,  and/or  
representative involvement or documentation as to why they  were not involved in 
care planning.37   The study also reported that  97 percent of  care plans were not  
developed by an interdisciplinary team (e.g.,  a physician and  RN  team).   These are 
aspects of care that must be conducted by  a qualified health professional and require 
involvement of an interdisciplinary team.   CMS concurred  with and implemented all  
recommendations in the report.  
Preventable,  medication-related adverse consequences and events are a serious  
concern in nursing homes.38   In 2014, OIG found that one in three short-stay (i.e.,  stay  
of  100  days or less)  residents experienced an adverse event or temporary  harm  
event.39   Thirty-seven percent of these adverse events were related to medications  
and 66 percent of all medication-related events  were preventable.   Consequences of  
medication-related adverse events  included prolonged nursing  home stays,  
hospitalizations, life sustaining interventions, permanent harm,  and deaths.   In  this  
report, OIG recommended that CMS raise awareness of adverse events in post-acute 
care and seek to reduce harm to nursing home residents through methods used to  
promote hospital safety.  By 2018, CMS had implemented this recommendation by  
taking actions that included creating an Adverse Drug Event Trigger Tool, enabling  
nursing homes to identify adverse events in periodic medical record reviews.40   
In 2020 and  2021, OIG reported findings regarding interdisciplinary staffing in nursing  
homes.41   One report  stated that 48 percent of nursing homes did not report any  
hours for  at least one type of critical non-nurse staff,  including staff required by all 
nursing homes (e.g., administrators, medical directors, and dieticians) and  workers 
that provide required services (e.g., pharmacists).   The report cited CMSs statement  
that [s]taffing in nursing homes has a substantial  impact on the quality of  care and  
outcomes residents experience.42   The other report found that 7 percent  of  nursing  
homes reported staffing levels below CMSs required levels for at least 30 total days in 
2018.   It also  cited results of a survey to collect local ombudsman perspectives on 
residents experiences  when nursing homes report many days  with staffing below  
required levels.   The results revealed that a scarcity of nurses led to care issues,  
including  medication management concerns.  
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In May  2021, OIG  published an Issue Brief  that  determined that CMS's use of the MDS  
as the sole data source to count the number of nursing home residents using  
antipsychotic drugs did not always provide complete information.43   By comparing  
Medicare  claims to MDS records for nursing home residents aged  65 and  older in 
2018, OIG found that many beneficiaries had  Medicare Part  D claims for antipsychotic  
drugs but were not reported in the MDS  as receiving an antipsychotic drug.   
Furthermore,  nearly one-third of residents who  were reported in the MDS  as having  
schizophreniaa diagnosis that excludes them from CMS's measure of antipsychotic  
drug usedid not have any  Medicare service claims for that diagnosis.   Finally, even 
for those residents included in the MDS  counts, the MDS  does not provide important  
details about the drug use (e.g., which antipsychotic drugs were prescribed,  at what 
quantities and strengths;  and for  what durations).   OIG recommended that  CMS:  
(1)  take additional steps to validate the information reported in  MDS assessments and  
(2) supplement the data it uses to monitor the use of antipsychotic drugs in nursing  
homes.   CMS concurred  with both recommendations, noting in its response to OIG 
that CMS efforts  were underway to supplement the data used to monitor the use of  
antipsychotic drugs in nursing homes.   CMS directed the Plan Program Integrity  
Medicare Drug Integrity  contractors  to increase their  focus  on proactive data analysis  
in Part D to identify inappropriate payments, potential program vulnerabilities,  and 
address issues, such as  abusive prescribing.  
Methodology  
Data collection  
For each year from  2011  through 2019,  we identified beneficiaries  who:  (1)  were aged  
65  or older,  (2)  were enrolled in a Medicare Part  D plan (including traditional  fee-for-
service or  Part C managed care enrollment),  (3) received at least one MDS  assessment  
during a  stay,  and (4)  were prescribed  psychotropic drugs.  
MDS assessment data.   We collected  MDS assessment data for calendar years  
2011 through 2019 to identify  long-stay nursing  home residents who  were  aged  65 
and older during their nursing home stay.  
Medicare Parts A, B, C, and D data.   We collected prescription drug event  
records for Medicare Part D claims from 2011 through 2019 for nursing home  
residents  who were aged  65  and older.   We also collected  Medicare Parts  A and B  
claims data from the National Claims History  File; and Part C encounter data.  
PBJ staffing data.   We collected  PBJ data for the nursing homes that provide care 
for the residents in this population.  
First DataBank data.  We collected data from the First DataBank to determine the  
National  Drug Codes (NDCs) that are  categorized as psychotropic drugs.  For  
consistency with other  OIG reports,  we used First  DataBanks Enhanced Therapeutic  
Class (ETC)  code  to  identify  psychotropic drugs.   
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Qualitative data.  We collected written responses to a structured interview with 
CMS officials to gain information about CMSs efforts toward monitoring psychotropic  
drug use in nursing homes.  We asked  about  activities that CMS  conducted in this  
area, including its use of  technology and data to detect errors  and trends in MDS  
reporting.   The team also engaged a representative from the National Council for  
Prescription Drug Programs regarding initiatives related to the inclusion of diagnostic  
information on prescription drug claims.44    
Data Analysis  
We combined the data collected from the sources listed above to analyze the extent  
of the use of psychotropic drugs in nursing homes, to identify the number  of  
residents who received a  prescription for any of these psychotropic drugs,  and to  
categorize the types of drugs paid for by the Medicare Part  D program over this span 
of time.  For the remainder of the report,  residents refers to long-stay nursing home 
residents who  were aged  65  and older  and were Medicare beneficiaries.  
Residents who  were prescribed  psychotropic drugs. For each  year  from  2011  
through 2019, we used  the data sources described above to  identify  residents  who  
received psychotropic drugs.  We examined all MDS records  with an assessment date 
in the year for any residents.  We determined the number of days of each residents  
stay in these nursing homes and limited the population to those residents with stays  
of 101 or more consecutive days  within a  single calendar year.  We then reviewed for  
this long-stay population all Medicare  Part D psychotropic drug  claims  with a date of  
service (i.e., date a  prescription was filled) during  a nursing home stay in the year.   We 
used First DataBank to determine the NDCs for psychotropic drugs.  We identified 19  
categories  of psychotropic drugs  that affect brain  activities associated with mental  
processes and behavior.   We then  used these to  identify  psychotropic drugs during  
our analysis of  Medicare  Part  D drug claims.  For the nursing homes identified in 
these MDS records,  we also analyzed nursing home staffing information from the 
PBJ.45   We used Medicare enrollment data to determine which residents were 
receiving a  Medicare Part D low-income subsidy in the year.46  
Residents with schizophrenia. For each year  from  2011  through 2019, we  
analyzed schizophrenia diagnoses reported in MDS and in Medicare claims.  For the 
residents identified as  aged  65  or older  for whom there was at  least  one MDS  
assessment in the year,  we determined the number of those residents for whom there 
was an MDS-reported diagnosis of schizophrenia.  We also determined the number of  
those residents aged  65  or older who had  claims in Parts A or  B or encounter data in 
Part C  with a schizophrenia diagnosis.   
Limitations  
The results of our analysis rely on the accuracy  of  the data in CMSs databases.  It is  
possible that some beneficiaries received services  that were not included in our  
analysis (e.g.,  due to  incorrect or incomplete  MDS coding;  drugs that were  not 
submitted to Medicare), which may lead to an underestimate  or overestimate 
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OEI-07-20-00500   Background |  7     
regarding some information for some beneficiaries.   Additionally,  our Part D  claims  
analysis  allows us to  only determine which medications were prescribed  and then 
filled by a pharmacy,  not which medications were administered.    
Standards  
We conducted this study according to  the Quality Standards for Inspection  and  
Evaluation  issued by the Council of the Inspectors General on Integrity and Efficiency.  
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FINDINGS  
Overall psychotropic drug use among nursing home residents  
was relatively constant from 2011 through 2019 at 80 percent;  
antipsychotic use declined while  use of another  category of  
psychotropic druganticonvulsantsincreased    
From 2011 through 2019, the overall use of  psychotropic  drugs  among  nursing home 
residents remained about constant  at about  80  percent.   (See endnote 11 for a list of  
all categories included in the analysis of all psychotropic drugs.)   While the use of one 
category of psychotropic drugantipsychoticsdecreased from 31  percent  in 2011 
to 22 percent in 2019, the use of another  category of  psychotropic drug 
anticonvulsantsincreased.  Anticonvulsants showed an increase in use among  
nursing home residents from 28 percent to 40 percent during the same period.  These 
data demonstrate that overall use of psychotropic drugs did not decrease but rather  
the use of psychotropic  drugs shifted toward a different category.  The use of  
psychotropic drugs in nursing homes can be concerning because of the serious side 
effects  associated  with the use of some psychotropic drugs that  could include 
increased risk of death, suicidality, or  falls  among  the elderly.    
Exhibit 1: While CMS focused its efforts on reducing antipsychotic  drug use, 
overall psychotropic drug use remained constant, and anticonvulsant drug  
use increased among long-stay residents aged  65 and older.   
% 
All psychotropic drugs 
80%                   
60% 
Anticonvulsants 
40% 
--- ~ - -- -----  --- -      
 
20% 
Anti psychotics 
0% 
2011  2012  2013  2014  2015  2016  2017  2018  2019   
Source:  OIG  analysis  of  MDS  and  Medicare  claims  data,  2022.   (See endnote  11  for a list  of  all  categories  
included in  the analysis of  all psychotropic drugs.)  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Findings |  9     
The  focus  of  CMSs  targeted  monitoring  of  antipsychotic  drugs  likely  contributed to  a 
decline in  antipsychotic  drug use among nursing home residents; however,  
anticonvulsant drug use increased during this effort.   In 2012, following OIGs report,  
CMS started monitoring  antipsychotic drug use in nursing homes,  which coincides  
with the decline in antipsychotic drug use.   In 2015, CMS began using the long-stay  
quality measure that tracks antipsychotic use in nursing homes in its Nursing Home 
Five-Star  Quality  Rating System calculations.   Antipsychotic drug use continued to  
decline while anticonvulsant drug use continued to increase after CMS made this  
change.   However,  CMS  guidance to State surveyors of nursing homes states use of  
psychotropic medications, other than antipsychotics, should not increase when efforts  
to decrease antipsychotic medications are being implemented, unless the other types  
of psychotropic medications are clinically indicated.47    
We  did  not  conduct  a medical  record  review  for  these  drug  claims  to determine  
whether  their use was clinically indicated  and  cannot  assess the appropriateness of the 
use of these drugs nor determine why they  were prescribed.  
Higher use of psychotropic drugs was associated with nursing  
homes that had  certain characteristics  in 2019    
Using  2019 data  sources  that  are  available  to  CMS,  we  identified  two  characteristics  
that correlate with higher use of psychotropic drugs in nursing homesstaffing and  
low-income subsidies.  
Nursing homes with lower RN staffing numbers were associated with  
higher use of psychotropic drugs  in 2019.  Using PBJ data that CMS  collects,  we  
determined that for the nearly  1,100 nursing homes that had RNs  on staff for 15  
minutes  or  less  per  resident  per  day,  81  percent  of  residents  had  claims for  
psychotropic drugs  in 2019.   In contrast,  for the nearly 2,000 nursing homes that had 
RNs on staff for more than 1 hour per resident per day,  75 percent of residents  had  
claims for psychotropic drugs  in 2019.   See Exhibit 2.  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Findings |  10     
Exhibit  2:  Nursing  homes  with  lower  RN  staffing  numbers  were  associated  
with a higher percentage  of  long-stay residents with claims for psychotropic  
drugs  in 2019.  
rage RN staffing  Percent of long-stay residents with claims 
time per resident per day  for psychotropic drugs 
15 minutes or less  81% 
Between 16 and 30 minutes  80% 
Between 31 and 45 minutes  79% 
Between 46 minutes and 1 hour  71% 
More than 1 hour  75% 
0  5  15  25  35  45  55  65  75  85 
 
Source:  OIG  analysis  of  Medicare  claims  and  PBJ  data,  2022.  
Nursing homes with  higher percentages of residents with low-income 
subsidies had higher use of psychotropic drugs  in 2019.  Using Medicare  
Part  D data,  we determined that higher use of psychotropic drugs is associated with 
nursing homes that serve more residents who receive low-income subsidies  in 2019.   
For instance, the nearly 5,000 nursing homes  in which  more than 95 percent of  
residents  received  a Medicare Part D  low-income subsidy had  79 percent of residents  
with claims for psychotropic drugs  in 2019.   In contrast, the nearly 550 nursing homes  
in which  50 percent or  fewer  residents  received  a Medicare Part D low-income subsidy  
had only  73 percent of residents with claims for psychotropic drugs  in 2019.  See 
Exhibit 3.    
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Findings |  11     
Exhibit 3: Nursing homes with  higher percentages  of residents with low-
income subsidies have higher percentages  of residents with claims for  
psychotropic drugs  in 2019.  
Nursing homes by 
percent of residents with 
Part D low-income subsidy 
25% or fewer  72% 
26% to 50%  74% 
51% to 75%  77% 
More than 75%  79% 
0  10  20  30  40  so  60  70  80   
Source: OIG analysis of Medicare claims and enrollment data, 2022.  
From  2015  through  2019,  there  were  increases  in  both  MDS  
reporting of schizophrenia and the  numbers  of residents who 
lacked  a corresponding schizophrenia diagnosis in Medicare  
claims and  encounters  
The reporting of residents in the MDS  as having schizophrenia increased from 2015  
through 2019.   After  2015, the number of nursing home residents reported in the 
MDS as having schizophrenia  
increased by 35 percent.   
Additionally, the number of residents   194%  increase  
There was a  
reported in the MDS as having  
schizophrenia but lacking a   in the  number  of  residents  reported  
corresponding schizophrenia   in  the MDS as  having  schizophrenia  
diagnosis in Medicare claims  and   but  who  lacked  a corresponding  
encounter data increased by 194   schizophrenia  diagnosis  
percent.   In 2015, there were 6,465   in  their  Medicare claims and  
residents who  were reported in the  encounters   (20152019).  
MDS as having schizophrenia but  
who lacked  a corresponding  
schizophrenia diagnosis in their  
claims for medical visits,  treatments, tests,  or supplies during 2015 or in the preceding  
year.  By 2019, this number  had almost tripled to  19,009 residents reported in  the  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Findings |  12     
MDS as having schizophrenia but who lacked a corresponding schizophrenia  
diagnosis in their claims  during 2019  or the preceding year.  
The timing of this increase coincides  with CMSs incorporation of the quality measure 
that tracks antipsychotic  use in nursing homes in 2015 into  one of its Nursing Home 
Five-Star Quality Rating  System  calculations,  which impacts the nursing homes rating 
on Care Compare.  The increases in MDS reporting of schizophrenia and the number  
of residents who lack a  corresponding diagnosis in Medicare claims is  concerning as  
schizophrenia is a  condition that is excluded from calculation in CMSs quality  
measure of  antipsychotic use.48   Therefore, any antipsychotic drug use for these 
residents may not be counted in their nursing homes quality measure of long-stay  
antipsychotic drug use.  
Additionally, more than 75 percent of these residents had a claim  for an antipsychotic  
drug in 2019 but qualified for exclusion from the antipsychotic measure because of  
MDS-reported schizophrenia.  
Certain nursing homes had particularly high levels of inconsistent reporting.   
Specifically,  99 nursing homes had 20 percent or  more of their residents  with this type 
of MDS reporting that  was inconsistent  with Medicare claims history.  Of these 99  
nursing homes, 88 percent were classified as for-profit.49  
One  Five-Star-rated nursing home reported 36 residents with  
schizophrenia in  the MDS in 2019,  even though  only 3 of those  
residents had  a Medicare encounter or claim  with a schizophrenia  
diagnosis.  Twenty-nine of these residents  were prescribed  
antipsychotics but qualified  for exclusion from being calculated in  
CMSs  quality  measure for long-stay antipsychotic use.  
By not collecting a diagnosis  on Medicare Part  D claims, CMS is  
limited in its ability to effectively  conduct oversight of  
psychotropic drugs  
Without a diagnosis on Medicare Part D  claims,  CMS is not able to determine the 
condition for which psychotropic drugs are prescribed without reviewing residents  
underlying medical records.   This raises two  concerns.  First, claims data provide no  
information  on why  a  drug was prescribed.   This limits CMSs ability to detect risky  
prescribing patterns and  protect vulnerable residents from inappropriate use.   
Antipsychotics, for example, are FDA-approved for certain conditions (e.g.,  
schizophrenia).  However, antipsychotics also have a boxed warning from the FDA.   
The boxed warning states that elderly patients  with dementia-related psychosis who  
are treated  with these drugs  face  increased risk of death.   Additionally,  drugs such as 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Findings |  13     
anticonvulsants  are approved to treat  conditions  such as  epilepsy  and manage some  
types of  nerve pain but are also sometimes prescribed off-label for  other types of  
pain management.   Second, the lack  of  diagnoses makes it difficult for CMS to 
determine whether  claims meet the payment requirement that drugs be used for  
medically accepted purposes.   Medical record reviews  are  conducted to evaluate the 
appropriate uses of psychotropic drugs, but  these are costly  and time-consuming.   
 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Findings |  14     
 
CONCLUSION AND RECOMMENDATIONS 
CONCLUSION  AND  RECOMMENDATIONS  
CMS and the Partnership  continue to  work  to reduce the use of  one category of  
psychotropic drugantipsychoticsin nursing homes.   During our period of review  
(2011  through 2019)  we found that while antipsychotic use declined in nursing  
homes, the use  of  another  category  of  psychotropic  druganticonvulsants 
increased.   Overall, about 80 percent of  Medicare long-stay nursing home residents  
each year  were prescribed some type of psychotropic drug.    
Higher use of psychotropic drugs was associated with nursing homes that have 
certain characteristics.  Higher numbers of psychotropic drug use were associated  
with  nursing  homes  with  lower  RN  staffing  numbers  and  nursing  homes  with  a  higher  
percentage of  residents with low-income subsidies.  
Additionally,  from 2015  through 2019, the number of beneficiaries reported by  
nursing homes as having schizophreniawithout corresponding  claims  or encounters  
that included  a  schizophrenia  diagnosisincreased  three-fold.  CMSs  quality  measure  
for  monitoring  antipsychotic drug use may not be capturing use for these residents.  
Other trends of psychotropic drug use in nursing  homes cannot be comprehensively  
monitored because  a  diagnosis  is  not  required  to  be  included  on  Medicare  Part  D  
claims.  This limits CMSs  ability to both fully understand how psychotropic  drugs are  
used for nursing home residents and target oversight  of  nursing  homes with 
concerning  patterns.  
There  are  ways  that  CMS  could  use  existing  dataand  collect  new  datato  monitor  
the use of psychotropic  drugs in nursing homes.  We identified three ways  that CMS  
could enhance its monitoring of the use of psychotropic drugs in nursing homes.  The 
use of this data  could identify areas of heightened concern and increase  CMSs ability  
to  focus  efforts on  monitoring  the use of psychotropic drugs in nursing homes.  
We  recommend  that  CMS:  
Evaluate  the use of  psychotropic drugs  among nursing home  
residents  to determine whether  additional action is needed to 
ensure that use among residents is appropriate  
Given the increased rate of anticonvulsant use we identified and the relatively  
unchanged overall  use of  all  psychotropic drugs, CMS should monitor the use of  
psychotropics, and the increased use of  anticonvulsants  in particular, to determine 
whether  additional action is needed to  better safeguard nursing home residents from  
overuse of any  psychotropic  drug.   CMS may identify other methods  of analysis  to  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Agency Comments and OIG Response  | 15     
ensure that the use of these drugs is appropriate.   In addition, CMS should evaluate 
the impact of  completely  excluding  certain conditions,  such as  schizophrenia, from  
calculations in future quality measures.   CMS may  consider excluding residents with 
MDS-reported schizophrenia from the quality measure calculation only  when the 
residents  have  corresponding diagnoses in CMS claims data  or other medical 
documentation.  
Use data to identify nursing homes or nursing home 
characteristics that are associated with a higher use of  
psychotropic drugs and  focus oversight on  nursing homes  in  
which  trends may signal inappropriate use    
CMS should increase its focused  oversight on  nursing homes that  appear  inconsistent  
with peer nursing homes or meet thresholds that  warrant  a followup.   It could  
accomplish this by establishing mechanisms to detect characteristics,  such as low  
nurse staffing,  that correspond with higher rates  of psychotropic drug use and target 
oversight of outlier nursing homes to determine whether they are using these drugs  
inappropriately.   
Expand the required data elements on Medicare Part D claims  
to include a diagnosis code  
The findings of this report reiterate the need for CMS to implement a previous  
recommendation by OIG: that CMS  facilitate access to information necessary to  
ensure accurate coverage and reimbursement determinations.  OIG understands that  
this would be a long-term investment that would benefit from a multistep  
implementation plan.  As a first step, CMS should  develop a pilot program  to include 
a diagnosis code (i.e., reason for the drug) on Medicare  Part  D claims for psychotropic  
drugs prescribed to long-stay nursing home residents.  CMS  could  consider  
partnering with other entities conducting  work in this area (e.g., the National Council  
for Prescription Drug  Programs, which recently  awarded a grant to The University of  
Arizona,  Department of  Pharmacy  Practice and Science to demonstrate the impact of  
including diagnostic  information.)  
   
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Agency Comments and OIG Response  | 16     
AGENCY  COMMENTS AND OIG  RESPONSE   
 
CMS concurred with two recommendations  and  did not concur  with one 
recommendation  in this report.  Additionally, CMS provided  details on its work to  
optimize the quality of life for residents in nursing homes by taking actions to reduce 
antipsychotic overuse.   
In response to our first recommendationfor CMS to evaluate the use of  
psychotropic drugs among nursing home residents to determine whether  additional  
action is needed to ensure that use among residents is appropriateCMS  agreed and 
stated it is evaluating  the use of psychotropic drug use among residents in nursing  
homes.   CMSs  evaluation includes the analysis of schizophrenia diagnosis history and  
prescribing trends.  CMS  plans to determine  what  actions, if needed, are appropriate 
after the evaluation is concluded.   We appreciate CMSs  continued efforts  and  
encourage CMS to  safeguard nursing home residents from the overuse of  any  
psychotropic drug.   
In response to our second recommendationfor  CMS to use data to identify nursing  
homes or nursing home characteristics that are associated  with a higher use of  
psychotropic drugs and  focus oversight on nursing homes in which trends  may signal  
inappropriate useCMS  agreed and described actions taken in recent years to use 
data to analyze the use of psychotropics and  other drugs that affect brain activity,  
such as  anticonvulsants.   These actions include changes to the survey process that  
specifically target inappropriate use of  anticonvulsants, analysis of data to  identify  
nursing homes  with a higher rate of diagnosed schizophrenia  among residents, and  
analysis of data to identify any trends or anomalies among nursing home residents,  
facilities, and prescriber levels.   We encourage CMS to include a range of psychotropic  
drugs in  its  data analysis  to ensure that trends do  not shift from highly monitored  
psychotropic drugs to less monitored psychotropic drugs.   
In response  to our third recommendationfor CMS to expand the required data  
elements on Medicare  Part D claims to include a diagnosis codeCMS  did not 
concur.   CMS  stated that it lacks  statutory  authority to require that prescribers include 
diagnosis codes on prescriptions,  noting that only States can directly mandate  
prescription requirements.   CMS  also  raised  concerns  with  requiring diagnosis codes  
on  Part D claims.  While  CMS did not dispute having the authority to do this, it is  
concerned that without a State mandate that  prescribers put the diagnosis code on 
the original claim,  rejected Part  D claims  could lead to potential delays in receiving  
medications related to  rejected claims.  CMS  finally  stated  this  change would lead to  
more  burden for  prescribers, pharmacies, Part D  sponsors, and pharmacy benefit  
managers.  Additionally,  CMS believes there are other ways to effectively  monitor  
nursing home compliance.   We continue to  urge CMS  to expand the required data  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Agency Comments and OIG Response  | 17     
elements on Medicare Part D claims to include a diagnosis code, seeking statutory  
authority,  as needed.   We appreciate the need to  maintain timely access to needed  
drugs for Part  D enrollees and ask CMS to take steps to protect  access and minimize  
burden in implementing such a requirement.   Without diagnosis  codes on Part  D 
claims,  CMS is limited to medical record reviews to  determine whether  drugs are  
prescribed for medically  accepted indications, which are  costly, time-consuming, and  
infeasible to conduct on a large scale.   This information is a critical data element to  
monitor the use of psychotropic drugs in nursing homes.   We continue to recommend  
that CMS  work  with its Part D sponsors and stakeholders in the  medical and  
pharmaceutical professions to ensure that  Part  D  drugs are only covered when used  
for medically accepted purposes.   
For the full text of CMSs  comments, see Appendix C.  
 
 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Agency Comments and OIG Response  | 18     
APPENDICES  
Appendix A:  CMS Enforcement Actions  
CMS increasingly took enforcement actions against nursing homes from  2011  
through 2019 for using unnecessary medications in nursing homes.  The number of  
citations  issued  for the use of unnecessary medications increased from  3,415  citations  
in 2011 to  4,321 citations in 2019.  Also, during this time  CMPs issued by CMS to  
nursing homes for the use of antipsychotic drugs increased.  In 2011, there were 152  
CMPs issued to nursing homes and in 2019 there were 706 CMPs issued to nursing  
homes.  The increase in citations for unnecessary  medications and the increase in 
CMPs indicates that some nursing homes continued to use psychotropic drugs  
inappropriately.  
Exhibit 4: CMS enforcement actions related to psychotropic drug use in  
nursing homes from  2011 through 2019  
,000 
 Citations for unnecessary medication 
 Civil monetary penalties for antipsychotic drugs 
5,000 
4,000 
152 
3,000 
2,000 
1,000 
0 
2011  2012  2013  2014  2015  2016  2017  2018  2019   
Source:  OIG  analysis  of  CMS  data,  2022.  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Appendix A |  19     
Appendix B:  Select CMS Regulatory Requirements    
  Care planning:  The facility must develop and implement a care plan for  
each resident that includes the instructions needed to provide effective and  
 
person-centered care of the resident.   Each resident has the right to  
42  CFR  
483.21(a)(3),   participate in choosing treatment options and must be  given the 
(b)(1)   opportunity to participate in the development, review, and revision of  their  
care plan.   The facility must provide the resident  and their representative 
with a summary of the care plan that includes a summary of the residents  
medications.  
  Sufficient and competent staffing:  Nursing homes are required to employ  
sufficient staff to provide care and services in assisting residents to attain or  
 
maintain their highest practicable level of physical, mental, and psycho-
42  CFR   social well-being.   Furthermore, each nursing home must ensure that it has  
483.40(a)   sufficient staff members who possess the basic competencies and skill sets  
to meet the behavioral health needs of residents.   These competencies and  
skills sets include, but are not limited to,  caring for residents with mental  
and psycho-social disorders, and implementing non-pharmacological 
interventions.  
 
 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Appendix B |  20     
Appendix  C: Agency Comments  
Following this page are the official comments  from CMS.  
   
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Appendix C |  21    Date:   October  11,  2022  
To:   Deputy Inspector  General  
Office  of  Inspector  General  
From:   Centers  for  Medicare &  Medicaid Services  
Subject:   Office  of  Inspector  General  Draft  Report:  Long-Term  Trends  of  Psychotropic 
Drug Use in  Nursing Homes  (OEI-07-20-00500)   
The Centers  for  Medicare &  Medicaid Services  (CMS)  appreciates  the opportunity to review  and 
comment  on  the Office  of  Inspector  General  (OIG)  draft  report.  
CMS takes  its   role in   improving the safety and quality of   care in   our   nations   nursing homes   
seriously. As  such,  CMS is  leading the Biden-Harris   Administrations   new   efforts   to increase 
accountability for  nursing homes.  The Administration  has  laid out  21 initiatives  spread across  
five key strategic goals,  including a goal  to reinforce  safeguards  against  unnecessary medications  
and treatments.1  These initiatives  were developed with  extensive input  from  advocates,  industry  
experts,  nursing home workers,  and    most  importantly     residents  and their  loved ones.   
Nursing homes  must  ensure that  residents  are free  from  unnecessary medications  (42 CFR  
483.45).  Since  CMS issued the Psychosocial  Outcome Severity Guide in  Appendix P of  the State  
Operations  Manual  in  2006,2  CMS  has  implemented a number  of  strategies  to reduce the  
inappropriate  use of  psychotropic drugs  in  long-term  care settings,  as  outlined below.  Most  
recently,  in  June 2022,  CMS revised its  guidance  addressing the inappropriate use of  medications  
not  defined as  psychotropic drugs  but  other  medications  that  affect  brain  activity and can  have  
adverse consequences. 3 
The use of  antipsychotic medications  has  decreased through  the National  Partnership to Improve  
Dementia Care  in  Nursing Homes  (the National  Partnership),  which  started in  2012 and is  
ongoing.4  Through  the National  Partnership,  CMS collaborates  with  federal  and state agencies,  
nursing homes,  other  providers,  advocacy groups,  and care partners  to optimize  the quality of  
care and quality of  life for  residents  in  nursing homes  by improving care for  all  residents,  
especially those with  dementia,  by reducing the use of  antipsychotic medications  and enhancing  
the use of  non-pharmacologic approaches  and person-centered dementia care practices.  There 
have been  notable reductions  in  the prevalence  of  antipsychotic medication use in  long-stay  
nursing home residents  since  the launch  of  the National  Partnership,  as  indicated by these quality 
1  The White House, FACT  SHEET:  Protecting  Seniors  by  Improving  Safety  and  Quality  of  Care in  the Nation's  Nursing  
Homes,  February  28,  2022.  
2  CMS  Memo  S&C-06-09, Nursing  Homes     Issuance of  Revised  Activities  Guidance  (Tags  F248  and  F249)  as Part  of  
Appendix  PP, State Operations  Manual,  and  Training  Materials,  March  10, 2006  
3  CMS  Memo  QSO-22-19-NH, Revised  Long-Term  Care Surveyor  Guidance:  Revisions to  Surveyor  Guidance for  
Phases  2  &  3, Arbitration  Agreement  Requirements,  Investing  Complaints &  Facility  Reported  Incidents, and  the  
Psychosocial  Outcome  Severity  Guide, June 29, 2022  
4CMS  Press Release, CMS  Announces  Partnership  to  Improve Dementia  Care  in  Nursing  Homes, May  30, 2012  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes 
OEI-07-20-00500  Appendix C | 22  measures.  Between  2011 and the fourth  quarter  of  2021,  the national  prevalence  of  antipsychotic 
medication  use among long-stay nursing home residents  was  reduced by 39.1  percent  to 14.5  
percent  nationwide.  Success  has  varied by state and CMS regions,  with  some states  and regions  
having  seen  a reduction  of  greater  than  45 percent.  While we have seen  progress  in  reducing the 
prevalence  of  antipsychotic drug use in  nursing homes,  CMS and its  partners  continue to use a 
variety of  interventions  to continue these efforts,  such  as  review  of  stakeholder  feedback on  the 
agencys   guidance   and trends   in   enforcement;   public data reporting;  and technical  assistance  
through  Quality Improvement  Organizations  (QIOs)  or  other  quality improvement  partners.  
CMS and its  partners  will  also continue to promote research  on  improving systems  of  care in  
nursing homes,  use of  individualized and person-centered approaches  to care for  people with  
dementia,  and inclusion  of  innovative programs  such  as  telepsychiatry for  rural  nursing homes.   
CMS  also  shares  management  of  nursing home oversight  with  State Survey Agencies  (SSAs),  
which  conduct  onsite surveys  to assess  compliance  with  federal  requirements  and investigate 
facility complaints.  SSAs  serve as  the front-line responders  to address  health  and safety concerns  
raised  by residents,  their  families,  and facility staff.  Psychotropic and other  medication  use is  
reviewed on  every standard survey and  surveys  conducted in  response to complaints,  as  
appropriate.  As  with  all  medications,  the indication  for  any prescribed psychotropic medication  
must  be thoroughly documented in  the medical  record.  During the survey,  relevant  resident  
medical  records  are reviewed to confirm  that  the prescribed psychotropic medications  have a 
documented clinical  indication  for  their  use and other  elements  related to medication  
management,  such  as  the implementation  of  person-centered,  non-pharmacological  approaches  
to care and consideration  of  the potential  for  tapering gradual  dose reduction  or  rationale for  
clinical  contraindication.  If  a surveyor  determines  that  a facility is  inappropriately using 
antipsychotic medications  among its  nursing home residents,  the surveyor  is  required to 
document   this   in   the facilitys   survey report.   Facilities   are then   required to correct   their   
noncompliance  by demonstrating to surveyors  that  they have implemented a plan  for  
discontinuing any unnecessary medications.   
CMS has  made  significant  outreach  efforts  to nursing homes  that  have continued to have high  
levels  of  antipsychotic medication  use among long-stay nursing home residents,   known   as   late 
adopters. CMS implemented enhanced enforcement   remedies   for   these late adopters,   such   as   
denial  of  payment  for  new  admissions  or  per  day civil  monetary penalties  (CMPs)  imposed for  
nursing homes  that  have had a prior  history of  noncompliance  citations  in  the areas  of  chemical  
restraints,  dementia care,  and antipsychotic  drugs,  and that  are determined in  a current  survey to 
be out  of  substantial  compliance  with  those requirements.  CMS and the SSAs  continue to 
monitor  these  nursing homes  to ensure that  they achieve and maintain  substantial  compliance  in  
these areas.  In  addition  to this  enhanced enforcement  approach,  CMS also engaged with  
corporate chains  that  owned or  operated a significant  number  or  percentage of  nursing homes  
identified as  late adopters  to seek their  assistance  with  addressing this  critical  issue at  nursing 
homes  owned or  operated by these companies.   
Additionally,  CMS uses  quality measures  as  tools  to quantify health  care processes,  outcomes,  
and organizational  systems  that  are associated with  effective,  safe,  and efficient  health  care.  
CMS has  developed two quality measures  relating to antipsychotics  that  use self-reported 
Minimum  Data Set  (MDS)  data to help safeguard against  unnecessary antipsychotic use  by 
nursing home residents:  Percent  of  Short-Stay Residents  Who Newly Received an Antipsychotic 
Medication (short-stay)  and Percent  of  Long-Stay Residents  Who Received  an Antipsychotic 
Medication (long-stay).  CMS publicly reports  these quality measures  on  its  Care Compare 
website,  and these measures   are incorporated into the methodology for   CMSs   Five Star   Quality 
Rating System.  While Care Compare  helps  consumers,  their  families,  and caregivers  compare 
nursing homes  more easily,  it  also makes  public information  on  antipsychotic use in  nursing 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes 
OEI-07-20-00500  Appendix C | 23  homes,  which  can  have a sentinel  effect  in  reducing the unnecessary usage  of  such  medications  
and provide additional  transparency around antipsychotic use.  
Separate from  the Five-Star  Quality Rating System,  CMS also uses  quality  measures  to track 
trends  in  utilization  across  the Medicare prescription  drug benefit  program  using Part  D  claims  
found in  Prescription  Drug Event  (PDE)  data.  In  2013,  CMS began  calculating a general  atypical  
antipsychotic utilization  rate for  each  Part  D  contract,  called Rate of  Chronic Use of  Atypical  
Antipsychotics  by Elderly Beneficiaries  in Nursing Homes,  for  inclusion  in the Part  D  display 
measures.  This  measure was  replaced  in  2016  when  CMS began  using a measure that  was  
endorsed by the Pharmacy Quality Alliance,  Antipsychotic Use in  Persons  with  Dementia 
(APD),  to monitor  the use of  antipsychotics  overall  for  Part  D  beneficiaries  in  both  nursing 
homes  and community settings.  At  this  same time,  CMS also began  using the measure APD  - for  
Long-Term  Nursing  Home  Residents.  CMS has  provided monthly measure  reports  to Part  D  
sponsors  on  the overall  APD  measure as  well  as  the APD  measure specific  to the long-term  
nursing home setting.  In  addition  to PDE  and MDS data,  the Part  D  measures  are calculated 
using data from  the Common  Medicare Environment  for  enrollment  information,  Risk 
Adjustment  Processing System  data,  the Encounter  Data Systems,  and the Common  Working 
File for  diagnoses.  Through  these reports,  CMS has  communicated with  Part  D  plan  sponsors  
about  their  performance  on  these APD  quality measures,  including sharing  information  about  
specific beneficiaries.  Part  D  plan  sponsors  who are outliers  on  each  APD  measure are 
encouraged to report  to CMS on  their  plan  to reduce inappropriate use.  
CMS added the overall  APD  measure to the 2018 Part  D  display measures  (based on  2016 data)  
on  CMS.gov  to draw  attention  to the use of  antipsychotics  in  persons  with  dementia without  a 
corresponding mental  health  diagnosis  in  both  the community and nursing home settings.5  CMS 
subsequently added the APD  measures  specific to long-term  nursing home  residents  to the 2019 
Part  D  display measures.  CMS publicly displays  the APD  measures  on  CMS.gov  at  the Part  D  
contract  level  in  order  to further  increase visibility around antipsychotic use.  Currently,  the 
average  APD  measure rate based on  the 2021 display measure using 2019 data remains  relatively 
low  and stable in  the Part  D  program:  ten  percent  among Medicare Advantage  Prescription  Drug 
Plan  contracts  and nine  percent  among stand-alone Prescription  Drug Plan  contracts. 6 
Another  CMS effort  that  has  addressed the prescribing rates  of  antipsychotic drugs  for  Part  D  
beneficiaries  is  the use of  the Plan  Program  Integrity Medicare Drug Integrity  Contractor  (PPI  
MEDIC)  which  has  a national  focus  related to plan  oversight  pertaining to the following Part  C  
and Part  D  program  integrity initiatives:  identification  of  program  vulnerabilities,  data analysis,  
health  plan  audits,  outreach,  education,  and law  enforcement  support,  which  includes  requests  for  
information.7  CMS has  directed the PPI  MEDIC  to  use  proactive data analysis  in  Part  D  to 
identify prescribers  who may have abnormal  or  aberrant  prescribing patterns  with  regard to 
certain  atypical  antipsychotic medications  known  to be targets  for  fraud,  waste,  and abuse.8  Plan  
sponsors  may use the results  of  this  project,  along with  their  established protocols,  to conduct  
supporting analyses  to determine if  potential  fraud,  waste,  and abuse exist.  9 
5  See Part C and D Performance  Data, 2018 Star Ratings  and Display  Measures (ZIP), available  at  
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.  
6  See Part C and D Performance  Data, 2021 Display Measures (ZIP), available  at  
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.   
7  U.S. Department  of  Justice  &  U.S. Department  of  Health  and  Human  Services,  Health  Care Fraud  and  Abuse  
Control  Program,  Annual  Report  for  Fiscal  Year  2021  
8  CMS Memo to All Medicare Part D Plan Sponsors, Drug  Alert: Nuedexta  - Potential  Inappropriate Part D  
Billing for Non-Medically  Accepted Indications  
9  CMS Memo to All Medicare Part  D Plan Sponsors, Drug  Alert: Nuedexta  - Effect of Prior  Authorizations  (PA)  
on Potential  Inappropriate Part D Billing  for  Non-Medically  Accepted  Indications, August 28, 2019  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes 
OEI-07-20-00500  Appendix C | 24  Through  all  of  these efforts,  CMS has  worked diligently to optimize the quality of  life for  
residents  in  nursing homes  by taking actions  to reduce antipsychotic overuse in  nursing facilities  
and improve comprehensive care approaches  to better  address  the psychosocial  and behavioral  
health  needs  of  all  residents.  CMS continues  to look for  opportunities  to strengthen  the survey 
process  and enforcement  efforts  to ensure that  nursing homes  are focused on  non-pharmacologic 
approaches  and that  residents  are not  receiving medications  that  do not  have a clinical  basis.  We  
appreciate the ongoing work of  the OIG  in  this  area  and will  continue to work with  them  as  we 
make  improvements  to our  oversight  efforts.   
OIGs   recommendations   and CMSs   responses   are below.   
OIG  Recommendation  
Evaluate the use of  psychotropic drugs  among nursing home residents  to determine whether  
additional  action  is  needed to ensure that  use among residents  is  appropriate  
CMS Response  
CMS concurs  with  this  recommendation.  CMS is  currently evaluating the use of  psychotropic 
drug use among residents  in  nursing homes  by analyzing schizophrenia diagnosis  history and 
prescribing trends.  After  the evaluation  is  concluded,  CMS will  determine what  actions,  if  
needed,  are appropriate.   
OIG  Recommendation  
Use data to identify nursing homes  or  nursing home characteristics  that  are  associated with  a 
higher  use of  psychotropic drugs  and focus  oversight  on  nursing homes  in  which  trends  may 
signal  inappropriate use  
CMS Response  
CMS concurs  with  this  recommendation.  CMS is  using  data to analyze  the use of  psychotropics  
and other  drugs  that  affect  brain  activity,  such  as  anticonvulsants.  As  stated above,  in  June 2022,  
CMS released changes  to the survey process  and guidance  that  specifically  target  inappropriate 
use of  anticonvulsants.  At  this  time,  CMS has  reviewed  and is  actively analyzing data to identify 
nursing homes  with  a higher  rate of  diagnosed schizophrenia amongst  residents  admitted  
between  January 2020 and June 2021  with  a new  claim  of  schizophrenia within  the last  five 
years.  CMS is  also reviewing data to identify any possible trends  or  anomalies  among nursing 
home residents,  facilities,  and prescriber  levels10.  
OIG  Recommendation   
Expand the required data elements  on  Medicare Part  D  claims  to include a diagnosis  code  
CMS Response  
CMS cannot  concur  with  this  recommendation.  CMS lacks  the statutory authority to require that  
prescribers  include diagnosis  codes  on  prescriptions.  State laws  govern  what  is  required to be 
included on  prescriptions.  Additionally, even  if  CMS had this  authority,  we would be concerned 
that  requiring diagnosis  codes  on  Part  D  claims  in  the absence  of  state requirements  for  
prescribers  to include diagnosis  codes  on  prescriptions  could lead to significant  access  concerns  
due to potential  delays  in  receiving medications  related to rejected claims.  This  would  also lead 
to more prescriber,  pharmacy,  Part  D  sponsor,  and pharmacy benefit  manager  burden  to 
adjudicate CMS-rejected claims  because they lack diagnosis  codes.  Nevertheless, CMS believes  
there are other  ways  to effectively monitor  nursing home compliance  for  this  vulnerable 
population,  which  we are in  the process  of  evaluating,  as  described above.  
10  CMS  Fact  Sheet,  CMS  releases prescriber-level  Medicare data  for  first  time,  April  30, 2015  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes 
OEI-07-20-00500  Appendix C | 25   
ACKNOWLEDGMENTS AND CONTACT  
Acknowledgments  
Andrea Staples and  Jamila Weaver served as the team leaders for this study.  Others  
in the Office of  Evaluation and Inspections  who  conducted the study include Caroline 
Filbrun and Jordan Swoyer.  Office of Evaluation and Inspections staff who  provided  
support include Robert Gibbons, Joseph Chiarenzelli, and Christine Moritz.  
We would  also like to acknowledge the contributions of other Office of Inspector  
General staff, including Jessica Swanstrom.  
This report was prepared under the direction of  Brian Whitley, Regional Inspector  
General for  Evaluation and Inspections in the Kansas City regional office, and Dana  
Squires and Abbi Warmker, Deputy Regional  Inspectors General.  
Contact  
To obtain additional information concerning this report, contact the Office of Public  
Affairs at  Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found  
on the OIG website at oig.hhs.gov.  
Office of  Inspector General  
U.S. Department of Health and Human Services  
330 Independence Avenue, SW  
Washington, DC 20201  
 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Acknowledgments and Contact |    26      
ABOUT THE  OFFICE OF  INSPECTOR  GENERAL  
The mission of the Office of Inspector General (OIG), as mandated by  Public Law  
95-452,  as amended, is to protect the integrity of  the Department of Health and  
Human Services (HHS) programs, as  well as the health and welfare of beneficiaries  
served by those programs.  This statutory mission  is carried out through a  nationwide  
network of audits, investigations, and inspections  conducted by the following  
operating components:  
The  Office  of  Audit  Services  (OAS)  provides auditing services for HHS,  
either by conducting  audits with its own audit resources  or by overseeing  audit work  
done by others.  Audits examine the performance of HHS programs and/or its  
grantees and  contractors in carrying out their respective responsibilities and are 
intended to provide independent assessments  of  HHS programs and operations.   
These audits help reduce waste, abuse, and mismanagement and promote economy  
and efficiency throughout HHS.  
The  Office  of  Evaluation  and Inspections  (OEI)  conducts national  
evaluations to provide HHS, Congress,  and the public with timely, useful, and reliable 
information on significant issues.  These evaluations focus on preventing fraud, waste,  
or abuse and promoting  economy, efficiency, and  effectiveness of departmental  
programs.  To promote impact, OEI reports also present practical recommendations 
for improving program operations.  
The Office of  Investigations  (OI)  conducts criminal, civil, and  administrative  
investigations of fraud and misconduct related to HHS programs, operations, and 
beneficiaries.  With investigators working in all 50 States and the District of Columbia,  
OI utilizes its resources by actively coordinating  with the Department of Justice and  
other Federal, State, and  local law enforcement  authorities.  The investigative efforts  
of OI often  lead to criminal convictions, administrative sanctions,  and/or  civil 
monetary penalties.  
The Office of  Counsel to  the Inspector  General  (OCIG)  provides  
general legal services to  OIG, rendering advice and opinions on HHS programs and  
operations and providing all legal support for OIGs internal operations.  OCIG 
represents OIG in all civil  and administrative fraud  and abuse cases involving HHS  
programs, including False Claims Act, program exclusion, and  civil monetary penalty  
cases.   In connection with these cases, OCIG also  negotiates and monitors  corporate 
integrity agreements.  OCIG renders  advisory opinions, issues compliance program  
guidance, publishes  fraud alerts, and provides other guidance to the health care 
industry concerning the anti-kickback statute and other OIG enforcement authorities.  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   About OIG  | 27      
ENDNOTES  
 
1  Social Security Act  1819(b); 42 CFR  Part 483 Subpart B.  
2  42 CFR  483.45.  
3  Office of Senator Chuck Grassley, news  release,  Congressional Policy Leaders Seek Review  Of Psychotropic Prescription Use  
In Nursing Homes,  April  7, 2020.  Accessed at  https://www.grassley.senate.gov/news/news-releases/congressional-policy-
leaders-seek-review-psychotropic-prescription-use-nursing  on October  25, 2022.  
4  The White House, Office of the Press Secretary, Fact Sheet:  Protecting Seniors by Improving Safety and Quality of Care in  
the Nations Nursing Homes, February, 2022.  Accessed at  https://www.whitehouse.gov/briefing-room/statements-
releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-
the-nations-nursing-homes/  on August 16, 2022.  
5  42 CFR  483.45(c)(3).   CMS,  State  Operations Manual, Appendix PPGuidance to Surveyors for Long Term Care Facilities,  
November 2017.   Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
6  Medicaid and CHIP Payment and Access Commission, Use of Psychotropic Medication among Medicaid Beneficiaries,  
p.  146,  June 2015.  Accessed at  https://www.macpac.gov/wp-content/uploads/2015/06/Use-of-Psychotropic-Medications-
among-Medicaid-Beneficiaries.pdf  on May 19, 2022.  
7  Marco Mula, Psychotropic Effects of Anticonvulsants in Patients with Epilepsy, Clinical Medicine Insights,  No. 2, 2010,  
p  286.  Accessed at https://journals.sagepub.com/doi/pdf/10.4137/CMT.S3285  on May 19, 2022.  
8  CMS,  State Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, November 2017.   
Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
9  CMS guidance related to psychotropic and antipsychotic medication regulations states that the use of other psychotropic  
medications should not increase when efforts to decrease antipsychotic medications are being implemented unless the other  
types of psychotropic medications are clinically indicated.  CMS further states that medications that may affect brain activity  
(including anticonvulsants and mood stabilizers) must be prescribed with a documented clinical indication.  CMS,  State  
Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, November 2017.  Accessed at  
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on July  
2022.  
10  CMS published guidance  effective October 2022 relating to medications that affect brain activity but are not specifically  
listed as psychotropic medications  by CMS.  The guidance notes that these medications that affect brain activity are subject  
to the psychotropic medication requirements if the documented use appears to be a substitution for another psychotropic  
medication rather than for the original or approved indication.  See CMS, memorandum, addressed to State Survey Agency  
Directors, QSO 22-19-NH, June 2022.  Accessed at  https://www.cms.gov/files/document/qso-22-19-nh.pdf-0  on July 20, 2022.  
11  For  consistency with other OIG reports, we used First DataBanks ETC code  and identified 19 categories of drugs that met  
CMSs description of psychotropic drugs (i.e., any drug that  affects brain activities associated with  mental  processes  and  
behavior).  This report uses the following 19 categories to identify Medicare Part D drug claims that represent psychotropic  
drugs:  antianxiety  agents;  antidepressants;  antipsychotics (neuroleptics);  bipolar  therapy  agents;  sedative-hypnotics;  central 
nervous  system  stimulants;  migraine  therapy;  anticonvulsants;  antiparkinsonian  therapy;  movement  disorder  drug  therapy;  
attention  deficit  hyperactive disorder therapy;  narcolepsy and  cataplexy  therapy  agents;  fibromyalgia agents;  pseudobulbar  
affect  agents;  psychoactive  drugsalternative  therapy/recreational use;  hypoactive  sexual  desire disorder  treatment  agents;  
benzodiazepines;  neuropathic  pain  therapy; and  agents to  treat  episodic  cluster  headaches.  
 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Endnotes  | 28      
 
12  CMS,  State Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, p.  518, November  
2017.  Accessed at https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
13  Anticonvulsants are approved by the FDA to treat seizures and many other medical conditions unrelated to seizure 
disorders, such as nerve pain.  Accessed at  https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-
Prevention/Medicaid-Integrity-Education/Pharmacy-Education-Materials/Downloads/ac-adult-factsheet11-14.pdf  on July 11,  
2022.  
14  Boxed warnings are the strictest warnings that can be issued  by the FDA.   FDA notified health  care professionals in 2008 
that both conventional and atypical antipsychotics were found to be associated with an increased risk of mortality  in elderly  
patients treated for dementia-related psychosis.   At that time, the  analyses of 17 placebo-controlled trials that enrolled 5,377 
elderly patients with dementia-related behavioral disorders revealed a risk of death  among antipsychotic drug-treated  
patients of between 1.6 and 1.7 times that seen among placebo-treated patients.   FDA,  Information for Healthcare  
Professionals:  Conventional Antipsychotics,  June 2008.   Accessed at  https://wayback.archive-
it.org/7993/20170722190727/https:/www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProvide 
rs/ucm124830.htm  on October 26, 2021.  
15  CMS, Anticonvulsant Medications: Use in Adults,  p. 5,  October 2015.   Accessed at  https://www.cms.gov/Medicare-
Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Pharmacy-Education-Materials/Downloads/ac-adult-
factsheet11-14.pdf  on March 16, 2022.  
16  Sheng-Min  Wang, Han Changsu, et. al,  Addressing the Side  Effects of Contemporary Antidepressant Drugs:  
A  Comprehensive Review, Chonnam Medical Journal,  2018.   Accessed at  
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5972123/pdf/cmj-54-101.pdf  on March 16, 2022.  
17  CMS, National Partnership to Improve Dementia Care in Nursing Homes.   Accessed at  
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/National-Partnership-to-
Improve-Dementia-Care-in-Nursing-Homes?msclkid=8d1644beab7611ecaa3e6f99441aa1d2  on March 28, 2022.  
18  CMS,  memorandum to State Survey Agency Directors S&C:  14-19-NH, Interim report on the CMS National Partnership to  
Improve Dementia Care in Nursing Homes: Q4 2011Q1 2014, April 2014.   Accessed  at  
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SC-Letter-14-
19-Partnership-Interim-Report.pdf  on May 1, 2019.  
19  CMS,  memorandum to State Survey Agency Directors S&C:  14-19-NH, Interim report on the CMS National Partnership to  
Improve Dementia Care in Nursing Homes: Q4 2011Q1 2014, April 2014.   Accessed on  
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SC-Letter-14-
19-Partnership-Interim-Report.pdf  on May 1, 2019.  
20  Medicaid and CHIP Payment and Access Commission, Nursing facilities explains that  States have broad flexibility to  
determine payments to nursing facilities.   Federal rules do not prescribe how nursing facilities should be paid or how much  
they should be paid, but require that Medicaid payment policies should promote efficiency, economy, quality, access, and 
safeguard against unnecessary utilization.   Under fee-for-service  payment arrangements, State Medicaid programs typically  
pay nursing facilities a daily rate, called a per diem.   States often apply a variety of adjustments and incentives to the base  
payment, and there is considerable variation in rates both within and across States.   Accessed at  
https://www.macpac.gov/subtopic/nursing-facilities/  on May 1, 2021.  
21  CMS,  memorandum to State Survey Agency Directors S&C:  14-22-NH, Focused Minimum Data Set (MDS) and Dementia 
Care Surveys, April 2014.   Accessed at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/SC-Letter-14-22-Focused-Survey-Pilot.pdf  on July 14, 2022.  
22  CMS,  memorandum to State Survey  Agency Directors S&C:  QSO-19-07-NH, Enhanced Oversight and Enforcement of  
Non-Improving  Late Adopters, May 2019.   Accessed at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/QSO19-07-NH.pdf  on July 14, 2022.  
 
 
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Endnotes  | 29      
 
23  CMS has an additional antipsychotic quality measure  for short-stay nursing home residents:  Percent of Short-Stay  
Residents Who Newly Received an Antipsychotic Medication.   Quality measures can be found at CMS, MDS 3.0 Quality  
Measures Users Manual.   Accessed at  https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursingHomeQualityInits/Downloads/MDS-30-QM-Users-Manual-V70.pdf  on October 26, 2021.  
24  CMS, 2016/2017 Nursing Home Action Plan.   Accessed at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/CertificationandComplianc/Downloads/2016-2017-Nursing-Home-Action-Plan.pdf  on October 26, 2021.  
25  Social Security Act  1819(b)(3)(A)(ii) and (f)(6)(A).   CMS, Long-Term Care Facility Resident Assessment Instrument 3.0 
Users Manual.   Accessed at  https://downloads.cms.gov/files/mds-3.0-rai-manual-v1.17.1_october_2019.pdf  on September 21,  
2020.  
26  These conditions that CMS excludes from its  calculation of the number of residents receiving antipsychotics are on the list  
of FDA-approved adult indications for antipsychotic medications.   The FDA-approved adult  indications for antipsychotic  
medications include other conditions as well.   CMS, Atypical Antipsychotic Medications: Use in Adults, May 2015.   Accessed  
at  https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Pharmacy-
Education-Materials/Downloads/atyp-antipsych-adult-factsheet11-14.pdf  on January 20, 2021.  
27  The  MDS contains federally mandated self-reports from nursing homes to quantify percentages for the long-stay  
antipsychotic quality measure.   The  MDS includes information about whether a resident received any of four categories  of 
psychotropic medications (i.e.,  antipsychotics, antidepressants, antianxiety  medications,  and hypnotics).  
28  Social Security Act  1819(f), (g) and 1919(f), (g).   See also  CMS, State Operations Manual,  Program Background and 
Responsibilities,  Section 1002.   Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/som107c01pdf.pdf  on December 4, 2020.  
29  Nursing home  surveys are conducted according to survey protocols and Federal requirements to determine whether a 
citation of noncompliance  is  appropriate.   The survey protocols and interpretive guidelines serve to clarify and/or explain the  
intent of the regulations.   All surveyors are required to use them in assessing compliance with Federal requirements.   CMS  
publishes Critical Element Pathways to guide surveyors as their  deficiency  assessments  of  nursing homes are based on  
violations of the regulations.   The survey is based on observations of  a  nursing homes performance or practices.   The Critical 
Element Pathway for Unnecessary Medications, Psychotropic Medications, and Medication Regimen Review requires  
surveyors to also assess  a nursing homes  compliance with each  of the regulatory requirements associated with medication  
management.  
30  42 CFR  483.40 (a).   Accessed at  https://www.law.cornell.edu/cfr/text/42/483.40.   
31  CMS,  State Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, November 2017.   
Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
32  CMS,  State Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, November 2017.   
Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
33  CMS,  memorandum  QSO-18-17-NH.   Accessed at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/QSO18-17-NH.pdf  on April 8, 2021.  
34  CMS,  Medicare Benefit Policy Manual and Prescription Drug Benefit Manual, Chap. 6.  Section 1860D-2(e)(4) of the Social  
Security Act defines a medically-accepted indication for a Part D drug by referencing section 1927(k)(6) of the Social  
Security Act as any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act, or  
the use of which is supported by one or more citations included or approved for inclusion in compendia as described in  
1927(g)(1)(B)(i) of the Act.   Furthermore, Ch. 6  10.6 of the Medicare Prescription Drug Benefit Manual defines a Part D-
covered drug as a drug that may be dispensed only upon a prescription and for a medically accepted indication.   Accessed at  
https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/part-d-benefits-manual-
chapter-6.pdf  on July 9, 2022.  
 
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OEI-07-20-00500   Endnotes  | 30      
 
35  OIG,  Medicare Atypical Antipsychotic Drug Claims for Elderly  Nursing Home Residents, May 2011.   Accessed at  
https://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf  on August 15, 2019.  
36  OIG,  Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs, July 2012.   Accessed  
at  https://oig.hhs.gov/oei/reports/oei-07-08-00151.asp  on April 9, 2021.  
37  OIG,  Nursing Facility Assessments and Care Plans for Residents Receiving Atypical  Antipsychotic Drugs, July 2012.   Accessed  
at  https://oig.hhs.gov/oei/reports/oei-07-08-00151.asp  on April 9, 2021.  
38  CMS,  State Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, November 2017.   
Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
39  OIG,  Adverse Events in Skilled  Nursing Facilities: National Incidence  Among Medicare Beneficiaries,  February 2014.   Accessed  
at  http://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf  on December 30, 2020.  
40  The tool referenced can be found at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/QAPI/downloads/adverse-drug-event-trigger-tool.pdf.   Accessed on  October 13,  2022.  
41  OIG,  CMS Use of Data on Nursing Home Staffing: Progress  and Opportunities To Do More, March 2021.   Accessed at  
https://oig.hhs.gov/oei/reports/OEI-04-18-00451.asp  on April 20, 2021.   See also HHS  OIG  Data Brief,  Some Nursing Homes  
Reported Staffing Levels in 2018 Raise  Concerns; Consumer Transparency Could Be Increased, August 2020.   Accessed at  
https://oig.hhs.gov/oei/reports/OEI-04-18-00450.pdf  on April 20, 2021.  
42  CMS,  memorandum  QSO-18-17-NH.   Accessed at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/downloads/QSO18-17-NH.pdf  on June 15, 2021.   Additionally, CMS,  Staffing Data 
Submission Payroll Based Journal  (PBJ)  informs nursing homes that staffing is one of the vital components of a nursing  
homes ability to provide quality care.  Accessed at  https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ  on June 15, 2021.  
43  OIG,  CMS Could Improve the  Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes, May 2021.   Accessed at  
https://oig.hhs.gov/oei/reports/OEI-07-19-00490.pdf  on October 26, 2021.  
44  One initiative includes awarding a grant to  The University of Arizona,  Department of Pharmacy Practice and Science to  
demonstrate the impact of including diagnostic information  on electronic prescriptions.  
45  For the RN staffing analysis, we included all residents.   However, only nursing homes that had matching nurse staffing data 
from PBJ and nursing homes with at least one long-stay  resident were included.  
46  For the Part D low-income  subsidy analysis, we analyzed only long-stay residents and included nursing homes with 10 or  
more long-stay residents.  
47  CMS,  State Operations Manual,  Appendix PPGuidance to Surveyors for Long Term Care Facilities, November 2017.   
Accessed at  https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/  
downloads/som107ap_pp_guidelines_ltcf.pdf  on July 22, 2021.  
48  Schizophrenia is typically diagnosed in the late teen years to early thirties and tends to  emerge earlier in males (late  
adolescence to  early twenties) than females (early twenties  to  early thirties).   National Institute of Mental Health,  
Schizophrenia, May 2022.   Accessed at  https://www.nimh.nih.gov/health/statistics/schizophrenia  on May 2, 2022.  
49  For this analysis, we included  beneficiaries who  were  aged  65 or older.   We only analyzed  nursing homes with 10 or more  
long-stay residents in 2019.   Of all the nursing homes that met this criteria, 71 percent were classified as for-profit.  
Long-Term Trends of Psychotropic Drug Use in Nursing Homes   
OEI-07-20-00500   Endnotes  | 31