U.S. Department of Health and Human Services  
O  ffice of Inspector General 
 
Issue Brief  
 
M ay  2021, OEI-07-19-00490  
 
CMS  Could  Improve  the  Data It  Uses  To  Monitor  Antipsychotic  Drugs 
in Nursing  Homes  
The Centers for Medicare  & Medicaid Services (CMS) has oversight of  
Key Result  
Medicare- and Medicaid-certified  nursing homes that are responsible for 
CMSs  use of nursing   the health and safety of  vulnerable residents.  CMS  is required to monitor 
homes  self-reported  nursing home activities, including how nursing homes use  antipsychotic 
information to  count  the   drugs to treat  residents various conditions.  These drugs can be effective in 
number  of  residents  
treating a range of conditions, but  they carry risk  and must be prescribed  
receiving  antipsychotic  
appropriately.  CMS uses the Minimum Data Set (MDS)i.e.,  data that 
drugs  has  important 
nursing homes self-reportas  its sole  data source  to count  the  number of 
limitations.  
nursing home residents receiving  antipsychotic  drugs.  CMS has  
acknowledged the risk for inappropriate use of antipsychotic drugs.   CMS  
has  taken  important  steps to reduce the use of  antipsychotic drugs in nursing homes and  could  further  
that  progress by collecting  more  complete data  on residents  use  of these drugs.  
Why This Issue Is Important 
Nursing home residents and their families rely on nursing homes to provide quality care in a safe  
environment; however, there are reasons for concern  specific to the use of antipsychotic drugs.   
Previous Office of  Inspector General (OIG) work  in  2011 raised  quality and  safety concerns regarding  the 
high use of  antipsychotic medications among nursing home residents.  Since then, CMS has taken 
important  steps to monitor  the use of these drugs in  nursing homes.  However, CMS has  acknowledged 
the potential for inconsistencies in the  dataself-reported by  nursing homesthat it uses to monitor 
nursing home  quality  and to monitor the safety of the use  of  antipsychotic  drugs.   
What OIG Found   
We found that  CMSs use of the MDS as the sole data source  to  count  the number  of  nursing home 
residents using  antipsychotic drugs  may  not always  provide  complete information.  This means some 
residents use of  antipsychotics  may not have been detected by CMSs quality measure intended to  
monitor these drugs.  By analyzing a  separate data sourceMedicare claimswe  found that using  the 
MDS did not always result in a complete assessment of the number of residents who are prescribed  
antipsychotic drugs.  Specifically, in 2018, 12,091  Part D beneficiaries  who were long-stay residents age 
65 and older5  percent  of all such beneficiarieshad a  Part  D claim for an antipsychotic drug  but  were 
not  reported in the MDS as receiving an antipsychotic  drug.   Further, nearly one-third of residents  who 
were  reported in the MDS as having  schizophreniaa  diagnosis that excludes them from CMSs  
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).   These findings suggest  that CMS could enhance  the information it uses to  monitor  antipsychotics  in  
nursing homes  by using additional  data sources in its measurement of this  complex issue that is critical  
for resident health and safety.   
What OIG  Recommends  
So that  CMS can  enhance the  information it  uses to monitor antipsychotic drugs in nursing homes, we 
recommend 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.   
Key Terms Regarding Antipsychotic  Drugs Prescribed in  Nursing  Homes  
   Nursing Home Resident: For  the  purposes of  this review,  nursing  home  refers to  Medicare- and  Medicaid-
certified  nursing  facilities  and  skilled  nursing  facilities;  and  resident  refers  to  a  person residing  in  a  nursing  
home  who  was  65  years  old or  older  on  January  1,  2018.   
   Antipsychotic  drug: Antipsychotic  drugs  are  an important  treatment  for  patients  with certain mental  health  
conditions.1   However,  the Food  and  Drug  Administration  (FDA)  has  warned  that  antipsychotic  medications  are  
associated with  an  increased risk  of death  when  used in  elderly  patients  with  dementia-related  psychosis.2   
These  drugs  may  be  effective for  some residents  in  treating a  wide  range of conditions,  but  must  be closely  
monitored for  effectiveness,  benefits,  risks, and harm, and adjusted as  necessary.3   
   National Partnership to Improve Dementia Care in  Nursing Homes (Partnership):  In  2012,  CMS  
formed the Partnership  with  Federal  and  State agencies,  nursing  homes,  other  providers,  advocacy  groups,  and  
caregivers  to  improve comprehensive dementia  care.4   Though the  initial  focus  was  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.5,  6  
   We discuss  two data sources in this report:  
o   Minimum  Data  Set  (MDS):  The  MDS  is part  of  the  federally mandated  process for  nursing  homes to self-
report  clinical  assessments  of  all residents  (i.e.,  both those who  are Medicare beneficiaries  and those who  
are not).7   At  routine  intervals,  nursing  homes  provide  CMS  with MDS  assessments.   These  assessments  
collect  information about  each  residents  health,  physical  functioning,  mental  status,  and  general  well-
being,  including use of  antipsychotic  drugs  and  certain  diagnoses.8   The  MDS  is  a  data source  for  Care  
Compare and  the  Star  Rating  System,  the  publicly  available  Web-based tool  that  provides  basic 
information about  quality  of  care  at  all  Medicare- and  Medicaid-certified nursing homes.9   CMS  requires  
nursing  homes to record  the  number  of  days  during the preceding 7  days  that  antipsychotic  drugs  were 
received by  each  resident.    
o   Medicare claims:  Medicare  coverage  is  provided  in  four  programs.   Medicare  Parts  A,  B,  and  C  help  cover  
the cost  of services  such  as  hospital  care,  office visits  with  doctors,  home health  care,  durable medical  
equipment,  and many  preventive  services.   Diagnoses  (i.e.,  the reasons  for  which  residents  received health  
services)  are  contained  in  claims data  from these  programs.   Medicare Part  D  helps  cover  the  cost  of  
prescription  drugs.   Part  D  claims  data  include  information about  the  drugs  dispensed,  but  these  data  do  
not  include diagnosis  information  because CMS  does  not  require or  collect  diagnoses  (i.e., the  reasons  for  
the drugs)  for  these items.  
   CMS monitors antipsychotic drug use in nursing homes using a quality measure and  onsite  
survey:  
o   Antipsychotic  quality  measure:  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.10   
CMS  uses  one  such quality  measure  to  quantify  the  percentage of long-stay  residents  (i.e., those with  
a  stay of  101  days or  longer)  who  received an  antipsychotic  drug.  CMS  uses  the  MDS  as  the  data source  
for  this  measure and publishes  these findings  in  Care  Compare and  the Star  Rating  System.11   CMS  
excludes  residents  with  MDS-reported diagnoses  of schizophrenia, Huntington's  disease,  or  Tourettes  
syndrome  from  inclusion in this  measure.12  
o   Onsite  survey  conducted by  State and Federal surveyors:  CMS  works  with  State  agencies  to  conduct  
onsite  visits  to nursing  homes approximately once  a  year.   CMS  uses this survey process  to ensure  that  
nursing  homes  comply  with  Federal  quality  and  safety  standards,  including  those  related  to  antipsychotic  
drugs.13   See Appendix  A  regarding these  standards.  
  Background  
 
Antipsychotic  drugs  in nursing  homes  
CMS is required to monitor nursing home activities, including how nursing homes use 
antipsychotic drugs to treat residents various conditions.  These drugs can be 
effective in treating a range of conditions, but they carry risk  and must be prescribed  
appropriately.   
Nursing home residents and their families rely on nursing homes to provide quality 
care in a safe environment; however, there are reasons for concern specific to the use 
of antipsychotic drugs.  Though CMS has taken important steps to monitor the use of 
these drugs in nursing homes, CMS  has acknowledged the potential for 
inconsistencies in the dataself-reported  by nursing homesthat it uses to monitor  
this concern.  
CMS  collects  information to  monitor the use of  antipsychotic 
drugs  in  nursing  homes  
CMS uses Minimum Data Set (MDS)  assessments as the data  source to track its 
progress toward reducing the use of  antipsychotic drugs  for  nursing home 
residents.14,  15   Nursing homes electronically transmit  their self-reported MDS  
assessments to CMS  at required intervals.16   CMS requires nursing homes to record  
the number of days an  antipsychotic  was received by a resident during the 7 days 
prior to the MDS assessment.17   CMS  uses this information to  calculate results for its 
quality measure regarding  the percentage of nursing home residents receiving  
antipsychotic drugs during the entire quarter.     
 
CMS uses the onsite  survey  process  to conduct validation  of MDS 
information   
Onsite nursing home surveys are a fundamental safeguard to  ensure that  nursing  
home residents are safe and receive quality care.  CMS, in conjunction with States, 
oversees nearly 16,000 Medicare- and Medicaid-certified  nursing homes to ensure 
that they meet Federal requirements.18, 19, 20   On behalf of CMS,  State  agencies  
conduct standard certification surveys for  nursing homes on average every 12 months 
but at least  every 15 months.21,  22   The  accuracy and completeness of  a  nursing 
homes MDS assessments are  among  hundreds of regulatory requirements  that 
surveyors may evaluate during surveys.23,  24  
 
Issue Brief:  CMS Could Improve the Data It Uses  To  Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490                                                                                                                                                        Background |  4  
  Through this onsite survey process, CMS  and States  have  documented the potential 
for inaccuracies in information collected through MDS assessments,  and  CMS  has 
increased some oversight activities in response.25   CMS detected an  increase in MDS  
reporting of  schizophreniaa  diagnosis that excludes residents from  measurement in 
the antipsychotic quality measureand CMS conducted  focused surveys on this 
concern in select nursing homes.26   
Previous  OIG  work  described  quality and  safety  concerns 
regarding  use of  antipsychotic  drugs  in nursing  homes    
Previous OIG work found that nursing home residents who were prescribed 
antipsychotics  were at risk for harm.27   Specifically, 83 percent  of  Medicare claims for 
atypical antipsychotic drugs28  were associated with conditions other than those for 
which FDA approved the use of the  medication,  and 88 percent were associated with  
a condition specified in the FDA black-box warning.  The black-box  warning states 
that elderly patients with dementia who are treated with these drugs are at an 
increased risk of death.  
 
 
Issue Brief:  CMS Could Improve the Data It Uses  To  Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490                                                                                                                                                        Background |  5  
  RESULTS  
    
CMSs use  of the  MDS  as  the sole data  source to  count  residents  
using  antipsychotic  drugs  in nursing  homes  may not  provide 
complete  information   
Part D claims identified  more  use of antipsychotic drugs  among  long-stay 
residents  than  the MDS did  
In 2018, we found that 249,135 long-stay 
More than  
beneficiaries (23  percent  of the 1,084,517 long-stay 
residents age 65 or older) had a Part D claim for an 
1  in  5  
antipsychotic drug.29   However, of these   
beneficiaries, 12,091 (5  percent) were not reported in 
long-stay residents age 65 
the MDS as  having received an antipsychotic drug in 
and older received an 
the  same quarter  in which they had a Part D claim.30   
antipsychotic drug  in 2018  
Nursing homes are required to submit MDS  
assessments on all residents at regular intervals, 
including  reporting  antipsychotics that a resident   Part D claims identified   
received  during the 7  days  prior to the MDS  
12,091  
assessment.  As a  way to monitor nursing home 
quality, CMS uses this self-reported information to  
calculate the quarterly percentage of all residents  more residents as receiving  
receiving antipsychotic drugs.   However, CMS could   antipsychotics than in 
expand its monitoring of  the volume of antipsychotic  MDS assessments  
drugs received by nursing home residents  by 
analyzing the information provided in Part  D claims  
data.    
There are limitations  with  CMSs  use of  the  MDS as the sole data source  to  count  
the number of residents receiving  antipsychotic  drugs  in nursing  homes.   Though 
the MDS provides useful data  on many health status items, it may not provide enough 
information to comprehensively evaluate the use of  antipsychotic drugs in nursing  
homes.  MDS instructions require the nursing home to record the number of days 
a  resident received an  antipsychotic drug  during  the 7 days prior to the assessment.  
CMS then uses that 7-day response to calculate the percentage of residents who 
received an antipsychotic drug during  the entire quarter.  Because of  the brevity of a 
7-day assessment period, nursing homes self-reporting  of  antipsychotic drug use 
may underestimate the actual number of residents who are treated with 
antipsychotics during the quarter.   Further,  though CMS uses limited edits (automated  
system processes)  to confirm that nursing homes meet all  technical requirements for 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490   Results  |  6  
  submitting their MDS assessments,  CMS does not have a process to validate the 
accuracy of the information that nursing homes report  regarding  antipsychotic drugs.  
In October 2017, CMS added  an  MDS requirement for  nursing homes to report 
whether a  resident  has received an antipsychotic drug  at any time  since admission; 
however, CMS  stated it was not using this MDS  assessment  response for quality  
measurement.31    
Nearly one in three residents reported  in  the MDS  as having 
schizophrenia did  not have any evidence of this diagnosis in their 
Medicare claims history  
According to  2018  MDS  data,  there were 
Exhibit  1:  Over 29,000 residents  reported 
98,227 residents  age 65 and older whom 
by nursing  homes as having schizophrenia 
nursing homes reported  as having 
did not  have  any evidence  of this  
schizophrenia.   Of those, 29,617 residents (30 
diagnosis in their Medicare claims; 
percent) had no record of a schizophrenia 
71  percent of these residents  had a Part D 
diagnosis in any of their 2017 and 2018 
claim for an antipsychotic drug.  
Medicare Part A or B claims  or  Part  C 
encounter  data  for visits, procedures, tests, or 
supplies.  This means there was no evidence 
that these residents received care for the 
diagnosis  that excluded  them from being  
measured in the percentage of residents 
receiving antipsychotics.   The same 
inconsistency was noted  with regard  to  
reporting of  Huntingtons disease and 
Tourettes syndrome; however, very few 
residents were reported in the MDS  to have 
these conditions.32  
Of those 29,617  residents whom  nursing 
homes reported as having schizophrenia but 
who had no  evidence of schizophrenia in their 
Medicare claims data, 71  percent 
(20,889  residents) had at least one Part  D claim  
for an antipsychotic drug.  This means these  
residents  were  prescribed  an  antipsychotic 
drug but  qualified for  exclusion  from the 
antipsychotic measure because of  MDS-
reported  schizophrenia.   
This concern related to  inconsistent  reporting  
of  schizophrenia in more than  29,000 residents 
is  concentrated  in  certain nursing homes.   
Source: OIG analysis of MDS  and Medicare  
Specifically,  52  nursing homes have 20 percent  
claims data, 2020.  
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490   Results  |  7  
  or more of their residents with this type of MDS reporting that is inconsistent with 
Medicare claims history.33   Though 69 percent of all nursing homes are classified as 
for-profit, we found  for-profit nursing homes account for 78  percent of the MDS 
entries that are inconsistent in this way.34  
This finding  raises concerns.  Because schizophrenia is one of the conditions that 
excludes nursing home residents  from CMSs quality measure of antipsychotic use, it  
is possible that  nursing homes may inaccurately report this diagnosis.   It is also  
possible that these beneficiaries do  have schizophrenia and  that the lack  of  Medicare  
claims  would therefore indicate that  they  are not receiving services for this serious 
diagnosis.   CMS has noted  similar concerns regarding  inconsistencies in the reporting  
of schizophrenia.  CMS has initiated an increased number of  focused surveys  and 
documented concerns with the quality of MDS  data.35    Though CMS uses limited  
edits to confirm that nursing homes meet all  technical requirements for submitting 
their MDS assessments, CMS does not have a process to validate the accuracy of the 
diagnosis information that nursing homes report in the MDS.  
The  MDS  does  not  provide important  details  about  the use of 
antipsychotic  drugs  in nursing  homes    
Both  the MDS and Part  D claims provide information about  the use of antipsychotic 
drugs in nursing homes.   The MDS provides nursing homes self-reported counts  of 
the number of residentseven  those who are not Medicare beneficiarieswho  
receive antipsychotic drugs,  but  the MDS  does not provide any detail about the 
drugs.  Part  D  claims data could enhance the analysis of these MDS data  by 
providingfor a  subpopulation of residents, i.e.,  those who are enrolled in Part  D 
objective measures regarding which  specific drugs are being dispensed, at what  
quantities and strengths, and for what  duration.   CMS could  use this information to  
validate and supplement the data reported in MDS assessments  and  gain important  
detail that would be useful in its work to protect  residents.  
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490   Results  |  8  
   
CONCLUSION AND  RECOMMENDATIONS  
 
 
In 2018, more than one in five Medicare long-stay nursing home  residents age 65 or over 
received an antipsychotic drug.  Although  antipsychotic drugs can be an important treatment  
for patients with certain mental health conditions, they also carry significant risks, including an 
increased risk of death when used in elderly patients with dementia.   CMS  uses MDS  data to  
monitor  the use of antipsychotic drugs for nursing home  residents.  However, CMSs  use of MDS 
assessments as the sole  data source to  count  the number of  residents receiving  antipsychotic 
drugs may not always provide  a  complete measure of the current use  of these drugs.  We found  
that Medicare Part D claims identified  an additional 12,091 residents  who received  antipsychotic 
drugs beyond the  residents whom MDS data identified.  Additionally, we found evidence to 
suggest that  up to  29,617 residents may have been inappropriately excluded from CMSs  
measure of antipsychotic drug use in nursing homes.  These residents were reported in the MDS  
as having schizophrenia in 2018; however, there was  no evidence of that  diagnosis in their 2017 
and 2018 claims in Medicare Part A  or  B, or  in  their encounter  data  in Part C.   
These findings raise concerns about the vulnerabilities associated with CMSs  use of limited data  
from  the MDS  as the sole source of  information to  count  the number of  nursing  home  residents 
receiving antipsychotic drugs.  First, the findings in this issue brief show that nursing homes 
self-reported data may underrepresent actual  use of antipsychotic drugs  and may 
inappropriately exclude residents from the quality measure regarding antipsychotic drugs.  
Second, CMS has very limited information about  the use of antipsychotic drugs for the 
beneficiaries  who  are counted in the MDS data.   CMS  is missing an opportunity to use existing  
Part D data to conduct more robust monitoring that  provides additional detail  on antipsychotic 
drug use (e.g., medication strength, quantity, and duration)  for a large subset of nursing home 
residents.  CMS should enhance the information it uses  to monitor antipsychotic drugs in 
nursing homes.  
We recommend  that  CMS:  
Take additional steps  to  validate the  information reported  in 
MDS  assessments  
CMS could consider using  additional  data analysis  tools  to ensure the accuracy of  
what  nursing homes report  in the MDS.   For example,  CMS could consider creating 
automated comparisons of claims and MDS information to detect inconsistencies 
between the two  (e.g., a  Part  D  claim for an antipsychotic drug for a resident  for  
whom the MDS does not report any antipsychotic use).   Using this information, CMS 
could increase its targeted oversight of nursing  homes that submit  MDS data that  are  
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490                                                      Conclusion /  Recommendations |  9  
  inconsistent with Medicare claims data, seem inconsistent with peer nursing homes, 
or meet thresholds that  might warrant followup.   
Supplement  the  data  it uses to  monitor  the  use  of antipsychotic 
drugs  in  nursing  homes    
Additionally, CMS  should  reconsider whether the current MDS measure provides 
sufficient  information to effectively  monitor nursing homes, and  CMS  should  take  
steps to supplement it.  For example, CMS could  use  Part D data to  enhance its  
monitoring  of overall  and  concerning prescribing patterns in nursing homes.   For a 
subpopulation of nursing home residents (i.e., those enrolled in Part  D), Part  D data  
provide  additional information such as  which specific drugs are being dispensed;  at  
what quantities and strengths;  and for what  durations.  
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490                                                      Conclusion /  Recommendations |  10  
   
AGENCY  COMMENTS AND OIG RESPONSE  
 
 
CMS concurred with both of  our recommendations.   
In response to our first recommendationfor CMS  to take additional steps to validate 
the information reported in MDS  assessmentsCMS stated  that it  would take steps 
to consider using additional data analysis tools to ensure the accuracy of what is 
reported on  the MDS, as may be feasible.  
In response to our second recommendationfor  CMS  to supplement the data it uses 
to monitor the use of antipsychotic drugs in nursing homesCMS stated  that it 
would consider whether alternative measures could be used to more effectively 
monitor the use of antipsychotics in nursing homes.  CMS provided an example of  
action it has already taken to use Part D claims to calculate a related measure.  
We appreciate CMSs  continued commitment to reducing the unnecessary use of  
antipsychotic drugs in nursing homes, including the formation of the National  
Partnership to Improve Dementia Care in Nursing Homes, the use of quality measures 
for tracking, and  its  holding facilities accountable for compliance with Federal  
requirements.  
Appendix  B provides the full text of  CMSs comments.   
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490                                                                                                            Agency Comments and OIG Response | 11  
   
METHODOLOGY  
 
 
Scope of  inspection  
We based this issue brief on a comparison of  Medicare claims to MDS records for 
nursing home residents age 65 and older in 2018.  The claims data  include  
prescription drug event (PDE) records for Part D  drugs;  Medicare Part A and B  claims  
data from  the National Claims History File;  and Part C  encounter data.  We  
determined the number of residents who  had  a Part D claim for an antipsychotic drug 
as compared to the number of residents whom  the MDS reported  as  receiving these 
drugs.  These analyses are not  comparable to the CMS quality measure.  Further, we 
determined the extent to which there were inconsistencies between residents MDS-
reported  diagnoses  of schizophrenia, Huntingtons disease,  or Tourettes syndrome 
and these residents Medicare claims in 2017 and 2018 for each respective diagnosis.  
Data  Collection and  Analysis  
Residents  who received  antipsychotic  drugs.   We used several data sources to  
identify residents who received  antipsychotic drugs.  We collected all  MDS records 
with an assessment date in 2018 for residents who were age 65 or older on 
January  1,  2018.  Then, we determined the number of days of each residents  stay in 
the nursing  home and limited the population to those with stays of  101  or more 
consecutive days.  For those individuals identified, we collected all Part  D claims with a  
date of service (i.e., date the prescription was filled) in 2018.  We used First DataBank  
to determine the National Drug  Codes (NDCs) that are categorized as antipsychotic 
drugs.   
For the residents identified, we determined the number of residents with a Part D  
claim for an  antipsychotic drug, and  the number of residents with an MDS record in 
the same quarter that indicated they had received an  antipsychotic drug.  We then 
compared the two.  To be included in the analysis, the resident had to have had at  
least one MDS assessment and at least one  Part  D claim in the same quarter.   This 
analysis is not designed  to be comparable to the CMS quality reporting;  the 
methodology differs in various ways (e.g., limited to long-stay residents who are Part 
D beneficiaries, does not consider whether the resident has a  diagnosis that is 
excluded from the quality measure).  
Residents  with schizophrenia, Huntingtons disease, or  Tourettes syndrome.   For  
the residents identified  as 65 or older for whom there were MDS assessments in 2018, 
we determined the extent to  which, if any, there  were inconsistencies in the 
prevalence of diagnoses that exclude residents from CMSs quality measure on the  
use of antipsychotic drugs.  We determined the number of those residents for whom  
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490      Methodology | 12  
  there was an  MDS-reported diagnosis of schizophrenia, Huntingtons disease, or  
Tourettes syndrome in 2018.  We then determined the number of those residents 
who did not have  claims in Parts A or B or encounter  data  in Part C  with a date of  
service in 2017 or 2018 with the corresponding  MDS-reported diagnosis.  We then 
compared residents in each analysis to determine if the data  were inconsistent.  
Structured interview with CMS.   We collected written responses to a structured  
interview with CMS  officials  to gain information  about  the agencys  efforts toward  
monitoring  antipsychotic  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.  We asked CMS about the extent to which it is using  
medical review to evaluate adherence to  its  guidance on documentation and MDS  
reporting.  
Limitations  
This study is limited  to  an evaluation of  Medicare claims and  MDS records.  We did  
not conduct medical record review or in-person clinical assessments of residents.  
Therefore, we did not assess the accuracy of diagnoses, effectiveness of drug  
regimens, inappropriate use of drugs, or quality of care.  Medicare claims data do not  
include claims for drugs or services that are self-paid or provided through other 
programs.  Therefore, we may underestimate the use of  antipsychotic drugs for the 
nursing home residents included in our review if they received drugs that were not  
billed to Medicare Part D.   Likewise, our analysis would not capture any services  that 
these residents may have received related to  a schizophrenia diagnosis if those  
services were not billed  to Medicare  Parts  A, B, or C.  
Standards  
We conducted this study in accordance with the Quality Standards for Inspection  and  
Evaluation  issued by the Council  of the Inspectors General on Integrity and Efficiency. 
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490      Methodology | 13  
   
APPENDIX A  
 
 
PART 483Requirements  for States  and  Long  Term  Care 
Facilities, Subpart  BRequirements  for Long  Term  Care 
Facilities  CFR 483.45  
483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated 
with mental  processes and behavior. These drugs include, but are not limited to,
drugs in the following categories: 
(i) Anti-psychotic; 
(ii) Anti-depressant; 
(iii)Anti-anxiety; and 
(iv)Hypnotic 
483.45(e) Psychotropic Drugs. Based on a comprehensive assessment of a resident,
the facility must ensure that-- 
483.45(e)(1) Residents who have not used psychotropic drugs are not given these
drugs unless the medication is necessary to treat  a specific condition as diagnosed 
and documented in the clinical record; 
483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions,
and behavioral interventions, unless clinically contraindicated, in an effort to 
discontinue these drugs.1  
 
_____________________________________________________________________________________________________________________________  
1   The  guidance  section corresponding  to    483.45(d)  Unnecessary  drugs  and   483.45(c)(3)  and (e)  Psychotropic  
Drugs,  found  in Appendix  PP of  the  State  Operations  Manual,  states  the  intent  is  that:  
 each  residents  entire drug/medication  regimen  is  managed and  monitored to  promote or  maintain  the
residents  highest  practicable  mental,  physical,  and  psychosocial  well-being; 
 the  facility  implements  gradual  dose  reductions  and  nonpharmacological  interventions,  unless  contraindicated, 
prior  to  initiating  or  instead  of  continuing  psychotropic  medication. 
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. 
The  residents  medical  record must  show  documentation  of adequate indications  for  a  medications  use and the
diagnosed  condition for  which  a  medication is  prescribed.   An evaluation  of  the  resident  by  the  interdisciplinary 
team  helps  to  identify  the residents  needs,  goals,  comorbid  conditions,  and  prognosis to  determine  factors
(including  medications  and  new  or  worsening  medical  conditions)  that  are  affecting  signs,  symptoms,  and  test 
results. 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490   Appendix A | 14   APPENDIX B:  Agency Comments
Date:  April 9, 2021 
To:  Suzanne Murrin 
Deputy Inspector General 
Office of Inspector General 
From:  Elizabeth Richter 
Acting Administrator 
Centers for Medicare & Medicaid Services 
Subject:  Office of Inspector General Draft Report: CMS Could Improve the Data It Uses 
to Monitor Antipsychotic Drugs in Nursing Homes, OEI-07-19-00490 
The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review and 
comment on the Office of Inspector General (OIG) draft report on CMSs use of data to monitor 
the number of nursing home residents receiving antipsychotic drugs.  
CMS is committed to reducing the unnecessary use of antipsychotic drugs in nursing homes and 
holding facilities accountable for compliance with federal requirements. Nursing homes must 
ensure that residents are free from unnecessary medications (42 CFR 483.45). As such, CMS has 
implemented a number of strategies to reduce inappropriate antipsychotic use in long-term care 
settings as outlined below, and will continue pursuing additional innovative approaches 
including those recommended within the OIGs draft report. 
One such effort is the National Partnership to Improve Dementia Care in Nursing Homes. The 
Partnership seeks to optimize quality of life for residents in Americas nursing homes by 
improving comprehensive care approaches to better address the psychosocial and behavioral 
health needs of all residents, especially those with dementia. The Partnerships overall goals are 
to enhance the use of non-pharmacologic approaches and person-centered dementia care 
practices. This robust public-private collaboration has engaged providers and provider 
associations, clinicians, researchers, advocates, government agencies, residents and families in 
every state and has established a multidimensional strategy to address this public health issue.  
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 Rating System, which 
helps consumers, their families, and caregivers compare nursing homes more easily.   
1 
Issue Brief: CMS Could Improve the Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes 
OEI-07-19-00490                      Appendix B | 15 There have been notable reductions in the prevalence of antipsychotic medication use in long-
term nursing home residents since the launch of the Partnership, as indicated by these quality 
measures. Between 2011 and the second quarter of 2020, the national prevalence of 
antipsychotic medication use among long-stay nursing home residents was reduced by 41 percent 
to 14.1 percent nationwide, with every state showing reduced rates.   
Monitoring resident safety and quality of care in facilities serving Medicare and Medicaid 
beneficiaries is an essential part of CMSs oversight. CMS works in partnership with State 
Survey Agencies (SSAs) to oversee nursing homes compliance with federal requirements, and 
this is determined through unannounced on-site surveys conducted at least annually, but no later 
than every 15 months. Antipsychotic medication use are reviewed on every standard survey as 
well as surveys conducted in response to complaints, as appropriate.  
As with all medications, the indication for any prescribed antipsychotic 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 
implementation of person-centered, non-pharmacological approaches to care and consideration 
of 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 who 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 psychotropic drugs, and that are determined in a current survey to 
be out of substantial compliance with those requirements. CMS continues 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. 
CMS requires that nursing facilities electronically transmit MDS assessments, which collect 
information about the residents health, physical functioning, mental status, and general well-
being, including use of antipsychotic drug and certain diagnoses. The MDS is the assessment 
instrument nursing homes use to self-report clinical assessments of all residents and is required 
to be submitted at routine intervals. CMS employs a process to validate the MDS assessments 
through the agencys Quality Improvement Evaluation System Assessment Submission and 
Processing system. When the provider-submitted transmission file is received by the system, it 
performs a series of validation edits to evaluate whether the data submitted meets certain 
2 
Issue Brief: CMS Could Improve the Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes 
OEI-07-19-00490                      Appendix B | 16 required standards. MDS records are automatically verified to ensure that clinical responses are 
within valid ranges, that inputted dates are reasonable, and that records are in the proper order 
with regard to records that were previously accepted by the system for the same resident. If any 
fatal errors are found, the record will be rejected and the provider will be notified of the results 
of this validation process. In addition to this validation process, when residents are prescribed 
anti-psychotic medications, the surveyor will review the residents medical record for 
documented clinical indication, which serves as an additional check to validate the accuracy and 
completeness of MDS responses. As OIG noted, when comparing MDS with Part D claims, there 
was 95 percent accuracy between the number of residents receiving antipsychotic drugs and the 
number of residents reported to be receiving antipsychotic drugs by the nursing homes.  
CMS also uses quality measures to track trends in utilization across the Medicare prescription 
drug benefit program using Part D claims. 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, 
Antipsychotic Use in Persons with Dementia (APD) - for Long-Term Nursing Home Residents. 
CMS has provided monthly measure reports to Part D sponsors on the overall APD measure and 
the measure specific to the long-term nursing home setting. In addition to MDS data, the Part D 
measures are calculated using data from the Common Medicare Environment (CME) for 
enrollment information, Prescription Drug Event (PDE) for drug claims, and Risk Adjustment 
Processing System (RAPS) data, the Encounter Data Systems (EDS), and the Common Working 
File (CWF) for diagnoses. Through these reports, CMS has communicated with contracts about 
their performance on these APD quality measures, including sharing information about specific 
beneficiaries. Part D contracts who are outliers on each APD measure are encouraged to report to 
CMS on their plan to reduce inappropriate use.   
Furthermore, 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.1 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: 10 percent among Medicare 
Advantage Prescription Drug Plan (MA-PD) contracts and 9 percent  among stand-alone 
Prescription Drug Plan (PDP) contracts.2 
1 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. 
2 See Part C and D Performance Data, 2021 Display Measures (ZIP), available at 
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData. 
3 
Issue Brief: CMS Could Improve the Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes 
OEI-07-19-00490                      Appendix B | 17 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 identifies and investigates potential fraud, waste, and abuse in Medicare Part C 
and Part D. CMS has directed the PPI MEDIC to increase its focus on proactive data analysis in 
Part D to identify inappropriate payments, potential program vulnerabilities, and address issues, 
such as abusive prescribing. CMS produces reports to plan sponsors on specific data projects in 
CMS Analytics and Investigations Collaboration Environment for Fraud, Waste, and Abuse 
system.  One of those projects is intended 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. 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 exists. 
Through all of these efforts, CMS has worked diligently to optimize the quality of life for 
residents in Americas 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 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 
Take additional steps to validate the information reported in MDS assessments. 
CMS Response 
CMS concurs with this recommendation to take steps to consider using additional data analysis 
tools to ensure the accuracy of what is reported on the MDS as may be feasible.  
OIG Recommendation 
Supplement the data it uses to monitor the use of antipsychotic drugs in nursing homes. 
CMS Response 
CMS concurs with this recommendation to consider whether alternative measures could be used 
to more effectively monitor the use of antipsychotics in nursing homes. As noted above, CMS is 
already taking considerable action to monitor use of antipsychotic drugs in nursing homes, 
including through Part D claims that are used to calculate the APD measures.   
4 
Issue Brief: CMS Could Improve the Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes 
OEI-07-19-00490                      Appendix B | 18  
ACKNOWLEDGMENTS AND CONTACT  
 
 
Acknowledgments  
Jamila Weaver served as the team leader for this study, and Abbi Warmker served as 
the lead analyst.  Others in the Office of Evaluation and Inspections who conducted  
the study include Katharine Fry.  Office of Evaluation and Inspections staff who  
provided  support include Joe Chiarenzelli, Kevin Farber,  Christine Moritz, and  
Jessica  Swanstrom.  
We would also like to acknowledge the contributions of other Office of Inspector 
General staff, including Eddie Baker, Jr., and Robert Gibbons.   
This report was prepared under the direction of  Brian Whitley, Regional Inspector 
General for Evaluation and Inspections in the Kansas City regional  office.  
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  
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes  
OEI-07-19-00490            Acknowledgments and Contact | 19   EEEENNNNDDDDNNNNOOOOTTTTEEEESSSS     
 
 
1  CMS,  Guidance to Surveyors for Long Term Care Facilities, Appendix PP,  State Operations Manual, November  2017.   
Accessed at  https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  
on March  6,  2019.  
2  CMS,  Guidance to Surveyors for Long Term Care Facilities, Appendix PP,  State Operations Manual, November  2017.   
Accessed at  https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  
on March  6,  2019.  
3  42 CFR  483.45(c)(3); CMS,  Guidance to Surveyors for Long Term Care Facilities, Appendix PP,  State Operations Manual, 
November 2017.  Accessed at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/  
som107ap_pp_guidelines_ltcf.pdf  on March 6, 2019.  
4  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  2011-Q1 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.  
5  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  2011-Q1 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.  
6  In its guidance to surveyors, CMS states that person-centered care means the facility focuses on the  resident as the center of  
control and supports each resident in making his or her own choices.  Person-centered care includes making an effort to  
understand what each resident is communicating, verbally and nonverbally; identifying  what is important to each resident with 
regard to daily  routines and preferred activities; and having an understanding of the residents life before  coming to reside  in  
the nursing home.  CMS outlines person-centered practices  and the importance of sufficient and competent staffing in its  
guidance to surveyors.  CMS  states that nursing homes should have sufficient staff members who possess the basic  
competencies  and skill sets to meet the behavioral health needs of residents.  Nursing homes should implement person-
centered approaches to care based upon comprehensive  assessment and be guided by the interdisciplinary team (a team that 
includes but is not limited to the physician; a  registered nurse; a  nurse aide; a staff member from food and nutrition services;  
and (to the extent practicable) the resident and the residents family/representative).  This team must identify individualized 
interventions or approaches to care that support the residents needs.  Accessed at https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March  6,  2019.  
7  CMS,  Minimum Data Set 3.0 Public Reports.  Accessed at  https://www.cms.gov/Research-Statistics-Data-and-
Systems/Computer-Data-and-Systems/Minimum-Data-Set-3-0-Public-Reports/index.html  on January 11,  2019.   
8  CMS,  Quality Measures.  Accessed at  https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursingHomeQualityInits/NHQIQualityMeasures.html  on January 11, 2019.   
9  CMS,  Design for Nursing Home Compare Five-Star Quality  Rating System:  Technical Users Guide, October 2020.  Accessed 
at   https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/CertificationandComplianc/downloads/usersguide.pdf  on December 21,  2020.  
10  CMS, Quality  Measures.  Accessed at  https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/QualityMeasures  on September 21, 2020.  
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes   
OEI-07-19-00490   Endnotes | 20    
11  CMS,  Design for Nursing Home Compare Five-Star Quality  Rating System:  Technical Users Guide, October 2020.  Accessed 
at  https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/CertificationandComplianc/downloads/usersguide.pdf  on December 21,  2020.   
12  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.  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.  
13  As a condition of participation in Medicare  and Medicaid, nursing homes must comply with these standards.  The guidance  
is intended to ensure that psychotropic medications are used only when the medication(s) is appropriate to treat a residents  
specific, diagnosed, and documented condition and the medication(s) is beneficial to the  resident, as demonstrated by  
monitoring and documentation of the residents response  to the medication.  We note both this regulation at 42 CFR    483.45 
and the corresponding guidance under the State Operations Manual  (SOM) have been revised multiple times.  The current 
study does not assess compliance with this regulation; past versions of this regulation; or the guidance  corresponding to past 
versions or the current version of this  regulation.  CMS, Guidance to Surveyors for Long Term Care Facilities, Appendix PP,  
State Operations Manual, November  2017.  Accessed at https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  on March  6,  2019.  
14  CMS,  Quality Measures.  Accessed at  https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursingHomeQualityInits/NHQIQualityMeasures.html  on June 26, 2020.  
15  CMS,  Minimum Data Set 3.0 Public Reports.  Accessed at  https://www.cms.gov/Research-Statistics-Data-and-
Systems/Computer-Data-and-Systems/Minimum-Data-Set-3-0-Public-Reports/index.html  on January 11,  2019.   
16  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.  
17  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.  
18  Social Security Act  1864(a); 42 CFR  488.330; CMS,  State  Operations Manual (SOM),  Pub. No. 10-07 ch. 1,  Program 
Background and Responsibilities, section 1002.  Accessed at  https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/som107c01pdf.pdf  on December 4, 2020.  
19  When we  refer to nursing homes, we make  no distinction between Medicare-certified Skilled Nursing Facilities and  
Medicaid-certified Nursing Facilities.  According to OIG analysis of CMS data, in 2018, there were 15,653 nursing  homes  
certified by CMS (source: OIG analysis, 2020).    
20  Social Security Act  1819(g) and 1919(g).  Accessed at  https://www.ssa.gov/OP_Home/ssact/title18/1819.htm  and 
https://www.ssa.gov/OP_Home/ssact/title19/1919.htm, respectively, on December 4, 2020.  
21  42 CFR  488.308.  Accessed at https://www.govinfo.gov/content/pkg/CFR-2010-title42-vol5/pdf/CFR-2010-title42-vol5-
sec488-308.pdf  on December  4, 2020.  
22  Sections 1819(g)(1)-(2) and 1919(g)(1)-(2) of the Social Security Act.  Accessed at  
https://www.ssa.gov/OP_Home/ssact/title18/1819.htm  and https://www.ssa.gov/OP_Home/ssact/title19/1919.htm, respectively,  
on December 4, 2020.  
23  CMS,  Guidance to Surveyors for Long Term Care Facilities, Appendix PP,  State Operations Manual, November  2017.   
Accessed at  https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf  
on March  6,  2019.  CMS, Federal Regulatory Groups for Long Term Care.  Accessed at  https://www.cms.gov/Medicare/Provider-
Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/List-of-Revised-FTags.pdf  on November 9, 2020.  
 
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes   
OEI-07-19-00490   Endnotes | 21    
24  CMS,  Federal Regulatory Groups for Long Term Care.  Accessed at  https://www.cms.gov/Medicare/Provider-Enrollment-
and-Certification/GuidanceforLawsAndRegulations/Downloads/List-of-Revised-FTags.pdf  on November  9, 2020.  
25  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  2011-Q1 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.  
26  CMS, Memorandum to State Survey Agency Directors Admin Info 20-03-ALL,  Fiscal Year  (FY) 2020 Mission & Priority  
document (MPD), December  2019.  Accessed at  https://www.cms.gov/files/document/admin-info-20-03-all.pdf  on 
August  27,  2020.   
27  OIG,  Medicare  Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents, OEI-07-08-00150, May  2011.  Accessed  
at  https://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf  on August 15, 2019.  
28  Atypical antipsychoticsalso known as second-generation antipsychotics and serotonin-dopamine antagonistsare a  type 
of psychotropic drug that the Food and Drug Administration (FDA) has approved to treat medical conditions such as 
schizophrenia,  Tourettes syndrome, Huntingtons disease, and bipolar disorder.   .  
29  The population of residents for this finding is limited to those with Medicare Part D  claims; therefore, it does not include  
every nursing home resident.  
30  We report  a quarterly finding because CMS  calculates and  reports the percentage of residents who received an antipsychotic  
drug during the entire quarter.  
31  CMS stated it has not completed analysis using this variable because  it needs at least a full year of data before using the  
information in analysis, so this would not have been possible until January  2019.    
32  In 2018, of that same nursing  home population, 59  percent (388 of 653 residents) of those reported as having Tourettes  
syndrome and  25 percent (344 of 1,390 residents) of those reported  as having Huntingtons disease did not have a 2017 or  
2018 Medicare  Part A or B claim or  any  Part C encounter  data  with the corresponding diagnosis.  OIG analysis of MDS and  
Medicare data, 2020.   
33  According to  OIG analysis  of CMS data, in 2018, there were 15,653 nursing homes certified by CMS.   
34  According to  OIG analysis of CMS data, approximately 69 percent of all nursing homes are classified as for-profit, 2020.  
35  Based on OIG analysis of data collected in its  written interview with CMS, 2020.  
Issue Brief:  CMS Could Improve the Data It Uses  To Monitor  Antipsychotic Drugs in Nursing Homes   
OEI-07-19-00490   Endnotes | 22