Antipsychotics & beyond: what you need to know Originally Presented February 26, 2013 Updated June 19, 2013

Antipsychotic Drugs and the Regulatory System Ellen J. Mullins RN Research and Development Director, The Compliance Store

Survey and Certification Letters S&C Letter 13-34 Videos S&C Letter 13-35 Clarifications Manual Instruction Advanced Copy Effective Date

No Regulation Changes Interpretive Guidance Guidance to Surveyors Interpretation

Dementia Care Principles Person Centered Care Quality and Quantity of Staff Evaluation of New and Worsening Symptoms Individualized Approaches to Care Critical Thinking re: Antipsychotic Drug Use Interviews with Prescribers Engagement of Resident and Family in Decision Making

Surveyor Focus “Process of Care” Interviews Observations Record Reviews

Sample Selection Appendix P QM > 75th percentile

Be Prepared! List of residents with dementia and orders for antipsychotic medications past 30 days Articulate how individualized care is provided to residents with dementia Policy for use of antipsychotic medications in residents with dementia

F-309 – Quality of Care Addresses care areas not specifically covered by other F-tags in this regulatory grouping No investigative protocol Checklist: “Review of Care and Services for a Resident with Dementia”

F-329 – Unnecessary Drugs Four new medications added to the list of antipsychotic medications: Saphris Fanapt Latuda Invega

Antipsychotic Medication Indications for Use: Schizophrenia Schizo-affective disorder Schizophreniform disorder Delusional disorder Mood disorders Psychosis in the absence of dementia Mental Illnesses with psychotic symptoms Tourette’s disorder Huntington disease Hiccups Nausea and vomiting

BPSD Behavioral or Psychological Symptoms of Dementia “Antipsychotic medications may be considered for elderly residents with dementia but only after medical, physical, functional, psychological, emotional psychiatric, social and environmental causes have been identified and addressed. Antipsychotic medications must be prescribed at the lowest possible dose for the shortest period of time and are subject to gradual dose reduction and re-review.”

Inadequate Indications Wandering Poor self-care Restlessness Impaired memory Mild anxiety Insomnia Inattention/indifference to surroundings Sadness or crying unrelated to depression or psychiatric disorders Fidgeting Nervousness Uncooperativeness Criteria for Antipsychotic Drug Use: Behavior is a danger to resident or others AND Symptoms are due to mania or psychosis OR Interventions attempted and included in the care plan (except in an emergency)

Emergency Use of Antipsychotic Medications Criteria in the prior slide must be met IN ADDITION TO ALL OF THE FOLLOWING… Acute treatment period is 7 days or less Clinician evaluation and documentation within 7 days Underlying causes Contributing factors Verification of the need to continue the antipsychotic medication Persistent behaviors Nonpharmacological interventions Attempted – unless contraindicated Documented

Enduring Conditions Clearly identify and document the target behavior Monitoring must include: Assuring the cause is not a medical condition or medication Environmental stressors Psychological stressors Persistence that negatively affects quality of life

New Admissions Attempt to identify an indication for use PASRR Physician’s orders Within 2 weeks, re-evaluate the use of the medication to consider reduction or discontinuation

“The facility MUST act upon this!” Adverse Consequences “The facility MUST act upon this!” The facility AND prescriber MUST document the rationale for the decision and the inclusion of the resident or family in the decision.

Documentation Diagnosis Expected outcome Monitoring of resident response Risk / benefit Adverse consequences Re-evaluation of behavioral symptoms Continued effectiveness Potential reduction

Prioritize Dose Reduction Efforts Avoid initiating antipsychotic drugs for residents not currently taking them Re-evaluate residents recently prescribed antipsychotic drugs for the first time Carefully assess all residents admitted with antipsychotic drugs for reason/benefit/side effects and reduction/elimination Residents with long term antipsychotic use should be carefully evaluated for dose reduction or elimination of antipsychotic drug use

F-329 – Antipsychotic Drugs Based on a comprehensive assessment of a resident, the facility must ensure that – Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

How Do We Reduce Our Reliance on Antipsychotics? Cheryl Swann RN-BC, BSN, WCC, LNHA Vice President of Content, Relias Learning

Getting Started on Reducing Antipsychotics Form a committee – an interdisciplinary team (IDT) to: Review residents’ diagnoses and medications Dementia diagnosis priority Reason for medication Last dose reduction Review behavior tracking log

Trends the IDT Will Find A large number of behaviors in residents with dementia occur during personal care Bathing Dressing Is this behavior inappropriate?

A Look at the Behavior Tracking Log Analyze the behavior tracking logs to determine if there is a particular trigger for the resident’s behaviors Shift Staffing

Meaning Behind the Behavior All behavior has meaning Shift from “How do I stop behaviors?” to “What are these behaviors trying to tell me?” Rule out medical causes Pain, constipation, infection, delirium Look at current medications Talk to the family Know the resident

Behavioral Triggers Three types of triggers: Internal Environmental Caregiver Must evaluate behavioral triggers to determine the most appropriate behavioral intervention

Behavioral Interventions Internal triggers Eliminate physical factors, such as pain, hunger, or elimination needs Provide stimulating, interactive exercise or activities Provide one-to-one care Redirection

Behavioral Interventions Environmental triggers Reduce or remove environmental stimuli Reduce/eliminate overhead paging Alarms TV/Radios Play music/headphones

Behavioral Interventions Caregiver triggers Consistent assignments Does the staff working with the resident know them? What is in the care plan? What do they like/dislike? How do they typically communicate needs/react in certain situations? How is information communicated? Allow to make simple decisions and choices

Behavioral Interventions Understand or explain the rationale for interventions/approaches Monitor the effectiveness of those interventions/approaches Provide ongoing assessment as to whether they are improving or stabilizing the resident’s status or causing adverse consequences

Documentation and Proof New Survey Process Compliance with care plan Staff knowledgeable of behaviors What did you do to try and figure out the cause of the behavior? What was the resident communicating with his/her behavior? What was the reason for the resident acting out? What interventions did you try to reduce the behavior?

Care Process for a Resident with Dementia Recognition and assessment Cause identification and diagnosis Development of care plan Individualized approaches and treatment Monitoring, follow-up and oversight Quality assessment and assurance (QAA)

Recognition and Assessment Past life experiences Cognitive status Presence of pain, medical conditions, medications Preferences for daily routines, food, music, exercise How do they communicate physical needs? Description of behaviors (specific)

Cause Identification and Diagnosis Meaning behind behavior Medical/psychiatric conditions Medications Look at root cause Boredom Changes in routine Unmet needs Environmental

Develop Care Plan Well-defined problem-statement/outline goals of care Identify staff responsibilities to implement approaches Goals to monitor the effectiveness Collaboration with resident and family

Monitoring and Follow Up Staff monitors and documents the effectiveness of interventions to target behaviors Interventions changed as needed Collaborate with physician regarding medications

Quality Assessment and Assurance Resident care policies reflect the facility’s approach to care of residents with dementia How the facility ensures that appropriate interventions are used Sufficient staffing Data to monitor pharmacological and non-pharmacological interventions Facility’s response to concerns identified during pharmacy review

Quality Assessment and Assurance Staff training Understanding the Meaning Behind Behaviors – Actions and Reactions Psychotropic Medications – Antipsychotics and Beyond

Measurement of Psychoactive Medications and Continuous Quality Improvement Theresa Schmidt MA, RAC-CT Manager of Education, eHealth Data Solutions

Goals Understand how CMS measures antipsychotic medications in CASPER and Nursing Home Compare Identify which residents trigger these measures and why Compare your performance to benchmarks Assess effectiveness of interventions and progress over time through trend and SPC charts Ellen and Cheryl have highlighted the importance of ensuring that antipsychotic medications are used only used when appropriate and given you some suggestions for how to accomplish this in your facility. Now we turn our attention to the way in which you will be measured by CMS, Surveyors, and the general public. To succeed in any endeavor, you have to know the rules. In this portion of the program, we will learn how the measures of antipsychotic medications are calculated, how to identify why individual residents are triggering, how to compare your own performance to benchmarks, and finally how to assess the effectiveness of your interventions and your progress over time.

Antipsychotic Quality Measures Short-Stay Measure Long-Stay Measure Percent Short-Stay Residents Who Newly Received Antipsychotic N0410A=[1,2,3,4,5,6,7] Target MDS must be different from initial MDS Exclusions: Antipsychotic use on initial MDS Schizophrenia, Tourette’s, Huntington’s Percent Long-Stay Residents Who Received Antipsychotic N0410A=[1,2,3,4,5,6,7] Exclusions: Schizophrenia, Tourette’s, Tourette’s on prior assessment, Huntington’s There are 2 Antipsychotic Quality Measures that appear on Nursing Home Compare, and in the CASPER reporting system, a h Short Stay and Long Stay measures. Both of these measures come from MDS Field N0410A. Percent Short-Stay Residents Who Newly Received Antipsychotic selects residents who have been in the facility for fewer than 101 days who have had at least two assessments. Residents will trigger this measure when they received an antipsychotic medication any number of days in the lookback period and were NOT coded as receiving antipsychotics on the initial MDS assessment. They will be excluded if they are coded for Schizophrenia, Tourette’s, or Huntington’s. The long stay measure uses the same field from the MDS, but does not exclude residents who received antipsychotics on the initial MDS. This is because long stay residents have been in the facility for more than 101 days, so staff has had the opportunity to consider dose reduction and other interventions. The measure will not trigger for residents with Schizophrenia, Tourette’s, Tourette’s on prior assessment, or Huntington’s. The full calculation of each of these measures appears in the supplementary materials of this power point.

Long-Stay vs. Short-Stay Select all residents whose latest episode either ends during the target period or is ongoing at the end of the target period This latest episode is selected for QM calculation For each episode that is selected, compute the cumulative days in the facility (CDIF) If the CDIF is less than or equal to 100 days, the resident is included in the short-stay sample If the CDIF is greater than or equal to 101 days, the resident is included in the long-stay sample

Nursing Home Compare Measures Available to the public at http://medicare.gov/nursing homecompare Long-stay and short-stay antipsychotic medication measures were added in summer, 2012 Key measure of Psychoactive medications are found on the Nursing Home Compare Quality Measures Reports. Medicare.gov’s Nursing Home Compare website provides publicly available information to allow consumers to compare Medicare or Medicaid certified Nursing Homes. This info includes Five-star quality ratings, health inspection results, nursing home staffing information, quality measures, along with penalties and enforcement actions against nursing homes. In the summer of 2012, Nursing Home Compare added both long stay and short stay antipsychotic quality measures. These measures have now been added to CASPER and replaced the prior Psychoactive Medication surveyor measure. As noted previously, Nursing Home Compare Quality Measure data and CASPER data are both calculated from MDS assessments.

CASPER – Certification And Survey Provider Enhanced Reports Quality measure reports are available to state surveyors and facility staff through CMS’ CASPER reporting system Psychoactive measures were updated this spring to match Nursing Home Compare Measures Prior to the updates, only a Long Stay Psychoactive measure was present, and more conditions were excluded If you compare your Long Stay measure from a CASPER report generated in February to one today, both your facility and benchmark rates will likely be higher today Quality Measure reports are also available to state surveyors and facility staff through CMS’s CASPER reporting system. They contain QM information at the national, state, facility and resident level for a reporting period that you can choose as a CASPER user. In traditional survey, surveyors review these QM reports prior to visiting your facility to identify a preliminary sample of residents for focused and comprehensive review during survey. These residents are selected based on the QM percentiles that we will talk about on the next slide. Facility Quality Measure data are calculated weekly so they can be updated with information from the MDS assessments that have been submitted since the previous week’s data calculation. State and National benchmarks are calculated monthly on the first day of the month, but calculation is delayed by two months in order to allow for submission of late and corrected assessments.

Here is an example of an MDS 3 Here is an example of an MDS 3.0 Facility Quality Measure Report from CASPER reporting system. The third column is the numerator, how many residents triggered the measure. The fourth column is the Denominator- how many residents in your population were eligible to trigger this measure because they had a target assessment in the date range, were long stay residents, and were not excluded. In this example, the Denominator for Falls was 118, but it was only 113 for Long Stay Antipsychotic medications. That is because at least 5 residents were excluded due to missing data or because they had at least one of the psychotic or related conditions I described on the prior slides. The next column, facility observed percent, is numerator divided by the denominator– the residents who triggered the measure divided by the residents who were eligible to trigger. Antipsychotics is not one of the QMs with an adjusted percent, so that column will be the same as the observed percent. The last three columns are your benchmarks- the state average, the national average, and the national percentile. These benchmarks are moving targets. When I pulled one of these reports just a few months ago, the national norm was higher than it is today. The percentile column is reviewed by surveyors and tells you the percent of other facilities better than your facility. So, in this example, 32 out of 113 residents triggered this measure. 32 divided by 113 gives the facility a Psychoactive rate of 28.3%. The National average is lower, at 22.1%, and 77% of other facilities have a lower rate of Long Stay Antipsychotic use.

To see which residents trigger for your Psychoactive Medication quality measure, request the Resident Level Quality Measure Report and scan through the list of active and discharged residents that triggered for that QM during the selected time interval. Then, you can return to the listed MDS to see the coding for each of these residents make sure that no residents trigger who should have been excluded because they have a psychoactive condition that was missed when coding for the MDS. Also, look at the coding for N0410A. Residents who receive the medications for fewer days may be good candidates for interventions because they would not need dramatic reductions to no longer trigger the measure.

CASPER Reports vs. Nursing Home Compare Time Run once a quarter Updated frequently Report Periods Uses most recent 3 months for LS and most recent 6 months for SS Customized by user Average Across Quarters Average across several calendar quarters For only one single report period Risk Adjusted (related to timing) Calculations performed at different times based on national average

Translating QMs to QI Static Displays of Data Dynamic Displays of Data Benchmark: Compares your data for a particular interval of time against national or state norm or against your historical data Percentile Ranking: (1-100) the percent of other facilities that are better than your facility Dynamic Displays of Data Trend Charts: Displays your performance over time Statistical Process Control Charts: Your performance over time plus control limits that indicate how predictable your process is and expose significant events When focusing on improving your use of psychoactive medications, it is important to consider not just the source of the data, but how it will be displayed and analyzed. When you look at Nursing Home Compare or at a CASPER QM report, you are viewing a static display of data. During a single time interval, your rate is 7.5, the benchmark is 13.0. This doesn’t tell you if you are getting better or worse. It also doesn’t tell you if that period of time is typical of your facility, or if 7.5 is abnormally high or low. Dynamic displays of Data, on the other hand, can reveal your performance over time and help you learn if your interventions are working. Trend charts simply display numbers or percentages week to week, month to month, quarter to quarter. SPC charts add control limits to help highlight abnormally high or low values. Use of these and other tools support quality assurance and performance improvement (QAPI) 5 Elements, especially Element 3: Feedback, Data Systems, and Monitoring In this element, the facility implements systems that draw data from multiple sources to monitor care and services and compare performance indicators to benchmarks and targets.

Statistical Process Control Charts (SPC) Is variation due to “common cause” or “special cause”? Need 12-15 periods of data Review monthly for QI committee. Look for: 5-7 points in a row increasing or decreasing 5-7 points in a row climbing higher or lower than your mean A data point (or points) outside your control limits Benchmark outside your control limits One of my favorite ways to view data is Statistical Process Control Charts. SPC charts help you decide if the changes in your data represent meaningful patterns, or if they are just ups and downs due to chance. To establish patterns, you have to start with enough time periods of data. We recommend 12-15 months or quarters for QMs. When I look at an SPC chart, first I look for trends of 5-7 or more points. In this example, the facility’s rate of psychoactives is the red line. I can see the rate decreased every month from April to November, 2012 – 8 points in a row. If I had just compared November to December, I would have determined the facility was getting worse. The second thing I do is look at the average, calculated by adding my rate for all the months together and dividing by the number of the months. I look for 5-7 points in a row above or below the average. In this case, the last 6 months were below average, suggesting the average has changed. Finally, I look for points above the upper control limit or below the lower control limit. On this chart, those would be points outside of the gray area and would represent a month that was either significantly higher or lower than normal. Points outside of the limits should be investigated to see if there is a special cause. If one of my benchmarks, like the national norm, is below lower control limit, it tells me that I will never be below the national norm unless I make process changes. Looking at this chart, there are no cases of ‘special’ cause, but there is evidence of performance improvement. If a facility wide intervention had been put in place in March, this chart would suggest it worked. If the facility had merely looked at a benchmark report comparing the 2012 average to the national norm, the staff might have concluded that rates were slightly higher and missed the progress that has been made

Trend Charts in Excel The chart on the previous slide was created by the CareWatch program, but you can also create trend and SPC charts by yourself in excel. Just put the weeks/months/or quarters in columns and record your rate and any benchmark in the rows. So I looked at my CASPER report in January and put my rate, in cell B3, then I put my average in B4, and the National Norm in B5. I calculated the average by adding all of the months together and dividing by the number of months. If you wanted to add the upper and lower control limits, you could also build those equations into the spreadsheets, and I would be happy to discuss how those limits are calculated if you want to reach out after today’s session. After I had all of the columns filled in, I highlighted all of the cells and clicked the Insert tab. I clicked the line chart picture and the chart appeared in the spreadsheet. You can make a chart like this from the QM percentages, but you can also create a trend chart for anything else you can count. Just determine the time periods you will use and what you will be measuring. So if you want to see if a intervention is effective for a particular resident who is displaying combative behaviors such as hitting staff during dressing you could begin counting the number of times a week the resident hits staff before putting an intervention in place, such as playing soothing music during care. After the intervention, if the resident is less combative for 5 consecutive weeks, this suggests the intervention worked. If there is no change, or if the rate was lower the first week and then higher the second, we can conclude the music wasn’t enough to solve the issue.

Six Steps to Process Improvement Ensure data are complete and accurate Identify opportunities for improvement Look for root cause of the current state (and determine if the process is stable) Set measurable goals Develop an action plan Follow-up to evaluate the effectiveness of your action plan In this session, we have discussed the importance of ensuring that psychoactive medications are used appropriately and given you some suggestions for how to accomplish this in your facility. We have also detailed how CMS will be measuring facility antipsychotic rates and how you can trend your rates over time. When your facility embarks on any performance improvement project, including reducing rates of psychoactive medication use, there are six key steps to consider. These steps support QAPI and the Plan Do Study Act cycle. [Read Steps] By incorporating these steps with some of the ideas, techniques, and interventions we have discussed on today’s webinar, you may be able to reduce your use of psychoactive medications and improve the quality of life of your residents. Thank you so much for the opportunity to talk with you today, I will now turn the program over to Monika Werling to see if we have had any questions.

QUESTIONS?

Thank you

Contact Us! Ellen J. Mullins RN, Research and Development Director, The Compliance Store www.thecompliancestore.com Ellen.Mullins@pmcoteam.com (334) 394-2310 ext. 2503 Cheryl Swann RN-BC, BSN, WCC, LNHA, VP of Content, Relias Learning www. reliaslearning.com cswann@reliaslearning.com (866) 763-4500 ext. 2004 Theresa Schmidt MA, RAC-CT, Manager of Education, eHealth Data Solutions www.ehds.biz tschmidt@ehds.biz (740) 814-0417

Full Quality Measure Calculations These will not be part of the presentation

NH Compare Calculation: Short-Stay Percent of Short-Stay Residents Who Newly Received Antipsychotic Medication Numerator Short-stay residents for whom one or more assessments in a lookback scan (not including the initial assessment) indicates that antipsychotic medication was received: For assessments with target dates on or before 03/31/2012: N0400A = [1]. For assessments with target dates on or after 04/01/2012: N0410A = [1,2,3,4,5,6,7]. Denominator All short-stay residents who do not have exclusions and who meet all of the following conditions: The resident has a target assessment, and The resident has an initial assessment, and The target assessment is not the same as the initial assessment. Exclusions The following is true for all assessments in the lookback scan (excluding the initial assessment): 1.1 For assessments with target dates on or before 03/31/2012: N0400A = [-]. 1.2 For assessments with target dates on or after 04/01/2012: N0410A = [-]. Any of the following related conditions are present on any assessment in a lookback scan: 2.1 Schizophrenia (I6000 = [1]). 2.2 Tourette’s Syndrome (I5350 = [1]). 2.3 Huntington’s Disease (I5250 = [1]). The resident’s initial assessment indicates antipsychotic medication use or antipsychotic medication use is unknown: 3.1 For initial assessments with target dates on or before 03/31/2012: N0400A = [1,-]. 3.2 For initial assessments with target dates on or after 04/01/2012: N0410A = [1,2,3,4,5,6,7,-]. Note that residents are excluded from this measure if their initial assessment indicates antipsychotic medication use or if antipsychotic medication use is unknown on the initial assessment (see exclusion #3).

CASPER and NH Compare Calculation: Long-Stay Percent of Long-Stay Residents Who Received Antipsychotic Medication Numerator Long-stay residents with a selected target assessment where the following condition is true: antipsychotic medications received. This condition is defined as follows: For assessments with target dates on or before 03/31/2012: N0400A = [1]. For assessments with target dates on or after 04/01/2012: N0410A = [1,2,3,4,5,6,7]. Denominator All long-stay residents with a selected target assessment, except those with exclusions. Exclusions The resident did not qualify for the numerator and any of the following is true: 1.1. For assessments with target dates on or before 03/31/2012: N0400A = [-]. 1.2. For assessments with target dates on or after 04/01/2012: N0410A = [-]. Any of the following related conditions are present on the target assessment (unless otherwise indicated): 2.1 Schizophrenia (I6000 = [1]). 2.2 Tourette’s Syndrome (I5350 = [1]). 2.3 Tourette’s Syndrome (I5350 = [1]) on the prior assessment if this item is not active on the target assessment and if a prior assessment is available. 2.4 Huntington’s Disease (I5250 = [1]).