1. Pharmacy Northern Region Update 2013 Doug Englebert, R.Ph. 608-266-5388 Douglas.englebert@dhs.wisconsin.gov August 28, 2013

2. What is Being Cited in NH?

3. F329 - Unnecessary Drugs

4. OIG Findings Fourteen percent of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs Eighty-three percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions; 88 percent were associated with the condition specified in the FDA boxed warning

5. OIG Findings Fifty-one percent of Medicare atypical antipsychotic drug claims for elderly nursing home residents were erroneous, amounting to $116 million Twenty-two percent of the atypical antipsychotic drugs claimed were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes

6. OIG Recommendations Assess whether survey and certification processes offer adequate safeguards against unnecessary antipsychotic drug use in nursing homes Explore alternative methods beyond survey and certification processes to promote compliance with Federal standards regarding unnecessary drug use in nursing homes

7. F329- Unnecessary Drugs- Survey Considerations Each resident’s medication regimen must be free from unnecessary medications. An unnecessary medication is any medication when used: – In excessive doses (including duplicate therapy); or – For excessive duration; or – Without adequate monitoring; or – Without adequate indication for use; or – In the presence of adverse consequences which indicate the dose should be reduced or discontinued

8. Psychotropic Drug Use

9. QI/QM Data Prevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions

10. QI/QM Data Prevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions: High Risk Residents who exhibit both cognitive impairment and behavior problems on most recent assessment

11. QI/QM Data Prevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions: Low Risk (Residents who are not high risk)

12. Dr. Gifford-Focus 2012

13. Dr. Gifford: Focus 2012

14. DX Code Not Enough* The behavioral symptoms present a danger to the resident or others – AND one or both of the following: The symptoms are identified as being due to mania or psychosis (such as: auditory, visual, or other hallucinations; delusions, paranoia or grandiosity); – OR Behavioral interventions have been attempted and included in the plan of care, except in an emergency Protecting and promoting the health and safety of the people of Wisconsin 14

15. Emergency 1.The acute treatment period is limited to seven days or less; AND 2.A clinician in conjunction with the interdisciplinary team must evaluate and document the situation within 7 days to identify and address any contributing and underlying causes of the acute condition and verify the continuing need for an antipsychotic medication Protecting and promoting the health and safety of the people of Wisconsin 15

16. Emergency 3.If the behaviors persist beyond the emergency situation, pertinent non-pharmacological interventions must be attempted, unless clinically contraindicated, and documented following the resolution of the acute psychiatric event Protecting and promoting the health and safety of the people of Wisconsin 16

17. Enduring Condition In addition, before initiating or increasing an antipsychotic medication for enduring conditions, the target behavior/s must be clearly and specifically identified and documented. Monitoring must ensure that the behavioral symptoms are… Protecting and promoting the health and safety of the people of Wisconsin 17

18. Enduring Condition Not due to a medical condition or problem (e.g., pain, fluid or electrolyte imbalance, infection, constipation, medication side effect or polypharmacy) that can be expected to improve or resolve as the underlying condition is treated or the offending medication(s) are discontinued; AND Protecting and promoting the health and safety of the people of Wisconsin 18

19. Enduring Condition Not due to environmental stressors alone (e.g., alteration in the resident’s customary location or daily routine, unfamiliar care provider, hunger or thirst, excessive noise for that individual, inadequate or inappropriate staff response), that can be addressed to improve the symptoms or maintain safety; AND Protecting and promoting the health and safety of the people of Wisconsin 19

20. Enduring Condition Not due to psychological stressors alone (e.g., loneliness, taunting, abuse), anxiety or fear stemming from misunderstanding related to his or her cognitive impairment (e.g., the mistaken belief that this is not where he/she lives or inability to find his or her clothes or glasses, unaddressed sensory deficits) that can be expected to improve or resolve as the situation is addressed; AND Protecting and promoting the health and safety of the people of Wisconsin 20

21. Enduring Condition Persistent. In this case, there must be clear documented evidence in the medical record that the situation or condition continues or recurs over time (persists) and that other approaches that have been attempted have failed to adequately address the behavioral/psychological symptoms and that the resident’s quality of life is negatively affected by the behaviors/symptoms as described above Protecting and promoting the health and safety of the people of Wisconsin 21

22. Antipsychotic Review: Dementia Cliff Notes Is the dementia behavior – Persistent?…No… then inadequate indications – Harmful?…No… then inadequate indications And… – Have other treatable causes been ruled out?…No… then inadequate indications – Have Non-Pharm interventions been attempted?…No…then indications Protecting and promoting the health and safety of the people of Wisconsin

23. New Admission This PASRR screening (F285) should provide pertinent information including appropriate clinical indications for the use of an antipsychotic Protecting and promoting the health and safety of the people of Wisconsin 23

24. New Admission For residents who do not require PASRR screening and are admitted on an antipsychotic medication, the facility must re- evaluate the use of the antipsychotic medication at the time of admission and/or within two weeks of admission (at the time of the initial MDS assessment) and consider whether or not the medication can be reduced (tapered) or discontinued Protecting and promoting the health and safety of the people of Wisconsin 24

25. Monitoring Effectiveness – Changes to other psychopharmacological medications or other antipsychotic medications – Qualitative/Quantitative Adverse Consequences – Anticholinergic, diabetes, TD, hypotension Protecting and promoting the health and safety of the people of Wisconsin 25

26. Monitoring Effectiveness – Changes to other psychopharmacological medications or other antipsychotic medications – Qualitative/Quantitative Adverse Consequences – Anticholinergic, diabetes, TD, hypotension Protecting and promoting the health and safety of the people of Wisconsin 26

27. Dr. Gifford-Focus 2012

29. Gradual Dose Reduction No Changes However, emphasis on new admissions evaluation sooner for potential tapering or dose reduction Protecting and promoting the health and safety of the people of Wisconsin 29

30. F329 GDR-Antipsychotics – GDR must be attempted in 2 separate quarters (1 month between) within 1 st year of being medicated or admitted on the antipsychotic – After 1st year, taper on annual basis

31. Clinically Contraindicated Behavioral symptoms related to dementia – The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility; and – The physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or increase distressed behavior.

32. Clinically Contraindicated To treat a psychiatric disorder other than behavioral symptoms related to dementia – The continued use is in accordance with relevant current standards of practice and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying psychiatric disorder; OR

33. Clinically Contraindicated To treat a psychiatric disorder other than behavioral symptoms related to dementia – The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

34. Dr. Gifford: Focus 2012

35. F329 New Update Summary Emphasis that antipsychotics not approved for dementia, have high risk, and often are ineffective for dementia behaviors Emphasis on assessing for adequate indications: DX Code not enough New Admission Assessment and Evaluation Protecting and promoting the health and safety of the people of Wisconsin 35

36. New Procedures/Tools for Surveyors

37. Appendix P-Sample Selection Goal: Insure a resident with dementia and antipsychotics is in the sample for ALL surveys Task 1: Off-Site Prep – Facility is flagged at 75 th percentile for either of the two antipsychotic quality measures. – During off-site prep a sample of residents with these flags will be included Protecting and promoting the health and safety of the people of Wisconsin 37

38. Appendix P-Sample Selection Task 2: Entrance – Ask for list of residents with diagnosis of dementia and who have received or are receiving or have PRN orders for antipsychotic medications in the last 30 days – If facility has residents with dementia ask for policies for dementia care and use of antipsychotic medications Protecting and promoting the health and safety of the people of Wisconsin 38

39. Appendix P-Sample Selection For 75 th percentile flagged facilities compare pre-selected residents to facility list of residents with dementia on antipsychotics within last 30 days Make sure pre-selected off-site includes one of these residents. If not, then exchange or add resident. Exchanged or added residents should have similar flagged QMs Protecting and promoting the health and safety of the people of Wisconsin 39

40. Appendix P-Sample Selection For facilities that did not flag make sure there is at least one resident from the facility- provided list of residents with dementia and on antipsychotic medications in the phase 1 sample. If not, exchange a resident from the facility-provided list to the phase I sample. The resident exchanged should have like or similar QM’s. Protecting and promoting the health and safety of the people of Wisconsin 40

41. Investigation of Selected Resident F309-Dementia Checklist – Goal is to evaluate dementia care provided in the facility – Checklist is a way to systematically review – When pieces of the system are broken other tags may be cited – When the system is broken or pieces are broken and it leads to the resident not receiving care to meet care needs, then F309 is cited Protecting and promoting the health and safety of the people of Wisconsin 41

42. Dementia Care Checklist Assess and Identify Underlying Cause of Dementia Behaviors (F272) Care Planning (F279) Care Plan Implementation (F282) Care Plan Monitoring and Revision (F280) Quality Assurance (F520) Did the facility provide…to highest practicable (F309) Protecting and promoting the health and safety of the people of Wisconsin 42

43. Focus of Interventions Indications – Persistent, Harmful, Other Causes Ruled Out Start via a telephone order Premonitor: Trends (Watchful Waiting) Drug Review prior to start? Line List? Stop Order Review?

44. Informed Consent

45. Act 281 WI Stats. 50.08 requiring written informed consent before administration of a psychotropic medication to a nursing home resident who has degenerative brain disorder

46. Chapter 50 Informed Consent Components Definitions General Requirement Exceptions Documentation Requirement

47. Degenerative Brain Disorder WI Stats 55.01 (1v) "Degenerative brain disorder" means the loss or dysfunction of an individual's brain cells to the extent that he or she [an individual] is substantially impaired in his or her ability to provide adequately for his or her own care or custody. Wis. Stats. 55.01 (1v)

48. Degenerative Brain Disorder Examples: – Alzheimer’s Dementia – Lewy Body Dementia – Frontal Lobe Dementia or – Pick’s Disease

49. Psychotropic Medication “Psychotropic medication" means an antipsychotic, an antidepressant, lithium carbonate, or a tranquilizer. Wis. Stats. 50.08 (1)(d)

50. Boxed Warning Only psychotropic medications with a boxed warning…commonly called black box Not all psychotropic medications have black box All antipsychotics. All Antidepressants. Lithium Not all sedative hypnotics or anxiolytics

51. Boxed Warning Is there a list? http://blackboxrx.com/

52. Exceptions Orders for medications by facilities off of the premises of the nursing home

53. Resources Flow Sheet: Decision Maker – http://www.dhs.wisconsin.gov/publications/p0/p00 336.pdf http://www.dhs.wisconsin.gov/publications/p0/p00 336.pdf Informed Consent Forms – http://www.dhs.wisconsin.gov/forms1/F2/MedBran dName.htm http://www.dhs.wisconsin.gov/forms1/F2/MedBran dName.htm

54. Med Pass Changes

55. Med Pass Task 5E Effective immediately Only complete a single med pass with a minimum of 25 medication opportunities You can go over 25 but not under Protecting and promoting the health and safety of the people of Wisconsin 55

56. Med Pass Task 5E Watch and document ALL of the resident’s medications being administered Do not stop the observation in the middle of a resident’s medication pass Stopping a potential medication error Drugs by protocol/OTC Formulary Protecting and promoting the health and safety of the people of Wisconsin 56

57. Med Pass Task 5E Make sure if multiple staff complete the task all observations are included for one calculation of the med error rate Review New Form Protecting and promoting the health and safety of the people of Wisconsin 57

58. Med Pass Task 5E G Tube Review Do Not Crush Resource MDI Review Omeprazole Review S&C memo: http://www.cms.gov/Medicare/Provider- Enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey- and-Cert-Letter-13-02.pdf http://www.cms.gov/Medicare/Provider- Enrollment-and- Certification/SurveyCertificationGenInfo/Downloads/Survey- and-Cert-Letter-13-02.pdf Protecting and promoting the health and safety of the people of Wisconsin 58

59. Questions Doug Englebert 608-266-5388 douglas.englebert@ dhs.wisconsin.gov