Pharmacy Northern Region Update 2013 Doug Englebert, R.Ph. 608-266-5388...

Pharmacy Northern Region Update 2013

Doug Englebert, R.Ph.

608-266-5388

[email protected]

August 28, 2013

What is Being Cited in NH?

F329 - Unnecessary Drugs

24 31

63 69 63 58

110 112

00

49

1

0

1

0

0

2

1

2

023

2

0

20

40

60

80

100

120

2005 2006 2007 2008 2009 2010 2011 2012

Level 4

Level 3

Level 2

Level 1

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

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

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

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

Psychotropic Drug Use

QI/QM DataPrevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions

18.2

20.7

17.6

19.8

17.1

19.3

16.3

18.6

16.1

18.5

0

5

10

15

20

25

2006 2007 2008 2009 2010

WI OverallNational Overall

QI/QM DataPrevalence 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

45

44.1

46.2

42.5

41

41.7

36.7

39.6

37.8

39.4

05

101520253035404550

2006 2007 2008 2009 2010

WI

National

QI/QM DataPrevalence of Antipsychotic Use in Absence of

Psychotic or Related Conditions: Low Risk (Residents who are not high risk)

14.2

17.2

13.7

16.5

13.5

16.2

12.5

15.6

12.9

15.6

0

2

4

6

8

10

12

14

16

18

2006 2007 2008 2009 2010

WI

National

Dr. Gifford-Focus 2012

Dr. Gifford: Focus 2012

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

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


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


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…


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


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


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


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


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

New Admission

This PASRR screening (F285) should provide pertinent information including appropriate clinical indications for the use of an antipsychotic


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


Monitoring

Effectiveness– Changes to other psychopharmacological

medications or other antipsychotic medications– Qualitative/Quantitative

Adverse Consequences– Anticholinergic, diabetes, TD, hypotension


Monitoring

Effectiveness– Changes to other psychopharmacological

medications or other antipsychotic medications– Qualitative/Quantitative

Adverse Consequences– Anticholinergic, diabetes, TD, hypotension




Gradual Dose Reduction

No Changes However, emphasis on new admissions

evaluation sooner for potential tapering or dose reduction


F329

GDR-Antipsychotics– GDR must be attempted in 2 separate quarters (1

month between) within 1st year of being medicated or admitted on the antipsychotic

– After 1st year, taper on annual basis

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.


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


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.

Dr. Gifford: Focus 2012

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


New Procedures/Tools for Surveyors

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 75th percentile for either of

the two antipsychotic quality measures.– During off-site prep a sample of residents with

these flags will be included



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



For 75th 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



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.


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


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

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?

Informed Consent

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

Chapter 50 Informed Consent Components

Definitions General Requirement Exceptions Documentation Requirement

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)

Degenerative Brain Disorder

Examples:– Alzheimer’s Dementia– Lewy Body Dementia– Frontal Lobe Dementia or– Pick’s Disease

Psychotropic Medication

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

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

Boxed Warning

Is there a list?

http://blackboxrx.com/

Exceptions

Orders for medications by facilities off of the premises of the nursing home

Resources

Flow Sheet: Decision Maker– http://www.dhs.wisconsin.gov/publications/p0/p00

336.pdf

Informed Consent Forms– http://www.dhs.wisconsin.gov/forms1/F2/MedBran

dName.htm

Med Pass Changes

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


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


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


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 Protecting and promoting the health and safety of the people of Wisconsin 58

Questions

Doug [email protected]

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Pharmacy Northern Region Update 2013 Doug Englebert, R.Ph. 608-266-5388...

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