Transcript Pharmacy Northern Region Update 2013
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
120 100 80 60 40 20 0 1 1 0 2 4 3 9 2 0 2 1 0 110 112 0 2 31 63 69 63 58 24 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 Data
Prevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions 25 20.7
20 18.2
19.8
17.6
19.3
17.1
18.6
16.3
18.5
16.1
15 10 5 0 2006 2007 2008 2009 2010 WI Overall National Overall
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 50 45 40 35 30 25 20 15 10 5 0 45 44.1
46.2
42.5
2006 2007 41 41.7
2008 36.7
39.6
2009 37.8
39.4
2010 WI National
QI/QM Data
Prevalence of Antipsychotic Use in Absence of Psychotic or Related Conditions: Low Risk (Residents who are not high risk) 18 16 14 14.2
17.2
13.7
16.5
13.5
16.2
12.5
15.6
12 10 12.9
15.6
8 6 4 2 0 2006 2007 2008 2009 2010 WI National
Dr. Gifford-Focus 2012
Dr. Gifford: Focus 2012
DX Code Not Enough*
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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
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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
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
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Protecting and promoting the health and safety of the people of Wisconsin
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…
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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
Enduring Condition
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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
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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
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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
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
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Protecting and promoting the health and safety of the people of Wisconsin
New Admission
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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
Monitoring
Effectiveness – Changes to other psychopharmacological medications or other antipsychotic medications – Qualitative/Quantitative Adverse Consequences – Anticholinergic, diabetes, TD, hypotension
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Protecting and promoting the health and safety of the people of Wisconsin
Monitoring
Effectiveness – Changes to other psychopharmacological medications or other antipsychotic medications – Qualitative/Quantitative Adverse Consequences – Anticholinergic, diabetes, TD, hypotension
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Protecting and promoting the health and safety of the people of Wisconsin
Dr. Gifford-Focus 2012
Dr. Gifford-Focus 2012
Gradual Dose Reduction
No Changes However, emphasis on new admissions evaluation sooner for potential tapering or dose reduction
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Protecting and promoting the health and safety of the people of Wisconsin
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
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.
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
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.
Dr. Gifford: Focus 2012
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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
New Procedures/Tools for Surveyors
Appendix P-Sample Selection
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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
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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
Appendix P-Sample Selection
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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
Appendix P-Sample Selection
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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
Investigation of Selected Resident
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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
Dementia Care Checklist
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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
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
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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
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
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Protecting and promoting the health and safety of the people of Wisconsin
Med Pass Task 5E
G Tube Review Do Not Crush Resource MDI Review Omeprazole Review
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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
Doug Englebert 608-266-5388 douglas.englebert@ dhs.wisconsin.gov