9/11/2012. Clare I. Hays, MD, CMD

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1 Clare I. Hays, MD, CMD Review regulatory background for current CMS emphasis on antipsychotics Understand the risks and (limited) benefits of antipsychotic medications Review non-pharmacologic management of patients with dementia Begin to develop a plan for anti-psychotic reduction in your facility 1

2 F329 Unnecessary Drugs F428 Drug (Medication) Regimen Review 2

3 Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: In excessive dose For excessive duration Without adequate monitoring Without adequate indication for use In the presence of adverse consequences Antipsychotics 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 medical record Residents who use antipsychotic drugs receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs Gradual Dose Reduction Considerations Specific to Antipsychotics In 1 st year must attempt GDR in 2 separate quarters (with 1 month between attempts) After 1 st year GDR attempted annually Contraindicated if target symptoms returned or worsened or MD documents clinical rationale for why any additional attempted dose reduction would impair resident s function or increase distressed behavior Contraindicated for specific psychiatric disorder 3

4 Thorough evaluation of medication regimen of resident required Promote positive outcomes and minimizing adverse consequences associated with medication Collaborate with other members of the IDT Treatment of psychotic disorder, e.g. schizophrenia Treatment of psychotic symptoms (e.g. delusions, hallucinations) associated with other conditions (e.g. Alzheimer s Disease or delirium) Treatment of behavioral and psychological symptoms associated with dementia (BPSD), when these symptoms present a risk of harm to the resident or others Black Box Warning Issued in 2004 for atypicals; expanded to include all antipsychotics in 2008 Elderly with dementia-related psychosis treated with these drugs are at increased risk for death compared to placebo Consistent across all antipsychotics Relative risk= Jeste et al, Neuropsychopharmacology 2008; 33:

5 Sedation Postural Hypotension Falls Extrapyramidal (Parkinsonism, tremor, akathisia) i Cerebrovascular (Stroke) Mortality, predominantly infection and cardiac Metabolic side effects (weight gain, DM, hyperlipidemia) The resulting emphasis on reducing the inappropriate prescribing of antipsychotic drugs for elderly nursing home residents 5

6 14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs 304,983 of 2.1 million NH residents 20% of all claims for atypicals for all Medicare beneficiaries 17% of NH residents with claims had claims for more than one atypical 83% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions 88% were associated with the condition specified in the FDA boxed warning (dementia with psychosis or behavioral symptoms) 51% of Medicare atypical antipsychotic drug claims for elderly nursing home residents were erroneous (did not comply with Medicare reimbursement criteria), amounting to $116 million Not used for medically accepted indications as supported by the compendia Not documented as having been administered to the elderly nursing home residents 6

7 22% of the atypical antipsychotic drugs claimed were not administered in accordance with CMS standards regarding unnecessary drug use in nursing homes ($63 million) 42% of those claimed drugs did not comply with CMS standards for more than one reason 22% of antipsychotic prescriptions in nursing homes are problematic Problem per CMS Standards % Claims Excessive Dose 10.4 % Excessive Duration 9.4% Without Adequate Indication 8.0% Without Adequate Monitoring 7.7% In the Presence of Adverse Effects 4.7% Cost ~$116 million Facilitate access to information necessary to ensure accurate coverage and reimbursement determinations. Recommended including diagnosis on claim but CMS did not concur (no requirement on Rx; no industry standard) 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. Take appropriate action regarding the claims associated with erroneous payments identified in the sample. 7

8 CMS Initiative Surveyor Training Raise awareness of antipsychotic misuse Improve regulatory oversight Train NH workers on non-drug treatments for aggressive and agitated dementia behaviors A CMS nursing home resident report found that almost 40 percent of nursing home patients with signs of dementia were receiving antipsychotic drugs at some point in 2010, even though there was no diagnosis of psychosis Multiple federal investigations/lawsuits involving drug companies and marketing of antipsychotics to nursing homes Failure of a proposed amendment meant to curb the off-label use of antipsychotic drugs to control elderly residents with dementia Involves federal and state agencies, advocacy groups, and caregivers at nursing homes and other eldercare facilities. 8

9 National Goal--Reduce use of antipsychotic drugs in nursing home residents by 15 percent by the end of Just a start Enhanced training Hand in Hand Increased transparency facility antipsychotic rates to be on Nursing Home Compare then updated quarterly Alternatives to antipsychotics nonpharmacologic alternatives CMS will report the percent of long-stay nursing home residents who are on an anti-psychotic drug And, CMS will report the percent of short-stay residents who are started on an antipsychotic drug after being admitted to a nursing home Reducing Antipsychotic Medications Alabama s Opportunity for Improvement Reporting Period 4/1/ /31/ /1/2011-3/31/2012 Average for all reporting nursing 27.3% 27.6% homes- AL Average for all reporting nursing homes- US 23.9% 23.9% 9

10 Problem Behavior Misinterpretation Amnesia (loss of memory) Apraxia (loss of ability to coordinate learned movements) Aphasia (inability to speak or understand) Agnosia Repeats questions often, misplaces objects Cannot use utensils, dress, use toilet Cannot follow directions or engage in coversation Cannot recognize faces, familiar places, or objects frustrating paranoid won t eat uncooperative quiet uncooperative agitated frightened combative wandering steals others belongings 10

11 Describe Decode Design intervention Do it Decide if intervention was successful Social Services Activities Nursing Direct Care Staff Medical Director, Attending Physicians, NPPs Dietary Staff Ancillary Staff 11

12 How does staff address behavioral responses by persons with dementia in your facility? Person-centered care Consistent assignment Increased exercise or time outdoors Environment o Reduce glare and shadows o Reduce noise o Reduce clutter Monitoring and managing acute and chronic pain Planning individualized activities Look for unmet needs o Hunger, thirst o Too hot, too cold o Tired o Bored o Overstimulated o Pain o Toileting 12

13 Rule out reversible causes prior to using a drug Try non-drug management strategies first Clearly document target symptoms Justify use of an antipsychotic Symptom must present danger to self or others or cause: o Inconsolable or persistent distress o A significant decline in function o Substantial difficulty receiving needed care Consider impact of side effects If the drug doesn t help, stop it Aggressive behavior (especially physical) Hallucinations (if distressing) Delusions (note: memory problems are often mistaken for delusions, e.g. thinks someone stealing lost items) Severe distress Wandering Unsociability Poor self-care Restlessness Nervousness, fidgeting, mild anxiety Impaired memory Uncooperativeness, resistance to care without aggressive behavior Inattention or indifference to surroundings Verbal expressions or behaviors that do not represent a danger to the resident or others 13

14 The use of antipsychotics in nursing facility residents should include: An appropriate indication for use A specific and documented goal of therapy Ongoing g g monitoring of the resident to evaluate effectiveness in achieving the therapy goal and the development or presence of adverse effects from the medication Use of the medication only for the duration needed, and at the lowest effective dose List of all residents with antipsychotic medication Confirm diagnosis. Eliminate Schizophrenia, Bipolar, Tourette s, Huntington s. Confirm target symptoms look for specific evidence of delusions, hallucinations, severe symptoms. Use behavior management program/social services. Find those without appropriate diagnosis/symptoms and work on those first Review baseline data Pull your own data Understand d the numbers Follow regularly 14

15 Get Medical Director on board Utilize pharmacy consultant Make sure Medical Director communicates with attending physicians and NPPs who write orders. Physicians must document WHY must show risk/benefit assessment done More frequent review of all patients on antipsychotics We want our loved ones with dementia to receive the best care and the highest quality of life possible, Acting Admin. Marilyn Tavenner. 15