11/8/2013. The Impact of the Affordable Care Act on Long Term Care. Quality Improvement Organization. Objectives

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1 11/8/2013 The Impact of the Affordable Care Act on Long Term Care Karen Southard, RN, MHA Program Manager, Care Transitions and Patient Safety Quality Improvement Organization Quality arm for CMS Physician led organization National Quality Strategy- work plan Work across providers and settings CCME- QIO for over 30 years Objectives Review the history of Long Term Care in the US Provide insight on need for health care reform Discuss the changes outlined in the Affordable Care Act Share strategy to survive the proposed changes 1

2 11/8/2013 Cycles Of Concerns And Solutions In Long-Term Care Over The Past Century: A Timeline. Smith D B, and Feng Z Health Aff 2010;29: by Project HOPE - The People-to-People Health Foundation, Inc. Controlling Indigent Care Costs: The Indoor Relief Solution Hold over of Elizabethan poor-law Minimize the cost of maintaining the indigent Outdoor Relief- cash assistance Indoor Relief- Poor House Auction System-bid on lowest care Eliminating Poorhouses: The Old Age Income Security Solution Title1- Old Age Security Act of 1935 Provided matching funds to states for low income elderly Private boarding homes-for profit nursing homes emerge Today: 64.5% for profit are Medicaid vs. 59.2% nonprofit 2

3 11/8/2013 Access to Affordable Medical Service Health Insurance for the Elderly Social Security Act Amendments of 1965 Elimination of economic and racial disparity for hospital and physician care Long Term Care- Medicaid emerges as a default payer 50% growth in nursing home beds Publicly traded for profit chains increase Controlling Provider Abuses: Strengthening State and Federal Enforcement IOM report called for nursing home reform- Omnibus Budget Reconciliation Act (OBRA) MDS creates a set of standards Online Survey, Certification, and Reporting System OSCAR Prospective Payment Methods A Shift in Long Term Care Spending Private-pay nursing homes move toward Assisted Living Assisted Living Federation of America founded ,000-40,000 facilities Nursing Home beds remain stagnant Push for enriching and high quality of life Pioneer Network Eden Alternative Green House Model 3

4 11/8/2013 The Next Cycle of Reform Long Term Care Challenges Growing need for long term care services by baby boomers Quality of Care concerns Growth in unregulated facilities (assisted living, adult homes, home care agencies) Absence in expanded federal assistance- less can afford services Fast Facts Nursing Home Data Number of nursing homes: 16,700 Number of nursing home beds: 1.7 million Occupancy rate: 86% Number of current residents: 1.6 million Average length of time since admission: 835 days Coast of Care- $143 billion 2007 CDC Break Down by Payer Long Term Care Reimbursement 37% 22% Medicare Medicaid Private Pay 41% 4

5 11/8/2013 Timeline for Reform 1987 OBRA 2009 Nursing Home Transparency Act 2010 Affordable Care Act Improve Quality of Care Allows for better accountability of ownership Elder Justice Act and Patient Safety and Abuse Prevention Act ACA: Improving NH Transparency Section 6101 Nursing Homes must report on: Organizational structure, entities and individuals with at least 5% ownership interest in real estate, corporation or limited liability company Monitoring: Come under Federal and State regulators and States Ombudsman Programs Implementation Final ruling deferred by CMS- seeking public input 2012 Currently enacted: Substantial increase in the information collected through PECOS system 2015 all Medicare and Medicaid providers will revalidate their information, thus fulfilling Section 6401 (Fraud Prevention) 5

6 11/8/2013 ACA: Accurate Information about Nursing Home Staffing Section 6106 Mandate CMS by March 2012 to implement a program to collect data on nurses and other direct care staff through payroll records, agency contracts and cost reports Report will include total number of residents, resident case index, turnover and retention rates, hours of daily care Implementation CMS estimates 2-3 years before system is complete Continues to utilize Nursing Home Compare IMPACT: Following CMS correction of Medicare overpayments to nursing home in FY reduction in staffing DON: Address turnover and develop retention plans with HR ACA: Categorize Expenditures from All Payments Sources Section 6104 Report on all expenditures from all payment sources on their cost reports and indicate if expenses are for: 1. Direct Care ( including therapy and medical service) 2. Indirect Care, including housekeeping and dietary services 3. Capital Expenses, building and land costs 4. Administrative services 6

7 11/8/2013 Implementation CMS currently collecting this information using the new Medicare cost report form (SNF ) Additional information direct care expenditures: FT, PT, Contract Staff Paid Wages Worked Hours Average expenditure per hour for each nursing and therapy category Impact Congressional Hearings High Medicare profit margin for the NH owners, while failing to meet quality of care standards average for profit margin was 20.7 % (twice the average for the nonprofit homes) Total Margins for SNF s for all payments sources was 3.6% MedPAC Advisory ACA: Improvement to Nursing Home Compare Website Section 6103 Mandates CMS to update with timely, easy to understand information Changes: Staffing data from payroll records Daily hours of direct care (section 6106) Staff turnover and tenure A standardized voluntary complaint (6105) 7

8 11/8/2013 Implementation July 2012, CMS introduced redesigned Nursing Home Compare website: New search for facility-based performance indicators Standardized complaint form/guidance (6105) Links to state consumer websites Substantiated complaints and CMP s Denials of payment for new admissions Updated MDS data New Antipsychotic measure Enhancements pending to Nursing Home Compare Website Section Staffing information from payroll records, as well as turnover and retention rates Report of adjudicated crimes by facilities and employees Complaint investigation reports (2567s) and facilities formal plan of correction Completion of all states to have consumer linked websites Complete owner information 8

9 11/8/2013 ACA: Compliance and Ethics, Quality Assurance and Improvement Plans Section 6102 New Mandates: 1. Compliance and Ethics- Criminal, civil and administrative violations 2. Quality Assurance and Performance Improvement (QAPI) 3. CMS demonstration project for independent monitoring of interstate and intrastate and large chain facilities Implementation Currently QAPI is the only ACA mandate that is being launched: Projected final rule release- 12/2013 with 1 year post implementation for survey QAPI at a Glance released- 12/2012 ACA: Civil Monetary Penalties Section 6111 CMP s placed in escrow pending outcome of formal appeal Nursing homes may request independent IDR separate from state survey agency (12/11) Facilities that waive the right for a hearing and promptly correct the deficiencies may receive a 50% reduction in a CMP based on severity 9

10 11/8/2013 Additional Use of CMP Activities which benefit residents Assisting in relocation of residents to another facility in the event of closure Facility improvement as approved by CMS Survey and staff training Technical assistance implementing a quality assurance program Temporary manager appointment of a chronically substandard facility Implementation of Independent IDR May be conducted by a state department that is separate from the agency that conducts health inspections, or by an independent entity identified by the state with no conflict of interest and an understanding of Medicare and Medicaid requirements No independent IDR if they had an IDR after a CMP Challenge the deficiency but not the survey process IDR recommendations are advisory Daily CMP s can still occur during the independent IDR ACA: Notification When Nursing Homes Close Section day written notice to State Survey and Ombudsman Plan for resident relocation (choice, needs and best interests) Issues: Penalty on noncompliance $100,000 to $500 No resident appeal for inappropriate transfers Does not apply to nursing home conversion/unit to provide different skilled services 10

11 11/8/2013 ACA: Programs on Culture Change and IT Section 6114 CMS to conduct 2 Demonstration Projects 1. Grant for facilities involve in culture change and develop best practices and resources 2. Grant focused on best practices in IT Implementation Update: No funds allocated at this time ACA: Dementia and Abuse Prevention Training Section 6121 Requires all nursing assistances to be trained in dementia care and abuse prevention Training in addition to the 75 hours required by OBRA 87 6 hour curriculum Hand in Hand ACA: Prevention of Abuse and other Crimes Section 6201 Provision of grant money to design comprehensive criminal background checks on employees with direct access to residents. March 2012: CMS has awarded 38.6 million to 17 states Section 2046 Mandatory reporting of suspicion of a crime against a resident to the state survey agency and local law enforcement 11

12 11/8/2013 Affordable Care Act- Impact on Business Hospital LTC Bundled Payments ACO ACA: Hospital 2012 Hospital Readmission Reduction Program- 1-3% penalty Value Based Purchasing 17 Clinical Process Measures, 10 Consumer Measures New Models of Shared Savings Accountable Care Organization Shared savings across the continuum Bundled Payments for Care Improvement (BCPI), Model 3 LTC 165 Nursing Homes in pilot, 48 conditions Utilizes data to drive down cost Focus on quality outcomes Competitive market Utilize Five Star Rating Trigger by acute care stay Rehab or Long Stay 30, 60, 90 length of stay Target price set, evaluated post event and cost savings shared among participants Patterns of Readmission Outcomes and Readmissions are factors 12

13 11/8/2013 Preparing for the Future QAPI Staffing/Retention Culture Change Programs to meet targeted population Community Transition Programs National Nursing Home Quality Care Collaborative (NNHQCC) CMS initiative State QIOs > 5,000 nursing homes 13 long stay measures Falls with major injury UTI s Moderate to severe pain Pressure ulcer Loss of bowels or bladder Catheter inserted in bladder or left in bladder Physical restraints Increased need for help with ADL Weight loss Depression AP s Flu immunization Pneumococcal immunization 13

14 11/8/2013 NNHQCC Quality Composite Measure Score Calculated by summing all 13 measure numerators and all 13 measure denominators Divide numerator by denominator Multiply by 100 January June 2013 MDS Data Quality Measure Facility ACE State Rate National Rate Rate Rate Percent of residents with one or more falls with injury % 3.5% 3.2% 3.3% Percent of residents with a UTI % 7.3% 6.9% 6.7% Percent of residents who self report moderate to severe pain % 11.9% 11.4% 8.8% Percent of high risk residents with pressure ulcer % 7.9% 7.9% 6.9% Percent of low risk residents with loss of bowels or bladder % 55.4% 53.3% 43.5% Percent of residents with catheter inserted or left in bladder % 3.5% 3.9% 4.0% Percent of residents physically restrained % 1.1% 1.4% 1.5% Percent of residents whose need for help with ADL has increased % 18.7% 19.4% 16.0% Percent of residents who lose too much weight % 10.4% 10.2% 8.5% Percent of residents who have depressive symptoms % 3.8% 5.1% 6.7% Percent of residents who received antipsychotic medications % 16.8% 16.8% 21.1% Percent of residents NOT assessed and appropriately given flu vaccine % 5.2% 5.5% Percent of residents NOT assessed and appropriately given Pneumococcal vaccine % 4.3% 5.1% COMPOSITE MEASURE % 9.2% 9.3% 8.97% 14

15 11/8/2013 National Trends Collaborative begins Composite Score All Homes NNHQCC Homes Non NNHQCC Homes AUG12 SEP12 OCT12 NOV12 DEC12 JAN13 FEB13 MAR13 APR13 MAY13 JUN13 JUL13 Rolling 6 month Time Periods (label indicates the last month of the time period) NOTE: Composite scores were calculated from QM data downloaded from the QIES workbench for rolling 6 month time periods. Nursing homes without CCNs are not included in the composite score calculation Improvement Trends 5.00 Relative Improvement Rate st full time period after NNHQCC launch All Homes NNHQCC Homes Non NNHQCC Homes FEB13 MAR13 APR13 MAY13 JUN13 JUL13 Rolling 6 month Time Periods (label indicates the last month of the time period) NOTE: Composite scores were calculated from QM data downloaded from the QIES workbench for rolling 6 month time periods. Nursing homes without CCNs are not included in the composite score calculation. Aug12 Jan13 is used as a baseline to calculate relative improvement. 15

16 11/8/2013 QI in Action- DON/ADON Leadership Coalition Grassroots movement Discussing issues Setting Goals Measuring Change Sustainability 16

17 11/8/2013 Requests and Offers Request Next week stop by your DON and NHA and ask them if there is anything you can do to help on a quality project Support change Offers We will continue to support the QI at the local level We will provide, educate and support nursing homes with evidenced based practice ccmemedicare.org References Smith, David, Zhanlian Feng, The Accumulated Challenges of Long Term Care: Health Care Affairs/Long Term Care Conference, Washington DC, 2007 Wells, Janet, Implementation of Affordable Care Act Provisions To Improve Nursing Home transparency, Care Quality and Abuse and Prevention Bundled Payment for Nursing Homes CMS.gov Data Drive ACO Involvement, Provider Magazine, Sept

18 11/8/2013 Questions? (NC) (SC) This material was prepared by The Carolinas Center for Medical Excellence (CCME), the Medicare Quality Improvement Organization for North and South Carolina, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. Product Number Needed 18

19 11/7/2013 Caring in the Carolinas November 9, 2013 Charlotte, NC Risk Management 101: Avoiding Legal Liability from Prescribing Antipsychotics Alan C. Horowitz, Esq., RN Speaker Disclosures Alan C. Horowitz, Of Counsel, Arnall Golden Gregory, Atlanta, Georgia, has disclosed that he has no relevant financial relationship(s). Learning Objectives: By the end of the presentation, participants will: Appreciate the heightened scrutiny by the Federal government (OIG, DOJ, CMS). Identify areas that surveyors will focus on concerning antipsychotic drugs. Understand liability concerns with antipsychotics and how to mitigate them. Learn effective strategies to reduce antipsychotics. 1

20 11/7/2013 Antipsychotics: What s the Problem? In 2005 the FDA issued a black box warning on antipsychotics and the increased risk of cardiovascular mortality when used in the elderly for behavioral symptoms in dementia Antipsychotics are not FDA approved for behavioral symptoms in dementia No psychotropic medications are FDA approved for behavioral symptoms There is some evidence supporting cautious use of antipsychotics at low doses New York Times Antipsychotic Drugs Called Hazardous for the Elderly May 9, 2011 (referencing 2011 OIG audit, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents, OIG May 2011 OEI ) Why the increased concern about atypical antipsychotics? Health concerns: Increased Mortality Cerebrovascular Adverse Events Hyperglycemia and Diabetes Mellitus In older patients with dementia, use increases relative risk of death by 70% For every 100 patients, only 9-25 will benefit and 1 will die Cost 2

21 11/7/2013 The Problem ~22% of antipsychotic prescriptions in nursing homes are problematic per Centers for Medicare and Medicaid Services (CMS) standards Problem per CMS standards % of claims Excessive dose 10.4% Excessive duration 9.4% Without adequate indication 8.0% Without adequate monitoring 7.7% Presence of adverse effects indicating 4.7% the dose should be reduced or D/C d Antipsychotic Drugs Indications: schizophrenia, bipolar disorder, psychosis NOT indicated: behavioral disturbances with Alzheimer s Disease, core treatment of depression Extremely expensive Under intense government scrutiny (CMS, DOJ, OIG) Potential Problems with Antipsychotic Drugs in LTC Dangerous and potentially life-threatening Off-label Used commonly for residents with dementia Appropriate informed consent typically not obtained Viable alternatives often not explored May be viewed as convenience drugging Chemical restraints F222 Unnecessary drugs F329 Quality of care F309 Standards of care F281 Physician review F386 Drug regimen review F428 3

22 11/7/2013 HHS Perspective Government, taxpayers, nursing home residents as well as their caregivers should be outraged and seek solutions. Daniel R. Levinson, Inspector General Department of Health & Human Services HHS Office of the Inspector General Too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use. Frequently, they are prescribed in ways that don't qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration. But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia. Source: Daniel R. Levinson, Inspector General, HHS (May 31, 2011) Office of the Inspector General 14% of residents had claims for atypical antipsychotic drugs (304,983 residents) during period 1/1/07-6/30/07 $309 million in claims (20% of all claims) 83% of Medicare claims were for off-label use 88% associated with FDA Black Box warning 4

23 11/7/2013 Office of the Inspector General 51% of Medicare atypical antipsychotic drug claims were erroneous ($116 million); 726,000 of the 1.4 million atypical antipsychotic drug claims did not meet Medicare reimbursement criteria. 22% of atypical antipsychotic drugs claimed were not administered in accord with CMS standards re: unnecessary drugs ($63 million) Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents, OIG May 2011 OEI Medicare Claims for Atypical Antipsychotics: January 1 June 30, 2007 Generic Drug Claims Amount Quetiapine 627,661 $85,847,131 Risperidone 536,600 $87,161,507 Olanzapine 356,695 $94,055,067 Aripiprazole 83,756 $29,565,887 Ziprasidone 44,681 $10,067,477 Clozapine 27,294 $1,691,718 Olanzapine/Fluoxetine 1,521 $431,799 Paliperidone 666 $207,731 Total 1,678,874 $309,028,317 Records That Did Not Contain Evidence That Federal Requirements Were Met Federal Requirements Not Documented Records Percentage Resident Assessments % Decision-making (Consideration of RAP for % psychotropic drug use) Care Plan Development % Care Plan Implementation % Overlapping (205) (54.6%) Total (net) % Source: OIG, Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs, OEI (July 2012) 5

24 11/7/2013 Department of Justice Actions Company Drug Action leading to false claim Pfizer Geodon Illegal Promotion, Kickbacks Bristol-Myers Squibb Abilify Inappropriate marketing to child psychiatrists and SNFs J & J Risperdal Kickbacks for marketing to Omnicare AstraZeneca Seroquel Kickbacks, marketing to MDs Eli Lilly Zyprexa 5 at 5 marketing to nursing homes Janssen Pharmaceuticals and J & J were ordered to pay $1.2 billion in fines in Arkansas. Janssen Pharmaceuticals paid roughly $743 million in fines to Texas, South Carolina, and Louisiana in similar cases. Eli Lilly paid $1.42 billion to settle off-label marketing violations. Atypical Antipsychotic Drugs Aripiprazole (marketed as Abilify) Asenapine Maleate (marketed as Saphris) Clozapine (marketed as Clozaril) Iloperidone (marketed as Fanapt) Lurasidone (marketed as Latuda) Olanzapine (marketed as Zyprexa) Olanzapine/Fluoxetine (marketed as Symbyax) Paliperidone (marketed as Invega) Quetiapine (marketed as Seroquel) Risperidone (marketed as Risperdal) Ziprasidone (marketed as Geodon) CMS Initiatives Continue tracking use in short-stay, long-stay residents Increased focus by surveyors (expect increased enforcement actions) Engage QIOs Part D coverage National Partnership 6

25 11/7/2013 What do CMS Regulations Require? (l) Unnecessary drugs (1) General. Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used: (i) In excessive dose (including duplicate drug therapy); or (ii) For excessive duration; or (iii) Without adequate monitoring; or (iv) Without adequate indications for its use; or (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (vi) Any combinations of the reasons above. 42 C.F.R (l)(1), F329 What do CMS Regulations Require? Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that (i) 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; and (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. 42 C.F.R (l)(2), F329 CMS Initiatives In July 2012, CMS added two new categories of quality measures information for nursing homes on the Nursing Home Compare website related to antipsychotic drug use. the percent of short-stay residents who newly received an antipsychotic medication (2.7% nationally) the percent of long-stay residents who received an antipsychotic medication (22.4% nationally) Nursing Home Compare provides data for comparison to other nursing homes as well state and national averages for both short-stay and long-stay residents. 7

26 11/7/2013 Survey and Certification Memo: NH Appendix P, Appendix PP of the State Operations Manual (SOM) updated Person-Centered Care Quality and Quantity of Staff Individualized Approaches to Care Critical thinking related to Antipsychotic Drug Use Engagement of Resident and/or Representative in Decision-Making Interviews with Prescribers Evaluation of new or worsening behaviors Quality of Care Pathway Adapted from CMS RAI User s Manual, Ver. 2.0 Assessment Care Plan Implementation Decision-making Care Plan Development CMS Initiatives: National Partnership to Improve Dementia Care CMS 2012 Goal: reduce antipsychotic use in LTC 15% by December 31, 2012 (same goal for 2013) December 31, 2012: 6% nationwide decrease Comparing last quarter of 2011 and 1 st quarter of 2013, antipsychotic use decreased 9% (long-stay residents) Eleven states met 15% reduction goal (AL, DE, GA, KY, ME, NC, OK, RI, SC, TN and VT) 30,000 (estimated) fewer residents on antipsychotics since CMS launched program Source: CMS August

27 11/7/2013 Kudos to the Carolinas North Carolina nursing homes had the largest reduction in antipsychotic drug use (>23%) North Carolina also had the highest percentage difference from Q Q South Carolina nursing homes reduced antipsychotic drug use by >16% (5 th highest reduction in nation) Inadequate Indications for antipsychotic medications - CMS Wandering Poor self-care Impaired memory Mild anxiety Insomnia Inattention or indifference to surroundings Sadness/crying unrelated to depression or other psychiatric disorders Fidgeting nervousness Uncooperative (refuses care, difficulty receiving care) Unless Inadequate Indications for antipsychotic medications - CMS The behavior symptoms present a danger to the resident/others AND: The symptoms are identified as being due to mania or psychosis (auditory/visual hallucinations, delusions, paranoia, grandiosity) AND/OR Behavioral interventions have been attempted and included in the plan of care, except in an emergency. 9

28 11/7/2013 FDA Black Box Warning Analyses of seventeen placebo controlled trials that enrolled 5106 elderly patients with dementia related behavioral disorders revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Clinical trials were performed with Zyprexa (olanzapine), Abilify (aripiprazole), Risperdal (risperidone), and Seroquel (quetiapine). Over the course of these trials averaging about 10 weeks in duration, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia related psychosis (see WARNINGS). FDA Black Box Warning FDA Alert [4/11/2005]: Increased Mortality in Patients with Dementia-Related Psychosis FDA has determined that patients with dementiarelated psychosis treated with atypical (second generation) antipsychotic medications are at an increased risk of death compared to placebo. Based on currently available data, FDA has requested that the package insert for Risperdal be revised to include a black box warning describing this risk and noting that this drug is not approved for this indication. Nurse and Medical Director Sentenced for Convenience Drugging The California Department of Public Health began an initial investigation in 2007, following complaints from an ombudsman that a patient in the skilled nursing facility had been held down and injected with psychotropic medicine by force. They found evidence of patient harm, and issued a Certificate of Immediate Jeopardy against the facility, before turning the case over to the Justice Department. Evidence indicated that Hughes directed the hospital s director of pharmacy to write doctor s orders for the unnecessary psychotropic medications. The orders were signed at a later time by the medical director. Pamela Ott, former chief executive officer of the Kern Valley Health District, pled no contest to one felony count of conspiracy to commit an act injurious to the public health based on her failure to adequately supervise the Director of Nursing. Ott was sentenced to three years formal probation, 300 hours of volunteer service, restitution pending conclusion of civil lawsuits. She is required to comply with all orders from the Registered Nursing Board, which is conducting its own investigation into the matter. In July 2012, Dr. Hoshang Pormir, the Medical Director, was also sentenced to 300 hours of volunteer service, restitution pending conclusion of civil lawsuits, and a requirement to comply with all orders from the Medical Board. Pormir failed to conduct examinations of patients or monitor their reactions to medications. Source: California Attorney General s Office, 10

29 11/7/2013 Professional liability claims related to antipsychotics Tardive dyskinesia Gynecomastia Diabetes Pancreatitis Neuroleptic Malignant Syndrome (NMS) Suicide Cardiovascular Death Practice tip: consider having a signed informed consent, adequately document all relevant information. Internet Ad From A Texas Tardive Dyskinesia Lawyer (Excerpt) Texas Tardive Dyskinesia Lawyer (Drug Reactions) If you or someone you love is suffering from tardive dyskinesia, Austin Texas Tardive Dyskinesia lawyer, Jason S. Coomer, helps individuals that have been injured from high doses or long term use of neuroleptic medications. If you have a question about a anti-psychotic medication or other neurological or gastrointestinal medications that may have caused Tardive Dyskinesia, contact Austin Texas Tardive Dyskinesia Lawyer Jason Coomer. He works with other Texas Medical Malpractice Lawyers including Houston medical and psychiatrist malpractice lawyers, Dallas Medical Malpractice Lawyers, San Antonio Psychiatrist Malpractice Lawyers, and other Austin Psychiatrist Negligence Lawyers on a variety of medical malpractice claims. Don t be this guy s target. Informed consent Informed consent for prescribing antipsychotics to patients/nursing home residents is required in several states (e.g., California, Wisconsin). Proposed federal and state legislation would require informed consent before prescribing antipsychotics. What are the barriers/problems associated with obtaining informed consent regarding prescribing an atypical antipsychotic in an off label manner? 11

30 11/7/2013 ManorCare at Palos Heights West, CR1847 (2008) 68 y/o 102 # transferred from hospital 1/15/07 Hx: multiple CVA, dementia, anxiety disorder, COPD, anemia, HTN Psych assessment: able to perform simple calculations, thought processes logical, organized, judgment only min. impaired, depressed While hospitalized, she received 0.5 mg risperidone (Risperdal) PO BID ManorCare at Palos Heights West Discharge/transfer medication reconciliation form error Nurse omits decimal point, writes: Risperdal 5 mg PO BID MD signed Rx No diagnosis to support antipsychotic med Nurse transcribes TVO as follows: Risperdal for anxiety, Ativan for psychosis Consulting pharmacist fails to question dose or diagnosis 12

31 11/7/2013 ManorCare at Palos Heights West Throughout her stay, resident received 5 mg Risperdal BID. No one questioned dosage. Resident was administered: Risperdal, Ativan and Zoloft. 1/26/07: resident suffered cardiac arrest, dies in hospital. What result? What are the problems here? ManorCare at Palos Heights West Pharmacist: no irregularities, dose w/in mfg recommendations, Geriatric Dosage Handbook MFG: doses 6 mg/day generally not recommended Surveyor: MD said Rx was a goof-up, he did not realize that 5 mg BID was excessive (no rebuttal, MD did not testify) Care plan: monitor and report signs of adverse reactions (lethargy, decline in mental status, c/o dizziness Pharmacist claimed to review hospital drug regimen but On cross-exam: I didn t see it, and I don t know if it was available to me. Nursing note: resident sleeping all the time, always lethargic, and often out of it. Resident sustained multiple falls No evidence anyone considered relationship of falls to 10 mg Risperdal daily. Lessons Learned Medication error demonstrates systems problem MD Pharmacist Nurses Software (maximum daily dose flags) Drug reconciliation Need for staff in-services Competency evaluation (20 doses Risperdal 5 mg given) 13

32 11/7/2013 Grace Living Center Jenks, CR1197 (2004) 5/23/00 93 y/o admitted from hosp., where she was tx d for bronchitis and dehydration Hx: Parkinson s Disease, acute bronchitis, OBS, HTN, aphasia, Alzheimer s disease moaning, hollering, removing mask during neb tx., yelling loudly 5/31/00 Rx: Trazadone for rest Crying and agitated behaviors continued Grace Living Center Jenks 6/12/00 Rx: 2.5 mg Zyprexa po HS (dx: psychosis) 6/19/00 increase Zyprexa to TID, increase Trazadone to 100 9:00 am and pm (7 days later) 6/22/00 RN calls MD, resident lethargic 6/22/00 Rx: hold Zyprexa x 5 days, resume at 2.5 mg hs 6/23/00 lethargy continues, Rx: hold both Zyprexa and Trazadone Grace Living Center Jenks 6/25 resident more alert, yelling, Zyprexa not given 6/26 Rx: D/C Zyprexa, Risperdal 0.5 mg BID for 6/27 and 1 mg BID on 6/28, then 2 mg every morning starting on 6/29/00 6/27-6/29 resident resting comfortably 6/ mg Risperdal hs begun, continues until discharge (7/24/00) CMS cites immediate jeopardy from 6/12/00 7/24/00 (entire period of residency) 14

33 11/7/2013 Grace Living Center Jenks What facts do you need to know to determine if IJ existed for 43 days? What are the problems with the physician orders (if any)? What are the problems with the nursing assessments and communications with the physicians (if any)? What are the problems with CMS determination (if any)? Case Study 89 yr old male hospitalized for UTI Started on Haldol 2 mg prn, then hs (delirium resolving, underlying cause tx d) Rx for Haldol 2 mg hs on re-admission to SNF for psychotic disorder Seen by psych CRNP 2 days after admission, Rx: Cogentin 0.5 mg Q hs for drooling (EPS) No behavioral problems until pt confused 15 days later Seven visits made by attending, no clinical rationale documented for Haldol Nurses, pharmacist do not question Rx When asked What is the psychiatric disorder? MD tells surveyor, agitation 14.6 # wt loss/8 days, multiple falls, in mental status, K = 7.7 Issues? Haverhill Care Center Resident tended to sleep all day and wander all night; She has to be watched at all times. Rx for Risperdal for sx of: agitation, delusions, disrupted sleep, and sundowning symptoms. Resident had 4 falls in two months CMS cites deficiency for F329, unnecessary drugs (failure for drug regimen to be free of unnecessary drugs). 15

34 11/7/2013 Haverhill Care Center CMS argues that there was no indication for antipsychotic drug and that yelling is insufficient reason to prescribe Risperdal ALJ noted that Resident had 3 physicians, including 2 psychiatrists Resident 14 s physicians analyzed, reduced, restored, and increased the dose of Risperdal. In finding that the resident was combative and a danger to herself and others, the ALJ held there is no evidence that Resident 14 was given any unnecessary drugs. Nonpharmacological Behavior Management Strategies for Staff Consistent Assignment Determine the cause of anxiety (noise, constipation, dehydration, hungry), remove cause to extent practical Leave if they are escalating Allow resident to call to a family or friend Switch TV or radio to a calming show Music therapy Pet therapy Communication Techniques for Caregivers Speak slowly Get resident s attention Listen Use a calm tone Don't argue Repeat, rephrase and clarify in simple terms Smile and laugh Orient to task Ask yes or no questions Use touch Reinforce positive responses and positive behavior Affirmations Use appropriate humor Be mindful of language 16

35 11/7/2013 Strategies to Reduce Risk Within the first year in which a resident is admitted on an antipsychotic medication or after the facility has initiated an antipsychotic medication, the facility must attempt a GDR in two separate quarters (with at least one month between the attempts), unless clinically contraindicated. After the first year, a GDR must be attempted annually, unless clinically contraindicated. For any individual who is receiving an antipsychotic medication to treat behavioral symptoms related to dementia, the GDR may be considered clinically contraindicated if: 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. Strategies to Reduce Risk For any individual who is receiving an antipsychotic medication to treat a psychiatric disorder other than behavioral symptoms related to dementia (for example, schizophrenia, bipolar mania, or depression with psychotic features), the GDR may be considered contraindicated, if: 1. 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 2. 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. Strategies to Reduce Risk QAPI Corporate Compliance Program Tracking of antipsychotics QA committee generates report to medical director (drugs, dose, indications, dx) Even though CMS has not issued regulations for QAPI, compliance programs yet, it expects facilities to have operationalized both 17

36 11/7/2013 Compare Performance to Peers Physicians respond to data comparing them to peers Compare to respected peers or top performers List all MD names & performance (e.g., prescribing rates) List all the physician s residents who are triggering the performance measure Acknowledge residents who have a valid reason for being on the list. Source: Dr. David Gifford, MD, MPH, Sr VP Quality & Regulatory Affairs, AHCA American Psychiatric Association (Choosing Wisely Campaign) Don t prescribe antipsychotic medications to patients for any indication without appropriate initial evaluation and appropriate ongoing monitoring Don t routinely prescribe two or more antipsychotic medications concurrently Don t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia Don t routinely prescribe antipsychotic medications as a first-line intervention for insomnia in adults Don t routinely prescribe antipsychotic medications as a first-line intervention for children and adolescents for any diagnosis other than psychotic disorders September 20, 2013 APA News Release 18

37 11/7/2013 Avoiding F329 Deficiencies (unnecessary medications) Select meds based on risk/benefit analysis Individualized evaluation Appropriate dose and duration Monitor efficacy & side effects Document diagnosis, other interventions, etc. Promote non-pharmacologic interventions F329 Common Pitfalls Lack of documented indication for med Lack of diagnosis Lack of charting outcomes Not monitoring for side effects Lack of recognizing adverse effects Not making appropriate dose changes F329 Common Pitfalls Lack of resident/family awareness of high risk meds (informed consent) Not attempting/documenting non-pharmacological alternatives tried before ordering meds Not acknowledging drug-drug interactions Not stopping meds when no longer needed Failure to do GDR 19

38 11/7/2013 Resources AMDA Clinical Practice Guidelines National Partnership to Improve Dementia Care CMS S & C Memo NH (May 24, 2013) Advancing Excellence in America s Nursing Homes Gitlin LN, Kales HC, Lyketsos CG. Nonpharmacologic Management of Behavioral Symptoms in Dementia. JAMA 2012; 308(19): Resources Ray WA, Chung CP, Murray KT, et al: Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med 2009; 360: Schneider LS, Dagerman K, Insel PS: Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. American Journal of Geriatric Psychiatry : Rochon P, Normand S, Gomes T et al. Antipsychotic therapy and shortterm serious events in older adults with dementia. Arch Intern Med 2008; 168: Huybrechts KF, Gerhard T, Crystal S, Olfson M, Avorn J, Levin R, Lucas JA, Schneeweiss S. Differential risk of death in older residents in nursing homes prescribed specific antipsychotic drugs: population based cohort study. BMJ Feb 23; 344:e

39 11/7/2013 Resources Questions? Alan C. Horowitz, Esq. Arnall Golden Gregory Atlanta, GA (404)

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42 TO DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C Baltimore, Maryland Center for Clinical Standards and Quality /Survey & Certification Group DATE: May 24, 2013 Ref: S&C: NH TO: FROM: SUBJECT: State Survey Agency Directors Director Survey and Certification Group Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309 Quality of Care and F329 Unnecessary Drugs Memorandum Summary Guidance This memo conveys clarification to Appendices P and PP related to nursing home residents with dementia and unnecessary drug use. Training - Mandatory surveyor trainings are available online at National Partnership On March 29, 2012, the Centers for Medicare & Medicaid Services (CMS) launched the National Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Drug Use in Nursing Homes (this is now referred to as the Partnership to Improve Dementia Care in Nursing Homes). The goal of this Partnership is to optimize the quality of life and function of residents in America s nursing homes by improving approaches to meeting the health, psychosocial and behavioral health needs of all residents, especially those with dementia. The CMS has joined with various stakeholders to improve dementia care in nursing homes. We are doing several things to support this work, including producing surveyor training videos as well as updating Appendix P and Appendix PP of the State Operations Manual (SOM). Individualized, person-centered approaches may help reduce potentially distressing or harmful behaviors and promote improved functional abilities and quality of life for residents. It has been a common practice to use various types of psychopharmacological medications in nursing homes to try to address behaviors without first determining whether there is a medical, physical, functional, psychological, emotional, psychiatric, social or environmental cause of the behaviors. Medications may be effective when they are used appropriately to address significant, specific underlying medical or psychiatric causes, or new or worsening behavioral symptoms. However, medications may be ineffective and are likely to cause harm -if given

43 Page 2 State Survey Agency Directors without a clinical indication. All interventions, including medications, need to be monitored for efficacy, risks, benefits and harm. The problematic use of medications, such as antipsychotics, is part of a larger, growing concern. This concern is that nursing homes and other settings (i.e. hospitals, ambulatory care) may use medications as a quick fix for behavioral symptoms or as a substitute for a holistic approach that involves a thorough assessment of underlying causes of behaviors and individualized, person-centered interventions. Antipsychotic medications are frequently prescribed for residents with dementia who have behavioral or psychological symptoms of dementia (BPSD). 1,2 The term BPSD is used to describe behavior or other symptoms in individuals with dementia that cannot be attributed to a specific medical or psychiatric cause. When antipsychotic medications are used without an adequate rationale, or for the purpose of limiting or controlling behavior of an unidentified cause, there is little chance that they will be effective. In addition, they commonly cause complications such as movement disorders, falls, hip fractures, cerebrovascular adverse events (cerebrovascular accidents and transient ischemic events) and increased risk of death. 3,4,5,6 The Food & Drug Administration (FDA) Black Box Warnings Regarding Atypical Antipsychotics in Dementia provides, Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. 7 Dementia Care Principles Fundamental principles of care for a resident with dementia include an interdisciplinary approach that focuses on the needs of the resident as well as the needs of the other residents in the nursing home. Sections 1819 and 1919 of the Social Security Act (the Act) and current regulations already require a number of essential elements to be in place in order for facilities to be in compliance with federal requirements on quality of care and quality of life. This revised CMS guidance and surveyor training highlight and re-emphasize a number of those key principles, including: 1. Person Centered Care. CMS requires nursing homes to provide a supportive environment that promotes comfort and recognizes individual needs and preferences. 2. Quality and Quantity of Staff. The nursing home must provide staff, both in terms of quantity (direct care as well as supervisory staff) and quality to meet the needs of the residents as determined by resident assessments and individual plans of care. 3. Thorough Evaluation of New or Worsening Behaviors. Residents who exhibit new or worsening BPSD should have an evaluation by the interdisciplinary team, including the physician, in order to identify and address treatable medical, physical, emotional, psychiatric, psychological, functional, social, and environmental factors that may be contributing to behaviors.

44 Page 3 State Survey Agency Directors 4. Individualized Approaches to Care. Current guidelines from the United States, United Kingdom, Canada and other countries recommend use of individualized approaches as a first line intervention (except in documented emergency situations or if clinically contraindicated) for BPSD Utilizing a consistent process that focuses on a resident s individual needs and tries to understand behavior as a form of communication may help to reduce behavioral expressions of distress in some residents. 5. Critical Thinking Related to Antipsychotic Drug Use. In certain cases, residents may benefit from the use of medications. The resident should only be given medication if clinically indicated and as necessary to treat a specific condition and target symptoms as diagnosed and documented in the record. Residents who use antipsychotic drugs must receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort discontinue these drugs. NOTE: If during a survey, the team identifies a concern that an antipsychotic medication may potentially be administered for discipline, convenience and not being used to treat a medical symptom, the survey team should review F (a) Right to be Free From Chemical Restraints. 6. Interviews with Prescribers. None of the guidance to surveyors should be construed as evaluating the practice of medicine. Surveyors are instructed to evaluate the process of care. Surveyors interview the attending physician or other primary care provider (NP, PA), behavioral health specialist, pharmacist and other team members to better understand the reasons for using a psychopharmacological agent or any other interventions for a specific resident. 7. Engagement of Resident and/or Representative in Decision-Making. In order to ensure judicious use of psychopharmacological medications, residents (to the extent possible) and/or family or resident representatives must be involved in the discussion of potential approaches to address behavioral symptoms. These discussions with the resident and/or family or representative should be documented in the medical record. Guidance Updates and Surveyor Training 1. Surveyor training videos Through work with our partners, CMS has developed a series of interactive training sessions around behavioral health and dementia care. Materials currently available to surveyors may be accessed on the surveyor training website at: We have made available three mandatory surveyor trainings (see S&C memo ALL). The first training provides an overview of dementia care and potential approaches to addressing behavioral distress. The second training walks surveyors through portions of an annual survey and focuses on the evaluation of one resident with dementia. These two trainings are currently available on the surveyor training website. A third training video is under development that will provide a review of the revised interpretive guidance at F309 and changes to Table 1 for antipsychotic medications at F329. This final training will present case studies and discuss how

45 Page 4 State Survey Agency Directors to identify potential F Tags and determine severity for non-compliance related to care of a resident with dementia. 2. Updates to Appendix P (Attachment A) include: Changes to the resident sampling process for the traditional survey (changes to QIS were included in the recent release). The change is intended to ensure that the survey sample includes an adequate number of residents with dementia who are receiving an antipsychotic medication. See Attachment A. 3. Updates to Appendix PP (Attachment B) include: A new section of interpretive guidance at F309 related to the review of care and services for a resident with dementia; Revisions to the antipsychotic medication section of Table 1 at F329; New severity example at the end of the interpretive guidance at F329 (Unnecessary drugs); A surveyor checklist that may be used in either the traditional or QIS process (modeled after the CE pathways) is also provided (Attachment C). This checklist is not part of the SOM. References: 1. Briesacher BA, Limcangco MR, Simoni-Wastila L et al. The quality of antipsychotic drug prescribing in nursing homes. Arch Intern Med 2005;165(June): Levinson DR. Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents. Department of Health and Human Services Office of Inspector General Report (OEI ) accessed at 3. Schneider L, Tariot P, Dagerman K. Effectiveness of atypical antipsychotic drugs in residents with Alzheimer's disease. N Engl J Med 2006;355: Ray WA, Chung CP, Murray KT, et al: Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med 2009;360: Schneider LS, Dagerman K, Insel PS: Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. American Journal of Geriatric Psychiatry : Rochon P, Normand S, Gomes T et al. Antipsychotic therapy and short-term serious events in older adults with dementia. Arch Intern Med 2008;168: ers/drugsafetyinformationforheathcareprofessionals/publichealthadvisories/ucm htm