Making Sense of the Long Term Care Mega Rule: Unnecessary Drugs & Psychotropics. Session Objectives. January 2018

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1 Making Sense of the Long Term Care Mega Rule: Unnecessary Drugs & Psychotropics Bridget McCrate Protus, PharmD, MLIS, BCGP, CDP Director of Drug Information Optum Hospice Pharmacy Services Session Objectives Summarize LTC Requirements of Participation with focus on psychotropics medication Discuss impact on hospice care within LTC facilities Review patient care scenarios 2 All Rights Reserved 1

2 Providing Hospice Care in LTC Facilities About 40% of hospice care is provided for patients in nursing facilities 1 About 4% of LTC residents with Alzheimer s disease receive hospice care 2 LTC facilities operate under heavy regulation 1 NHPCO Facts & Figures, CDC FastStats Alzheimer s disease 3 Reform of Requirements for Long-Term Care AKA Mega Rule or RoP First major update to LTC regulations since CFR Parts 40, 431, 447, 482, 483, 48, 488, & CFR (d) Pharmacy Services Hospice care is fully integrated into regulatory & interpretive guidance No hospice exceptions 3 Federal Register, All Rights Reserved 2

3 Reform of Requirements for Long-Term Care State Operations Manual (SOM) Interpretive Guidance appendix PP Document written by CMS containing the regulations and guidelines that govern nursing facilities Used as the basis for the survey process to assist surveyors in evaluating compliance with CMS standards F tags & citing deficiencies Classification system to categorize sections of the SOM IG explaining the regulatory requirements Surveyors finding issues with compliance cite by the F tag 3 Federal Register, 2016 Mega Rule Implementation Phases 3 Phase 1 Phase 2 Phase 3 Effective: November 28, 2016 Final Rule effective date Planned implementation in 3 phases Regulatory language updates New reporting process for medication irregularities to the nursing home s medical director Facility must have P&P for Drug Regimen Review Effective: November 28, 2017 Revised SOM IG released Updated psychotropics definition All psychotropics held to 14d PRN with rationale & duration Antipsychotics 14d PRN limit, no renewal & resident evaluation before new PRN order QAPI, ABX, Med errors Effective: November 28, 2019 Requirements that need more time to implement Additional QAPI & ABX stewardship components Implementing trauma informed care Compliance & ethics program 4 LAO, All Rights Reserved 3

4 Reform of Requirements for Long-Term Care Phase 2 implementation Majority of Pharmacy Services components Title F Tag Old Tag Drug Regimen Review F76 F428 Unnecessary Drugs F77 F329 Psychotropic Drugs F78 F329 / F428 Medication Errors F79 F760 F332 F333 7 Regulation (CFR) versus Guidance (SOM) Regulation (F tag) Word Count (CFR v SOM) Drug Regimen Review (F76) CFR: 28 words SOM Interpretive Guidance for just these Unnecessary Drugs (F77) CFR: 80 words sections Psychotropic Drugs (F78) Medication Errors (F79/F760) CFR: 190 words CFR: 3 words Word Count Totals 90 words > 1,000 words All Rights Reserved 4

5 Regulation (CFR) versus Guidance (SOM IG) CFR wording is pretty sparse SOM IG provides the context and intent Standards of practice Patient centered care Resources and tools Must vs Should Must comply with the regulations, this is how you should do it Risk reduction Is there evidence to support the practice/treatment? Does the benefit outweigh the risk? Was the resident/family involved in the decision making? 9 Unnecessary Drugs (F77) All Rights Reserved

6 Unnecessary Drugs (F77) 1. Inadequate indications for use 2. Inadequate monitoring 3. Excessive dose 4. Excessive duration. Adverse consequences Permission given by or a request made by the resident and/or representative does not serve as a sole justification for the medication itself. 11 Unnecessary Drugs (F77) inadequate indications for use failure to provide a clinically pertinent rationale, failure to attempt non pharmacological approaches, failure to consider other factors (infection, dehydration) that may be contributing to the resident s expression of distress Example: Mrs. Jones is prescribed Ditropan (oxybutynin) for urinary incontinence Other causes ruled out before prescribing?» Side effects from other drugs, infection, ambulation difficulty Assistance with toileting attempted? 12 All Rights Reserved 6

7 Unnecessary Drugs (F77) inadequate monitoring failure to monitor response to medication, lack of progression towards therapeutic goal, failure to consider worsening symptoms may be related to a medication, failure to monitor effectiveness of non pharmacological approaches before prescribing medications Example: Mrs. Jones is prescribed Ditropan (oxybutynin) for urinary incontinence If oxybutynin started, did the incontinence improve? Is Mrs. Jones satisfied with the improvement? Is Mrs. Jones experiencing any side effects (dry mouth, constipation, confusion)? How did Mrs. Jones respond to toileting assistance? 13 Unnecessary Drugs (F77) excessive dose giving any amount of medication that exceeds manufacturer s recommendations or clinical practice guidelines, or standards of practice without documented clinically pertinent rationale, failure to consider continued necessity or possibility to taper the medication Example: Mrs. Jones is prescribed Ditropan (oxybutynin) for urinary incontinence Recommended dose is mg BID to TID, lower for elderly» Why is Mrs. Jones dose 10mg Q6AM and Q6PM?» Would a lower, more frequent dosing strategy be better? 14 All Rights Reserved 7

8 Unnecessary Drugs (F77) excessive duration continuation of a medication after desired therapeutic goal is achieved without evaluating if there is a continued need for the medication Example: Mrs. Jones is prescribed Ditropan (oxybutynin) for urinary incontinence How long has she been taking this medication? Should she continue oxybutynin forever? 1 Unnecessary Drugs (F77) adverse consequences failure to act upon or report presence of adverse consequences, failure to monitor for presence of adverse consequences (especially high risk medications) Example: Mrs. Jones is prescribed Ditropan (oxybutynin) for urinary incontinence Is Mrs. Jones experiencing any side effects (dry mouth, constipation, confusion)?» If yes, was a dose reduction attempted?» If yes, why is she still taking the medication? Would another medication be as effective, but safer for Mrs. Jones? 16 All Rights Reserved 8

9 Psychotropic Medications (F78) Psychotropic Medications (F78) any drug that affects brain activities associated with mental processes and behavior includes, but is not limited to*, 4 broad categories: Antidepressants Anxiolytics Hypnotics Antipsychotics (Other*) 18 All Rights Reserved 9

10 Psychotropic Medications (F78) 19 Psychotropic Medications: PRN Requirements Category Examples* PRN Requirements Antidepressants sertraline (Zoloft) citalopram (Celexa) duloxetine (Cymbalta) amitriptyline (Elavil) nortriptyline (Pamelor) trazodone (Desyrel) Anxiolytics Hypnotics alprazolam (Xanax) lorazepam (Ativan) diazepam (Valium) hydroxyzine (Atarax) clorazepate (Tranxene) zolpidem (Ambien) temazepam (Restoril) suvorexant (Belsomra) eszopiclone (Lunesta), phenobarbital 14 day limit on PRN orders PRN order may be extended if the attending physician or prescriber believes it is appropriate to extend the order Rationale for extended time period must be documented in the medical record and must indicate a specific duration *Note: the Interpretive Guidelines do not provide specific medication examples for each category of psychotropics; medications above are commonly prescribed examples. This is not intended to be a comprehensive list. 20 All Rights Reserved 10

11 Antipsychotics & PRN Requirements Category Examples* PRN Requirements Antipsychotics haloperidol (Haldol) 14 day limit on PRN orders quetiapine (Seroquel) olanzapine (Zyprexa) ziprasidone (Geodon) aripiprazole (Abilify) prochlorperazine (Compazine) chlorpromazine (Thorazine) If attending physician or prescriber wants to write a new order for the PRN antipsychotic, the attending physician or prescriber must evaluate the resident to determine if the order for a PRN antipsychotic is appropriate *Note: the Interpretive Guidelines do not provide specific medication examples for each category of psychotropics; medications above are commonly prescribed examples. This is not intended to be a comprehensive list. 21 Additional Antipsychotic PRN Info As part of the evaluation, the attending physician or prescribing practitioner should, at a minimum, determine and document the following in the resident s medical record: Is the antipsychotic medication still needed on a PRN basis? What is the benefit of the medication to the resident? Have the resident s expressions or indications of distress improved as a result of the PRN medication? Note: Report of the resident s condition from facility staff to the attending physician or prescribing practitioner does not constitute an evaluation. 22 All Rights Reserved 11

12 The Big Other any drug that affects brain activities associated with mental processes and behavior includes, but is not limited to Examples of Other CNS Active Medications Antihistamines Diphenhydramine (Benadryl), dimenhydrinate (Dramamine), cyproheptadine (Periactin) Anti epileptic drugs Anti Parkinson s drugs Muscle relaxants Newer Non Antipsychotics Gabapentin (Neurontin), valproate (Depakote), topiramate (Topamax), pregabalin (Lyrica) Ropinirole (Requip), pramipexole (Mirapex), amantadine Tizanidine (Zanaflex), cyclobenzaprine (Flexeril), carisoprodol (Soma) Pimavanserin (Nuplazid), Quinidine DXM (Neudexta) 23 Scenario 1 Psychotropics Mrs Jones Med List Sertraline (Zoloft) 100mg PO daily for depression GDR required within the first year after resident is admitted on a psychotropic or after initiation of a psychotropic, the facility must attempt a GDR in two separate quarters (at least one month between attempts). After the first year, GDR must be attempted annually, unless clinically contraindicated. Stepwise tapering to see if symptoms can be managed by a lower dose or med can be d/c d Clinically contraindicated target symptoms returned or worsened after GDR + physician documents why additional GDR attempts might impair function or increase distress Non pharm, adequate monitoring for effectiveness and adverse consequences Sertraline 100mg PO daily for depression Lorazepam 0.mg PO Q6H PRN for anxiety Quetiapine 0mg PO Q12H for dementia related behaviors Quetiapine 0mg PO Q6H PRN for agitation 24 All Rights Reserved 12

13 Scenario 1 Psychotropics Mrs Jones Med List Lorazepam (Ativan) 0.mg PO Q6H PRN anxiety Prescriber must document diagnosed condition and indication for PRN Time limited to 14 day PRN from initiation Order can be extended past initial 14 day period Prescriber must document rationale for extending PRN use past 14 days and indicate specific duration Sertraline 100mg PO daily for depression Lorazepam 0.mg PO Q6H PRN for anxiety Quetiapine 0mg PO Q12H for dementia related behaviors Quetiapine 0mg PO Q6H PRN for agitation 2 Scenario 2 Antipsychotics Mrs Jones Med List Quetiapine (Seroquel) 0mg PO Q12H for dementia related behaviors (harm to self/others) GDR required within the first year after resident is admitted on a psychotropic or after initiation of a psychotropic, the facility must attempt a GDR in two separate quarters (at least one month between attempts). After the first year, GDR must be attempted annually, unless clinically contraindicated. Stepwise tapering to see if symptoms can be managed by a lower dose or med can be d/c d Clinically contraindicated target symptoms returned or worsened after GDR + physician documents why additional GDR attempts might impair function or increase distress Multiple non pharm interventions in care plan, adequate monitoring for effectiveness and adverse consequences Sertraline 100mg PO daily for depression Lorazepam 0.mg PO Q6H PRN for anxiety Quetiapine 0mg PO Q12H for dementia related behaviors Quetiapine 0mg PO Q6H PRN for agitation 26 All Rights Reserved 13

14 Scenario 2 Antipsychotics Mrs Jones Med List Quetiapine (Seroquel) 0mg PO Q6H PRN for agitation* Prescriber must document diagnosed condition and indication for PRN Time limited to 14 day PRN from initiation No new order for PRN quetiapine unless prescriber evaluates Mrs Jones to determine if a new quetiapine needed on PRN basis Benefit of quetiapine to Mrs Jones Has Mrs Jones distress improved as a result of PRN quetiapine *agitation is not sufficient as diagnosis, must be specific Sertraline 100mg PO daily for depression Lorazepam 0.mg PO Q6H PRN for anxiety Quetiapine 0mg PO Q12H for dementia related behaviors Quetiapine 0mg PO Q6H PRN for agitation 27 Scenario 3 What About Seizures? Mr Smith Med List Levetiracetam (Keppra) 1000mg PO Q12H Lorazepam 2mg PR Q1mins PRN breakthrough seizure, MRx3, max dose 8mg Both orders are for psychotropics but both have clear clinical indication GDR not typically indicated per best practice & clinical need for levetiracetam to control Mr Smith s seizures* Lorazepam PRN orders to stop acute seizure also has clinical need for use extended past 14 days and prescriber should document expected duration of need (6 months for hospice patient is reasonable) *still need to consider if this is correct dose & when was last documented seizure Levetiracetam 1000mg PO Q 12H Lorazepam 2mg PR Q 1 minutes PRN breakthrough seizure, may repeat 3 times, max dose 8mg 28 All Rights Reserved 14

15 Challenge or Opportunity? Opportunity to build relationships Change in practice will be required Don t push to work around the regs Innovate to work within the regs Develop a hospice team member as LTC liaison 29 Recently Announced Enforcement Delay Enforcement postponed until May 2019 for some components of Phase 2 (includes F78) Surveyors will still cite for noncompliance 18 month moratorium to learn and adapt 30 All Rights Reserved 1

16 Key Points Mega Rule is much more than psychotropic restrictions No hospice exceptions, hospice is fully integrated No published lists of target meds Implementation of Phase 2 just started on November 28, 2017, expect to see interpretations evolve over time 31 References 1. National Hospice & Paliative Care Organization (NHPCO). NHPCO Facts & Figures: Hospice Care in America, 2016 edition. Alexandria, VA:NHPCO; September Accessed December 12, National Center for Health Statistics. FastStats Alzheimer s disease. October 6, Atlanta, GA:CDC/National Center for Health Statistics. Accessed December 12, Centers for Medicare & Medicaid Services (CMS). Medicare and Medicaid Programs; reform of requirements for long term care facilities. Federal Register 2016;81(192): Available at /pdf/ pdf Accessed October 19, LeadingAge Ohio. Medicare and Medicaid Programs; Reform of requirements for long erm care facilities. Final Rule summary. Available at Accessed December 13, Centers for Medicare & Medicaid Services (CMS). Publication State Operations Manual (SOM) Appendix PP Guidance to Surveyors for Long Term Care Facilities. Rev 173, Available at: and Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf Accessed December 13, Centers for Medicare & Medicaid Services (CMS). Survey & Certification. Guidance to Laws & Regulations. Nursing Homes. Enrollment and Certification/GuidanceforLawsAndRegulations/Nursing Homes.html Accessed October 19, Requirements for States and Long Term Care Facilities. Subpart B Requirements for long term care facilities. Pharmacy Services. 42 CFR Accessed December 12, All Rights Reserved 16

17 Thank You! Bridget McCrate Protus, PharmD, MLIS, BCGP, CDP Director of Drug Information Hospice Pharmacy Services All Rights Reserved 17