3/6/2017. CMS nursing home requirements have not been comprehensively updated since 1991 despite significant changes in the industry.

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Debra Brown, PharmD Pharmaceutical Consultant II Specialist Licensing and Certification QCHF/CAHF Spring Legislative Conference

Drug Regimen Review requirements and phasic implementation Define psychotropic drug and Phase 2 impact Identify the potential

pharmacist/phase 2 QAPI plan 2 CMS nursing home requirements have not been comprehensively updated since 1991 despite significant

1 Debra Brown, PharmD Pharmaceutical Consultant II Specialist Licensing and Certification QCHF/CAHF Spring Legislative Conference March Describe impact of 2016 CMS Final Rule on SNF pharmacy services Summarize F 428 revisions with regard to federal Drug Regimen Review requirements and phasic implementation Define psychotropic drug and Phase 2 impact Identify the potential role of the consultant pharmacist in supporting SNF antibiotic stewardship Discuss the potential role of the consultant pharmacist/phase 2 QAPI plan 2 CMS nursing home requirements have not been comprehensively updated since 1991 despite significant changes in the industry. The proposed rule received over 9800 public comments, resulting in a number of revisions to the proposed requirements. 3 1

2 Substantial changes in the service and delivery of care Significant innovations in resident care Quality assessment practices Residents more diverse Clinically complex 4 Person-Centered Care Quality Facility Assessment, Competency-Based Approach Alignment with HHS priorities Comprehensive Review and Modernization Implementation of Legislation 5 Phase 1: existing requirements Began: Nov. 28, 2016 Phase 2: Includes all Phase 1 & Phase 2 requirements Begins: Nov 28, 2017 Phase 3: Includes all Phase 1 & Phase 2 requirements & those that need more time Begins: Nov. 28,

3 Definitions Resident Rights Admission, transfer, & discharge Res. Behavior & facility practices Quality of Life Resident Assessments Quality of care Nursing Services Dietary Services Physician Services Specialized rehab Dental Pharmacy Services Infection Control Physical Environment Administration 7 Definitions Resident Rights Freedom from Abuse, neglect & exploitation Admission, transfer, & discharge Resident Assessments Comprehensive Person Centered care Planning Quality of Life Quality of care Physician Services Nursing Services Behavioral Health Pharmacy Services Lab, Radiology & other Dental Food & Nutrition Services Specialized rehab Administration QAA/QAPI Infection Control Compliance & Ethics 2017 Physical Environment Training Requirements 8 Protections continued (freedom from unnecessary medications and medication errors, medication storage requirements) Phase 1 Drug regimen review and reporting Phase 2: review of medical record Phase 2: definition of a psychotropic medication PRN usage of psychotropic medication 14 days difference between psychotropic and antipsychotic medications 9 3

F425: Procedures and Service Consultation F428: Drug Regimen Review F329: Unnecessary Drugs and

Biologicals 483.45(a) and (b) 483.45(c) 483.45(d) and (e) 483.45(f) (1) (2) 483.

different regulatory sections If the F tag WAS a SQC tag before Nov.

4 F425: Procedures and Service Consultation F428: Drug Regimen Review F329: Unnecessary Drugs and (Phase 2) Psychotropic Drugs F332/333 Medication Errors F431: Labeling and Storage of Drugs and Biologicals (a) and (b) (c) (d) and (e) (f) (1) (2) (g) and (h) 10 No longer limited to the Big Three SQC can now potentially be found in 8 different regulatory sections If the F tag WAS a SQC tag before Nov. 28, 2016; It remains a SQC tag The criteria for SQC has NOT changed Source: Title 42 Chapter IV Subchapter G Part 488 Subpart E

Each resident s drug regimen must be free from unnecessary drugs.

monitoring; or (4) Without adequate indications for its use; or (5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued;

13 Based on comprehensive resident review, the facility must ensure that -- (1) Residents are not given psychotropic drugs unless necessary to treat a specific

discontinue these drugs; (3) Residents do not receive PRN psychotropic drugs unless necessary to treat a specific documented condition; and (4) PRN psychotropic drugs

5 Each resident s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used -- (1) In excessive dose (including duplicate drug therapy); or (2) For excessive duration; or (3) Without adequate monitoring; or (4) Without adequate indications for its use; or (5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section. 13 Based on comprehensive resident review, the facility must ensure that -- (1) Residents are not given psychotropic drugs unless necessary to treat a specific documented condition; (2) Residents who use psychotropic drugs receive GDRs and behavioral interventions (unless clinically contraindicated) in an effort to discontinue these drugs; (3) Residents do not receive PRN psychotropic drugs unless necessary to treat a specific documented condition; and (4) PRN psychotropic drugs are limited to 14 days if beyond 14 days prescriber documents rationale. (5) PRN antipsychotic orders are limited to 14 days and cannot be renewed unless the prescriber evaluates the resident for appropriateness of the medication. 14 Definition (CMS Final Rule dated 10/4/16): Any drug that affects brain activities associated with mental processes and behavior 15 5

6 Antipsychotics Antidepressants Anxiolytics Sedative-hypnotics CMS has the authority to add other drugs to the definition through sub-regulatory guidance. 16 Identified, documented clinical rationale for administering a medication Based on assessment of the resident s condition + therapeutic goals Consistent with Manufacturer s recommendations and/or clinical practice guidelines Clinical standards of practice Medication references Clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals Source: Appendix PP, F Were other potential causes for the symptoms ruled out? Were physical and/or psychosocial signs, symptoms persistent or significant enough to warrant therapy? Were non-pharmacological interventions tried? Was the medication clinically indicated to manage the symptom or condition? and Does the intended or actual benefit justify the potential risk(s) or adverse consequences associated with the medication, dose, and duration?

7 Within the first year a resident is admitted on an antipsychotic or after facility has initiated: Facility must attempt GDR in two separate quarters (with at least one month between attempts) unless clinically contraindicated. After the first year: GDR must be attempted annually, unless clinically contraindicated. 19 For behavioral symptoms related to dementia: Resident s target symptoms returned/worsened after the most recent GDR attempt within the facility; and The physician has documented the clinical rationale for why any additional attempt at reduction would likely impair the resident s function or increase distressed behavior. 20 For psychiatric disorder other than dementia: Continued use is in accordance with relevant current standards of practice and the physician has documented why attempted reduction would be likely to impair function or cause psychiatric instability by exacerbating an underlying psychiatric disorder; or Resident s target symptoms returned/worsened after the most recent GDR attempt within the facility and the physician has documented the clinical rationale for why any additional reduction attempts would be likely to impair the resident s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder. 21 7

8 For as long as resident receives routinely and beyond manufacturer s recommendations for duration of use: Facility should attempt to taper quarterly unless clinically contraindicated. Clinically contraindicated means: Continued use is in accordance with relevant current SOP and the physician has documented clinical rationale for why attempted reduction would be likely to impair function/cause psychiatric instability by exacerbating an underlying medical/psychiatric disorder; or Resident s target symptoms returned/worsened after the most recent taper attempt and the physician has documented clinical rationale why any additional attempt would impair the resident s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder. 22 Within the first year a resident is admitted on a psychopharmacological medication or after facility has initiated: Facility should attempt to taper during at least two separate quarters (with at least one month between attempts) unless clinically contraindicated. After the first year: Tapering should be attempted annually, unless clinically contraindicated. 23 The tapering may be considered clinically contraindicated if: The continued use is in accordance with relevant current SOP 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 medical or psychiatric disorder; or The resident s target symptoms returned or worsened after the most recent attempt at tapering the dose 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. 24 8

9 Utilized during Task 5C resident review In conjunction with Assessment of Drug Therapies Links unnecessary medications with the medication regimen review Identifies s/sx that may be medicationrelated adverse effects (AEs) How did facility assess need + care plan resident medications? Did pharmacist identify actual/potential medication AEs as irregularity during MRR? 25 The regulatory language (1)The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist. (2) This review must include a review of the resident s medical chart (Section will be implemented in Phase 2 beginning 11/28/17) (3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Antipsychotic; (ii) Antidepressant; (iii) Anti-anxiety; and (iv) Hypnotic. 26 (4) The pharmacist must report any irregularities to the attending physician and the facility s medical director and director of nursing, and these reports must be acted upon. 27 9

10 (4)(i) Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug. (4)(ii) Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician and the facility s medical director and director of nursing and lists, at a minimum, the resident s name, the relevant drug, and the irregularity the pharmacist identified. 28 (4)(iii) The attending physician must document in the resident s medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is no change in the medication, the attending physician should document his or her rationale in the resident s medical record. 29 (5) The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, but are not limited to, time frames for the different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident

11 Chaptered October 2015 Adds Section to Health and Safety Code SNFs shall adopt and implement antimicrobial stewardship policy by 01/01/17 Consistent with guidelines developed by CDC, CMS, SHEA or similar recognized organizations 31 Title 22, CCR, Div. 5, Chapter 3, Article 5, (a): infection control committee required (c): committee composition/function Physician, nursing, administration, dietetic, pharmaceutical, activities, housekeeping, laundry, maintenance Establishing, reviewing, monitoring and approving policies and procedures for investigating, controlling and preventing infections in the facility Maintaining, reviewing and reporting statistics of the number, types, sources and locations of infections within the facility 32 Current requirements Phase (a) Infection Prevention and Control Program The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements (3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use (Phase 2 beginning 11/28/17) 33 11

Pharmacy-driven Interventions Review of antibiotic prescribing and use Review of microbiology culture results

appropriate timing of antibiotics Source: CDC: Core Elements of Antibiotic Stewardship for Nursing Homes/Appendix

reports related to process and use measures Antibiotic starts report trends/concerns Reports on pertinent

12 Pharmacy-driven Interventions Review of antibiotic prescribing and use Review of microbiology culture results Renal antibiotic dosing Anticipating antibiotic interactions with other medications (such as warfarin) Ensuring appropriate timing of antibiotics Source: CDC: Core Elements of Antibiotic Stewardship for Nursing Homes/Appendix A 35 Quarterly QA/infection control committee meetings Consultant Pharmacist participates in discussion of reports related to process and use measures Antibiotic starts report trends/concerns Reports on pertinent findings from Medication Regimen Reviews Identify target goals and opportunities for improvement, and evaluate progress over time 36 12

13 Phase 1: Existing QAA Committee requirements (minimum committee composition, frequency of meetings, reports to governing body) Phase 2 (11/28/17) Present QAPI Plan to State Survey Agency Phase 3 (11/28/19) Full implementation of QAPI and integration of Infection Preventionist (ICPO) QAPI Goals Scope Guidelines for Governance and Leadership Feedback, Data Systems and Monitoring Guidelines for Performance Improvement Projects (PIPs) Systematic Analysis and Systemic Action Communications Evaluation Establishment of Plan Source: Certification/QAPI/downloads/QAPIPlan.pdf. Comprehensive and ongoing Data driven Reflect the complexities, unique care and services that the facility provides Focus on indicators of the outcomes of care and quality of life Program may include but not limited to systems and reports demonstrating: Systemic identification, reporting, investigation, analysis and prevention of adverse events; and Documentation demonstrating the development, implementation, and evaluation of corrective 39 actions or performance improvement activities. 13

14 Must include: Feedback (from direct care staff, other staff, residents, and resident representatives Data collection systems Opportunities for improvement Effective systems to identify, collect and use data from all departments to identify problems that are high risk, high volume or problem-prone Facility development, monitoring and evaluation of performance indicators Adverse event monitoring/methods to identify, report, track, investigate, analyze and use data to prevent adverse events 40 Must include: Facility must set priorities for PI activities that focus on high risk, high volume, or problem-prone areas of care Must track medical errors and adverse resident events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the facility. Number/frequency of PI projects conducted by the facility must reflect the scope and complexity of the facility s services and available resources. 41 Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries (OEI ) One of three Medicare beneficiaries experienced an adverse or temporary harm event in their first 35 days of a SNF stay. 37 percent of adverse events were related to medication. OIG determined many of these events were likely or clearly preventable

15 Issued July 17, 2015 Focused survey on Medication Safety Systems CMS collaborated with AHRQ and OIG to develop draft Adverse Drug Event Trigger Tool To assist surveyors when investigating adverse events (including systems for prevention) and for providers (risk management tool) Available on CMS Nursing Home QAPI website 43 Adverse event: An untoward, undesirable, and usually unanticipated event that causes death, serious injury, harm or the risk thereof. Adverse Drug Event: An injury resulting from drug-related medical interventions. Adverse Drug Reaction: Harm directly caused by a drug at normal doses. Source: Certification/QAPI/downloads/adverse-drug-event-trigger-tool.pdf. 44 Adverse Drug Event Trigger Tool: Certification/QAPI/downloads/adverse-drug-event-trigger-tool.pdf Surveyor tool not mandated for regulatory compliance nor does its use ensure regulatory compliance! Identifies high risk medications associated with adverse drug events Including risk factors, signs/symptoms indicating potential ADE, clinical intervention triggers and surveyor probes 45 15

Medication Regimen Review data Quality of Care Indicators (examples)

Committee that are high risk or associated with adverse events Antibiotic

California Department of Public Health Center for Healthcare

16 Medication Regimen Review data Quality of Care Indicators (examples) Medication Errors Adverse Drug Events Any medications identified by the QA Committee that are high risk or associated with adverse events Antibiotic use/stewardship 46 Q&A Debra Brown, PharmD, Pharmaceutical Consultant II California Department of Public Health Center for Healthcare Quality/Licensing and Certification Program Phone: (916)

Medication Related Changes Phase 1&2

Medication Related Changes Phase 1&2 Medicare and Medicaid Programs Reform of Requirements for Long-Term Care Facilities Published January 23, 2017 Medication- Related Changes* Changes will be implemented