3/6/2017
Debra Brown, PharmD
Pharmaceutical Consultant II Specialist
Licensing and Certification
QCHF/CAHF Spring Legislative Conference
March 2017
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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
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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.
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Substantial changes in the service and
delivery of care
Significant innovations in resident care
Quality assessment practices
Residents more diverse
Clinically complex
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Person-Centered Care
Quality
Facility Assessment, Competency-Based
Approach
Alignment with HHS priorities
Comprehensive Review and Modernization
Implementation of Legislation
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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, 2019
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Definitions
Resident Rights
Admission, transfer, &
discharge
Res. Behavior & facility
practices
Quality of Life
Resident Assessments
Quality of care
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Nursing Services
Dietary Services
Physician Services
Specialized rehab
Dental
Pharmacy Services
Infection Control
Physical Environment
Administration
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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
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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
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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
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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
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§483.45(a) and (b)
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§483.45(c)
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§483.45(d) and (e)
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§483.45(f) (1) – (2)
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§483.45(g) and (h)
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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 → §488.301
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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.
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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.
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Definition (CMS Final Rule dated 10/4/16):
“Any drug that affects brain activities associated with
mental processes and behavior”
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Antipsychotics
Antidepressants
Anxiolytics
Sedative-hypnotics
CMS has the authority to add other drugs to
the definition through sub-regulatory
guidance.
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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, F329
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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?
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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.
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After the first year:
◦ GDR must be attempted annually, unless clinically
contraindicated.
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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.
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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.
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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
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psychiatric disorder.
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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.
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After the first year:
◦ Tapering should be attempted annually, unless
clinically contraindicated.
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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.
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Utilized during Task 5C resident review
◦ In conjunction with Assessment of Drug
Therapies
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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?
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Did pharmacist identify actual/potential
medication AEs as irregularity during MRR?
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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.
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(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.
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(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.
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(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.
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(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.
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Chaptered October 2015
Adds Section 1275.4 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
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Title 22, CCR, Div. 5, Chapter 3, Article 5, §72525
(a): infection control committee required
§ 72525 (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
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Current requirements – Phase 1
483.80(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)
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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
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Source: CDC: Core Elements of Antibiotic Stewardship for
Nursing Homes/Appendix A
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Quarterly QA/infection control
committee meetings
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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
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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)
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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: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/QAPI/downloads/QAPIPlan.pdf.
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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
actions or performance improvement activities.
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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
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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.
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Adverse Events in Skilled Nursing Facilities:
National Incidence Among Medicare
Beneficiaries (OEI-06-11-00370)
◦ 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.
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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
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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.
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Source: https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/QAPI/downloads/adverse-drug-event-trigger-tool.pdf.
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Adverse Drug Event Trigger Tool:
https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/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
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Medication Regimen Review data
 Quality of Care Indicators (examples)
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◦ Medication Errors
◦ Adverse Drug Events
◦ Any medications identified by the QA Committee
that are high risk or associated with adverse events
◦ Antibiotic use/stewardship
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Q&A
Debra Brown, PharmD, Pharmaceutical Consultant II
California Department of Public Health
◦ Center for Healthcare Quality/Licensing and
Certification Program
 Email: [email protected]
 Phone: (916) 319 - 9239
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