Preparing for the PACE 2020 Audit Protocol

Laura Ferrara, Acting CEO, Chief Strategy Officer, Senior Care Partners PACEChris van Reenen, Vice President, Regulatory Affairs, National PACE Assoc.

Session Objectives

• Understand key differences between the 2017 and proposed 2020 CMS PACE audit protocols and data collection requirements. (Note: As of 9/30/2019, CMS had not released updated information regarding the PACE 2020 audit protocol since it was initially released for comment in March 2019. NPA and others commented extensively on the protocol and are awaiting CMS’ response. For this presentation, we have no option but to address the materials released March 2019.)

• Consider options for collecting and reporting data consistent with proposed audit data requirements.

• Learn how to use several risk assessment tools to monitor ongoing compliance with key PACE requirements.

Background on PACE 2020 Audit Protocol

• On March 15th, 2019, CMS released a request for comment on the PACE 2020 Audit Protocol in the Federal Register.

• 33 documents associated with the request for comment are available on CMS’ website: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-10630.html?DLPage=6&DLEntries=10&DLSort=1&DLSortDir=descending.

• NPA and others responded to CMS’ request for comment due May 28th, 2019.• The PACE community is awaiting CMS’ release of further information on the PACE 2020

Audit Protocol.• Today’s presentation is based on the materials that were disseminated in

connection with the March 15th Federal Register release. As of 9/30/2019, CMS had not yet released additional information subsequent to submission of comments due May 28, 2019.

Timelines for CMS’ Release of 2017 and 2020 PACE Audit Protocols

PACE 2017 Audit Protocol PACE 2020 Audit Protocol

August 5th, 2016: Release of PACE 2017 Audit Protocol for 60-day comment period

March 15th, 2019: Release of PACE 2020 Audit Protocol for 60-day comment period

December 2nd, 2016: Release of PACE 2017 Audit Protocol for 30-day comment period (119 days after 8/5/2016)

As of 9/30/2019, awaiting release of PACE 2020 Audit Protocol for 30-day comment period (199 days through end of September)

2017: CMS release and implementation of final PACE 2017 Audit Protocol

??: CMS release of final PACE 2020 Audit Protocol

Broad Differences: CMS’ PACE 2017 vs. 2020 Audit Protocols

• Under updated PACE regulation, CMS audits are no longer required at least every two years subsequent to completion of initial 3-year trial period.

• Proposed increase in number of data collection instruments from 18 in 2017 to 31 in 2020 largely due to increase in number of impact analyses (IAs). CMS’ explanation is that add’l IAs (increase from 14 to 25) will “clarify CMS expectations and result in improved data collection and analysis while reducing PO and CMS burden overall.”

• Considerable increase in PACE organization (PO) burden associated with 2020 audit protocol: CMS estimates 600 hours ($41,250); NPA’s comment suggests 1,210 hours ($83,187.50).

Audit Purpose

“To evaluate PACE organizations’ compliance with regulatory and/or manual requirements in the following four areas related to the Programs of All-Inclusive Care for the Elderly (PACE)…• Service Delivery Requests, Appeals and Grievances (SDAG);• Clinical Appropriateness and Care Planning (care planning, participant

assessments, interdisciplinary team (IDT) requirements, medical records, participant observations, etc.);

• Personnel Records; and • Quality”Note: Onsite Review audit element from 2017 protocol dropped although related compliance standards assessed in context of Clinical Appropriateness & Care Planning.

Audit Process• PO receives Audit Engagement Letter• PO submits extensive documentation to CMS• CMS selects sample cases for review (SDAG, personnel, participants)• Audit Fieldwork

• Desk Review• On-site Review, including real time observations of participants and equipment• Daily updates regarding potential conditions identified• Exit conference to identify preliminary summary of conditions identified during audit

• PO uploads documentation requested by auditors to HPMS• PO responds to auditors’ request for RCAs and IAs• PO notified of ICARs, if applicable• PO receives Draft Audit Report with opportunity for comment• PO receives Final Audit Report with final audit score (sum of points for ICARs (2) and

CARs (1), divided by number of audit elements (4))• Implementation and monitoring of Corrective Action Plans to address issues of non-

compliance

PACE 2020 Audit Protocol Materials

Released on March 15, 2019 for comment:• Supporting Statement A: The PO Monitoring & Audit Process• PACE 2020 PRA Crosswalk (identifies differences between 2017 and 2020 protocols)• PACE Audit Process and Data Request (REVISED)• PACE Supplemental Questions (REVISED)• Pre-Audit Issue Survey (REVISED)• On-site Observation Participant List (NEW)• Root Cause Analysis Template (NO CHANGE)• Impact Analysis Templates (REVISED and NEW, increase in number of templates

from 14 to 25)• PACE Audit Survey (NEW)

Documentation Required of POs

• PACE Supplemental Questions (due within 5 business days of audit engagement letter)• Pre-Audit Issue Summary (due within 5 business days of audit engagement letter)• Data Universes (due within 20 business days of audit engagement letter)• Quality Improvement (QI) plan(s) for data collection period (due within 20 business days of

audit engagement letter)• Participant Advisory Committee minutes for data collection period (due within 20 business

days of audit engagement letter• Current Organization chart (due within 20 business days of audit engagement letter) • Onsite Observation Participant List (due on first day of onsite audit)• Documentation associated with targeted sample cases (see following slides)• Root Cause Analyses/Impact Analyses (due within 24 hours/10 business days of CMS’

request)• Any additional supporting documentation requested throughout the audit period (due as

instructed)• PACE Audit Survey (optional; due within 30 days of issuance of final audit report)

PACE Supplemental Questions

• Due within 5 business days of receipt of audit engagement letter (no change)

• Increase in number of ?s from 9 to 16• Responses must reflect practices, policies and procedures in place during

audit review period (6 months prior to audit engagement letter)• New questions may speak to CMS’ potential compliance concerns, e.g.:

• Does your organization have any policies that place limits on the amount, duration, or frequency of the following items or services: glasses, hearing aides, home care services, respite, specialist consultations, NF services, hospital or ER services, dental services, DME, personal alert systems, medications?

• Numerous Part D-related questions, e.g., related to use of prior authorization, step therapy, quantity limits; identification of preferred drugs

Pre-Audit Issue Summary

• Due within 5 business days of receipt of audit engagement letter (no change)• Increase in number of ?s from 15 to 19

• New ?s focus on situations in which remediation or correction of non-compliance has not yet been completed

• To include list of all issues of non-compliance disclosed to CMS prior to date of audit engagement letter

• May not include issues identified by CMS or the SAA through ongoing monitoring or other account manager and oversight activities

• Not to include data that is not relevant to the audit elements• CMS may require a completed RCA and/or IA for any disclosed issue• When CMS determines a disclosed issue was “promptly identified, corrected, and

the risk to participants has been mitigated,” CMS will not apply ICAR condition

Data Universes

6 Data Universes (previously 7; Quality Assessment Initiatives Records (QAIR) eliminated)

• Service Delivery Requests (SDR)• Appeal Requests (AR)• Grievance Requests (GR)• List of Personnel (LOP) (all PO employees; employees of contracted entities if provide

services to participants in home, PACE Center, ACS or transport participants)• List of Participant Medical Records (LOPMR)• On-Call (OC) (all after-hours calls)Data collection period: 6 months prior to, and including, date of audit engagement letter for SDR, AR, GR, LOP, LOPMR unless otherwise specified; 3 months for OC (previously 12 months for SDR, AR, GR, LOP, LOPMR)

Data Universes, continued

• Due within 20 business days of receipt of audit engagement letter (previously 30 calendar days)

• PO has maximum of three attempts to provide complete and accurate universes

Changes to Universe Record Layouts

• Change in format of all calendar dates from CCYY/MM/DD to MM/DD/YYYY• Eliminated Quality Assessment Initiative Records (QAIR) Record Layout• Service Delivery Request (SDR) Record Layout

• Person who submitted service request: participant or designated representative (previously participant, caregiver, family, IDT, other)

• Additional changes intended to clarify data requested• Appeals Request (AR) Record Layout

• Person who submitted appeal: participant or designated representative (previously participant, caregiver, family, IDT, other)

• Removed Date/Time of Oral Notification• Removed question regarding whether analysis of appeal was included in QI program• Additional changes intended to clarify data requested

Changes to Universe Record Layouts, cont.

• Grievance Request (GR) Record Layout• Person who submitted grievance: participant or caregiver (previously participant,

caregiver, family, other)• Specifies that multiple issues may be identified in a grievance and all issues

should be described• Clarifies that “Grievance Resolution” should be “N” if all issues in the grievance

were not resolved • Combined “Date of Resolution Notification, Oral and/or Written”• Removed “Date of Resolution”• Removed question regarding whether analysis of grievance was included in QI

program• Additional changes intended to clarify data requested

Changes to Universe Record Layouts, cont.

• List of Personnel (LOP) Record Layout• Specifies that in addition to employees of the PO, contracted employees

(including employees of contracted entities) that provide care/services to participants in the home, PACE center or alternative care setting or who transport participants should be included in this data universe (no change)

• Added “IDT Member” to indicate if employee is a member of the PO’s IDT• Added “IDT Role” to identify the discipline the individual represents on IDT

Changes to Universe Record Layouts, cont.

• List of Participant Medical Records (LOPMR) Record Layout• Substantial changes with many new data elements requested, up from 36 to 49• Most significantly, added questions related to:

30-day hospital readmissions Specialist consultations/visits to determine if examined/treated by cardiology, gastroenterology, hematology,

oncology, pulmonary medicine, rheumatology Presence of numerous diagnoses: diabetes, CHF, COPD, AIDS, Hepatitis C, cancer, anemia, MS, etc. Whether specialists prescribed and/or recommended medications and, if so, if these medications were

provided Presence of pain Opioid utilization Weight gain with much more detail for existing question related to weight loss Blood glucose level Oxygen saturation level

• Removed questions related to: transportation services, recovering from fall, treatment for pressure ulcer, parenteral or enteral feeding, psychoactive medications, skilled therapy, impaired hearing

• NPA has recommended significant changes to CMS’ proposed revamping of the LOPMR, emphasizing the burden associated with many of the proposed additions to this record layout; awaiting CMS response

Data Retrieval and Management for LOPMR Record Layout

• Prior LOPMR Record Layout Data included in 2020 audit protocol

• Current EMR reporting mechanisms to retrieve data from EMR

• New data elements that are recorded in the EMR but not currently in a field that can be mapped and retrieved by reports

• Participant pain – may be mapping if diagnosis included in life plan

• Limitation on opioid usage• Significant weight gain• Low blood glucose level• High blood glucose level • Oxygen saturation level

Data Retrieval and Management for LOPMR Record Layout, cont.

• New data elements that are currently recorded in the EMR and expected to be mapped and retrieved by reports:

• PACE center• 30 day hospital readmissions• Direct SNF admission• Specialist consultation/visits• Diagnoses (DM, CHF, COPD,

dementia, other)• Transplant

• New data elements that are in EMR via provider documents that will require manual tracking

• Specialist ordering medications –PBM can provide report

• Delivery of specialist ordered medications – pharmacy reports can be utilized in combination with PBM report

• Specialist recommended medications• Delivery of specialist recommended

medications • Opioid utilization - PBM can provide

Audit Fieldwork

• Desk review/Webinar (Week 1), typically for SDAG and personnel elements

• Review of samples cases for service delivery requests, appeals and grievances drawn from SDR, AR and GR data universes

• Review of sample of personnel drawn from LOP data universe• Onsite audit (Week 2) for Clinical Appropriateness and Care Planning, and

Quality (and anything that may not have been completed in Week 1)• Review of sample of medical records for participants drawn from LOPMR data

universe• Onsite observations drawn from Onsite Observation Participant List Skilled care in home and center including wound care and medication administration;

dietary/meal services• Inspection of emergency equipment and emergency medications• Vehicle inspection• Interviews and review of data/documentation related to PO’s quality

improvement program

Sample Cases

• Sample cases chosen based on data provided in universes and additional documentation

• For audit elements evaluated via desk review (e.g., SDAG and/or Personnel), CMS requests sample cases from PO 2 business days before review of element (no change vs. 2019)

• Requests for medical record samples for the Clinical Appropriateness & Care Planning element provided to PO 1 hour prior to start of review of medical records (previously 1 business day)

• Specific documentation requirements for selected sample cases listed in PACE Audit Process and Data Request document

• Sample cases reviewed for regulatory compliance consistent with PACE regulation and compliance standards in PACE Audit Process and Data Request document

SDAG Sample CasesSDAG – 40 sample cases (up from 30)

• Service Delivery Requests 10 denied SDRs 10 approved SDRs (up from 5) Detailed documentation of SDR, need for extension (if any), assessment(s), IDT decision to

approve/deny, involvement of IDT in review of SDR, notification of approval/denial, etc. (See PACE Audit Process and Data Request document)

• Appeals 5 denied appeals 5 approved appeals (up from 0) Detailed documentation of appeal request, why expedited (if applicable), third-party

reviewers and their credentials, third-party decision; notification of approval/denials, etc.(See PACE Audit Process and Data Request document)

• Grievances 10 grievances Detailed documentation of all issues in grievance/complaints, steps to resolve, resolution

notification, etc. (See PACE Audit Process and Data Request document)

Personnel Sample Cases

Personnel Records • 10 personnel records, including representative of various types of staff, i.e.,

employed, contracted, employees of contracted entities, full-time, part-time, volunteers, etc.

• PO must have documentation of: Any and all background checks Any and all OIG exclusion checks Current and active licensure Completion of competencies Determinations of free of communicable diseases Although not listed specifically, documentation of CMS preclusion list checks should also

be available

Clinical Appropriateness & Care Planning Sample Cases

Clinical Appropriateness & Care Planning – 15 medical records (up from 10)• CMS will select participant medical records on basis of clinical significance• Medical records representative of various types of medical, functional and social

needs Hospitalizations Wound care Dialysis Social needs Home bound Nursing home care

• Detailed documentation related to assessments, care plans, provision of all services indicated in care plan, involvement of all IDT members as required, medical specialist consults, hospital and SNF/NF care, etc. (See PACE Audit Process and Data Request document)

On-site Observation Participant List (NEW)

• Intended for auditors’ use in selecting 5 participants for on-site observation. • To be provided to auditors on first day of on-site audit• To include participants

• Scheduled for wound care or medication administration in home or PACE Center• Scheduled for in-home care• Scheduled to attend the Center, have specialized diets, and receive meals

• Asks for specific participant-level information• Place/days/methods of medication administration • Place/days/type of wound care• Days/type of in-home care• Days/type of specialized diet

• NPA has recommended significant changes to CMS’ approach to selecting participants for on-site observations; awaiting CMS response

• Focus on participants assigned to single center• Provide list of participants who will attend center and/or receive home care during onsite audit period• List would include some, but far less detailed, information on participants’ receipt of medication

administration, wound care, specialized diet

Quality Assessment• Interview with QI staff (no longer “tracer methodology”)• Review of QI program documentation including:

• Documentation that PO collects, analyzes, and uses data to improve performance in following areas: Utilization of PACE services Participant and caregiver satisfaction Participant assessment data including: physiological well-being, functional status, cognitive ability,

social and behavioral functioning, and quality of life Effectiveness and safety of staff and contracted services including competency of clinical staff,

promptness of service delivery, achievement of treatment goals Nonclinical areas such as: grievances, appeals, transportation, meals, environmental issues

• Specific actions taken in response to detected issue(s), if applicable• Documentation that staff and contractors are involved in development/implementation of

QI program• Documentation that results of quality initiatives are communicated to staff and contractors

Root Cause Analyses (RCAs)

• Requested of PO when CMS identifies potential issue of non-compliance during audit fieldwork

• Due to CMS within 24 hours of request• Requests info on possible issue of noncompliance:

• Explain what happened and why• Identify number of participants impacted – these questions are not required

but, in absence of information on # of participants impacted, request for impact analysis more likely

• Explain actions taken to resolve issues, if any, and remediate impact

• No change to RCA template in PACE 2020 Audit Protocol

Impact Analyses (IAs)

• Intended to identify all participants subject to or impacted by issue of non-compliance

• Timeframe for IA is generally from the beginning of the data collection period, i.e., 6 months prior to and including date of audit engagement letter, through the audit exit conference (no change vs. 2019)

• PO typically has 10 business days to complete IA once requested• If IA cannot be produced, is incomplete, or is determined to be

inaccurate, CMS will report that the scope of non-compliance cannot be determined and impacted unknown number of participants

Impact Analyses, cont.

• IAs included in PACE 2020 Audit Protocol are even more detailed than IAs implemented beginning 2017

• NPA commented extensively on IAs included in PACE 2020 Audit Protocol:• Concern re: thresholds for requiring IAs too low• Request that auditors limit need for exhaustive IAs, e.g.,

Definition of service requests too expansive Definition of grievances too expansive

• Excessive burden, in part due to medical record reviews required by IAs• POs should have access to PACT (PACE Audit Consistency Team) in response to

request for IA• Use of sampling methodology to determine if systemic problem before requiring

100% of scope of IA, e.g., all enrolled participants, all grievances, all SDRs, etc.

Focuses of Impact Analyses

• SDAG• Were all SDRs identified and processed consistent with requirements in

§460.104(d)(2)?• Were all grievances identified and processed consistent with requirements in

§460.120?• Were appeals, including expedited appeals, identified and processed

consistent with requirements in §§460.104(d)(2), 460.122 and 460.24?

• Personnel• Were all personnel related requirements met, e.g., for licensure,

competencies, OIG exclusion list checks, CMS preclusion list checks, background checks, communicable disease clearance, driver-specific training?

Focuses of Impact Analyses, cont.• Clinical Appropriateness and Care Planning

• Were all assessments completed as required (initial, semiannual, annual, change of status, SDR)?

• Were all IDT members involved in care planning?• Were all care planning requirements met, e.g, were all problems/interventions/goals

included?• Was participant and/or caregiver involved in creation/reevaluation of care plan?• Were all required services available at PACE center?• Circumstances surrounding use of emergency services• Availability of emergency equipment and medications • IDT composition• IDT participation in care planning• Was all “pertinent information” regarding participant’s medical, functional or

psychosocial condition communicated to members of the IDT?

Focuses of Impact Analyses, cont.

• Clinical Appropriateness and Care Planning• Staff adherence to CDC standard precautions• Accessibility/accuracy/completeness of medical records• Did staff act outside their scope of practice?• Were restraints used consistent with requirements in §460.114?• Was home care provided as approved/ordered?• Did participants experience any medication errors?• Wound care• Provision of all recommended/approved/ordered services• Were any limitations applied to amount, duration of scope of Medicare or

Medicaid benefits?

And, finally, PACE Audit Survey (NEW)

• Optional• Due to CMS within 30 days following issuance of Final Audit Report• CMS asks for feedback on:

• Pre-audit activities, e.g., clarity of instructions; availability of audit lead for questions• Audit activities, e.g., transparency of communications with CMS; opportunities to

respond to potential issues of non-compliance with add’l documentation; clarity of requests for RCAs, IAs; reasonableness of deadlines for IAs; extent to which daily updates included information on potential conditions of non-compliance

• Post-audit activities, e.g., clarity of draft and final audit reports; responsiveness of audit lead to CAP questions; responsiveness of account manager to CAP monitoring questions

• General audit questions, e.g., needs for increased transparency; for entities with multiple POs, consistency of audit experiences across POs; suggestions for improving audit process

Use of risk assessment tools to monitor ongoing compliance with key PACE requirements

• Risk Assessment tools available through NPA• Service Delivery Requests Risk Assessment • Appeal Requests Risk Assessment • Grievance Requests Risk Assessment • Clinical Appropriateness and Care Planning Risk Assessment • Personnel Records Risk Assessment

• Use of the Risk Assessment tools • Support quality and compliance efforts and the ability to identify regulatory quality

and compliance issues in real time • Integrate regulatory requirements into daily operations.• Utilize ongoing data analysis efforts to identify trends and/or isolated issues of

noncompliance. • Focused efforts on identifying real or perceived regulatory noncompliance that may

impact the quality of participant care.

Use of risk assessment tools to monitor ongoing compliance with key PACE requirements, cont.

• Risk Assessment Process• Service Delivery Request Risk Assessment

Monthly audit of random probe sample – 30 service delivery requests randomly selected from total universe

• Clinical Appropriateness and Care Planning Risk Assessment Quarterly audit of random probe sample – 20 participants randomly selected from total

universe. Care plan and related assessments and daily documentation audited

• Personnel Records Risk Assessment Quarterly audit of random probe sample – 20 personnel records (employees and

contracted staff) randomly selected from total universe.

Use of risk assessment tools to monitor ongoing compliance with key PACE requirements, cont.

• Risk Assessment Process• Appeal Requests Risk Assessment

Quarterly audit of all appeals from the previous quarter• Grievance Risk Assessment

Quarterly audit of random probe sample – 30 grievances randomly selected from total universe

• Risk Assessment Results• Isolated issues of non-compliance addressed through education and performance

improvement efforts as needed• Trends of non-compliance

Reported via monthly calls with regional CMS account manager Included on pre-audit issue summary (only 6 months reported for audit purposes) RCA, corrective action, contract management initiatives implemented as needed for

resolution of non-compliance Results reported to board level quality improvement committee

Risk Assessment Tool for Grievances

Discussion