A webinar hosted by PYA and the Alliance for Quality Improvement (AQIPS) explored “Current Trends in Data Protection for Integrated Health, Centralized Peer Review Systems, and Other Innovative Programs.” PYA Principal Martie Ross participated in the webinar, which focused on how patient safety organization (PSO) protections can bring value to accountable care organizations and other integrated health systems. In addition, the webinar provided instruction for using: Patient Safety and Quality Improvement Act (PSQIA) protections in Medicare Shared Savings Programs, centralized peer review programs, and other collaboratives. PSQIA protections for new types of clinical analysis, clinical quality reports, and performance tools that contain information that may not be protected under existing state peer review privilege or are shared among an integrated network.

1. Presented by:
Martie Ross, JD, PYA
Peggy Binzer, AQIPS
ALLIANCE FOR QUALITY IMPROVEMENT AND PATIENT SAFETY
Current Trends in Data Protection
for Integrated Health, Centralized
Peer Review Systems and Other
Innovative Healthcare Programs

2. Page 1
We are focusing too much on medical errors and need to
focus on connecting the Health Care Continuum. …Total
Systems view needs to be understood more deeply and
PSOs should be leading this…
-Don Berwick, Free from Harm: Accelerating Patient
Safety Improvement, NPSF

3. Page 2
Managing the Shift from Volume to Value
 PSO opportunities concerning healthcare delivery reform and
structures
 Clinically integrated networks
 MACRA/bundled payments – patient registries
 Dashboards and data sharing arrangements
 Centralized peer review systems/high-reliability systems
 The PSQIA privilege and confidentiality protections are the only
protections for sharing performance information among
unaffiliated providers or affiliated providers
across state lines
 Protected collaboratives under section 1311 of the ACA
 PSOs can dive into events data and determine interventions
 Share through convening
 Perform greater and more advanced analytics than the HEN

4. Martie Ross, JD
Clinically Integrated Networks and
PSOs
Pursuing Worry-Free Performance Improvement

5. Page 4
Trends in Healthcare Delivery
 Patient-centered and
team-based care
 Focus on healthy
lifestyles, prevention,
disease management
 Data sharing, data
mining, predictive
analytics
 Greater transparency
 Payment
 Quality (MIPS)
FOCUS
Patient
Outcomes

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Value-Based Reimbursement
FEE-FOR-SERVICE
(FFS) PAYMENTS
POPULATION-BASED
APMs
ADJUSTED FFS
PAYMENTS
APMs INCORPORATING
FFS PAYMENTS
$
$
Bank
A Pay For
Reporting
B Pay For
Performance
C Pay/Penalty
For
Performance
A Total Cost of
Care Shared
Savings
B Total Cost of
Care Shared
Risk
C Retrospective
Bundled
Payment
D Prospective
Bundled
Payment
A Condition-
Specific
Population-
Based
Payments
B Primary Care
Population-
Based
Payments
C Comprehensive
Population-
Based
Payments
A Traditional
FFS
B Infrastructure
Incentives
C Care
Management
Payments

7. Page 6
Clinical Integration
• Collectively define
and enforce
standards of care
• Coordinate patient
care
Providers
accountable to
each other and
to community to
deliver value –
high-quality
care in efficient
manner

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Clinically Integrated Network
• Governance
• Management
• Participation
Lean
infrastructure
to support
provider
accountability
• Promote evidence-based decision-making
• Engage in performance improvement
• Facilitate care coordination
• Support care management
Core Functions

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Learning Lab
 Identify potential issues through data reporting
and analysis
 Pursue performance improvement through
collaborative projects and benchmarking

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The Challenge
 How can independent providers participating in a CIN
engage in the following without litigation risk?
 Implement new evidence-based guidelines
 Share data for performance improvement
 Evaluate their performance as compared to other
participants

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Case Example
 CIN establishes ER stroke protocol with target
response time
 Participants train staff on protocol
 Participants each report to CIN on performance
measures
 CIN staff identifies potential issue at one facility
 How to proceed

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Safety Zone
CIN affiliation with
and participation
in an existing PSO
CIN sponsorship
and operation of a
PSO

13. Page 12
MSSP vs. PSO
Application for
Medicare Shared
Savings Program
AHRQ PSO
Certification for
Initial Listing

14. Page 13
Accountability for Beneficiaries
MSSP Application
 You certify that your ACO [and]
your ACO participants… agree
to become accountable for the
quality, cost, and overall care
of the … beneficiaries assigned
to the ACO.
PSO Certification for
Listing
 Does the entity have policies
and procedures to improve
patient safety and the quality
of healthcare delivery?

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Quality Assurance and Improvement Program
MSSP Application
 You have a qualified healthcare
professional responsible for the
ACO’s quality assurance and
improvement program that
encompasses...
 Promoting evidence-based
medicine
 Promoting beneficiary engagement
 Reporting internally on quality and
cost metrics
 Coordinating care
PSO Certification for Listing
 Does the entity have policies
and procedures in place to
assure the utilization of
appropriately qualified staff?
 Will the entity’s workforce both
(a) be appropriately qualified
and (b) include licensed or
certified medical
professionals?

16. Page 15
Quality Assurance and Improvement Program
MSSP Application
 [H]ow your ACO will require ACO
participants … [to] implement a
quality assurance and
improvement program including,
but not limited to… processes to
promote evidence-based medicine,
beneficiary engagement,
coordination of care, and internal
reporting on cost and quality.
PSO Certification for
Listing
 Does the entity have policies
and procedures to use PSWP to
encourage a culture of safety,
to provide feedback, and to
provide assistance to
effectively minimize patient
risk?

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Internally Reporting on Quality and Cost Metrics
MSSP Application
 [D]escribe how your ACO defines,
establishes, implements, evaluates,
and periodically updates its
process… to support internal
reporting on quality and cost
metrics that [provides] feedback,
and evaluation of ACO
participant… performance.
 [D]escribe how your ACO will use
the internal assessments… to
continuously improve your ACO’s
care practices.
PSO Certification for
Listing
 Does the entity have policies
and procedures to use PSWP to
encourage a culture of safety,
to provide feedback, and to
provide assistance to
effectively minimize patient
risk?

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Data Flow

19. Peggy Binzer, Esq.
Using a PSO to investigate how to do a better
job in a protected learning culture
Producing Better Outcomes for the Benefit of Patients
18

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Few Limits for the PSO Protections
Communications with other institutions; Peer
review; Coordinating care; Missed or delayed
diagnosis; Gap or systems analysis; Laboratory
testing review; Convenings; Surveys; Real-time
monitoring by the PSO; Scorecards; Clinical
protocol development; FMEA; Peer meetings;
Case studies; Core measures; Benchmarking;
Safety culture surveys; Dashboards; Statistical
analysis; Analysis of factors that affect quality;
Root cause analysis; Peer conversations; Quality
meetings; Real-time analysis of errors; Near
misses; Interviews; Reports; Incident reports;
PSO takes the signals and
investigates/evaluates; Trigger tools; Event
registries; Employee or visitor injury related to
patient safety; Utilization; Drug compliance;
Transfer gaps; Medical necessity; Second victim
programs; predictive analysis
Facts in the
medical
record or
from
interviews
HIPAA: Written
information
relied upon for
treatment
decisions
Administrative practices (e.g., billing)
Mandatory State Reporting
Criminal Activity

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High Reliability of Care
Establish clinical
guidelines and
best practices
Collect data by
each facility
Review for
Quality
Validate findings
and best
practices
Share data
(reactive to
proactive)
Raise standards
through system-
wide learning

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Using PSO in Centralized Peer Review
Hospital System recognizes that its entities
have not been adequately addressing peer
review due to lack of expertise, lack of
resources, conflicts, and other reasons.

23. Page 22
Solution PSO
PSOPSES
Conduct RCA in
PSES. RCA results
reported to PSO
and with other
hospital PSESs
Establish standardized
review and data
collection
PSO analyzes, tracks
and trends cases,
outcomes. Shares RCA
improved clinical
guidelines and
benchmarking with all
providers
Report findings, recommendations,
best practices, and cases that may
need further investigation
Cases needing additional
investigation or FPPE
Adopts best practices,
improves clinical
guidelines, and
continually measures
improvement

24. Page 23
Can Help Comply with External Requirements
 RCA can be conducted in the PSES and is PSWP. PSWP
RCA information can be used in credentialing (see
rulemaking). Accrediting body may work with hospitals in
PSES and improve RCA process and ensure compliance
under the PSQIA’s confidentiality protections.
 PSO review is canary in coal mine – if a performance problem
or potential compliance issue is found, need follow up and
further investigation from medical staff, compliance, and legal.
 PSO does not hide poor performance.
 If a provider could be causing harm to patients or potentially
acting below the standard of care, the PSO must give notice to
the facility to further investigate.
 Falls outside of the PSO at that time.

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Benefits of the PSO
 Data privileged and confidential
 Sharing learnings system-wide
 Result in improved procedures system-wide, continual
quality improvement for standards of care, and
development of high reliability for centerpiece programs
 Saves external review costs
 Result valuable big data – mined for publications, to
improve medical devices

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A New Kind of Transparency
 PSES allows the confidential sharing of case studies,
events, and solutions with affiliated and unaffiliated
providers
Provider
(Integrated
Dashboard)
EMS
PSES
Long-Term
Care PSES
Home Care
PSES
Health
System
PSES
Ambulatory
Care PSES
External
PSO

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Protections for the PSO
 A PSO cannot be compelled unless the court or
government can:
 Identify the specific information
 Prove the information is not patient safety work product
 Show they cannot be reasonably available from another source
 Shifts the burden of proof and requires a special pleading
under the rules of Civil Procedure
 Privilege for PSWP in the PSO is self-effectuating,
meaning cannot be challenged in court and is not
therefore subject to judicial interpretation

28. Page 27
Innovative Models of Care Lead to Benefits
“PSQIA is flexible ‘to accelerate the
development of new, voluntary provider-
driven opportunities for improvement’ and to
‘set the stage for breakthroughs in our
understanding of how best to improve
patient safety.’”
Source: Patient Safety and Quality Improvement, Proposed Rule, 73 Fed. Reg. 8112, 8113 (February 12, 2008).

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Questions?