the future of protecting data: recent trends in using the psqia privilege and confidentiality...

Presented by: Karen L. Davila, JD/MBAMartie Ross, JDPeggy Binzer, Esq.

AMERICAN HEALTH LAWYERS ASSOCIATION ANNUAL MEETING, JUNE 24-25, 2016

The Future of Protecting Data: Recent Trends in Using the PSQIA Privilege and Confidentiality Protections to Improve Care Quality and Reduce Risks

What is a PSO?

The “alphabet soup” of the PSQIA

Karen L. Davila, JD/MBA

Prepared for American Health Lawyers Association Annual Meeting

Topic Outline The “alphabet soup” of the PSQIA Role of PSO in keeping patient safety data safe Interplay between PSQIA and other federal/state

regulatory requirements Pressures and opportunities of healthcare

delivery reform and structures Dashboards and data sharing

arrangements Case studies demonstrating benefits

of PSO


The single greatest impediment to error prevention in the medical

industry is that we punish people for making mistakes.

Dr. Lucian Leape


The “Alphabet Soup” of the PSQIA

PSQIAPatient Safety and Quality Improvement Act of 2005,

Patient Safety Act

PSOPatient Safety Organization

PSES Patient Safety

Evaluation System

PSWPPatient Safety Work

Product


A Few Fundamentals

Purpose of the PSQIA: to promote quality improvement through the collection, sharing, and analyzing of patient safety and quality information in all healthcare settings.

State peer review protections: Vary widely Don’t cover all healthcare professionals/settings Don’t apply across state lines Generally don’t cover data uses for quality

improvement


What is a PSO? Allows healthcare providers to share

information to improve quality and reduce patient safety events

Encourages a culture of safety and quality

Creates a reporting “safe harbor” Allows for analysis of systems,

processes and people in an effort to identify and mitigate patient safety risks


Patient Safety Evaluation System (PSES)

The mechanism through which patient safety and quality data are collected, maintained, analyzed, and communicated to or by a PSO

Data collected, maintained, analyzed, and submitted to the PSO within a PSES is protected under the privileges afforded by the PSO

Data outside the PSES is not protected by the PSO


Patient Safety Work Product (PSWP)

Quality or patient safety data and analysis, whether oral or written Developed by a provider for reporting to a PSO or

developed by the PSO Which could improve patient safety, quality or outcomes,

AND Are analyzed and developed within a PSES

Does not include: Medical record information Billing/insurance information Other original patient or provider information Anything collected, maintained, or developed outside a

PSES


PSO Protections PSQIA provides peer review privilege for all participating healthcare

providers PSWP is privileged

Not subject to subpoena, discovery, or admission into evidence Preempts state tort laws Does not preempt reporting requirements to various state regulatory

agencies Does not preempt state peer review where

stricter protections are provided Statutory prohibition against disclosure of PSWP,

absent exception (penalties for violation) Civil money penalties of $10,000 for each

violation of prohibition against disclosure of identifiable patient safety information


Walmart’s Journey to Safety Culture PSO

Non-punitive reporting

Learning Environment

Just Culture

Safety Culture

Learning from data and analytics


Navigating Discovery Requests

Requests from professional boards

Private litigation subpoenas

Other government agency enforcement requests


Discovery Request in PSO Environment

Clinically Integrated Networks and PSOs

Martie Ross, JD

Pursuing Worry-Free Performance Improvement


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)

FOC

US Patient

Outcomes


Value-Based Reimbursement

FEE-FOR-SERVICE(FFS) PAYMENTS

POPULATION-BASEDAPMs

ADJUSTED FFSPAYMENTS

APMs INCORPORATINGFFS PAYMENTS

$ $ $

Bank

A Pay For Reporting

B Pay For Performance

C Pay/PenaltyForPerformance

A Total Cost of Care Shared Savings

B Total Cost of Care SharedRisk

C Retrospective BundledPayment

D Prospective BundledPayment

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


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


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


Learning Lab Identify potential issues through data reporting

and analysis Pursue performance improvement through

collaborative projects and benchmarking


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?


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?


Safety Zone

CIN affiliation with and participation

in an existing PSO

CIN sponsorship and operation of a

PSO


MSSP vs. PSO

Application for Medicare Shared Savings Program

AHRQ PSO Certification for

Initial Listing


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?


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


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?


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.


and procedures to use PSWP to encourage a culture of safety, to provide feedback, and to provide assistance to effectively minimize patient risk?


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.


and procedures to use PSWP to encourage a culture of safety, to provide feedback, and to provide assistance to effectively minimize patient risk?


Data Flow


High Reliability of CareEstablish 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

Using a PSO to investigate how to do a better job in a protected learning culture

Peggy Binzer, Esq.

Producing Better Outcomes for the Benefit of Patients


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; Bench marking; 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

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


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, and Show they cannot reasonably be 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 it cannot be challenged in court and is not therefore subject to judicial interpretation.


Using PSO Investigation and Analysis

PROBLEM: Orthopedic Group recognizes that its entities have not been adequately addressing peer review in certain procedures due to lack of expertise, lack of resources, conflicts, and other reasons.


Drawbacks to Existing Protections Attorney-client privilege No established peer review protections for a specialty

group and inadequate for health system External review can be costly and result in variations in

quality of the review Bringing in additional experts costly


Solution PSOPSOPSES

Collect data, x-rays,

reports, medical records

Credentialed reviewer (PSO

workforce) reviews blinded cases

Analytics center analyzes, tracks, and trends cases,

outcomes

Advisory board adopts best

practices-improves clinical guidelines

PSES evaluate feedback for use

in care improvement

Data reported to PSO

Blinded cases sent to

reviewer

Report findings, recommendations, best practices, and cases that may

need further investigation

Cases needing additional investigation or FPPE


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


Can Help Comply with External Requirements

Pattern of Medicare claims for unnecessary procedures, gov’t typically will investigate whether provider has an effective audit or peer review program.

PSO review is canary in coal mine – if a performance problem is found, need follow up and further investigation from 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.


A New Kind of Transparency PSESs allow the confidential sharing of case studies,

events, and solutions with affiliated and unaffiliated providers

Provider (Integrated Dashboard)

EMSPSES

Long-term

Care PSES

Home Care PSES

Health System PSES

Ambulatory Care PSES

ExternalPSO


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).


Questions?

Karen L. Davila, JD/MBA

Senior Associate General Counsel

Wal-Mart Stores, Inc.Phone (479) 277-5147 [email protected]

Peggy Binzer, Esq.Executive DirectorAlliance for Quality Improvement and

Patient Safety (AQIPS)(703) 581-9285

[email protected]

Martie Ross, JDPrincipal

Pershing Yoakley & Associates (PYA)(913) 232-5145

[email protected]

mailto:[email protected]




