current trends in data protection for integrated health, centralized peer review systems and other...

Presented by: Martie Ross, JD, PYAPeggy 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

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

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

Martie Ross, JD

Clinically Integrated Networks and PSOs

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

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

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?

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.


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?

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.


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?

Data Flow

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

19

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

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

Using PSO in Centralized Peer ReviewHospital System recognizes that its entities

have not been adequately addressing peer review due to lack of expertise, lack of resources, conflicts, and other reasons.

Solution PSOPSOPSES

Conduct RCA in PSES. RCA results

reported to PSO and with other

hospital PSESsEstablish 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

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.

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

A New Kind of Transparency PSES allows 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

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

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?