clinical integration 2.0 – the informatics revolutionmeeting process and outcomes measures, and...

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CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTION Christi J. Braun, Mintz Levin Paul R. DeMuro, Schwabe Williamson & Wyatt Jill H. Gordon, Nixon Peabody

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Page 1: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTION

Christi J. Braun, Mintz Levin Paul R. DeMuro, Schwabe Williamson & Wyatt Jill H. Gordon, Nixon Peabody

Page 2: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

WHAT IS CLINICAL INTEGRATION?

An active and ongoing program to evaluate and modify the clinical practice patterns of the physician participants so as to create a high degree of interdependence and cooperation to control costs and ensure quality

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 3: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

THE RELEVANT ANTITRUST LAWS

– Section 1 of the Sherman Act (15 U.S.C. § 1) – Section 5 of the FTC Act (15 U.S.C. § 45(a)(1))

Both statutes prohibit agreements among private, competing businesses, such as physician practice groups or hospital systems, that unreasonably restrain competition.

– Only the FTC may enforce the FTC Act– DOJ, state AG and private parties may bring suit

under Section 1

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 4: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

APPLICATION TO IPAS, PHOS, CINS AND ACOS

Competitor-controlled contracting organizations

– E.g., independent practice associations, physician organizations, physician-hospital organizations, clinically integrated networks and accountable care organizations

– Acts and understandings in these competitor-controlled contracting organizations, such as committee recommendations and Board resolutions, are agreements among the competing providers that can violate Sherman Act Section 1 and Section 5 of the FTC Act

– Doesn’t matter whether competing providers own the organization, only that they have control and make decisions that affect all participants

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 5: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

APPLICATION OF SHERMAN ACT SECTION 1 AND FTC ACT SECTION 5

— Agreements among competitors, such as those in competitor- controlled contracting organizations, on the prices of their individual services are generally per se, or automatically, illegal

— UNLESS the providers are sufficiently financially or clinically integrated

— AND the price agreement is ancillary, or reasonably related, to the achievement of procompetitive benefits (e.g., higher quality and reduced or contained costs)

— THEN the competitive restraint will be analyzed under the more lenient Rule of Reason, which is a balancing test

— AND the joint negotiations will only be illegal IF, on balance, the harm to consumers and competition outweighs the procompetitive benefits.

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 6: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

ACOS ARE CINS

Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (“The Antitrust Policy Statement”)

– Joint statement of the Federal Trade Commission (FTC) and the Department of Justice Antitrust Division (DOJ)

– 76 FR 67026, published on October 28, 2011

– http://www.ftc.gov/os/fedreg/2011/10/111020aco.pdf

Must be read in conjunction with the CMS MSSP final rule

The antitrust agencies assume that ACOs that (1) meet CMS’s eligibility criteria and (2) are approved for the MSSP meet the indicia of clinical integration set forth in the Statements of Antitrust Enforcement Policy in Health Care (1996)

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 7: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

COMMON CHARACTERISTICS OF CLINICAL INTEGRATION

— Selection of high quality physicians

— Investment in the program and entity (financial and “sweat equity”)

— Declared commitment to clinical integration by participants

— Appropriate use of information technology

— Collaboration in the care of patients

— Quality- and cost-improvement initiatives

— Electronic data collection/dissemination

— Accountability and interdependence

— Benefits to payors and focus on patients

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 8: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

IMPORTANCE OF IT IN ACHIEVING CLINICAL INTEGRATION AND DEALING WITH POTENTIAL ANTITRUST ISSUES

The FTC and DOJ support many clinical integration models, but without a robust IT platform and program, it will be difficult to achieve true clinical integration

– "When used to its fullest potential, a robust HIT system can serve as a hub for effective coordination-of-care efforts"– Reduce medical errors

– Reduce duplicative testing

– Increase transparency regarding comparative quality

– Make patient health records portable

– Data-driven UM and outcome measurement

– Reduce fragmentation and foster interdependence

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 9: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

WHAT ARE THE CRITICAL "MUST HAVES" FOR ANY ACO IT DESIGN IN THE NEAR TERM?

Electronic Health Records (EHR) with Clinical Decision Support Systems (CDSS)– Making possible management of data, particularly

meeting process and outcomes measures, and quality reporting

Interoperability with respect to all departments in hospitals and ambulatory settings, making patient-centered healthcare possible, along with cross-collaborative team care, particularly for chronic conditions

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 10: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

MUST HAVES (CON’T)

An mHealth platform that facilitates entry of data and review of analytics

Social medial health sites which provide support groups and other healthcare management through a patient-centered model

– Patient networks sharing data, particularly clinical data

– Can facilitate outcomes research

Robust telehealth/telemedicine capabilities

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 11: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

MUST HAVES (CON’T)

Ability to use Evidence-Based Medicine (EBM) and data analytics to determine whether a treatment is 100% effective for 80% of the people and not effective at all for the other 20%

For which patients is a treatment effective?

Work toward designer treatments specific to as little as one individual

Personalized treatment plans

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 12: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

HOW DO VARIOUS SOFTWARE SYSTEMS OVERLAY TO CREATE AN INTEGRATED IT PLAN FOR THE FUTURE?

The KEY is interoperability

Are the systems interoperable?– not just within a hospital or system– or including the physician and/or

ambulatory component– but wherever a patient seeks care– mHealth can facilitate this

happening

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 13: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

SOFTWARE SYSTEMS OVERLAY (CON’T)

Do the interfaces really work?

Can you access the data you need to provide better quality care?– Can a quality nurse access the data he or she needs to track

and monitor data to influence quality?

EHR needs to be in a format that you can access the data you need

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 14: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

HOW DO YOU BRIDGE THE GAP BETWEEN CMIO/CIO DOMAIN AND OTHER EXECUTIVE MANAGEMENT?

Increasingly, CMIOs and Chios are working with big data, informatics, and analytics for quality purposes

Other healthcare executive management has traditionally not played much of a role in this regard, and particularly from a financial perspective

It is important for other healthcare executives to see the link between quality, cost-effectiveness and better financial performance

There needs to be a cultural shift

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 15: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

ACCOUNTABLE CARE ORGANIZATIONS (ACOS) NEED GOOD DATA AND NEED TO LEVERAGE IT

To do so, ACOs need to align incentives, generate useful data, break down silos, and ensure that all parts of the ACO are working together– ACOs can best accomplish all of this with robust data

bases and ability to query those databases– Pay for quality and effective treatment

Personalized Treatment Algorithms (How Data Science is Transforming Healthcare, by T. O’Reilly, et al.)

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 16: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

THE POWER OF IT FOR CLINICAL INTEGRATION

IT is the backbone of clinical integration

It provides the basis for obtaining and mining the data to meet the clinical integrators

The ability to mine data and query data bases can improve quality and cost-effectiveness

Target certain issues, problems, e.g. hospital acquired infections

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 17: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

Personal fitness devices– monitor HbA1c, blood pressure, etc.

Monitoring of chronic conditions through telehealth

POWER OF IT (CON’T)

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 18: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

Traditional

Health IT

Consumer Driven

IT/Personal Devices

TURNING THEORY INTO PRACTICE

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 19: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

DEVELOPING THE BIGGER PICTURE

What are the system’s goals?– Integrating existing providers– Data exchange with clinical partners– Data exchange with payors– Data exchange with patients– Accumulating data– Developing metrics/benchmarking

POPULATION HEALTH STRATEGY?

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 20: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

ORGANIZATIONAL APPROACH TO ADDRESSING IT

EMR

CPOE

Patient Portal

Telemedicine

Disease Registries

HIE

Analytics

Reports

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 21: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

INTEGRATING INTERNAL PROVIDER PROCESSES WITH PATIENT EXPERIENCE

Patient IdentificationPatient Needs Assessment

Care Plan DevelopmentCare Plan Implementation

Care Plan Monitoring

Patient DataProvider Data Payor Data

Disease RegistriesPredictive Modeling

Clinical Guidelines

Care Manage

ment

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 22: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

CASE STUDIES

The “Intensivist” Model

Health system pulls chronically ill/frequent utilizers out of its medical home model and assigns them to an “intensivist” clinic

Clinic has team of dedicated physicians, nurses and care coordinators assigned to these patients

Patients actively monitored via in-person visits, phone calls, email, personal feedback devices (e.g., scales, heart monitors)

Care managers actively monitor medication fill rate and compliance

RESULT: Significant drops in ED visits, inpatient admissions and overall cost of careNATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 23: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

CASE STUDIES

The “Co-Location” ModelHealth system co-locates primary care and certain specialist providers in a common building, focused around specific health conditions

Chronic patients schedule extended visits and see multiple providers in one visit rather than separate, individual specialist appointments

As part of the visit, the patient’s “care team” meets together and discusses integrated care/maintenance strategies with the patient

In between scheduled visits, providers have case conferences to monitor progress coupled with phone and home monitoring

RESULT: Significant drops in ED visits, inpatient admissions and overall cost of care

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 24: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

CASE STUDIES

Advanced EMR Use

Large physician practice with multiple locations on a common EMR

Combines clinical information from its EMR with analysis of claims data from its largest payor– Analyze patterns of care, allowing evaluation of performance of

PCPs and contracted specialists– Specialists who are outliers in care patterns must conform or be

terminated– Assignment of patient referrals from PCPs to specialist with highest

match of experience and skill based on patient’s data – identity- blind to PCPs

NATIONAL ACCOUNTABLE CARE CONFERENCE

November 5, 2013

Page 25: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

STAYING FOCUSED

Support for clinical integration

– Furthers a contracting/payment strategy– Furthers an alignment/networking/market share strategy– Furthers a legal compliance strategy

Reducing cost of care

– Solutions to reduce medication errors/safety/infections– Solutions to reduce unnecessary utilization – volume & type of care– Solutions to support population health

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 26: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

STAYING FOCUSED

Improving quality– Solutions to benchmark, track and report

outcomes– Unobtrusive patient monitoring/apps

incentivizing behavior

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 27: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

STAYING FOCUSED

Improving patient experience– Solutions for online registration/scheduling– Solutions for smartphone maps/navigations– Solutions for online payment/account management– Online test and lab results, post-discharge instructions– Email scheduling & follow-up– Secure messaging– On-line price estimates

November 5, 2013

NATIONAL ACCOUNTABLE CARE CONFERENCE

Page 28: CLINICAL INTEGRATION 2.0 – THE INFORMATICS REVOLUTIONmeeting process and outcomes measures, and quality reporting Interoperability with respect to all departments in hospitals and

This presentation contains images used under license. Retransmission, republication, redistribution, and downloading of this presentation, including any of the images as stand-alone files, is prohibited.

This presentation may be considered advertising under certain rules of professional conduct. The content should not be construed as legal advice, and readers should not act upon information in this publication without professional counsel. All rights reserved.

Christi J. Braun | Mintz Levin Cohn Ferris Glovsky & Popeo PC Partner 202-434-7479 [email protected]

Paul R. DeMuro | Schwabe, Williamson & Wyatt, P.C.CPA, MBA, MBI (Biomedical Informatics), JD National Library of Medicare Post-Doctoral Fellow,

Oregon Health & Science University School of Medicine

NLM Grant No. T15LM007088 [email protected]

Jill Gordon | Nixon Peabody LLP Partner 213-629-6175 [email protected]

CONTACT INFO