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What Required to Evolve fromLab 1.0 (Volume) to Lab 2.0 (Value)

James M Crawford, MD, PhDjcrawford1@northwell.edu

Senior Vice President for Laboratory Services, Northwell Health

Professor and Chair, Pathology/Lab MedicineDonald & Barbara Zucker School of Medicine at Hofstra/Northwell

Manhasset, NY

Disclosures

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• ClaraPath (tech transfer from Cold Spring Harbor Laboratory)─ Scientific Advisory Committee

• Northwell Health Genomics Alliance (OPKO/BioReference)─ President of LLC

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The Road for Project Santa Fe

2017-2018Push existing projects through

Try to get them publishedPresent to Assoc Path ChairsNov 2017 PSF Workshop #1

Shamelessly talk-it-up

2018 Mar-May3rd Annual Retreat

1st project “in press”2 projects “submitted”EWC PSF Workshop #2

Begin forming Non-Profit

2018-2018Build the Evidence Base

Nov 2018 PSF Workshop #2Promote an open community

of Labs pursuing “Lab 2.0”

April 2015“Best Practices”, “Cost Efficiencies”

are not enoughFind like-minded laboratories who

are willing to put their reputationsat risk to change the paradigm

March 2016First PSF meeting (Santa Fe, NM)

MissionThink TankCompare current efforts

Commit to sharing project ideas

2016: Call-to-Action

2016-201712-month agenda

Institutional project trackingBusiness Value StatementsDevelopment of White Paper

2017: Work!2017 Mar-May2nd Annual RetreatWhite Paper publishedEWC PSF Workshop #1

2018: What is the Evidence?

Fundamental Premise

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• We have an advantage as in-system laboratories.

• Use it! (while you still have time….)

Lab 1.0 → Lab 2.0General Principles

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Know your StakeholdersWhat is their language? On what basis do they make their decisions?

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• Patients (Consumers)

• Providers (Physicians and the broader health care team)

• Hospital and Health System Administration

• Payers (including Benefits design)

• (And in an indirect fashion):

─ Employers (Plan design, Costs)

─ Civic Agencies and the Community

Lab 1.0 Value Statements: Stakeholders*

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What is “given” (a “commodity”)

• Access of Patients to Laboratory Testing

• Accuracy of lab results

• Absence of error

• Timely resulting (TAT)

• Expertise in what we do (AP, Molecular, Coag, BB/TM….)

• Functional Information Technology (LIS, EHR interfaces)

• Responsiveness: for Medical Practice; for Problem-Solving

Are any of these “Pain Points”? And for Whom?

*What they “know”

What distinguishes your 1.0 Lab from others?*

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PAYER

• [Cost-per-Test] – ambulatory (not factored in to DRG payments)

• Ability to report [Lab Data] to the Payer/Plan

HEALTH SYSTEM LEADERSHIP

• [Cost to organization] (DRG payment system)

• [Absence/Presence of Pain Points]

• [Financial Contribution]

• [Monetizable Valuation] if sold to a commercial lab

PROVIDERS

• [Expertise] • [Turn-around Time] • [Test Menu]

PATIENTS

• [Co-Pay] (Benefits design) • [in-network] (or not)

• [Access to Draw Sites] *What they “know”

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• Financial Outcomes (Total cost-of-care, Total revenue)• Patient Outcomes• Patient Experience• Provider Experience• Health System Quality Metrics• Health System Ratings by Plans• Health System Brand & Reputation

*What they “don’t know”

What 2.0 Evidence can make you the Lab-of-Choice?

So what should your Lab prioritize? (1.0 → 2.0)*

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Follow-the-money?

• Revenue Cycle initiatives (e.g., coding, billing)

• Value-Based Payments

• Risk Adjusters (e.g., MCC, HCC)

• Total cost-of-care (pmpm)

• Leakage out-of-network

• Market Growth – for Lab, for health system

• Favorable contribution to health system

Actually Caring for Patients?

• Gaps-in-Care

• Risk identification, escalation-of-care

• Individual programmatic initiatives (e.g., AKI, ASP, Sepsis, DMT….)

*What we should “know”

How does a 2.0 Laboratory deliver “Value”?*

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FINANCIAL

Contribute positively to health system Financial Outcomes

• Improve Health System Revenue: Documentation and Coding

• Provide lower cost services: or will someone else do it instead?

• Support Value-based Payment: meeting contractual metrics

• Support Risk-based Payment: Coordinating care at lower cost

CLINICAL

• Improve Patient Access: Patient-centered care

• Improve Patient and Provider Experience: Are you a “good lab”?

• Actually improve Patient Outcomes: Can you quantify it?

Leverage the Information you are already generating.Demonstrate your impact on Outcomes (of whatever nature).

*How we get there

Why is it so hard to demonstrate our 2.0 Value?*

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• Lab is not (traditionally) the effector arm of health care delivery

• Lab has not demonstrated cause-and-effect:-we cannot prove that Patients are better for using our Lab-Attribution is not given to Lab if others have already claimed it

• Decision-making about Lab does not factor in avoidance of cost:-closure of Gaps-in-Care-identification of Patients-at-Risk (and intervention)-Diagnostic optimization, Treatment optimization

• In the current system, Lab is either:- an Expense (in-patient)- a declining source of Revenue (ambulatory)

• Lab does not have independent value in informing Risk:─ Plans already have the Lab data!

*Barriers

There is no time like the Present

• Never let a good crisis go to waste

• The cost of doing nothing is immense

• Be insistent and intrusive

• Listen, talk, and deliver

• Prioritize (or be over-taken by events = OBE)

• Build upon your in-system advantage while you have it

“Clinical Lab 2.0” is about Leadership, not Followship

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Lab 1.0 → Lab 2.0Further PSF Examples

(with permission)

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Using Laboratory Data To Generate ‘Value’ (improve outcomes and decrease costs)

Across the Healthcare Enterprise

Grand Rounds, University of WashingtonSeattle, Washington October 5th 2016 16

Dr. Gaurav Sharma

Director, Regional Laboratory

Henry Ford Health System

Dr. Ilan Rubinfeld

Associate Chief Medical Officer

Henry Ford Hospital, Detroit

Data Value

Laboratory Utilization Task Force

1. Identify the Common Goal (for all Stakeholders)

2. Acquire organizational Legitimacy

3. Form the Governance mechanism

4. Gather required Team Members

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5. Define the Process

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ConclusionAdoptionGovernancePilotSteering

GroupIdeation

LAB Providers EMR AnalyticFinance

Eliminating DAILY Labs

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ConclusionAdoptionGovernanceAnalytics

And Pilot

Steering

GroupIdeation

Should we do daily

labs?

Let us ask the stake holders?

Yes, this looks valid Approved

EMR change 6/8/16

IPD OPD ER ICUExceptions FK506 Cyclosporine INR

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Other Henry Ford Health System LUTF* Projects

1. 3rd Troponin (following 2 negatives) in ED “rule-outs”

2. Proper use of Vitamin D testing

3. Blood Transfusion in Patients with Hb > 7 g/dL

*Lab Utilization Task Force

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The Laboratory Has More to Offer Than Test Results We deliver (using the Scientific Method)

Myra Wilkerson, MDDonna Wolk, PhDJordan Olson, MDDiane KremitskeHosam Farag, MD

Program “Intervention”*

(e.g., At Home Care)

Outcome Cost of care

Mortality rate Disease or event

Length of stay in hospital

Patient oriented research (POR) choices

*also termed “Exposure”

Outcome Cost of care

Mortality rate Disease or event

Length of stay in hospital

POR questions

Temporal relationship?Causality?

Program “Intervention”

(e.g., At Home Care)

Confounding Variable(s)

e.g.Type of the disease

Outcome Cost of care

Mortality rate Disease or event

Length of stay in hospital

POR controls

Program “Intervention”

(e.g., At Home Care)

Temporal relationship?Causality?

• Laboratory ServiceTraditional Care

With Lab 1.0

• Laboratory ServiceAt Home Care with

Lab 1.0

Geisinger Outcomes with No Laboratory Input: ED visits per 1000, Readmissions per 1000, episode/ 30 & 90 days, Total cost of care/Admission

HCAHPS Score (Hospital Consumer Assessment of health care provider System)

Exposures Outcomes

Number of (Strokes, MI, Amputations, specialist visits) Type and number of reported infection Medication adherence Quality of Life, Mortality rate Laboratory trends (HbA1c, lipid profile, ALT/AST, BUN, creatinine, urea, CK )

Outcomes: No Laboratory Input

• Laboratory ServiceTraditional Care

With Lab 1.0

• Laboratory ServiceAt Home Care with

Lab 1.0

Geisinger Outcomes with No Laboratory Input: ED visits per 1000, Readmissions per 1000, episode/ 30 & 90 days, Total cost of care/Admission

HCAHPS Score (Hospital Consumer Assessment of health care provider System)

Exposures Outcomes

• Laboratory Leadership and Prediction

At Home Care with Lab 2.0

Number of (strokes, MI, amputations, specialist visits) Type/number of reported infections Medication adherence Quality of life, Mortality rate Laboratory test trends: HbA1c, lipid profile, ALT/AST, BUN, creatinine, urea, CK, other

Outcomes with Laboratory Input

Outcomes: No Laboratory Input

Traditional Care

With Lab 1.0

At Home Care with Lab 1.0

Geisinger Outcomes with No Laboratory Input: ED visits per 1000, Readmissions per 1000, episode/ 30 & 90 days, Total cost of care/Admission

HCAHPS Score (Hospital Consumer Assessment of health care provider System)

Exposures Confounding factors Outcomes

At Home Care with Lab 2.0

Number of (strokes, MI, amputations, specialist visits) Type/number of reported infections Medication adherence Quality of life, Mortality rate Laboratory trends (HbA1c, lipid profile, ALT/AST, BUN, creatinine, urea, CK )

Outcomes with Laboratory Input:

Geisinger Outcomes with No Laboratory Input:

Age, Gender, Race Socioeconomic statusEducation, InsuranceType of disease (Top 6): e.g. Chronic kidney disease (CKD) Congestive Heart Failure (CHF), Coronary artery disease (CAD), Pulmonary artery disease (PAD), Chronic obstructive Pulmonary Disease (COPD) Diabetes, Hypertension, Obesity

Meta-analysis (EBLMPG)

Systematic review (EBLMPG)

Randomized controlled trial (RCT)

Quasi-experimental studies

Cohort study (Prospective is better than Retrospective)

Case control study

Case report & Case series Effort is low Value of evidence is low

Effort is highValue of evidence is high

1. Consider the needs for “Hierarchy of Evidence”

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Study Design

Basic Science ”Bench” research

Clinical research

Experimental ObservationalInvestigator assigns exposure

Case Report Case-Control Study

Cohort Study

Cross Section Study

AnalyticalDescriptive

Case Series

Ecological Study

Comparison group?

Random allocation

Randomized Controlled Trial

(RCT)

Non-Randomized Controlled Trial

Systemic review

Meta-analysis

Clinical practice guidelineAnimal study

Cell study

Biochemistry study

Cross Section Study

Prospective Cohort Study

Retrospective Cohort Study

Primary research Secondary research

Transitional research ”Bench to

bedside”

Yes No

YesNoNoYes

OE

E O

E

O

What has Project Santa Fe learned (2016-2018)?

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Translating 2.0 “Thought” into “Action” is hard

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Institutional “Projecting”

• Institutional “receptivity” to a Lab-initiated project varies widely

• Institutional need for any given Lab-initiated project varies widely

• Institutional entry-points (aka, “politics”) for Lab vary widely

• Lab capabilities for doing any given project vary widely

→ Each PSF member is bringing its own “lessons learned” forward

Do PSF members act apart or in a multi-institutional fashion?

• To date: “inspiration” is multi-institutional; “projecting” is local

• 2018-2019: formal work groups to drive direct collaboration

Key “Lessons Learned”

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• Examine Institutional programs: is Lab participation “1.0” or “2.0”?

• Prioritize projects on what will get attention of C-suite

• Track your Metrics before-during-after “Intervention”

• “Clinical Lab 2.0” is an oxymoron: it should be “Medicine 2.0”

→ Lab cannot generate “2.0” on its own

Right-to-Play

• If Lab is creating Data, Lab should plan for monetizing that Data:

→ What is the Value of the Data?

How can that Value be attributed to Lab?

What is the monetizable (Lab) Product?- Impact on Clinical Care- Impact on Cost-of-Care

- Impact on Revenue/VBP

Figure this outbeforehand

Lab 2.0 must have separate valuation.Do not cannibalizeyour existing 1.0 value.

Key points from (as yet unpublished) PSF projects

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• For those projects with Economic Impact Analysis, ROI > 10:1

• Successful projects had outcomes that mattered to the CEO

• Critical Project Features─ Conduct projects rigorously using the Scientific Method*─ Projects take time: “continuous improvement”, not “before:after”─ Isolate variables, control for confounding variables─ Strive for ROI in the 1st year, with sustainable 5-year benefit─ Lab must be able to “own the outcome”

- Impact on “Expense” is more proximate than impact on “Revenue”─ While “statistical” outcomes are nice, do not overlook the “Absolute”─ Only take Risk on what you (Lab) can control

• Focus relentlessly on the [Economic Value of Lab Data]

─ Address the Business Models of your Stakeholders

* “Quasi-Scientific” (= Observational) is OK – and real-life

Key Success Factors*

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• Shared Values, Responsibility and Purpose (Positive Interdependence)

• Individual Accountability

• Norms, Structure, and Process; Willingness to Fail**

• Good “Sociology”: Face-to-Face interactions, but─ Do the real work off line; Prep and have all your ducks-in-a-row─ Pre-syndicate when possible─ Cultivate your Participants, and give them reason to participate─ Know your Agitators and Radicals; love them, but keep them close─ **The more impact the project has, the less risk you can take

• Failure points: ─ Lack of clear Authority─ Lack of joint-ownership with Clinical Leaders─ Lack of actual Data─ Lack of a clear and defined Process *From Henry Ford Health System LUTF

Particular Opportunities for Lab

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• Organizations can have Vision and Strategies, but might be weak at Tactics. Lab is really good at Tactics. Find the tactical “sweet spot” for Lab involvement in system projects.

• “Back-mining” high cost patients can be very productive: How did they become high-cost? What are the predictors?

Two definitions of “Lab 1.5”

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1. (Bad): Lose Revenue as a result of Utilization Management, without yet monetizing the Value-Added that Lab is providing to the overall Shared Savings in health care delivery.

2. (Good):

─ 1.0: Maximize Lab efficiencies and achieve Growth

─ 1.5: Diversify Revenue Streams with complementary business

─ 2.0: Drive Lab’s Value for “Medicine 2.0”: work out prospective payment

“Go Vertical” in your learning

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Topics you (or someone in your group) must master

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Value-Based Payments

• HEDIS, P4P, Star Ratings, Shared Risk, MCCs, HCCs, Risk Adjusters

Economic Attribution

• The costs of delivering all of your institutional health care─ (e.g., LOS, Pharmacy, Diagnostic/Therapeutic Optimization)

• Actionable opportunities that Lab can impact

AS IT IMPACTS YOUR HEALTH SYSTEM, continuous tracking of:Changes in Federal and State policy and payment schemes

Changes in Commercial Payer policy and payment schemes

Acknowledgement

Project Santa Fe

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Thank You

jcrawford1@northwell.edu