generating quality data through collaborative research with an aco

Generating Quality Data through Collaborative Research with an ACO: Bridging the Gap to the Unmet Needs of Patients

!Todd Berner MD Director, Health Economics & Clinical Outcomes Research Astellas Scientific and Medical Affairs !

2nd Partnering with ACOs Summit May 29, 2013

Muller RW, ECRI Institute Conference 11.28.2012

Number of public and private ACOs is growing

Muhlestein D Health Affairs Blog “Continued Growth Of Public And Private Accountable Care Organizations” February 19, 2013

➢106 new ACOs join CMS Medicare Shared Savings Program (MSSP) January 2013 ➢Total number of CMS MSSP ACOs more than 250 ➢Covering 4 million Medicare beneficiaries



➢Medicare ACOs only tell part of the story- ACO growth has continued apart from the Medicare program with 428 total ACOs now existing in 49 states


➢Physician groups and hospital systems have become the largest backers of ACOs

ACOs

Physician GroupsHospital SystemsInsurersCommunity Based Organizations47%

44%

7.5%

1%


Improving Population Outcomes through the Triple Aim™

Improved Outcomes

Transforming Care Delivery

•

Transformation of Care

Accountable

Care

Payment

Models

Primary Care

Snyder R, ECRI Institute Annual Conference Nov 28,2012

EMR

Best Practices

The Train has left the station…..

FEE FOR SERVICE TO INTEGRATED CARE, NEW PAYMENT MODELS AND RISK

Listening to the Patient Voice in Research

Starting with the End in Mind

• Goal is to: • Disseminate valued information regarding

effectiveness and cost of care to payers and/or policy makers

Easy to say, harder to

do.

“When you come to a wall that is too high to climb, throw your hat over the wall,

and then go get your hat.”

!

!

-Old Irish Adage

Value Information= Valued Information

• Disseminate valued information regarding cost-effectiveness to payers and/or policy makers

• Real World Evidence Development • Follows from clinical findings, real-world

observations – Retrospective data studies – Models of care – Prospective observations – PROs “Value is in the

eyes of the Beholder”

Efficacy

14

Real World Evidence

Effectiveness

Real World Evidence:Efficacy vs. Effectiveness

Example- ➢ Overactive Bladder (OAB)

• RCT data • Extremely high placebo response rates • Difficult to show efficacy for drug compared to placebo • It is essentially all non-pharmacologic therapy compared

to non-pharmacologic therapy + drug • Real World data

• All of the behavioral, non-pharmacologic intervention associated with the RCT moves over to the drug side of the ledger

• This becomes a comparison of activated, engaged Rx recipients vs. those with just an Rx

Identifying the various Stakeholders

Identify the Value to Manufacturer: Match to needs of your audience

• Align corporate needs with customer needs

• Look for cost centers that are causing ‘pain’

• Evaluate quality measures for ‘real world relevance’

• Identify large patient populations with suboptimal treatment Ask

them!

Ask Them! … the details

• Uncovering the true needs • In this changing landscape, they may not have

a clear idea • Use therapeutic expertise to generate ideas

• Build on those ideas they do have

• But this might not be enough • May need to actually work together to figure it

out

The “We don’t have the bandwidth ”

Challenge

Winning under reform: Critical success factors

▪ High quality; reduce costs

▪ Ability to aggregate clinical capabilities and deliver evidence-based care

▪ Access to capital

▪ Ability to aggregate lives

▪ Physician / Hospital alignment

▪ Ability to aggregate and analyze data

▪ Ability to engage consumers

▪ Manage transition with one foot in FFS and stepping into risk-based contracting

▪ Ability to manage risk

▪ Understand benefit design

Opportunities for ACOs to Better Manage Costs

• Consider distinctions among medications • Acquisition costs • Utilization • Overall medical costs

• Identify interventions • Utilization management strategies • Drug formulations • Best practices for risk management • Care coordination

Complexities of Defining Quality

• Measurement Challenges • Disparate data sources needed

• What data should be reported that will be useful to stakeholders? • to achieve behavior change • for patient choice • for payer market decisions

• Criteria for Outcome Measures • Risk adjustment • Capture few unintended consequences

Quality Metrics

Benefit from a focused clinical set of proven, evidenced-based process and outcome measures that are most likely to drive quality outcomes and have utility for patients •Tie to the power of payment policies •Appreciate that clinical measures not credible to clinicians don’t get measured well, nor do they result in quality improvement •Many measures may not even contain the information needed to make QI changes

Evidenced Based Solutions

Measurement is not the endpoint •Need to find ways to improve on performance, using tested proven solutions that are sustainable because they are imbedded into practice & are widely accepted

• Bring process improvement into solutions • Solutions must be customizable to setting • Improvements must be able to be measured to

know if they work and at what cost

What Does Good Look Like?Toward Continued Excellence

• More patient-centered care • More predictable outcomes • Low tolerance for unwarranted deviations

from the norm • Collective Mindfulness • Greater efficiencies, less waste • More appropriate/evidence based care that

meets shared expectations • Evolving “Learning” Systems

Innovation Life Cycle and the ‘O’ Gap

Focus of the Chronic Pain Collaborative Intervention

• Reduce costs and improve outcomes in the chronic opioid utilization population across the continuum care • Patients using opioids have been documented to be especially

difficult to manage, and their care can be costly and complicated

• ACOs and continuum of care systems are in a particularly challenging arena as they must work within a capitated environment while improving the quality of care

• Systems with significant ownership in PCP and Specialty Practices are at significant advantage to capitalize on shared savings programs

• The chronic pain population is growing in size and the burden of care is increasing. There are more patients with chronic pain in the U.S. than with heart disease, stroke, diabetes and cancer combined (IOM 2011)

12-Month Chronic Opioid Utilization in Patients with Chronic Disease

0%

7%

13%

20%

26%

COPD Cancers Diabetes CKD CHF

COPD CancersDiabetes CKDCHF

Roberts M, Mapel D, Hartry A, Thomson H Ann Am Thoracic Soc 2013 (in press)

N=7952 N=4584 N=1694N=1841 N=6594

The Imperative to Remain Relevant

• Premier Research and Endo each had a desire to forge a new type of relationship to answer questions of relevance to ACOs

Working Together

• Relationship with an entity that can access the kind of data that’s important to the questions you’re trying to answer

!• In our case – we wanted to demonstrate

that some simple changes in pain medication management could make an important difference in system costs

Working Together: The Component Parts

• Patient Centeredness • Population Health • System Level Accountability • Leveraging Risk/Incentives

“Nothing happens in our business until a Doctor writes a prescription” The old days are over ,

the old ways have evolved…..

!• Hospitals | Health Systems

• Medical and Quality Leadership • C-suite Executive sponsorship • IT collaboration !

• Sponsor • Manufacturer- R&D, Outcomes !

• Facilitating Entity • Research • Analytics • Population Health !

• Subject Matter Experts • KOLs

Collaborative Participants

Define the scope of the solution

Nexus between what’s important to Manufacturer and what’s important to Health Systems

• Use best practices- be on the clinical cutting edge

• Keep in mind the need for cost containment • You’re gonna want to more than you really can

do • Start with seemingly reasonable goals and be prepared

to pare those down to Actually reasonable goals

Developing the change package

Our hypothesis Manufacturer’s deep understanding of therapeutic area Facilitator’s deep understanding of Healthcare and Health Systems Informed by Subject Matter Experts Moderated by cooperating sites

• Personnel and Resources • Institutional Strategies The Centrality

(and untapped opportunity)

to Utilize Pharmacists

Negotiating Process

• Co-develop the change package • Facilitator + Manufacturer in collaboration • Outline it in pencil

• Modify based on specific needs and realities once site leads are engaged • Not all sites have the same system or data

capabilities

Iron bar becomes an Iron Triangle!

Collaborative methodology

ACCELERATING IMPROVEMENT

©Premier Inc. 2012

Performance Improvement Research Collaborative Model: Disease State Level Collaboration

©Premier Inc. 2012

EFFECTIVENESS Does the change package affect the clinical outcomes of the patients in the intervention group?

SAFETY Does the change package impact the safety of the care provided to patients?

PROCESS How does the intervention / approach affect procedure choice, concomitant medications and devices?

CHANGE PACKAGE SUCCESS: Do the control and intervention cohorts compare in terms of outcomes, clinical success, patient, experience, resource utilization and duplication of best practices into multiple settings?

RISK | BENEFIT What patients are most likely to benefit? What risks, behaviors and comorbidities predispose for selection?

COST / PERFORMANCE How does the change package affect patient outcomes, and health care resource utilization? Was total cost of care appreciated?

Measuring Success:Applying a Patient-Centric Framework to Determine the Value of the Intervention

©Premier Inc. 2012

Expert Advisory

Panel Meeting

Training & Alignment Outcomes

Analysis

Outcomes Measured (these are identified by stakeholders which are represented in the ACO Chronic Pain Core Team

∗ Reduced Number of Drug Interactions ∗ Improved Readmission Scores ∗ Fewer Health Care Resources Used * Replicable Process Improvement

Pilot: Chronic Pain Improvement Model Example !

ACO Chronic Pain Core Team Established: Represents all Stakeholders

Expert Ad Panel is to guide work of team and are representative subject matter experts in chronic pain

Quantitative Data Captured in EMR and Premier Data Base

Change Package & Supporting

Data Provided

1 2 3Maintaining: Improvement: Best practice finalizations.

!Spread: National Sprint Initiatives via WebEx

Dissemination through agencies, healthcare networks and pubs.

Each PDSA (plan, do, study, act) Phase is Informed by the Learning Session Preceding It and Lasts 90

Days

Training & Alignment

©Premier Inc. 2012

Pharmacist Intervention

Targeted Medication

Review

Opioid Risk Assessment Tool

PCP Communication

SAO only use

Acetaminophen toxicity (for discussion)

Quality Improvement

Cost Reduction

Chronic Pain Collaborative Intervention

CYP450 interaction exposure-Eliminate pDDI

Medication Reconciliation

Inclusion Criteria: 1. 60/75 day opioid use 2. Insurance Coverage: All 3. PCP belongs to ACO or part of hospital owned group* Exclusion Criteria: 1.Patient has no PCP 2. PCP is not part of an ACO or a hospital owned physician group

Population: Non-admitted Emergency Department Patients

Study Period: 180 Days •90-day initial data collection •90-day secondary data collection/follow-up

Pharmacy Resident - 90-Day Follow-up

Chronic Pain Performance Improvement Research Collaborative:

Phase I Phase II

!Pilot ACOs recruited!Preliminary Predictive Model Applied to hospital specific data!Considerations for Data collection:!Admits w/72 hours!Resource Utilization! Costs!Readmits w/I 30 days!Continued High Risk Practices!!Initial Statistical Analysis Plan Developed!!!

Phase III Phase IVResearch: Burden of Illness &!

Predictive Model Blue Print

Project Phases

Work Products Completion

Recruit Hospital Pilots &!Faculty/Design !

Change Package

Implement Change Package !in Pilots &!

Collect Data

Disseminate Best Practices! learned & !

“Sprint” Through alliance

Kick- Off Meeting and Learning Sessions Conducted for 3-4 Hospital Pilots:!Data elements and collection methodology finalized!!Outcomes collected and analyzed!!Publication and Dissemination Plan Approved!!Meeting to train Pharmacy Residents at participating institutions!!!

Analyze Align Implement Spread

!Burden of Illness Study completed to address chronic pain patients across continuum of care; Premier creating comprehensive comparative analysis of chronic pain DDE determinants!!SME’s recruited and on contract for change package draft!!Initial design session for Change Package conducted!!!!

Partnering with Endo Pharmaceuticals, SMEs from Brigham and Women’s Hospital, Saint Louis University, Drexel University School of Medicine and Premier Hospital Systems to deliver improved care at a reduced cost.

!Kick Off Meeting for National Sprint Series and Speaking Events!!Best Practices Posted!!Final Publications Submitted!!!!!!

Emergency Department Analyses:9,214 Patients

Retrospective Study Results: How Likely are Suboptimal Medication Practices to be Resolved After an ED Visit?

Suboptimal Medication Practices!!!!!Any Pre-ED Suboptimal Medication Practice

Any Post-ED Suboptimal Medication PracticeDischarged with Suboptimal med

practice

Discharged without Suboptimal med

practice

Total

Yes (Suboptimal med practice present)

8007 (96%) 532 (4%) 8539 (93%)

No (Suboptimal med

practice not present)

345 (62%) 330 (38%) 675 (7%)

Total 8352 (91%) 862 (9%) 9214

!➢91% of chronic opioid users seen in the ED have one or more Suboptimal medication practices. ➢96% of patients with a pre-ED Suboptimal medication practice continued to have 1 or more Suboptimal practices within 90 days following discharge. ©2012 Endo Pharmaceuticals Inc. All rights reserved.

Rate of Admission to Hospital or Return to Emergency Department Among the Total Chronic Opioid Patient Population (N=9214)

0

12.5

25

37.5

50

≤ 72 hrs ≤ 30 days ≤ 45 days ≤ 60 days ≤ 90 days

Berner T, Ernst F, House J, Mills JR Poster presentation ASHP Summer meeting Minneapolis, MN June 6, 2013

Return to ED: Suboptimal PracticeReturn to ED

Unadjusted Adjusted*

Time Suboptimal Medication Practicesn = 8352

No Suboptimal Medication Practicesn = 862

Odds Ratio (95% CI) P-value

≤ 72 hrs 1204 (14.4%) 89 (10.3%) 1.51 (1.18-1.94) 0.001

≤ 30 days 1417 (17.0%) 114 (13.2%) 1.36 (1.09-1.71) 0.007

≤ 45 days 1447 (17.7%) 120 (13.9%) 1.33 (1.07-1.66) 0.011

≤ 60 days 1538 (18.4%) 123 (14.3%) 1.37 (1.10-1.70 0.004

≤ 90 days 1621 (19.4%) 133 (15.4%) 1.31 (1.06-1.62) 0.012

*Odds Ratios calculated using hierarchical logistic regression model adjusting for 28 comorbid conditions Ŧ Statistically Significant

• Suboptimal Medication practices have more return visits to the ED

• 50% more likely to return to ED within 72 hoursBerner T, Ernst F, House J, Mills JR Poster presentation ASHP Summer meeting Minneapolis, MN June 6, 2013

In-patient Hospital Admission Rate after Initial ED Discharge Among the Chronic Opioid Patient Population

(Total Cohort N=9214)

0

10

20

30

40

≤ 72 hrs ≤ 30 days ≤ 45 days ≤ 60 days ≤ 90 days


Total cost:

Total CostUnadjusted Adjusted*

Time Exclusive SAO

with pDDI n = 4812

Exclusive SAO without pDDI

n = 2015

Difference Mean (95% CI)

≤ 72 hrs $2492 ± 4119 $2172 ± 3309 $214 (22-395)

≤ 30 days $5823 ± 9458 $4493 ± 7600 $836 (403-1257)

≤ 45 days $7342 ± 11698 $5637 ± 9744 $1023 (468-1554)

≤ 60 days $8710 ± 13428 $6785 ± 12184 $1022 (313-1665)

≤ 90 days $11565 ± 17350 $8723 ± 14811 $1536 (658-2311)* Bootstrapped Analyses Ŧ Statistically Significant

❖ Total costs for patients with pDDI + Exclusive SAO were higher within 72 hours and continued through 90 days


Total Cost: C-II vs. C-III

Total CostUnadjusted Adjusted*

Time C- II Exclusive

SAOn = 5240

C- III Exclusive SAO

n = 1587

Difference Mean (95% CI)

≤ 72 hrs $2411 ± 4023 $2354 ± 3461 $48 (-143-252)

≤ 30 days $5694 ± 9210 $4561 ± 8069 $731 (314-1158)

≤ 45 days $7244 ± 11580 $5500 ± 9640 $1152 (610-1685)

≤ 60 days $8678 ± 13601 $6369 ± 11120 $1586 (939-2192)

≤ 90 days $11571 ± 17400 $7938 ± 13736 $2457 (1698-3217)* Bootstrapped Analyses Ŧ Statistically Significant

❖ $2,457 Potential increased cost when prescribing Exclusive C-II SAOs compared to C-III through 90 days

Ernst F, House J, Mills JR, Davis T, Berner T Poster Presentation ISPOR Annual Meeting New Orleans, LA May 20, 2013

Conclusions!

➢93% of the patients in this study left the emergency department on a combination of different suboptimal opioid medication practices

• These suboptimal practices were associated with more subsequent in-patient hospital visits and emergency room visits, as well as increased costs to the hospitals, the payors, and the patients. !

➢Patients with pDDIs are 18% more likely to have an inpatient hospital admission within 30 days post ED discharge and are 24% more likely to have an admission within 90 days

Conclusions!

➢C- II Exclusive SAO patients are 27% more likely to have an inpatient admission within 90 days than C- III Exclusive SAO patients

• A targeted medication review for patients prescribed chronic opioids to evaluate the presence of suboptimal prescribing practices could decrease the number of return visits to the ED within 72 hours by 50%.

!➢Elimination of one single type of suboptimal prescribing

patterns within chronic opioid patients (pDDI) could decrease 90-day costs by approximately $1,300 per patient

Conclusions

!➢C- II Exclusive SAO use cost approximately $2,762 more

within 90 days compared to C- III Exclusive SAO usage. !

➢Describing the interaction between both of the defined suboptimal opioid prescribing practices (pDDI +exclusive SAO) could be of even greater relevance in the future, as several regulatory bodies are currently considering modifications to opioid controlled substance schedules for short acting combination hydrocodone products

Finishing Strong: The Dissemination Plan

• Quality Messaging across Hospital System Alliances

• Convention and Meeting Podiums • Manuscripts • Posters • Account Manager and Field HEOR

presentation materials • Partnerships with CMMI, AHRQ, CMS- Hospital

Value Based Purchasing Program & Demonstration Projects, Commercial payers

“Knowing is not enough; we must apply. Willing is not enough; we must

do.” -Johann Wolfgang von Goethe

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