This document summarizes a presentation about generating quality data through collaborative research with an ACO. The number of public and private ACOs is growing rapidly, with over 250 CMS MSSP ACOs covering 4 million Medicare beneficiaries. The goal of the collaborative research is to disseminate valued information on effectiveness and costs of care to payers and policymakers. Real-world evidence studies can provide insights beyond randomized controlled trials by observing patient outcomes across delivery system models. Measuring quality requires considering multiple stakeholder perspectives to identify metrics that drive improvement and have utility.
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Generating Quality Data through Collaborative Research with an ACO
1. 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
3. 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
4. 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
➢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
5. 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
6. Number of public and private ACOs is growing
➢Physician groups and hospital systems have become
the largest backers of ACOs
ACOs
Physician Groups
Hospital Systems
Insurers
Community Based47%
44%
7.5%
1%
Muhlestein D Health Affairs Blog “Continued Growth Of Public And Private Accountable Care Organizations” February 19, 2013
11. 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.
12. “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
13.
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”
15. 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
17. 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!
18. 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
19. 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
20. 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
21.
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
22. 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
23. 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
24. 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
26. 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)
27. 12-Month Chronic Opioid Utilization in
Patients with Chronic Disease
0%
7%
13%
20%
26%
COPD Cancers Diabetes CKD CHF
COPD Cancer
Diabetes CKD
CHF
Roberts M, Mapel D, Hartry A, Thomson H
Ann Am Thoracic Soc 2013 (in press)
N=7952 N=4584 N=1694N=1841 N=6594
28. 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
29. 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
30. 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…..
31. !
• 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
32. 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
33. 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
34. 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!
39. 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
40. 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 IV
Research: 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!
!
!
!
!
!
44. 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
45. Return to ED: Suboptimal Practice
Return to ED
Unadjusted Adjusted*
Time
Suboptimal
Medication
Practices
n = 8352
No
Suboptimal
Medication
Practices
n = 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
47. 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
Berner T, Ernst F, House J, Mills JR
Poster presentation ASHP Summer meeting Minneapolis, MN June 6, 2013
49. Total cost:
Total Cost
Unadjusted 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
Berner T, Ernst F, House J, Mills JR
Poster presentation ASHP Summer meeting Minneapolis, MN June 6, 2013
50.
51. Total Cost: C-II vs. C-III
Total Cost
Unadjusted Adjusted*
Time
C- II Exclusive
SAO
n = 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
52. 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
53. 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
54. 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
55. 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
56. “Knowing is not enough; we must
apply. Willing is not enough; we must
do.”
-Johann Wolfgang von Goethe