1. April 27, 2017
Using Evidence to Streamline Technology Selection and Decision Making Process Society for Arkansas Healthcare Purchasing and Materials Management
Marc Schlessinger, MBA, FACHE
Senior Associate, Applied Solutions Group
ECRI Institute

2. Patient Protection & Affordable Care Act
Increased emphasis on clinical efficacy, safety, and cost benefit of adopting and utilizing medical technologies
Despite challenges to:
Comply with Quality & Safety Mandates
Improve Health of Populations Served
Improve Management of Anticipated Future Medicare Cuts
Deliver Care Aligned with Evidence-Based Best Practices
Earn VBP & ACO Bonuses
Avoid Medicare Penalties for Excessive Readmissions
Avoid Medicare Cuts
Avoid Financial Penalties for “Never Events”

3. Can we satisfy the ACA’s opposing forces?
Financial Stability
Clinical Quality
Evidence-Based Value Analysis (EBVA):
The key to enabling healthcare professionals to provide high quality clinical care, improve patient outcomes, and realize significant cost savings concurrently

4. Evidence-based value analysis differentiators
Translates scientific data into actionable information
Engages greater physician and key executive involvement
Increases physician collaboration
Sustains cost savings
Enables evolution of value analysis efforts

5. Adapted from “Value Analysis: A new model for healthcare” by Strategic Marketing Initiatives (SMI) (2015)

6. Audience Polling Question
Where does your organization fall on the Value Analysis Maturity Curve? No Process Novice Intermediate Advanced Future

7. A wide variety of evidence sources
Pending FDA approvals
Short assessments
In-depth analyses
Literature searches
Technology overviews
Patient registries
Custom comparisons
Trend reports
Comparative effectiveness reviews

8. Levels of evidence HIGH LOW Meta-analysis from multiple trials
Large, multi-center randomized controlled trials (RCTs)
Meta-analysis from multiple trials
Smaller, single-site RCTs
Prospective studies
Retrospective studies
Studies with historical controls
Case reports/series
Expert/Consensus opinion
LOW

9. Grading evidence for objective decisions
Use pre-defined, standardized ratings to reflect the strength and direction of the evidence for each application of a technology, including:
Safety and efficacy
Patient selection criteria
Indications for use
Impact on health outcomes
Comparison with other options

10. “Best available evidence” vs. best evidence
Limited to currently available evidence
May or may not be “best evidence”
Best evidence is obtained from well-conducted:
Randomized controlled trials (RCTs)
Meta-analyses
Systematic reviews

11. Audience Polling Questions
Is your value analysis process supported by a systematic review of the evidence? No Yes In what format would it be most helpful to have evidence presented? What major points should be included in evidence reviews?

12. Health Technology Assessment Continuum
1,000s of topics
Emerging Technology Evidence Report
Custom Product Brief, Custom Rapid Review
FDA Approvals and Clearances Database
Health Technology Forecast
“Healthcare technology” may refer to any drug, device, surgical procedure, or diagnostic.

13. Why Is Evidence Based Value Analysis Necessary?

14. Why Is Evidence Based Value Analysis Necessary?

15. EBVA Case Study
Bone Substitutes: Utilization of Demineralized Bone Matrix (DBM) Allografts at Plymouth Medical Center

16. PMC’s DBM background
5 – 7 Orthopedic & Neurosurgery cases performed weekly in which DBM used as:
Bone void filler
Nonunion fracture treatment
Autologous bone graft extender
Suppliers historically successful with introducing their latest DBM products
DBM inventory stretched space & staff time resources
PMC’s Orthopedic surgeons and Neurosurgeons performed
approximately five to seven cases weekly over the past year in
which DBM was used:
As a bone void filler when void is due to trauma or tumor removal
For treatment of nonunion fractures
As an autologous bone graft extender for spinal fusion and
orthopedic procedures
With or without synthetic bone graft substitutes & allograft bone
Suppliers have been historically successful with introducing
their latest DBM products while assisting surgeons in cases in
which they know a DBM would be used
PMC stocked 50 DBM SKUs; managing this inventory stretched
space and staff time resources

17. Evidence-based standardization initiative
February Orthopedic & Neurosurgery section leaders asked to lead DBM standardization initiative
Evidence-based approach required by policy
Discussions with surgeons revealed:
Medtronic’s Grafton products preferred
No preference for other DBM products

18. PMC baseline annual DBM purchases

19. PMC baseline annual DBM units

20. Objective evidence collected and reviewed
Multiple internal data sources analyzed:
MMIS, Charge Master, EMR, & Quality data identifying utilization, cost, & outcomes with DBM products at PMC over the past year
Confirmed lack of protocol to guide DBM utilization
Compared PMC’s DBM products through ECRI’s Health Technology Assessment and PriceGuide services
Indications
Safety
Quality
Cost
Outcomes

21. Key findings from review of objective evidence
Allomatrix
Only RCT - no benefit with Allomatrix plus autologous bone vs. autologous bone alone
Case series - unacceptably high complication rate in nonunion fracture bone grafting
Bone void filler benefit identified in other case series
Grafton
Small RCT - similar fusion rates 2 years post-op for Grafton combined with local bone vs. autologous iliac crest bone graft
Successful use in scoliosis, hip reconstruction, anterior cervical discectomy and fusion reported in other studies

22. Key findings from review of objective evidence
Progenix
No human trial evidence supporting Progenix DBM’s efficacy in orthopedic use
Puros
Non-randomized comparison: Puros comparable to autologous bone for sinus augmentation
Only other study – Puros formed good quality sinus bone grafts

23. Securing support for DBM standardization
Findings shared with surgeons, who helped formulate product standardization recommendations
Administration approved surgeons’ recommendations
Materials Management & Surgical Services leaders briefed each DBM sales representative

24. DBM standardization results
Allomatrix restricted to bone void filler use
Grafton auto-substitution for other indications
Progenix eliminated - lack of clinical evidence
Puros eliminated - lack of clinical evidence for prior use
Grafton became PMC’s primary DBM product line
Inventory adjusted to cover historical utilization
More aggressive prices negotiated with Medtronic

25. DBM standardization results
Reduced DBM suppliers to one primary supplier and one small-volume supplier
Reduced DBM product SKUs by 78%
Annual DBM expenditures reduced by 15%
Second phase to initiative focused on utilization management already in progress
Elke’s Notes:
Reduced number of DBM suppliers from 4 to 1 primary
supplier (Medtronic) and one small-volume supplier
(Wright Medical)
Reduced DBM product SKUs by 78% (from 50 to 11)
Inventory space requirement reduced
Staff time to manage inventory significantly reduced
Projected annual DBM expenditures reduced by 15% ($49K)
SVAT and DBM physician users agreed to a second phase to
this initiative, focused on utilization management, which is
already in progress!
Optimizing DBM unit size by case type and complexity
Developing a DBM Utilization Protocol

26. Audience Polling Question
Does your value analysis process engage clinicians and allow them to vote on decisions? Yes No

27. Making new technology decisions
Decision-making
EBVA
Evidence
Evidence-based value analysis (EBVA) levels the playing field between clinical service lines, administration, and supply chain

28. Key concepts for implementing EBVA
Ensure clinical quality is kept at the forefront
Recognize that sound clinical evidence is compelling, especially to physicians
Create separate teams for high-cost, high-impact areas; focus on new service lines & those with potential safety concerns
Embed EBVA within the strategic planning process

29. Key concepts for implementing EBVA
Include multiple stakeholders on each team
Initiate and nurture physician engagement
Require C-suite support and engagement
Discuss how to handle weak or absent evidence
Calculate the ROI and share the results broadly

30. Thank You Questions? Marc Schlessinger, MBA, FACHE
ext
Thank You