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

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”

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

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

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

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

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

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

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

“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

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?

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. http://gallery.yopriceville.com/Yoville/Pot-of-Gold#.VsTawML2bmQ

Why Is Evidence Based Value Analysis Necessary?

Why Is Evidence Based Value Analysis Necessary?

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

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

Evidence-based standardization initiative February 2015 - 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

PMC baseline annual DBM purchases

PMC baseline annual DBM units

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

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

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

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

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

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

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

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

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

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

Thank You Questions? Marc Schlessinger, MBA, FACHE 610-825-6000 ext. 5420 mschlessinger@ecri.org Thank You