16th Semi-Annual Diagnostic Coverage and Reimbursement Conference

February 11-12, 2020 | San Diego, CA

Hilton Garden Inn San Diego Downtown/Bayside

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DAY TWO | WEDNESDAY, DECEMBER 4

8:15 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON’S OPENING REMARKS
L. Patrick James, Chief Clinical Officer, Health Plans and Policy, Medical Affairs
QUEST DIAGNOSTICS

ACHIEVING SATISFACTORY PAYMENT FOR INNOVATIVE TESTS
In the continually evolving diagnostic landscape, where innovation is the key to both treatment improvement for patients and long-term profitability for the industry, companies seek proven strategies to maximize favorable coverage decisions. With a variety of methods to secure reimbursement, less traditional routes to payment such as the establishment of partnerships with pharmaceutical companies for clinical trials, as well as lessons learned by manufacturers of innovative tests having obtained reimbursement, are of high interest to professionals aiming to propel the field of diagnostics forward. This two-part case study series presents practical approaches to the core challenges faced by reimbursement executives.

 

9:00 PART 1 – OVERCOMING CHALLENGES FACING LIQUID BIOPSY MANUFACTURERS

  • Insight into business model enabling options for reimbursement
  • Timeline & methods for engaging with CMS & commercial payers
  • Constructing partnerships with pharmaceutical corporations

Mark Oldroyd, Senior Vice President, Commercial Markets, TEMPUS

 

9:30 PART 2 – CASE STUDY: ADVANCED DIABETES TECHNOLOGY

  • Factors for embrace or rejection of innovation by payers
  • FDA to CMS exchange & loss of information during translation
  • Future direction & clinical impact of innovative technology
  • Economic impact implications to payers & patients

Bruce Taylor, Director, Government Affairs & Market Access, DEXCOM

 

10:00 PRICING FOR NEW TESTS UNDER PAMA & PATHWAYS FORWARD FOR THE DIAGNOSTIC INDUSTRY

  • Influence of initial rate-setting of CLFS on private payers
  • Examining the impact of CDLT advisory panel
  • Risks associated with pricing under the gapfill payment method
  • Navigating variability & unpredictability in the pricing process

Paul Sheives, Director, Federal Health Policy & Reimbursement, ROCHE DIAGNOSTICS CORPORATION

 

10:45 COFFEE & NETWORKING BREAK

 

11:15 EXCHANGE GROUPS: REVEALING & COMPARING SOLUTIONS TO TEST-SPECIFIC CHALLENGES
With an abundance of diagnostic test types on the market, as well as in development, each necessitating unique considerations when developing and implementing the strategy for optimal payment, executives need to identify drawbacks and work through challenges specific to the test category. Through a collaborative session format, delegates have the chance to gain knowledge of established methods for engaging payers and promoting interest in a particular test category, as well as of emerging practices that have resulted in successful reimbursement. Through the lens of each specific test type, professionals will explore nuanced solutions to shared challenges alongside peers.

  • Group 1: Molecular Diagnostics
    Jennifer Hoglin, MYRIAD GENETICS
  • Group 2: Laboratory IVDs
    Lola Valenciano, DANAHER CORPORATION
  • Group 3: Next Generation Sequencing
    L. Patrick James, QUEST DIAGNOSTICS
  • Group 4: Companion Diagnostics
    Rob Dumanois, THERMO FISHER SCIENTIFIC

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:00 PANEL: EXPLORING THE POSITION OF DIAGNOSTICS IN VALUE-BASED HEALTHCARE MODELS
In contrast with the traditional fee-for-service model, value-based healthcare systems offer insurers and providers the opportunity to improve patient outcomes while reducing costs by taking a holistic approach to reimbursement. Payers are placing increasing emphasis on value-based payment as a means of ensuring that only truly valuable products are receiving coverage. With the continuous challenge of shedding light on the role of diagnostic tests in the overall patient treatment plan, reimbursement leaders are in need of insight into viable value-based agreement formats, as well as strategies to proactively establish partnerships with payers.

  • Clarifying value-based healthcare versus fee-for-service
  • Understanding DRGs & where diagnostics fit in the system
  • Approaches to establishing value-based agreements with payers

MODERATOR: Stephen Morales, MARWOOD GROUP

PANELISTS:
Ben Eckert, ADAPTIVE BIOTECHNOLOGIES

Tom Dugan, BIODESIX

Heather Brown, HEARTFLOW

Elizabeth Cormier, PERSONA HEALTH, INC.

 

2:00 COFFEE & NETWORKING BREAK

 

2:30 STATUS OF NATIONAL COVERAGE DETERMINATION FOR NEXT-GENERATION SEQUENCING TESTS
While originally finalized in 2018, the CMS national coverage determination for next-generation sequencing which approved testing in late-stage cancer patients was viewed by part of the industry as insufficient in scope. The decision was reopened for comments with a focus on germline testing and hereditary testing in early-stage cancer patients, addressing certain concerns from the industry but leaving many questions unanswered. Reimbursement leaders must understand implications of the modified version of the decision in order to inform reimbursement strategies for NGS testing.

Rob Dumanois, Manager, Reimbursement Strategy, THERMO FISHER SCIENTIFIC

 

3:15 UPDATES ON GOVERNMENT POLICY AFFECTING COVERAGE & REIMBURSEMENT OF DIAGNOSTICS
The US healthcare environment is continuously evolving based on policy changes at the federal level, leading to uncertainty for the healthcare industry and causing unique challenges for diagnostic manufacturers and laboratories. To ensure optimal reimbursement for tests, executives must remain abreast of new developments on an ongoing basis, and cultivate knowledge of the intricacies of various revisions to government policy. This session explores recent policy updates of most pressing importance to diagnostics manufacturers and laboratories in the effort of ensuring swift integration into reimbursement strategies.

Stephanie P. Hales, Partner, SIDLEY AUSTIN LLP

 

4:00 CLOSING REMARKS & CONFERENCE CONCLUSION