A Special Thanks to Our Sponsors

Day One Agenda | Wednesday, December 6

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS
FRONTRUNNER HC

9:00    PANEL DISCUSSION: DEFINING CRITICAL COMPONENTS OF A HOLISTIC APPEALS STRATEGY
• Addressing the increasing volume of appeals to manage
• Methods to expedite first & second level lab-submitted appeals
• Diving further into third, fourth level appeals & more
• Potential partnerships with patients & appealing to outside entities
Julie Wiedower Kaylor, Director of Medical Affairs, Managed Care
GUARDANT HEALTH
Julia Dawson, Associate Director, Managed Care
PACIFIC EDGE DIAGNOSTICS

9:45   FUTURE OF THE FRONT-END CLAIMS PROCESS: TEST ORDERING & PRIOR AUTHORIZATION
• Improving the front end claims process would involve having the PA workflow begin in the physician offices
          » Right now it is happening in the lab workflow, after the fact
• Automation can reduce human effort & burden on all healthcare service provider side
• One key item is the benefits eligibility process, there are certain pitfalls that occur, these can be avoided
Andrew Mignatti, CEO
CAREVISO
Stephanie Gandomi, Director, Market Access
GENEDX

10:30   COFFEE & NETWORKING BREAK

11:00   LEVERAGING DATA TO MAXIMIZE REVENUE CYCLE TEAM PRODUCTION
• Understanding the data
• Applying actionable items
• Setting team priorities
• Maximizing team output & ROI
Michael Marshall, Managing Director
e5 WORKFLOW

11:45   PANEL DISCUSSION: TRANSFORMING HEALTHCARE THROUGH TRANSPARENCY & DIALOG
• The crucial intersection of the patient’s financial experience & clinical experience
• Breaking down the silos to create transparency & dialog across the continuum
• The impact of a “super-clean order” at the front-end & why it matters to the industry
• What it will take to disrupt healthcare & drive transformation
Mark Hiatt, Chief Medical Officer
RADSITE
John (JD) Donnelly, President & CEO
FRONTRUNNER HC

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30  PANEL DISCUSSION: UNDERSTANDING THE PSYCHOLOGY OF THE PAYER & CLINICIAN TO PURSUE MARKET ACCESS EFFECTIVELY
• Appealing to what matters most to the payer
• Addressing Medical Directors as Clinicians
• Elaborating upon payers’ mindset, mission & vocabulary
• Targeting the payer’s primary focus: Patients/members
Mark Hiatt, Chief Medical Officer
RADSITE
Kathryn Mraz, Manager of Clinical Payor & Policy Relations
CARIS LIFE SCIENCES
Dan Visage, SVP of Payor Access
DERMTECH

2:15    OPTIMIZING REIMBURSEMENT OPERATIONS FOR TESTS UNDER INCREASINGLY COMPLEX MEDICAL POLICIES
• Securing a clear understanding of payer medical policies & ensuring compliance
• Common obstacles encountered by labs amidst the growing complexity of specialized testing
• Specific challenges with different disease states & multiple clinical coverage criteria application to a single test
• Effective strategies & actions to implement to optimize reimbursement processes
• Analysis of essential data & insights pertaining to favorable coverage policies to improve revenue cycle management
Tom Cronin, Senior VP of Revenue Cycle Strategy & Analytics
QUADAX

3:00   COFFEE & NETWORKING BREAK

3:30  PAYER & LBM ROUNDTABLES
Part 1 – SHEDDING LIGHT ON LBMs’ PREPONDERANT POSITION IN THE REIMBURSEMENT LANDSCAPE
• Position of LBMs vis-à-vis private payer organizations
• Increasing reliance of payers on LBM decisions
• Methodology for test validation & decision-making process
• Opportunities for labs & developers to communicate
• Involvement & areas of focus once the test is on the market
• Forecast of LBM weight in the foreseeable future
Tanya Hendrickson, Senior Director of Product Management, Ancillary Benefit Management
OPTUM
Rob Dumanois, Director, Reimbursement Strategy
THERMO FISHER SCIENTIFIC

4:15   Part 2 – CLARIFYING PAYER METHODOLOGIES TO MAKE INFORMED COVERAGE DECISIONS
• Technology evaluation process walkthrough
• Preferences towards clinical testing methodologies
• Expectations towards evidence to demonstrate:
        » Clinical utility
        » Economic value
• Positive decision criteria: Key data to secure coverage
• Policy development & updating mechanisms & influences
MODERATOR:
Paige Nardi, VP Market Access, Reimbursement & Billing
HEPQUANT
PANELISTS:
Gabriel Bien-Willner, Program Medical Director, MolDX & CMO
PALMETTO GBA
Matt Fickie, Sr Medical Director
HIGHMARK
Eugean Jiwanmall, Sr Research Analyst; Medical Policy & Technology Evaluation
INDEPENDENCE BLUE CROSS
Sarah Kurley, Associate Director – Molecular Diagnostics Evidence
OPTUM GENOMICS

5:00   PANEL DISCUSSION: CLARIFYING Z-CODES & INCREASING REQUIREMENTS FROM PAYERS
• Z-codes history & purpose in the diagnostic field
• Rationale for recent shift in UHC’s requests for Z-codes
• Implications for test developers in obtaining payment
• Managing the ripple effect & forecast of the near future
Gabriel Bien-Willner, Program Medical Director, MolDX & CMO
PALMETTO GBA
Sarah Overton, Director, Revenue Cycle Management
VELSERA
Brian Carey, Partner
FOLEY HOAG 

5:45   Closing Remarks & End of Day 1

Day Two Agenda | Thursday, December 7

8:30   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS
Tom Cronin, Senior VP of Revenue Cycle Strategy & Analytics
QUADAX

9:00   IMPACT OF THE INFLUX IN BIOMARKER STATE LAWS ON DIAGNOSTIC REIMBURSEMENT
• Clarifying the rationale for biomarker-specific legislation
• Panorama of current implementation & expectations for the future
• Enforcement in practice & effect on diagnostic labs to date
• Successes or lack thereof in communicating with State agencies
Erik Schulwolf, Associate
FOLEY HOAG

9:45  DISSECTING THE FDA’S PROPOSED RULE GOVERNING LDTs & EFFECT ON LABORATORIES
• 21CFR part 809 amendment to clarify the definition of IVD
• Phaseout of current approach & enforcement roll-out
• Rule adoption & industry transition timelines
• Open questions pertinent to:
           » Potential grandfathering regime
           » Compliance issues relevant to the nature of LDTs
           » Phaseout program alignment with other programs
• Next steps & expectations for rule finalization
Christine P. Bump, Principal
PENN AVENUE LAW & POLICY

10:30   COFFEE & NETWORKING BREAK

11:00    LISTEN TO YOUR DOCTOR! HOW MEDICAL DECISION SCIENCE CAN (AND SHOULD) STEER MARKET ACCESS TO NOVEL DIAGNOSTICS
• Quantify the current gaps in care & factors that influence physicians’ testing decisions, in preparation of payer & market positioning
• Evaluate how healthcare providers comprehend the educational/detailing materials to be provided for a given test, laying the groundwork for adoption
• Assess the eagerness, as well as indicated & equitable use of a test, informing the creation of IFUs
• Project downstream budget impacts that are likely to occur as a consequence of physician decision-making, ensuring that a given test is economically sustainable
Randy E. David, VP, Clinical & Life Sciences Programs
QURE HEALTHCARE

11:45   CASE STUDY PRESENTATION
HULL ASSOCIATES, AN AVANIA COMPANY

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   OPPORTUNITIES IN COLLABORATING WITH HOSPITALS TO GENERATE HEOR EVIDENCE
• Identifying research partners at leading US hospitals for diagnostics HEOR studies
• HEOR study types, feasibility, prerequisites & relevance for reimbursement & assay adoption decisions
• HEOR study types to support product launch vs hospital adoption of diagnostic tests
• Creating cost-efficiencies in partnering with hospitals & containing budgets
Artem Boltyenkov, Director, Global HEOR
SIEMENS HEALTHINEERS

2:15   MASTERING & ENHANCING STRATEGIES TO OPTIMIZE EVIDENCE PRODUCTION
Given the critical importance of demonstrating clinical utility, scientific validity, and economic value to healthcare payer organizations in order to secure coverage and reimbursement, teams must ensure a sound evidence generation strategy is in place. Working off of each participant’s personal experience, this session enables attendees to discuss with peers in a small group format, and share valuable lessons learned relevant to methods aiming at enhancing evidence generation in the clinical setting.
Part 1 – Case Study: Practical Approach to Analyze Evidence Needs & Reach Targeted Goals
Anna Ogloblina, Director of Product Management
BOSTONGENE

3:00   Part 2 – Small Group Discussions: Sharing Experience & Lessons Learned
Julie Wiedower Kaylor, Director of Medical Affairs, Managed Care
GUARDANT HEALTH
Lena Chaihorsky, SVP, Payor Innovation
ALVA10
Anna Ogloblina, Director of Product Management
BOSTONGENE

3:45   Closing Remarks & Conference Conclusion