Diagnostic Coverage & Reimbursement Conference

A Special Thanks to Our Sponsors

Day One Agenda
Tuesday, February 4

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   OPENING ICE BREAKER: MAKING “V-I-P” CONNECTIONS & SHARING INSIGHTS
In this interactive kick-off session, attendees are encouraged to rate themselves as a V-”Veteran” in the industry, I-”Intermediate” or P-”Potential”, and meet with at least 2 other participants of different ranks in order to form a V-I-P group and build new contacts. Furthermore, “Intermediates” and “Potentials” enjoy an opportunity to learn directly from industry “Veterans” by sharing a top-of-mind challenge with the group for brainstorming and immediate feedback.
Kat Pugh, Director of Market Access
AMBRY GENETICS

9:30   PANEL DISCUSSION: ANALYZING SPECIFICATIONS IN THE FDA FINAL RULE FOR LAB DEVELOPED TESTS
• Determination of LDT type & timeline to compliance
• Addressing industry comments from preamble
• Expectations for enforcement discretion policies
• Long-term influence if final rule withstands objections
Paige C. Nardi, HEPQUANT
Michael Ryan, MCDERMOTT, WILL & EMERY
Emma Alme, GUARDANT HEALTH

10:15   PRESENTATION BY XIFIN
Clarisa Blattner, Sr. Director of Revenue & Payor Optimization
XIFIN

11:00   COFFEE & NETWORKING BREAK

11:30   OVERCOMING LIMITATIONS IN CURRENT PAYMENT FRAMEWORKS FOR COMPANION
DIAGNOSTICS
• Collaborative partnerships with pharmaceutical companies
• Developing a value proposition to reflect true cost savings
• Gaining adequate reimbursement for dx & drug therapy
• Emerging pathways to increase efficiency for dx-drug pairings
Kalliopi Trachana, Director, Market Access
ILLUMINA

12:15   PRESENTATION BY QUADAX

1:00   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

2:00   FIRESIDE CHAT: ESSENTIAL COMPONENTS OF AN EFFECTIVE PAYER CONTRACTING STRATEGY
• Minimum criteria needed to enter contract negotiations
• Market knowledge to engage in effective dialogue
• Informative data & models to support favorable terms
• Policy & contracting mechanisms influencing decisions
• Expectations & mindset regarding prior authorization
Barb Liwosz, BCBSA
Tom Dugan, BIODESIX

2:30   PRESENTATION BY AVANIA LLC
Eric Lam, Vice President
AVANIA

3:15   SMALL GROUP DISCUSSION: ADDRESSING ONGOING CONCERNS OF THE Z-CODE INITIATIVE
• Eligibility for z code usage outside of network or geographical area
• Commonly seen examples of critiques leading to rejection
• Navigating next steps with a Z code denial
• Appeals process to re-approach MolDx upon adverse result
• Impact of Moldx program introduction on overall strategy
Gabriel Bien-Willner, Medical Director, MolDX; Chief Medical Officer
PALMETTO GBA

4:00   COFFEE & NETWORKING BREAK

4:30   OPPORTUNITIES TO LEVERAGE GOLD CARD PROGRAMS FOR PRIOR AUTHORIZATION
• Legislation to enact gold card programs in various states
• Commercial payers initiating programs within networks
           » Eligibility criteria
           » Application process
• Outreach to providers to encourage participation
• Practical approach to maintaining gold card eligibility
Debbie Windsor, Payer Contracting
MAYO CLINICAL LABORATORIES

5:00   FIRESIDE CHAT: CREATING EFFICIENCIES IN MANAGING APPEALS & DEMONSTRATING MEDICAL NECESSITY
• Identifying cases warranting an appeals process
• Building impactful arguments to overturn denials
• Supporting the rationale to authenticate medical necessity
• Successes in involving the patient in the process
• Lessons learned to increase efficiencies in case management
Mark Hiatt, RADSITE
Dennis Robbins, IDEAS

5:30   Closing Remarks & End of Day 1

Day Two Agenda
Wednesday, February 5

8:00   REGISTRATION & WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30   PANEL DISCUSSION: OUTREACH TO COMMERCIAL PAYER ORGANIZATIONS TO ADOPT STATE BIOMARKER LAWS
• Uncertainty in legislation leading to pushback from payers
• Insights from states where biomarker laws are in effect
• Communication & advocacy strategies to further adoption
• Ramifications of overruling commercial coverage decision-makers
Jerry Conway, BELAY DIAGNOSTICS
Travis Adams, NEOGENOMICS LABORATORIES
Julie Wiedower, GUARDANT HEALTH
Clarisa Blattner, XIFIN

9:15   PRESENTATION BY E5 WORKFLOW
Michael Marshall, Managing Director – North America
E5 WORKFLOW

10:00   COFFEE & NETWORKING BREAK

10:30   FIRESIDE CHAT: REFLECTIONS ON PAYER POLICY IN RECOGNITION OF CHANGING REGULATORY LANDSCAPE
• Incorporation of FDA oversight of LDTs in payment frameworks
• Organizational policy in light of state biomarker laws
• Continued influence of Budget Neutrality on decision making
• Importance of breakthrough designation for commercial plans
Dr. Timothy Law, HIGHMARK
Dr. Ben Horton, AVALON HEALTHCARE SOLUTIONS
Jennifer Fernandez, CARIS LIFE SCIENCES

11:15   CCO PERSPECTIVE: INCORPORATING REIMBURSEMENT INTO PREPARATIONS FOR
EFFECTIVE PRODUCT LAUNCH
• Role of market access & reimbursement in commercialization
• Opportunities to learn from or work alongside sales, marketing & customer service teams
• Effective planning for evidence generation in product development
Maital Rasmussen, Chief Commercial Officer
GLX ANALYTIX

11:45   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

12:45   PANEL DISCUSSION: EXPECTATIONS FOR ADMINISTRATIVE FOCUS FOR HEALTHCARE POST-ELECTION
• Congressional ruling on FDA oversight of LDTs
• Goals of next administration for healthcare spending
• Movements of state legislatures to enact healthcare laws
• Cybersecurity incidents & manufacturers role going forward
• Implications of 21st Century Cures Act
Nicholas Halzack, ROCHE
Darla Wanitschke, TELCOR
Emma Alme, GUARDANT HEALTH

1:30   UPDATES TO CLINICAL LAB FEE SCHEDULE
• Overview of annual clinical lab fee schedule changes
• Major themes shown in past year & expectations for 2025
• Incorporation of new technology & impact on legacy products
Erik Schulwolf, Counsel
HOGAN LOVELLS

2:15   COFFEE & NETWORKING BREAK

2:30   SMALL GROUP DISCUSSION: RESPONDING TO CHALLENGES WITH MEDICARE
ADVANTAGE COMMERCIAL PLANS
• Successes in overturning denials in appeals process
• Patient education to push back on coverage
• Prior authorization requirements specific to medicare advantage
GROUP 1: MARKET ACCESS – Jeffrey Salzman, DEVYSER
GROUP 2: BILLING – Alena Androsenka, LUCID DIAGNOSTICS

3:15   TECHNOLOGY & ALGORITHMS BEHIND AUTOMATED COVERAGE & CLAIMS DENIALS
• Identifying real-world applications of algorithms in health plans
• Safeguards for the employment of artificial intelligence & automation
• Litigation & congressional oversight to further refine usage
Mark Hiatt, Chief Medical Officer
RADSITE

4:00   Closing Remarks & Conference Conclusion