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
Clarisa Blattner, Sr. Director of Revenue & Payor Optimization
XIFIN

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   NAVIGATING THE CLINICAL & FINANCIAL COMPLEXITIES OF MRD TESTING
• Role of MRD testing in personalized oncology & impact on patient outcomes
• Identifying key challenges with coding, payor policies, & documentation requirements
• Strategies to optimize financial outcomes through market access insights, prior authorization technology & patient cost education
• Approaches to improve operational efficiency & overcome reimbursement hurdles
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  BIOMARKER LEGISLATION ACROSS THE STATES: A MACRO & MICRO CLAIM ANALYSIS
Join Quadax as we examine a macro analysis of claims reimbursement across the country after the introduction of various biomarker laws in 19 states. We will also review detailed examinations of specifi c states at a micro level to understand the current status of state biomarker legislation on reimbursement.
Chad Miles, Director of Reimbursement Management
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  KEY REIMBURSEMENT PATHWAYS & BUILDING BLOCKS FOR A SUCCESSFUL IVD REIMBURSEMENT STRATEGY
• Reimbursement pathways available to diagnostics across the different settings of care
• Various pathways to securing coding, coverage & payment
• Evidence demands from payers to support diagnostic coverage
• The pivotal rule of clinical utility evidence.
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
Megan Landsverk, PhD, Science Director, MolDx, Chief Science Officer
PALMETTO GBA

4:00   COFFEE & NETWORKING BREAK

4:30  A MARKET ACCESS LEADER’S GUIDE TO PRIOR AUTHORIZATION
The panelists—with experience as leaders of diagnostic labs, a benefit management company, and a health plan—will take the audience on a trek through the past and future of prior authorization, discussing its origin, intent, successes, and misadventures, and sharing a map to help navigate the evolving process.
Debbie Windsor, VP of Payer Contracting
MAYO CLINICAL LABORATORIES
Mark Hiatt, Chief Medical Officer
RADSITE

5:00  UTILIZATION MANAGEMENT: WHAT WENT WRONG?
• Re-examining the upsides and downsides of utilization management
• Fiscal arrogance and economic experimentation
• Integrating ethics, fiscal integrity, and medical necessity
• Recapturing trust, integrity, and accountability
Mark Hiatt, Chief Medical Officer
RADSITE
Dennis Robbins, Principal
INTEGRATED DECISIONS, ETHICS, ALTERNATIVES, AND SOLUTIONS

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
Glenn Harbold, Director of Revenue Cycle Solution Strategy
QUADAX

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  DIAGNOSTIC TRENDS, GROWTH, TECHNOLOGY & EFFICIENCY
• Forecasting growth trends for healthcare & laboratories
• Leveraging data now & for the future
• Considerations to combat increasing denials
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. 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   INNOVATION, ARTIFICIAL INTELLIGENCE, AND AUTOMATION: RE-IMAGINING PRIOR AUTHORIZATION
• Real-world applications
• Safeguards & AI
• Legal, ethical, and regulatory challenges
Mark Hiatt, Chief Medical Officer
RADSITE

4:00   Closing Remarks & Conference Conclusion