Diagnostic Coverage & Reimbursement Conference

A Special Thanks to Our Sponsors

Day One Agenda
Wednesday, May 21

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   ICE BREAKER: TRANSFORMING UNCERTAINTY & ADVERSITY INTO OPPORTUNITY
In this interactive kick-off session, attendees are encouraged to consider their current state as well as the promise of tomorrow.
Mark Hiatt, Chief Medical Officer
RADSITE
Dennis Robbins, Principal
IDEAS

9:30   CMS PERSPECTIVE: OPPORTUNITIES FOR DIAGNOSTICS TO ACCELERATE REIMBURSEMENT STRATEGY UNDER TCET FINAL RULE
• Clarification on IVD eligibility for TCET & payment pathway
• Proper outreach to CMS to secure medicare coverage along TCET timeline
• Evidence requirements for FDA vs. CMS medicare coverage
• Safer Technologies Program (SteP) recognition under CMS
Lee A. Fleisher, Former CMS Chief Medical Officer/Principal & Founder
RUBRUM ADVISING

10:15   INNOVATIVE PATIENT ENGAGEMENT PROGRAMS TO OPTIMIZE DIAGNOSTIC PRODUCT DEVELOPMENT, ADOPTION & PAYMENT
• Building solutions to assist commercialization efforts
• Identifying technology to support optimization
• Lessons learned in engaging with patients
Jerry Conway, SVP, Market Access
BELAY DIAGNOSTICS

10:45   COFFEE & NETWORKING BREAK

11:15   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

12:00   SMALL GROUP DISCUSSIONS: LESSONS LEARNED IN PREPARING FOR A MOLDX TECHNICAL ASSESSMENT
• Strategies to engage when test is ready for assessment
• Designing & leveraging health economic models & clinical evidence
• Determination of what is & is not impactful for Moldx
• Opportunities to promote Z-code in the marketplace
Jeffrey Salzman, DEVYSER
Michael Ryan, MCDERMOTT, WILL & EMERY

12:45   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

2:00   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

2:45   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

3:30   COFFEE & NETWORKING BREAK

4:00   UTILIZATION MANAGEMENT: WHAT WENT WRONG?
• Re-examining the upsides and downsides of utilization management
• Fiscal arrogance and economic experimentation
• Integrating ethics, fiscal integrity, & medical necessity
• Recapturing trust, integrity, & accountability
Mark Hiatt, Chief Medical Officer, RADSITE
Dennis Robbins, Principal, IDEAS

4:45   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
Christine P. Bump, PENN AVENUE LAW & POLICY
Emma Alme, GUARDANT HEALTH

5:30   CLOSING REMARKS & END OF DAY 1

Day Two Agenda
Thursday, May 22

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
Noreen Manning, CASTLE BIOSCIENCES
Christopher Ho, MYRIAD GENETICS
Michael Ryan, MCDERMOTT, WILL & EMERY

9:15   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
Brent Gibbs, CAREDX
Darla Wanitschke, TELCOR
Emma Alme, GUARDANT HEALTH

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
Julie Wiedower, GUARDANT HEALTH

11:15   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

11:45   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

12:45   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

1:45   COFFEE & NETWORKING BREAK

2:15   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

3:00   BALANCING INNOVATION IN CARE VERSUS STEWARDSHIP OF HEALTH RESOURCES: MOLECULAR DIAGNOSTICS FOR OUTPATIENT SEXUALLY TRANSMITTED DISEASE (STD) EVALUATION
• Barriers to access of primary care & GYN care for the evaluation of STDs
• Molecular testing offers high sensitivity to detect pathogens & rapid turnaround time
• Coverage policy matrices & claims coding considerations
• Impact of payment constructs influencing technology’s adoption in outpatient setting
• Relationship between payer coverage policy & consumer access to self-collection
Steven Goldberg, Chief Medical Officer
HEALTHTRACKRX

3:30   CLOSING REMARKS & CONFERENCE CONCLUSION