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   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

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
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
Alena Androsenka, Sr. Director, RCM
LUCID DIAGNOSTICS
Dyana Williams, Director of RCM Operations
LIGHTHOUSE LAB SERVICES

3:30 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

4:00   COFFEE & NETWORKING BREAK

4:30   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
Julie Wiedower, Senior Director of Medical Affairs, Managed Care
GUARDANT HEALTH

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, & medical necessity
• Recapturing trust, integrity, & accountability
Mark Hiatt, Chief Medical Officer
RADSITE
Dennis Robbins, Principal
IDEAS

5:45   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   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

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. Kristie Ressler, AVALON HEALTHCARE SOLUTIONS
Julie Wiedower, GUARDANT HEALTH

11:15   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

12:00   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:00   THE PHILOSPOPHY OF DENIALS
• The dark side of denial: what all the (network) noise is about
• Denial in 6D: what a denial means, depending on a (potentially six-fold) perspective
• The demands of denial: what may be required to generate, or respond to, a denial depending on your position
• Toward the diminution of denial: how to evolve past the need for denials
Mark Hiatt, Chief Medical Officer, RADSITE
Kenneth Schaecher, Associate Medical Director, SELECT HEALTH

1:40   DRIVING ADOPTION THROUGH HEALTH PLANS & EMPLOYERS PILOTS: BEST PRACTICES & CASE STUDIES 
A discussion about the different stakeholders at health plans, how to map and identify stakeholders aligned to innovation, and review of best practices with case studies on how to drive adoption.
Kevin Liang, VP Optum Evidence Generation
OPTUM

2:30   COFFEE & NETWORKING BREAK

2:40   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

3:15   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

4:00   CLOSING REMARKS & CONFERENCE CONCLUSION