Diagnostic Coverage & Reimbursement Conference

A Special Thanks to Our Sponsors

Day One Agenda | Tuesday, December 10

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS
John Donnelly, Founder & CEO
LABXCHANGE

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 2 other participants of different ranks in order to form a V-I-P group and build new contacts. Additionally, each participant is welcome to briefly share insight into market intelligence resources commonly used to stay abreast of continuously evolving market trends.

9:30   PANEL DISCUSSION: ANALYZING SPECIFICATIONS IN THE FDA FINAL RULE FOR LAB DEVELOPED TESTS
• Expectations for when this will happen & the what if’s
• Forecasting the impact to labs for enforcement discretion policies
• Long-term influence if final rule withstands objections
• Influence of FDA oversight on payer policy & payments
Christine Bump, PENN AVENUE LAW & POLICY
Paige Nardi, HEPQUANT
Stephanie Ibbotson, LUMINEX CORPORATION

10:15   SMALL GROUP DISCUSSIONS: DEVISING INITIAL STEPS TO COMPLIANCE WITH NEW FDA OVERSIGHT
• Reflections as to what is keeping your labs up at night
• Tackling obstacles while implementing the FDA final rule
• Decision-making for next steps in light of court challenges
Christine Bump, PENN AVENUE LAW & POLICY
Paige Nardi, HEPQUANT
Stephanie Ibbotson, LUMINEX CORPORATION

10:45   COFFEE & NETWORKING BREAK

11:15   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
Christopher Ho, MYRIAD GENETICS
Michael Ryan, MCDERMOTT, WILL & EMERY
Julie Wiedower, GUARDANT HEALTH

12:00   APPEAL STRATEGIES & BEST PRACTICES TO SECURE COVERAGE & MAXIMIZE REIMBURSEMENT
• Define is a quality appeal & demonstrate the importance of appeals on revenue
• Discuss the required stakeholder engagement to build advocacy
• Using technology to improve the efficiency & effectiveness of appeals
• Collaboration across organizations & with payers for a most effective appeals process
Tom Cronin, QUADAX, INC
Cris McMahon, BIODESIX

12:45   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

2:00   STEPS TO STRENGTHEN REIMBURSEMENT OUTCOMES WITH MEDICARE ADVANTAGE PLANS
• Ways medicare advantage diverges from traditional medicare
• Utilization management techniques leading to medicare advantage claims denials
• Advocacy to inform medicare advantage of biomarker laws
Sarah Thibault-Sennett, Sr Director, Reimbursement Policy
AMERICAN CLINICAL LABORATORY ASSOCIATION

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 – Sarah Thibault-Sennett, ACLA
GROUP 2: BILLING – Alena Androsenka, LUCID DIAGNOSTICS

3:30   COFFEE & NETWORKING BREAK

4:00   SMALL GROUP DISCUSSIONS: CONDUCTING A RISK ASSESSMENT IN LIGHT OF RECENT CYBERSECURITY BREACHES
• Reflections of recent payment delays related to Change Healthcare
• Managing workflow despite data breaches to providers & plans
• Privacy concerns when managing HEOR data under HIPAA laws
• Steps to complete a comprehensive departmental risk assessment
Julie Wiedower, GUARDANT HEALTH
Melissa Levine, HOGAN LOVELLS

4:45   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
INTERVIEWEE: Barb Liwosz, BCBSA
INTERVIEWER: Tom Dugan, BIODESIX

5:30   CLOSING REMARKS & END OF DAY 1

Day Two Agenda | Wednesday, December 11

8:00   REGISTRATION & WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS
Tom Cronin, Senior Vice President, Revenue Cycle Strategy & Analytics
QUADAX, INC

8:30   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

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
Brian Carey, HOGAN LOVELLS
Darla Wanitschke, TELCOR
Brent Gibbs, CAREDX

10:00   COFFEE & NETWORKING BREAK

10:30   PAYER PANEL DISCUSSION: 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
INTERVIEWEE: Dr. Maliha Kamal, UPMC HEALTH PLAN
INTERVIEWER: Julie Wiedower, GUARDANT HEALTH

11:30   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 COLLABORATIVE SERVICES

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15   MASTERING ELIGIBILITY VERIFICATION TO ENSURE ACCURATE & TIMELY REIMBURSEMENT
• Importance of accurate eligibility verification on reimbursement
• Payer increasing demand for medical record documentation
• Provider-relation strategies to delicately approach billing issues
• Techniques to collect missing information when insurance claim is incomplete
Carlyn Ramsdell​​​​, Director, Market Access
VERACYTE

2:00 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

2:45   PROMOTING EARLY ADOPTION AMONG PAYERS THROUGH PROVIDERS
• Plans & providers with the DNA to adopt novel technologies
• Success with pilot models including risk-based contracting
• Best practices when transitioning from pilot to broad adoption
• Strategies when coding, payment & coverage have not been established
Kevin Liang, VP, Strategy and Growth
OPTUM GENOMICS

3:30   CLOSING REMARKS & CONFERENCE CONCLUSION