DAY TWO | WEDNESDAY, FEBRUARY 12
8:15 REGISTRATION & WELCOME COFFEE
8:45 CHAIRPERSON’S OPENING REMARKS
9:00 PANEL: EXAMINING THE STATUS OF PLA CODING & IMPACT ON REIMBURSEMENT FOR DIAGNOSTICS
Initially expected to benefit reimbursement professionals by reducing barriers to payment caused by long waiting periods to obtain CPT codes, PLA codes are being used by diagnostic companies to bill for tests with mixed results, with CMS reimbursing PLA codes in very limited localities and commercial payer reimbursement levels remaining even less transparent. Additionally, submission of claims to a given payer without having first secured a coverage decision for the product can result in lack of payment even in cases when a specific PLA code has been obtained and properly applied. It is therefore imperative for reimbursement leaders to understand the larger outlook of PLA codes for the diagnostic industry.
- Insight into PLA code reimbursement success
- Beneficial timelines for pursuing PLA codes
- Future outlook & impact on coverage decisions
David Parker, PRECISION FOR MEDICINE
Lee Hilborne, QUEST DIAGNOSTICS & UCLA
Leslie Prellwitz, AMERICAN MEDICAL ASSOCIATION
Rob Guigley, AMBRY GENETICS
Tami York Powell, EXAGEN, INC.
Marijke Annis, GENOMIC HEALTH
10:00 STATUS OF NATIONAL COVERAGE DETERMINATION FOR NEXT-GENERATION SEQUENCING TESTS
While originally finalized in 2018, the CMS national coverage determination for next-generation sequencing which approved testing in latestage cancer patients was viewed by part of the industry as insufficient in scope. The decision was reopened for comments with a focus on germline testing and hereditary testing in early-stage cancer patients, addressing certain concerns from the industry but leaving many questions unanswered. Reimbursement leaders must understand implications of the modified version of the decision in order to inform reimbursement strategies for NGS testing.
Rob Dumanois, Manager, Reimbursement Strategy, THERMO FISHER SCIENTIFIC
10:30 COFFEE & NETWORKING BREAK
11:00 ACHIEVING SATISFACTORY PAYMENT FOR INNOVATIVE TESTS
In the continually evolving diagnostic landscape, where innovation is the key to both treatment improvement for patients and long-term profitability for the industry, companies seek proven strategies to maximize favorable coverage decisions. With a variety of methods to secure reimbursement, less traditional routes to payment such as the establishment of partnerships with pharmaceutical companies for clinical trials, as well as lessons learned by manufacturers of innovative tests having obtained reimbursement, are of high interest to professionals aiming to propel the field of diagnostics forward. This two-part case study series presents practical approaches to the core challenges faced by reimbursement executives.
PART 1 – OVERCOMING CHALLENGES FACING LIQUID BIOPSY MANUFACTURERS
- Insight into business model enabling options for reimbursement
- Timeline & methods for engaging with CMS & commercial payers
- Constructing partnerships with pharmaceutical corporations
Mark Oldroyd, Senior Vice President, Commercial Markets, TEMPUS
11:30 PART 2 – OTHER DIAGNOSTIC TEST TYPES
- Rationale for strategy to generate clinical evidence
- Streamlining communication & timelines with payers
- Practical step-by-step approach to reimbursement
Brock Schroeder, Senior Director, Global Market Access Strategy & Health Economic and Outcomes Research, ILLUMINA
12:00 LUNCHEON FOR ALL PARTICIPANTS
1:00 PANEL: EXPLORING THE POSITION OF DIAGNOSTICS IN VALUE-BASED HEALTHCARE MODELS
In contrast with the traditional fee-for-service model, value-based healthcare systems offer insurers and providers the opportunity to improve patient outcomes while reducing costs by taking a holistic approach to reimbursement. Payers are placing increasing emphasis on value-based payment as a means of ensuring that only truly valuable products are receiving coverage. With the continuous challenge of shedding light on the role of diagnostic tests in the overall patient treatment plan, reimbursement leaders are in need of insight into viable value-based agreement formats, as well as strategies to proactively establish partnerships with payers.
- Clarifying value-based healthcare versus fee-for-service
- Understanding DRGs & where diagnostics fit in the system
- Approaches to establishing value-based agreements with payers
Stephen Williams, MARWOOD GROUP
Artem Boltyenkov, SIEMENS HEALTHINEERS
Tom Dugan, BIODESIX
Heather Bowerman, DOTLAB
Elizabeth Cormier, PERSONA HEALTH, INC.
Heather Brown, HEARTFLOW
1:45 PRICING FOR NEW TESTS UNDER PAMA & PATHWAYS FORWARD FOR THE DIAGNOSTIC INDUSTRY
- Influence of initial rate-setting of CLFS on private payers
- Examining the impact of CDLT advisory panel
- Risks associated with pricing under the gapfill payment method
- Navigating variability & unpredictability in the pricing process
Paul Sheives, Director, Federal Health Policy & Reimbursement, ROCHE DIAGNOSTICS CORPORATION
2:30 COFFEE & NETWORKING BREAK
3:00 EXCHANGE GROUPS: TEST-SPECIFIC CONSIDERATIONS IN DEMONSTRATING CLINICAL UTILITY
With the vast array of tests in the diagnostic arena, inclusion into a payer healthcare network depends largely on the evidence provided to shed light onto product-specific clinical utility. Reimbursement professionals must therefore determine the appropriate weight of elements such as real-world evidence and health economic information to convey to payers, and generate it through sound clinical testing plans. Through interactive peer-to-peer sharing within groups specific to test types, delegates will have the opportunity to dive deep into the intricacies of proving clinical utility to meet payer expectations.
- GROUP 1: MOLECULAR DIAGNOSTICS
- GROUP 2: LABORATORY IVDS
- GROUP 3: NEXT GENERATION SEQUENCING
- GROUP 4: COMPANION DIAGNOSTICS
Denise Robinson, CAREDx, INC.
Brock Schroeder, ILLUMINA
Holly LaDuca, AMBRY GENETICS
3:30 CASE STUDY: STRUCTURING TRIALS TO PROVE CLINICAL UTILITY FOR DIAGNOSTIC TESTS
In order to be included in payer networks, diagnostic manufacturers must demonstrate clinical utility using payer-approved frameworks, often based on logical considerations for pharmaceutical products and therefore not easily translated to diagnostic products. Because diagnostics form a critical basis for treatment decisions rather than providing direct treatment to patients, constructing a clinical trial that will satisfy payer requirements for accuracy and usefulness necessitates careful consideration of end-points, to guarantee the generation of specific evidence that will be most valuable to payers. Reimbursement leaders will benefit from a practical look at the steps taken by one manufacturer to establish robust clinical trials, simultaneously meeting differing payer evidence requirements in the pursuit of securing payment.
Mauricio A. Berdugo, Director, Global Scientific & Medical Affairs, BIOMÉRIEUX
4:00 CLOSING REMARKS & CONFERENCE CONCLUSION