DAY TWO | WEDNESDAY, FEBRUARY 13
8:30 REGISTRATION & COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 DIAGNOSTIC INDUSTRY ADVOCACY, LOBBYING & INITIATIVES IN ENGAGING WITH GOVERNMENT
The diagnostic industry encounters a variety of limitations in reimbursement and market access pathways, notably in lengthy timelines to obtain a positive or negative decision from payers and the lack of specific innovative testing method knowledge from assessors. While reimbursement executives continue to be challenged with requirements often more suitable to the pharmaceutical sector, key opinion leaders and trade associations undertake the task of uniting and advocating for the industry with the aim of enabling a stronger recognition of diagnostic specificities and pivotal position in the overall healthcare market. Overall, moving from individual company difficulties faced in similar manners by the majority of the industry to a joint approach in tackling challenges can ultimately bring to promising results in coverage opportunities.
- Legislative & regulatory agenda for 2019
- Trade association advocacy core focus points
- Engaging with Congress & the government
Danielle Scelfo, Senior Director, Health Policy & Reimbursement, HOLOGIC, INC.
9:45 PANEL: ADRESSING DIAGNOSTIC CODING CHALLENGES & OPPORTUNITIES IN PLA APPLICATION
The diagnostic industry continues to face challenges in obtaining codes specifically defining the scientific purpose of a test, resulting in the use of more general codes applied to a variety of products, and potentially irrelevant reimbursement rates. In order to better categorize and identify diagnostics for payers, the AMA has recently established PLA codes meant to provide enhanced description of ADLTs and CDLTs in particular, and assist in securing pertinent coverage. Laboratories as well as test developers are currently investigating benefits and limitations of the new code set and application process, in addition to potential opportunities in the use of PLAs for other test types.
- Addressing the lack of test-specific CPTs
- Risks associated with the use of general CPTs
- Pros & cons in the application of PLA codes
- Clarifying which tests are eligible to PLAs
Jeff Salzman, Head of Reimbursement, CAREDX, INC.
Robert Bruce, Vice President – Reimbursement, CLINICAL GENOMICS
10:30 COFFEE & NETWORKING BREAK
11:00 IMPACT OF VALUE-BASED AGREEMENTS ON THE DIAGNOSTIC MARKET
- Opportunities for larger laboratories
- Limitations for smaller organizations
- Concerns in narrowing networks
- Bolstering competitive pricing
Greg Richard, Chief Commercial Officer, INTERPACE DIAGNOSTICS
11:45 EXCHANGE GROUPS: SHARING SOLUTIONS TO TEST-SPECIFIC CHALLENGES
With the expansion of IVDs into new testing methods and an overall wide variety in diagnostic types, reimbursement executives face different challenges from one category to another, ultimately shaping unique methods to secure successful coverage. This peer-to-peer learning session allows participants to share creative strategies and solutions uniquely applicable to distinct IVD test methods, ensuring an optimized approach to each test category and maximized take-away. To enable the exchange, the audience will break into smaller groups, each focusing on a specific IVD category as listed below, with the possibility of adding further groups and test types as deemed necessary by the audience.
Group 1: Next Generation Sequencing:
Julie Ramage, National Account Director, Diagnostics, PFIZER ONCOLOGY
Group 2: Molecular Diagnostics:
Nicholas Potter, Director, Reimbursement & Medical Affairs, EPIGENOMICS, INC.
Group 3: Companion Diagnostics:
Lindsay Mateo, Senior Vice President Commercial Operations, NAVICAN
Group 4: Laboratory IVDs:
Liana Romero, Senior Director, US Strategic Marketing & Scientific Clinical Affairs, SIEMENS HEALTHINEERS
*Additional groups may be formed on site to address further IVD categories.
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 SECURING SUCCESSFUL REIMBURSEMENT AFTER A NEGATIVE COVERAGE DECISION
- Preliminary reimbursement strategy walk-through
- Clarifying the rationale for payer decline
- Identifying gaps in satisfying payer requirements
- Restructuring evidence & value demonstration
- Obtaining coverage at the following attempt
Jill Blanchard, Market Access Manager, Payer Network Contracting, EXACT SCIENCES
2:15 INDUSTRY CASE STUDY: STRATEGIZING FOR FAVORABLE COVERAGE DECISIONS
As market demands fluctuate, and private and public payer coverage decisions vary based on ever-changing requirements, test manufacturers and laboratories continue to strive for meaningful improvements to reimbursement strategies. Although multiple routes exist to achieve the end goal, budgetary and time constraints demand that reimbursement professionals plan proactively to anticipate next all necessary steps towards favorable coverage. Via a short and incisive case study, industry members are invited to view successful approaches from an insider perspective and learn about creative, actionable solutions to shared obstacles in the path to obtaining reimbursement.
Paige Nardi, Director of Managed Care, BIODESIX, INC.
3:00 EXCHANGE GROUPS: NEW CATEGORIES OF INNOVATIVE TESTS & FOLLOW-ON REIMBURSEMENT CHALLENGES
Through small group discussions focused on peer to peer exchange and interaction, participants are given the opportunity to dive deeper into a topic related to specific challenges with ascending trends progressively disrupting diagnostic tests’ access to coverage, and prone to shape new policies. All participants are given the opportunity to select a topic among those listed below to dive into in a perspective-sharing manner. Gathering with peers experiencing the same challenges, and engaging in debates and brainstorming provides invaluable insights into practical approaches to complex reimbursement dilemmas.
Group 1: Consumer genetic tests:
Natalie Cummins, SVP of Marketing & Payer Relations, BIOREFERENCE LABORATORIES
Group 2: mHealth & mobile diagnosis:
Stephen Floe, Director, Corporate Strategy, ATIVA MEDICAL
3:45 CLOSING REMARKS & CONFERENCE CONCLUSION