DAY TWO | FRIDAY, DECEMBER 7
8:00 REGISTRATION & WELCOME COFFEE
8:20 CHAIRPERSON’S OPENING REMARKS
Markus Ott, Head Global Market Access & Health Policy
ROCHE DIAGNOSTICS INTERNATIONAL
8:30 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.
9:00 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
Timothy McCrystal, Partner, ROPES & GRAY
9:45 EXCHANGE GROUPS: SHARING SOLUTIONS TO TESTSPECIFIC 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 takeaway. 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, PFIZER ONCOLOGY
Group 2: Molecular Diagnostics:
Nicholas Potter, EPIGENOMICS, INC.
Group 3: Companion Diagnostics:
Lindsay Mateo, NAVICAN
Group 4: Laboratory IVDs:
Liana Romero, SIEMENS HEALTHINEERS
*Additional groups may be formed on site to address further IVD categories
10:30 COFFEE & NETWORKING BREAK
11:00 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
- Building and/or restructuring evidence & value demonstration
- Obtaining coverage at the following attempt
Chris Cisar, Executive Director National Accounts, Managed Care, MYRIAD GENETICS
11:45 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 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.
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 ACHIEVING NCDs: THE FOUNDATION MEDICINE CASE
- Step-by-step approach to the NCD approval process
- Misalignment between CMS & private payers
- Clarifying the overall impact on the diagnostic industry
- Opportunities for smaller labs to achieve similar NCDs
Rachel Anhorn, Director, Payer Policy & Health Outcomes, FOUNDATION MEDICINE
2:15 EXCHANGE GROUPS: NEW CATEGORIES OF INNOVATIVETESTS & 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, BIOREFERENCE LABORATORIES
Group 2: mHealth & mobile diagnosis:
Stephen Floe, ATIVA MEDICAL
3:00 CLOSING REMARKS & CONFERENCE CONCLUSION