8:00 PAMA DATA COLLECTION AND REPORTING: GUIDANCE TO KNOW FOR 2017
Kyle Fetter, Vice President & General Manager of Diagnostic Services Operations, XIFIN
Wendy Baehne, VP, Product Management, TELCOR
8:45 COMMERCIALIZATION CONSIDERATIONS FOR ADLTS IN THE POST-PAMA ERA The PAMA Act of 2014 has fundamentally changed the way laboratories think about commercializing advanced diagnostic laboratory tests. In this session, the speaker will describe the major commercialization considerations that LDT labs should be considering as they plan to launch new assays in the Post-PAMA era. Since pricing for ADLTs is now linked to commercial reimbursement, Mr. Hanna will also discuss recent trends in the commercial coverage marketplace influencing product strategy for ADLTs.
John W. Hanna, MBA, Vice President, Endocrinology, VERACYTE, INC
9:30 COFFEE & NETWORKING BREAK
10:00 NAVIGATING TESTING PAYMENT & PARTNERSHIPS IN NON-US MARKETS
In recent years, a growing number of diagnostic companies have expanded their global footprint by taking a test to markets such as EU, APAC and LATAM with the goal of building upon the success established in the US. Market access, adoption processes and laboratory partnerships can vary significantly from country to country as payment and evidence thresholds are calculated differently. To gain efficiencies with OUS launch planning, it is helpful to leverage certain evidence across multiple markets and to understand the laboratory, payer and provider landscape in target regions.
Overview of payer archetypes & evidence requirements
Decision makers and drivers of adoption in key markets
Review case study example of taking a test global
Mark Girardi, Principal Consultant, GFK HEALTH, MARKET ACCESS
Elizabeth A. Sheppard, Senior Director, Market Access ROCHE TISSUE DIAGNOSTICS
11:00 MASTER CLASS
BLUE CROSS BLUE SHIELD ASSOCIATION’S EVIDENCE STREET PILOT PROGRAM FOR DIAGNOSTICS
Program design, guidelines and review processes
BCBSA clinical guidelines and recommendations
Advantages & disadvantages of participation in Evidence Street
Recent evidence reviews for diagnostic technologies
Suzanne Belinson, PhD, MPH, Executive Director, Center for Clinical Effectiveness BLUE CROSS BLUE SHIELD ASSOCIATION
11:45 BASECASE POSTER PRESENTATION Diarmuid Glynn, BASECASE, INC.
12:00 LUNCHEON FOR ALL ATTENDEES
1:00 MEDICARE ADMINISTRATIVE CONTRACTOR INSIGHT AND PERSPECTIVE Staying abreast of changes happening within CMS on a national and local level is imperative to executing a purposeful diagnostic reimbursement strategy. In this session, Dr. Thom Mitchell will discuss the industry’s most pressing questions bringing clarity and candidness to key issues. Participants will walk away from this discussion with an improved understanding of coverage determinations and how best to work with MACs in securing reimbursement.
Thom Mitchell, MD, FACP, FACEP, Sr Contractor Medical Director, CAHABA GBA
1:45 PERFORMANCE-BASED RISK SHARING AGREEMENTS: POSSIBILITIES FOR DIAGNOSTICS
There is a growing interest among payers, providers and diagnostic companies for performance based risk sharing arrangements where the price, level, and nature of reimbursement is related to the actual performance of the product in either the research or ‘real world’ environment. While fascinating and attractive in theory, many stakeholders question the true validity of such agreements and seek to find conclusive examples of how risk sharing can be applied to the payment of diagnostics tests. An esteemed panel of industry stakeholders will discuss the issues surrounding risk sharing agreements and speak to various perspectives to the buzz term.
Mitchell Burken, MD, HEALTH DATA INSIGHTS
Nicole St. Jean, ASTRAZENECA
Jerry Conway, Vice President of Reimbursement & Payer Strategy FOUNDATION MEDICINE
Gordon Brown, Managing Partner, A&R CONSULTANTS LLC