2021 +Dx Diagnostics Forum
Explore a comprehensive discussion and analysis of pertinent regulatory and reimbursement issues that focus on the laboratory diagnostics field’s transformative nature.
Media interested in event, please reach out to publicrelations@mwe.com.
SCHEDULE
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EXPLORING THE MEDICARE COVERAGE LANDSCAPE
Get up-to-the-minute insights into the coverage trends shaping the diagnostics industry, thanks to our expert panelists. This distinguished group of leaders from the Centers for Medicare & Medicaid Services’ Coverage and Analysis Group and medical directors from local Medicare Administrative Contractors will also discuss the future of the MolDX program.
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FDA OVERSIGHT OF DIAGNOSTICS – WHAT’S NEXT?
Our panel of dynamic industry leaders will explore critical lessons learned during the COVID-19 pandemic, plus other hot topics in the diagnostics field today. Together, we’ll take an intensive look at the potential for congressional action related to the US Food and Drug Administration’s regulatory framework for diagnostics, including the VALID Act proposed in 2020.
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NAVIGATING THE EVOLVING FRAUD AND ABUSE LANDSCAPE
Federal and state fraud and abuse laws have a profound impact on the diagnostics industry. This panel will examine recent regulatory, legislative and enforcement actions under the Anti-Kickback Statute, Physician Self-Referral Law (Stark Law) and the Eliminating Kickbacks in Recovery Act of 2018—and what they might mean for your business.
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DECIPHERING PRIVATE PAYER EVIDENCE REQUIREMENTS
The evidence requirement for reimbursement of in vitro diagnostic tests can be confusing, but our panel of benefit managers and private payers is here to help. This session will demystify evidence requirements and illuminate their importance.
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DIAGNOSTICS ON THE HILL
Eric Zimmerman hosts senior congressional staff from committees that will consider legislation impactful to the diagnostics community to discuss planned and likely legislative priorities for the year ahead.
Program
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Gain insight into how the industry addresses regulatory and business challenges and embraces new and exciting technology in an ever-evolving health policy landscape. New this year, a unique partnering experience to connect with key players in the industry.
Industry innovators, lawmakers and leading regulators will provide in-depth analysis, thoughtful guidance and strategic insights on:
- Local and national coverage for the molecular testing marketplace, featuring both Centers for Medicare & Medicaid Services (CMS) leadership and Medicare Administrative Contractors (MACs) from MolDX and Novitas
- Food and Drug Administration (FDA) oversight of diagnostic testing, including laboratory-developed tests
- Fraud and abuse trends in diagnostic testing arrangements
- Private payer positioning and evidence for diagnostic testing
- The new administration’s focus on the scientific and research community to accelerate vaccines, therapies and diagnostics
Speakers
Gabriel Bien-Willner, MD
Palmetto GBA
Kristine Bordenave, MD
KK Bordenave Consulting Group and The Outcomes Team
Pamela Bradley
Adaptive Biotechnologies
Mitchell Burken, MD
eviCore healthcare
James Cannatti
McDermott Will & Emery
Scott Coward
Exact Sciences Corporation
Deborah Godes
McDermott+Consulting
Paul Gerrard, MD
McDermott+Consulting
Shauna Hay
Beacon Lab
Julie Khani
American Clinical Laboratory Association
Tony Maida
McDermott Will & Emery
Jyme Schafer, MD
Novitas Solutions, Inc.
Rachel Stauffer
McDermott+Consulting
Tamara Syrek Jensen
Centers for Medicare & Medicaid Services
Leigh Rubinstein
Invitae Corporation
Mike Ryan
McDermott Will & Emery
Elizabeth Truong
Centers for Medicare & Medicaid Services
Susan Van Meter
AdvaMedDx
Sheila Walcoff
Goldbug Strategies
Rodney Whitlock
McDermott+Consulting
Eric Zimmerman
McDermott+Consulting