2023 Archived Content

Cambridge Healthtech Institute’s 11th Annual

Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Assessing Trends and Building a Roadmap for the Future

August 22 - 23, 2023 ALL TIMES EDT

As diagnostics become increasingly complex, coverage and reimbursement come to the forefront of challenges that diagnostic companies face. Deep understanding of how policy is developed and implemented and how policy will change over time will provide a distinct advantage. Similarly, keeping reimbursement pathways top of mind early on in the diagnostic development process is vital to ensuring commercial success. Cambridge Healthtech Institute's 11th annual Coverage and Reimbursement for Advanced Diagnostics conference will bring together policymakers and payers alike to hear from both sides of the table. This meeting seeks to bring clarity and forward-looking perspectives on diagnostic development and commercialization.

Sunday, August 20

Registration Open1:00 pm

Tuesday, August 22

11:30 am PLENARY PANEL DISCUSSION:

Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care

PANEL MODERATOR:

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition

Many oncology patients who are eligible to receive high-value personalized treatments do not. Despite a lengthy history of targeted treatment availability in advanced non-small cell lung cancer (aNSCLC), a recent study found that 644 of every 1,000 newly diagnosed aNSCLC patients (64.4%) did not receive a personalized treatment due to clinical practice gaps in the delivery of precision oncology.

What are the clinical practice and policy challenges related to diagnostic testing and the delivery of appropriate targeted therapies leading to a failure of patients to receive precision oncology strategies?
What impact does each clinical practice gap have on the population-level delivery of precision oncology?
How can we optimize biomarker testing and treatment decision-making to help best address clinical practice gaps?
What policies and practices can help assure optimal and equitable delivery of appropriate high-value personalized medicines?

PANELISTS:

Robert H. Dumanois, Director, Reimbursement Strategy, Thermo Fisher Scientific

Anthony N. Sireci, MD, Senior Vice President, Clinical Biomarkers & Diagnostics Division, Loxo@Lilly

Apostolia-Maria Tsimberidou, MD, PhD, FASCO, FAASS, Professor of Medicine, Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center

Enjoy Lunch on Your Own12:30 pm

1:45 pm

Chairperson's Remarks

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC

1:50 pm KEYNOTE PRESENTATION:

Medicare and Molecular Diagnostics: Emerging Trends Local & National

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC

As the largest payer, Medicare's approaches to innovation are closely watched by the diagnostics and devices industries. Unlike the FDA, Medicare policies can strongly influence LDTs through control of the reimbursement structure. But nationwide Medicare policies invariably, and strongly, favor FDA-approved versions. At the local level, the 50 states are divided into three groups, whether they follow policies of MolDx, Novitas, or NGS MACs. Of these three, MolDx has complicated "policy systems" of LCDs, articles, topic-specific elaborate FAQs, tech assessment checklists, and other documentation. We will review what's new in Medicare policy for innovative technology, updated through July 2023 rulemaking.

2:20 pm

Demystifying Molecular Diagnostics Coverage and Reimbursement in Medicare: MolDX

Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA

This talk will explore the complexities of molecular diagnostic billing for Medicare and provide explanations of the processes and requirements of submitting for coverage and reimbursement under existing or prospective policies.

Refreshment Break in the Exhibit Hall with Poster Viewing3:20 pm

3:30 pm SPEED NETWORKING:

How Many Contacts Can You Make in 30 Minutes? IN-PERSON ONLY

Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute

Bring yourself, your business or e-cards, and be prepared to share and summarize the key elements of your work in a short, two-minute sound bite. This session will be located in the exhibit hall and will be moderated.

4:00 pm KEYNOTE PRESENTATION:

Coverage of Novel Technologies: Lessons From My Time at CMS

Lee A. Fleisher, MD, Professor Emeritus, University of Pennsylvania; Former CMS Chief Medical Officer and Director, Center for Clinical Standards and Quality

Dr. Fleisher will review the CMS coverage for devices and Coverage and Analysis Group process for making national coverage determinations. He will also review the recently published Transitional Coverage of Emerging Technologies and its implications.

4:30 pm

The Building Blocks to Successful IVD Reimbursement

Eric Lam, PhD, Vice President, Hull Associates LLC

Overview of the US and International Reimbursement Pathways for IVD Reimbursement
Various pathways to secure coding, coverage & payment
Pivotal role of clinical utility evidence in:
- Securing coverage
- Supporting market adoption

5:00 pm

Overcoming Challenges to Enhance Commercial Success of Advanced Diagnostics

Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI

An overview of key considerations for advanced diagnostic innovators to achieve reimbursement success in a competitive environment. This presentation will provide insights into how reimbursement planning can be incorporated into test development to optimize coverage and payment, observations on market access strategies that work and ones that don’t, and pitfalls to avoid when launching advanced molecular diagnostics in the marketplace.

Close of Day5:30 pm

Wednesday, August 23

Registration Open7:15 am

7:30 amInteractive Discussions with Continental Breakfast

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussions page on the conference website for a complete listing of topics and descriptions.

BREAKOUT DISCUSSION:

The Role of Government Reimbursement in Encouraging (or Discouraging) Innovation in Diagnostic Testing

John Warren, Owner and Principal Consultant, Gettysburg Healthcare Consulting, LLC

- Diagnostic technology continues to evolve, but government reimbursement policies have not fundamentally changed since the 1990s. To what extent should we question the viability and effectiveness of employing policies that were formulated three decades ago in a market that is constantly undergoing rapid transformations?

- In what ways can government reimbursement strategies for diagnostic testing be optimized to strike a balance between incentivizing innovation and ensuring accessibility and affordability for patients, considering the evolving nature of healthcare technologies and the need for continuous advancements in diagnostic capabilities?

- What potential consequences could arise from either encouraging or discouraging innovation through updated reimbursement policies?

BREAKOUT DISCUSSION:

Coverage and Reimbursement of Comprehensive Genomic Profiling (CGP)

Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI

- Leveraging key opportunities and tackling challenges for coverage & reimbursement

- Capitalizing on recent successes

- Determining expectations for new Genomic Sequencing Procedure CPT Codes

8:55 am

Chairperson's Remarks

Megan Anderson Brooks, PhD, President, Innovation Policy Solutions LLC

9:00 am

Ensuring Test Quality to Support Coverage and Access

Jeff Allen, PhD, President and CEO, Friends of Cancer Research

For the past several years, there has been substantial debate among policymakers and various stakeholders regarding modernization of regulatory oversight for diagnostic tests to ensure performance quality. This session will explore recent trends for diagnostic tests use in cancer, case examples of variability in results from different tests, and, in the absence of regulatory modifications, whether payers will take a more active role in test performance standards.

9:30 am

Achieving Market Access: How Can Labs Meet Evolving Requirements for Reimbursement?

Sarah Thibault-Sennett, PhD, Senior Director, Reimbursement Policy, American Clinical Lab Association

The US payer landscape is incredibly diverse, requiring laboratories to develop relationships with multiple public and private payers in order to assure reimbursement for their services. Over the years, this landscape has continued to evolve with the growing addition of laboratory benefit managers and other evidentiary review organizations. Clinical laboratories are currently faced with the daunting prospect of developing and maintaining unique claim submission processes to meet all these requirements. This session will explore the challenge these requirements pose for reimbursement and discuss activities taken by stakeholders to respond to these issues.

Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing.10:00 am

11:00 am PANEL DISCUSSION:

The Shifting Reimbursement Policy Landscape for Genetic Testing

PANEL MODERATOR:

Megan Anderson Brooks, PhD, President, Innovation Policy Solutions LLC

Policymakers are increasingly focused on developing reimbursement policies to expand access to comprehensive biomarker testing in oncology, rare disease, pharmacogenomics, and more. From legislative campaigns in many states, the federal government focus on access to innovative testing, and the increasing use of professional guidelines as a component of coverage policy, tremendous opportunities are on the horizon to expand coverage of biomarker testing. Using pharmacogenomics as a case example, this panel discussion will focus on what to expect from federal and state policy efforts as well as the lessons learned from recent strategies.

PANELISTS:

Chantelle Schenning, PhD, Head of Healthcare Transformation, Invitae

Annette K. Taylor, MS, PhD, Associate Vice President, Strategic Director, Pharmacogenomics, Labcorp

Mark Fleury, PhD, Principal, Policy Development, Emerging Science, American Cancer Society Cancer Action Network

12:00 pm

Using Simulated-Patient RCTs to Expedite and Broaden Clinical Utility Evaluation with National Samples of Providers

Randy David, MSc, PhD, Vice President of Clinical and Life Sciences Programs, Life Science, QURE Healthcare

Demonstrating clinical and economic utility is integral to securing coverage and reimbursement for advanced diagnostics. Procuring direct, hypothesis-driven utility evidence by engaging an appropriate sample of provider participants with the rigorous statistical standards required by payers can, however, be a considerable challenge. By quantifying test contributions to physician decision-making, patient health outcomes, and value, simulated-patient RCTs are a rapid, reliable and cost-effective method for evaluating the utility of novel diagnostics.

Enjoy Lunch on Your Own12:15 pm

Session Break1:30 pm

Networking Refreshment Break1:40 pm

2:00 pm

Chairperson's Remarks

Mark Hiatt, MD, MBA, MS, CMO, RadSite

As technology surges, and a virus changes the world, what trends are emerging in how diagnostic procedures are covered by health plans and reimbursed?

2:05 pm

Precision Is a Decision: Disparate Paths Taken by Patients, Physicians, Pathologists, and Payers

Mark Hiatt, MD, MBA, MS, CMO, RadSite

The decision to embrace precision oncology is a complex one, with different paths pursued depending on one’s perspective as a patient, physician, pathologist, or payer. This presentation outlines these parallel journeys in the context of the groundbreaking technology of liquid biopsy in uncovering the specific genomic drivers of cancer so that they may be more precisely targeted.

2:35 pm

Implications of Automation on Government Reimbursement

John Warren, Owner and Principal Consultant, Gettysburg Healthcare Consulting, LLC

Automation and Artificial Intelligence platforms are becoming more commonplace in today's lab environment. Deploying these kinds of solutions to address reductions in staffing and increases in workloads is becoming more and more evident in today's laboratories. But what are the implications of these advancements on Government reimbursements? Explore the policies underpinning Medicare reimbursement for lab services and how those policies may not be able to continue to keep up with changing technology.

3:05 pm

Multiplex Test Reimbursement and Access Considerations Post-COVID PHE

Nicholas Halzack, MPH, Director, Health Policy, Roche Diagnostics

The reimbursement landscape for multiplex testing has been shifting and evolving consistently since 2018, made all the more complicated by mandates and guidance issued as part of the COVID-19 Public Health Emergency. This session will provide some historical context around multiplex test access, key policies that have driven changes, and to what extent the COVID-19 PHE and its expiration may impact multiplex test reimbursement and access into the future.

3:35 pm PANEL DISCUSSION:

What Payers Have to Say about Medical Policy, Contracting, and Reimbursement for Genomic Testing

PANEL MODERATOR:

Mark Hiatt, MD, MBA, MS, CMO, RadSite

As technology surges and a virus changes the world, what has changed and what has remained the same, with respect to how payers approve, contract, and pay for genomic testing to diagnose cancer? This panel of experts will opine from their experiences as payers, as moderated by one who has been a payer and provider himself.

PANELISTS:

Eugean Jiwanmall, Senior Research Analyst, Technology Evaluation & Medical Policy, Facilitated Health Networks, Independence Blue Cross

Carmen F. Alfonso, DO, CMO, Managed Care Consultants

Steven R. Peskin, MD, MBA, MACP, Senior Advisor, ADVI; Associate Clinical Professor, Medicine, Rutgers RWJ Medical School; Course Director, Internal Medicine Grand Rounds, Penn Medicine Princeton Healthcare