2022 Archived Content

Cambridge Healthtech Institute’s Tenth Annual

Coverage and Reimbursement for Advanced Diagnostics

Latest Developments in the Payment Landscape

August 23 - 24, 2022 ALL TIMES EDT

Achieving commercial success for an IVD product or an LDT assay is becoming progressively more difficult. In today's rapidly changing healthcare environment, it is important to stay both informed and current to ensure commercial success. Cambridge Healthtech Institute’s 9th Annual Coverage and Reimbursement for Advanced Diagnostics will provide its participants with a unique opportunity to discuss winning strategies with public and private payers as well as with their peers who are working on similar tasks.

Day 1
Day 2

Tuesday, August 23

11:00 am Registration Open for Part B Tracks

11:15 am Transition to Plenary Keynote

11:25 am

Plenary Panel Introduction

Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

11:30 am PANEL DISCUSSION I:

Legislative Efforts to Modernize Diagnostic Oversight

Panel Moderator:

Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

Why has there been a sustained, multi-year push for legislation to modernize the regulatory and oversight landscape for diagnostics?
How will leading legislative proposals, like the Verifying Accurate Leading-edge IVCT Development (VALID) Act, change diagnostics regulation and oversight? What impacts will these changes have on the diagnostics industry and on patient care?
How have legislative proposals such as the VALID Act evolved over time based on extensive stakeholder feedback and technical assistance from the federal agencies?
Are there lessons from the COVID-19 pandemic that the Food and Drug Administration and the diagnostics industry have learned that will serve as a foundation for regulatory and oversight activities in the future?

Panelists:

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

Sarah Thibault-Sennett, PhD, Director, Public Policy & Advocacy, Association for Molecular Pathology

Lauren R. Silvis, PhD, Senior Vice President, External Affairs, Tempus, Inc.

Susan Van Meter, President, American Clinical Laboratory Association

Zach Rothstein, PhD, Executive Director, AdvaMedDx; Senior Vice President, Technology & Regulatory Affairs, AdvaMed

12:15 pm

Plenary Panel Introduction

Franklin R. Cockerill III, MD, Founding Partner, Trusted Health Advisors; Adjunct Professor, Medicine, Rush University

12:20 pm PANEL DISCUSSION II:

Self-Testing – Applying What We Have Learned from the Pandemic for Future Applications

Panel Moderator:

Franklin R. Cockerill III, MD, Founding Partner, Trusted Health Advisors; Adjunct Professor, Medicine, Rush University

In your opinion, what is the single most important advance in diagnostic testing that has occurred with the COVID-19 pandemic?
What are the pluses and minuses of self-swabbing for respiratory viruses (can be other specimen sources for self-collections, e.g., HPV, STD)?
What are the pluses and minuses of self-testing for respiratory viruses (e.g., COVID self-testing antigen tests)?
What have we learned from the EUA FDA approval process for COVID testing (antigen, nucleic acid amplification, antibody)? Can this approach be applied for any LDT validation as proposed by the FDA?
What is the next big advance you see in diagnostic testing especially related to self-collection and self-testing?

Panelists:

Karen A. Heichman, PhD, Deputy Director, Bill & Melinda Gates Foundation

Jack Jeng, MD, MBA, CMO, Hone Health

Elizabeth M. Marlowe, PhD, D(ABMM) Senior Scientific Director, Head R&D Infectious Diseases & Immunology, Quest Diagnostics Nichols Institute

Raquel M. Martinez, PhD, D(ABMM), MBA, Director, System & Core Lab, Clinical & Molecular Microbiology, Geisinger Health System

Nicole Zitterkopf, PhD, D(ABMM), MPH, MT(ASCP), Vice President Laboratory, Service Line Advancement Team, OptumHealth

1:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

2:15 pm

Chairperson's Remarks

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

2:20 pm

Demystifying Molecular Diagnostics Coverage and Reimbursement in Medicare

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

MolDX is a program operated by PalmettoGBA to set molecular diagnostics policy and payor controls in 28 states. This talk will cover the scope and philosophy of the program, as well as provide instruction to providers on how to approach payors seeking coverage and reimbursement.

3:20 pm

Cost Efficacy of Rapid Whole Genome Sequencing (rWGS) in the Pediatric Intensive Care Unit

Erica F. Sanford Kobayashi, MD, Assistant Professor, Rady Children's Hospital, San Diego

The diagnostic and clinical utility of rapid whole genome sequencing (rWGS) for critically ill children in the pediatric intensive care unit was examined. Retrospective cost data for a cohort of children in the pediatric ICU who received rWGS found that the net cost of rWGS was $54,554, representing $4,509 per QALY gained. This quantitative, retrospective examination of healthcare utilization associated with rWGS-informed medicine interventions revealed approximately one-third of a QALY gained per patient tested at a cost per QALY that was approximately one-tenth of that typically sought.

3:50 pm Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 pm KEYNOTE PRESENTATION:

Do Medicare Legacy Policies Threaten Progress in Precision Medicine?

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

In 2013, just as modern precision medicine was taking off, CMS began to bundle all lab tests in the hospital outpatient setting, except genetic tests. In 2022, this policy is becoming increasingly impractical. Major new advances are occurring in areas like proteomics, and artificial intelligence is moving quickly into pathology applications. However, pathology testing and proteomic testing are usually "bundled" in the original cost of the tissue biopsy or office visit for a blood draw. With separate payment only for genomics, CMS potentially discourages other important fields of innovation.

5:00 pm PANEL DISCUSSION:

The Evolution of Medical Policy and Coverage Requirements in Genomic Testing

Panel Moderator:

Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health

As technology surges, and a virus changes the world, what has changed, and what has remained the same, with respect to what it takes for a diagnostic technology to be endorsed in medical policy and paid for by a health plan? This panel of experts will opine from their rich experiences as payers in the public and private sectors, for both national and regional plans.

Panelists:

Rahul Singal, MD, Chief Medical Officer, Avalon Healthcare Solutions

Eugean Jiwanmall, Senior Research Analyst, Technology Eval & Med Policy, Facilitated Health Networks, Independence Blue Cross

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

6:00 pm Close of Day

Day 1
Day 2

Wednesday, August 24

7:15 am Registration Open

7:30 am Breakout Discussions with Continental Breakfast

Breakout 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 Discussion page on the conference website for a complete listing of topics and descriptions.

IN-PERSON ONLY TABLE 5: Reimbursement of Genomic Profiling in Oncology – Best Practices

Gillian Hooker, PhD, CSO, Concert Genetics

What are the key challenges and opportunities for genomic profiling related to coverage and reimbursement?
How to achieve value-based market access and reimbursement: Key best practices

IN-PERSON ONLY TABLE 6: Reimbursement Process for New Genomic Technologies

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

How does the medical policy process work?
Is there a standard definition of clinical utility?
Do technology assessment companies influence medical policy decisions?

8:25 am

Chairperson's Remarks

Gillian Hooker, PhD, CSO, Concert Genetics

8:30 am PANEL DISCUSSION:

The Impact of the COVID-19 Pandemic on Laboratory Reimbursement Trends

Panel Moderator:

John F. Warren, Owner, Gettysburg Healthcare Consultants

The COVID-19 pandemic has brought unprecedented changes to our lives and to the way we do business. Join our panel of industry and government experts as they discuss how their day-to-day operations and their strategic business planning have changed. Learn how payers and laboratories alike have had to adjust to the new normal and how you can learn from their experience.

Panelists:

Deborah R. Godes, Vice President, McDermott+Consulting LLC

Chandra N. Branham, JD, Vice President, Payment & Health Care Delivery Policy, AdvaMed

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

Sarah Thibault-Sennett, PhD, Director, Public Policy & Advocacy, Association for Molecular Pathology

9:30 am

Trends in the Genetic Testing Landscape: Offerings, Utilization & Coverage

Gillian Hooker, PhD, CSO, Concert Genetics

This talk will review trends across the genetic testing landscape. Drawing on a consistently maintained database of tests marketed in the U.S., growth in the number and type of genetic tests in the market will be reviewed. Additionally, data from a nationwide claims data set of genetic testing claims will be presented to support a discussion of trends in utilization and coverage of genetic tests among the commercially insured population.

10:00 am Coffee Break in the Exhibit Hall with Poster Viewing

10:45 am PANEL DISCUSSION:

Paying for Innovation: Emerging Trends in Value-Based Care

Panel Moderator:

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

Legislators and other policymakers increasingly focus on leveraging coverage and reimbursement policy to incentivize discovery and innovation. Between the anticipation of a new rule on transitional coverage for emerging technologies (TCET) rule this fall, efforts to expand statutory coverage of new categories for multi-cancer screenings, and Medicare’s proposals for new care models, opportunities abound to better align coverage policies with the current state of the science. This panel discussion will focus on what to expect from the Biden Administration and Congress, how to identify opportunities for your business, and strategies on how to engage.

Panelists:

Chantelle Schenning, PhD, Head of Healthcare Transformation, Invitae

Dora L. Hughes, MD, MPH, Chief Medical Officer, CMS Innovation Center, Centers for Medicare & Medicaid Services

Sarah Shapiro, Legislative Director, Office of Representative Eric Swalwell (D-CA)

Tara Burke, PhD, Vice President, Payment and Healthcare Delivery Policy, AdvaMed

11:15 am

Evaluating the Evidence: Exposing the Process by Which Plans Determine Policy

Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health

Eugean Jiwanmall, Senior Research Analyst, Technology Eval & Med Policy, Facilitated Health Networks, Independence Blue Cross

Current and former leaders of health plans (as well as a current leader of a precision oncology company) will opine from their experiences in evaluating the evidence to determine coverage policy for new diagnostic technologies in the context of a case study involving liquid biopsy for genomic profiling of cancer.

11:45 am Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:45 pm Refreshment Break in the Exhibit Hall – Last Chance for Poster Viewing

1:30 pm

Chairperson's Remarks

Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health

1:35 pm

Fireside Chat: The Role of Alternative Payers in the Adoption of a Diagnostic

Lena Chaihorsky, Co-Founder & Vice President, Payer Innovation, Alva10

Nick Page, Chief Clinical and Strategy Officer, WellDyneRX

Convincing traditional health insurers of the medical necessity of novel diagnostics can be a difficult and complex endeavor. The discussion in this fireside chat will address how payers with alternative economic incentives (such as pharmacy benefit managers, employers, unions, and benefit groups) are implementing innovative strategies to adopt diagnostics and enable the commercialization and/or utilization of diagnostics.

2:05 pm

NGS Testing in aNSCLC: A Retrospective Analysis Using Real-World Data (RWD) to Measure Testing Turnaround Time and Its Impact on Patient Results and Coverage

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

This presentation will elaborate on the 2018-2020 NGS testing and coverage experiences specific to the diagnosis and treatment for stage IV, non-small cell lung cancer patients, utilizing real-world data from ~1,000 U.S. oncologists. Addressed topics will include how NGS testing impacts first-line therapy decisions at the beginning of treatment (before biomarker results are available), coverage considerations, and the overall impact on patient outcomes.

2:35 pm

The Role of Coalitions to Accelerate Diagnostic Testing Access, the ACGP example

Maude Champagne, Associate Director, Market Access Strategy, Illumina

When seeking coverage for a diagnostic assay, laboratories may be facing challenges that are shared amongst providers and manufacturers of the same class of diagnostic tests. Coalitions can provide a framework to educate payers and other stakeholders on the clinical utility and economic value of this class of assay, above the provider’s brand. Market access focused coalitions have accelerated coverage of diagnostic tests by sharing best practice amongst the industry and educating payers in a uniform voice on complex topics such as the value molecular biology assays bring to the healthcare system. Looking into the inception, growth, and achievements of the Access to Comprehensive Genomic Profiling Coalition (ACGP) as an example of coalition focused on increasing US patient access.

3:05 pm

Making Healthcare More Integrated, Efficacious, and Affordable for High Claimants

Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health

As costs to health plans skyrocket (particularly as pertaining to high claimants), what strategies are payers considering to integrate and improve care to make it more efficacious and affordable?

3:35 pm Close of Summit