Cambridge Healthtech’s 8th Annual

Coverage and Reimbursement for Advanced Diagnostics

Latest Developments in the Dx Reimbursement Landscape

August 20-21, 2019

Achieving commercial success for an IVD product or an LDT assay is becoming progressively more difficult in the current healthcare environment. The combination of tightening budgets and the launch of a large number of expensive molecular tests creates complications for payers to respond in traditional ways. Prior authorization and product registration require IVD companies and laboratories to deliver additional information from clinical trials, real world data sources, tumor boards, medical societies, etc. It is important to stay informed and current in the rapidly changing environment in order to achieve commercial success. Cambridge Healthtech Institute’s Eighth 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.

Final Agenda

TUESDAY, AUGUST 20

7:30 am Registration and Morning Coffee

CMS, PALMETTO AND LAB BENEFIT MANAGERS
Constitution B

8:30 Chairperson’s Opening Remarks

John Warren, Senior Director, Health Policy, McdermottPlus Consulting LLC

8:40 Updates Implementing Diagnostics Decisions at CMS

Katherine B. Szarama, PhD, Presidential Management Fellow, CMS

The Centers for Medicare & Medicaid Services (CMS) took action to advance innovative personalized medicine for Medicare patients with cancer when finalizing a National Coverage Determination (NCD) that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. This presentation will provide updates along the implementation timeline of the NCD and share any identified process improvement opportunities discovered by the Agency.

9:10 Moldx: Coverage, Policy, and Updates

Gabriel A. Bien-Willner, MD, PhD, Medical Director, Moldx, Palmetto Gba

This presentation will provide an overview of recent coverage decisions and the implications they may have for the future CMS decision seekers.

9:40 Working with Laboratory Benefit Managers: Tips & Best Practices

Mitchell Burken, MD, Associate Medical Director, Genetics, eviCore

Whether you’re in the early stages of working with Laboratory Benefit Managers (LBMs) or have more experience, understanding how to best work with LBMs is essential for reimbursement professionals. The goal is to best attempt to achieve a mutual understanding of what evidentiary thresholds are necessary to support reimbursement for their laboratory tests. Diagnostic professionals should aim to present emerging lab testing technology in a clear, concise manner that directly makes the case for clinical utility. This is a critical lever for successful reimbursement. These and other related main points will be covered in this presentation, under the planned umbrella that outlines the particular strategy of one major LBM, eviCore Healthcare.

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

10:55 Chairperson’s Remarks

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

11:00 PANEL DISCUSSION: PAMA Update and NCDs Implementation Conundrum

While the rapid evolution of clinical genomic technologies speeds ahead, federal policies are also evolving at a rapid place, both at CMS and on the Hill. While the lab industry works to adjust to and absorb these federal changes, commercial payers often adapt and change in response to federal payment policies. This panel will provide a lively, frank, sometimes controversial, and fully up-to-date review of what’s happened in 2019 so far and what to expect next.

Panelists: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

Brian Carey, JD, Partner, Co-Chair, Administrative Law Department, Foley Hoag LLP

Jennifer R. Leib, ScM, CGC, Founder, Innovation Policy Solutions, LLC

John Warren, Senior Director, Health Policy, McdermottPlus Consulting LLC

12:00 pm Incorporating Market Access into the Product Development Process

Mark Girardi, Vice President, Boston Healthcare Associates Inc.

In this presentation, Mark Girardi, Vice President of Boston Healthcare, will discuss the product development process and Market Access considerations and challenges, including real-world examples to demonstrate the importance of Market Access in the business decision-making process.

12:15 How to Proactively Combat Downward Reimbursement Pressure

Patti Karabel, Account Executive, Telcor

Laboratories are feeling the negative impact from regulatory changes. With reimbursement obstacles, laboratories need to take a hard look at ways to improve profitability and offset these downward pressures. During this session, learn how other laboratories are successfully re-engineering processes to positively impact profitability and how your laboratory can benefit.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Cookie & Refreshment in the Exhibit Hall with Poster Viewing

CASE STUDIES AND OPINIONS
Constitution B

1:25 Chairperson’s Remarks

Laura T. Housman, MPH, MBA, Head, Access, Outcomes and Population Health, Exact Sciences; Founder, Access Solutions Consulting

1:30 NCDs, LCDs, and Next-Generation Sequencing: The Commercial Lab Perspective

Jim Almas, MD, Vice President and National Medical Director for Clinical Effectiveness, LabCorp

In March 2018, CMS issued a national coverage decision on the use of next generation sequencing tests for patients with cancer. In place of coverage with evidence development, the Medicare Administrative Contractors (MACs) were allowed (under the NCD) to grant coverage for tests not covered by the NCD. The restrictions of that coverage have emerged and its effect on the operation of commercial clinical labs will be discussed.

1:50 The Quest to Win Coverage for Liquid Biopsy: From Gate Keeper to Bridge Builder

Mark D. Hiatt, MD, MBA, MS, Vice President, Medical Affairs, Guardant Health

Convincing payers of the medical necessity of a new diagnostic test can be challenging. A three-pronged approach can help with this otherwise formidable effort through enlisting support from the three “P’s” of persuasion: (1) third-party review organizations, (2) positive coverage from other plans, and (3) peer-reviewed publications. These three tactics will be explored in the real-world context of actual successful advocacy for a liquid biopsy test.

2:10 Expanding Health Access to Screening Testing through Population Health

Laura T. Housman, MPH, MBA, Head, Access, Outcomes and Population Health, Exact Sciences; Founder, Access Solutions Consulting

According to the Kaiser Family Foundation, employer-sponsored health insurance plans cover more than half of the country’s non-elderly population and nearly 80% offer wellness programs, yet screening testing for colorectal cancer and other diseases that benefit from early detection is underutilized. Can population health programmatic approaches make an impact to access and adoption for these organizations? How can barriers due to reimbursement challenges be overcome?

2:30 CO-PRESENTATION: Next-Generation Diagnostics as an Information Network: Addressing Evidence Gaps Through Real-World Data Integration

Kaushal Desai, PhD, Director, Informatics & Outcomes Research, Merck & Co., Inc.

As the US reimbursement environment transitions to a value-based model, value propositions for newer treatments need to be supported with timely, high-quality real-world evidence. This talk will highlight the importance of mapping the entire patient journey to evaluate the incremental value of diagnostic testing.

Robert Metcalf, MBA, CEO, Concert Genetics

As the US healthcare ecosystem transitions to value-based care models, advanced diagnostic technologies can only be evaluated based on evidence generated from high-quality real-world testing and outcomes data currently siloed across diverse stakeholders. This talk will review the information needs of three critical stakeholders in diagnostics-- providers that order, laboratories that render, and payers that reimburse—and discuss how point solutions can simultaneously connect the genetic health information network.

2:50 Reimbursement of POCT

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

This talk will discuss reimbursement challenges for point-of-care testing and what role point-of-care testing plays in a value-based payment system.

3:10 Wearables – RWE to Support Coverage and Reimbursement of Diagnostics

Anita Chawla, PhD, Managing Principal, Analysis Group

Real-world evidence (RWE) is increasingly developed to support both regulatory and reimbursement decisions for new health technologies. Wearable sensors that collect RWE can help diagnostic manufacturers demonstrate the utility and value of their diagnostic tests. This presentation will review recent examples of wearable data capture to generate evidence supporting coverage and reimbursement of diagnostics, considering how wearable technology is used today, and may be used in the future.

3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

HOT BUTTON ISSUES IN DX REIMBURSEMENT
Constitution B

4:25 Chairperson’s Remarks

Patrick Terry, CEO, Gray Group Ventures

4:30 PANEL DISCUSSION: Expanded Carrier Screening: Adoption, Market Access, and Collaboration 

Expanded Carrier Screening (ECS) assesses couples for 15+ serious genetic diseases for family planning and empowers them with actionable information that can improve outcomes and quality of life.  A significant percentage of physicians choose ECS over traditional ethnic-specific carrier testing, but payers struggle to cover this new approach despite its endorsement by the relevant professional Colleges. This results in inequality of care across diverse patient populations.  A coalition has been formed to address this issue.

Topics to be Discussed:

• Clinical utility of expanded carrier screening (ethnicity-based screening has reduced effectiveness compared with pan-ethnic approach, using NGS)
• Motivations behind the formation of an ECS coalition (Access to Expanded Carrier Screening)
• What are OB/GYNs ordering, and how does this align with current guidelines?

Moderator:

Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific

Panelists:

Jim Goldberg, MD, Chief Medical Officer, Myriad Women’s Health
Kimberly Martin, MD, Chief Clinical Advisor, Women's Health, Natera, Inc. 

Lee P. Shulman, MD, Anna Lapham Professor of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University 

5:00 PANEL DISCUSSION: Hot Button Issue in Dx Reimbursement

Moderators:

Danielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic, Inc.

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

Panelists:

Jim Almas, MD, Vice President and National Medical Director for Clinical Effectiveness, LabCorp

Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, AdvaMed

Tara Burke, PhD, Senior Director, Public Policy and Advocacy, Association for Molecular Pathology

Melina Cimler, PhD, CEO & Founder, PandiaDx

6:00 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

WEDNESDAY, AUGUST 21

7:15 am Registration

Independence B-E and Foyer

7:30 Problem Solving Breakout Discussions with Continental Breakfast

Working with Laboratory Benefit Managers

Moderator: Mitchell Burken, MD, Associate Medical Director, Genetics, eviCore

• What should be the key goal of diagnostic companies when working with Laboratory Benefit Managers (LBMs)?
• What is the most important piece of advice diagnostic professionals should keep in mind when working with LBMs?
• What is additional advice or suggestions for companies who are in the early stages of working with LBMs?

ASSURING ACCESS TO PERSONALIZED MEDICINE: REIMBURSEMENT STRATEGIES FOR ADVANCED DIAGNOSTICS AND novel THERAPIES
Farragut/Lafayette

8:25 Chairperson’s Remarks

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

8:30 Influence of Genomic Tests on Decision Pathways for Reimbursement Practices for Oncological Therapeutics

Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation & Medical Policy, Claim Payment Policy Department, Facilitated Health Networks, Independence Blue Cross

Achievement of optimal clinical care must be driven by multiple objective factors. Understanding and establishing the confidence in these contributing factors are essential due to their impacts on any proposed net improvement in relevant health outcomes. Development, advancement, integration, and routine clinical usage of options in oncological therapeutics are closely tied to availability, reliability, and acceptance of certain aspects of genomics. We will explore the impact of different facets of genetic testing on multiple phases of oncological therapeutics, and payment considerations based on these relationships.

8:45 Humana’s Perspective on Personalized Medicine

Kristine Bordenave, MD, FACP, Corporate Medical Director, NMCARE, Healthcare Services, Humana

9:00 Global Commercial and Partnership Considerations for Companion Diagnostics

Joseph Ferrara, President & CEO, Boston Healthcare Inc.

Key commercialization considerations for drug and test innovators, including balancing test access and quality, and embedding CDx global commercial considerations in pharma and diagnostic company partnerships will be highlighted.

9:30 PANEL DISCUSSION: Funding Common Ground with Payers and Policy Makers to Advance Personalized Medicine in Oncology and Beyond

While emerging personalized medicine technologies and platforms have the potential to make drug development more economical and make health systems more efficient by targeting treatments to only those who will benefit, they are also challenging reimbursement systems accustomed to one-size-fits-all medicine. Indeed, personalized medicine has led payers to think differently about coverage and reimbursement of high-value diagnostics and novel cell-based and genetic therapies that have the potential to cure diseases with one or only a few treatments. The approval of tissue-agnostic drugs such as Keytruda and Vitrakvi, for example, will force payers to figure out policies for pan-cancer indications and associated genetic testing, while the approval of cellular-based CAR-T therapies and gene therapies such as Luxturna, Kymriah, and Yescarta are challenging the traditional way that high-cost therapeutics can be reimbursed.

Moderator:

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

Panelists:

Kristine Bordenave, MD, FACP, Corporate Medical Director, NMCARE, Healthcare Services, Humana

Shuvayu S. Sen, PhD, Executive Director, CORE Oncology, Merck & Co., Inc.

Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation & Medical Policy, Claim Payment Policy Department, Facilitated Health Networks, Independence Blue Cross

Stella Stergiopoulos, Associate Director, Health Economic Outcomes Research and Payer Policy, Foundation Medicine, Inc.

Katherine B. Szarama, PhD, Presidential Management Fellow, CMS

Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific

Topics to be discussed:

• What are the key reimbursement challenges for advanced diagnostic tests?
• What strategies are emerging for the coverage and reimbursement of cell-based and genetic therapies?
• What evidence is necessary to demonstrate the value of personalized medicine technologies to payers and providers?
• How can practice-based evidence be developed in an environment of limited reimbursement and reduced access?

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

Constitution A&B

11:30 Plenary Keynote Session

11:30 Chairperson’s Remarks

Charles Mathews, Principal, ClearView Healthcare Partners

11:40 NEW: Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future

Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.

12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)

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

• How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
• How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
• How are policymakers addressing the role of CMS and CLIA in the VALID Act?
• How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
• What impact will changes in diagnostics regulation and oversight have on patient care?

Panelists:

Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)

Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings

Susan Van Meter, Executive Director, AdvaMedDx

Tara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)

Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research

1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 End of Coverage & Reimbursement for Advanced Diagnostics