Cambridge Healthtech Institute’s Seventh Annual
Coverage and Reimbursement for Advanced Diagnostics
Latest Developments in the Dx Reimbursement Landscape
August 23-24, 2018 | Grand Hyatt Washington | Washington, DC
More and more payers are implementing processes that make it progressively more difficult for molecular diagnostics companies and labs to secure payment for their tests. Prior authorization and product registration require laboratories to deliver additional information from clinical trials, physicians, 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 Seventh Annual Coverage and Reimbursement for Advanced Diagnostics will provide its participants with a unique opportunity to discuss winning strategies with government and private payers as well as with their peers who are working on similar tasks.
Final Agenda
THURSDAY, AUGUST 23
10:00 am Registration (Independence Foyer)
11:15 am Chairperson’s Remarks
11:20 am - 12:00 pm TECHNOLOGY PANEL: Disruptive Technologies in Lab Medicine
Moderator: Gregory J. Tsongalis, PhD, HCLD, CC, Professor, Pathology; Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth
- What is appropriate test utilization?
- How do you ensure both user and patient safety?
- How are tests implemented in the clinical setting?
- How do they get regulated?
- How do results get reported?
- How do you enforce quality control in implementation?
- How does it impact emerging applications such as liquid biopsies, infectious disease outbreaks, and POC diagnostics?
Panelists:
Rakesh Nagarajan, MD, PhD, Chief Biomedical Informatics Officer, PierianDx
Greg Richard, Chief Commercial Officer, Interpace Diagnostics
Crystal R. Icenhour, PhD, CEO, Aperiomics, Inc.
Additional Panelists to be Announced
12:00 - 12:45 pm Changing Approaches to Sustainable Funding in Diagnostics
Moderator: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Today, many innovators in the diagnostics industry struggle for funding, and yet news of large scale acquisitions or large (over $30M) funding rounds pops up regularly. How can innovators better understand the changing dynamics of the funding environment to succeed? How can investors know if they are getting exposed to the potentially best investments? Whether government or private, what drives the final difficult decisions and how can companies raise their chances of success? This session features leaders from several different channels of funding for innovators, including the NIH, other federal programs, and corporate and traditional venture investors.
Panelists:
Alex DeWinter, PhD, Managing Director, GE Ventures
Tyler Merkeley, BARDA’s CARB-X Program Manager, Health Scientist, Division of CBRN Countermeasures, BARDA
Todd Haim, PhD, Program Director, National Cancer Institute SBIR Development Center
Wouter Meuleman, PhD, Director, Venture Investments, Illumina Ventures
David Sans, PhD, MBA, F.A.A.R.M., Managing Director, Healthcare Capital Markets, THINK EQUITY (A Division of Fordham Financial Mgmt., Inc.)
12:45 pm Luncheon Presentation to be Announced (Franklin/McPherson)
1:15 Ice Cream and Cookie Break in the Exhibit Hall with Poster viewing (Independence Ballroom)
2:00 Chairperson’s Opening Remarks
Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific
2:05 PANEL DISCUSSION: Parallel Review of FoundationOne
This session will discuss the process and ramification of the parallel review of FoundationOne. Key reviewers from CMS and FDA as well as reimbursement and regulatory leaders from FMI will participate in the session.
Participants:
Katherine B. Szarama PhD, Presidential Management Fellow, CMS
Anand Pathak, MD, Medical Officer, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, FDA
Gary Martucci, Senior Vice President, Payer Relations & Reimbursement Strategy, Foundation Medicine
Christine Vietz, Vice President, Regulatory Affairs, Foundation Medicine
2:50 Accelerating the Path to Coverage: NGS Testing in Lung Cancer
Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific
A multiplex test which efficiently manages tissue and yields dozens of results seems like an obvious choice. However, single gene tests are still common among physicians, CLIA labs, and many health plan coverage policies. This discussion will address 2017-18 coverage experiences with changing NGS testing policies at CMS, local MACs, commercial payers and their impact on testing by some of the nation’s largest reference labs.
3:05 Precision Diagnostics in Light of the Recent NCD
Jim Almas, MD, Medical Director, MolDX, PalmettoGBA
The FDA has approved tumor mutational profiling tests (Foundation and ThermoFisher). CMS has issued an NCD providing coverage. What does this mean to the LDT world for coverage?
3:35Aligning Coding and Evidence Pathways to Secure Coverage in the Age of PLA Coding
Shivang Doshi, MSc, Director, Boston Healthcare Associates
PLA coding has presented Dx innovators with an accelerated path to securing novel codes and the ability to bill payers with greater specificity. These codes are now available for emerging tests, some of which lack evidence of robust clinical utility, exposing tests to the risk of explicit non-coverage policies. This presentation will highlight the need to evaluate the evidence to needed to communicate vale, and align evidence development with coding and billing timelines to optimize coverage.
4:05 Networking Refreshment Break (Independence Foyer)
4:30 What Keeps Payers Up at Night: Genomic Testing Issues
Lee Newcomer, MD, Consultant
This talk will be a discussion of key issues that concern payers for genomic testing.
5:00 PANEL DISCUSSION: Evolving Payer Coverage Policies on Next-Generation Sequencing Tests – Examining Possible Impact of New CMS Guidance on NGS for Cancer Patients - and Beyond
Moderator: 
Louis Jacques, MD, SVP and Chief Clinical Officer, ADVI
Katherine B. Szarama PhD, Presidential Management Fellow, CMS
Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific
Jim Almas, MD, Medical Director, MolDX, PalmettoGBA
Lee Newcomer, MD, Consultant
Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation and Medical Policy, Independence Blue Cross
Let’s assume that the guidance is implemented as proposed. The panel will discuss the possible implications and takeaways for the audience including the following topics:
- Implications for regulators
- Impact on private payers
- Education of payers
- Defining economic value
- Marketing messages
- Working with labs
- Health policy context
6:00 Close of Day
6:00 Dinner Short Course Registration (Independence Foyer)
6:30 - 9:00 pm Recommended Dinner Short Course*
SC10: Leveraging Key Opinion Leaders (KOLs): Building a Bridge Between R&D and Commercialization of Companion and Non-Companion Diagnostics
Lawrence J. Worden, Principal, IVD Logix
Charles Mathews, Principal, ClearView Healthcare Partners
Peggy Robinson, Vice President, Angle PLC
*Separate registration required
FRIDAY, AUGUST 24
8:00 am Registration and Morning Coffee (Independence Foyer)
8:25 Chairperson’s Remarks
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
8:30 Tools & Processes for Making Evidence-Based Policy Decisions
Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation and Medical Policy, Independence Blue Cross
The exponential advents of advances in techniques and types of molecular diagnostic testing, and modifying strategies for these tests, are encouraging; but these evolutions simultaneously continue to introduce challenges in clinical evaluations and subsequent medical policy and reimbursement decisions related to these events. Robust critiques and standardized analyses are always recommended for coverage decisions, but flexibilities may need to be considered when appropriate. ACCE & PICOTS Models etc. must drive any assessments before financial/economic capacities come into play.
9:00 Importance of Companion Diagnostics Evidence for US and Global Coverage
Stephen Hull, Founder and Principal, Hull Associates LLC.
As new market entrants in the companion diagnostics space proliferate, payers in the USA and around the globe recognize the significant incremental costs of diagnosis. Developers should not assume automatic coverage and payment for companion lab tests following coverage of the associated therapeutic. In today’s environment many payers will require a clear economic value proposition and evidence for the companion test itself before extending coverage to the full potential target population. Prior authorization, coverage criteria and pressure on price are increasingly common for companion tests, including tests aimed at diagnosis or stratification of rare diseases. This session will explore the trends in coverage among US Commercial and other payers, as well as major European and other Global market payment systems.
9:30 PANEL DISCUSSION: PAMA Pricing at Medicare: Implications
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 2018 so far and what to expect next.
- Medicare Payment Policies
- PAMA Price Changes - How Industry Is Reacting
- New Rules for ADLTs - Key Strategic Considerations
- Trends at MolDX and Stakeholder Responses
- Summer 2018 Rulemaking - What You Need to Know
- Medicare and the FDA
- The CMS NCD for Next-Gen Sequencing in Oncology
- How Payers Interpret Combination vs Complimentary Diagnostics
- Congress and Diagnostics
- Outlook for Fixing PAMA
- Outlook for Changing the Regulation of Clinical Diagnostics
Panelists: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Marc Samuels, Founder, CEO, ADVI
Dan Todd, Principal, Todd Strategy
10:30 Networking Coffee Break (Constitution Foyer)
11:00 PANEL DISCUSSION: The Value Proposition of Point-of-Care Testing
Moderators: 
John Warren, Senior Director, McDermottPlus Consulting
Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
Join a panel of experts from payers, providers and patients discussing the value and future of point-of-care testing. During this informative panel discussion, listen to these leaders as they discuss:
- How point-of-care testing adds value to the patient experience
- What role point-of-care testing plays in a value-based payment system
- What new advancements in point-of-care testing are on the horizon
Panelists:
Joseph Rubino, PhD, Senior Reimbursement Specialist, Cepheid
Rachael Evans, CMO, Family Medicine, Henry J. Austin Health Center
New Panelists:
Valery Keyi, MT, MBA, Hospital Point of Care Manager
Chelse Dyer, Senior Director, Business Operations, Abbott (formerly Alere Toxicology)
Chandra Branham, Vice President, Payment and Health Care Delivery Policy, AdvaMed
12:30 Enjoy Lunch on Your Own
1:00 Session Break
1:30 Chairperson’s Remarks
Daryl Pritchard, PhD, Senior Vice President, Science Policy, PMC
1:35 Clinical and Economic Value of NGS in Cancer Care
Daryl Pritchard, PhD, Senior Vice President, Science Policy, PMC
To provide evidence of the clinical and economic value of mNGS-based diagnostic testing for developers, payers, and providers, we developed a value model to compare the costs and effects of mNGS testing to those of single-marker testing. Given the rapid advance of mutation testing and targeted therapies in metastatic non-small cell lung cancer (mNSCLC), we first analyzed the clinical and cost-effectiveness of mNGS in this cancer type and validated the model with existing real-world data. In this session, we discuss the clinical and economic value of mNGS-based diagnostic testing and discuss how the results of our analysis have been and can be affected by clinical practice patterns. These findings provide evidence that helps demonstrate the potential role and utility of mNGS testing in cancer care.
2:05 CO-PRESENTATION: IIllumina/Harvard Pilgrim on NIPT: Addressing the Biggest Commercial Problem in Diagnostics
Ammar Qadan, Vice President, Global Market Access, Illumina
Roger Longman, CEO, RealEndpoints
Flooded with new and often expensive diagnostics, most without much clinical or economic proof of utility, payers have put the brakes on payment. The result: a commercial pile-up of unreimbursed tests. Illumina and Harvard Pilgrim decided to tackle the problem head on in a major risk-sharing deal for a screening test that can both save money for a plan and improve outcomes. HP, in a competitive payer market, will be able to provide a new, major benefit with Illumina taking much of the risk around additional costs – and Illumina will get the real-world evidence other plans need to prove NIPT’s value. Illumina’s Ammar Qadan, who created and spearheaded the deal, and Roger Longman of Real Endpoints, the independent 3rd party which brokered the deal and will provide the analytics and financial reconciliation for it, will provide a case study in how genetic diagnostic companies can address their single biggest commercial challenge: reimbursement.
2:35 Operational and Economic Considerations Impacting the Decision to Implement NGS Testing in the Clinical Laboratory
Anthony Sireci, MD, MSc, Physician Manager, Personalized Genomic Medicine, Assistant Professor of Pathology Columbia University, Medical Director, Medical Affairs, Loxo Oncology
NGS technology has been rapidly adopted in the care of cancer patients. While the technology has matured rapidly, its effective integration into the clinical laboratory is challenged by unique infrastructure and informatics requirements and uncertain coverage and reimbursement by payers. This talk highlights the challenges faced by a large, academic medical center in introducing clinical NGS testing in oncology testing.
3:05 End of Summit