Cambridge Healthtech Institute’s Sixth Annual
Coverage and Reimbursement of Advanced Diagnostics
Establishing Clinical Utility and Working with Payers
August 15-16, 2017 | Grand Hyatt Washington | Washington, DC
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 a health care budget and the launch of a large number of expensive molecular tests creates complications for payers to respond in traditional ways. With the new PAMA legislation and the increasing role of private payers in setting the reimbursement rates, it is important to stay informed and current in the rapidly changing environment. Cambridge Healthtech Institute’s 6th Annual Coverage and Reimbursement of 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
Recommended Short Course(s)*
SC4: Commercialization Boot Camp: Manual for Success in Molecular Diagnostics
SC13: Regulatory and Reimbursement Issues with Advanced Diagnostics and Circulating Biomarkers
*Separate registration required
TUESDAY, AUGUST 15
7:30 am Main Conference Registration & Morning Coffee
8:30 Chairperson’s Opening Remarks
Dwight Denham, Vice President, Global Health Economics & Reimbursement, Danaher Corp
8:40 Study Design Concepts for Evidence Development to Demonstrate Clinical Validity and Utility of Advanced Diagnostics
Dwight Denham, Vice President, Global Health Economics & Reimbursement, Danaher Corp.
Various organizations are conducting technology assessments to aid payers in medical policy decisions. This creates a challenging environment for test developers to assess the variances, and to determine how to plan evidence development. This presentation will share some concepts to encourage discussion with the panel and the audience on experiences and approaches for evidence development to inform medical policy.
9:05 Reporting the Services our Laboratories Provide: Proprietary Laboratory Analyses (PLA) Codeset
Lee Hilborne, M.D., MPH, Professor, Pathology and Laboratory Medicine, David Geffen School of Medicine, UCLA HealthSystem; Senior Medical Director, Medical Affairs, Quest Diagnostics; Health Policy Researcher, Global Health, RAND
Initially in response to the Protecting Access to Medicare Act of 2014 (PAMA), the CPT Editorial Panel created a new PLA section of the Current Procedural Terminology (CPT®) codebook that addresses the needs specified under PAMA (e.g., Advanced Diagnostic Laboratory Tests, ADLTs). However, these alphanumeric codes are new, not specific for PAMA, and there are different criteria for creating a PLA code compared to the traditional Category I CPT code. Laboratories that receive a PLA code can work with payers that review the evidence (e.g, Evidence Street), obtain coverage recommendations based on the clinical utility of the service described by the code, negotiate appropriate reimbursement, and specifically track their service. How will the community react to these new codes? We will have the opportunity to engage in a discussion with the laboratory and payer community!
9:30 KEYNOTE PRESENTATION: Evidence Street™: Where the Market Meets Evidence
Suzanne Belinson, Ph.D., Executive Director of Clinical Markets, Blue Cross Blue Shield Association
The Evidence Street™, a first of its kind web-based platform, is designed to represent where the market meets evidence. Evidence Street™ enables BlueCross BlueShield Plans to serve its members and the marketplace by providing transparency and efficiency of evidence reviews for device, diagnostics, and pharmaceuticals. Evidence Street™ launched in October 2015 with Blue Plan and manufacturer users. Within six months, Evidence Street™ expanded to include government contractors and clinical experts.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, Evicore Healthcare
11:00 Developing Dossiers for Technical Assessment of Advanced Diagnostics
Dave Nellesen, Ph.D., Vice President, Analysis Group
Technical assessments of advanced diagnostics have become more rigorous and more comprehensive in the review of supporting evidence. To obtain broad coverage and favorable reimbursement, manufacturers need a package of clinical and economic evidence that communicates the value of the new diagnostic in an effective and balanced manner. This presentation will review critical components of diagnostic dossiers, with key considerations for manufacturers on how diagnostic dossiers are used today and may evolve in the future.
11:30 Optimizing the Reimbursement of Comprehensive Genomic Profiling in Cancer
Jerry Conway, Vice President, Payer Relations & Reimbursement, Foundation Medicine, Inc.
Reimbursement of comprehensive genomic profiling in cancer has been a large challenge. This new diagnostic approach framed as precision medicine is a confounder for payers who have traditionally covered molecular testing in cancer on a gene and tumor type basis. Cancer is a disease of the genome, and a comprehensive genomic profiling strategy proposes to sequence many cancer genes at once regardless of tumor type in order to uncover the bio-mechanistic rationale for the use or avoidance of high impact targeted and immunotherapy treatments. Some payers have started to cover and pay for this new transformative approach, and this session will reveal unique insights on why and how reimbursement is getting traction.
12:00 pm Evolving Value Definitions and Evidence Development Dynamics for Diagnostics
Charles Mathews, Vice President, Boston Healthcare
As advanced clinical diagnostics move from simply analytical tools to powerful sources of information, so are the dynamics around defining and articulating novel test value. This session will review the types of information that clinical diagnostics provide and discuss ways to express the value of various clinical positions. Using case studies, we will explore diverse clinical utility evidence design concepts that can be deployed to meet varying evidence needs associated with various test types.
12:30 Novel Diagnostic Technologies: Coverage Today and in the Future
Kyle Fetter, Vice President & General Manager, Diagnostic Services, XIFIN, Inc.
Early stage and wearable diagnostic device companies face great hurdles to commercialization and reimbursement. The combination of clinical research, market adoption, and reimbursement challenges makes it imperative to synch up efforts. Understand the necessary tools with information on current challenges and how diagnostics companies are positioning themselves for success.
1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:30 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing
2:00 Chairperson’s Remarks
Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, Evicore Healthcare
2:05 PANEL DISCUSSION: Establishing Evidence Dossier
Moderator:
Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, Evicore Healthcare
Translational Medicine describes the scientific process of moving diagnostics from research to the clinic. Similarly, the concept of Translational Evidence could apply to the reimbursement process of moving diagnostics from Investigational & Experimental to Medically Necessary. While the quality of the evidence generated is important, the way the information is organized and presented to a payer is equally critical in ensuring success. This panel will:
- Discuss not only what types of evidence payers look for, but the way they like it presented
- Share personal observations on what works—and what doesn’t
- Reveal how the pieces all fit together to determine coverage
Panelists:
Elaine Jeter, M.D., Medical Director, MolDX
Suzanne Belinson, Ph.D., Executive Director of Clinical Markets, Blue Cross Blue Shield Association
Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation and Medical Policy, Independence Blue Cross
Katherine B. Szarama, Ph.D., Presidential Management Fellow and Lead Health Policy Analyst, Coverage and Analysis Group, The Centers for Medicare & Medicaid Services
Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration
3:05 Successes and Opportunities in Working with Payers for Reimbursement
Nate Morgan, Regional Revenue Integrity Manager, Revenue Cycle Organization (RCO), Intermountain Healthcare
Intermountain Healthcare established its Precision Genomics program in the fall of 2014. Since that time, we have experienced many successes and identified several opportunities regarding payers and reimbursement. This presentation will explore the strategies and pain points in establishing evidence and working with payers for reimbursement.
3:20 PANEL DISCUSSION: Enter Your Payment Information Here: Patient Contributions toward Next-Generation Sequencing Testing in Today’s Reimbursement Environment
Moderator: 
Laura T. Housman, Founder, Access Solutions Consulting
Join the panelists as they share insights, research and commercial strategies into both reimbursement and payment challenges and opportunities in patient access to innovative NGS testing. Discussion will include insights for engaging patients and understanding financial limitations in the context of affordability, access and innovation.
Panelists:
Kathryn A. Phillips, Ph.D., Professor, University of California San Francisco
Nate Morgan, Regional Revenue Integrity Manager, Revenue Cycle Organization (RCO), Intermountain Healthcare
4:05 Refreshment Break in the Exhibit Hall with Poster Viewing
4:50 PANEL DISCUSSION: Establishing the Value of Point-of-Care Testing
Moderator:
John Warren, Senior Director, McDermottPlus Consulting
This panel will explore the benefits of a robust point-of-care testing program in the management of public health issues. You’ll hear from providers and patient advocates who know firsthand how important point-of-care testing is to the effective and efficient management of public health related conditions. They will explore roadblocks to implementing a point-of-care testing program as well. You will also hear the payer perspective on the value of covering point-of-care testing.
Panelists:
Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
Joseph Rubino, Ph.D., Senior Reimbursement Specialist, Cepheid
Steven J. Brotman, M.D., J.D., Senior Vice President, Payment & Health Care Delivery Policy, AdvaMed
5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:50 Close of Day
WEDNESDAY, AUGUST 16
7:15 am Registration
7:30 Problem-Solving Breakout Discussions with Continental Breakfast
Reimbursement of Genomic Profiling in Oncology – Best Practices
Moderator: Jerry Conway, Vice President, Payer Relations & Reimbursement, Foundation Medicine, Inc.
- Is/Can genomic profiling transforming cancer care?
- What are the reimbursement challenges and opportunities for genomic profiling?
- What are some best practices to achieve value-based market access and reimbursement of genomic profiling?
Coverage and Reimbursement of Advanced Diagnostics
Moderators: Danielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic, Inc.
Victoria M. Pratt, Ph.D., FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana University School of Medicine
- PLA codes from AMA
- ADLTs from CMS
- Successful (?) or lack of successful reimbursement strategies
8:25 Chairperson’s Opening Remarks
Victoria M. Pratt, Ph.D., FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana University School of Medicine
8:35 Clinical Utility of a CfDNA Assay versus Research Utility
Gary Spitzer, M.D., Director Clinical Validity and Clinical Utility Evaluation, MolDx, Palmetto GBA
Design of prospective transparent registries to validate the clinical utility of a test in a clear intent to study patient population. Obstacles of existing registry and trial design and present ideas on how costs can be diminished through non-traditional data extraction techniques, but with a emphasis on transparency, scientific independence and open data collection.
8:55 The Reimbursement Crisis in Molecular Diagnostics Is a Myth
William Haack, Vice President, Market Access & Business Operations, Commercial Operations, OncoCyte
While it is true that there is ambiguity within the reimbursement landscape, in most cases, the lack of reimbursement in our industry is the result of self-inflicted wounds. Payors have made it clear what industry must do to get paid and the industry continues to ignore what they hear.
9:15 ADLT versus PLA Codes: Are There Any Winners?
Victoria M. Pratt, Ph.D., FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana University School of Medicine
Protecting Access to Medicare Act (PAMA) defines an ADLT as a laboratory test that is covered under Medicare Part B and is offered and furnished only by a single laboratory, that is not sold for use by a laboratory other than the original developing laboratory. Proprietary Laboratory Analyses (PLA) codes are a new addition to the CPT® code set and are for labs or manufacturers that want to more specifically identify their test. This session will review the merits of each type of code and its implications for reimbursement.
9:40 PANEL DISCUSSION: Identifying and Reporting Data under PAMA
Moderator:
John Warren, Senior Director, McDermottPlus Consulting
Topics to be discussed:
- Review the data reporting requirements put in place by the Protecting Access to Medicare Act
- Share real-world experiences from labs who were tasked with identifying, reviewing and collecting this data
- Present lessons learned that participants can take back with them to improve their own data collecting and reporting processes
Panelists:
Seema Singh Bhan, Head of Public Policy, Foundation Medicine
Danielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic, Inc.
Jeff Salzman, MS, Head of Billing & Reimbursement, CareDx, Inc.
Laurie Howard, Vice President, Reimbursement, LabCorp
10:30 Coffee Break in Exhibit Hall with Poster Viewing
1:05 pm Luncheon Presentation:Transitioning Emerging Research Tools into Clinical Diagnostics
Moderator:
David Cavanaugh, Partner, DeciBio Consulting
Panelists:
Anna Berdine, Vice President, Marketing, NanoString Technologies
Asia Chang, Senior Director, Oncology, Product Management, Clinical NGS Division, Thermo Fisher Scientific
Kyle Fieleke, Senior Director, Global Strategic Marketing, Luminex Corporation
Many innovative technologies struggle to make the leap from research to clinical applications. DeciBio Consulting partner David Cavanaugh will host a panel with KOLs and experienced stakeholders who have successfully navigated the transition to demystify the process and elaborate on the keys to success.
1:35 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing
1:35 Close of Coverage and Reimbursement of Advanced Diagnostics