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. The Cambridge Healthtech Institute’s Fourth Annual Coverage and Reimbursement of Advanced Diagnostics will provide its participants with unique opportunity to discuss winning strategies with government and private payers as well as with their peers who are working on similar tasks.

TUESDAY, AUGUST 18

7:30 am Main Conference Registration & Morning Coffee

FROM TECHNOLOGY CENTERED TO PATIENT CENTERED ASSESSMENT

8:30 Chairperson’s Opening Remarks

Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, CareCore National

9:10 Long Day’s Journey into Night - The Quest for Clinical Utility

Steven Gutman, M.D., Myraqa Strategic Advisor, Illumina, Inc.

Over the past ten years there has been an explosive increase in the number of biomarker assays available for the study and evaluation of human disease. To ensure stakeholders are able to use this growing menu of tests responsibly, there is a compelling need to understand the clinical utility of these assays. Unfortunately a surprising number of tests are plagued by inadequate information on clinical utility. This talk will focus on obstacles, challenges and opportunities for addressing this problem

9:40 Technology Assessment Best Practices: The Palmetto GBA Perspective

Girish Putcha, M.D., Ph.D., Director, Laboratory Science, Palmetto GBA (MolDX)

Palmetto's MolDX is a pilot program launched in 2011 that attempts to make more transparent, consistent and robust the mechanisms by which molecular tests are coded, covered, and reimbursed. During this presentation, we will briefly review the technical assessment process at MolDX

9:55 The Final Frontier: Securing Reimbursement from Payers

John Fox, M.D., Associate Vice President, Medical Affairs, Priority Health

Commercial payers are often the final hurdle in the reimbursement journey for new molecular tests. The type of information payers require in order to provide coverage—including what they are looking for in clinical utility studies—will be discussed. Attendees will also hear about how the opinions of technology assessment organizations, guidelines and specialty societies might influence payer decisions.

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

10:55 Chairperson’s Remarks

11:00 Integrating Evidence into Practice: NCCN’s Approach to Guidelines Development

Joan S. McClure, Senior Vice President for Clinical Information and Publications, NCCN

Inclusion in guidelines frequently expedites payers’ acceptance of new molecular technologies. Integrating effectiveness, risk, characteristics of supporting evidence, and cost permits selection of interventions based on the values of the patient and the clinician. Attendees will also find out about the nuances of balancing expert opinion with the information available in the published literature and how each can contribute to the final decision.

11:15 AHRQ Approaches for Diagnostics Technology Assessment and Case Studies

Elise Berliner, Ph.D., Director, The Technology Assessment Program, AHRQ

The Agency for Healthcare Research and Quality (AHRQ) provides technology assessments to CMS to inform coverage decisions and other policy questions. This session will describe the methods used by AHRQ for technology assessment, particularly methods relevant to the critical appraisal of diagnostic tests.

11:30 2015 and Beyond! Reimbursement Lessons for Another Year

Kyle Fetter, Vice President, Advanced Diagnostics, XIFIN, Inc.

Rina Wolf, Vice President, Strategic Commercialization, Consulting & Industry Affairs, XIFIN, Inc.

This session will highlight any updates on PAMA, Medicare and commercial payor trends in coverage and pricing, and what labs should be looking out for this year, and beyon

12:00pm PANEL DISCUSSION: TO PAY OR NOT TO PAY, THAT IS THE QUESTION: Different Perspectives on the Reimbursement Hurdles for New Technologies

Moderator: Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, CareCore National

• Hear what organizations believe are the key elements of clinical utility
• Discover how assessments from CMS and guideline organizations influence payers’ decisions
• Understand how payers ultimately decide whether or not to include new tests
• Determine whether their approach will meet these goals—or if they need to refine their tactics

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

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing

CHALLENGES AND SOLUTIONS

2:00 Chairperson’s Remarks

Rina Wolf, Vice President, Strategic Commercialization, Consulting & Industry Affairs, XIFIN, Inc.

2:05 POC Test and PAMA: Challenges to the Industry

Ester Stein, Director, Corporate Reimbursement, Abbott Molecular

Point-of-care testing (POCT) is a small, innovative but growing area of the U.S. healthcare system. The driving concept behind POCT is that is provides convenient and immediate testing to the patient and accelerates the availability of diagnostic test results to enable healthcare professionals to make treatment decisions sooner. Protecting Access to Medicare Act of 2014 is the first major reform to the Clinical Laboratory Fee Schedule since 1984, which will create environmental changes to the laboratory community. This presentation will examine how this new market based system may impact the point of care testing segment.

2:35 Reimbursement for Multi-Analyte Assays: Different Ways to Clinical Utility Data and Improved Health Outcome Data, a Case Study on Prospective Study Design in Molecular Diagnostics

Bastiaan Van Der Baan, Vice President, Clinical Affairs, Agendia

Clinical utility as it is defined by payers continues to be an ongoing challenge for diagnostic reimbursement professionals as there are often variations in the way that payers view this data. With most diagnostic companies following the ACCE model system for collecting, analyzing and disseminating information, payers still interpret data from clinical utility studies differently, making the review process feel wearisome and somewhat subjective for reimbursement professionals.

3:05 Whole Exome Sequencing in the Clinic: The Test Reimbursed, What Have You Done For Me Lately?

Mark E. Nunes, M.D., Associate Professor, Pediatrics, Division Chief, Medical Genetics, Kaiser Permanente

The majority of clinical whole exome sequencing (WES) return “not positive”, creating challenges for the genetic counselor. However, positive WES results create just as many vexing challenges for the ordering specialist. The Diagnostic and Treatment Odyssey continues in most cases, and the mechanisms for accomplishing and paying for this, outside the academic setting, are not established. This gap in Personalized Medicine is discussed, in contrast to targeted next generation sequencing (NGS) panels.

3:35 Commercializing Advanced Diagnostics: Challenges, Strategies, and Finding Paths to Success

Brian Gorin, Managing Principal, Analysis Group

Evidence requirements for coverage, reimbursement and uptake of advanced diagnostics are on an ever increasing trajectory. Developers need to articulate clear value propositions as early in development as possible. These propositions must be supported by well-designed and thoughtful evidence strategies. Even when these activities are well executed, successful commercialization faces significant risk. Upcoming changes to the regulatory and reimbursement processes in the U.S. will better align diagnostic approval and reimbursement with market forces. Hear about how companies are managing these challenges.

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

POLICIES REVIEW AND WHAT IS AHEAD

4:50 PAYER PANEL DISCUSSION:

Moderator: Andrew C. Fish, Executive Director, AdvaMedDx

• Payer evidence expectations
• Making the case for clinical utility
• Contrasting diagnostics with therapies
• When does cost matter?
• Interplay of Medicare and private payer policies

Panelists:

Arthur Lurvey M.D., Contractor Medical Director, JE Noridian Healthcare Solutions

John Fox, M.D., Associate Vice President, Medical Affairs, Priority Health

Chris L. Jagmin, M.D.,Senior Medical Director, National Medical Policy and Operations, Aetna

Mark E. Nunes, M.D., Division Chief, Medical Genetics, Kaiser Permanente

5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:50 Close of Day

WEDNESDAY, AUGUST 19

7:15 am Registration

CASE STUDIES AND FDA-CMS PARALLEL REVIEW

8:25 Chairperson’s Opening Remarks

 Yarmela Pavlovic, Partner, Hogan Lovells US LLP

8:30 Genomic Testing: A Case Study in Maximizing Value in Hereditary Condition Screening

Chris L. Jagmin, M.D.,Senior Medical Director, National Medical Policy and Operations, Aetna

The growing technical scope of genomic testing can allow for additional low penetrance markers to be explored at the same cost as previous testing for a more confined set of markers. How should insurance companies manage this capability? We created a two-tier system to allow for members to receive either the focused or expanded genomic panel at no additional cost to the members.

9:00 Bringing Cologuard to Market: What It Takes to Work Simultaneously with FDA and CMS

John Ridge, Senior Director, Managed Care and Reimbursement, Exact Sciences

Sandra Statz, Vice President, Clinical, Quality & Regulatory, Exact Sciences

9:20 FDA-CMS Parallel Review Pilot - Cologuard^TM

Joseph Chin, M.D., M.S., Senior Medical Advisor, Acting Deputy Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

This presentation will feature the CMS perspective on review of Cologuard^TM in the FDA-CMS Parallel Review Pilot Program. It will discuss CMS involvement and specific requirements that needed to be met for CMS to expedite the national coverage determination process 

9:35 FDA-CMS Parallel Review – FDA Perspective

Nina Hunter, Ph.D., Regulatory Scientist, Division of Molecular Genetics and Pathology, Food and Drug Administration (FDA)

On August 11, 2014, FDA approved Cologuard, the first stool-based colorectal screening test. Concurrently, CMS issued a proposed national coverage determination for Cologuard. Cologuard is the first product reviewed through a joint FDA-CMS pilot program known as parallel review where the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage. . A description of the program can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409021.htm

9:50 PANEL DISCUSSION: Lessons Learned from the Pilot Program

Moderator: Yarmela Pavlovic, Attorney at Law, Hogan Lovells US LLP

The existing FDA-CMS pilot parallel review program is currently slated to continue accepting applicants until December 2015. Hear from participants (FDA, CMS and Exact Sciences) from the one successful case study of parallel review regarding their experiences with the program as they engage in discussion around the benefits and challenges. The panel discussion will cover the following topics:

• Recommendations for companies considering the process, including factors to evaluate in determining whether to apply
• Planning for participation – how to make the most out of the process
• Evolution of the program – any changes to be expected in the future?

Panelists:

John Ridge, Senior Director, Managed Care and Reimbursement, Exact Sciences

Sandra Statz, Vice President, Clinical, Quality & Regulatory, Exact Sciences

Nina Hunter, Ph.D., Regulatory Scientist, Division of Molecular Genetics and Pathology, Food and Drug Administration (FDA)

Joseph Chin, M.D., M.S., Senior Medical Advisor, Acting Deputy Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

10:30 Coffee Break in Exhibit Hall with Poster Viewing

1:10 Close of Coverage and Reimbursement of Advanced Diagnostics