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 Fifth 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.
TUESDAY, AUGUST 23
7:30 am Registration & Morning Coffee
8:30 Chairperson’s Opening Remarks
Girish Putcha, M.D., Ph.D., Director, Laboratory Science, Palmetto GBA (MolDX)
8:40 The Value of Diagnostics in the Changing Healthcare Environment: From Fee-for-Service to Value-Based Payments
Dwight Denham, Vice President, Global Health Economics & Reimbursement, Danaher Corp
The diagnostics industry and the laboratory medicine community are challenged by the ever-changing face of the healthcare systems they serve. In particular, the evolving shift towards value-based payments. This presentation will introduce the forces behind value based payment, and provide some perspectives on health economic methods to address tests/platforms of varying utilities. Perspectives on the broader number of stakeholders involved in adoption, under value based payment models, will be shared.
9:10 Facing Challenges Regarding the Reimbursement Paradigms for Advanced Diagnostics
Lee Hilborne, MD, MPH, Professor, Pathology and Laboratory Medicine, David Geffen School of Medicine UCLA HealthSystem, Senior Medical Director, Medical Affairs, Quest Diagnositics, Health Policy Researcher, Global Health, RAND
Advanced diagnostics are critically important to improving the value of medicine. New and innovative strategies to improve patient care have outpaced current systems to appropriately reimburse providers for the costs of services and the value provided. At the same time, the Institute of Medicine estimates that 30% of U.S. healthcare is duplicative or unnecessary. Inappropriate or over-utilized medical tests account for $250 to $300 billion in U.S. medical expenses annually. Our challenge must be to quickly establish both clinical validity AND clinical utility for new diagnostic services while taking responsibility for effective utilization of both new and existing diagnostic services.
9:40 Challenges and Solutions for Molecular Diagnostics in Healthcare
Girish Putcha, M.D., Ph.D., Director, Laboratory Science, Palmetto GBA (MolDX)
This presentation will discussion several key issues such as: review the MolDX technical assessment process and potential coverage outcomes; present case studies to demonstrate varying ways to approach coverage, share lessons learned, and personal observations on what works–and what doesn’t.
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 The Art of Evidence Generation: How to Win Friends and Influence Payers
Daniel Halevy, MD FASN, Medical Director II, Horizon Blue Cross Blue Shield
This presentation will discussion several key issues such as: examine how medical policy committees evaluate your evidence package, recognize what payers look for in a clinical utility study and discover how the pieces all fit together to determine coverage.
11:30 Interacting with the AMA: It’s Not Just for Doctors Anymore
Lauren Feldman, M.H.A., Associate Director, ADVI Health
In this presentation I will review how to work with the AMA to secure a CPT code, assess the types of molecular diagnostic codes available and discuss the new proprietary laboratory analysis codes and examine example use cases.
12:00pm 2016 and Beyond! Reimbursement: Lessons for Another Year
Rina Wolf, Vice President, Commercialization Strategies, Consulting & Industry Affairs, XIFIN, Inc.
Kyle Fetter, AVP, Advanced Diagnostics Services, 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 beyond.
12:30 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, Evicore Healthcare
Panelists:
Rina Wolf, Vice President, Commercialization Strategies, Consulting & Industry Affairs, XIFIN, Inc
Daniel Halevy, MD FASN, Medical Director II, Horizon Blue Cross Blue Shield
Lauren Feldman, M.H.A., Associate Director, ADVI Health
- 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 and Cookie Break in the Exhibit Hall with Poster Viewing
2:00 Chairperson’s Remarks
Katherine Tynan, Ph.D., President, Tynan Consulting LLC
2:05 Coverage and Reimbursement Landscape of Genomic Profiling in Oncology
Jerry Conway, Vice President, Payer Relations & Reimbursement, Foundation Medicine, Inc.
As genomic profiling tests pose to assist in the improvement of overall treatment efficacy and patient outcomes, it is crucial for providers of genomic profiling tests to have extensive knowledge regarding drug formulary and coverage trends in the current diagnostic marketplace to ensure future genomic profiling tests will have optimal patient access routes.
2:35 Who Cares, When, and What Can Be Done: Justifying Somatic and Germline NGS Panels
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.
3:05 Successes and Opportunities in Working with Payers for Reimbursement of NGS
Jason L Gillman, MSPH, Director, Cancer Genomics, 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.
3:35 Securing Medical Policy Coverage while Eliminating Coverage of Outdated Technology
Vanessa DePalma, Senior Corporate Director, Health Plan and Payer Markets, Meridian Bioscience, Inc.
Diagnostic organizations want to offer the most appropriate laboratory tests to payers, providers and patients with the goal of offering best in class technology that promote: early detection, prevention, quality improvement and cost savings to the system. Additionally, if an outdated diagnostic test exists, key elements must be dully presented to demonstrate why the inferior technology should not be utilized or reimbursed. This case study will review this simultaneous approach and lessons learned in the disease management of helicobacter pylori ( H. pylori).
4:05 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Direct to Wallet: Understanding and Managing Patient Responsibilities associated with Next Generation Sequencing Testing in Today's Reimbursement Environment
Laura T. Housman, MPH, MBA, Founder, Access Solutions Consulting (ASC)
This talk shares my thoughts on the importance of considering patient contribution when developing an access and commercialization plan, particularly as patients are increasingly taking on more decision-making and first-dollar payment for their care. Examples of current challenges and opportunities for engagement will be provided.
5:05 Panel Discussion: Establishing Clinical Utility and Cost Effectiveness of Diagnostic Testing
Moderation: Katherine Tynan, President, TynanDx
Panelists: Speakers of the session
Richard S. Cooper, Member, McDonald Hopkins LLC
During this panel we will discuss through examples the state of diagnostic testing as it relates to overcoming reimbursement issues. Some of the topics to be discussed include:
- Becoming an active part of the coverage conversation with payers
- Approaches for communicating product and market differentiation to payers and providers
- Cost effectiveness studies and who to present them to
5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:50 Close of Day
WEDNESDAY, AUGUST 24
7:15 am Registration
7:30 Problem-Solving Breakout Discussions with Continental Breakfast
This session features various discussion groups that are led by a moderator/s who ensures focused conversations around the key issues listed. Attendees choose to join a specific group and the small, informal setting facilitates sharing of ideas and active networking. Continental breakfast is available for all participants.
What Does PAMA Bring for Diagnostics Companies?
Moderator: Ester Stein, Director, Corporate Reimbursement, Abbott Molecular
- Is it important to keep the open discussion going?
- How is POC specifically affected compared to core lab and molecular?
- Does PAMA take in consideration companies’ interests?
Reimbursement of New Genomic Technologies
Moderator: Jason L Gillman, MSPH, Director, Cancer Genomics, Intermountain Healthcare
- Identifying how to overcome the “clinical utility” problem with NGS
- Building a dialogue between patients, clinicians and payers
- Confidentiality agreements between payers and test developers
8:25 Chairperson’s Opening Remarks
Roger Klein, M.D., J.D., Medical Director, Molecular Oncology, Cleveland Clinic Foundation
8:30 Clinical Laboratory Payment Reform: Implementing Provisions of the Protecting Access to Medicare Act
Carol Blackford, Acting Deputy Director, Hospital and Ambulatory Policy Group, Center for Medicare, Centers for Medicare and Medicaid Services
This session will discuss Medicare reform of the Clinical Laboratory Fee Schedule based on private payer prices. Topics will also include Medicare payment for advanced diagnostic laboratory tests, coding and pricing for new clinical diagnostic laboratory tests and more.
9:00 PAMA: The Final Rule Is Out – What Does It Mean for Labs?
Roger Klein, M.D., J.D., Medical Director, Molecular Oncology, Cleveland Clinic Foundation
Signed into law on April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) includes the most extensive reform of the Medicare Clinical Laboratory Fee Schedule (CLFS) since it was established in 1984. Section 216 of PAMA creates a new Section 1834A of the Social Security Act, which contains many of the CLFS reforms. Starting on January 1, 2017, most rates on the CLFS will be derived from private payor rates for laboratory services.
9:30 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.
10:00 Developing and Communicating Evidence of Economic Value
Dave Nellesen, Ph.D., Vice President, Analysis Group
Demonstrating clinical utility of a novel advanced diagnostic test is typically necessary for coverage, but may be insufficient for reimbursement. Frequently, evidence of how a new technology can reduce cost—or deliver substantial value for added cost—is necessary to support premium pricing. This presentation will provide strategies for developing an economic value story, including frameworks for generation of economic evidence and best practices in communicating this evidence to payers, hospitals and other key stakeholders.
10:30 Coffee Break in Exhibit Hall with Poster Viewing
12:50 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:20 Close of Coverage and Reimbursement of Advanced Diagnostics
1:25 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing