Evidence-Based Reimbursement of Molecular Diagnostics Conference - Day 1

Evidence-Based Reimbursement of Molecular Diagnostics Banner

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 it is important to stay in the loop and to discuss the latest developments with your peers. The Third Annual Evidence-Based Reimbursement of Molecular Diagnostics is a unique forum that provides the participants with the opportunity to openly discuss and search for solutions to the A to Z coverage and reimbursement issues. 

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12:00 pm Conference Registration


1:20 pm Chairperson’s Opening Remarks

John Warren, Senior Director, Health Policy, McDermott+Consulting

1:30 Medicare Law and Lab Tests: Changing More than the Price

BruceQuinn2Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag, LLP

A new Medicare law, PAMA 2014, has triggered the biggest changes in over three decades for lab tests. While much attention has focused on pricing changes with a new market-pricing changes, this presentation will highlight major reforms to local coverage, nationalization of coverage, and increasing the power of guidelines that are being caused by new legislation.

1:50 Medicare Payment for Diagnostics, Speed Bumps or Road Blocks

JohnWarrenJohn Warren, Senior Director, Health Policy, McDermott+Consulting

As the science and technology behind diagnostics continues to evolve at a rapid pace, Medicare payment has struggled to keep up with the times. This session will provide insight into the background of Medicare’s Clinical Lab Fee Schedule, discuss how new tests are evaluated, and take a look at some of the factors that keep the Fee Schedule a step behind the state of the art. Proposed changes to the Fee Schedule for 2014 will also be reviewed.

2:10 Industry Evolution: Responding to the Changing Tides of Payment Reform

MicheleSchoonmakerMichele M. Schoonmaker, Ph.D., Vice President, Government Affairs, Cepheid

CMS and other payors are moving from fee-for-service to fee-for-value based reimbursement systems. New methods for pricing diagnostic tests are being established, forcing laboratories and manufacturers to re-think their value proposition(s) for new diagnostic tests under bundled payment systems. This session will focus on potential economic data requirements that will help test developers be better prepared to navigate the evolving reimbursement landscape.

Analysis Group2:30 Reimbursement of Advanced Diagnostics in the Context of a Broken & Evolving System: Real World Perspectives & Examples 

BrianGorinBrian S. Gorin, MBA, Managing Principal, Analysis Group

Diagnostics developers need to formulate relevant value propositions and demonstrate clinical utility to stakeholders in the context of a broken business model. Diagnostic tests were historically subject to fee schedules based on cost, not value. Valuable tests don’t receive adequate reimbursement, are abandoned, or under-invested in. In 2016, the system is due to change, aligning diagnostic reimbursements more closely with market forces. Hear about failings in the current system, implications of changes on the horizon, and discuss examples.

3:00 Panel Discussion with Speakers of the Session

Moderator: John Warren, Senior Director, Health Policy, McDermott+Consulting

Panelists: Speakers of the Session

3:30 Networking Refreshment Break  


4:00 Panel Discussion: Reimbursement of Stand-Alone versus Companion Molecular Tests

Felix FruehModerator: Felix Frueh, Ph.D., CSO, Human Longevity, Inc.


Jerry ConwayPanelists: Jerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine, Inc.


Benjamin EckertBenjamin Eckert, Executive Director, Market Access, Metamark Genetics


Laura HousmanLaura Housman, MPH, MBA, Senior Vice President, Chief Commercial Officer, Molecular Health


5:00 Close of Day and Registration for Dinner Short Course

5:30- 8:30 pm Dinner Short Course: Reimbursement of Cancer Genomic Analysis*


JerryConwayJerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, Inc.


JorgeLeonJorge Leon, Ph.D., President, Leomics Associates, Inc.

  • Overall situation of the reimbursement landscape today
  • Coding, coverage, policies and payment fees for cancer genomic tests
  • The Medicare/CMS new view of the value of new tests
  • The view from large private payers
  • How to generate cost effectiveness data that payers will buy into
  • How to generate clinical utility data that payers will endorse
  • Case studies in pathology, molecular diagnostics, proteomics, gene expression, next-generation sequencing

*Separate registration required

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