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Generating Evidence for Reimbursement Decisions: Diagnostics Conference - Day 1

Conference Proceeding CD Now Available
  • Speaker Presentations
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2013 Archived Content

Generating Evidence for Reimbursement Decisions - Diagnostics 



Achieving commercial success for an IVD product or a device 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. Recent changes to the CPT coding system complicate the situation even more. Comprehensive clinical data demonstrating clinical utility and medical value have increasingly become the condition of getting a test reimbursed.

The second annual Generating Evidence for Reimbursement Decisions: Diagnostics conference is designed to bring together major players in the field of evidence-based reimbursement in diagnostics. The conference will be preceded by the second annual Generating Evidence for Reimbursement Decisions: Therapeutics conference, with a shared session on Evidence-Based Reimbursement in Personalized Medicine/Companion Diagnostics bringing the two audiences together.

Day 1 | Day 2 | Download Brochure 

Tuesday, October 22nd

Diagnostics Cross  


7:30-8:20 am Conference Registration and Morning Coffee

8:00 Problem Solving Breakout Discussions



TABLE 1: Reimbursement of Companion Diagnostics  

Laura Housman, Vice President, Global Market Access, Pricing and HE&OR, Novartis Molecular Diagnostics


TABLE 2: Oncology Reimbursement: Evidence Considerations 

Roy D. Baynes, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences, Inc.


Topics to be discussed: 



  • Generalizability and hierarchy of evidence 
  • Subset analyses for which the study was not randomized 
  • Indirect treatment comparisons 



TABLE 3: Pharma-Payers Collaboration: Approaches and Logistics 

Rebecca Chiappinelli, RPh , Director Business Development, HealthCore, Inc. (A WellPoint Company)


8:55 Chairperson's Remarks

David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

9:00 Leaning In: Successful Strategies as a Manufacturer to Engage Payers in Diagnostic Technology Assessment and Coverage

Laura Housman, MPH, MBA, SVP, Chief Commercial Officer, Molecular Health

There has never been a more dynamic opportunity for diagnostic manufacturers to demonstrate their assay utility and advocate for commensurate value from payors. What is considered utility? Is it measureable improvement in patient outcomes based on patient management changes directed by the result of the test? Or, a change in patient management based on test results that is expected to benefit the patient? Or some combination? And how should a manufacturer prepare for evolving and incomparable assessment criteria across payors? Strategies, opportunities for learning and anticipation of future changes will be shared.

9:30 Translating Clinical Need into Clinical Utility that Delivers Payer Value

David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

Diagnostic test development often begins with the identification of an unmet clinical need that is particularly amenable to addressing with a company’s platform and proprietary technology. Often this process is driven by interaction between clinical KOLs and the company’s scientists. Unfortunately, meeting clinical needs as expressed by front-line physicians does not necessarily deliver high-value clinical utility as perceived by payers. When that happens, a diagnostic test innovator can “win the battle, but lose the war”. In this session, we will share practical approaches to this real-world problem, such as: identifying clinical needs with high payer impact; selecting clinical utility propositions that payers will value; distinguishing between potential and realizable payer value; and matching company resources and business goals with clinical utility evidence needs.

10:00 Coffee Break in the Exhibit Hall

10:30 Oncology Drug Development - Meeting The Evidentiary Needs of Various Stakeholders

Roy D. Baynes, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences, Inc.


11:00 Building an Effective Reimbursement Strategy for the Era of Personalized Medicine 

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

As the industry moves farther away from a “one-size-fits-all” approach to prescribing medicines, the use of diagnostic tests and targeted therapies to fuel healthcare decisions has never been greater. The field of personalized medicine is advancing at a rapid pace, offering several advantages to healthcare providers and patients - namely, the ability to make more informed medical decisions, eliminate unnecessary treatments and reduce the probability of adverse drug reactions. The result is a higher probability of desired health outcomes and reduced healthcare costs. During this session, we will align current reimbursement and market access strategies with recent and future developments in the field of personalized medicine.

SimulConsult11:30 Automatable, Evidence-Based Prior Authorization for Gene Tests: A Reality Now

Lynn Feldman, MBA, CEO, SimulConsult

Reimbursement relies at its core on a decision of medical necessity. Today, approval remains mostly arbitrary and time-consuming.  An NIH-funded study showed that using patient’s symptoms and existing clinical diagnostic decision support tool scan document medical necessity in a consistent, automatable, evidence-based way for all inherited diseases. It’s time to establish evidence-based, prior authorization as the standard in genetic testing.

11:45 Evaluating Novel Diagnostics for Reimbursement

Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

12:00 pm Panel Discussion: Evidence-Based Reimbursement for Evidence-Based Personalized Medicine: Does Any of It Exist?

Moderator: David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

Panelists: Speakers of the Session 

12:30 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

REIMBURSEMENT OF Molecular Diagnostics: Analysis and FORECAST 

1:55 Chairperson’s RemarksDanielle Scelfo, Director, Government Affairs, Genomic Health 

2:00 Medicare Payment for Diagnostics, Speed Bumps or Road Blocks

John Warren, Senior Director, Health Policy, McDermott Will & Emery

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.

2:30 The Road to Reimbursement:  Clinical Utility

Elaine Lyon, PhD. Director, Genetics Division Co-Medical Director, Pharmacogenomics Co-Director, Clinical Molecular Genetics Fellowship Program, ARUP Laboratories

To address payer dissatisfaction with the stacking codes, the Association for Molecular Pathology (AMP) proposed coding models for new molecular pathology CPT codes to increase transparency.  Although the codes were adapted into the clinical laboratory, coverage placement, lack of transparency in costing, and misinterpretations of Tier 2 and ‘Unlisted’ codes have hindered reimbursement.  Recent Palmetto local coverage decisions (LCDs), which may be adopted nationally, require laboratories to obtain a unique identifier and submit information demonstrating clinical utility for each of its molecular tests.  Although establishing analytical and clinical validity has been the responsibility of clinical laboratories for tests they offer, clinical utility traditionally has been demonstrated by large case/control studies.  These studies are expensive, and rarely could a clinical laboratory undertake them.  Models are needed to establish appropriate standards to demonstrate clinical utility for molecular tests.  This presentation will discuss current guidance, unique challenges for molecular tests, and the need for novel solutions to establish utility. 

3:00 Next Generation Sequencing vs. Individual Assays – Implications for Demonstrating Clinical Utility in the Context of Reimbursement Decisions                                Analysis Group 

Brian Gorin, Managing Principal, Analysis Group, Inc.

Costs of next generation sequencing have fallen, providing clinical decision makers additional information at lower cost compared with individual assays.  New approaches to demonstrate clinical utility and generate evidence of value are needed. They must consider the merits of both short and longer term uses of diagnostic information that will exist in an enriched context, potentially conferring greater predictive value. We provide a framework for evaluating evidence strategy and discuss marketplace examples.

3:30 Refreshment Break in the Exhibit Hall

4:00 Reimbursement Reform for Advanced Personalized Diagnostic

Danielle Scelfo, Director, Government Affairs, Genomic Health


4:30 Panel Discussion: Reimbursement of Molecular Diagnostics: Analysis and ForecastModerator: Danielle Scelfo, Director, Government Affairs, Genomic HealthPanelists: Speakers of the Session

5:00 End of Day, Registration for Dinner Short Course

Day 1 | Day 2 | Download Brochure 

Conference at a Glance