Dx Reimbursement Outlook

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 budgets and the launch of a large number of expensive molecular tests creates complications for payers to respond in traditional ways. Cambridge Healthtech Institute’s Inaugural Dx Reimbursement Outlook 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.

Thursday, February 15

7:00 am Registration Open and Morning Coffee


8:25 Chairperson’s Opening Remarks

Katherine Tynan, Ph.D., Tynan Consulting LLC

8:30 Pre-Authorization: Why Payers Do It and How to Convince Them to Stop

Lon Castle, M.D., CMO, eviCore healthcare

Various organizations are conducting technology assessments to aid payers. The pre-authorization process is a challenge nearly every company faces when bringing a new molecular diagnostic test to market. But you can successfully navigate this process and, if you are disciplined, even get payers to modify or remove their pre-authorization criteria. How is this possible? Through negotiation, collaboration and most importantly: data (I promise, the transfer of your first-born child will NOT be required).

9:00 Global Lab Test Management Solutions

Trisha Brown, Vice President, Product and Business Development, BeaconLBS

There are >20,000 lab tests in the market today. BeaconLBS assists health plans and providers with lowering out of pocket costs for patients, complying with evidence based guidelines, and improving quality lab selection. In this session we will describe our evidence based process for managing molecular tests and our seamless integration into physician work flows. Physician satisfaction, improved compliance with standards of care, and lowered patient costs will be discussed.

9:30 The Diagnostic and Genetic Testing Coverage, Coding, and Reimbursement Evolving Environment

Damon Cox, Vice President Health Plans, Market Access & Reimbursement, Counsyl

With over 60,000 diagnostic and genetic tests on the market, double-digit year over year growth, and costs expected to exceed $15 to $25 billion by 2021, payors are implementing utilization management programs and engaging lab benefit management (LBM) companies to control the rapid expansion. Discover how prior authorizations, genetic counseling, and restrictive policies are shaping the future of this healthcare segment.

10:00 Trends in Reimbursement for Genetic Tests

Mark Harris, Founder and CIO, Concert Genetics

Health plans have struggled to adapt to the growing volume and complexity genetic tests. Many say only a tiny fraction of the tests on the market have sufficient data to warrant coverage. As a result, coverage and payment can vary widely between plans, and even claim-to-claim. Dr. Mark Harris will draw on data from more than 100 million insured members to discuss the latest reimbursement trends and cost management strategies from health plans.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

Quadax 11:15 pm Early Results of Anthem & UHC Prior Authorization Initiatives

Walt Williams, Director, Revenue Optimization & Strategy, Quadax
Focusing less on theory and more on reality, we will discuss some of the early trends found in the claims adjudication and revenue cycle process for molecular pathology claims exposed to the prior authorization programs of Anthem and UnitedHealthcare.  From the unique perspective of a company that manages revenue cycle for many of the nation’s most prominent molecular pathology laboratories and is one of the nation’s largest EDI clearinghouses, we will explore the programs’ real impact on claims processing timelines, receipts, payment timeliness, denial trends and more.

11:40 PANEL DISCUSSION: The Changing Landscape of Molecular Test Management

Moderator: Lon Castle, M.D., CMO, eviCore healthcare

Panelists: Steve Stonecypher, Managing Director, Shipwright Healthcare Grp LLC

  • Examine the new challenges facing molecular diagnostic companies brining novel tests to market.
  • Assess the changing dynamics between health plans, physicians and laboratories.
  • Review how technology can support integration efforts among the various stakeholders.

12:30 Session Break

Interpace Diagnostics12:40 Luncheon Presentation: Overcoming New Payer Trends in Managing Molecular Testing

Greg Richard, Chief Commercial Officer, Interpace Diagnostics

More and more payers, including several of the largest national health plans, are implementing processes that create additional challenges for molecular diagnostic companies to secure reimbursement for their tests. Prior authorization and product registration requirements in particular will require laboratories to develop and implement processes to capture additional information from physicians, thereby potentially creating delays in claim adjudication and collection of testing related revenues. This presentation will provide suggested methods for addressing this and other current and evolving issues.

1:15 Session Break


1:55 Chairperson’s Remarks

Trisha Brown, Vice President, Product and Business Development, BeaconLBS

2:00 PAMA Final Rule: Key Issues for Advanced Diagnostic Laboratory Tests (ADLTs)

Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates

The implementation of PAMA has posed huge challenges for the diagnostic test industry in the U.S., and even for CMS itself. One of the last “puzzle pieces” had been the CMS implementation of special rules for Advanced Diagnostic Laboratory Tests or ADLTs. Oddly, some tests that would qualify for this category may actually be better off without it. We will review CMS’s approach to ADLTs and help decision-makers understand their options.

2:30 Contract Renegotiation: The Realities and Approach

Andrew Stimmler, Managing Partner, Shipwright Healthcare Group

CMS plans on implementing PAMA, market based pricing January 1, 2018. The basis of the data has been delayed because of the data collection complexity. CMS has not requested this same data from most hospital systems, based on the PAMA rules related to the percentage of Medicare volume billed. The hospital volume represents more than 50% of the outpatient laboratory testing and would impact the weighted average of any proposed PAMA reimbursement.

3:00 CO-PRESENTATION: Enter Your Payment Information Here: Patient Contributions toward Next-Generation Sequencing Testing in Today’s Reimbursement Environment

Laura T. Housman, Founder, Access Solutions Consulting

Kathryn A. Phillips, Ph.D., Professor, University of California San Francisco

Join the presenters 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.

3:30 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall


4:15 Dx Reimbursement Outlook- Reimbursement of Oncology Tests

Ammar Qadan, Vice President, Global Market Access, Illumina

Testing for cancer susceptibility and hereditary cancer syndromes in certain individuals has been broadly reimbursed. The same applies for single gene panels where clinical utility has been demonstrated and companion diagnostics. Comprehensive Genomic Profiling (CGP) using multigene panels on the other hand has faced significant challenges and is still moving slowly. Recent developments in this field could accelerate reimbursement. Future clinical applications like Liquid Biopsy could also prove to be challenging. Innovative and pragmatic clinical utility studies, change in payer technology assessment frameworks and payment methods are needed to accelerate adoption and open opportunities for new applications that have the potential to improve quality of care in cancer patients.

4:45 Clinical Utility through the Lens of Payors and Physicians

Kristine Mechem, Ph.D., Vice President, Marketing and Planning, OncoCyte Corporation

Understanding what payors and physician look for in clinical utility will help manufacturers and service providers better focus their resources to areas of high unmet need, and subsequently increase the probability of commercial success. This discussion will walk through a framework to help better determine if a diagnostic is meeting unmet clinical needs from the eyes of a physician and from the eyes of a payor.

5:15 PANEL DISCUSSION : Evolving Payer Coverage Policies on Next Generation Sequencing Tests – Examining Possible Impact of new CMS guidance on NGS for Cancer Patients - and Beyond

Moderator: Katherine Tynan, Ph.D., Tynan Consulting LLC

Panelists: Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates

Andrew Stimmler, Managing Partner, Shipwright Healthcare Group

Ammar Qadan, Vice President, Global Market Access, Illumina

Kathryn A. Phillips, Ph.D., Professor, University of California San Francisco

Kristine Mechem, Ph.D., Vice President, Marketing and Planning, OncoCyte Corporation

Let’s assume that the guidance is implemented as proposed. The panel will discuss the possible implications and takeaways for the audience including the following topics:

- Implications for Regulators

- Impact on private payers

- Education of payers

- Defining economic value

- Marketing messages

- Working with labs

- Health policy context.

5:45 Reception in the Exhibit Hall with Poster Viewing

6:45 Close of Day

Friday, February 16

8:00 am Registration Open and Morning Coffee


8:25 Chairperson’s Remarks

Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates

8:30 PANEL DISCUSSION: Labs Compete With More Sophisticated Reports And Services

Moderator: Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates


Stan Skrzypczak, Vice President, Corp. Development and Reimbursement, Guardant Health

Ammar Qadan, Vice President, Global Market Access, Illumina

Carl Morrison, President, OmniSeq Precision Medicine Technology; Professor of Pathology, Roswell Park Cancer Institute

Taher Abbasi, COO, Corporate, Cellworks Group Inc.

Robert Nussbaum, M.D., CMO, Invitae

Girish Putcha, M.D., CMO and Clinical Laboratory Director, Freenome

Topics to be Discussed:

  • Understand how both new labs and existing labs are battling to differentiate their products
  • Reports are becoming more sophisticated and are no longer just "look up tables" that match single genes and drugs
  • To cope with the complexity of precision medicine, access to genetic counselors, tumor boards, clinical trials will be competitive factors
  • New approaches to reimbursement may be necessary

10:30 Coffee Break in the Exhibit Hall with Poster Viewing


11:15 Health Economics for POC Testing “the Good, the Bad and the Ugly”

Katherine Tynan, Ph.D., Tynan Consulting LLC

Device developers are under increasing pressure to substantiate claims of cost reduction or equivalence through increased efficiency (reduction in testing & clinical visits, improvement in work flows, reduction in prescriptions for antibiotics, etc.) through health economic modeling. Examples of how to demonstrate these claims to convince stakeholders/payers to favor POC diagnostics over more central lab approaches will be discussed.

11:45 Demonstrating Economic Value of POC Diagnostics

Dwight Denham, MBA, Vice President, Global Health Economics & Reimbursement, Danaher Corp., Diagnostics & Life Science Platforms

12:15 pm POC Adoption of Molecular Infectious Disease Testing within an Integrated Healthcare Delivery Network

Diana Hernandez, Ph.D., Research Director, Clinical Microbiology, Geisinger Health System

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.

12:45 Close of Symposium

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