( 診断に対する償還の展望 )

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 2nd Annual Dx Reimbursement Outlook symposium 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.

Final Agenda

Thursday, March 14

7:00 am Registration Open and Morning Coffee


8:25 Chairperson’s Opening Remarks

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

8:30 A Comprehensive Diagnostic Hub Service Model

Perry Dimas, Co-Founder, Chief Business Officer, CoverMyTest

The Innovation-Reimbursement Gap (IRG) represents a significant issue in healthcare. IRG is the gap between innovation and limitations that payors place upon patient access to these innovations. This issue initially had the largest impact on pharmaceutical companies, whose offerings were subject to access limitations by payors using formulary management, step edits, steep co-payments, high deductibles or non-coverage policies. And now diagnostic/laboratory companies are/will be facing similar challenges.

9:00 The Payer Perspective on Prior Authorization

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

In this talk, Ms. Brown will review the different economic frameworks that key stakeholders have about laboratory testing and laboratory benefit management with a focus on payers. She will review the payer perspective, the issues payers are concerned about, and the different approaches they may employ to manage lab tests. The approaches that labs can take to have meaningful discussions with payers around lab benefit management will be reviewed.

9:30 Technical Challenges in Prior Authorizations for Molecular Diagnostics

Ashish Dua, CEO, Glidian, Inc.

Electronic prior authorization adoption is very low (less than 30%) and the recent trends have shown a decrease in electronic utilization. Often it is because electronic standards and portals do not allow for efficient data exchange and are especially poor for molecular tests that may have panels of codes. Improving the prior authorization experience will require updating current electronic standards as well as adoption by payors.

10:00 Sponsored Presentation (Opportunity Available)

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


11:15 Common Missteps when Presenting Evidence to Payers: Implications for Medical Policy Review, Coverage Discussions and Payment

Jennifer MalinJennifer Malin, MD, Senior Medical Director, Oncology & Genetics, UHC

This presentation will share UHC and private payers’ view on evidence dossiers for molecular tests as well as key issues that concern payers for genomic testing.

11:45 Discoveries in Health Policy: Ideas for or from an Evolving Healthcare System

Bruce QuinnBruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

This presentation will provide an overview of recent coverage decisions and the implications they may have for the future CMS decision seekers. ClonoSEQ, Veracyte Envisa, Invivata InvisionFirst, MyPath Melanoma, Decipher Prostate Prognostic and other tests will be used as examples.

12:15 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break


1:55 Chairperson’s Remarks

Katherine TynanKatherine Tynan, PhD, Tynan Consulting LLC

2:00 Challenges (and Solutions) in Designing Studies to Support Validity and Utility

Girish PutchaGirish Putcha, MD, PhD, Director, Laboratory Science, MolDx, Palmetto GBA

Payer coverage and reimbursement decisions about new diagnostic tests include assessments of their analytical validity, clinical validity, clinical utility, and health economics. Understanding how study designs affect these decisions is critical, and will be the focus of this discussion.

2:20 Changing Landscape of Evidence: Adaptive Fit-for-Purpose Strategies to Balance Patient Access and Safety

John Sninsky, PhD, Translational Medicine Consultant

The keystone of contemporary medicine is evidence-based patient care precisely targeted with diagnostics to subsets of patients with a disease with consideration of cost-effectiveness. Adaptive staged strategies for regulatory approval and reimbursement recognize that patients have different benefit risk outcomes for management decisions. The evidence continuum ranges from RCTs to more recently proposed innovative approaches and is best fit-for-purpose aligned with the contextual patient unmet clinical need.

2:40 Evidence Is in the Eye of the Beholder: The Importance of Mapping Out Stakeholders and Their Evidentiary Requirements

Katherine Tynan, PhD, Tynan Consulting LLC

Managing the clinical narrative for your diagnostic test requires careful evaluation of the evidentiary requirements of stakeholders. Using those evidentiary requirements to determine your clinical and economic study designs is the cornerstone of effective product development. Availability of data and the timing of publications are key to effective deployment of all forms of capital.

3:00 Presentation to be Announced

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

4:15 The Challenges of Clinical Data Review by Experts and NON-Subject Matter Experts: Implications for Dealing with Payer Medical Policy Review

Lloyd Hutchinson, PhD, Scientific Director, Laboratory of Diagnostic Molecular Oncology, Department of Pathology, UMass Memorial Healthcare, UMass Medical School

The coverage of a companion diagnostic approved in a clinical trial is noncontroversial. In clinical practice however, limitations of these single gene assays led to requests for multi-gene “laboratory developed tests” to better support therapeutic decisions. Payer coverage decisions rely on interpretation of available evidence, chiefly by non-molecular pathology experts, who may focus on clinical guidelines which lag behind the medical literature. Specific examples from different payer jurisdictions will be discussed.

4:35 Role of Evidence Development to Achieve Optimal Efficiencies in Precision Medicine

Eugean Jiwanmall, MPH, Senior Research Analyst – Medical Policy & Technology Evaluation, Facilitated Health Networks, Independence Blue Cross

Multi-faceted benefits are exponentially stemming from advancements in clinical care based in and evolving from molecular diagnostics. However, as these advancements travel through the value chain to – potentially – become part of routine clinical care, several outstanding challenges remain. An effective solution to many of these challenges is the right type and level of evidence to optimize the future of healthcare.

4:55 Targeted Machine Learning for Generating Real-World Evidence from Observational Data

Mark van der Lann, PhD, Jiann-Piang Hsu and Karl E. Peace Endowed Chair in Biostatistics Professor, Biostatistics and Statistics, Berkeley University of California

We discuss the general approach Targeted Learning (i.e., Targeted Maximum Likelihood estimation) for generating actionable information from observational and randomized studies. It uses causal modeling to define the estimand that best answers the causal question of interest. It utilizes the state of the art in machine learning through ensemble learning (super-learning) to fit the relevant part of data distribution, and, by targeting the fit towards the estimand, it obtains an optimal estimator with valid inference (i.e., confidence interval).

5:15 PANEL DISCUSSION: Navigating the Imperfect Sea of Evidence

Moderator: Katherine Tynan, PhD, Tynan Consulting LLC

Panelists: Girish Putcha, MD, PhD, Director, Laboratory Science, MolDx, Palmetto GBA

John Sninsky, PhD, Translational Medicine Consultant

Lloyd Hutchinson, PhD, Scientific Director, Laboratory of Diagnostic Molecular Oncology, Department of Pathology, UMass Memorial Healthcare, UMass Medical School

Jennifer Malin, MD, Senior Medical Director, Oncology & Genetics, UHC

Mark van der Lann, PhD, Jiann-Piang Hsu and Karl E. Peace Endowed Chair in Biostatistics Professor, Biostatistics and Statistics, Berkeley University of California

  • Finding a balance in the relationship between business and science
  • How to curate the medical literature for a diagnostic
  • Bridging the gap from imperfect clinical endpoints through real-world data

5:45 Reception in the Exhibit Hall with Poster Viewing

6:45 Close of Day

Friday, March 15

8:00 am Registration Open and Morning Coffee


8:25 Chairperson’s Remarks

Ammar QadanAmmar Qadan, Vice President, Global Market Access, Illumina

8:30 PANEL DISCUSSION: Payer Health Technology Assessment (HTA) of NGS: Are Current HTA Frameworks Aligned with NGS Technology Evolution?

Moderator: Ammar Qadan, Vice President, Global Market Access, Illumina

Panelists: Jim Almas, MD, President, JPA Pathology

Brock Schroeder, PhD, Director, Health Economic and Outcomes Research at Illumina

Additional Panelists to be Announced

Over the last decade, genetic testing to inform precision medicine has evolved from the use of single-gene tests to more complex tests that measure multiple genes, the entire exome (coding region of the genome) or the entire genome using next-generation sequencing (NGS) technology. As the cost of NGS technology has decreased and NGS-based tests are increasingly being incorporated into clinical patient care, health insurance companies, health technology assessment organizations, and governments must assess the clinical and economic value of NGS-based tests. In the last few years, there has been an emerging consensus that conventional frameworks used by payers to assess the value of new drugs are not well suited for evaluating the value of genomic testing.

This panel specifically focuses on assessing the value of NGS-based clinical testing. While it’s critical to assess the value of NGS, there are many methodological challenges to doing so. This panel discussion pushes the envelope by not only highlighting the challenges, but by suggesting innovative solutions to move the value assessment process forward for precision medicine. The panel will incorporate a wide range of perspectives and topics and case studies – but they all focus on the overarching issue of proposing new methodologies to assess the value of NGS-based technologies in clinical care. The proposals included are not intended only for health economic researchers, but also to other stakeholders including health technology assessment organizations, payers, clinical researchers, diagnostic, biotechnology and pharmaceutical industries.

Topics to be discussed:

  • There is a need to align coverage frameworks and what is defined as “Medical Necessity” with the features of NGS technology.
  • Further adaptation of the coverage framework for NGS and other genomic tests may help to facilitate a better suited assessment of future genomics innovations.
  • There are potential solutions for adapting the coverage framework relevant to NGS .

10:00 Sponsored Presentation (Opportunity Available)

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


Chairperson: Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

11:15 Precision Medicine: Advocacy and Lobbying In a Screening Population

Danielle ScelfoDanielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic

Precision medicine and the promise of liquid biopsy means that we may see a transition in application of our personalized medicine tools from companion diagnostics guiding treatment decisions and monitoring into a screening population. While reimbursement challenges in the companion diagnostic setting is more readily understood, there are a different set of challenges that exist within a screening population and the recommendations that determine coverage and reimbursement. The Affordable Care Act requires insurers to cover all preventative services with a USPSTF rating “A” or “B” without cost sharing. This session will provide an overview of the Task Force Guideline role in establishing screening recommendations and outline key challenges that diagnostics face when under review by the United States Preventative Services Task Force.

11:45 Current and Future Reimbursement Challenges Along the Path to a Digital Revolution in Infectious Disease

Paul Sheives, Medical Director, Diagnostics Lead, Medical Affairs, Roche

Technologies in the detection of pathogens and antimicrobial resistance are rapidly evolving to produce data with greater volume, efficiency, accuracy and utility. From tracking antimicrobial resistance across populations to the ability to use multiplex platforms to detect a myriad of pathogens simultaneously, these innovative, flexible and transformative platforms are marching along the path to a digital revolution in the detection, management and treatment of infectious disease. However, these innovations must mesh with a rigid and slow-changing reimbursement system.

12:15 pm Proprietary Laboratory Analyses: Perspectives Two Years Down the Road – More Questions Than Answer

Lee H. Hilborne, MD, Professor of Pathology and Laboratory Medicine, David Geffen School of Medicine, UCLA, Medical Director, Quest Diagnostics, and Deputy Director for Global Health, RAND Corporation

It has now been two years since the American Medical Association CPT Editorial Panel established the Proprietary Laboratory Analysis (PLA) and the PLA Technical Advisory Group (PLA-TAG). Since its inception, there have been about 100 codes requested by laboratory providers. Although not initially anticipated, CMS has established payment rates on the Clinical Laboratory Fee Schedule for many of the initial PLA Codes. As we discuss new and emerging technologies at this session, it is important to identify the most effective way to be reimbursed for the legitimate services we provide. PLA codes represent the newest and fastest strategy to obtain a CPT/HCPCS code. Although there are limitations, this strategy is essential for some emerging diagnostics, particularly those classified as ADLTs under PAMA.

12:45 Close of Symposium

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