11TH SEMI-ANNUAL DIAGNOSTIC COVERAGE AND REIMBURSEMENT CONFERENCE EAST

DECEMBER 4-5, 2017 | CAMBRIDGE, MA

HYATT REGENCY CAMBRIDGE

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DAY ONE | MONDAY, DECEMBER 4

7:45 REGISTRATION & WELCOME COFFEE


8:20 CHAIRPERSONS’ OPENING REMARKS
Charene Pillai, Senior Director of Business Development, PREMIER SOURCE


8:30 OPENING ICE BREAKER: SHARING KEY COMPONENTS OF A ROBUST DIAGNOSTIC REIMBURSEMENT STRATEGY
The opening ice breaker will kick-off the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in short and targeted discussion. In this interactive session, participants are encouraged to briefly share perspectives on the main drivers of an impactful and robust diagnostic reimbursement strategy, without delving into details nor proprietary information but rather highlighting key components that have benefited the company in obtaining successful reimbursement. Furthermore, participants in this warm-up session are also given the opportunity to build contacts with industry peers at the very start of the event, kicking off the program networking platform.

LEAD MODERATOR:
Kurt Matthes, TELCOR

MODERATOR:
Vanessa DePalma, MERIDIAN BIOSCIENCE

 

8:50 HEALTH POLICY RESEARCH & IMPACT ANALYSIS ON DIAGNOSTIC REIMBURSEMENT & MARKET ACCESS
As health policy continues to evolve at both the national and international levels, diagnostic manufacturers must ensure that tests remain at the forefront of importance, and meet the needs of value-driven care models. As such, recognizing trends in health policy as well as forecasting the potential impact of varied scenarios is of the utmost importance in preparing for times of continued change. Analysis of existing health policy research and the follow-on impact on diagnostic testing, from genetic testing to at home, point-of-care testing will provide executives with a forward thinking outlook on market access for the future.

George Boswell Moseley III, Lecturer in Health Law & Management
HARVARD SCHOOL OF PUBLIC HEALTH

 

9:20 PAYER ROUNDTABLE: PERSPECTIVES ON DIAGNOSTIC REIMBURSEMENT
Reimbursement approvals are determined within each private payer organization through specific review mechanisms, creating confusion for reimbursement executives in terms of applicable evidence to exhibit. As payers will take into account Laboratory Benefit Management Provider and in-house HTA reviews to process the approval or decline, but also further analyze cost-benefit ratios pertinent to the market’s needs, diagnostic reimbursement executives must ensure a clear understanding of payer expectations and evidence requirements in order to develop comprehensive value pitches that will be relevant to decision-makers. In addition, with the recent and ongoing shift towards value-based reimbursement schemes, the industry is eager to obtain enhanced clarity on payers’ perspectives of value demonstration and reimbursement approval processes.

MODERATOR:
Mark Rayan, MDXHEALTH

PANELISTS:
Ricardo Johnson, CAREFIRST BCBS

Mary Stevens, BLUE CROSS BLUE SHIELD OF MINNESOTA

James Dell’Arena, HORIZON BCBS OF NJ

Jeff Mason, UNITED HEALTHCARE

Paul Aitkin, MD, AETNA

 

10:20 COFFEE & NETWORKING BREAK

 

10:45 CLARIFYING LABORATORY BENEFIT MANAGEMENT PROVIDER’S ROLE & COLLABORATION WITH INDUSTRY
With the continued increase in annual healthcare spending per capita, health insurers have been prompted to better control spending and unnecessary medical product use. Laboratory Benefit Management Providers-LBMPs offer services to insurers to ensure network access and reimbursement is granted solely to diagnostics that meet unmet or under-represented patient needs, as well as innovative tests enabling significant improved patient outcomes. To establish successful partnerships and efficient collaborations between the industry and LBMPs, it is necessary to have a clear understanding of the position of benefit managers within the overall reimbursement decision-making process.

  • LBMP diagnostic review mechanism
  • Added value of LBMP in network management
  • Practical approach to contracting with LBMPs

Jerry L. Garner, VP Payer Relations, BIO-REFERENCE LABORATORIES

 

11:15 COST EFFECTIVE & VALUE-BASED EVIDENCE DEVELOPMENT
One of the more significant barriers to obtaining coverage and reimbursement for a new or established advanced diagnostic is the high cost of evidence development establishing clinical relevance. Creative approaches and a multi-prong strategy are critical to successfully balance evidence development with budget limitations and internal/investor pressure to broadly launch commercially.

  • Clearly defining and staying within intended use
  • From study to publication:
    • Value-based utility
    • Traditional studies
    • Value-based contracting
  • Advocacy through KOLs & relevant societies
  • Relevant patient-level appeals

Gordon Brown, Managing Partner, A&R CONSULTANTS LLC
Presented by QUADAX, INC.

 

12:00 SUCCESSFUL INDUSTRY & PAYER PARTNERSHIPS
Diagnostic reimbursement executives are continuously challenged by a variety of obstacles, most commonly relevant to product integration in a competitive market. In the effort of advancing life-improving tests to patients and HCPs, forward thinking companies have established proactive strategies to engage and directly collaborate with payers in order to facilitate, streamline and expedite access to  reimbursement. This session will present industry and payer collaboration case studies, focusing on the practical steps taken to initiate and achieve the partnership as well as encountered pitfalls and lessons learned.

CAREFIRST BCBS & EXOSOME DIAGNOSTICS CASE STUDY
Case Study: Novel Private Payer/Innovator Collaboration for Evidence Development

  • Structure & Value Drivers
  • Key Design Considerations for Measuring Clinical Utility in a Real World Setting
  • Applications Beyond Initial Project

 

Ricardo Johnson,Special Assistant to the President & CEO, CAREFIRST BCBS

Tom McLain, COO, EXOSOME DIAGNOSTICS

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:30 SUCCESSFUL INDUSTRY & PAYER PARTNERSHIPS – Continued
AETNA HEALTH PLAN & MERIDIAN BIOSCIENCE CASE STUDY:  DIAGNOSTIC DEVELOPMENT TO MEDICAL POLICY COVERAGE & IMPLEMENTATION

  • Diagnostic technology:  What is important to Payers
  • Guideline review & clinical benefits: Patient, physician, lab & payer
  • Dossier, FDA, Palmetto, PAMA considerations
  • Financial Impact: Commercial, Medicaid, ACO, 5 star metrics on re-admissions
  • Medical Policy Development: Commercial & ACO
  • Education: Dear Provider communication, lab outreach, web portal

Vanessa DePalma, VP, Business Strategy & Payer Markets, MERIDIAN BIOSCIENCE

Paul V. Aitkin Junior, MD,  MPH, CPE, FAAFP, Senior Medical Director, Clinical Transformation, AETNA

 

2:00 PAYERS & DIAGNOSTICS: COMING TO CONSENSUS

  • Key concepts to diagnostics-payer partnerships
  • Alva10: Specific challenges of the diagnostics industry
  • BCBS MN: Specific challenges of the payer industry
  • Examples & applications

Lena Chaihorsky, VP Payer Innovation, ALVA10

Mary Stevens, Director of Network Contracts, Compliance & Audit, BLUE CROSS BLUE SHIELD OF MINNESOTA

 

2:45 COFFEE & NETWORKING BREAK

 

3:15 EVIDENCE DEVELOPMENT TO SUPPORT COVERAGE & REIMBURSEMENT OF ADVANCED DIAGNOSTICS
The oncology care paradigm is rapidly evolving with the use of advanced molecular diagnostics including NGS and MAAAs. Payers have raised concerns around the cost of such diagnostics compared to conventional single-marker assays, and are increasingly deploying utilization management tactics such as automatic prior authorizations and GBMs. This session will review of the types of clinical utility studies diagnostics innovators must incorporate in their evidence development plans to accelerate payer coverage, in addition to different study design concepts, and clinical and economic endpoints that resonate with payers. Further, the current evidence base on diagnostics and the impact on coverage and reimbursement will be examined using specific case studies.

Shivang Doshi, Manager, BOSTON HEALTHCARE ASSOCIATES

 

4:00 CLINICAL STUDY DESIGNS ESTABLISHING CLINICAL UTILITY & ROBUST EVIDENCE

  • Bridging the gap with clinical teams:
    • Study design impact on evidence generation
    • Educating clinical teams on evidence for reimbursement
  • Defining clinical utlity & how to demonstrate it
  • RCT & diagnostics: applicability & evidence relevance
  • Results with cohort, prospective/restrospective & more
  • Ideal study design & results for payers

Federico A. Monzon, CMO, CASTLE BIOSCIENCES

 

4:45 PANEL DISCUSSION: PEER–REVIEWED PUBLICATION VS. CLINICAL EVIDENCE

  • Weighing publication against clinical testing:
    • Timelines
    • Budgets
    • Evidence acceptability
  • Utilization of payer standards for publication & outcomes

Jeffrey Jones, SKYLINE DX

Jerry L. Garner, BIO-REFERENCE LABORATORIES

Michele Schoonmaker, CEPHEID

 

5:30 CLOSING REMARKS & DAY 1 CONCLUSION

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