Short Courses
and Symposia
Reimbursement
Track 1: Health Economics
of Personalized Genomic
Medicine
SUMMIT
Track 2: Evidence-Based NOVEMBER 17 - 19, 2014
Reimbursement of Molecular HYATT REGENCY BETHESDA
Diagnostics BETHESDA, MD
Short Courses
Dinner Short Courses*
and Symposia Reimbursement of Cancer Genomic Analysis
Tuesday, November 18, 2014 | 6:00 – 9:00 pm
Instructors:
Track 1: Health Economics Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, Inc.
of Personalized Genomic Jorge Leon, Ph.D., President, Leomics Associates, Inc.
Medicine • 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
Track 2: Evidence-Based • The view from large private payers
Reimbursement of Molecular • How to generate cost effectiveness data that payers will buy into
Diagnostics • How to generate clinical utility data that payers will endorse
• Case studies in pathology, molecular diagnostics, proteomics, gene expression, next-generation sequencing
Co-Located Symposium
Hotel & Travel Information
Click Here to It is believed that it holds immense promise for patient care, enabling personalized intervention to prevent and treat disease, but the full clinical and economic value of
NGS is only just beginning to be understood. Clinicians are now beginning to demand and adopt this powerful tool to guide treatment decision-making. Assessing this
Register Online! emerging value is complex - while NGS offers the potential to transform clinical care, the technology will likely alter the economics of medicine, disrupting established
stakeholder business models.
Healthtech.com/Evidence-Based- This symposium offers an opportunity to learn and engage on the early real-world clinical applications of NGS in the oncology space. It will involve review of the clinical
Reimbursement-Summit and health economic value perspectives of providers, payers, and technology innovators, and examine how the technology may fit with emerging oncology payment/
business model approaches. The symposium gathers a range of clinical and economic stakeholders in advanced genomics, and creates a participatory forum for dialogue
on how to define the value of NGS, determine the evidence required to support it and incorporate it in the on-going delivery of patient care.
Register now!
Stakeholders participating this forum include:
• Treating Clinicians and Hospital Providers
• Clinical Laboratory Providers
• Government and Commercial Payers
• Targeted Therapy Innovators
• Diagnostic Content and Platform Innovators
• Genomic Research Institutions
Register Online!
effective, saving time, money, and access.
9:10 Meeting the Evidentiary Needs of Various Stakeholders
Healthtech.com/Evidence-Based- Roy D. Baynes, M.D., Ph.D., Senior Vice President, Global Clinical Development, Merck SUPPORTING PHARMACEUTICAL INNOVATION
Reimbursement-Summit Meeting the complex and evolving evidentiary needs of various stakeholders
11:40 Evolution of Pharmaceutical Innovation
represents a significant ongoing challenge and opportunity for industry.
Additionally scientific progress has increasingly led to innovative novel agents Robert Popovian, Pharm.D., Senior Director, US Government Relations, Pfizer, Inc.
with unambiguous large effect sizes in grievous disease and with clear advantage Pharmaceutical innovation is critical to the long-term health of our economy.
Register now! over current therapies. This has in certain areas led to a marked expansion of the Supporting pharmaceutical innovation is a complex issue where several policy
addressable incident and prevalent populations and, despite demonstrable value, issues intersect and impact the final outcome. It is shortsighted to focus on any
a significant increase in budgetary pressure. It is key that innovation penalties not single issue as the primary driver of pharmaceutical innovation.
limit advancing these important therapies for patients. Such complex course of action requires a regime that facilitates this dynamism and
a public that understands its machinations.
9:40 Pharmacogenetic-Guided Intervention: Where Are We and where
Are We Headed? 12:10 pm Sponsored Presentations (Opportunities Available)
Gregory Hess, M.D., Senior Fellow, LDI Health Economics & Policy, University of 12:40 Luncheon Presentation (Sponsorship Opportunity Available) or
Pennsylvania
Lunch on Your Own
This session will examine the growth of pharmacogenetic testing to guide therapeutic
selection and interventions across a variety of disease areas. The discussion will 1:10 Session Break
include reported measures of effectiveness and outcomes, including an in-depth case
study of psychiatric intervention, observed adherence and cost impacts. Trends and
future directions for genetic guided interventions including potential payment models
and pricing implications will be discussed.
Register now!
Medicine, Professor of Public Health, Boston University School of Public Health,
3:10 Sponsored Presentations (Opportunities Available)
Executive Director, Massachusetts Veterans Epidemiology Research and Information
3:40 Networking Refreshment Break Center at Department of Veterans Affairs
Healthtech.com/Evidence-Based-
Reimbursement-Summit
SPONSORSHIP & EXHIBIT INFORMATION
Register now!
Exhibit Contract Podium Presentations — Available within Main Agenda! User Group Meeting/Custom Event
Showcase your solutions to a guaranteed, targeted audience through a 15- or Co-locate your user group meeting or custom event. CHI will help market the
30-minute presentation during a specific conference program, breakfast, lunch, or event, manage logistical operations, develop the agenda, and more. CHI can handle
separate from the main agenda within a pre-conference workshop. Package includes the entirety of the meeting or select aspects.
exhibit space, on-site branding, and access to cooperative marketing efforts by CHI.
Presentations will sell out quickly, so sign on early to secure your talk! Exhibit
Exhibitors will enjoy facilitated networking opportunities with qualified delegates,
Breakfast & Luncheon Podium Presentations making it the perfect platform to launch a new product, collect feedback, and
Opportunity includes a 30-minute podium presentation. Boxed lunches are generate new leads. Exhibit space sells out quickly, so reserve yours today!
delivered into the main session room, which guarantees audience attendance and
participation. A limited number of these presentations are available for sponsorship. Additional branding and promotional opportunities are available, including:
• Conference Tote Bags • Badge Lanyards
Invitation-Only VIP Dinner/Hospitality Suite
• Literature Distribution (Tote Bag Insert • Program Guide Advertisement
Select specific delegates from the pre-registration list to attend a private function at or Chair Drop) • Padfolios and More...
an upscale restaurant or a reception at the hotel. From extending the invitations, to
venue suggestions, CHI will deliver your prospects and help you make the most of
this invaluable opportunity. For additional sponsorship & exhibit information, please contact:
Focus Group Joseph Vacca
Cambridge Healthtech Institute, CHI will gladly provide you the opportunity of running a focus group on-site. This exclusive Business Development Manager
250 First Avenue, Suite 300, gathering can be useful to conduct market research, collect feedback on a new product 781-972-5431 | jvacca@healthtech.com
Needham, MA 02494 idea, and collect marketing intelligence from industry experts on a specific topic.
www.healthtech.com
Cover
TRACK 2: NOVEMBER 18-19
Short Courses
and Symposia Evidence-Based Reimbursement of Molecular Diagnostics
Partnering with KOLs, Healthcare Centers and Payers
Track 1: Health Economics
of Personalized Genomic 12:00 pm Conference Registration COVERAGE AND REIMBURSEMENT STRATEGIES
Medicine DEMYSTIFYING CMS PERSPECTIVE 4:00 Panel Discussion: Reimbursement of Stand-Alone versus
Companion Molecular Tests
1:20 pm Chairperson’s Opening Remarks Moderator: Felix Frueh, Ph.D., CSO, Human Longevity, Inc.
Track 2: Evidence-Based John Warren, Senior Director, Health Policy, McDermott+Consulting Panelists: Jerry Conway, Vice President, Reimbursement & Payer Strategy,
Foundation Medicine, Inc.
Reimbursement of Molecular 1:30 Medicare Law and Lab Tests: Changing More than the Price Benjamin Eckert, Executive Director, Market Access, Metamark Genetics
Diagnostics Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag, LLP Laura Housman, MPH, MBA, Senior Vice President, Chief Commercial Officer,
A new Medicare law, PAMA 2014, has triggered the biggest changes in over three Molecular Health
decades for lab tests. While much attention has focused on pricing changes with a
5:00 Close of Day and Registration for Dinner Short Course
Sponsor & Exhibit Opportunities new market-pricing changes, this presentation will highlight major reforms to local
coverage, nationalization of coverage, and increasing the power of guidelines that 5:30- 8:30 pm SC2 Dinner Short Course: Reimbursement of Cancer
are being caused by new legislation. Genomic Analysis*
Hotel & Travel Information 1:50 Medicare Payment for Diagnostics, Speed Bumps or Road Blocks Instructors:
Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation
John Warren, Senior Director, Health Policy, McDermott+Consulting
Medicine, Inc.
As the science and technology behind diagnostics continues to evolve at a rapid
Registration Information pace, Medicare payment has struggled to keep up with the times. This session
Jorge Leon, Ph.D., President, Leomics Associates, Inc.
will provide insight into the background of Medicare’s Clinical Lab Fee Schedule, •Overall situation of the reimbursement landscape today
discuss how new tests are evaluated, and take a look at some of the factors that •Coding, coverage, policies and payment fees for cancer genomic tests
Click Here to keep the Fee Schedule a step behind the state of the art. Proposed changes to the
Fee Schedule for 2014 will also be reviewed.
•The Medicare/CMS new view of the value of new tests
•The view from large private payers
Register Online! 2:10 Industry Evolution: Responding to the Changing Tides of
•How to generate cost effectiveness data that payers will buy into
•How to generate clinical utility data that payers will endorse
Healthtech.com/Evidence-Based- Payment Reform •Case studies in pathology, molecular diagnostics, proteomics, gene expression,
Reimbursement-Summit Michele M. Schoonmaker, Ph.D., Vice President, Government Affairs, Cepheid next-generation sequencing
CMS and other payors are moving from fee-for-service to fee-for-value based *Separate registration required
reimbursement systems. New methods for pricing diagnostic tests are being
Register now!
established, forcing laboratories and manufacturers to re-think their value WEDNESDAY, NOVEMBER 19
proposition(s) for new diagnostic tests under bundled payment systems. This
session will focus on potential economic data requirements that will help test 7:30– 8:15 am Problem Solving Breakout Discussions with
developers be better prepared to navigate the evolving reimbursement landscape. Continental Breakfast
2:30 Panel Discussion with Speakers of the Session Concurrent Problem Solving Breakout Sessions are interactive, topic-specific
discussions hosted by a moderator. These sessions are open to all attendees,
Moderator: John Warren, Senior Director, Health Policy, McDermott+Consulting
sponsors, exhibitors, and speakers and provide a forum for discussing key issues
3:00 Reimbursement of Advanced Diagnostics in Sponsored by and meeting potential partners. Please pick a topic of your choice and join in.
the Context of a Broken & Evolving System: Real Medical Affairs as a Powerful Tool for Market Access and Coverage
World Perspectives & Examples CatherineSchnabelCatherine Schnabel, Ph.D., Vice President, Translational Science,
Brian S. Gorin, MBA, Managing Principal, Analysis Group bioTheranostics, Inc.
Diagnostics developers need to formulate relevant value propositions and
demonstrate clinical utility to stakeholders in the context of a broken business Billing and Reimbursement in Advanced Diagnostics: Working with
model. Diagnostic tests were historically subject to fee schedules based on cost, Private Payors and Government
not value. Valuable tests don’t receive adequate reimbursement, are abandoned, Laurie Howard, Vice President, Reimbursement, LabCorp
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 CASE STUDIES AND SOLUTIONS
Cambridge Healthtech Institute, current system, implications of changes on the horizon, and discuss examples.
250 First Avenue, Suite 300, 8:25 Chairperson’s Opening Remarks
Needham, MA 02494 3:30 Networking Refreshment Break Terry Robins, Molecular RxDx Strategies
www.healthtech.com
Cover
TRACK 2: NOVEMBER 18-19
Short Courses
and Symposia Evidence-Based Reimbursement of Molecular Diagnostics
Partnering with KOLs, Healthcare Centers and Payers
Track 1: Health Economics
8:45 Joint Presentation: A Do-It-Yourself Guide to Partnerships MEDICAL AFFAIRS AT WORK
of Personalized Genomic between Payers and Molecular Diagnostic Companies 1:45 Chairperson’s Remarks
Medicine Lon Castle, M.D., Medical Science Liaison, Medical Affairs, CardioDx Joseph V. Ferrara, President, Boston Healthcare Associates, Inc.
Robert McDonough, Head, Clinical Policy Research & Development, Aetna
Creating real-world evidence to support coverage of your test by payers can be a 2:00 The Evolving Role of Medical Affairs in the Genomic Testing Industry
Track 2: Evidence-Based challenging process. While few provide a blueprint for success, some payers are Brock Schroeder, Director, Medical & Scientific Affairs, Biotheranostics
open to collaborations designed to demonstrate the value of the test. This session With shifts towards evidence-based medicine and value-based models, the role for
Reimbursement of Molecular will provide a step-by-step guide on how to design, pitch and execute the types of Medical Affairs in market access and reimbursement efforts continues to increase
Diagnostics studies payers want to see when establishing coverage policies. in importance. Integral to this is the evolution of Medical Affairs from a supportive
and reactive function, to a strategic driver that leads key aspects of scientific
9:30 Medicare Coverage Process of an Epigenetic Test for Prostate discourse to respond to the needs and diversity of evidentiary requirements,
Cancer Under the New MolDX Program
Sponsor & Exhibit Opportunities Jan Groen, Ph.D., President & CEO, MDxHealth
and engages payers and providers accordingly. This presentation will highlight
the impact of Medical Affairs and medical programs to strengthen access and
Validation, clinical utility and health economic data for an epigenetic test for reimbursement for bioTheranostics’ proprietary molecular tests.
prostate cancer, demonstrated an improvement of the diagnosis, a significant
Hotel & Travel Information reduction in repeat biopsy procedures and a reduction in healthcare costs. To LABORATORIES’ PERSPECTIVE
obtain Medicare coverage for the test one has to comply with the new MolDx
program for multi-maker tests. In this case study we discuss the roadmap for an 2:30 A Reference Laboratory Perspective: A Discussion of Multiple
Registration Information epigenetic test going through the MolDX program from Medicare. Hurdles which Have to be Overcome to Minimize Disruptions in Cash
Flow due to Lack of Coverage and Reimbursement in the Molecular
10:00 System Economic Justification: Tools for Sponsored by
Diagnostics Testing Space
Success in the New Reimbursement Environment
Click Here to Gary Gustavsen, M.S., Vice President, Health Advances
Laurie Howard, Vice President, Reimbursement, LabCorp
Facing difficult Policy and Reimbursement obstacles, the Laboratory industry
Register Online! With more and more innovative diagnostics hitting the market, scrutiny and
evidentiary requirements from payers is at an all-time high. To meet these
is dealing with many implications that will affect how they operate and are
reimbursed in the future that will be addressed during this discussion. Key issues
Healthtech.com/Evidence-Based- demands, developers must make large investments which in turn drive a need include: Pace of test development vs. pace of coverage guidelines issuance and
Reimbursement-Summit for premium pricing to capture a return. To justify this, system economic analyses reimbursement determination, physician demand for the test, and clinical utility for
have become a critical component of a diagnostic’s launch plan. This case study Private Payors and Government.
will review the process for such an analysis, the resulting outcomes, and highlight
specific payer-facing tools for future use. 3:00 A Molecular Diagnostic Perfect Storm: The Convergence of
Click Here to
yourself as a Cambridge Healthtech Institute conference attendee to receive the discounted room • Contact our designated travel agent, Rona
rate with the host hotel. Reservations made after the cut-off date or after the group room block has Meizler, at 617-559-3735 or rona.meizler@
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are limited, so please book early.
Healthtech.com/Evidence-Based- TOP REASONS TO STAY AT THE HYATT REGENCY BETHESDA: Car Rental Discounts:
Reimbursement-Summit • Located only 10 miles from Reagan International Airport (DCA) Special rental discounts have been established
• Complimentary wireless internet access in guest rooms with Hertz for this conference.
• No commute as conference takes place in hotel • Call Hertz 800-654-3131 and use our Hertz
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• Located directly above Bethesda’s metro station Red Line Convention Number (CV): #04KL0005
• Within walking distance from Maryland’s best shopping, dining and cultural attractions. • Go to hertz.com and use our Hertz
Convention Number (CV): #04KL0005
We understand that you have many choices when making your travel arrangements, and may ultimately
decide to stay at another hotel. Please understand that reserving your room in the CHI room block
allows you to take full advantage of the conference sessions, events and networking opportunities, and
ensures that our staff will be available to help should you have any issues with your accommodations.
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shipping), please visit www.healthtech.
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Reimbursement-Summit Registrations after October 17, 2014, and on-site $2349 $1229
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Each registration includes all conference sessions,
posters and exhibits, food functions, and access to
Advance Registration Discount until October 17, 2014 $1549 $659 the conference proceedings link.
Registrations after October 17, 2014, and on-site $1749 $729 Handicapped Equal Access: In accordance with the
ADA, Cambridge Healthtech Institute is pleased
to arrange special accommodations for attendees
SYMPOSIUM PRICING (Includes access to the Capturing Value in Next-Generation Sequencing, excludes short courses) with special needs. All requests for such assistance
must be submitted in writing to CHI at least 30 days
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To view our Substitutions/Cancellations
Registrations after October 17, 2014, and on-site $699 $599 Policy, go to
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Track 1: Health Economics of Personalized Track 2: Evidence-Based Reimbursement of Boston Healthcare Capturing Value in Next-
Genomic Medicine Molecular Diagnostics Generation Sequencing Symposium