Evidence-Based

Cover Cambridge Healthtech Institute’s Third Annual

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

Sponsor & Exhibit Opportunities Summit for Leaders in Pharmacogenomics,

Hotel & Travel Information
Stratified Medicine, and Molecular Diagnostics
The Third Annual Evidence-Based Reimbursement Summit is designed to bring
together major stakeholders from pharmaceutical, biotech, IVD companies, laboratory
Registration Information medicine community and healthcare providers community to exchange opinions and to
search for solutions in the innovative medicine commercialization equation.

Click Here to TRACK 1: TRACK 2:

Register Online!
Healthtech.com/Evidence-Based- Health Economics of Personalized Evidence-Based Reimbursement
Reimbursement-Summit
Genomic Medicine of Molecular Diagnostics
Register now! Measuring the Impact of Novel Genomic Technologies
& Supporting Innovation
Partnering with KOLs, Healthcare Centers and Payers

NOVEMBER 17 - 18, 2014 NOVEMBER 18 - 19, 2014

Featuring Presentations by Featuring Presentations by
Roy Baynes, M.D., Dane Dickson, M.D., Bruce Quinn, M.D., Robert McDonough,
Senior Vice President, Director, Clinical Ph.D., Senior Health Head of Clinical Policy
Global Clinical Science-MolDx, Policy Specialist, Foley Research &
Development, Merck Palmetto GBA Hoag, LLP Development, Aetna

Corporate Stay on and attend the Capturing Value in Next-Generation

Sponsors Sequencing Symposium Attend all four days for best value!

Cambridge Healthtech Institute,

250 First Avenue, Suite 300,
Needham, MA 02494
CAPTURING VALUE IN NEXT-GENERATION SEQUENCING
www.healthtech.com NOVEMBER 20, 2014 | HYATT REGENCY BETHESDA, BETHESDA, MD
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
Dinner Short Courses*
Reimbursement of Cancer Genomic Analysis
Tuesday, November 18, 2014 | 6:00 – 9:00 pm
Instructors:
Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, Inc.
Jorge Leon, Ph.D., President, Leomics Associates, Inc.
• 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
• The view from large private payers
• How to generate cost effectiveness data that payers will buy into
• How to generate clinical utility data that payers will endorse
• Case studies in pathology, molecular diagnostics, proteomics, gene expression, next-generation sequencing
*Separate registration required
Co-Located Symposium
Capturing Value in Next-Generation Sequencing
Clinical and Economic Impact and Emerging Models in Advanced Genomics
Next Generation Sequencing is delivering on its promise as a life sciences research tool. Yet the adoption of NGS technology in the clinical laboratory is in its infancy.
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
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.
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
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.
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
For full details visit BHA-Symposium.com
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
TRACK 1: NOVEMBER 17-18
Health Economics of Personalized Genomic Medicine
Measuring the Impact of Novel Genomic Technologies and Supporting Innovation
MONDAY, NOVEMBER 17
7:30 am Conference Registration & Morning Coffee
APPLICATION OF HEALTH ECONOMICS TO
DEMONSTRATE VALUE OF PERSONALIZED THERAPY:
EVIDENCE CONSIDERATIONS
8:30 Chairperson’s Opening Remarks
Gregory Hess, M.D., Senior Fellow, LDI Health Economics & Policy, University of
Pennsylvania
8:40 Evidence Needs When Developing a Personalized Medicine
Josephine A. Sollano, Dr.PH, Vice President, Outcomes & Evidence, Global Health
and Value, Pfizer, Inc.
As the development of oncologics and other specialty and biologics become
increasingly targeted, pharmaceutical manufacturers must develop new approaches
to demonstrating value. Often times the standard approaches to the generation
of cost-effectiveness and outcomes evidence do not adequately address particular
aspects that the new medicine delivers to patients, payors, and society. In this
discussion we will examine new approaches to unlocking value for targeted
therapies including those with companion diagnostics.
9:10 Meeting the Evidentiary Needs of Various Stakeholders
Roy D. Baynes, M.D., Ph.D., Senior Vice President, Global Clinical Development, Merck
Meeting the complex and evolving evidentiary needs of various stakeholders
represents a significant ongoing challenge and opportunity for industry.
Additionally scientific progress has increasingly led to innovative novel agents
with unambiguous large effect sizes in grievous disease and with clear advantage
over current therapies. This has in certain areas led to a marked expansion of the
addressable incident and prevalent populations and, despite demonstrable value,
a significant increase in budgetary pressure. It is key that innovation penalties not
limit advancing these important therapies for patients.
9:40 Pharmacogenetic-Guided Intervention: Where Are We and where
Are We Headed?
Gregory Hess, M.D., Senior Fellow, LDI Health Economics & Policy, University of
Pennsylvania
This session will examine the growth of pharmacogenetic testing to guide therapeutic
selection and interventions across a variety of disease areas. The discussion will
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.
10:10 Networking Coffee Break
10:40 Application of Health Economics to Demonstrate Medical Value
of Companion Diagnostics
Usman Iqbal,M.D., Senior Medical Affairs Leader, Neuroscience, Global Medical
Affairs, AstraZeneca
Companion diagnostics, either genomic or tumor-based, can readily influence
efficacy gains and personalize treatment at the patient level. However the use
of molecular diagnostics to aid treatment decisions has been restricted in many
areas due to economic and coverage restrictions. The presentation will provide
a framework to apply health economic considerations in genomic medicine and
discuss methodological techniques that can demonstrate the clinical and economic
utility of molecular diagnostics.
11:10 Justifying Next Generation Sequencing in the Clinic: Lessons
from Cost-Effectiveness Analysis
Mark E. Nunes, M.D., Associate Professor, Pediatrics, Division Chief, Medical
Genetics, Kaiser Permanente
To produce financial and utility tools justifying clinical exome sequencing, we
performed cost-effectiveness analysis (CEA) of next generation sequencing (NGS)
multi-locus panels in congenital hearing loss evaluations. Total, average, and
marginal cost per diagnosis established were determined for sequential (single
gene, then NGS) and “NGS only” testing schemes introduced at varied points in the
Diagnostic Odyssey. NGS introduced early in hearing loss evaluations demonstrated
effective, saving time, money, and access.
SUPPORTING PHARMACEUTICAL INNOVATION
11:40 Evolution of Pharmaceutical Innovation
Robert Popovian, Pharm.D., Senior Director, US Government Relations, Pfizer, Inc.
Pharmaceutical innovation is critical to the long-term health of our economy.
Supporting pharmaceutical innovation is a complex issue where several policy
issues intersect and impact the final outcome. It is shortsighted to focus on any
single issue as the primary driver of pharmaceutical innovation.
Such complex course of action requires a regime that facilitates this dynamism and
a public that understands its machinations.
12:10 pm Sponsored Presentations (Opportunities Available)
12:40 Luncheon Presentation (Sponsorship Opportunity Available) or
Lunch on Your Own
1:10 Session Break
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
TRACK 1: NOVEMBER 17-18
Health Economics of Personalized Genomic Medicine
Measuring the Impact of Novel Genomic Technologies and Supporting Innovation
PRICING AND REIMBURSEMENT OF
STRATIFIED MEDICINE
2:00 Chairperson’s Remarks
Usman Iqbal,M.D., Senior Medical Affairs Leader, Neuroscience, Global Medical
Affairs, AstraZeneca
2:10 Precision Pricing for Precision Medicines
Finley Austin, Ph.D., President, Founder, RxDx Experts
The failure of current pricing and reimbursement practices to incent companion
diagnostics development is a well recognized impediment to targeting medicines. A
novel approach that supports patient response evidence collection and companion
diagnostic development post-drug launch will be described. The new model both
creates and rewards better patient outcomes. While not applicable to all medicines it
applies to many treatment regimes underdevelopment.
2:40 Demonstrating Product Differentiation
Stephanie Dyson, Senior Director, Government Affairs, Genentech
The reimbursement landscape will be challenging in 2014 and beyond. It has
become more apparent that regulatory success does not automatically equate
to commercial success. By understanding “market access” implications during
development companies can design the right trial, better leverage “evidence-based”
or “outcome-based” medicine, and eliminate “access hurdles” by demonstrating
patient, payer and provider value.
Manufacturers must develop an informed view of the market and develop a process
that evaluates elements that can impact the future success of a product such as
challenging traditional assumptions and understanding the broader commercial
issues impacting a product.
3:10 Sponsored Presentations (Opportunities Available)
3:40 Networking Refreshment Break
CHANGING REIMBURSEMENT ENVIRONMENT
4:10 Panel Discussion: Changing Reimbursement Environment to
Move Precision Genomic Cancer Treatment fORWARD
Moderator: Jorge A. Leon, Ph.D., President & CEO, Leomics Associates, Inc.
Panelists: Dane Dickson, M.D., Director, Clinical Science, MolDx, Palmetto GBA
John E. Steiner, Jr., Esq., CHC, Chief Compliance and Privacy Officer, Associate
General Counsel, Cancer Treatment Centers of America
Additional Panelists to Be Announced
5:10 Welcome Reception
6:00 Close of Day and Registration for Dinner Short Course
6:15-9:15 SC1 Dinner Short Course: CPT Coding and Reimbursement
in Diagnostics 101*
Instructor:
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana
University School of Medicine
Additional Instructors to Be Announced
•Overview of the Molpath CPT codes: Difference between Tier 1 and Tier 2; how to
obtain a CPT code
•Overview of reimbursement and billing processes
*Separate registration required
TUESDAY, NOVEMBER 18
7:30 – 8:15 am Problem-Solving Breakout Discussions with
Continental Breakfast
Concurrent Problem Solving Breakout Sessions are interactive, topic-specific
discussions hosted by a moderator. These sessions are open to all attendees,
sponsors, exhibitors, and speakers and provide a forum for discussing key issues and
meeting potential partners. Please pick a topic of your choice and join in.
Establishing and Relaying the Value of Companion Testing/
Personalized Treatment: a Pharma Company Perspective
Usman Iqbal Moderator: Usman Iqbal, M.D., Senior Medical Affairs Leader,
Neuroscience, Global Medical Affairs, AstraZeneca
Learning Healthcare Systems
Louis Fiore, M.D., MPH, Professor of Medicine, Boston University School of
Medicine, Professor of Public Health, Boston University School of Public Health,
Executive Director, Massachusetts Veterans Epidemiology Research and Information
Center at Department of Veterans Affairs
LEARNING HEALTHCARE SYSTEM
8:25 Chairperson’s Opening Remarks
Brian Kennedy, Executive Director, Alliance for Patient Access
8:30 The Department of Veterans Affairs Efforts towards Creating a
Learning Healthcare System
Louis Fiore, M.D., MPH, Professor of Medicine, Boston University School of
Medicine, Professor of Public Health, Boston University School of Public Health,
Executive Director, Massachusetts Veterans Epidemiology Research and Information
Center at Department of Veterans Affairs
The Department of Veterans Affairs Healthcare System offers a unique opportunity
to explore the logistics and feasibility of creating a learning healthcare environment.
Features of the system that support such an effort include utilization of a national
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
TRACK 1: NOVEMBER 17-18
Health Economics of Personalized Genomic Medicine
Measuring the Impact of Novel Genomic Technologies and Supporting Innovation
electronic medical record, integration of research activities within most healthcare
facilities and progressive clinical care and research leadership. Researchers and
clinical care providers at the Boston VA Medical Center can currently apply business
intelligence (BI) tools to national medical record data to allow for enhanced clinical
care and research activities. Through the Point-of-Care Research (POCR) Program
pragmatic clinical trials are conducted within the clinical care ecosystem almost
entirely within the electronic medical record application.
9:00 Precision Oncology Program at Veteran Affairs Cancer Center
Mary Brophy M.D., MPH, Attending Oncologist, VA Boston Healthcare System
The Precision Oncology Program utilizes these tools described in the previous
presentation to make available precision therapy to cancer patients.
9:30 Physicians Advocating for Patient Access
Brian Kennedy, Executive Director, Alliance for Patient Access
Brian Kennedy is Executive Director of the Alliance for Patient Access, a national
network which advocates for patient access to approved therapies and appropriate
clinical care. Mr. Kennedy will explain how since 2006, AfPA has successfully trained,
organized and mobilized physicians to engage policymakers and the media on health
policy issues impacting the physician-patient relationship.
10:00 Sponsored Presentations (Opportunities Available)
10:30 Networking Coffee Break
SPONSORSHIP & EXHIBIT INFORMATION
Exhibit Contract Podium Presentations — Available within Main Agenda!
Showcase your solutions to a guaranteed, targeted audience through a 15- or
30-minute presentation during a specific conference program, breakfast, lunch, or
separate from the main agenda within a pre-conference workshop. Package includes
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!
Breakfast & Luncheon Podium Presentations
Opportunity includes a 30-minute podium presentation. Boxed lunches are
delivered into the main session room, which guarantees audience attendance and
participation. A limited number of these presentations are available for sponsorship.
Invitation-Only VIP Dinner/Hospitality Suite
Select specific delegates from the pre-registration list to attend a private function at
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.
Focus Group
CHI will gladly provide you the opportunity of running a focus group on-site. This exclusive
gathering can be useful to conduct market research, collect feedback on a new product
idea, and collect marketing intelligence from industry experts on a specific topic.
TOOLS FOR GENERATING AND SYNTHESIZING EVIDENCE
11:00 Synthesizing and Applying Evidence for Decision-Making
Susan R. Snyder, Ph.D., MBA, Research Investigator II/ Health Economist, Geisinger
Center for Health Research
The goal of comprehensive and transparent approaches to valuation and decision-
making in healthcare including pharmacogenomics has generated alternative
decision-making frameworks relevant to investment, authorization, prescription,
reimbursement, and resource allocation. This presentation will review the nature and
application of evidence synthesis to support healthcare decision-making including the
use of a flexible and valuable tool, multi-criteria decision analysis (MCDA).
11:30 Evaluating the Medical Utility of a Biomarker or Biomarker
Score Test for Informing Treatment Decision
Richard Simon, Ph.D., Chief, Biometric Research Branch, NCI
A biomarker has medical utility if it informs treatment decisions in a manner
that results in improved patient outcome compared to using standard of care
diagnostics. Establishing the medical utility of a test is much more demanding than
merely establishing that a test is prognostic. Prognostic tests can have medical
utility but most do not. Medical utility must be established for each specific medical
decision context, i.e. indication. I will discuss how to evaluate whether a test has
medical utility for a specified indicate.
12:00 pm Close of Conference
User Group Meeting/Custom Event
Co-locate your user group meeting or custom event. CHI will help market the
event, manage logistical operations, develop the agenda, and more. CHI can handle
the entirety of the meeting or select aspects.
Exhibit
Exhibitors will enjoy facilitated networking opportunities with qualified delegates,
making it the perfect platform to launch a new product, collect feedback, and
generate new leads. Exhibit space sells out quickly, so reserve yours today!
Additional branding and promotional opportunities are available, including:
• Conference Tote Bags • Badge Lanyards
• Literature Distribution (Tote Bag Insert • Program Guide Advertisement
or Chair Drop) • Padfolios and More...
For additional sponsorship & exhibit information, please contact:
Joseph Vacca
Business Development Manager
781-972-5431 | jvacca@healthtech.com
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
TRACK 2: NOVEMBER 18-19
Evidence-Based Reimbursement of Molecular Diagnostics
Partnering with KOLs, Healthcare Centers and Payers
12:00 pm Conference Registration
DEMYSTIFYING CMS PERSPECTIVE
1:20 pm Chairperson’s Opening Remarks
John Warren, Senior Director, Health Policy, McDermott+Consulting
1:30 Medicare Law and Lab Tests: Changing More than the Price
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag, LLP
A new Medicare law, PAMA 2014, has triggered the biggest changes in over three
decades for lab tests. While much attention has focused on pricing changes with a
new market-pricing changes, this presentation will highlight major reforms to local
coverage, nationalization of coverage, and increasing the power of guidelines that
are being caused by new legislation.
1:50 Medicare Payment for Diagnostics, Speed Bumps or Road Blocks
John Warren, Senior Director, Health Policy, McDermott+Consulting
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.
2:10 Industry Evolution: Responding to the Changing Tides of
Payment Reform
Michele M. Schoonmaker, Ph.D., Vice President, Government Affairs, Cepheid
CMS and other payors are moving from fee-for-service to fee-for-value based
reimbursement systems. New methods for pricing diagnostic tests are being
established, forcing laboratories and manufacturers to re-think their value
proposition(s) for new diagnostic tests under bundled payment systems. This
session will focus on potential economic data requirements that will help test
developers be better prepared to navigate the evolving reimbursement landscape.
2:30 Panel Discussion with Speakers of the Session
Moderator: John Warren, Senior Director, Health Policy, McDermott+Consulting
3:00 Reimbursement of Advanced Diagnostics in Sponsored by
the Context of a Broken & Evolving System: Real
World Perspectives & Examples
Brian S. Gorin, MBA, Managing Principal, Analysis Group
Diagnostics developers need to formulate relevant value propositions and
demonstrate clinical utility to stakeholders in the context of a broken business
model. Diagnostic tests were historically subject to fee schedules based on cost,
not value. Valuable tests don’t receive adequate reimbursement, are abandoned,
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
current system, implications of changes on the horizon, and discuss examples.
3:30 Networking Refreshment Break
COVERAGE AND REIMBURSEMENT STRATEGIES
4:00 Panel Discussion: Reimbursement of Stand-Alone versus
Companion Molecular Tests
Moderator: Felix Frueh, Ph.D., CSO, Human Longevity, Inc.
Panelists: Jerry Conway, Vice President, Reimbursement & Payer Strategy,
Foundation Medicine, Inc.
Benjamin Eckert, Executive Director, Market Access, Metamark Genetics
Laura Housman, MPH, MBA, Senior Vice President, Chief Commercial Officer,
Molecular Health
5:00 Close of Day and Registration for Dinner Short Course
5:30- 8:30 pm SC2 Dinner Short Course: Reimbursement of Cancer
Genomic Analysis*
Instructors:
Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation
Medicine, Inc.
Jorge Leon, Ph.D., President, Leomics Associates, Inc.
•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
•The view from large private payers
•How to generate cost effectiveness data that payers will buy into
•How to generate clinical utility data that payers will endorse
•Case studies in pathology, molecular diagnostics, proteomics, gene expression,
next-generation sequencing
*Separate registration required
WEDNESDAY, NOVEMBER 19
7:30– 8:15 am Problem Solving Breakout Discussions with
Continental Breakfast
Concurrent Problem Solving Breakout Sessions are interactive, topic-specific
discussions hosted by a moderator. These sessions are open to all attendees,
sponsors, exhibitors, and speakers and provide a forum for discussing key issues
and meeting potential partners. Please pick a topic of your choice and join in.
Medical Affairs as a Powerful Tool for Market Access and Coverage
CatherineSchnabelCatherine Schnabel, Ph.D., Vice President, Translational Science,
bioTheranostics, Inc.
Billing and Reimbursement in Advanced Diagnostics: Working with
Private Payors and Government
Laurie Howard, Vice President, Reimbursement, LabCorp
CASE STUDIES AND SOLUTIONS
8:25 Chairperson’s Opening Remarks
Terry Robins, Molecular RxDx Strategies
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
TRACK 2: NOVEMBER 18-19
Evidence-Based Reimbursement of Molecular Diagnostics
Partnering with KOLs, Healthcare Centers and Payers
8:45 Joint Presentation: A Do-It-Yourself Guide to Partnerships
between Payers and Molecular Diagnostic Companies
Lon Castle, M.D., Medical Science Liaison, Medical Affairs, CardioDx
Robert McDonough, Head, Clinical Policy Research & Development, Aetna
Creating real-world evidence to support coverage of your test by payers can be a
challenging process. While few provide a blueprint for success, some payers are
open to collaborations designed to demonstrate the value of the test. This session
will provide a step-by-step guide on how to design, pitch and execute the types of
studies payers want to see when establishing coverage policies.
9:30 Medicare Coverage Process of an Epigenetic Test for Prostate
Cancer Under the New MolDX Program
Jan Groen, Ph.D., President & CEO, MDxHealth
Validation, clinical utility and health economic data for an epigenetic test for
prostate cancer, demonstrated an improvement of the diagnosis, a significant
reduction in repeat biopsy procedures and a reduction in healthcare costs. To
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
epigenetic test going through the MolDX program from Medicare.
10:00 System Economic Justification: Tools for Sponsored by
Success in the New Reimbursement Environment
Gary Gustavsen, M.S., Vice President, Health Advances
With more and more innovative diagnostics hitting the market, scrutiny and
evidentiary requirements from payers is at an all-time high. To meet these
demands, developers must make large investments which in turn drive a need
for premium pricing to capture a return. To justify this, system economic analyses
have become a critical component of a diagnostic’s launch plan. This case study
will review the process for such an analysis, the resulting outcomes, and highlight
specific payer-facing tools for future use.
10:30 Networking Coffee Break
11:00 Payer Panel: Policies Review and What
Co-organized with
Is Ahead Vital Insights
Moderator: Andrew C. Fish, Executive Director, AdvaMedDx
Panelists:
Tamara Syrek Jensen, Director of the Coverage and Analysis Group, CMS
Charles A. Stemple, D.O., M.B.A., Corporate Medical Director, Clinical Policy,
Commercial, Humana, Inc.
Robert McDonough, Head, Clinical Policy Research & Development, Aetna
12:00 pm Sponsored Presentations (Opportunities Available)
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or
Lunch on Your Own
1:00 Session Break
MEDICAL AFFAIRS AT WORK
1:45 Chairperson’s Remarks
Joseph V. Ferrara, President, Boston Healthcare Associates, Inc.
2:00 The Evolving Role of Medical Affairs in the Genomic Testing Industry
Brock Schroeder, Director, Medical & Scientific Affairs, Biotheranostics
With shifts towards evidence-based medicine and value-based models, the role for
Medical Affairs in market access and reimbursement efforts continues to increase
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
discourse to respond to the needs and diversity of evidentiary requirements,
and engages payers and providers accordingly. This presentation will highlight
the impact of Medical Affairs and medical programs to strengthen access and
reimbursement for bioTheranostics’ proprietary molecular tests.
LABORATORIES’ PERSPECTIVE
2:30 A Reference Laboratory Perspective: A Discussion of Multiple
Hurdles which Have to be Overcome to Minimize Disruptions in Cash
Flow due to Lack of Coverage and Reimbursement in the Molecular
Diagnostics Testing Space
Laurie Howard, Vice President, Reimbursement, LabCorp
Facing difficult Policy and Reimbursement obstacles, the Laboratory industry
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
include: Pace of test development vs. pace of coverage guidelines issuance and
reimbursement determination, physician demand for the test, and clinical utility for
Private Payors and Government.
3:00 A Molecular Diagnostic Perfect Storm: The Convergence of
Regulatory & Reimbursement Forces that Threaten Patient Access to
Genomic Medicine
Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana
Transforming Care
University School of Medicine
Dark clouds of public policy are threatening the bright future of genomic medicine.
Efforts by the U.S. Food and Drug Administration (FDA) to require premarket
review of laboratory developed procedures (LDPs), and also an FDA proposal of
a one test-one therapy model for companion diagnostics limit patient access to
testing. Furthermore, the Centers for Medicare and Medicaid Services (CMS)
has begun a trend towards non-coverage of the new molecular pathology current
procedural terminology (CPT) codes and reduced payment for covered tests create
a challenging environment for laboratories to translate new genomic discoveries
into clinical applications. This talk will review the regulatory environment that is
creating challenges for laboratories to keep their doors open.
3:30 Close of Conference
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
Stay on and attend the Capturing Value in Next-Generation Sequencing Symposium
November 20, 2014 | Attend all four days for best value!
Next Generation Sequencing is delivering on its promise as a life sciences research tool. The adoption of NGS technology in the clinical laboratory
is in its infancy, and holds immense promise for patient care, enabling personalized intervention to prevent and treat disease. Clinicians are now
beginning to demand and adopt this powerful tool to guide treatment decision-making, but the full clinical and economic value of NGS is only just
beginning to be understood. Assessing this 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.
This symposium offers an opportunity to learn and engage on the early real-world clinical applications of NGS; the economic perspectives of
providers, payers, and technology innovators; and emerging business model approaches. The event will gather the range of clinical and economic
stakeholders in advanced genomics, and create a participatory forum for dialogue on sustained value capture in a future where NGS as an essential
component of patient care.
For full details visit BHA-Symposium.com
HOTEL & TRAVEL INFORMATION
Conference Venue and Hotel: Flight Discounts:
Hyatt Regency Bethesda Discounted Room Rate: $189 s/d
One Bethesda Metro Center Discounted Reservation Cutoff Date: October 17, 2014
Special discounts have been established with
American Airlines for this conference.
Bethesda, MD 20814 • Call American Airlines 800-433-1790 and use
Tel: 301-657-1234 Conference code 61N4BI.
www.bethesda.hyatt.com
• Go to aa.com/group and enter Conference
Please call the hotel directly to reserve your sleeping accommodations. You will need to identify code 61N4BI in promotion discount box.
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@
been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms protravelinc.com
are limited, so please book early.
TOP REASONS TO STAY AT THE HYATT REGENCY BETHESDA: Car Rental Discounts:
• 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
• 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.
MEDIA PARTNERS
CLINICAL
INFORMATICS
NEWS
 Cover
Short Courses
and Symposia
Track 1: Health Economics
of Personalized Genomic
Medicine
Track 2: Evidence-Based
Reimbursement of Molecular
Diagnostics
Sponsor & Exhibit Opportunities
Hotel & Travel Information
Registration Information
Click Here to
Register Online!
Healthtech.com/Evidence-Based-
Reimbursement-Summit
Register now!
Cambridge Healthtech Institute,
250 First Avenue, Suite 300,
Needham, MA 02494
www.healthtech.com
How to Register: www.healthtech.com/ Please use keycode PAY F
Evidence-Based-Reimbursement-Summit.com when registering!
reg@healthtech.com • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288
Pricing and Registration Information
DINNER SHORT COURSES CONFERENCE DISCOUNTS
Commercial Academic, Government, Hospital-affiliated REGISTER 3 ­- 4th IS FREE: Individuals
must register for the same conference or
One short course $599 $299
conference combination and submit com-
Two short courses $899 $599 pleted registration form together for discount
to apply.
November 17 November 18 Alumni Discount: Cambridge Healthtech
Institute (CHI) appreciates your past partici-
SC1: CPT Coding and Reimbursement in Diagnostics 101 SC2: Reimbursement of Cancer Genomic Analysis
pation at Evidence-Based Reimbursement
Summit. As a result of the great loyalty you
CONFERENCE PRICING have shown us, we are pleased to extend
SUMMIT PLUS PRICING - BEST VALUE!
to you the exclusive opportunity to save an
additional 20% off the registration rate.
(Includes access to two tracks AND the Capturing Value for Next-Generation Sequencing Symposium, excludes short courses)
Group Discounts: Discounts are available
Advance Registration Discount until October 17, 2014 $3149 $1549 for multiple attendees from the same
Registrations after October 17, 2014, and on-site $3449 $1749 organization. For more information on group
rates contact
SUMMIT PRICING (Includes access to two tracks, excludes short courses) David Cunningham at +1-781-972-5472
Advance Registration Discount until October 17, 2014 $2649 $1149 If you are unable to attend but would
like to purchase the Evidence-Based
Registrations after October 17, 2014, and on-site $2849 $1249 Reimbursement Summit CD for $750 (plus
shipping), please visit www.healthtech.
BASIC CONFERENCE PLUS PRICING
(Includes access to one track AND the Capturing Value for Next-Generation Sequencing Symposium, excludes short courses)
com/Evidence-Based-Reimbursement-
Summit.com. Massachusetts delivery will
Advance Registration Discount until October 17, 2014 $2049 $1059 include sales tax.
Registrations after October 17, 2014, and on-site $2349 $1229
ADDITIONAL REGISTRATION DETAILS
BASIC CONFERENCE PRICING (Includes access to one track, excludes short courses)
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
Advance Registration Discount until October 17, 2014 $599 $499 prior to the start of the meeting.
To view our Substitutions/Cancellations
Registrations after October 17, 2014, and on-site $699 $599 Policy, go to
http://www.healthtech.com/regdetails
Video and or audio recording of any kind is
November 17-18 November 18-19 November 20 prohibited onsite at all CHI events.
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