THE Evidence-Based ReimbursementOctober 21-23, 2013 Hyatt Regency Bethesda | Bethesda, MD

SummiTFinal Agenda

2nd Annual

Generating Evidence for Reimbursement Decisions: DiagnosticsEstablishing the Value of a Test

Part 2October 22-23, 2013

featureD speakers

Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

Roger Klein, M.D., J.D., Department of Molecular Pathology, Cleveland Clinic Foundation

Jerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine, Inc.

2nd Annual

Generating Evidence for Reimbursement Decisions: therapeuticsIntegrating Payer’s Perspective into Product Development

Part 1October 21-22, 2013

featureD speakers

J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President, Research, Evidera

Josephine Sollano, Dr.P.H., Vice President, Health Economics and Outcomes Research and Medical Communications, Oncology Business Unit, Pfizer, Inc.

Mark J. Cziraky, Pharm.D., Vice President, Industry Sponsored Research, Healthcore

Organized byCambridge Healthtech Institute healthtech.com/Evidence-Based-Reimbursement-Summit

Register by September 27 & SAVE up to $200

Corporate SponsorsCorporate Support Sponsor

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October 21st, 2013 | 6:30-9:00

Clinical Studies for the Development of Evidence-Based Diagnostics*Instructors:

Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.

Brock Schroeder, Ph.D., Director, Medical & Scientific Affairs, bioTheranostics, Inc.

Development of a strong clinical program for diagnostic tests requires consideration and integration of key strategic drivers such as clinical adoption, reimbursement, & regulatory filing based on a proposed indication for use. In considering the appropriate use of new tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity), the risks and benefits resulting from test use (clinical utility), and the medical value of the test (health economics/outcomes).

This workshop will provide a basic framework for establishing comprehensive clinical evidence based on analytical validity, clinical validity, clinical utility, and health economics and effectiveness, and utilize a case study of the 92-gene assay, CancerTYPE ID to build these points.

• Clinicalstudydesignsforbiomarkerresearch/levelsofevidence• Formulatingclinicalendpoints• Frameworkforclinicalevidence• Datarequirementsforvariousstakeholders• Casestudy

October 22nd, 2013 | 6:30 – 9:00

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.

Genomic analysis of cancer has been established as an integral part of cancer patient management as well as of cancer clinical trials. The volume of this category of molecular testing is growing and more and more laboratories include it in the “test menu” and/or “services provided”. Hereby, the issue of reimbursement of clinical genotyping of cancers is at utmost importance for laboratories and molecular diagnostic companies. The situation is complicated by the fact that pharmaceutical companies working in the field of personalized oncology possess vested interest in these matters because many of the tests are falling in the category of companion diagnostics. The landscape of the diagnostics reimbursement in the health care industry is changing dramatically, as the usual mixed bag of payers is being compressed now by the reimbursement decisions of the number one customer: The US Govermnent.

In this workshop we will present, analyze and discuss thefollowing points.

• Overallsituationofthereimbursementlandscapetoday• Coding,coverage,policiesandpaymentfeesforcancergenomictests• TheMedicare/CMSnewviewofthevalueofnewtests• TheviewfromlargeInsurancepayers• Howtogeneratecosteffectivenessdatathatpayerswillbuyinto• Howtogenerateclinicalutilitydatathatpayerswillendorse• CasestudiesinPathology,MolecularDiagnostics,Proteomics,GeneExpression,

Next Gen Sequencing.

DinnER SHORT COURSES*

*Separate registration required

The Evidence-Based Reimbursement Summit is host to 150+ high level reimbursement professionals. Don’t miss networking opportunities with our distinguished audience.DirectorCorpReimbursement,AbbottMolecularVP, AstraZenecaHeadPortfolioMgmt,BayerHealthCareAGSeniorManager,BeckmanCoulterIncVP,BiocareMedicalVP,bioMerieuxVP Clinical Affairs, Boston Heart DiagnosticsDirector,BristolMyersSquibbCoDirector, Celgene CorpDirector Reimbursement, diaDexus Inc

Director, EXACT Sciences CorpVP of Reimbursement & Payer Strategy, FoundationMedicineIncSenior Director, Genentech IncExecutiveDirectorMedicalDiagnostics,GenoptixMedicalLabCMO,GenovaDiagnosticsCommercialDirectorAccessMarket,GlaxoSmithKlineSeniorDirector&Head,GlaxoSmithKlinePresident, HealthCore IncVPMarketing,HTGMolecularDiagnosticsIncManagerBiomarkerResearch,IntlGenomicsConsortiumDirectorLearningDevMarketing&Education,MayoClinic &FoundationDirectorClinicalRevenue&Reimbursement,MDAndersonCancer Ctr

VP,MedtronicIncSeniorVP&GM,NanoStringTechnologiesPresidentNAmerica,OxfordImmunotecIncSenior Director Global Health Economics, Pfizer IncDirectorMolecularPathology,RoswellParkCancerInstituteSeniorVP&ChiefCommercialOfficer, Saladax Biomedical IncVP Global Evidence & Value Dev, sanofi GrpDirector, Siemens Healthcare DiagnosticsSenior VP Clinical R&D, Takeda Global R&D CtrDirector,VAMedicalCtrBostonDirector Reimbursement, Vermillion IncVPPricing&GovernmentAffairs,ViforPharmaLtd

2012 ATTEnDEE PROFilE

Day 1, Monday

October 21, 2013Day 2, Tuesday

October 22, 2013Day 3, Wednesday

October 23, 2013

Morning Generating evidence for reimbursement Decisions: therapeutics

Generating evidence for reimbursement Decisions: therapeutics

Generating evidence for reimbursement Decisions: Diagnostics

afternoon Generating evidence for reimbursement Decisions: therapeutics

Generating evidence for reimbursement Decisions: Diagnostics

Generating evidence for reimbursement Decisions: Diagnostics

evening Dinner short Course (6:30 to 9 pm) Dinner short Course (6:30 to 9 pm)

COnFEREnCE-AT-A-glAnCE

* separate registration required

3 | The Evidence-Based Reimbursement Summit healthtech.com/Evidence-Based-Reimbursement-Summit

2nd Annual

Generating Evidence for Reimbursement Decisions: therapeuticsOctober 21-22, 2013 | Hyatt Regency Bethesda | Bethesda, MD

Monday, October 21st

7:30-8:15 am Conference Registration and Morning Coffee

HEALTH ANALYTICS AS A TOOL FOR REIMBURSEMENT DECISION-MAkINg8:20 Chairperson’s Opening RemarksGregory Hess, M.D., Executive Vice President, Symphony Health Solutions

8:30 Real-World Data as a Tool for Establishing the Value of a TherapeuticMark J. Cziraky, Pharm.D., Vice President, Industry Sponsored Research, HealthCore, Inc.

9:00 Joint Presentation: Utilizing EHRs in HEORGregory Hess, M.D., Executive Vice President, Symphony Health Solutions

Sheikh Usman Iqbal, M.D., MPH, MBA, Senior Director & Head, Oncology, Global Evidence & Value Development (EVD), Medical Affairs,

Global R+D, Sanofi

Real world Data and Practice based research networks (PBNs) are key innovation platforms that provide representative assessment of the true treatment landscape and patient outcomes. PBNs can effectively provide rich information that can be systematically and strategically leveraged to optimize developmental strategy, inform decision making on trial design, execution and placement. Comprehensive assessment of unmet needs & competitive positioning followed by informed guidance on molecular epidemiology, trial design, target population is critical for both “Portfolio Prioritization & Trial Execution” as well as “Patient Access and Health Technology Assessment.” How is Pharma leveraging Big data towards drug development and what opportunities are at hand to position real world research to inform trial design and developmental Strategy?

10:00 Coffee Break

10:30 Towards a Continuous Learning Ecosystem: Data Innovations and Collaborations to Improve Clinical Outcomes and Reduce Cost of CareVipul Kashyap, Ph.D., Senior Director, Clinically integrated networks, NYU Langone Medical Center

A holistic view of the healthcare systems as a continuous learning ecosystem will be presented with a special emphasis on collaborations between payers, providers and pharmaceutical stakeholders. An illustrative list of different types of metrics, analytics and insights created by payers, providers and pharma is discussed along with overlaps and possible collaborations enabled by them. Examples of collaboration across various stakeholders will also be discussed. A use case scenario based on medication adherence/compliance will presented along with a discussion on how the investments and incentives required to facilitate the collaboration and realize the resulting value.

11:00 Why Hasn’t Your Real-World Data Given You the Real-World Evidence?Hui Cao, M.D., Ph.D., Senior Director, Personalized Healthcare, R&D Information, AstraZeneca

In this talk, we try to answer the question ”why high investment on real-world data has not generated a high return” by examining true stories of failure. In recognition of the benefits, limitations and methodological challenges in using real-world data, we propose a strategy and a path forward to maximize the success of using real-world data to answer R&D and commercial questions and to support evidence generation.

11:30 Using Simulation Modeling to Generate sponsored by

Evidence for Reimbursement DiscussionsBadri Rengarajan, M.D., Medical Director, Archimedes, Inc.

Product sponsors often have to negotiate reimbursement when they do not yet have a complete dataset (including long-term outcomes and real-world usage). Unfortunately, this makes it challengingtosecureahighreimbursementprice.Full-scalesimulationmodelingwithvirtualpatients proceeding through a virtual healthcare system can generate longitudinal data in real-world settings in a matter of days, thereby changing the tone of the negotiation and potentially supporting a higher reimbursement.

11:45 Sponsored Presentation (Opportunity Available)

12:00 pm The Value and Impact of Real World Data in Healthcare Decision Making: A Case StudyRussell Knoth, Ph.D., Director, US Health Economics & Outcomes Research, Eisai, Inc.

Formularydecisionmaking,inparticular,canbeenlightenedby“real-world”data.Claimsdataare of particular value because they contain both utilization and costs, and are easily stratified by demographic, diagnostic, and treatment variables. Using a case from the oncology marketplace, Dr. Knothwilldemonstratehowsuchananalysiscaninformthevaluepropositionofadrugforpayers.The example will illustrate a classic retrospective analysis over a drug’s lifecycle, its inferred outcomes, its potential impact, and its limitations.

12:30 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

NEW pOLICIES: NEW STRATEgIES

1:40 Chairperson’s Opening Remarks

1:45 Value-Based Pricing: Holy Grail or Fool’s GoldJ. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President, Research, Evidera

Establishing an acceptable price is the major hurdle to market access and obtaining reimbursement. The basic idea is straightforward: the price should reflect the value of the benefits provided by the product in question. But, the devil is in determining that value. The efficiency approachesbasedontheQALYfailbecausetheyleavetoomuchoutandarediscriminatory.Willnew“value-based”initiativesachievetheholygrail?Oraretheydoomedtofailaswell?

2:15 Controlling the Cost of Cancer Drugs in Europe – HTA

sponsored by

and the Case for a Fresh StartChristian Elze, Senior Partner, Catenion

After briefly reviewing the rising cost of cancer drugs in Europe and the various approaches payors are taking to stem this trend, it is argued that we have collectively maneuvered ourselves into a dead end detrimental to patients, healthcare cost and innovation. To exit from this dead end, a novel reimbursement approach based on a “competitive market without prices” is presented for discussion.

2:45 What Are the Practical Drug Policies that Will Help Drive Down Health Care Spending and Improve Patient Outcomes?Robert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.

Health care in the United States consumes greater than 18 percent of gross domestic product (GDP). Pharmaceuticals consume roughly greater than 10 percent of the overall health care costs. Otherdevelopedcountriesspendagreaterpercentageoftheirhealthcarecostsondrugs.Thusitis important to consider pharmaceutical policies that will drive down overall health care costs and improve patient outcomes.

3:15 Generating Evidence for Reimbursement Decisions: Strategies and TacticsJosephine Sollano, Dr.P.H., Vice President, Health Economics and Outcomes Research and Medical Communications, Oncology Business Unit, Pfizer, Inc.

3:45 Refreshment Break in the Exhibit Hall

4:15 Case Study: Building a Global Value Dossier for a Novel Antibiotic and Differentiating a New Therapeutic ClassCarl Foster, Executive Vice President, Business Development, Cempra Pharmaceuticals

Unlike most other drug classes, the efficacy of antibiotics declines over time as bacterial resistance develops. Allowing pricing and reimbursement decisions to be made through reference to older antibiotics does not account for the fact that these products may no longer be effective or that the new product may reduce hospitalization costs. Using a global value dossier to differentiate a novel antibiotic will allow for pricing decisions to more accurately reflect therapeutic value.

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8:00 Problem Solving Breakout Discussions with Continental Breakfast

9:00 Leaning In: Successful Strategies as a Manufacturer to Engage Payers in Diagnostic Technology Assessment and CoverageLaura Housman, MPH, MBA, SVP, Chief Commercial Officer, Molecular Health

There has never been a more dynamic opportunity for diagnostic manufacturers to demonstrate their assay utility and advocate for commensurate value from payors. Whatisconsideredutility?Isitmeasureableimprovementinpatientoutcomesbasedonpatientmanagementchangesdirectedbytheresultofthetest?Or,achangeinpatientmanagementbasedontestresultsthatisexpectedtobenefitthepatient?Orsomecombination? And how should a manufacturer prepare for evolving and incomparable assessment criteria across payors? Strategies, opportunities for learning and anticipation of future changes will be shared.

9:30 Translating Clinical Need into Clinical Utility that Delivers Payer ValueDavid Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

Diagnostic test development often begins with the identification of an unmet clinical need that is particularly amenable to addressing with a company’s platform and proprietary technology.OftenthisprocessisdrivenbyinteractionbetweenclinicalKOLsandthecompany’s scientists. Unfortunately, meeting clinical needs as expressed by front-line physicians does not necessarily deliver high-value clinical utility as perceived by payers. Whenthathappens,adiagnostictestinnovatorcan“winthebattle,butlosethewar”.In this session, we will share practical approaches to this real-world problem, such as: identifying clinical needs with high payer impact; selecting clinical utility propositions that payers will value; distinguishing between potential and realizable payer value; and matching company resources and business goals with clinical utility evidence needs.

10:00 Coffee Break in the Exhibit Hall

10:30 Oncology Drug Development - Meeting The Evidentiary Needs of Various StakeholdersRoy D. Baynes, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences, Inc.

11:00 Building an Effective Reimbursement Strategy for the Era of Personalized MedicineJerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine, Inc.

As the industry moves farther away from a “one-size-fits-all” approach to prescribing medicines, the use of diagnostic tests and targeted therapies to fuel healthcare decisions has never been greater. The field of personalized medicine is advancing at a rapid pace, offering several advantages to healthcare providers and patients - namely, the ability to make more informed medical decisions, eliminate unnecessary treatments and reduce the probability of adverse drug reactions. The result is a higher probability of desired health outcomes and reduced healthcare costs. During this session, we will align current reimbursement and market access strategies with recent and future developments in the field of personalized medicine.

11:30 Automatable, Evidence-Based Prior Authorization for Gene Tests: A Reality Now

sponsored by

Lynn Feldman, MBA, CEO, SimulConsult Reimbursement relies at its core on a decision of medical necessity. Today, approval remains mostly arbitrary and time-consuming. An NIH-funded study showed that using patient’s symptoms and existing clinical diagnostic decision support tool scan document medical necessity in a consistent, automatable, evidence-based way for all inherited diseases. It’s time to establish evidence-based, prior authorization as the standard in genetic testing.

11:45 Evaluating Novel Diagnostics for ReimbursementElaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

12:00 pm Panel Discussion: Evidence-Based Reimbursement for Evidence-Based Personalized Medicine: Does Any of It Exist?Moderator: David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

12:15 pm Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

pLENARY SHARED SESSION: EVIDENCE-BASED REIMBURSEMENT IN pERSONALIZED MEDICINE /COMpANION DIAgNOSTICS

Tuesday, October 22nd

4:45 Panel Discussion: Integrating Payer’s Perspective into Product DevelopmentModerator: Robert Popovian, Pharm.D., MS, Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.

- How do we mesh the payer needs with regulatory expectations?

-Whatisthetypeofdatathatneedstobecollectedtoensurecoveragebypayersofinnovativetechnologies?Whatisthebestvehicletocollectsuchdata?Whataretheprinciples that will ensure appropriate analysis and access to the data?

-Whatlevelofimportancedoreductioninoverallhealthcarecosts,improvementsinpatient productivity, quality of life and patient satisfaction play in coverage decision by payers? How do we ensure such parameters are meaningful in silo’d health care reimbursement schemes?Panelists: Speakers of the Day

5:15 Welcome Reception in Exhibit Hall for Both Tracks of the Summit**Registration for Generating Evidence for Reimbursement Decisions: Diagnostics starts at 4:30 pm

6:15 End of Day

Monday, October 22nd (continued) CO-lOCATED WiTH:

October 21-23, 2013 | Bethesda, MD

Strategic Resource Management

Portfolio Management

Executive Decision Making

October 21-23, 2013 | Bethesda, MD

Clinical Trial Optimization:Strategy, Planning + Recruitment

Patient Centricity in Developing Strategies for Trial Execution

Evidence-Based, Data-Driven Patient Recruitment and Retention

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pLENARY SHARED SESSION: EVIDENCE-BASED REIMBURSEMENT IN pERSONALIZED MEDICINE /COMpANION DIAgNOSTICS*

8:00 Problem Solving Breakout Discussions with Continental Breakfast

9:00 Leaning In: Successful Strategies as a Manufacturer to Engage Payers in Diagnostic Technology Assessment and CoverageLaura Housman, MPH, MBA, SVP, Chief Commercial Officer, Molecular Health

9:30 Translating Clinical Need into Clinical Utility that Delivers Payer ValueDavid Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

10:00 Coffee Break in the Exhibit Hall

10:30 Oncology Drug Development - Meeting The Evidentiary Needs of Various StakeholdersRoy D. Baynes, M.D., Ph.D., Senior Vice President, Oncology Therapeutics, Gilead Sciences, Inc.

11:00 Building an Effective Reimbursement Strategy for the Era of Personalized MedicineJerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine, Inc.

11:30 Automatable, Evidence-Based Prior Authorization for Gene Tests: A Reality Now

sponsored by

Lynn Feldman, MBA, CEO, SimulConsult

11:45 Evaluating Novel Diagnostics for ReimbursementElaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

12:00 pm Panel Discussion: Evidence-Based Reimbursement for Evidence-Based Personalized Medicine: Does Any of It Exist?Moderator: David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine

12:15 pm Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

REIMBURSEMENT OF MOLECULAR DIAgNOSTICS: ANALYSIS AND FORECAST1:55 Chairperson’s Remarks

2:00 Medicare Payment for Diagnostics, Speed Bumps or Road BlocksJohn Warren, Senior Director, Health Policy, McDermott Will & Emery

Asthescienceandtechnologybehinddiagnosticscontinuestoevolveatarapidpace,Medicarepayment has struggled to keep up with the times. This session will provide insight into the backgroundofMedicare’sClinicalLabFeeSchedule,discusshownewtestsareevaluated,andtakealookatsomeofthefactorsthatkeeptheFeeScheduleastepbehindthestateofthe art.ProposedchangestotheFeeSchedulefor2014willalsobereviewed.

2:30 The Road to Reimbursement: Clinical UtilityElaine Lyon, PhD. Director, Genetics Division Co-Medical Director, Pharmacogenomics Co-Director, Clinical Molecular Genetics Fellowship Program, ARUP Laboratories

Toaddresspayerdissatisfactionwiththestackingcodes,theAssociationforMolecularPathology(AMP)proposedcodingmodelsfornewmolecularpathologyCPTcodestoincreasetransparency. Although the codes were adapted into the clinical laboratory, coverage placement, lack of transparency in costing, and misinterpretations of Tier 2 and ‘Unlisted’ codes have hinderedreimbursement.RecentPalmettolocalcoveragedecisions(LCDs),whichmaybeadopted nationally, require laboratories to obtain a unique identifier and submit information demonstrating clinical utility for each of its molecular tests. Although establishing analytical and clinical validity has been the responsibility of clinical laboratories for tests they offer, clinical utility traditionally has been demonstrated by large case/control studies. These studies are expensive,andrarelycouldaclinicallaboratoryundertakethem.Modelsareneededtoestablishappropriate standards to demonstrate clinical utility for molecular tests. This presentation will discuss current guidance, unique challenges for molecular tests, and the need for novel solutions to establish utility.

3:00 Next Generation Sequencing vs. Individual sponsored by Assays – Implications for Demonstrating Clinical Utility in the Context of Reimbursement Decisions Brian Gorin, Managing Principal, Analysis Group, Inc.

Costs of next generation sequencing have fallen, providing clinical decision makers additional information at lower cost compared with individual assays. New approaches to demonstrate clinical utility and generate evidence of value are needed. They must consider the merits of both short and longer term uses of diagnostic information that will exist in an enriched context, potentiallyconferringgreaterpredictivevalue.Weprovideaframeworkforevaluating evidence strategy and discuss marketplace examples.

3:30 Refreshment Break in the Exhibit Hall

4:00 Reimbursement Reform for Advanced Personalized DiagnosticDanielle Scelfo, Director, Government Affairs, Genomic Health

4:30 Panel Discussion: Reimbursement of Molecular Diagnostics: Analysis and Forecast5:00 Panel Discussion: Reimbursement of Molecular Diagnostics: Analysis and Forecast Moderator: Danielle Scelfo, Director, Government Affairs, Genomic Health

Panelists: Speakers of the Day

6:00 End of Day, Registration for Dinner Short Course

2nd Annual

Generating Evidence for Reimbursement Decisions: DiagnosticsOctober 22-23, 2013 | Hyatt Regency Bethesda | Bethesda, MD

*Pleaseseetheabstractsofthetalksonpage4

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Wednesday, October 23rd

ESTABLISHINg THE VALUE OF A TEST8:00 Problem Solving Breakout Discussions with Continental BreakfastConcurrent 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. See website for topics.

8:55 Chairperson’s Remarks

9:00 Demonstrating Clinical Utility Towards Commercialization of Proprietary Molecular DiagnosticsCatherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.

The evolving landscape of molecular diagnostics in the practice of genomic medicine presents challengestoenablingcommercializationofhighcomplexitytests.Forproprietarydiagnosticsinparticular, where the evidence base is built versus leveraged, an integrative roadmap is critical towards demonstrating clinical utility. Building evidence strategies for multiple stakeholders and the impact on clinical adoption and access will be highlighted through discussion of CancerTYPE ID, a 92-gene expression-based assay used for definitive diagnosis of tumor type and determination of primary site in metastatic disease.

9:30 Beginning with the End in Mind: Planning to Address Payer Coverage ConsiderationsPam Baker, Senior Director, Market Access & Policy, CardioDx, Inc.

Meaningfulimprovementsingeneticandgenomic-baseddiagnostictestscanmakeasignificantimpact on patients’ lives. However, without payer coverage, many diagnostic tests run the risk of remaining interesting concepts that weren’t able to impact the practice of medicine in any significantway.We’lldiscusshowtonavigatethesometimesunclearrequirementsforcoverageby public and private payers and how to plan for these requirements early in the development phase.We’llalsodiscusssomeofthemainstumblingblockstopayercoveragefordiagnostics,why they exist, and recommendations on how to avoid them.

10:00 Strategies for the Successful Launch of a Companion Diagnostic TestJohn R. Ridge, Director, Global Reimbursement and Healthcare Economics, Ventana Medical Systems, a member of the Roche Group

Personalized healthcare in the form of companion diagnostic testing has the potential to transform Healthcare. The session will explore the various challenges that diagnostic manufacturers will face from payers and funding agencies to acquire payment for companion diagnostics. Through an analysis of the current environment for companion diagnostics, manufacturers will learn what they have to do throughout the product development process to successfully launch a companion diagnostic test.

10:30 Coffee Break in the Exhibit Hall

11:00 Understanding the Value of Advanced Diagnostics: Aligning Labs, Clinicians and Payers to Make Better DecisionsMatthew Zubiller, Vice President, Decision Management, McKesson Health Solutions

Today,over3000moleculardiagnostic(MDx)testsaremarketedforclinicaluseandnewdiagnostics are regularly emerging at a rate of several per month. No standardized system for uniquely identifying these tests or capturing and analyzing the clinical and financial impact of individual tests currently exists. The discussion will show how the coordinated effort between theAMAandMcKessonwillbringspecificitytotheuse,identification,reportingandtrackingofMDxtests.Thiscoordinatedprocesswillhelptoimprovecommunicationandcollaborationbetween clinicians, hospitals, labs and payers.

CpT CODE CHANgE, pRICINg AND COVERAgE DECISIONS11:30 CPT Codes for Multigene Testing Using Next-Generation Sequencing: Opportunities and Challenges AheadRoger Klein, M.D., J.D., Department of Molecular Pathology, Cleveland Clinic Foundation

2013 heralds broad implementation of more transparent CPT coding for higher volume molecular pathology tests in the oncology and genetics arenas. A number of salient issues to include fee schedule placement and valuation of new molecular pathology CPT codes should be at least partially resolved. Advancements in new technologies such as next generation sequencing of gene panels, exomes and even full genomes pose new challenges for transparent and rational coding for labs and payers. This presentation will update and review developments on these and other topics of current interest.

12:00 Development of the new AMA Molecular Pathology CPT CodesVictoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine

WiththecompletionoftheHumanGenomeProjectandincreasedunderstandingofthegenesinvolved in human disease and cancer biology, clinical molecular testing has grown by leaps and bounds. New biomarkers were brought to market and largely reimbursed by using a molecular current procedural terminology (CPT) code stacking system where each step of the process had itsownCPTcode.Attherequestofpayers,theAmericanMedicalAssociation(AMA)developedanewCPTcodingsystembasedonawhitepaperproposedbyAssociationofMolecularPathology(AMP).Sincetherearewelloverathousanddifferentmolecularpathologytests,atier system was created. Tier 1 where each individual test gets a unique CPT code was created to encompass the more commonly ordered category 1 tests throughout the country. Tier 2 where there are nine levels of complexity was created to address the more rarely ordered category 1 tests. This session will review the new CPT coding system.

12:30 Panel Discussion: What New Codes Mean for Various Diagnostics Stakeholders

1:00 CPT Codes for Multigene Testing Using Next-Generation Sequencing: Opportunities and Challenges AheadRoger Klein, M.D., J.D., Department of Molecular Pathology, Cleveland Clinic Foundation

2013 heralds broad implementation of more transparent CPT coding for higher volume molecular pathology tests in the oncology and genetics arenas. A number of salient issues to include fee schedule placement and valuation of new molecular pathology CPT codes should be at least partially resolved. Advancements in new technologies such as next generation sequencing of gene panels, exomes and even full genomes pose new challenges for transparent and rational coding for labs and payers. This presentation will update and review developments on these and other topics of current interest.

1:00 End of Generating Evidence for Reimbursement Decisions: Diagnostics Molecular Diagnostics

Foradetailedagendaandconferenceupdatesvisit Healthtech.com/Evidence-Based-Reimbursement-Summit

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Conference Venue & Hotel: Hyatt Regency BethesdaOne Bethesda Metro CenterBethesda, MD 20814 301-657-1234

Discounted room rate: $249 s/dDiscounted room rate Cutoff Date: september 23, 2013

Please visit our conference website to make your reservations online or call the hotel directly to reserve your sleeping accommodations. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space- and rate-availability basis. Rooms are limited, so please book early.

flight Discounts:Special discounts have been established with American Airlines. Please use one of the following methods:

• Call 1-800-433-1790 (authorization code 32H3AC).

• Go online at www.aa.com/group (enter 32H3AC in promotion discount box).

• Contact our dedicated travel agent, Rona Meizler at 1-617-559-3735 or rona.meizler@protravelinc.com

Car rental Discounts:Special discount rentals have been established with Hertz for this conference. Please use one of the following methods:

• Call HERTZ, 800-654-3131 use our Hertz Convention Number (CV) 04KL0003

• Go online www.hertz.com use our Hertz Convention Number (CV) 04KL0003

HOTEl & TRAVEl inFORMATiOn

Top Reasons to Stay at the Hyatt Regency Bethesda

•Complimentarywirelessinternetinyourguestroom•Takeadvantageofthe$249grouprate!•DCMetroislocatedunderthehotel•RestaurantsandShopsarejustminutesfromtheHotel

CHI offers comprehensive sponsorship packages which include presentation opportunities, exhibit space and branding, as well as the use of the pre and post-show delegate lists. Customizable sponsorship packages allow you to achieve your objectives before, during, andlongaftertheevent.Signingonearlywillallowyoutomaximizeexposuretoqualifieddecision-makers!

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Breakfast & Luncheon PresentationsOpportunityincludesa30-minutepodiumpresentation. Boxed lunches are delivered into the main session room, which guarantees audience attendance and participation. A limited number of presentations are available for sponsorship and they will sell out quickly. Sign on early tosecureyourtalk!

Invitation-Only VIP Dinner/Hospitality SuiteSponsors will select their top prospects from the conference pre-registration list for an evening of networking at the hotel or at a choice local venue. CHI will extend invitations and deliver prospects. Evening will be customized according to sponsor’s objectives:

• Purelysocial• Focusgroup• Receptionstyle• Plateddinnerwithspecificconversationfocus

ExhibitExhibitors will enjoy facilitated networking opportunities with highly-qualified delegates making it the perfect opportunity to speak face-to-face with prospective clients and showcase your latest product, service, or solution.

Lookingforadditionalwaysto drive leads to your sales team? CHIcanhelp!Weofferclientsnumerousoptionsforcustom lead generation programs to address their marketing and sales needs, including:

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SHORT COURSES

One short course $699 $399

Two short courses $999 $699

Monday, October 21, 2013 Tuesday, October 22, 2013

Clinical Studies for the Development of Evidence-Based Diagnostics

Reimbursement of Cancer Genomic Analysis

CONFERENCE PRICING

3-DAY SUMMIT PRICING - Best Value! (Includes access to both conference programs, excludes short courses) Advance Registration Discount until September 27, 2013 $1999 $1099

Registrations after September 27 and on-site $2199 $1199

INDIVIDUAL CONFERENCE PRICING (Includes access to one conference, excludes short courses)

Advance Registration Deadline until September 27, 2013 $1599 $729

Registrations after September 27 and on-site $1799 $799

October 21st - 22nd October 22nd - 23rd

Generating Evidence for Reimbursement Decisions: Therapeutics Generated Evidence for Reimbursement Decisions: Diagnostics

CONFERENCE DISCOUNTS Alumni Discount SAVE 20%: We appreciate your past participation at the Evidence-Based Reimbursement Summit. Through loyalty like yours, this event has become a must-attend for reimbursement professionals. As a result of your great loyalty, we are pleased to extend this exclusive opportunity to save an additional 20% off the registration rate. Simply select the “Alumni Discount” option on the online registration form to take advantage of this special offer. Please note: In order to quality, our records must indicate you are a past attendee of the Evidence-Based Reimbursement Summit.

Register 3 - 4th is Free! Individuals must register for the same conference or conference combination and submit completed registration forms together for discount to apply. Please reproduce this registration form as needed.

Group Discounts are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts contact David Cunningham at 781-972-5472

(AlumniandRegister3-4thisfreediscountscannotbecombined)

If you are unable to attend but would like to purchase either the Generating Evidence for Reimbursement Decisions: Therapeutics or Generating Evidence for Reimbursement Decisions: Diagnostics CDfor$350(plusshipping),pleasevisitwww.healthtech.com/Evidence-Based-Reimbursement-Summit.Massachusettsdeliverywillincludesalestax.

ADDITIONAL REGISTRATION DETAILSEach registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link.Handicapped Equal Access: In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.To view our Substitutions/Cancellations Policy, go to http://www.healthtech.com/regdetailsVideo and or audio recording of any kind is prohibited onsite at all CHI events.

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Barnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in thedrugdevelopmentprocess.Formoreinformation, visit barnettinternational.com.

Cambridge Healthtech Associates™ (CHA™) leverages its extensive network and unique collaborative model in consulting, technology evaluations and community-based communication services to help clients in the life sciences industry commercialize and penetrate the marketplace to increase revenue. Visit www.chacorporate.com.

How to Register: healthtech.com/evidence-based-reimbursement-summitreg@healthtech.com • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288

Please use keycode PAY F

when registering!

THE Evidence-Based Reimbursement SummiT October 21-23, 2013

Hyatt Regency BethesdaBethesda, MD

Cambridge Healthtech Institute250 First Avenue, Suite 300Needham, MA 02494www.healthtech.comFax: 781-972-5425