1. One-on-One
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MARCH 17-18, 2015 • HYATT REGENCY SAN FRANCISCO AIRPORT • BURLINGAME, CA
Medical Device and
Diagnostics Reimbursement
Generate Evidence to Support Coverage, Coding and Payment
Decisions within Emerging Value Reimbursement Models
Anne A. Stefurak,
Vice President, Reimbursement
and Government Affairs,
Amniox Medical Inc.
Discuss the impact of the
Affordable Care Act on reimbursement,
including the shift from volume to value
Examine the transition from the
standard prescribe and reimburse model
to ACO decisions about purchasing
Create strategies for collaborating
with bundled payment entities
Frame the economic benefit of your
product based on how hospitals are
measuring value
Tie guaranteed financial incentives
into an implant or device performance
to alleviate buyer concerns
Develop tools to help drive market
access, including license claims data
and strategic publications
Develop Strategies to Navigate the Evolving Requirements for Coverage and Reimbursement
ELITE FACULTY REPRESENTING:
Amniox Medical Inc. • Beckman Coulter • Boston Scientific • Dune Medical Devices
Ethicon Inc, a J&J Company • Intersect ENT • Philips • Zimmer
MEDICAL DEVICE AND DIAGNOSTICS BREAKOUTS:
PLUS! Don’t miss the opportunity to meet one-on-one with a UK payer to
have your most pressing reimbursement questions answered:
Distinguished Co-Chairs:
Jeffrey Bush, CT (ASCP), MBA,
Vice President,
Payer Markets & Reimbursement,
AssureRx Health, Inc.
Medical Device —
Partner with Payers and Providers
to Improve Population Health
Diagnostics —
Examine How DiagnosticTests
Impact the Care Pathway
Andy Stainthorpe,
Subject Matter Expert,
NICE Health Technology and Device Assessment
Media Partner:

2. REGISTER AT WWW.CBINET.COM/DEVICEREIMBURSEMENT • 800-817-8601
DAY ONE Tuesday, March 17, 2015
7:30 Conference Registration & Continental Breakfast
8:30 Co-Chairs’ Welcome and Opening Remarks
AnneA.Stefurak,VicePresident,Reimbursementand
GovernmentAffairs,Amniox Medical Inc.
JeffreyBush,CT(ASCP),MBA,VicePresident,PayerMarkets&Reimbursement,
AssureRx Health, Inc.
8:45 OPENING ADDRESS
Reimbursement Winners and Losers
in 2014 — Lessons Learned for
Device and Diagnostic Manufacturers
• Examine new Medicare coverage policies for medical
devices and diagnostic tests during 2014
• Understand new technology DRG add on payments
and which ones succeeded
• Discuss hospital outpatient new device APCs that will
go into effect in 2015
• Analyze why CPT and HCPCS codes were approved
• Create strategies for market access by coordinating
reimbursement, regulatory, marketing, advertising,
sales and customer support stakeholders
• Look ahead to what you can do during 2015
GordonSchatz,LifeScienceReimbursementPartner,Reed Smith LLP
Respond to the Changing
Reimbursement Landscape
9:25 The Affordable Care Act in 2015 —
Implications for Medical Device and
Diagnostics Companies
• Discuss the impact of the Affordable Care Act on the
healthcare marketplace
* how has ACA changed the U.S. health delivery
system? What can we expect in the future?
* what’s likely in the new Congress —
will ACA be repealed?
* shift from volume to value — ACOs, bundled
payments, pay for performance.
Is fee for service a thing of the past?
* impact on decision making and evidence
requirements for medical technology
• Create strategies for market access in a changing
healthcare environment
• Examine the winners and losers in an era of market
consolidation
• Consider shifts in risk — Is the consumer the
new customer? A look at price transparency,
high deductible plans and newly insured
LaurelSweeney,SeniorDirector,HealthEconomicsandReimbursement,
Philips
10:05 ACO Healthcare Reform Initiatives —
Navigate the Changing Environment to
Heighten Reimbursement Probability
• Discuss the transition from the standard prescribe and
reimburse model to ACO decisions about purchasing
• Examine CMS’s progress with goal of controlling
healthcare costs to improve quality of care
* has the initiative been successful?
* what does the changing platform mean for your
device or diagnostic?
• Partner with ACOs from a health economics
and reimbursement perspective, including IDNs
and GPOs
• Build up evidence to show value of technology to
purchasing groups
* create evidence for longitudinal care across the
whole care delivery cycle
• Consider what the overall goal of lowering costs
means for your product’s level of reimbursement
StaceyCooper,Director,Reimbursement,ERMI Incorporated
10:45 Networking and Refreshment Break
11:15 Value-Based Contracting —
The Legal Issues and How to Address Them
Value-based purchasing has been praised by everyone
from the President to health care system participants,
large and small, as a concept that can yield savings and
improve outcomes and quality of care. Some device
and diagnostics companies have attempted to use
value-based contracting with payers and providers as a
means to secure favorable coverage and reimbursement
and to improve sales. Although policymakers widely
praise value-based purchasing approaches, the existing
legal system is not yet well-adapted to value-based
contracting efforts. This presentation explores the
FDA promotional, antikickback, state insurance, privacy
and other issues that can arise in executing a value-
based contracting strategy, including how best to
address them.
WilliamSaraille,Partner,Sidley Austin
Generate a Blueprint for
Evidence Needs and Evolving
Reimbursement Models
11:55 Understand the Role of Reimbursement/
Market Access in Navigating the Value
Analysis Committee
• Frame the economic benefit of your product based on
how hospitals are measuring “value”
• Create relevant sales training and tactical marketing
programs that can clearly show your product’s
“benefits” to the value analysis committee
MaryWalchak,Director,MarketAccessReimbursementStrategy,
Dune Medical Devices
12:35 Networking Luncheon

3. REGISTER AT WWW.CBINET.COM/DEVICEREIMBURSEMENT • 800-817-8601
1:35 Bundled Payments for Care Improvement
(BPCI) — Strategies, Risks and Rewards
• Examine the four bundling models,
as defined by CMS
* models 1-4 — looking at differences and
level of engagement with each model
* understanding the impact to providers and how
to respond
• Create strategies for collaborating with bundled
payment entities
• Review risks and rewards associated with BPCI
* will the model evolve?
* do the risks outweigh the rewards?
• Examine risks and rewards associated with
commercial bundled payment plans
• Discuss other innovative models being piloted
and the impacts
YvonneBokelman,MBA,FACHE,VicePresident,GlobalMarketAccess,
HealthEconomics&Reimbursement,Zimmer, Inc
2:15 TOPIC INTENSIVE BOOT CAMP
Investigate the Different Evidence Needs for
Regulations and HTA Assessments
I. Review the Basics of How Devices Are
Regulated by the FDA versus International
Regulators, Including Similarities
and Differences
• Examine device and diagnostic assessments,
including the differences and lessons learned
and successes
• Consider whether reimbursement mechanisms in
various countries can be compared or contrasted
• Discover whether the findings in one market have an
impact on another market’s decisions for approval
and reimbursement
II. Evaluate Health Policy Initiatives, Including
Regulations and Legislation
• Uncover what you need to know when
entering new markets to avoid nuanced
surprises and data ignorance
III. Identify Evidentiary Needs That Need
to Be Known for HTA Assessments
• How do I put together the evidence strategy?
• Should this be a formal process?
• How do I prove that my technology illustrates value
above and beyond what is already available?
• What can be learned from progressive
markets like the UK, Asia and Germany?
• Collect data in tier 1 and tier 2 countries to
expedite the submission and reimbursement
process in other markets
IV. Create a Strategic Reimbursement Plan
• Work with your business counterparts to
realize a common goal
• Examine how payment coding, reimbursement and
payment delivery system reforms interact•
Include a 5+
year plan when bringing a technology to
market, including clinical studies, publications and
identifying stakeholders
AndyStainthorpe,SubjectMatterExpert,
NICE Health Technology and Device Assessment
Construct Evidence and Data
Strategies to Increase Reimbursement,
Market Access and Better Science
2:55 Effectively Work with Government
Affairs and Policy Counterparts to Increase
Product Reimbursement
During this session, learn how to work with CMS,
FDA, NCI, AHIP and congressional contacts in
Washington, DC to communicate the value
of new technologies.
• Identify parties that need to be involved;
Capital Hill contacts that will be influential and actions
that need to be taken to lobby for your product
• Discuss the challenges in advocacy,
specifically for diagnostics
* create a planned sequence of events
* understand necessity for algorithms
* discuss physician decision making
• Advocate for a new device to support reimbursement,
including the use of key opinion leaders, government
affairs office, direct to
consumer marketing and legislators
• Review the current status and progress on
the medical device tax
KarlFlorence,DirectorofReimbursement,USGI Medical
3:25 Networking and Refreshment Break
3:55 Create Strategies for Clinical Utility
and Evidence Generation Coverage and
Reimbursement
• Identify key elements and requirements for
developing a coverage and reimbursement
dossier submission
• Uncover best practices for actual evidence
generation – Build evidence strategies to
fulfill requirements
• Examine case study examples of successes and
failures that resulted in approved and rejected
coverage and reimbursement
NicoleLittmann,VicePresident,ClientServices,
Quorum Consulting
CASE
STUDY

4. REGISTER AT WWW.CBINET.COM/DEVICEREIMBURSEMENT • 800-817-8601
4:35 B R E A KO U T S
Navigate Medical Evidence Health Outcomes and Data Requirements for Payer Coverage and
Appropriate Reimbursement
Generating and providing evidence and data requirements for reimbursement can differ greatly between devices and
diagnostics. During these interactive breakout sessions, attendees break into groups to discuss
the challenges that are unique to device and diagnostic reimbursement.
MEDICAL DEVICE
Partner with Payers and Providers to
Improve Population Health
Coverage and payment policies vary from payer to
payer. This session explores real-world case studies
for successfully gaining and improving coverage
using a procedural-based approach to affect
population health.
• Examine how to drive improvements for
process, quality, cost and outcomes in support of
the Triple Aim while improving access to care and
reimbursement
• Discuss clinical and economic evidence and
data requirements to support device/procedural
reimbursement and innovative payment models
employed by payers (employers, coalitions,
health plans)
• Explore collaboration opportunities to build
a value-based payment strategy to ensure
appropriate coverage and reimbursement while
maintaining provider (practice, hospital, hospital
system) profitability
DawnBowden,Ph.D.,G.B.A.,Director,HealthPolicyandEconomics,
Ethicon, Part of the Johnson & Johnson Family
of Companies
DIAGNOSTICS
Examine How Diagnostic Tests Impact
the Care Pathway
• Discuss the definitions of clinical validity and
clinical utility from a payer perspective
• Consider clinical evidence requirements for reimbursement
* the different categories of diagnostic test utilization
* diagnostic test performance —
how good is good enough?
* associated clinical trial designs for
demonstrating clinical utility
• Review what other factors are considered in
coverage determinations
* clinical practice influence and
economic consequences
* peer-review and expert panels
* Health Technology Assessments
• Reflect on MAAA codes, Z-codes and stacking codes —
What do they all mean?
MarkA.Reynolds,Ph.D.,
Director,HealthEconomicsandOutcomesResearch,
GlobalHealthEconomicsandReimbursement,Beckman Coulter
DAY TWO Wednesday, March 18, 2015
7:30 Continental Breakfast
8:00 Co-Chairs’ Review of Day One
AnneA.Stefurak,VicePresident,ReimbursementandGovernmentAffairs,Amniox Medical Inc.
JeffreyBush,CT(ASCP),MBA,VicePresident,PayerMarkets&Reimbursement,AssureRx Health, Inc.
CASE
STUDIES
5:20 Close of Day One
Networking, Wine and Cheese Reception
immediately following the final session on day one

5. 8:15 Workshop Leaders’ Welcome & Opening Remarks
Workshop Objective:
Securing FDA approval/clearance is only half the battle to market
entry for a new technology. If coverage and payment for the
technology is needed for market access, creation of codes is the
next critical step in the process. This workshop describes coding
options for various device categories and the criteria for each. The
timelines, regulatory requirements, clinical evidence requirements
and anticipated hurdles are reviewed. Also to be discussed are
translating codes to coverage and payments when “no code” may
be the best strategic option for a new technology.
Key Questions to Be Addressed:
• Can an existing code be utilized for reimbursement
or is a new code needed?
• Which code for what product?
• When should the code creation process be started?
• What is the link between CPT codes and Medicare
payments to physicians and hospitals?
• How does the implementation of ICD-10 impact processing
hospital claims for reimbursement?
• What are the implications of ICD-10 conversion on access?
• What needs to be considered for emerging trends in early
phase coding of new and upgraded products, i.e., HCPCS?
• How can you plan for complications with coding
in various provinces and countries?
Workshop Outline:
I. Overview of Coding Strategies to
Optimize Reimbursement
• What coding paths exist for new technologies?
• What are the implications of code creation?
• Is “no code” the best strategy?
• Are two separate strategies needed for commercial
and government payers?
• What constitutes a bad coding strategy decision?
• How can I manage internal expectations regarding
coding strategy costs, timelines and implications?
II. Establish CPT Coding Assignments
• Review differentiation of Category I versus Category III
codes and describe appropriateness criteria
• Describe the architecture of the CPT application
process, timelines and evidence requirements
• Inspect the role of specialty societies and
how they can help you develop new CPT
codes or work against you in the process
• Discuss the CPT link between Medicare payments
and physicians and the annual review process
III. Examine Pass-through Payment and HCPCS
Coding Options for Outpatient Treatment
• Review the mechanics of the pass-through
application process
• Describe the history of technologies which
have qualified for pass-through payment
• Dissect the “substantial clinical improvement”
requirement and evidence generation strategies
• Discuss supportive strategies to secure
pass-through payment
IV. Examine the Implementation of
ICD-10 — Transition Smoothly from
ICD-9 for Optimal Reimbursement
• Examine how the downstream effect from
incorrect coding can impact provider availability
and reimbursement
* create strategies to avoid any negative business
and reimbursement impact
• Ensure hubs, specialty pharmacies, physicians and
hospitals understand proper coding and how to
verify benefits
• Update enrollment forms and coding information
on your website
• Discuss how to create appropriate and effective
messaging to physicians post ICD-10 implementation
* how is it different than ICD-9?
11:45 Close of Workshop and Conference
There will be a 30-minute networking and refreshment break at 10:15am.
Workshop Leaders:
LaurenCraig,CPC-H,FieldReimbursementManager,CentralRegion,
Boston Scientific
LaurenCraigstartedherreimbursementcareerasananalystforFEIWomen’sHealth. She
hasworkedwithnumerousstart-upsinsalesandreimbursement,whichhaveallbeen
successfullyacquired. Ms.CraigisCPC-Hcertifiedandhasareimbursementbackground
witha strongfocusonpayeranalyticsandinternal/externalreimbursementwithmedical
deviceanddiagnostictestingproductsfocusinginwomen’shealth,oncology,woundcare
andpulmonaryhealth. Ms.CraigreceivedaBAininternationalbusinesswithafocusin
entrepreneurshipfromLoyolaMarymountUniversity.
BetsyGross,RN,BSN,CPC,CENTC,VicePresident,HealthEconomicsandReimbursement,
Intersect ENT
BetsyGrossisanursebytrainingandaCertifiedCoderwhohasspentover25yearsinthe
manufacturerspaceofthehealthcareindustry. Herexperiencerangesfromoffice-based
injectablebiotechproductstodevicesusedintheoutpatientsurgicalsettingtotechnologies
usedduringinpatientadmissions. Intheseroles,shehasestablishedabreadthofknowledge
andexperienceintraditionalcoding,coverageandpaymentmechanisms,aswellas
innovativeevidencedevelopmentandmarketaccessstrategies.
REGISTER AT WWW.CBINET.COM/DEVICEREIMBURSEMENT • 800-817-8601
Conference Sponsors:
A Great Place to MeetYour Market!
Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought
leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact
Lauren Moras at 339-298-2172 or email lauren.moras@cbinet.com.
Enhance Reimbursement through Comprehensive
Coding Strategies
IN-CONFERENCE
WORKSHOP

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devicereimbursement
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Medical Device and Diagnostics Reimbursement PC15029
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Hotel Reservations: 888-421-1442
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• Phone reservations: 888.421.1442 and mention CBI’s Medical Device
Book Now! The Hyatt Regency San Francisco Airport is accepting reservations
on a space and rate availability basis. Rooms are limited, so please book early.
All travel arrangements subject to availability.
REGISTRATION FEE:
ADVANTAGE PRICING Standard
Conference $1599 $1899
One-on-One U.S./UK Payer Meetings — Limited space available, call for details.
Register by January 16, 2015 and SAVE $300. Fee includes continental breakfast, lunch,
wine and cheese reception, refreshments and conference documentation. Please make checks
(in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)
PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.
TEAM DISCOUNT:
For every three paying registrations from your company, you will receive a fourth complimentary*
registration to the conference (must register four at same time to qualify). To receive the team discount
you must register with our customer service department by calling 339-298-2100.
* Advantage pricing rates do apply when applicable. Offer may not be combined with any other
special pricing promotions. Offer may be used at CBI co-located events.
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CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference,
a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-
8601 for further information. Advanced preparation for CBI conferences is not required.
SUBSTITUTION AND CANCELLATION:
Your registration may be transferred to a member of your organization up to 24 hours in advance of the
conference. Cancellations received in writing on or before 14 days prior to the start date of the event
will be refunded, less a $399 administrative charge. No refunds will be made after this date; however,
the registration fee less the $399 administrative charge can be credited to another CBI conference if
you register within 30 days from the date of this conference to an alternative CBI conference scheduled
within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the
conference registration fee only. CBI reserves the right to alter this program without prior notice. Please
Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort
to find a suitable replacement will be made without notice. The opinions of the conference faculty do
not necessarily reflect those of the companies they represent or CBI.
REGISTER AT WWW.CBINET.COM/DEVICEREIMBURSEMENT • 800-817-8601
MARCH 17-18, 2015 • HYATT REGENCY SAN FRANCISCO AIRPORT • BURLINGAME, CA
Medical Device and
Diagnostics Reimbursement
Generate Evidence to Support Coverage, Coding and Payment
Decisions within Emerging Value Reimbursement Models
R E G I S T E R B Y J A N U A R Y 1 6 , 2 0 1 5 A N D S A V E $ 3 0 0 !
ANY QUESTIONS OR TO REGISTER
CALL SONIA LIMA 339-298-2142
OR FAX TO MY ATTENTION 781-939-2466
email: sonia.lima@cbinet.com