Pre Market Reimbursement
Strategies for New Technologies
Marilyn Denegre-Rumbin, JD MBA
Director Payer-Reimbursement Strategy
Strategy & Business Development
December 1, 2015
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Early Strategy Integration is CRITICAL
to any Product’s Success
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Reimbursement Must Start with the
Initial Development of Product
•  Product Design
•  Diagnostic vs. therapeutic
•  R&D must understand the need to show clinical value
•  Setting of Care
•  Different reimbursement based on site of care
•  Provider type
•  Surgical vs. Medical
•  Physician vs. Non-physician
•  Clinical Indications
Define subset of patients. Include target patients in clinical trials
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Pre Market Assessment ‘s
Market Analysis
*Market Size
* Target Pricing
* Current trends and disease treatments on populations
Competitive Landscape
* Competition Mix ( companies, products, substitutes)
* Points of Service ( trends, reimbursement)
* Product mix and penetration, market share
Intellectual Property
* Licensing,
* Patent application,
* Trademark, Copyright
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Additional Puzzle Pieces
Regulatory Path
* Review of FDA Application, product classification
* Identify the pathway for FDA review, process, approval
* SWAT Analysis
* Data requirements
* Clinical Evidence and trials
* Status technologies in the pathway
Reimbursement Path
*Define products, services, technology currently covered.
* Coding analysis ( CPT/DRG/APC codes)
* Coding application and strategy
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Reimbursement Assessment is Critical
Reimbursement is one of the most critical elements in the
life cycle of your product.
Must understand current “reimbursement landscape” for a product/
procedure.
• Coverage
• Coding
• Payment
• Competitive landscape
• Legislative impact
• Impact of ACA
• Market Access
• Partnering
• Payers
• Payment Initiatives
• Domestic and International markets and strategy
**Investors will ask about your reimbursement strategy!
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Reimbursement Building Blocks
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Understanding How the Key Elements
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
What is Coding?
•  Coding represents the reimbursement language that
payers and providers use to communicate.
•  Its explains Who? What? Where?
» CPT
» DRG
» HCPCS
» RVU’S
» ICD-9
» ICD-10
•
Resources listed in slide notes
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Key Elements for Success
!  Reimbursement Terminology
!  Reimbursement Methodologies
!  Payment Systems
!  Health Policy
!  Contract strategies
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Incorporating Reimbursement Into Your Strategy
Pre Commercialization
•  Clinical Study Review Cost, Coverage, Coding, Payment
Assessment, Payer Mix Analysis, Payer Insights, Reimbursement
Strategy
Commercialization
•  Coverage, Coding, Payment Assessment, Publication Strategy,
Cost Effectiveness; Health Care Policy Analysis, Code
Applications** Advocacy, Payer Communication; Sales Force
Training, Tools, Reimbursement Guides
Post Commercial:
•  Targeted Payer Activities, Payor Experience Tracking, Health
Policy Updates, Advocacy, Market Updates, Reimbursement
Landscape;
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Data Criteria and Collection
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Development of the Payment Strategy
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Collecting the Highpoints to
Leverage the Payment Strategy
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Why are Studies and Data Important?
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Bring the Team Together…
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Incorporating the Economic Value Proposition
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Filling in the Gaps
•  Prioritize studies based on their costs and likelihood of
influencing reimbursement decision makers.
•  Develop a preliminary Economic Model and use it to
identify gaps in available data.
•  Share the model to verify strengths and weaknesses.
•  Develop Payer Advisory Board
•  Technology Assessment Reports- Coverage Policies
for Proxy Devices ( supports reimbursement and
direction of coding, bundling.
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Evaluate and Start the Coding Process
•  Review Coding requirements, background and
categories, including CMS and with AMA for
requirements.
•  Requirements for Pass through Payments.
•  Application for DRG add-on can be submitted.
•  CMS’s Application for New Medical Services and
Technologies Seeking Quality for Add-On Payments
under the Hospital Inpatient Prospective Payment
System.
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Four Key Strategies
There are four key strategies hospitals and physicians should use to
prepare for upcoming reimbursement changes:
1. Develop medical staff-hospital collaborations that include both
private and employed physicians.
2. Develop integrated and comprehensive continuums of specialty
care.
3. Deliberately invest in and implement clinical and functional
outcomes collection and reporting.
4. Proactively define quality with payors and pilot alternative
reimbursement models.
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Plans for Project Funding
Funding Requirements
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•
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Identify and quantify the needed funding
Pre FDA Project for *3-5 years
Post FDA Early Market entry *3-5 years
Constraints, potential leakages
Budget and plan for a “Rainy Day”
Assess resources, grants, investors, partners
Develop your “Value Proposition” Messaging
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Moving Forward…
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ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Project Plan
Develop your project plan,
Track and assess,
Work your Plan.
© Copyright 2014, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and
ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Marilyn Denegre-Rumbin, JD MBA
Director, Payor - Reimbursement Strategy
Strategy & Business Development
7000 Cardinal Place Dublin, OH 43017
614.553.4737 dir | 513.284.0677 mobile
marilyn.denegrerumbin@cardinalhealth.com
© Copyright 2014, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and
ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.
Thank you!
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© Copyright 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and
ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health.