Reimbursement Advocacy in Todays US Healthcare Environment

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Reimbursement Advocacy in Todays US Healthcare
Environment

• Edward J. Dougherty
• Senior Vice President
• March 11, 2008

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Were seeing an innovation arms race . . .
Development is outpacing regulations by 2-3
years.

• The rapid pace of innovation presents increasing
  opportunities to improve the quality, efficiency
  and effectiveness of patient care at reduced cost
  
• Industry, provider and patient interests may be
  aligned
• Regulators appear to resist innovation
• E.g., What is clinical impact of higher
  resolution imaging?
• Payment policy is set by precedent
• Payers must balance cost, quality and access
• Accountability to their own customers (employers
  and the public)

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Innovation in medical technology challenges the
healthcare system to develop new paradigms

• New product classes, new modes of action, new
  treatment settings, etc. . . may require
• Different regulatory pathways
• New approaches to payer assessments
• Novel evidence development strategies
• Persuasive advocates for marketing clearance,
  coverage and payment
• In this environment, we just need a new code is
  not sufficient

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The business of innovation has tended to occur in
silos, disrupting the value chain
Sales Marketing Customer interaction Coverage Co
ding Payment Appropriate Patient access
Discovery Development Proof of Concept IP
Protection Investors Regulatory
strategy Marketing clearance
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Aligning the value perception across stakeholders
enhances product success
Regulatory Agencies
Professional Societies
Payers
Broad Access, Appropriate Coverage and Payment in
Key Markets
Practicing Providers
Congressional Allies
Compliant Manufacturer Support
State Advocates
Patient Groups
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Stakeholders perceptions of product value will
differtargeting value messaging is key to success

• Statistically significant improvement in clinical
  outcomes
• Is statistical difference clinically relevant?
• Significantly improved clarity in diagnostic
  imaging
• Does superior diagnostic improve clinical
  decision-making?
• Cost-effective management of chronic condition
• Will patient be with payer long enough to realize
  savings?

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Targeting value messaging is key to success

• Shorter, more efficient procedures
• Can provider increase throughput in OR?
• NexGen alternative to existing therapies
• Is product less expensive than current
  alternatives?
• Simplify procedure, move from specialist to PCP
• Site of service restrictions? Will specialists
  agree?
• Improved quality of life
• Does treatment
• increase survival or decrease pain?
• enhance productivity?
• move from institutional to community-living?

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Appropriate access and payment are more likely to
result from aligned perceptions of value
Coordinate regulatory and reimbursement efforts

• Review evidence needs
• Evidence for market clearance and payer review
• Peer-reviewed publications
• Reasonable requirements given time and budget
  constraints
• Understand the coverage environment you will
  enter
• Evidence requirements are growing
• Payers may conduct technology assessments
• Plan (not too) early meetings with decision
  makers to gauge responses, identify/fill gaps
• Consider coding options
• Will existing code(s) be appropriate?
• If not, develop interim plan

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The value of innovation drives engagement in
reimbursement advocacy
Proactive address problems before they arise
manage trends
High
Differential Value
Reactive act when problems arise
Low
Low
High
Innovation
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The senior leadership team should own
reimbursement advocacy

• Ensure regulatory and reimbursement teams work
  closely together from beginning of product
  development
• Understand differing interests of key
  stakeholders
• Target and respond to specific requirements
• One size does not fit all, can be
  counter-productive
• Dedicate sufficient attention to evidence
  development
• Practicing clinician interaction
• KOLs, professional society members
• Treatment guidelines
• Blinded payer interviews
• Informal payer meetings
• Refine publication/communications cascade
• Dont underestimate the power of the patient

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Effective reimbursement advocacy is more like a
marathon than a sprint. . .

• Emerging ethical guidelines provide guard
  rails, but these allow for appropriate,
  effective interaction
• Publications
• Clinical experience
• Clinician and patient

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• Edward J. Dougherty
• Senior Vice President
• BD Consulting
• 805 Fifteenth Street, NW
• Suite 700
• Washington, DC 20005
• 202-312-7425
• Edward.Dougherty_at_BakerD.com
• www.bakerdconsulting.com