Step-by-Step Reimbursement Process for Drugs & Medical Devices

Activity Description Phase May Impact
1. Reimbursement Landscape
a. Money flows and financial incentives
b. Reimbursement mechanisms
c. Decision makers and strategy
 R&D
Features and applications
Predicate device / intended use
Price
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2. Reimbursement Planning
a. Value story
b. Economic model
c. Support of clinical data
d. Feedback from decision makers
 Pre Clinical
Clinical study protocol
Business case
Market size
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3. Implementation
a. Billing guide/Dossier
b. Support of local medical community
c. Prior authorizations and denial appeals
d. Pilot projects with individual payors
e. Funding of clinical study by payers
f. New reimbursement mechanisms
 Pre Sales
Time to market
Revenue
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