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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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5.6 Reimbursement Strategy

Introduction
A significant proportion of the recent growth in the United States government’s total healthcare budget can be linked to the proliferation of just two medical devices: implantable cardioverter defibrillators and drug eluting stents.1 With medical devices playing an increasingly prominent –; and expensive –; role in patient care, public and private payers are more rigorously scrutinizing new technologies. The current trend is to provide reimbursement for new devices only if the evidence supporting their use is overwhelmingly strong. In fact, it has reached the point where the most serious hurdle faced by new medical technologies is not gaining approval from relevant regulatory bodies, but obtaining favorable ...

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