Originally Published MX September/October
2002

GOVERNMENTAL &
LEGAL AFFAIRS

The FDA Approval
and Medicare Coverage Processes

Part I: Current Interconnections

Bradley Merrill Thompson

For U.S. medical technology manufacturers, negotiating current
government processes remains a duplicative and delay-prone exercise.

These days, when medical device executives and investors look
at the business plan for a new medical technology, one of the first things they
examine is its so-called policy risk—meaning the full range of governmental
policies that could affect the viability of the technology. Two of the key elements
of such policy risk are the uncertainties related to securing FDA approval and
obtaining Medicare coverage. As executives and investors study these elements,
they often wonder whether there is some connection between the two. If the technology
is good enough to attain FDA approval, will it be good enough to deserve Medicare
coverage?

Together, the administrative processes for FDA approval and
Medicare coverage exert significant influence over the speed with which a product