Need opinions on billing for a specific device situation.  We have been
approached to perform a category B investigational device clinical trial
that involves patients presenting in our ED with a stroke.  The patient
would receive a procedure in our angio suite with the investigational
device which would be implanted for a few hours and then removed.  The
patient would then be placed in a bed as an inpatient receiving standard
of care services for stroke patients.  The Sponsor states we do not have
to apply to medicare for coverage as the Sponsor is paying for the
device and the angio suite procedure.  The Sponsor is not paying for the
standard of care services while the patient is an inpatient.  We do not
agree with the Sponsor and believe we should send in the information to
Medicare even though Medicare is not paying for the device or procedure
associated with the Device.  Medicare will still be paying the routine
costs.  Also the device should be listed as investigational when billing
with $1.00 attached to indicate provided free of charge.

What are your thoughts on sending the application for approval to
Medicare?

Kim Dunbrook-Babbie, CPA
Corporate Compliance and Audit
xxxxxx@mail.amc.edu
518-262-5496

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