As an interesting update to the saga with the Sponsor.  The sponsor had
their outside contracted reimbursement consultant send us a letter
stating that we did not have to contact the FI or notify Medicare of the
Investigational Device because we would not be seeking reimbursement
from Medicare for the services related to the clinical trial.  The
Sponsor is paying for the clinical trial related services.  In addition,
The reimbursement consultant stated that as far as adverse events
Services furnished to address medical complications arising from the use
of the device (and that are not incident to normal recovery) may be
covered.   Since the reimbursement consultant can not protect us from
Medicare if they disagree and see this differently we are still not in
agreement and will proceed with the application to Medicare.
Anyone else had experience with a Sponsor this aggressive over Medicare
submission issues?

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

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