Thank you for all of your responses.  We are going to continue to take
the conservative approach and submit the clinical trial to Medicare for
approval.  The sponsor is giving us a hard time so we wanted to make
sure we were not the only Insitution interpreting this type of clinical
trial as a submission to Medicare.

Kim

>>> xxxxxx@AURORA.ORG 02/08/2006 3:26:21 PM >>>
I conferred with our Medical Audit Department, with whom we resolve
these
types of issues as part of contract/budget negotiation and I've
included
their comments below.  We believe that  ALL devices have to go to the
fiscal intermediary regardless of whether the sponsor is providing them

free or not.  I will acknowledge that we are very conservative on these

types of issues, and almost always submit to CMS.

405.211 Procedures for Medicare contractors in making coverage
decisions
for a non-experimental/investigational (Category B) device.
(a) General rule. In their review of claims for payment, Medicare
contractors are bound by the statute, regulations, and all CMS
administrative issuances, including all national coverage decisions.
(b) Potentially covered non-experimental/investigational (Category B)
devices. Medicare contractors may approve coverage for any device with
an
FDA-approved IDE categorized as a non-experimental/investigational
(Category B) device if all other coverage requirements are met.
(c) Other considerations. Medicare contractors must consider whether
any
restrictions concerning site of service, indications for use, or any
other
list of conditions for coverage have been placed on the device's use.

This one sounds like it is going somewhere in the cranial vasculature.

Medicare has restrictions for some of these vessels.
Sponsors rarely take responsibility for injuries.

http://www.washingtonwatchdog.org/documents/cfr/title42/part405.html#405.201

Here is the link to the policy as published in the Federal Register.

 It says that the FDA reports all IDE# devices to CMS (which means that

the FI always can go into that file at CMS and get more information.
This
of course is a restricted file).

Category B devices are the least risky.  We bill them at cost.  If
provided by sponsor or non-covered we would bill with the $1.00 as
stated.
The next question is the PROCEDURE approved. If the procedure is not
covered, then complications of that procedure would not be covered
during
that visit. Complications treated at subsequent visits would be
covered.

Stroke care of course is SOC and payable by Medicare. So in the event
of a
complication from the device placement, care that is standard for stoke

patients would continue to be covered even while care related to the
complications of a non-covered procedure or device would be
non-covered-
and non-billable.

Geoffrey Schick
Manager, Research Contracts & Business Operations
Department of Clinical Research
Aurora Health Care
Ph: 414.649.5903
Fx: 414.649.5042

Kim Dunbrook-Babbie <xxxxxx@MAIL.AMC.EDU>
Sent by: Research Administration List <xxxxxx@HRINET.ORG>
02/08/2006 06:57 AM
Please respond to
Research Administration Discussion List <xxxxxx@HRINET.ORG>

To
xxxxxx@HRINET.ORG
cc

Subject
[RESADM-L] Medicare Device Trials

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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