Hi Kim, Donna, et al.
I think another piece of information is needed before ruling here. To
recap (please let me know if I am missing something):
1. A Medicare eligible patient presents for a covered benefit, so absent
the investigational device, CMS would be billed?
2. The sponsor is paying for the investigational device (category B) and
procedures to implant and explant the device? Since the sponsor is
paying, these should not be billed to CMS (even with a Cat B
designation).

The missing piece is what to do about coverage for adverse events. If
the sponsor has agreed to cover AEs, then it has assumed primary
coverage responsibility and I think you would be safe in not contacting
CMS in advance for either the device related costs or any resultant AEs.
If not, then contacting your local contractor or FI, would be the only
way to get CMS buy-in and an absolute must.

Now the disclaimer: since quick call to your contractor or FI to get
their opinion on a CD would not be a bad idea. At least you'll get
documentation one way or another.

Good luck with the study.

Bruce

Bruce Steinert, PhD, CCRA
Administrative Director, Clinical Trials Center
ENH Research Institute
Evanston Northwestern Healthcare

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On
Behalf Of Donna Creese
Sent: Wednesday, February 08, 2006 8:10 AM
To: xxxxxx@HRINET.ORG
Subject: Re: [RESADM-L] Medicare Device Trials

It is required to be sent to Medicare for coverage determination.
Follow the CMS (previously referred to as national coverage determine
guidelines) guidelines that came out in August 2003.  The website is
www.cms.hhs.gov/medlearn/matters.

Donna Creese, CCRP
Grants Specialist
Office of Sponsored Research
Allegheny Singer Research Institute
Phone:  412/359 4026
Fax:  412/359 3151
xxxxxx@wpahs.org

-----Original Message-----
From: xxxxxx@MAIL.AMC.EDU
Sent: Wednesday, February 08, 2006 7:57 AM
To: xxxxxx@MAIL.AMC.EDU; xxxxxx@HRINET.ORG
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 investigationa!
l 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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