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 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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