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 ----------------------------------------- CONFIDENTIALITY NOTICE: This email and any attachments may contain confidential information that is protected by law and is for the sole use of the individuals or entities to which it is addressed. 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