Good summary, I am in agreement with Bruce. J.T. Matthews RRT, MBA Director, Clinical Trials Office Stokes Research Institute Children's Hospital of Philadelphia 34th & Civic Center Blvd., Suite A-230 Philadelphia, PA 19104 >>> xxxxxx@ENH.ORG 02/08/06 10:33 AM >>> 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 ----------------------------------------- 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. If you are not the intended recipient, please notify the sender by replying to this email and destroying all copies of the communication and attachments. Further use, disclosure, copying, distribution of, or reliance upon the contents of this email and attachments is strictly prohibited. To contact Albany Medical Center, or for a copy of our privacy practices, please visit us on the Internet at www.amc.edu. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ********************************************************************** This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the West Penn Allegheny Health System Help Desk at 412 330-4357. This footnote also confirms that this email message has been swept by MIMEsweeper for the presence of computer viruses. ********************************************************************** ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
