Re: SOC vs study related costs Steinert, Bruce, W 24 Feb 2005 16:58 EST
Hi Linda, This is an interesting interpretation of 'Standard of Care'. Is your rogue department saying that they routinely inject patients with investigational drugs? Sorry for the sarcastic tone. I would not consider this a standard of care procedure unless there was an approved drug involved or other justifiable need for the IV. A few things to consider before ordering orange jumpsuits in assorted sizes. 1. The Medicare National Coverage Decision for Clinical Trials (Sept, 19, 2000) does allow Medicare to cover research related costs (including the costs of administering an investigational article) for qualified clinical trials. Note that I said 'allows', not 'requires'. This is a common misinterpretation of the NCD. See http://www.cms.hhs.gov/coverage/8d.asp for details. Check with your Medicare contractor for details and authorization to bill (special billing code modifiers are also needed, -QV, I think). As far as the insurance billing goes, your mileage may vary. Coverage will depend on the individual carrier and their contract with your institution. Some will follow Medicare's lead and others won't. Denial of coverage could get pricey for the subject's parents and messy for the institution if pre-approval of the procedure with the subject's carrier or Medicare could be inferred from the consent form. The parents do have the option to pay out of pocket for anything except the investigational drug, but that would have to be very clearly spelled out in the consent process. 2. Is the IV medically indicated for another purpose (e.g., hydration, electrolyte balance, etc) unrelated to the administration of the investigational drug? If so, the research could be piggy-backed through the side port and the rest billed as SOC. However, that doesn't seem to be the case. Hope that helps, Bruce Steinert, PhD, CCRA Director, Clinical Trials Administration The Children's Mercy Hospital Kansas City, MO -----Original Message----- From: Linda Ward [mailto:xxxxxx@CHILDRENSHC.ORG] Sent: Thursday, February 24, 2005 1:40 PM To: xxxxxx@HRINET.ORG Subject: [RESADM-L] SOC vs study related costs Hello folks - I've got a clinical trial question for you. We have a rogue department trying to say that while the study drug is obviously study related, the method to inject the drug (IV, conscious sedation (for babies/children), etc.) is standard of care and the department is trying to bill insurance/medicare for these costs. To me, this seems inappropriate. The rationale provided by the department is that in the absence of the study drug, the patient would have received a non-study drug, and so the method of injection should be SOC (standard of care). 1. What are your opinions on this situation? 2. Can anyone cite a source backing up their viewpoint? Thank you all for any input you can provide!! Linda Ward, MBA Sr. Accountant Research Administration 35-123A Children's Hospitals and Clinics 2910 Centre Pointe Dr. Roseville, MN 55113 651-855-2603 651-855-2690 Fax email: xxxxxx@childrenshc.org __________________________________ Confidentiality Statement: This email/fax, including attachments, may include confidential and/or proprietary information and may be used only by the person or entity to which it is addressed. If the reader of this email/fax is not the intended recipient or his or her agent, the reader is hereby notified that any dissemination, distribution or copying of this email/fax is prohibited. If you have received this email/fax in error, please notify the sender by replying to this message and deleting this email or destroying this facsimile immediately. ====================================================================== 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") ======================================================================