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Office of Research Administration

Clinical Trial Billing: What's New

Training

Did you know that effective January 1, 2012 a COVERAGE ANALYSIS (CA) needs to be created by you and submitted to the Research Billing Compliance Manger, Deb Temple for all new studies meeting the following requirements?

Required for any research study that interacts with subjects when that interaction could generate a charge such as a clinic visit, lab draw, EKG, x-ray, CT, MRI, etc…Under the current Medicare rules, there is no way around reviewing the details of each research study in order to find out what is billable to Medicare and what is not!

Kelly Willenberg, an outside consultant, held training sessions on how to complete the COVERAGE ANALYSIS early in October 2011 and we have posted the sessions on the Research Administration website for reference, but for anyone who would like more in-depth instruction, Deb Temple will be holding training sessions on Thursday mornings, from 8-9:30 in the Aldrich 5 conference room.

Bring your study information (protocol including a schedule of events, external budget, draft informed consent, etc...) and she will take you through the process. The CA TEMPLATE we will be using can be located on our website along with the QUALIFYING CLINICAL TRIAL (QCT) DETERMINATION FORM.

What's New

The first change will be the requirement to complete an ENROLLMENT FORM for all subjects enrolled into studies which will utilize any Lifespan service including a onetime blood draw from a Lifespan lab, EKG’s, MRI, x rays, CT scan, etc..Any service that would generate a charge (even is your study is paying for the service).  A separate form needs to be filled out for each subject at the time of enrollment, withdrawal and completion of the study. The forms will be online and can be filled out electronically and sent to the billing manager dtemple@lifespan.org , or a hard copy can be completed and FAX’d to x46895 at the time of enrollment! This is mandatory effective November 1, 2011.

You will still be required to complete ENCOUNTER FORMS for each and every Lifespan service a subject obtains.  Please use the newest version of the ENCOUNTER FORM which will capture information regarding the visit number (Example: screening, baseline, visit 1, cycle 4-day1).

The second change, creation of a COST ANALYSIS (CA) will be effective January 1, 2012 for all new studies submitted to the Office of Research Administration meeting the following requirements. This will be required for all research studies that interact with subjects when that interaction could generate a charge (clinic visit, lab draw, EKG, x ray, etc...) Under current Medicare rules, there is no way around reviewing the details of each research study in order to find out what is billable to Medicare and what is not! Communicating this information to the ORA is the cornerstone for research billing compliance.  

Kelly Willenberg, an outside consultant from Synergism held trainings during the week of October 4-6, 2011 to help prepare us for completing the Coverage Analysis. These sessions are posted on our website for new hires and anyone who was not able to attend our recent two day seminars or maybe just to refresh your memory.

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