Approved or 510K Cleared Devices
This study category includes studies of devices that are approved or have been cleared for market under the 510K process. The device must be used according to the Instructions for Use manual. If the study objective is for an indication not covered in the IFU, then the protocol must be reviewed for IDE Significant Risk or IDE Non-significant risk determination. Assistance with IDE determinations and submissions can be found at https://tracs.unc.edu/index.php/services/regulatory/ind-and-ide-application-support/investigational-device-exemptions
UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:
Who will pay for procedures and services listed in the protocol of your research study?
| Payer | Definition | Required BCA Worksheets |
|---|---|---|
| Bill to sponsor only. | Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor. |
|
| Bill to sponsor and patientʼs insurance. BCA Fee Required: $2,000.00 (Except for Federally funded studies.) | Procedures/Services are being done for a mix of research and routine care purposes only. This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance. |
|
| Bill to patientʼs insurance only. | All procedures/services are routine care. |
|
| There is nothing to bill. | Study team effort only, no billable procedures/services. | BCA Worksheet completion is not required. HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu. |
Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.
Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. The National Coverage Determination (NCD 310.1)-final determination requires the study to meet specific criteria in order for you to be able to bill any services to the patient or a third party. Documentation of qualified status is determined by completing the top section of this worksheet. Complete the bottom section pertaining to device studies. You do not have to complete the center section pertaining to drug/biologic studies. If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.
Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.