Non Significant Risk Devices
This study category includes studies of devices which have not been approved or have not been cleared for market under a 510K clearance. There may or may not be an IDE non-significant risk designation assigned by the FDA. These studies are subject to abbreviated FDA IDE regulations. CMS billing regulations apply if you plan to bill the device or any routine services associated with the study to the patient (see Deemed and Qualifying worksheet instructions below).
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. Documentation of qualified status is determined by completing the bottom section of this worksheet. You do NOT have to complete the top or center sections of the worksheet.
Approval to bill items and services related to IDE NSR studies is determined by the local Medicare Administrative Contractor (MAC): Medicare Benefit Policy Manual, Chapter 14, section 30. The MAC for NC is Palmetto. The PI will have to submit for approval to bill for the device and/or routine items and services providing the same information to Palmetto as is required to be submitted to CMS for IDE significant risk devices: https://www.cms.gov/Medicare/Coverage/IDE/index.html. For assistance with submitting to Palmetto, contact Daniel Wayland (Daniel.Wayland@unchealth.unc.edu). When you receive the billing determination, Please upload the letter into CRMS. If the determination is via email, please convert to a pdf file and upload. 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.