Research Billing Compliance
BILLING COVERAGE ANALYSIS
In order to comply with federal, state and institutional regulations and standards for clinical trial billing, the University is responsible for establishing effective processes to ensure that all services for a study are billed properly. These processes can be complex because clinical trials often involve multiple entities that are responsible for costs incurred during the course of a trial. During a single visit a research participant may receive routine medical care in addition to services or procedures conducted purely for research purposes.
The purpose of the Billing Coverage Analysis is to determine deemed and qualifying status as well as which routine care costs may be billed to Medicare or other insurers and which costs must be paid by the sponsor. The BCA is required to be performed prior to the initiation of the clinical trial to ensure proper billing of services and financial feasibility.
The BCA process is completed by downloading the BCA spreadsheet available under the “Submissions” tab of the CRMS protocol record home page. Use the table below to determine which worksheets require completion 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 patient’s 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 patient’s insurance.
|Bill to patient’s insurance only.||All procedures/services are routine care and would be done whether or not the participant was in the trial.||
|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 email@example.com
|*Routine Care is defined as the procedures/services that would have been provided to the research subject were they not participating in the clinical research.|
Links and guidance documents to help in building the coverage analysis:
- CITI Training: Clinical Trial Billing Compliance: https://www.citiprogram.org/index.cfm?pageID=14
- BCA Tip Sheets and Power Point presentation: https://irbis.research.unc.edu/crms/researchcentral/
- Medicare coverage for clinical trials (310.1), benefit categories: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=BAABAAAAAAAA
- CMS Clarification of Medicare Payment for Routine Costs in a Clinical Trial: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se0822.pdf
- CMS Approved IDE studies: https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html
- CMS Medical Devices policy: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c14.pdf
- NCCN practice guidelines: https://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site
- Lab test information, McLendon Labs: http://www.uncmedicalcenter.org/mclendon-clinical-laboratories/