Billing Coverage Analysis (BCA) Guidance for Research
Billing Coverage analysis (BCA) is a systematic process of developing a billing plan for a clinical research study. The BCA provides an in-depth analysis of how all the items and services listed in the clinical research protocol are billed per guidelines provided by federal agencies. Items and services are designated as bill to patient or bill to research/sponsor.
A BCA is important to ensure double billing does not occur. Double billing occurs when the study sponsor and the patient’s insurance are billed for a study procedure. The guidance provided below will help ensure double billing does not occur at UVA.
When a site double bills for a study procedure they violate Medicare billing compliance guidance and may become the subject of investigations from OIG/ OMIG/DOJ that could result in hefty financial settlements, loss of accreditations, and other various implications. Improper billing to Medicare for clinical research services can result in significant fines and can result in large public settlements.
The Centers for Medicare & Medicaid Services offers the following guidance on their website:
“Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial should likewise not be billed to Medicare. Items and services provided regularly free of charge to any segment of the study’s enrollees are not included as routine costs and are not dependent on payer type. For example, because Medicare may pay for certain costs in the study, but other payers will not and the study sponsor provides those items or services for free to those study participants, then Medicare likewise must not be billed for those items and services. Medicare’s potential willingness to pay for an item or service does not determine whether that item or service is covered. Medicare must be on a level playing field with all payer types regarding billing for the routine costs in clinical trials. The one exception to this rule is for patients who are indigent and for whom the hospital routinely offers care without payment. Services to such individuals who do not have the ability to pay and for whom the hospital policy is to provide free care would not inhibit the hospital from billing Medicare for those same items and services it has furnished to these individuals without reimbursement.”
If you have any questions about clinical research billing and BCA’s, please contact the CTU’s Clinical Research Financial Management team at somctufinsupport@uvahealth.org.