Research Billing Compliance is responsible to understand, interpret, and aid in process development related to federal billing guidelines. All services provided during a study should be billed — but determining the appropriate route for billing is critical, please click here for an overview of charge routing. During the study, encounters/tests/procedures which are considered usual and customary care for a patient may be billed to insurance. Care/interventions which are being delivered only for research purposes (ie. NOT usual and customary care) are typically billed to a study fund (see below for the exception).
For a basic overview of billing for clinical research activity, please click here. For more detailed instructions about the specific process of billing for study activity, please review the Clinical Trials Billing Toolkit. This toolkit has been created to provide information and education about topics related to clinical trials billing. It explains how we determine the appropriate route for billing clinical care provided within a clinical trial and the responsibilities for charge direction and monitoring and managing of study funds.
In some specific cases (is the study is determined to be a “Qualifying Trial”), research interventions and related care may be billed to and paid for by insurance, but the study must meet very specific “Qualifying” criteria. A Medicare coverage analysis (MCA) is conducted by the Partners Clinical Trials Office (CTO) to assess whether a study is a “Qualifying Trial”, and, if so, determines which research services may be billed to insurance (note: The MCA is specific to Medicare billing, but typically the other insurers follow the MCA determination). When the analysis is complete, the investigator receives a study-specific billing summary that lists all items and services to be provided as part of the clinical trial with notations of what should be billed to the research sponsor and what can be billed to Medicare. These billing grids are a valuable tool to ensure appropriate billing. BWH Research Billing Compliance is meeting with study teams whose protocol is deemed Qualifying, click here to review slide set.
If a study is non-Qualifying, it is understood that all usual and customary patient care will be billed to insurance and all research-specific care will be billed to the study fund.
The Partners Clinical Trials Office (CTO) is responsible for conducting MCAs for Qualifying Trials. In addition, CTO offers budgeting services to Principal Investigators (PIs) for corporate-sponsored clinical research studies. For more information, see the CTO site.
In addition to Epic required trainings, which touch upon the process to route charges appropriately, we offer: several content based trainings; meet with study teams; perform internal probe, routine, and targeted audits; and work closely with Partners wide Research Administration and Epic staff to ensure compliant research billing practices.