Clinical Trial Billing

The Eskenazi Health Research Office has a research finance and billing compliance specialist available to provide expert clinical trial billing guidance. The research billing specialist works in conjunction with the Eskenazi Health Revenue Cycle team to assist research teams with clinical trial billing.

All clinical trial billing must be billed properly and in compliance with applicable clinical trial billing laws and regulations. Any research-associated billing must be documented and verifiable, coded accurately, charged based on the actual services provided, allowable by the regulations that govern medical billing procedures, comply with all applicable contractual requirements, and be in accordance with the informed consent signed by the research participant.

Clinical trial billing compliance procedures ensure charges for patient care services such as clinic visits, treatments, procedures, lab tests, radiology services, etc. that may result in a bill, but independent of the funding source, are billed to the appropriate responsible party. This may be a third party (such as Medicare or an insurance company) or the research study sponsor. Clinical trial billing compliance ensures that you are billing the appropriate party when someone participates in a trial.

To be certain that charges are billed appropriately, a coverage analysis must be completed. A coverage analysis is a detailed review of study items, services, procedures and Medicare billing rules to determine the appropriate payer/funding source for each. A coverage analysis consists of a narrative section (memo) and a table section (billing grid).

Performance of a coverage analysis will ensure compliant clinical trial billing. A coverage analysis is necessary for all new clinical trials that have medical procedures or services provided to participants by Eskenazi Health. During the course of a study if there are changes to the protocol that impact medical procedures or services provided, the study personnel must inform the Eskenazi Health Research Office and research billing compliance specialist immediately.

In brief, clinical trial billing rules:

  • Do NOT bill for services already paid by the sponsor (double billing).

  • Do NOT bill for services that were promised free in the Informed Consent Form signed by the participant.

  • Do NOT bill for services that are for research study purposes only or are part of a non‐qualifying clinical trial.

  • Only bill for services rendered.

  • Only bill for services that have no external funding source and are medically necessary.

If you have questions related to clinical trial billing at Eskenazi Health, please call 317.880.3219. For more information related to Medicare clinical trial policies, please visit the CMS website.

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