Introduction to Clinical Research Billing


There are three basic clinical research billing scenarios:

A.   Study related clinical services are paid by the study.This could be an industry sponsor, grant, or the department.No clinical services on the study are billed to the research subject or his/her insurer.

B.  Study related clinical services are standard of care and would be provided to the research subject even if not on a clinical research study. These services are typically billed to the research subject or his/her insurer, but can be paid by the study sponsor if contractually agreed upon.NOTE:A sponsor must agree to pay for specific standard-of-care services for ALL study patients.It is not allowable for a sponsor to agree to pay only when insurances does not.

C.   Mixed services.Some of the study related  clinical services are standard of care and paid by insurance or the research subject, and some are performed for research purposes only and paid for by the study.

Compliance Risks

There are four primary compliance risks associated with clinical research billing:

A. Billing for clinical services that are being paid for by the study;
B. Billing for clinical services that are promised free in the study consent;
C. Billing for clinical services being performed for research purposes only; and
D. Billing for clinical trial services under the Center for Medicare and Medicaid Services (CMS) Clinical Trials Policy National Coverage Determination (CTP NCD) that do not meet the criteria for a qualifying clinical trial.

CMS is clear that institutions must have policies and procedures in place to ensure billing for clinical research services is compliant with federal rules and regulations.


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