Clinical Trial Billing Requirements

Date Issued: 9/7/2018

According to a Centers for Medicare & Medicaid Services (CMS) policy, any service identified as part of a clinical trial must be billed with modifier Q0 (Investigational clinical service provided in a clinical research study that is in an approved clinical research study), or Q1 (Routine clinical service provided in a clinical research study that is in an approved clinical research study).

The billed service must also be accompanied by ICD-10 code Z00.6 (Encounter for examination for normal comparison and control in clinical research program) on the claim. Failure to include the requisite diagnosis will result in claim denial.

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