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Investigational / Device (Q0): Investigational clinical service provided in an approved clinical research study

• Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) under Medicare.

Routine (Q1): Routine clinical service provided in an approved clinical research study

• Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers); and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function).

BILLING RECONCILIATION IN EPIC: If a study patient has a procedure, encounter, or other charge entered in EPIC that was determined to be "Study Related - Bill to Insurance/Patient" on the UVA Study Billing Coverage Analysis, a study coordinator will need to associate the event with the study in EPIC and then reconcile the resulting charge(s) by indicating "Bill To: Patient/Insurance" and selecting one of the two above modifiers ("Routine" or "Investigation/Device").

A screen shot from EPIC is provided below.