Primary Designations
Tells you how the procedure/event will be paid for
PR = When a study procedure is going to be paid for by the study budget, it is marked with the "Pure Research" designation.
RC = When a study procedure is not going to be paid for by the study budget and has been deemed as billable to patient/insurance, it is marked with the "Routine Care" designation.
Common Supporting Designations
Tells you how or by whom the procedure/event will be performed
HSU = When a study procedure will be ordered in Epic or requires hospital involvement, it is marked with the "Hospital Service Utilization" designation.
OFF = When a study procedure will be sent or performed at a central study lab or a non-Rutgers entity, (i.e., Covance or Univ. Radiology Group), it is marked with the "OFF" designation.
CRSE = When a study procedure is performed by research staff and has no risk of being billed to the patient/insurance (such as I/E assessment or questionnaires), it is marked with the "Clinical Research Staff Effort" designation.
DATA = When a procedure has been performed for routine, clinical reasons unrelated to the study, but the protocol asks for the resulting data to be collected, it is marked with the "DATA" designation.
Additional Codes & Modifiers Required by CMS for
Clinical Research Claims
Disclaimer: Don't worry, in most cases, you won't need to commit
this information to memory, but it is important to understand
the rationale and concept behind these clinical research regulations!
For Medicare qualified clinical studies that have study procedures marked as RC, CMS requires one of the following codes be listed to identify if CMS is paying for (1) a routine procedure (common) or (2) an investigational procedure (rare).
Q0 = Investigational clinical service provided by CMS in a clinical research study that is an approved clinical research study.
Q1 = Routine clinical service provided by CMS in a clinical research study that is in an approved clinical research study
Why are you telling me this?
Fortunately, OnCore sends the Designations and Modifiers for each study to Epic and the hospital billers automatically, but, first, the research nurse or coordinator needs to confirm this for each patient/procedure via Epic's Research Charge Review module.
Then, when hospital billers receive your confirmation, they'll do one of the following:
- If PR: remove the charge from the patient chart and invoice the study team/department
-
If RC1 (RC+Q1): file claim to bill Medicare as a routine procedure that is study-related
-
If RC0 (RC+Q0): file claim to bill Medicare as an investigational procedure, but ONLY as permitted by CMS regulation