What is a Coverage Analysis?
Coverage Analysis is a systematic review that determines how each protocol-required item/service should be billed: to the study participant/payor or to the research account. It requires a three-part process according to NCD 310.1 to determine:
- Whether a study meets Medicare’s definition of a Qualifying Clinical Trial that may support billing to a payor
- Which items/services meet Medicare’s definition of a Routine Cost
- Whether other Medicare rules allow or limit coverage for the items/services (e.g., NCDs/LCDs)
The document resulting from the review is referred to as a Coverage Analysis (CA). It is maintained in OnCore and used to direct medical center charges.
Coverage Analysis at UCSF
At UCSF, Coverage Analysis function is performed by the Office of Clinical Trial Activation (OCTA). Please see the OCTA Coverage Analysis website for additional information, including when Coverage Analysis is required, and how to request it.