What is 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.
Why is Coverage Analysis Important?
Coverage Analysis ensures clinical research billing compliance and protects both our institution and study participants from major consequences of improper billing. Examples of improperly billing a payor include:
- Billing for items/services that are for research-purposes only
- Billing for items/services that are already paid for by the Sponsor (double billing)
- Billing for items/services promised free in the informed consent form (ICF)
- Billing for items/services variably between study participants
If a study does not have a Coverage Analysis in place, then all clinical items/services will continue through the medical center’s standard revenue cycle processing (i.e., non-research processing). In other words, all clinical charges will continue to be automatically directed to the study participant/payor. (See next section, “How Does a Coverage Analysis (CA) Work?”)
How Does a Coverage Analysis (CA) Work?
|
No Coverage Analysis in Place (Non-Clinical Research Billing) |
Coverage Analysis in Place (Clinical Research Billing) |
|
All patients’ medical center charges automatically flow to the patient/payor. |
All study participants’ medical center charges are redirected to the Research Revenue Cycle (RRC) Team for review. The RRC Team references the CA to guide them on how to direct the charges. If an item/ service is not on the CA, then it is assumed it is not required by the study and tossed back into the medical center’s non-clinical research billing flow. |
When is Coverage Analysis Required?
Coverage Analysis Required*
The study protocol requires clinical items/services that will generate charges in UCSF’s Electronic Medical Record (e.g., APeX or Epic).
- This applies regardless of funding source
- This applies to all sponsor-paid studies
Coverage Analysis NOT Required
The study protocol does not require clinical items/services that will generate charges in UCSF’s Electronic Medical Record. For example:
- No participants will be enrolled at a UCSF (or UCSF affiliate) location
- Interview-/questionnaire-only studies
- Meta-analysis studies
- IRB-exempt studies
- Observational/prospective/retrospective chart review studies that do not require clinical items/services to be performed that will generate charges in UCSF’s Electronic Medical Record
*Pursuant to the federal Clinical Trial Policy (NCD 310.1)
Below are examples of what are considered “study-required” and “clinical items/services”:
Study-Required
(“Performed for the Study”)
- The protocol or ICF contains a Schedule of Assessments specifying when clinical items/services must be performed for study participants.
- The protocol or ICF contains language such as clinical items/services "will be performed" or "must be performed."
- The protocol or ICF states data will primarily be collected from the study participants' medical records or primary care visits. If the data are not available or are outside of the protocol-defined time windows, then the clinical item/service will be performed for the study.
- The PI performs clinical items/services at Screening to verify study eligibility as defined by the protocol's inclusion/exclusion criteria.
NOT Study-Required
(NOT “Performed for the Study”)
- A study is enrolling patients who are scheduled for kidney transplants by their primary care physicians, as specified in the inclusion criteria. The kidney transplant is not study-required, even if it is indicated in the protocol's Schedule of Events as a reference point (i.e., to collect hospital data).
- The protocol states CBC and CMP results will be collected from participants' routine care post-surgical follow-up. The CBC and CMP are not study-required.
- The protocol or ICF states an ECG may be performed only as clinically indicated (e.g., only upon adverse reactions). The ECG is not study-required. It will be performed only as part of the participants' individual clinical care to diagnose or treat their signs and symptoms; not per the requirement of the protocol.
Clinical Items/Services
- Physical exam
- Blood draw
- Laboratory assessment
- ECG
- Imaging
- Biopsy
- Archived tissue collection
- Drugs obtained from UCSF Clinical Pharmacy
- Infusion/injection/implantation of investigational item(s)
NOT Clinical Items/Services
- Study participant questionnaires
- Medical chart reviews
- Collecting AEs/SAEs or concomitant medication information
- Survival follow-up phone calls
- Collecting data from clinical procedures that are already scheduled or ongoing as part of the patients’ regular clinical care