Clinical Trial Coverage Analysis, Billing & Budget

Last revised: 

What is a Coverage Analysis?

Leading institutions use a formal Coverage Analysis process to ensure compliant clinical research billing (CRB). A Coverage Analysis identifies all clinical items or services associated with a particular clinical trial, including identification of the financially accountable party, such as the trial sponsor, other funding source, patient, or a third party payor. The outcome of the Coverage Analysis process is sometimes called the “Billing Grid”.

Coverage Analysis Requirements at UCSF

As of June 1, 2013, all new studies at UCSF were required to receive Coverage Analysis before study activities begin. You will still need to do this even if you believe your study will not have any items or services that are or might be invoiced to Medicare. Coverage Analysis is necessary for all clinical research projects that have medical procedures or services provided to subjects at UCSF.

Who Needs it? ALL new clinical studies/trials done on human subjects at UCSF in which there are medical procedures.

Why is it Needed? Performance of a coverage analysis will ensure compliant clinical research billing. Location and provider information may impact billing designations, so that is collected upfront from the study team by the Office of Clinical Research (OCR). CTSI's Clinical Research Services also needs the same “who & where" information to develop a service quote.

Who Will Perform Coverage Analysis for My Study? All clinical research has coverage analyses performed by the Office of Clinical Research (OCR).

Coverage Analysis Costs

Study Type Fee
NIH-sponsored studies (or other nonprofit agencies) No charge
PI-initiated studies No charge
Industry-sponsored studies $2,800
Protocol amendments $1,000

Coverage Analysis fees include the administrative cost of developing a compliant billing grid in the UCSF Clinical Trial Management System (CTMS), which involves review of clinical trial documents, NCDs, LCDs and conventional care guidelines in order to determine the appropriate billing status for services within the trial.

Questions Regarding the Coverage Analysis Process? Contact the Office of Clinical Research (OCR) at [email protected] or call 415-514-4998

OnCore and Coverage Analyses

OnCore (Online Collaborative Research Environment) is the current system of record for Coverage Analyses performed on trials conducted at UCSF. OnCore provides a secure, standardized, and reportable database, and permits efficient sharing of protocol information between the Study Team and the Coverage Analyst. For clinical trial services performed at UCSF Medical Center, OnCore also retains information that will be used for the APeX study build.

Effective July 1, 2014, the Office of Research requires ALL clinical trials and human subject research protocols in which there are medical procedures to have a Coverage Analysis completed in OnCore. This directive includes both new and legacy studies.

Once the initial billing grid recording the service provider and location for each protocol service is completed for your new study, the Clinical Research Services group can provide costing estimates.

Submission Questions? Contact the Office of Clinical Research (OCR) at [email protected] or call 415-514-4998