At UCSF we use a formal Coverage Analysis (CA) process to ensure compliant clinical research billing. A CA is necessary for all clinical trials involving interventions in which any items and services are or may be invoiced to the patient insurer(s) or Sponsor. Any clinical research on human subjects submitted to the Institutional Review Board (IRB) will be analyzed to determine whether a CA will be required.
To learn more about the importance of Coverage Analysis, watch our Introductory video on the Coverage Analysis Resources page.
If you have questions about Coverage Analysis, please contact Cynthia Vera, Supervisor for Coverage Analysis.
What is Coverage Analysis?
Coverage Analysis is an independent review of a human research study to determine which clinical procedures and services are billable to insurance and which are not. It is a systematic review of clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) to determine the billing status of items and services that are documented in the research protocol and/or research plan.
When the analysis is complete, the investigator receives a study-specific billing summary that lists all items and services to be provided as part of the clinical trial with notations of what should be billed to the research sponsor and what can be billed to insurance based on Medicare rules. These billing grids are a valuable tool to ensure appropriate billing.
Why is Coverage Analysis Important?
Coverage Analysis is important for many reasons including:
- Facilitating Billing Compliance
- Mitigating Risks
- Avoiding billing errors
- Assisting in budget negotiations
Not having good Coverage Analysis procedures and structure in place may present organizational and individual risks. Improper billing can have severe consequences, including civil and criminal penalties.
Additionally, if a Coverage Analysis is performed early in the contract negotiations with the sponsor, a coverage review can also have the added benefit of helping either the PI or the study staff negotiate an accurate budget with the sponsor.
Who do I contact for a CA request and for questions regarding the CA process?
- For CA requests, contact the Operations Team: [email protected] / 415-514-4998
- To escalate intake requests, email [email protected]
- For other questions, contact the Supervisor for Coverage Analysis: Cynthia Vera/415-857-4253
What is the cost for my Coverage Analysis?
There is a cost associated with your coverage analysis. Coverage Analysis Fee includes the administrative cost of developing a compliant billing grid for all studies, whether billed to insurance or all fully funded by the Sponsor, for use in the UCSF Clinical Trial Management System (CTMS), OnCore.
|
Study Type |
Fee |
|
NIH Sponsored Studies (or other nonprofit agencies) and PI initiated studies |
No Charge |
|
Industry-sponsored studies |
$2,800 |
|
Protocol amendments |
$1,000 |