Coverage Analysis

Stanford Medicine’s Coverage Analysis (CA) process is a requirement from Stanford Health Care (SHC) and School of Medicine (SoM) leadership to ensure that SHC billing for clinical research to Medicare is compliant and aligned with industry best practices.

CA is a formal review of study documentation and Medicare billing rules to determine which items and services performed as a part of a clinical research study may be legally billed to insurance, and which items and services must be paid for by the study account (i.e. sponsor). 

For industry funded clinical research, CA is a necessary component at study start-up as it informs how to reflect hospital costs within our site’s study budget and protects us from compliance concerns like double billing.  CA is also a necessary component for all other externally funded clinical research projects prior to starting the study.

Huron Consulting Group (Huron), an external consulting firm engaged by SHC, will complete the CA for Stanford clinical research studies. This transition occurred in August of 2023. A Workbook with a CA Billing Grid prepared by Huron in partnership with RMG is required for study activation (98 Account), patient enrollment, and billing. Please review the Processes and Procedures below based on your type of project.

CA is NOT required for studies that only utilize CTRU services. If no clinical services will be done at SHC as part of the study, then Huron will not need to perform CA. Studies are in scope for CA if they are externally funded and require patient care services billed through SHC (SCH services go through a different process).

If you have any questions regarding the CA process for non-cancer industry funded clinical research studies, contact your assigned CT RPMs.
For industry funded cancer clinical trials, please reach out to SCI-CTO.  
For CA process questions regarding all other externally funded clinical research projects, contact RMG_Grants_HelpDesk@stanford.edu.

Benefits of Huron CA include:

• Reduced billing errors and increased speed to value. Huron’s experts will review all aspects of CA for even the most complex studies.
• Optimized use of funding while mitigating risks associated with the ever-changing insurance reimbursement landscape.
• PI input and expertise will be reflected and agreed upon in the final CA output to support these activities.