Coverage Analysis

Coverage Analysis (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 must be paid for by the study account (or sponsor). Stanford’s CA process is a requirement from SHC and SoM leadership to ensure that billing for clinical research to Medicare is compliant and aligned with industry best practices. The Harmonized CA workbook, provided to by the Ankura group, will be needed for study activation (98 Account), patient enrollment and billing. Please review the Processes and Procedures below based on your type of project.

Coverage Analysis is NOT required for studies that utilize CTRU services only. If no services will be done at SHC as part of the study, then Ankura will not need to perform Coverage Analysis.

If you have any questions regarding the Coverage Analysys process, please contact

An external consulting firm, Ankura Consulting, will complete the Coverage Analyses  for Stanford clinical research studies. Benefits include:

  • Savings in staff time/labor. Reduction of the burden of coverage analysis by the investigators and study staff.
  • Reduce billing errors and increase speed to value. Ankura’s experts will review all aspects of Coverage Analysis even the most complex studies.
  • Optimize use of funding while mitigating risks associated with the ever-changing insurance reimbursement landscape
  • Facilitate realistic study budgeting and assist with sponsor negotiations. PI input and expertise will be reflected and agreed upon in the final CA output to support these activities.

Processes and Procedures