Coverage Analysis

Coverage Analysis (CA) allows us to do a systematic, objective review of study related documents to determine which items or services are billable and to whom: the insurer; sponsor or patient.  

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Defining Coverage Analysis (CA)

When preparing a CA, we are trying to determine the study's underlying eligibility for coverage. We review clinical events specified in the protocol to decide which can be reimbursed by Medicare/Medicaid or insurance and which should be covered by the research sponsor.

For example, a CT scan could be part of standard care for a patient enrolled in a clinical research protocol and therefore billed to his or her insurance. However, if it is deemed that the CT scan is being done only because of the patient's participation in the research study, then it should be reimbursed by the research sponsor.  

CA Questions

Rosanne Johnson, Clinical Research Budget & Coverage Analyst

(716) 888-4844

Why do we need coverage analysis?

If clinical research includes tests, procedures and interventions that potentially could be billed to third party payers such as insurance companies and Medicare/Medicaid, then you must have a coverage analysis. This is essential to ensure appropriate billing and to avoid double billing. Inappropriate or improper billing can have serious financial and legal consequences for the institution, the research team and the sponsor.

Whom do we work with to complete a coverage analysis?

For questions regarding coverage analysis, contact: Rosanne Johnson, Clinical Research Budget & Coverage Analyst

How do we complete a coverage analysis?

The investigator and staff complete the initial coverage analysis (protocol billing grid) and submit it to the CRO for review and approval. You would need to include:

  • Coverage Analysis checklist
  • Protocol
  • Consent form 
  • Budget
  • Contract (if applicable)
  • Miscellaneous documents (FDA approval letters etc.) 

The UB CRO will work closely with investigators/staff during CA review so that the final document reflects their expertise and insights.

How much time does it take to complete a coverage analysis?

Completion time depends on complexity of the study being performed. In most instances, it takes about one to two weeks to complete a coverage analysis.

Notes / Additional References

Coverage Analysis Checklist and Coverage Analysis Billing grid (Excel) are located at:

The Clinical Research Coverage Analysis Policy document is located at: