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Coverage Analysis

An independent review of healthcare billing in clinical studies

Coverage Analysis Protects Patients, Investigators, and Our Institution

Principal investigators (PIs) are ultimately responsible for ensuring that all billing practices associated with their studies are conducted in compliance with relevant regulations, institutional policies, and sponsor requirements. Indiana University and IU Health require that a Coverage Analysis has been completed prior to patient enrollment. The OCR Financial Compliance Team provides support and guidance to researchers and their staff by performing this required review.

A Coverage Analysis is a thorough review of clinical trial protocols, contracts, and other study documents to determine the appropriate billing mechanisms for research-related services and items. This involves assessing whether services are billable to third-party payers, such as Medicare, Medicaid, or private insurance, or should be covered by the research sponsor. This review is critical for identifying and mitigating risks related to clinical research billing, including potential overbilling, underbilling, or billing for non-covered services.

The Office of Clinical Research for Indiana and IU Health require a Coverage Analysis for all clinical research protocols where items or services are potentially billable to a third-party payer. This review ensures compliance with federal regulations, such as the Medicare Clinical Trial Policy, and helps prevent billing errors. Additionally, it ensures that research costs are appropriately allocated and that billing practices are consistent and transparent. Overall, a Coverage Analysis is crucial for maintaining the financial integrity of clinical research studies and ensuring compliance with regulatory requirements. You can find related policies on the OCR Policies Page.

Document Alignment

When a clinical research study is submitted to the OCR and requires a coverage analysis, document alignment is included as part of the coverage analysis performed by the OCR Coverage Analysis Team. If a study does not require a coverage analysis, the study team is responsible for working with the IRB and contracts office, as applicable, to ensure that the essential study documents are aligned.

A document alignment review compares essential study documents to confirm consistent language. These documents may include the study protocol, informed consent documents, and contract and budget documents, when applicable. The review focuses primarily on consistency in financial responsibility and cost language and confirms that the language complies with university guidelines and federal regulations governing clinical research billing.

An initial review should occur while the documents are still in draft form so revisions can be made without requiring amendments to finalized consent or contract documents. If inconsistencies are identified, they should be addressed before the documents are finalized. A final review should then confirm that all issues have been resolved, and the final documents are aligned. The following items are primary considerations during document alignment:

  • Are procedures clearly and consistently designated as sponsor paid or billable to the patient within the coverage analysis, contract, budget and informed consent form (ICF)?
  • Are additional costs to the patient clearly identified in the ICF?
  • Is participant compensation consistent across the contract, budget and ICF?
  • Does the contract, budget or ICF contain any language that may violate the Medicare Secondary Payer policy? Is there conditional payment language?
  • Has responsibility for subject injury been appropriately assigned and is it consistent between the contract and ICF?

Completing the document alignment process helps ensure that applicable financial responsibility and cost language is consistent across the informed consent form, clinical trial agreement, budget, coverage analysis, and other essential study documents before they are finalized.

For guidance on research-related injury payment responsibility, conditional payment language, acceptable exclusions, and required alignment between the informed consent form and clinical trial agreement, refer to the Policy on Conditional Payment Language and Research-Related Injury in Industry-Sponsored Clinical Trials. This guidance should be used when reviewing applicable study documents to ensure consistent and compliant language.