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.
Reviews and Approvals
For OnCore Entry & Coverage Analysis Review as well as IRB Approval, please click on the links below.
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.
Studies submitted for entry into OnCore through the IU Office of Clinical Research Protocol Submission Form are automatically assessed by the OCR Financial Compliance Team, or delegated individuals within the IU Simon Comprehensive Cancer Center Clinical Trials Office (CTO). When Coverage Analysis is required, it is documented directly in OnCore.
Note: The link for the OCR Submission Form above is the same as the Initiate Study / Submit Protocol button in the right-hand column.
The OCR encourages a parallel process for new study start-up reviews. As shown on the process map below, you should submit your study for OnCore Entry and Coverage Analysis review at the same time that you are routing your contract and submitting to the IRB.
First Time Submissions
If you have not submitted a study through the IU Office of Clinical Research Protocol Submission Form before, you should enroll in the OCR New Study Initiation Process Training course below. This is a 25-minute video that covers:
- How to submit a New Study or a Study Amendment to the OCR entry process
- Information about the OCR’s Coverage Analysis Process
- Overview of the Study Submission Timeline and OnCore Workflow Status
Document Alignment
When a clinical research study is submitted to the OCR for entry into OnCore, a coverage analyst is assigned. Even if a study does not require a full coverage analysis, the study will still receive a document alignment review. This review, which is also performed as part of a coverage analysis, compares the language in essential study documents for consistency. These essential study documents include the study protocol, informed consent documents, and the contract and budget documents, when applicable. When reviewing these documents, the coverage analyst is primarily looking for consistency in financial responsibility and cost language and ensuring that the language does not violate University guidelines or federal regulations regarding clinical research billing.
The initial review of these documents should be performed while they are still in draft status. This allows for revisions to be made without having to process an amendment to the consent or contract documents. The assigned coverage analyst will work with the study team if inconsistencies are identified in the initial review. When the essential documents have been finalized, the coverage analyst will perform a final review to ensure that issues have been resolved and documents are aligned in their final versions. The following items are of primary concern for our coverage analysts as they complete the 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?
The Coverage Analysis Team works closely with the OCR Contracts Team to make sure that the appropriate language is in both the Informed Consent Form (ICF) and the Clinical Trial Agreement (CTA) and that these documents align.
For studies of greater than minimal risk, the informed consent (ICF) and clinical trial contract (CTA) should address the issue of who bears financial responsibility for costs incurred in diagnosing and treating study-related injuries.
Sometimes, industry sponsors will propose language that indicates the sponsor will pay for study-related injuries only if the participant’s insurance denies payment. Any statements that indicate a Sponsor’s obligation may vary based upon a participant’s insured status or be contingent upon a denial of payment (either in part or in full) by the participant’s primary insurer will be considered conditional payment language. Our Institution will not accept such language or similar language that requires that Institution to bill the third-party insurance companies prior to billing the Sponsor. In such cases, the conditional language must be removed.
Examples of unacceptable language:
- “The sponsor will pay for that medical treatment to the extent it is not covered by your medical or hospital insurance or by third party or governmental program in which you participate.”
- “Sponsor will pay for reasonable and routine costs of treatment for injuries incurred while on study, as long as the following conditions are met: The cost of treatment is not covered by any other health insurance, government health program, or others providing coverage for health care.”
- “The Sponsor of the study will pay for reasonable and necessary out-of-pocket medical costs for the diagnosis and treatment of any injury or illness resulting from the study device or a procedure that you had only because you are in the study.”
- “The sponsor will pay any charges that are not covered by insurance policy or the government, provided the injury was not due to your underlying illness or condition and was not caused by you or some other third party.”
These conditional payment scenarios may be viewed as a violation of the Medicare Secondary Payer (MSP) Act. The Sponsor’s agreement to pay for medically necessary services required for the diagnosis and treatment of research related injury, constitutes a liability insurance plan or policy under which payment can reasonably be expected to be made in the event such an injury occurs. Therefore, Medicare would no longer have primary payment responsibility and cannot be billed. To avoid any Medicare Secondary Payer violation concerns, IU takes the position that the sponsor should agree to cover research‐related injuries in the contract without regard to the participant’s health plan coverage.