Coverage Analysis

Complying with federal guidelines for healthcare billing associated with a clinical trial is important but can be complicated. Principal investigators are responsible for ensuring services associated with a clinical trial are billed appropriately. The OCR Coverage Analysis Team provides support and guidance to researchers and their staff by performing an independent review of clinical studies to determine which clinical procedures and services are billable to insurance.

Coverage analyses are important to facilitate billing compliance, mitigate risks, and avoid billing errors. Additionally, a thorough CA can have the benefit of negotiating an accurate study budget.

A documented coverage analysis (CA) is required for all clinical studies involving interventions in which any items or services are or may be invoiced to the patient insurer(s). Any clinical studies on human subjects submitted to the IU Institutional Review Board (IRB) must determine whether a CA will be required.

  • Qualifying trial determination: Medicare Coverage Analysis (MCA) for drug studies
  • CMS determination documentation for device studies
  • Supplemental Coverage Review by the Medicare contractor Medical Director of Fiscal Intermediary for services for which coverage is not yet established
  • Review of cost allocation language in all study documents for consistency

OnCore includes a checklist to help you determine and document that your study is a Qualifying Clinical Trial (QCT) according to Medicare rules. It can also record billing information for each procedure listed in the protocol and provide you with a Billing Grid that includes a calendar view of all scheduled procedures and their respective billing designations. Check out our OnCore Learning Manuals, Tools, Tips and FAQ’s for additional information on the Coverage Analysis Console of OnCore.

Study Start-Up: Document Review Process

Document Alignment

When clinical research studies are submitted to the OCR for entry into OnCore, a coverage analyst is assigned to perform a document alignment review, which 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 Contracting 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.

The informed consent (ICF) and clinical trial contract (CTA) are required to 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 patient’s insurance denies payment. The Institution will not accept such language or similar language that requires that Institution to bill the third-party insurance companies or the research subjects in lieu of recovery of such costs from the sponsor. In such cases, the conditional language must be removed.

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.”

These types of statement are a violation of Medicare Secondary Payer rules, which indicate that Medicare must be the payer of last resort for all participants of the research study. This means that Medicare cannot be considered as an option for payment for research injury if the sponsor has promised to cover these costs To avoid any Medicare Secondary Payer regulatory concerns, IU takes the position that the sponsor should agree to cover research‐related injuries in the sponsor agreement regardless of the patient/trial participant’s health plan coverage. This avoids not only the Medicare Secondary Payer issue but also protects patients who have no health plan coverage or whose health plan will not cover research-related injuries.


Acceptable language:

    • “If the injury or illness is directly related to the proper management of the study drug or proper performance of research procedures, Sponsor will pay the reasonable costs of that treatment to the extent those costs were necessary and directly related to the study.”
    • “In the event of injury or illness resulting from participation in the research study, the patient/patient insurance will be responsible for the cost to treat such injuries.”