Beginner’s Guide to Medicare Coverage Analysis

Medicare coverage analysis (MCA) is a systemic process of developing a billing plan for a clinical research study. Also known as coverage analysis, MCA provides an in-depth analysis of how all the items and services listed in the clinical research protocol are billed per guidelines provided by the federal agencies.

The Centers for Medicare and Medicaid Services (CMS) provides information and guidelines to determine whether billable items and services to be billed to the third party (insurance/patients) as routine cost or will be paid by the sponsor as a research-related procedure. Since 2000, Medicare has covered the cost of the routine care for the Medicare beneficiaries who are enrolled in qualifying clinical research studies. Effective January 2022, Clinical Treatment Act requires all U.S. states and territories to cover the cost of routine care for the Medicaid beneficiaries who are participating in a qualifying research study.

Advantages of Having an MCA

Developing a billing plan by performing MCA will help both the individual research site and sponsor estimate their expenses on protocol-required items and services. Clinical research studies enrolling human subjects also need to adhere to the approved MCA-generated billing plan if routine services are billed to the patient or their insurance. If not, sites enrolling the human subjects may face serious consequences, including federal lawsuits, financial penalties, and/or the ban of CMS coverage for the applicable institution or investigator. Additionally, by performing an MCA, research participants are assured of the financial liability (payments and copayments for the items and services) while participating in the clinical research.

Performing an MCA

The first step in considering what items and services are covered by insurance is first determining whether the clinical trial is eligible for coverage. The National Coverage Determination (NCD) 310.1 for Routine Costs in Clinical Trials outlines the requirements for clinical trials to be deemed eligible for coverage.

If the study is determined to be a qualifying clinical trial, each potentially billable item or service listed in the protocol should be analyzed to determine coverage. NCD 310.1 outlines coverage routes available for items or services provided in absence of a clinical trial (e.g., conventional care), performed to monitor known human side effects of an investigational agent, and/or considered reasonable and necessary for the management of the patient’s underlying condition. Further support can be obtained in referencing peer-reviewed treatment guidelines approved by Medicare.

Please note, service-specific NCDs and local coverage determinations (LCDs) may further affect coverage. Service-specific NCDs and LCDs should be prioritized when determining coverage, as any limitations noted will trump support found in peer-reviewed guidelines mentioned above.

It is also important to note coverage must remain consistent across the entire patient population. As per NCD 310.1 and ethical standards, no costs should differ between two patients entering the same clinical trial. If an assessment is determined to be routine care for one patient but solely research-related for another, the assessment in both patients should be covered by the sponsor conducting the clinical trial. This is yet another key benefit of performing an MCA, where potentially hidden costs are identified prior to budget execution.

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