Medicare Coverage Analysis

All Clinical Trials Involving Billable Patient-Care Services Require A Medicare Coverage Analysis (MCA)

The Coverage Analysis team supports investigators and study teams by reviewing study protocols for billing compliance before study activation. This review is required for all trials that include patient care services. MCAs identify which study procedures are billable to insurance versus sponsor-funded, providing a standardized billing framework that ensures alignment with Medicare coverage rules and institutional policies.   Medicare Coverage Analysis (MCA) A Medicare Coverage Analysis (MCA) is a required review for any clinical research study that includes patient-care items or services. As part of the pre-award process, Coverage Analysis team determines the appropriate payer for each protocol-required service in accordance with federal guidelines from the Centers for Medicare & Medicaid Services (CMS) and regional Medicare Administrative Contractor policies.

Utilizing the Medicare Clinical Trial Policy (National Coverage Determination 310.1), the MCA team evaluates each study to determine if it meets the “qualifying” status. This status dictates the billing path for billable services as follows:   Routine Cost / Standard of Care – Items and services that may be billed to insurance/third-party payers. Research-only – Items and services that must be covered by the study sponsor.

This analysis results in a detailed Billing Grid that outlines how each study-related service will be billed. The Billing Grid serves as a framework for study teams, supporting budget development, contract review, and informed consent language while ensuring billing compliance and consistency across all study documents.