Medicare Coverage Analysis

The Yale Center for Clinical Investigation (YCCI) prepares Medicare coverage analyses for all clinical research protocols at the Yale School of Medicine and Yale affiliates.

What is an MCA? When is it required?

A Medicare coverage analysis (MCA) is required for all clinical trials in which tests, procedures, and interventions associated with a clinical trial are invoiced to third party payers. Preparing an MCA involves determining the underlying eligibility of the study for Medicare coverage and reviewing clinical events specified in the protocol to determine which can be reimbursed by Medicare. YCCI provides investigators the completed MCA for review and approval.

Medicare will not cover costs that are:

• paid for by the sponsor
• promised free in the informed consent document
• not ordinarily covered by Medicare, or
• solely to determine trial eligibility or for data collection or analysis

What is the result of the MCA?

When the analysis is complete, the investigator receives a study-specific billing summary that lists all items and services to be provided as part of the clinical trial with notations of what should be billed to the research sponsor and what can be billed to Medicare. These billing grids are a valuable tool to ensure appropriate billing.

A fee of $4,160.00/drug study (inclusive of Yale University overhead) is charged to corporate/industry/pharma sponsors for the initial preparation and completion of a Medicare Coverage Analysis if an MCA is required. A fee of $1,300.00 is charged to corporate/industry/ pharma sponsors for the amended preparation and completion of a Medicare Coverage Analysis for major protocol amendments that included added or changed procedures/arms, if an MCA was required. YCCI will invoice the sponsor for the MCA fee.