MCA is an independent review of a research study to determine which clinical procedures and services are billable to the research subject, third-party payer or sponsored award. The MCA includes a review of the clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) to determine the billing status of items and services that are documented in the research protocol and/or research plan. Yale requires that all research studies involving the provision of billable clinical procedures and services must undergo a Medicare Coverage Analysis. Yale School of Medicine's Policy, Research Studies with Billable Clinical Services
, dated April 1, 2019, is requiring The Yale Center for Clinical Investigation’s Central Medicare Coverage Analysis Unit to complete a coverage analysis on all qualifying trials. Furthermore, all finalized budgets will be reviewed and signed off by this unit to ensure that the MCA is accurately represented within the clinical trial budget.