Medicare Coverage Analysis

Centralized Medicare Coverage Analysis (MCA) Services

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 consults with investigators while preparing Medicare coverage analyses so that the PI’s expertise and insights are reflected in the final documents. 


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. 

Fee to Corporate Sponsors for MCA's

A fee of $550.00 is charged to corporate/industry/pharma sponsors for the preparation and completion of a Medicare Coverage Analysis if an MCA is required. YCCI will invoice the sponsor for the MCA fee.

Forms and Information




Investigational Device Exemption Requests
Providers that participate in an Investigational Device Exemption (IDE) clinical study and anticipate filing Medicare claims must notify their Medicare contractor. This applies to all IDEs assigned an identifying number beginning with a ‘G’ and a Centers for Medicare & Medicaid Services (CMS) category B (B1, B2, B3, or B4) by the Food and Drug Administration (FDA); a category A IDE device clinical study before billing routine costs of clinical studies involving a Category A device; post-market approval studies or registries of carotid stents; and studies for proximal embolic protection devices (EPDs) in carotid artery stenting (CAS) procedures. Notice is not required for humanitarian use devices, post-market approval studies or registries of devices other than carotid stents, or clinical studies other than those described above. See the NGS website here.

All new or renewal IDE clinical study requests should be directed to National Government Services by one of the following methods:

Fax: (717) 565-3432  

Mail:    National Government Services IDE Request

           2400 Thea Dr., Ste. 3B

           Harrisburg, PA 17110

Submission by fax or e-mail is preferred.

MCA Request and Completion

To request MCA completion click here for the online form or for additional questions, please contact Joseph Sorrentino, Clinical Research Analyst for YCCI at joseph.sorrentino@yale.edu

Medicare Coverage Analysis

Please complete the online form here for your Medicare Coverage Analysis Department Completion. If you have questions please contact Joseph Sorrentino at joseph.sorrentino@yale.edu or 203-785-7760.