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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 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.

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.

Medicare Coverage Analysis Questions