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Investigational Device Exemption (IDE)

Applying for Medicare Coverage for IDE Clinical Trial Services

UW Medicine requires local or national approval via the Centers for Medicare and Medicaid Services (CMS)/Medicare in order to host IDE trials if there will be any billing to patient accounts. Only device studies that are billed 100 percent to the study budget may forego the CMS/Medicare application.

If advance approval is not obtained, CMS/Medicare will not cover any study-related items or services on hospital or physician claims. If a patient was admitted to the hospital for an IDE-related procedure, then the entire stay and all related services are at risk of being non-covered and not reimbursed.

The Food and Drug Administration (FDA) assigns IDEs as either Category A (higher risk) or Category B devices. With prior approval, CMS/Medicare may cover the related services in a Category A device trial (but not the Category A device) and both the Category B device and related services in a Category B device trial. CMS/Medicare coverage is only available when an application is approved in advance.

Effective January 1, 2015, CMS/Medicare began a transition from a local contractor approval process to a national approval process:

IDEs with FDA approval letters dated on or after 01/01/2015

These studies will follow a national application review at CMS/Medicare. An approval decision allows coverage of study-related services and Category B devices at all study sites. See the UW Medicine Compliance for IDE national coverage applications.

IDEs with FDA approval letters dated prior to 01/01/2015

These studies continue to apply for CMS/Medicare coverage to the local CMS/Medicare Contractor, Noridian Healthcare Solutions. See the UW Medicine Compliance for IDE local coverage applications.