Special guidance for device studies If the study is investigator-initiated, who submits the device study to CMS for approval to bill?The study sponsor has the responsibility to submit to the Centers for Medicare & Medicaid Services (“CMS”) for central coverage approval. If your UCLA device study is investigator-initiated and UCLA holds the Investigational Device Exemption (IDE), UCLA is the study sponsor. The study team will need to work with the Clinical Trial Administration Office during coverage analysis review to determine who the sponsor is and ensure required submission to CMS for coverage approval by the appropriate party.3 | |
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