CMS Submissions Overview

All Category A and B Device Studies containing routine care costs to CMS (Centers for Medicare and Medicaid) must have prior approval by Novitas Solutions, the local CMS Intermediary, before enrolling and billing a CMS eligible patient.  

The cost of a Category A device may not be billed to CMS or other third-party payors, though the cost of a Category B device may be billed to CMS upon written confirmation by Novitas Solutions.  CMS approval must be granted prior to enrolling and billing any CMS-eligible patient.  Category B devices provided at no cost to the Health System may never be billed to CMS.

If the sponsor is providing the device at No Cost and reimbursing UPHS for all associated routine care costs including insertion, monitoring, and treatment of adverse events caused by the device, then Novitas approval is not required.

How to Submit for CMS Approval

Study Teams should work with respective hospital Admission Departments to ensure that all precertification requirements by patients’ third-party insurance companies prior to enrollment

Who to Contact

Hospital of the University of Pennsylvania

Penn Presbyterian Medical Center

Pennsylvania Hospital

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