The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR) under coverage with evidence development (CED) when specific conditions are met, as outlined in the Medicare National Coverage Determination (NCD) manual, chapter 1, part 1, section 20.32 for TAVR and NCD 20.33 for TMVR. Therefore, Medicare administrative contractors (MACs) do not require study investigators to submit the same documentation for additional review. However, it would be beneficial to both contractor and physician/facility to submit the CMS letter approving the IDE to First Coast before claims are submitted. This will allow the contractor to make necessary preparations for claims receipt. This should not cause any delays in study enrollment and participation. Prior to submitting claims to MAC jurisdiction N (JN), your study site should follow the CMS guidelines available in Pub. 100-04 Medicare Claims Processing Manual, Chapter 32, Sections 290.1 and 340. The CMS approval is not a claim-level coverage decision, and participating providers (study sites submitting claims to A/B MAC JN) must be able to demonstrate if audited (pre or post payment) that all applicable requirements of the program were met, including but not limited to having an active Investigational Review Board (IRB) approval, documentation supporting reasonable and necessary services, and accurate billing/coding of claims.