The Heart Valve Disease Policy Task Force represents a diverse group of patient,disease, and research advocacy groups with a shared interest of ensuring that patientshave access to safe, innovative new technologies – “Breakthrough Devices” – as soonas possible after receiving market authorization from the Food and Drug Administration. While we understand the rationale behind delaying … Continue reading Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date (Docket No. CMS-2021-05490)