The data collection is required by the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) entitled, “Transcatheter Aortic Valve Replacement (TAVR)”. The TAVR device is only covered when specific conditions are met including that the heart team and hospital are submitting data in a prospective, national, audited registry. CMS finds that the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TAVR. The TVT Registry will support a national surveillance system to monitor the safety and efficacy of the TAVR technologies for the treatment of aortic stenosis.
The latest form for (CMS-10443) Transcatheter Valve Therapy Registry and KCCQ-10 expires 2021-01-31 and can be found here.
Document Name |
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Form and Instruction |
Form and Instruction |
Supporting Statement B |
Supporting Statement A |
Extension without change of a currently approved collection | 2020-11-30 | ||
Approved with change |
Extension without change of a currently approved collection | 2016-06-21 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2012-11-20 |
Federal Enterprise Architecture: Health - Consumer Health and Safety
Form CMS-10443 | TVT Registry | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.