OMB control number
(CMS-10443) Transcatheter Valve Therapy Registry and KCCQ-10
OMB 0938-1202 · HHS/CMS.
OMB 0938-1202
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 is listed under ICR 201606-0938-003.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form CMS-10443 KCCQ-10 | Form and Instruction |
| Form CMS-10443 TVT Registry | Form and Instruction |
 CMS-10443 Supporting Statement - Part B - 8-26-20.docx | Supporting Statement B |
 CMS-10443 Supporting Statement Part A - 120617.doc | Supporting Statement A |
 KCCQ-10 |
Form and Instruction |
| TVT Registry |
Form and Instruction |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202011-0938-010 | Extension without change of a currently approved collection | 2020-11-30 | ||
| 201606-0938-003 | Extension without change of a currently approved collection | 2016-06-21 | Approved with change | |
| 201211-0938-005 | New collection (Request for a new OMB Control Number) | 2012-11-20 | Approved without change |
OMB Details
TVT Registry
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form | Name | Electronic access | Type |
|---|---|---|---|
| Form CMS-10443 | TVT Registry | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.