The procedures include vascular access, catheterization, balloon valvuloplasty, valve deployment and (as needed) repositioning, temporary pacemaker insertion for rapid pacing, and access site closure.
0483T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including trans-septal puncture, when performed
0484T Transthoracic exposure (eg, thoracotomy, transapical)
How to Avoid Denials?
1. CPT must have primary modifier 62 & secondary modifier Q0
2. The diagnosis must have “Mitral Valve Regurgitation and/or Mitral Valve Insufficiency”
3. Place of Service (POS) should be 21
4. Claim must be submitted with Clinical Trial number based on the sponsor.
Approved Clinical Study:
Transcatheter mitral valve repair (TMVR) is a procedure used to treat mitral regurgitation which is the most common type of heart valve insufficiency in the country.
CMS issued a Medicare National Coverage Determination on August 7, 2014 which allows for coverage of TMVR under Coverage with Evidence Development (CED) with certain conditions. The complete determination is available on our website. As part of CED, we are identifying below the Medicare approved registry and Medicare approved clinical trial which have been reviewed and determined to meet the requirements of coverage.
STS/ACC TVT Registry Mitral Module (TMVR)
Sponsor: American College of Cardiology
ClinicalTrials.gov Number: NCT02245763
CMS Approval Date: 08/07/2014
Clinical Study Approvals:
Study Title: Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
Sponsor: Edwards SAPIEN XT™and SAPIEN 3™
ClinicalTrials.gov Number: NCT02370511
CMS Approval Date: February 25, 2015
Study Title: Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID) Pivotal Trial
Sponsor: Edwards Lifesciences
ClinicalTrials.gov Number: NCT03706833
Investigational Device Exemption (IDE) Number: G170166
CMS Approval Date: 11/19/2018
Study Title: Cardiovascular Outcomes Assessment of the MitraClip® Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (the COAPT trial)
Sponsor: Abbott Vascular
ClinicalTrials.gov Number: NCT01626079
Investigational Device Exemption (IDE) Number: G120024/S021
CMS Approval Date: 02/05/2015