Document ID: chunk:federal_register_of_legislation:F2024L01386:schedule:1:p403
Version: federal_register_of_legislation:F2024L01386
Segment Type: schedule
Provision Reference: sch 1 (pt 403/696)
Character Range: 14252719–14282516

Evolut FX transcatheter aortic valve                                                                                                         Transcatheter aortic valve, self-expanding, re-sheath and/or complete recapture after partial deployment and redeployment including a loading system (L-EVOLUTFX-2329, L-EVOLUTFX-34) and a delivery catheter system (D-EVOLUTFX-2329, D-EVOLUTFX-34)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    23mm-34mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $22,932.00

08.17.02 - Mitral Valve Repair
  08.17.02.01 - Leaflet
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ460                                                                                                                                                               MitraClip G4 system                                                                                                                                    Transmitral valve repair clip, steerable guide catheter, clip delivery system                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            9 - 12 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      $26,386.00
SJ453                                                                                                                                                               MitraClip System                                                                                                                                       Steerable Guide Catheter, Clip Delivery System (Delivery Catheter, Steerable sleeve and the MitraClip Implant)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           NTR MitraClip Implant: 15-17 mm  XTR MitraClip Implant: 18-22 mm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               $26,386.00

09 - Cardiothoracic
Billing Code                                                              Product Name                                                                                                                                                                                             Description                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Size                                                                                                                                                                                                                                                                                                                                          Minimum Benefit  Condition
09.01 - Mechanical Valves
09.01.01 - Bi-Leaflet, rotatable
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ317                                                                     Regent Prosthetic Heart Valve                                                                                                                                                                            Standard Cuff                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Standard cuff - 17-23mm/25mm-29mm, Flex cuff - 17-23mm/25mm-29mm                                                                                                                                                                                                                                                                              $4,962.00
SJ037                                                                     Masters Series Heart Valve Mitral and Aortic - Expanded Cuff/Hemodynamic Plus                                                                                                                            Aortic Expanded Cuff, Aortic Hemodynamic Plus Cuff, Mitral hemodynamic Cuff, Aortic & Mitral Rotatable Cuff                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Aortic Expanded 19 - 31mm, Aortic Hemodynamic 17 - 27mm, Mitral Hemodynamic 17 - 27mm, Rotable 17 - 33mm                                                                                                                                                                                                                                      $4,962.00

     CORCYM AUSTRALIA PTY LTD
JS004                                                                     Carbomedics Standard Mitral M700 - Prosthesis,  internal, valve, cardiac, artificial                                                                                                                     Prosthesis, internal, valve, cardiac, artificial                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   16.2  18.8  21.8  23.8  25.8  27.8  29.8  31.8                                                                                                                                                                                                                                                                                                $4,962.00

     DEVICE TECHNOLOGIES AUSTRALIA PTY. LTD.
DE607                                                                     On-X Prosthetic Heart Valve                                                                                                                                                                              Bileaflet Mechanical Heart Valve                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   19-33mm                                                                                                                                                                                                                                                                                                                                       $4,962.00

     Livanova Australia Pty Limited
SA129                                                                     Optiform                                                                                                                                                                                                 Mechanical Valve                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   19mm to 33mm                                                                                                                                                                                                                                                                                                                                  $4,962.00

     MEDTRONIC AUSTRALASIA PTY LTD
MI124                                                                     Open Pivot Heart Valve AP360 - Mitral                                                                                                                                                                    Supra-annular mechanical valve; Pyrolythic Carbon, Double Velour Polyester, Titanium                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Mitral: 16, 18, 20, 22, 24, 26,  28 and 30 mm                                                                                                                                                                                                                                                                                                 $4,962.00
MC980                                                                     Open Pivot Heart Valve (Model 500FA)                                                                                                                                                                     Pyrolythic Carbon, Double Velour Polyester, Titanium                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               16-33mm                                                                                                                                                                                                                                                                                                                                       $4,962.00
                                                                          Open Pivot Heart Valve (Model 500DM)
MI125                                                                     Open Pivot Heart Valve AP360 - Aortic                                                                                                                                                                    Supra-annular mechanical valve; Pyrolythic Carbon, Double Velour Polyester, Titanium                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Aortic: 16, 18, 20, 22, 24, 26 and 28 mm                                                                                                                                                                                                                                                                                                      $4,962.00

09.02 - Tissue Valves
09.02.01 - Stented, anatomical
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ136                                                                     SJM Biocor Heart Valve                                                                                                                                                                                   Stented Porcine tissue valve                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Aortic Valves - Tissue Annulus Diameter - 21 - 29mm                                                                             Mitral Valves - Tissue Annulus Diameter - 25-35mm                                                                                                                                                             $4,750.00
SJ201                                                                     Epic FlexFit Supra                                                                                                                                                                                       Triple-composite Bioprosthetic heart valve for supra-annular placement in the aortic position                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Tissue Annulus Diameter - 19mm-23mm. Total Height 14mm-16mm.                                                                                                                                                                                                                                                                                  $4,750.00
SJ192                                                                     Epic Flexfit                                                                                                                                                                                             Triple-composite Bioprosthetic heart valve                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Aortic Valves 21-29mm tissue annulus diameter, 14-20mm total height. Mitral Valves 25-33mm tissue annulus diameter, 15-20mm total height.                                                                                                                                                                                                     $4,750.00

     EDWARDS LIFESCIENCES PTY LIMITED
EL064                                                                     Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A                                                                                                                                                      A stented, trileaflet aortic valve, with leaflets comprised of RESILIA bovine pericardial tissue mounted on a flexible cobalt-chromium alloy frame (see Attachment 1 for product images).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          INSPIRIS