Document ID: chunk:federal_register_of_legislation:F2025L00198:schedule:1:p410
Version: federal_register_of_legislation:F2025L00198
Segment Type: schedule
Provision Reference: sch 1 (pt 410/706)
Character Range: 1359955–1363378

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

  DMR only
     EDWARDS LIFESCIENCES PTY LIMITED
EL069  PASCAL Precision System (PASCAL Implant and PASCAL ACE Implant)   The PASCAL Precision system is intended to repair an insufficient mitral valve via percutaneous reconstruction through tissue approximation. The PASCAL Precision System is comprised of the Implant System and Guide                                                                                                                                                 10 mm PASCAL and 6mm PASCAL ACE Implant   $23,104.00  The Prescribed List reimbursement for the devices listed under the billing code (listed item) is restricted to the use of the devices in the procedure described under the Medicare Benefits Schedule (MBS) item 38461, meaning transcatheter mitral valve repair (TMVr)  in patients with degenerative (primary) mitral valve regurgitation (DMR).
                                                                         Sheath. The Implant System consists of the Loader, Steerable Catheter, Implant Catheter and Implant which comes in two sizes: 10 mm and 6 mm. The 10 mm Implant is referred to as PASCAL Implant and the 6 mm Implant is referred to as PASCAL Ace Implant. The Guide Sheath consists of the Guide Sheath, Introducer and an additional Loader for user convenience.

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.
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

SJ317  Regent Prosthetic Heart Valve  Standard Cuff  Standard cuff - 17-23mm/25mm-29mm, Flex cuff - 17-23mm/25mm-29mm  $4,962.00

     BTC CARDIO PTY LTD
XQ004  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

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

MC980  Open Pivot Heart Valve (Model 500FA)  Pyrolythic Carbon, Double Velour Polyester, Titanium  16-33mm  $4,962.00
       Open Pivot Heart Valve (Model 500DM)

09.02 - Tissue Valves
09.02.01 - Stented, anatomical
     ABBOTT MEDICAL AUSTRALIA PTY LTD.
SJ201  Epic FlexFit Supra  Triple-composite Bioprosthetic heart valve for supra-annular placement in the aortic position  Tissue Annulus Diameter -