Document ID: chunk:federal_register_of_legislation:F2024C01088:reg:38463
Version: federal_register_of_legislation:F2024C01088
Segment Type: reg
Provision Reference: reg 38463
Character Range: 7900–9927

38463                                TMVr, by transvenous or transeptal techniques, for permanent coaptation of mitral valve leaflets using one or more Mitraclips™, including intra‑operative diagnostic imaging, if:                    1,490.25
                                     (a) the patient has each of the following risk factors:
                                      (i) moderate to severe, or severe, symptomatic functional (secondary) mitral valve regurgitation (grade 3+ or 4+);
                                      (ii) left ventricular ejection fraction of 20% to 50%;
                                     (iii) left ventricular end systolic diameter of not more than 70mm;
                                      (iv) symptoms of mild, moderate or severe chronic heart failure (New York Heart Association class II, III or IV) that persist despite maximally tolerated guideline directed medical therapy; and
                                     (b) as a result of a TMVr suitability case conference, the patient has been:
                                     (i) assessed as having an unacceptably high risk for surgical mitral valve replacement; and
                                     (ii) recommended as being suitable for the service; and
                                     (c) the service is performed:
                                     (i) by a cardiothoracic surgeon, or an interventional cardiologist, accredited by the TMVr accreditation committee to perform the service; and
                                     (ii) via transfemoral venous delivery, unless transfemoral venous delivery is contraindicated or not feasible; and
                                     (iii) in a hospital that is accredited by the TMVr accreditation committee as a suitable hospital for the service; and
                                     (d) a service to which this item, or item 38461, applies has not been provided to the patient in the previous 5 years
                                     (H) (Anaes.) (Assist.)