Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021 made under subsection 3C(1) of the Health Insurance Act 1973 Compilation No. 5 Compilation date: 1 November 2024 Includes amendments: F2024L01220 About this compilation This compilation This is a compilation of the Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021 that shows the text of the law as amended and in force on 1 November 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Name 3 Authority 4 Definitions 5 Treatment of transcatheter mitral valve services 6 TMVr suitability case conferences 7 Indexation Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history 1 Name This instrument is the Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021. 3 Authority This instrument is made under subsection 3C(1) of the Health Insurance Act 1973. 4 Definitions Note: A number of expressions used in this instrument are defined in the Act, including the following: (a) clinically relevant service; (b) general medical services table; (c) hospital; (d) item; (e) practitioner; (f) professional service. In this instrument: Act means the Health Insurance Act 1973. TMVr is short for transcatheter mitral valve repair. TMVr accreditation committee means the committee of that name administered by Cardiac Accredited Services Limited. TMVr suitability case conference means a case conference that meets the requirements set out in section 6. 5 Treatment of transcatheter mitral valve services (1) A health service (the service) described in an item of the table in subsection (5) is to be treated, in the circumstances specified in subsection (2) and for the purposes of the provisions specified in subsection (3), as if: (a) it were both a professional service and a medical service; and (b) there were an item in the general medical services table in the location mentioned in subsection (4), corresponding to the item of the table in subsection (5) that describes the service, that: (i) related to the service; and (ii) specified a fee for the service, in relation to each State, that corresponds to the fee set out in the item of the table in subsection (5) that describes the service. (2) For the purposes of subsection (1), the circumstances are that the service is provided as a clinically relevant service. (3) For the purposes of subsection (1), the provisions of the following that relate to professional services, medical services or items are specified: (a) the Act and regulations made under the Act; (b) the National Health Act 1953 and regulations made under that Act. (4) For the purposes of paragraph (1)(b), the location is: (a) for items 6082 and 6084—Part 2 of the general medical services table (which deals with attendances); and (b) for items 38461 and 38463—Subgroup 6 of Group T8 of Part 5 of the general medical services table (which deals with cardio‑thoracic surgical operations). (5) For the purposes of subsection (1), the health services are as follows. Transcatheter mitral valve services Column 1 Column 2 Column 3 Item Description Fee ($) 6082 Attendance at a TMVr suitability case conference, by a cardiothoracic surgeon or an interventional cardiologist, to coordinate the conference, if: 52.95 (a) the attendance lasts at least 10 minutes; and (b) the surgeon or cardiologist is accredited by the TMVr accreditation committee to perform the service Applicable once each 5 years 6084 Attendance at a TMVr suitability case conference, by a specialist or consultant physician, other than to coordinate the conference, if the attendance lasts at least 10 minutes 39.50 Applicable once each 5 years 38461 TMVr, by transvenous or transeptal techniques, for permanent coaptation of mitral valve leaflets using one or more tissue approximation implants, 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 degenerative (primary) mitral valve regurgitation (grade 3+ or 4+); (ii) left ventricular ejection fraction of 20% or more; (iii) symptoms of mild, moderate or severe chronic heart failure (New York Heart Association class II, III or IV); 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 38463, applies has not been provided to the patient in the previous 5 years (H) (Anaes.) (Assist.) 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.) 6 TMVr suitability case conferences (1) This section sets out the requirements that a case conference must meet to be a TMVr suitability case conference. (2) The requirements are as follows: (a) the conference must be for the purpose of determining if a patient is suitable for a service described in item 38461 or 38463; (b) the conference must last at least 10 minutes; (c) the conference must be conducted by a team of at least 3 participants, including: (i) a cardiothoracic surgeon; and (ii) an interventional cardiologist; and (iii) a specialist or consultant physician, neither of whom will provide a service to the patient to which item 38461 or 38463 applies; (d) at least one participant of the conference must be accredited by the TMVr accreditation committee to perform a service described in item 38461 or 38463; (e) the coordinator of the conference must ensure that the patient: (i) is aware of the purpose and nature of the conference; and (ii) has consented to the conference being held; and (iii) is made aware of the recommendations made as a result of the conference; (f) during the conference: (i) each member of the team must provide expertise in assessing the patient and informing the recommendations to be made; and (ii) the patient's risk and technical suitability for a service described in item 38461 or 38463 must be assessed, including by taking into account the risk and technical suitability of the patient to receive a surgical mitral valve replacement and the patient's cognitive function and frailty; and (iii) the team must make a recommendation as to whether the patient is suitable for a service described in item 38461 or 38463; (g) the coordinator must create a record of the conference, including: (i) the day the conference is held; and (ii) the time the conference starts and ends; and (iii) the names of each of the participants of the conference; and (iv) the details of the conference, including the particulars of the assessment of the patient during the conference and the recommendations made as a result of the conference. 7 Indexation (1) At the start of 1 July 2024 (the indexation time), each amount covered by subsection (2) is replaced by the amount worked out using the following formula: Note: The indexed fees could in 2024 be viewed on the Department of Health and Aged Care's MBS Online website (http://www.health.gov.au). (2) The amounts covered by this subsection are the fee for each item in a Schedule of this Determination. (3) An amount worked out under subsection (1) is to be rounded up or down to the nearest 5 cents (rounding down if the amount is an exact multiple of 2.5 cents). Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Editorial changes The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date. If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003. If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history. Endnote 2—Abbreviation key ad = added or inserted o = order(s) am = amended Ord = Ordinance amdt = amendment orig = original c = clause(s) par = paragraph(s)/subparagraph(s) /sub‑subparagraph(s) C[x] = Compilation No. x Ch = Chapter(s) pres = present def = definition(s) prev = previous Dict = Dictionary (prev…) = previously disallowed = disallowed by Parliament Pt = Part(s) Div = Division(s) r = regulation(s)/rule(s) ed = editorial change reloc = relocated exp = expires/expired or ceases/ceased to have effect renum = renumbered rep = repealed F = Federal Register of Legislation rs = repealed and substituted gaz = gazette s = section(s)/subsection(s) LA = Legislation Act 2003 Sch = Schedule(s) LIA = Legislative Instruments Act 2003 Sdiv = Subdivision(s) (md) = misdescribed amendment can be given effect SLI = Select Legislative Instrument SR = Statutory Rules (md not incorp) = misdescribed amendment cannot be given effect Sub‑Ch = Sub‑Chapter(s) SubPt = Subpart(s) mod = modified/modification underlining = whole or part not commenced or to be commenced No. = Number(s) Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021 21 June 2021 (F2021L00800) 1 July 2021 (s 2(1) item 1) Health Insurance Legislation Amendment (Indexation) Determination 2022 7 Apr 2022 (F2022L00553) Sch 1 (item 12): 1 July 2022 (s 2(1) item 1) — Health Insurance Legislation Amendment (Indexation) Determination 2023 24 Mar 2023 (F2023L00348) Sch 1 (item 7): 1 July 2023 (s 2(1) item 1) — Health Insurance Legislation Amendment (Indexation No. 2) Determination 2023 4 Sept 2023 (F2023L01183) Sch 1 (item 7): 1 Nov 2023 (s 2(1) item 1) — Health Insurance Legislation Amendment (Indexation) Determination 2024 21 May 2024 (F2024L00563) Sch 1 (item 6): 1 July 2024 (s 2(1) item 1) — Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Amendment Determination 2024 26 Sept 2024 (F2024L01220) 1 Nov 2024 (s 2(1) item 1) — Endnote 4—Amendment history Provision affected How affected s 2..................... rep LA s 48D s 5..................... am F2024L01220 s 7..................... ad F2022L00553 ed C2 am F2023L00348; F2023L01183; F2024L00563