{"id":"F2021L00800","name":"Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021","slug":"health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":101936,"registerId":"commonwealth-F2021L00800-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 3C(1) of the Health Insurance Act 1973.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n (a) clinically relevant service;\n (b) general medical services table;\n (c) hospital;\n (d) item;\n (e) practitioner;\n (f) professional service.\n In this instrument:\n\n> Act means the Health Insurance Act 1973.\n\n> TMVr is short for transcatheter mitral valve repair.\n\n> TMVr accreditation committee means the committee of that name administered by Cardiac Accredited Services Limited.\n\n> TMVr suitability case conference means a case conference that meets the requirements set out in section 6.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Treatment of transcatheter mitral valve services","content":"#### 5 Treatment of transcatheter mitral valve services\n\n (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:\n (a) it were both a professional service and a medical service; and\n (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:\n (i) related to the service; and\n (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.\n (2) For the purposes of subsection (1), the circumstances are that the service is provided as a clinically relevant service.\n (3) For the purposes of subsection (1), the provisions of the following that relate to professional services, medical services or items are specified:\n (a) the Act and regulations made under the Act;\n (b) the National Health Act 1953 and regulations made under that Act.\n (4) For the purposes of paragraph (1)(b), the location is:\n (a) for items 6082 and 6084—Part 2 of the general medical services table (which deals with attendances); and\n (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).\n (5) For the purposes of subsection (1), the health services are as follows.\n\n```html\n

Transcatheter mitral valve services

Column 1

Item

Column 2

Description

Column 3

Fee ($)

6082

Attendance at a TMVr suitability case conference, by a cardiothoracic surgeon or an interventional cardiologist, to coordinate the conference, if:

(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

52.95

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

Applicable once each 5 years

39.50

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:

(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.)

1,490.25

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:

(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.)

1,490.25

\n```","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"TMVr suitability case conferences","content":"#### 6 TMVr suitability case conferences\n\n (1) This section sets out the requirements that a case conference must meet to be a TMVr suitability case conference.\n (2) The requirements are as follows:\n (a) the conference must be for the purpose of determining if a patient is suitable for a service described in item 38461 or 38463;\n (b) the conference must last at least 10 minutes;\n (c) the conference must be conducted by a team of at least 3 participants, including:\n (i) a cardiothoracic surgeon; and\n (ii) an interventional cardiologist; and\n (iii) a specialist or consultant physician, neither of whom will provide a service to the patient to which item 38461 or 38463 applies;\n (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;\n (e) the coordinator of the conference must ensure that the patient:\n (i) is aware of the purpose and nature of the conference; and\n (ii) has consented to the conference being held; and\n (iii) is made aware of the recommendations made as a result of the conference;\n (f) during the conference:\n (i) each member of the team must provide expertise in assessing the patient and informing the recommendations to be made; and\n (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\n (iii) the team must make a recommendation as to whether the patient is suitable for a service described in item 38461 or 38463;\n (g) the coordinator must create a record of the conference, including:\n (i) the day the conference is held; and\n (ii) the time the conference starts and ends; and\n (iii) the names of each of the participants of the conference; and\n (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.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"Indexation","content":"#### 7 Indexation\n\n (1) At the start of 1 July 2025 (the indexation time), each amount covered by subsection (2) is replaced by the amount worked out using the following formula:\n ![1.024 multiplied by the amount immediately before the indexation time](image.002.png)\n\n> Note: The indexed fees could in 2025 be viewed on the Department of Health and Aged Care’s MBS Online website (https://www.mbsonline.gov.au).\n\n (2) The amounts covered by this subsection are the fee for each item in a Schedule of this Determination.\n (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).","sortOrder":5}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"The instrument establishes new MBS items and rules for TMVr services without amending broader classes or removing existing services. It confines change to treating specified TMVr services and conference attendances as professional/medical services under the Health Insurance Act and sets eligibility, accreditation and indexation rules (see ss5–7). There is no text indicating a change from an earlier stated legislative scope."},"complexity_factors":["Detailed clinical eligibility and exclusion criteria for two procedure items (items 38461 and 38463), including diagnostic thresholds, ejection fraction and prior treatment limits (see s5(5)).","Accreditation dependence: surgeons, cardiologists and hospitals must be accredited by the TMVr accreditation committee to qualify (see s4; s5(5)(c)).","Multidisciplinary suitability case conference requirements: minimum team composition, duration, consent, assessment obligations and record‑keeping (see s6).","Linking novel services to locations within the existing General Medical Services table and specifying corresponding fees by State (see s5(1)(b), s5(4)).","Temporal and reuse limits: items and attendances are applicable only once each 5 years for a patient (see s5(5) and items 6082/6084).","Cross‑statutory application: treatment as professional and medical services for provisions of the Health Insurance Act and the National Health Act (see s5(1),(3)).","Indexation mechanics and rounding rule effective 1 July 2025, applying a 1.024 multiplier and 5‑cent rounding (see s7).","Procedural delivery constraints (transfemoral venous delivery requirement unless contraindicated) and device‑specific naming (see s5(5)(c),(d))."],"plain_english_summary":"This Determination creates four Medicare items for transcatheter mitral valve repair (TMVr) and related suitability case‑conference attendances, setting specific fees, clinical eligibility rules, accreditation requirements and a 5‑year frequency limit. It affects accredited cardiothoracic surgeons, interventional cardiologists, participating hospitals and patients who meet the clinical and conference criteria; Medicare pays the listed fees and those fees are indexed from 1 July 2025."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a targeted, single-purpose instrument that does exactly what its name suggests — it establishes Medicare rebates for transcatheter mitral valve repair services. The scope remains tightly focused on this specific cardiac procedure and its prerequisite case conferences, with no evidence of scope creep beyond the original intent."},"complexity_factors":["Multiple nested conditions for eligibility (patient criteria, accreditation requirements, case conference prerequisites, and 5-year frequency limits)","Cross-references to the Health Insurance Act 1973 and National Health Act 1953 for definitions and operational rules","Specific technical medical terminology requiring clinical knowledge (e.g., 'left ventricular ejection fraction', 'transfemoral venous delivery', 'degenerative vs functional mitral valve regurgitation')","External accreditation dependency — services only payable if performed by TMVr accreditation committee-approved practitioners and hospitals","Two distinct procedural items (38461 and 38463) with nearly identical structures but different clinical indications (degenerative vs functional regurgitation)","Indexation formula with specific rounding rules in section 7"],"plain_english_summary":"This bill adds Medicare rebates for transcatheter mitral valve repair (TMVr), a less invasive option for people with severe mitral regurgitation who are high surgical risk, funding both the multidisciplinary case review and the procedure itself. \n\nCoverage is tied to strict clinical criteria and requires accredited clinicians and hospitals plus a formal multi‑specialist case conference, expanding subsidised access while aiming to ensure appropriate patient selection."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination","history":"/api/acts/health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination/history","analysis":"/api/acts/health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination/analysis","conflicts":"/api/acts/health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination/conflicts","importantCases":"/api/acts/health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination/important-cases","documents":"/api/acts/health-insurance-section-3c-general-medical-services-transcatheter-mitral-valve-repair-determination/documents"}}