Health Insurance (Section 3C General Medical Services—Transcatheter Mitral Valve Repair) Determination 2021

The core concept is the deemed MBS item. Section 5(1) treats each service as if it had always been in the general medical services table. This avoids the need for a full amendment of the table and allows targeted coverage for a specific technology. The location of the deemed item matters: items 6082 and 6084 sit in Part 2 (attendances) of the table, while items 38461 and 38463 sit in Subgroup 6 of Group T8 (cardio‑thoracic surgical operations) of Part 5. This placement affects how the items interact with other MBS rules such as the scheduled fee for attendances or the requirements for surgical operations.

TMVr accreditation committee is a body administered by Cardiac Accredited Services Limited, a private company. It accredits both practitioners and hospitals. This is a form of private standard setting with public effect: only accredited entities can perform the service or host it. The committee is not a government body, but its decisions directly control access to Medicare benefits. This raises the risk of capture or anti‑competitive behaviour, as the instrument does not prescribe criteria by which the committee must accredit. Practitioners or hospitals denied accreditation have no statutory review mechanism in this instrument.

TMVr suitability case conference is a mandatory procedural step before any claim for item 38461 or 38463. Section 6 sets out seven requirements. The conference must last at least ten minutes, involve at least three participants (one cardiothoracic surgeon, one interventional cardiologist, and one specialist or consultant physician who will not perform the TMVr), and at least one participant must be accredited. The coordinator must ensure the patient is informed and consents, and the team must assess risk and technical suitability for both the TMVr and conventional surgical mitral valve replacement, including cognitive function and frailty. A written record must be kept. The conference may be billed separately via items 6082 and 6084, each capped at once per five years per patient.

Clinically relevant service is the trigger for deeming under s 5(2). This term is defined in the Health Insurance Act and requires the service to be reasonably necessary for the patient’s clinical management. It imports an additional layer of clinical judgment that may be scrutinised under Medicare compliance audits.

Indexation is set at a fixed factor of 1.024 from 1 July 2025. This is not tied to CPI or any other economic indicator; it is a simple statutory increase. The note points to MBS Online for updated fees. The rounding rule in s 7(3) means the fee after multiplication will be to the nearest five cents, down for exact multiples of 2.5 cents.

Patients with degenerative or functional mitral regurgitation meeting the specific echocardiographic and clinical thresholds are the direct beneficiaries. The instrument opens a Medicare funded alternative to open heart surgery for those deemed at unacceptably high surgical risk. The five‑year rule means each patient can access the benefit only once in that period, which reduces the potential for repeat procedures and limits total taxpayer exposure per patient over time. Patients who do not meet the strict criteria (for example, LVEF below 20% for degenerative MR, or LVEF outside 20‑50% for functional MR) are excluded, regardless of clinical judgment. The requirement for a multidisciplinary conference adds a time cost and potential access delay.

Cardiothoracic surgeons and interventional cardiologists gain a new billable item, but only if they obtain and maintain accreditation from a private body. They must also participate in case conferences, which may not be billable by all participants (only the coordinator and the specialist attendee have specific items). Specialists who are not performing the procedure (the third participant) cannot bill for that attendance unless they are the coordinator, but they might bill other items. This creates a compliance burden and may deter some specialists from participating, reducing conference availability.

Hospitals that perform TMVr must be accredited by the TMVr accreditation committee. This imposes a cost and a potential barrier to entry for smaller or regional hospitals. The instrument does not specify criteria for hospital accreditation, leaving it to the private committee. Hospitals that cannot obtain accreditation lose the ability to host the procedure and attract public patients seeking this care.

Private health insurers are indirectly affected because the MBS item determines the Medicare benefit, which in turn affects patient out‑of‑pocket costs and insurer gap cover calculations. The instrument does not directly regulate insurers, but the fee schedule influences market pricing.

Taxpayers bear the subsidy cost per procedure ($1,490.25 plus associated conference items). The indexation provision will increase that cost from 2025. There is no mechanism in the instrument to limit volume; utilisation is controlled only by the clinical criteria, accreditation, and the five‑year rule.

The instrument imposes a set of procedural duties on practitioners and hospitals before a Medicare benefit can be claimed. The primary duty is conducting a TMVr suitability case conference that complies with s 6. The coordinator must ensure the patient is informed of the purpose and nature of the conference, has consented, and is made aware of the recommendations. The team must assess risk and technical suitability for surgical replacement as well as TMVr, and must consider cognitive function and frailty. A record must be created including date, start and end times, participant names, and details of the assessment and recommendations. This record is likely to be requested in a Medicare compliance audit.

The accreditation duty is not legally imposed by this instrument on practitioners or hospitals; rather, it is a condition for the service to be treated as an MBS item. If the practitioner or hospital is not accredited, the service cannot be claimed. In practice, this creates a strong incentive to obtain accreditation from the TMVr accreditation committee, even though the committee is a private body not subject to this Determination. The right to be accredited is not guaranteed; the instrument does not set criteria or a review process.

The patient right to informed consent and to be told the conference recommendations is explicit. However, there is no right to a conference if the treating practitioner does not arrange one, nor a right to a particular outcome. The patient also has the right to refuse the conference (consent must be given).

The right to claim the Medicare benefit arises only if all conditions are met: the service is clinically relevant; the item specific criteria (e.g., LVEF range, NYHA class, prior conference) are satisfied; the delivery route is transfemoral venous unless contraindicated; and the five‑year exclusion has not been triggered. The practitioner must also be the accredited person performing the service. For the conference items, the coordinator must be accredited to perform the TMVr service (s 6(2)(d) requires at least one participant to be accredited; item 6082 requires the coordinating surgeon or cardiologist to be accredited). Item 6084 requires the attending specialist to be other than the coordinator but does not expressly require accreditation for that participant, though the conference itself requires at least one accredited participant.

Documentation duties fall on the coordinator to create the record. There is no duty to retain the record for any minimum period in this instrument, but the Health Insurance Act and MBS requirements would apply.

This Determination does not itself create any penalty provisions. However, claiming a Medicare benefit for a service that does not meet the conditions is likely to be a contravention of the Health Insurance Act 1973. Section 128B of that Act makes it an offence to knowingly make a false or misleading statement in connection with a claim for a Medicare benefit. The maximum penalty is imprisonment for 12 months (or 24 months for serious fraud). Section 129 also creates an offence for obtaining payment to which a person is not entitled. The Professional Services Review scheme under Part VAA of the Act may investigate and potentially reprimand, disqualify, or impose a reprimand on practitioners who provide services that are not clinically relevant or that breach item conditions.

Because the Determination uses s 3C to deem items, the usual MBS compliance mechanisms apply. The Department of Health and Aged Care and the Medicare Benefits Schedule Compliance Program can audit claims. For hospitals, failure to maintain accreditation could result in disallowance of benefits for all TMVr services performed during the period of non‑accreditation. The TMVr accreditation committee itself is not a government body and is not subject to the Act’s penalty regime, but its decisions can have the effect of excluding practitioners or hospitals from the scheme. There is no appeal mechanism in the instrument; judicial review under the Administrative Decisions (Judicial Review) Act 1977 may be available if the committee is exercising a public function, but that is uncertain.

The indexation provision at s 7 does not impose penalties; it is a formulaic adjustment. But any error in rounding or calculation could affect the amount payable, potentially leading to overpayment recovery.

The Determination operates within the framework of the Health Insurance Act 1973 and its regulations. In particular, the concept of clinically relevant service under s 3C(2) of that Act is incorporated via s 5(2) of this instrument. The general medical services table itself is not amended; rather, the Determination deems items to exist in certain parts of it. This means that all other rules in the table that apply to attendances (Part 2) and surgical operations (Group T8) also apply to these deemed items unless otherwise provided. For example, the rule requiring a referral for specialist attendances would apply to items 6082 and 6084.

The National Health Act 1953 and its regulations are specified in s 5(3) as provisions to which the deeming applies. This affects hospital arrangements and private health insurance benefit rules. A hospital that is accredited may be able to claim additional Commonwealth subsidies for the procedure, but that depends on broader hospital funding agreements.

The Private Health Insurance Act 2007 may interact indirectly: the MBS fee sets a benchmark for insurer gap cover. The instrument does not reference private insurance, but in practice a patient with private health insurance may receive benefits that cover the gap between the MBS fee and the hospital’s or doctor’s charge.

The Therapeutic Goods Act 1989 is not mentioned, but the TMVr services involve the implantation of devices. Item 38463 specifically names Mitraclips™, a proprietary product. The instrument does not require TGA approval, but Australian law generally requires implantation of TGA‑registered devices. This could create a tension if the device is not registered or is used off‑label.

State and territory health legislation concerning hospital accreditation and professional registration is not displaced. The TMVr accreditation committee is separate from state health department licensing. A hospital must still comply with all state laws; the Determination adds an additional layer of private accreditation.

The Competition and Consumer Act 2010 may apply to the conduct of the accreditation committee if it unreasonably restricts access to the market for TMVr services. The instrument does not provide for oversight of the committee’s decisions.

The source text provides no amendment history other than the indexation provision at s 7, which will operate on 1 July 2025. The Determination itself is dated 2021. It would have been registered on the Federal Register of Legislation on a specific date. The instrument may have been amended between 2021 and the present, but the text supplied does not show any. Given that s 7 refers to indexation at “the start of 1 July 2025”, it is likely that the fees remain unchanged until that date. The note referencing MBS Online suggests that the Department of Health and Aged Care would publish updated fees after indexation. Without a consolidated history, the assumption must be that the instrument has not been amended in any substantive way. This is typical for s 3C determinations, which are often made for a limited period and then replaced or revoked.

The source text does not cite any cases. Given the narrow and technical nature of this Determination, litigation is unlikely. Challenges could theoretically arise if a practitioner or hospital is denied accreditation and seeks judicial review of the TMVr accreditation committee’s decision. However, the committee is a private body, so the Administrative Decisions (Judicial Review) Act 1977 may not apply unless the committee is considered to be exercising a power conferred by Commonwealth legislation. The Federal Court has not yet ruled on this issue in this context. Another possible avenue is a dispute with the Medicare Benefits Schedule Compliance Program over whether a service met the item conditions, but such disputes typically go through internal review and then the Administrative Appeals Tribunal. No reported Tribunal decisions specifically on items 38461 or 38463 are known at the time of writing.

1. Private accreditation with no statutory criteria. The TMVr accreditation committee is a private company that holds near‑monopoly power over who can perform TMVr under Medicare. The instrument does not specify the criteria for accreditation of practitioners or hospitals. This creates uncertainty and a risk that the committee could deny accreditation based on commercial considerations or subjective standards. An accredited practitioner in one jurisdiction may find their accreditation not recognised in another if the committee uses different criteria. There is no right to reasons or review.

2. Five‑year lock‑out. Once a patient receives a service under item 38461 or 38463, that patient cannot receive another such service for five years, even if the mitral regurgitation recurs or the implant fails. This may affect clinical decision making and patient access to re‑treatment.

3. Transfemoral venous delivery requirement. The item descriptions require the service to be “via transfemoral venous delivery, unless transfemoral venous delivery is contraindicated or not feasible”. This limits the approach. A practitioner who uses a different access route (e.g., transapical) because they believe it is clinically superior, or because the patient has anatomical contraindications not listed, may still need to document why transfemoral was not feasible. The instrument does not define “contraindicated or not feasible”, leaving room for compliance risk.

4. Conference participant who will not perform the procedure. The third participant in the case conference (the specialist or consultant physician) must be someone who will not provide the TMVr service to the patient. This is designed to prevent a self‑referral or biased conference. But it also means that a team must include a specialist who may not have a direct clinical relationship with the patient. That specialist must be briefed and must provide expertise. If a hospital has limited specialist availability, this requirement could delay conferences or force use of locums.

5. Conference record requirements. The coordinator must create a record including start and end times. During a busy clinical day, a conference that lasts ten minutes exactly might be documented as such, but if the record shows nine minutes, the item may not be claimable. The time requirement is strict: “at least 10 minutes”. There is no deeming of a shorter conference if the assessment is incomplete.

6. Indexation is not automatic. The indexation at s 7 will apply only from 1 July 2025. Before that date, the fees remain fixed at the amounts in the table. After indexation, the fees will increase by exactly 2.4%, not by CPI. Over the long term, this may erode or increase real value relative to inflation.

7. “Clinically relevant service” ambiguity. The service must be provided as a clinically relevant service under s 5(2). The Act defines this term s 3C(2) and it requires the service to be “generally accepted by the medical profession as necessary for the appropriate treatment of the patient”. This is a normative standard that can change over time. A service that was clinically relevant in 2021 may later be deemed obsolete, yet the instrument would still allow claims until it is revoked.

Practitioners and hospitals aiming to claim benefits under this Determination should follow a structured process.

Step 1: Obtain accreditation from the TMVr accreditation committee. The committee is administered by Cardiac Accredited Services Limited. Practitioners must be cardiothoracic surgeons or interventional cardiologists. The accreditation must cover the specific service (items 38461 or 38463). Hospitals must also be accredited. Practitioners should contact the committee directly to understand the application process, renewal periods, and any continuing education requirements. Maintain documentation of accreditation status.

Step 2: Conduct a TMVr suitability case conference as required by s 6. Assemble a team of at least three: a cardiothoracic surgeon, an interventional cardiologist, and a specialist/consultant physician who will not perform the procedure. At least one participant must be accredited. The team must assess the patient’s surgical risk, including for mitral valve replacement, and consider cognitive function and frailty. Obtain the patient’s informed consent for the conference and inform them of the recommendations. Create a written record with date, start/end times, participant names, and detailed assessment and recommendations. Retain this record for at least the Medicare audit period (typically 5 years). Be mindful that the conference must last at least 10 minutes; document the actual times accurately.

Step 3: Select the correct item based on the patient’s condition. For degenerative (primary) MR, use item 38461. For functional (secondary) MR, use item 38463. Ensure the patient meets all echocardiographic and clinical thresholds. For item 38461: moderate‑severe or severe symptomatic MR (grade 3+ or 4+), LVEF ≥ 20%, NYHA II-IV. For item 38463: same MR severity, LVEF 20-50%, LVESD ≤ 70 mm, symptoms persisting despite maximally tolerated guideline‑directed medical therapy.

Step 4: Perform the procedure in an accredited hospital using transfemoral venous access unless contraindicated. Document the reason if alternative access is used, as compliance auditors may question it.

Step 5: Check the five‑year rule. If the patient has received a service under item 38461 or 38463 in the previous five years, no benefit is payable. Maintain a system to track patient history.

Step 6: Bill with appropriate item numbers. For the conference, the coordinator bills item 6082 ($52.95) and other attending specialists bill item 6084 ($39.50). For the procedure, bill item 38461 or 38463 ($1,490.25). These fees may be indexed from 1 July 2025. Check MBS Online for the current fees.

Step 7: Ensure all claims are supported by clinical documentation demonstrating compliance with the item descriptors. Common audit triggers include incomplete conference records, missing LVEF measurements, or lack of documentation of surgical risk assessment. Practitioners should also ensure that the service is “clinically relevant” in the particular patient; this is an additional layer of review not specified in the item but imported by s 5(2). Keep a file note confirming why TMVr was chosen over surgery or medical management.