Health Insurance (Section 3C Diagnostic Imaging Services – Cardiac MRI for Myocarditis) Determination 2024

The central concept is a “relevant service” - a health service specified in Schedule 1 of the instrument. That service is item 63390, described as an MRI scan of the cardiovascular system for assessment of myocardial structure and function and characterisation, but only for the three specific indications listed. The service is to be treated as both a “professional service” and a “diagnostic imaging service” under the relevant provisions, which span the Health Insurance Act, its regulations, the National Health Act 1953, and that Act’s regulations. The concept of “permissible circumstance” is borrowed from the diagnostic imaging services table: clause 2.5.3 sets out when an MRI service can be performed (e.g. it must not be for screening, must be appropriate, etc.). The instrument incorporates that definition by reference. The requirement that the request indicate one of the three clinical scenarios is crucial. The concept of “would otherwise require endomyocardial biopsy” is a clinical judgment that the referring specialist must make; it is not defined further, raising interpretation risk. The instrument also defines “(R)” as restricted (meaning the service cannot be claimed if it is performed for a purpose outside the item descriptor), “(Anaes.)” meaning an anaesthetic is ordinarily required, and “(Contrast)” meaning the service involves administration of contrast agent. The definition of “MRI” is taken from the diagnostic imaging services table. The instrument incorporates the concept of “eligible equipment” and “partial eligible equipment” from clauses 2.5.5 and 2.5.6, which set technical standards for MRI machines (field strength, software, accreditation). The concept of “accreditation” appears: the performing specialist must be a participant in the RANZCR Quality and Accreditation Program or be recognised by the Conjoint Committee for Certification in Cardiac MRI. This creates a barrier to entry for providers who lack those credentials. The concept of “clinically relevant service” is imported from s 3(1) of the Act, which effectively means the service is of a kind that is generally accepted in medical practice. The instrument uses a “deeming” mechanism: the service is treated as if there were an item in the diagnostic imaging services table. This avoids the need to amend the table directly, and gives the Minister flexibility under s 3C. Finally, the concept of “contrast” is handled by reference to item 63491, which is an existing item for contrast administration; the fee for the new item is additional to any fee payable for that separate item.

The determination directly affects several groups. First, patients with suspected myocarditis who meet the narrow clinical criteria: they gain access to a Medicare-funded MRI scan that previously would have to be paid out-of-pocket or through private health insurance, if available. However, only those whose condition is severe enough to be considered for endomyocardial biopsy (or, for drug-induced myocarditis, where three other tests are inconclusive) will qualify. This excludes many patients with less severe presentations or chronic myocarditis. Second, referring specialists and consultant physicians are affected because they must assess the patient and include on the request form an indication that falls within one of the three categories. They bear the burden of documenting that an endomyocardial biopsy would otherwise be required, or that troponin, chest x-ray and echocardiogram are inconclusive. This creates an administrative and clinical judgment burden. Third, providers of MRI services - radiologists and consultant physicians who perform cardiac MRI - are affected. Only those who are specialists in diagnostic radiology and participants in the RANZCR Quality and Accreditation Program, or those who are specialists in diagnostic radiology or consultant physicians recognised by the Conjoint Committee for Certification in Cardiac MRI, can perform the service and bill Medicare for it. This restricts the pool of eligible providers, which may reduce competition and increase wait times, but also aims to ensure quality. Fourth, pathology laboratories and cardiac imaging centres that offer cardiac MRI may see increased demand if they have accredited staff and eligible equipment. Fifth, the Commonwealth Department of Health and Aged Care and Services Australia (which administers Medicare) are affected: they must process claims for item 63390 and ensure compliance with the criteria. The financial impact is a new Commonwealth liability of $616.60 per scan (plus the contrast fee if applicable). The number of scans will likely be modest given the narrow indications, but if interpretation of “would otherwise require endomyocardial biopsy” is broad, costs could exceed estimates. Sixth, private health insurers are indirectly affected because the Medicare benefit reduces the amount that can be charged privately (if a patient chooses to go private, the Medicare benefit still applies). Finally, hospitals (both public and private) may see changes in practice: if cardiac MRI becomes a first-line alternative to biopsy, it may reduce the use of invasive procedures, but it may also increase demand for MRI time.

The instrument imposes duties primarily on the referring specialist or consultant physician and on the performing practitioner. The referring practitioner must have assessed the patient and must indicate in the request that the scan is for one of the three specified clinical scenarios. This duty is not merely a formality; the request must state that acute onset heart failure of less than three months from suspected myocarditis would otherwise require endomyocardial biopsy, or that unexplained arrhythmia would otherwise require biopsy, or that drug-induced myocarditis is suspected and that troponin, chest x-ray and transthoracic echocardiogram are inconclusive. The duty is to make a clinical judgment that the patient meets the criteria and to document it. The performing practitioner has a duty to ensure that the service falls within the item descriptor and that all conditions are satisfied. That includes verifying that the equipment is eligible or partial eligible, that the practitioner holds the required credentials, and that the service is performed in a permissible circumstance (clause 2.5.3). The performing practitioner also has a duty not to claim the item if the service does not meet the criteria, as doing so could constitute an offence under the Health Insurance Act (false statements). The instrument also confers rights: patients have a right to access a Medicare rebate for this service if they meet the clinical criteria and the provider is eligible. The performing practitioner has a right to charge a fee and receive the Medicare benefit (subject to the usual rules about assignment and gap payments). However, the item is a “restricted” item, meaning it cannot be used for any indication other than those specified; the practitioner has no right to bill Medicare for a cardiac MRI for myocarditis that falls outside the three scenarios. The instrument does not create a private right of action for patients if the service is wrongly denied or wrongly provided; enforcement is through the Medicare compliance system. The instrument also preserves the right to use contrast and receive the separate fee under item 63491, but only if contrast is actually used. There is no right to charge for contrast separately beyond that item.

This instrument itself does not create new penalty provisions. Instead, it applies the existing enforcement framework of the Health Insurance Act 1973 and the National Health Act 1953 to the new item. The most relevant offence is making a false or misleading statement in connection with a Medicare claim, which is an offence under s 128A of the Health Insurance Act (strict liability) or under the Criminal Code. If a practitioner claims the item 63390 fee for a service that does not meet the criteria, they could face criminal penalties, administrative penalties (such as repayment of benefits plus a penalty), or removal from the Medicare provider directory. The Professional Services Review (PSR) scheme also applies: if a practitioner engages in “inappropriate practice” by ordering or performing excessive or unnecessary services, they can be investigated and sanctioned, including reprimand, disqualification, or repayment. Because the criteria are narrow, the risk of inappropriate practice claims is higher than for a general item - a practitioner who regularly bills item 63390 for patients who do not meet the “would otherwise require endomyocardial biopsy” threshold may attract scrutiny. The instrument also incorporates provisions of the diagnostic imaging services table by reference, including clause 2.5.3 (permissible circumstances). Breach of that clause could mean the service is not a “clinically relevant service” and the claim is invalid. Services Australia can recover overpayments. Additionally, the determination is made under s 3C, which gives the Minister power to revoke or vary the determination if misuse occurs. There is no express penalty in the instrument, but the consequence of non-compliance is that the service is not treated as a professional service or diagnostic imaging service, so the Medicare benefit is not payable, and any payment already made must be refunded. Practitioners should also be aware of the requirement to satisfy the Chief Executive Medicare regarding participation in the RANZCR Quality and Accreditation Program - that is a condition for claiming. If that condition is not met, any claim would be invalid.

The determination operates within the broader legislative framework of the Health Insurance Act 1973. It is made under subsection 3C(1) of that Act, which allows the Minister to determine that a health service is to be treated as if it were listed in the MBS. This bypasses the usual process of amending the diagnostic imaging services table through a regulation or legislative instrument under s 4A, but it is a valid exercise of delegated legislation. The determination expressly incorporates definitions from s 3(1) of the Act (clinically relevant service, diagnostic imaging services table, etc.). It also applies the “relevant provisions”, which include the Act, regulations under the Act, the National Health Act 1953, and regulations under that Act. This means that all the rules about claiming, assignment of benefits, Medicare safety nets, and prohibitions on fee splitting apply. The determination interacts with the Health Insurance (Diagnostic Imaging Services Table) Regulations 2024 (or the table in force) by deeming that item 63390 is to be treated as if it were an item in that table. That means the general rules in the diagnostic imaging services table - such as the rules on who can perform diagnostic imaging services (Part 2.5), the prohibition on multiple services (clause 1.2.15), and the requirement for a request in writing - apply to this item. Clause 2.5.4 (which restricts who can perform items in certain subgroups) is specifically made applicable. The determination also interacts with the Health Insurance (General Medical Services Table) Regulations for anaesthetic services (since the item is marked Anaes.). If an anaesthetic is required, the usual rules for claiming anaesthetic items apply. The determination also interacts with the National Health Act 1953 regarding pharmaceutical benefits and private health insurance: if a patient is admitted to hospital and the service is hospital-related, the rules about hospital treatment and Medicare eligibility may apply. There is no interaction with state workers’ compensation or motor vehicle accident schemes, except that those schemes often use Medicare as a benchmark - the creation of a new item may influence how those schemes fund cardiac MRI. The determination may also interact with the Therapeutic Goods Act if the MRI machine or contrast agent is subject to regulation, but that is not direct. Importantly, the determination does not affect the existing item 63491 for contrast administration; it merely adds that the fee for the new item is additional to that item. There is no amendment to other instruments; this is a standalone determination.

This is a new instrument, made in 2024 and commencing on 1 January 2025. There are no amendments to it yet, as it is a first version. The instrument was likely published on the Federal Register of Legislation in late 2024. There is no information in the source about any predecessor determinations or earlier versions. However, the use of s 3C determinations for cardiac MRI is not unprecedented; there are other s 3C determinations for cardiac MRI for other conditions (e.g. for ischaemic heart disease, cardiomyopathy). This determination adds myocarditis as a new indication. The instrument is not an amendment to an existing determination; it is a separate instrument. Practitioners should be aware that the Minister may later amend or revoke it, for example, if evidence changes or if budget savings are needed. Because s 3C determinations are time-limited or conditional, there may be a sunset clause in the instrument (none is stated, so it continues indefinitely until amended or revoked). The instrument does not include a review date. The commencement table shows only whole-of-instrument commencement on 1 January 2025. The note indicates the table relates only to the instrument as originally made; it will not be amended. So there is no amendment history to report beyond noting its entry into force.

As at the date of the source text (the instrument itself, published in 2024, before commencement), there is no litigation history concerning this determination. No court or tribunal has interpreted its provisions. Because the instrument is new and untested, the risk of litigation is prospective. Potential areas of dispute include: the meaning of “would otherwise require endomyocardial biopsy” - is that a purely clinical judgment or is there an objective standard? If a referring specialist considers that biopsy is indicated but a reviewer disagrees, there could be disputes about whether the item was properly claimed. The phrase “inconclusive to form a diagnosis” for drug-induced myocarditis may also generate litigation if the results of troponin, chest x-ray and echocardiogram are arguable. The requirement that the request “indicates” one of the scenarios may be interpreted strictly; a request that does not use the exact wording might be rejected. There could be challenges to the validity of the determination if it is argued that the service is not a “health service” under s 3C(8) or that the Minister exceeded power. However, s 3C is broad and such challenges are rare. There is also the possibility of administrative law challenges to decisions of the Chief Executive Medicare regarding whether a specialist satisfies the accreditation requirement. The instrument does not provide a merits review mechanism, so judicial review under the Administrative Decisions (Judicial Review) Act 1977 is available. Litigation might also arise from private health insurers if they dispute coverage or from providers if they are denied payment. As yet, no cases.

Several traps exist for the unwary. First, the item is marked (R), which means it is restricted to the specific clinical indication. A practitioner who orders a cardiac MRI for a patient with suspected myocarditis but who does not meet the strict criteria (e.g. acute onset longer than 3 months, or where biopsy is not considered necessary) cannot claim item 63390. The likely alternative is to use a different item, such as item 57360 (cardiac MRI for other indications) or a general MRI item, but those may not cover the service if it is not separately listed. Practitioners must ensure the request precisely matches the descriptor. Second, the requirement that the request be made by a “specialist or consultant physician who has assessed the patient”. This means the referring practitioner must have physically examined or consulted the patient; a request based on a phone call or records review is insufficient. Third, the phrase “would otherwise require endomyocardial biopsy” is a high threshold. It does not mean “might be considered”; it means that in the referring practitioner’s clinical judgment, the alternative to MRI is an invasive biopsy. If a practitioner routinely uses MRI instead of biopsy without genuinely considering biopsy, they may later be found to have misrepresented the need. Fourth, for drug-induced myocarditis, the three tests (troponin, chest x-ray, transthoracic echocardiogram) must be “inconclusive”. If one of those tests is conclusive (e.g. troponin normal, chest x-ray normal, but echo diagnostic), the item cannot be claimed. Fifth, the provider must be either a specialist in diagnostic radiology who is a participant in the RANZCR Quality and Accreditation Program (and must satisfy the Chief Executive Medicare of that fact) or a specialist in diagnostic radiology or consultant physician recognised by the Conjoint Committee for Certification in Cardiac MRI. There is no grace period; if the provider is not accredited on the day of service, the claim is invalid. Sixth, the equipment must be eligible or partial eligible. MRI machines that are not accredited under the relevant clauses (e.g. older machines, or those used in a mobile van) may not qualify. Seventh, the item includes (Anaes.), but note that the fee of $616.60 does not include the anaesthetic fee; the anaesthetic item must be claimed separately and is subject to its own rules. Eighth, contrast administration is not included in the fee; the fee for item 63491 is additional. If contrast is used but not billed correctly, the claim may be reduced. Ninth, the internal Territory (Jervis Bay) is deemed part of New South Wales for fee purposes; providers must apply the correct state fee. Tenth, the instrument incorporates provisions of the diagnostic imaging services table as in force from time to time. If the table is amended after 1 January 2025, the rules for this item change automatically, which could affect eligibility.

Compliance requires attention at each step from referral to billing. The referring specialist or consultant physician must first assess the patient and determine whether the clinical scenario fits one of the three categories. The request (usually a written referral or electronic order) must clearly indicate which criterion is satisfied. For acute onset heart failure or unexplained arrhythmia, the request should state that endomyocardial biopsy would otherwise be required to confirm the diagnosis of myocarditis. For suspected drug-induced myocarditis, the request should indicate that troponin, chest x-ray and transthoracic echocardiogram were performed and are inconclusive. The referring practitioner should document the basis for that conclusion in the patient’s medical record. The request must be made by a specialist or consultant physician (not a general practitioner). When the service is performed, the performing practitioner must verify that they meet the credentialing requirements: if a specialist in diagnostic radiology, they must be a participant in the RANZCR Quality and Accreditation Program and satisfy the Chief Executive Medicare of that fact. If a consultant physician or specialist in diagnostic radiology, they must be recognised by the Conjoint Committee for Certification in Cardiac MRI. It is wise for the practice to maintain a register of current certifications. The equipment must be eligible or partial eligible under the diagnostic imaging services table. The practice should have documentation from the equipment manufacturer or from the RANZCR confirming accreditation. The service must also be performed in a permissible circumstance (clause 2.5.3) - meaning it is not for screening, is clinically appropriate, and is not excluded by any other rule. The performing practitioner should check that the item is not already performed for the same patient within a specified period (the table may have frequency limits). If contrast is used, item 63491 must be claimed in addition; the billing system should be set up to add that item when contrast is administered. The fee for item 63390 is $616.60 (state-based). The claim must be submitted to Medicare with the correct item number and the request details. It is advisable to keep a copy of the request and the patient’s clinical records showing compliance with the criteria for at least two years (the period for Medicare audits). Practices should also ensure that the provider number of the performing practitioner is linked to the accreditation. If the performing practitioner changes accreditation status, claims must cease until reinstated. Finally, because this is a new item under s 3C, it may be subject to heightened scrutiny by Services Australia’s compliance unit. Practices should conduct internal audits of a sample of claims to ensure the criteria are consistently met. Training for referring doctors and MRI booking staff is essential. Any doubt about eligibility should be resolved in favour of not claiming the item; alternative items or private billing should be considered.