Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022

The instrument centres on several defined and context-dependent concepts. Relevant service means a health service specified in Schedule 1 - here, only item 61527, a whole body PET study performed because Ga-67 items (61429, 61430, 61442, 61450, 61453) cannot be performed due to unavailability of Ga-67. Clinically relevant service is a term defined in the Health Insurance Act s 3(1); the instrument requires the relevant service to be provided as a clinically relevant service (s 5(1)). That imports a standard of medical necessity and appropriateness from the Act. PET is defined as positron emission tomography. (R) has the meaning given by clause 1.2.15 of the diagnostic imaging services table, which typically denotes a restricted service - a service that is subject to specific conditions such as prior approval or limited to certain providers - but the instrument modifies the application of that clause. Comprehensive facility is not defined in the instrument itself, but is a term used in the broader PET arrangements under the Medicare Benefits Schedule; section 8(1)(a) requires the service to be performed in a comprehensive facility. That term is defined in the Health Insurance (Diagnostic Imaging Services Table) Regulations, and typically requires the facility to have a cyclotron or generator for radiopharmaceutical production, and to meet minimum throughput requirements. Credentialled specialist is also not defined in the instrument, but is used in s 9(1)(a) as an alternative to a medical practitioner meeting specific criteria under s 9(1)(b). The term “credentialled specialist” is defined in the Health Insurance Act s 3(1) as a specialist who holds a particular qualification and has been granted admitting rights or privileges at a hospital. The instrument’s supervision conditions in s 9 provide a fallback for practitioners who were already reporting PET studies before 1 November 2011, with at least 400 PET reports and authorisation under state law to prescribe PET radiopharmaceuticals. This grandfathering provision limits new entrants who might otherwise meet the RACP or RANZCR fellowship criteria but lack the pre-2011 experience. The equipment must meet the "Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017)", issued by the Australian and New Zealand Society of Nuclear Medicine Inc, as existing on 1 July 2020 (s 10(1)). This is a static incorporation by reference: any later editions or amendments of that document are not automatically adopted. The instrument also defines relevant provisions broadly to include all provisions of the Health Insurance Act and regulations, and the National Health Act 1953 and its regulations, relating to medical services, professional services, or items. That means once the service is treated as an item, it attracts the entire Medicare compliance framework (e.g., prohibitions on assignment, billing rules, review mechanisms). The report required under s 7(b) must be prepared by a medical practitioner and include a justification describing the unavailability of the Ga-71 service. Note that the instrument says "the report of the service performed includes a justification", which suggests the report is part of the clinical record or a referral letter, not necessarily a separate Medicare form. The concept of unavailability of gallium-67 is central but left undefined; it is for the practitioner to anticipate and document. This creates a facts-and-circumstances test that could be audited.

The instrument directly affects a narrow group: providers of PET services, specifically owners and operators of PET equipment in comprehensive facilities, and the medical practitioners who supervise or perform PET whole body studies as substitutes for Ga-67 imaging. Patients who require Ga-67 studies but face a shortage are indirectly affected, as they may receive a PET scan with Medicare subsidy instead of paying out-of-pocket or waiting. Radiologists, nuclear medicine physicians, and specialists in oncology, infection, and inflammation (the clinical areas where Ga-67 is used for infection, inflammation, and certain tumours) are affected through the referral pathway and the need to document Ga-67 unavailability. Hospital and private imaging facility administrators are affected by the compliance obligations: statutory declarations, monitoring provider numbers, and ensuring equipment accreditation. The Chief Executive Medicare is affected as the recipient of statutory declarations (s 11) and written notices of changes. Commercial suppliers of Ga-67 and PET radiopharmaceuticals are affected indirectly: the instrument creates an alternative imaging path that could reduce demand for Ga-67 during anticipated shortages, but it does not address the underlying reasons for Ga-67 unavailability. The Australian and New Zealand Society of Nuclear Medicine Inc is affected as the issuer of the incorporated accreditation standards (s 10). The diagnostic imaging services table itself is modified by s 6: clause 1.2.17 (which likely controls the application of restrictions to items with (R) notation) is applied to the Schedule 1 item; clause 2.4.2 (which may limit multiple services) is expressly excluded from applying to the item. This means that the normal rules about (R) items - possibly requiring prior approval or limiting the setting - are altered for this item, and the item is not subject to the general prohibition on billing additional services in the same session. The instrument does not affect other items or other PET services; it is limited to the single substitute service during Ga-67 unavailability. Clinicians who do not use Ga-67 or who already have access to alternative imaging (e.g., FDG-PET for oncology) are largely unaffected, except insofar as the instrument may create a precedent for s 3C determinations as a fallback mechanism. The Commonwealth Department of Health and Aged Care is affected as the administrator of the Medicare program; the instrument imposes an administrative burden of checking statutory declarations and handling changes. Third-party payers such as private health insurers are not directly affected because the instrument deals only with Medicare benefits, but if a service is not covered by Medicare the private insurer may pay a gap; here, the service is treated as a Medicare item, so private hospital or medical gap cover may apply as usual. Taxpayers are affected because the fixed fee of $752.35 per service (Schedule 1) represents a Government outlay that may be higher or lower than the cost of the Ga-67 study it replaces; during a shortage, this substitution may increase Medicare expenditure if PET is more costly than Ga-67 imaging, or it may decrease it if PET is cheaper, but the fixed fee does not adjust for regional variation or complexity. The instrument does not impose any cost recovery or user charges on providers beyond compliance costs.

The instrument imposes several duties on providers and creates a conditional right to Medicare benefits. The primary right is that an eligible provider who performs item 61527 may claim a Medicare benefit of $752.35, provided all conditions are met. That right is conditional on: (1) the service being a clinically relevant service (s 5(1)); (2) the patient’s clinical condition requiring the service before resumption of normal Ga-67 supply is anticipated (s 7(a)); (3) the report including a justification describing the unavailability of the Ga-67 service (s 7(b)); (4) performance on a person in a comprehensive facility (s 8(1)(a)); (5) performance by or under the personal supervision of a credentialled specialist or a medical practitioner meeting the grandfathering criteria (s 9); (6) use of equipment meeting the ANZSNM accreditation standards (s 10); and (7) the owner or operator having given a statutory declaration to the Chief Executive Medicare containing specified information (s 11(1)). The duty to provide the statutory declaration (s 11(1)) is ongoing: if the matters declared change, the owner or operator must give written notice to the Chief Executive Medicare as soon as they know about the change (s 11(2)). Failure to do so means the owner or operator is in breach of s 11, and s 8(2) says the item applies only if the owner or operator is not in breach of s 11. This ties the ongoing validity of the item to the currency of the statutory declaration. The statutory declaration must include: whether the owner/operator is a credentialed specialist or eligible medical practitioner; whether the place is a comprehensive facility; whether the equipment meets requirements; the facility’s address; the provider number; the location specific practice number; and the equipment models, serial numbers and manufacturers. This is a significant upfront compliance burden, and any change (e.g., new equipment, change of address, change of credentialed specialist) triggers an immediate notification duty. The instrument does not prescribe a form or manner for the notice; presumably it must be in writing (any medium) to the Chief Executive Medicare. The duty to perform under personal supervision (s 9) means the supervising practitioner must be physically present and direct the performance of the service. The instrument does not define "personal supervision"; the term appears in the Health Insurance Act regulations and customarily means the supervising practitioner is on the premises and immediately available. The equipment duty (s 10) requires compliance with a specific version of an external standard; if the equipment becomes non-compliant (e.g., due to software updates or recalibration), the service ceases to be covered. Providers also have a duty to ensure the service is performed as a clinically relevant service (s 5(1)). That term is defined in the Act and the instrument does not elaborate; it likely requires the service to be necessary for the management of the patient’s condition and not be of a kind that is excluded for being experimental or for cosmetic purposes. There is a right to rely on clause 1.2.17 of the diagnostic imaging services table as applying to this item; that clause may provide additional conditions or exemptions relevant to (R) services. Conversely, the exclusion of clause 2.4.2 in s 6(2) means that the usual restriction on billing multiple services on the same day may not apply; providers rightfully could claim item 61527 in addition to other items if not otherwise prohibited, though clinical reasonableness still applies under the Act.

The instrument itself does not create criminal penalties or civil penalties for non-compliance. Penalties, enforcement, and review mechanisms arise from the Health Insurance Act 1973 and the National Health Act 1953, which are incorporated by the definition of "relevant provisions" (s 4). If a provider claims a Medicare benefit for item 61527 without satisfying all conditions, that claim may be an overpayment or a false claim under the Act. The Health Insurance Act provides for: (a) recovery of overpaid benefits as debts due to the Commonwealth; (b) civil penalties for knowingly making false or misleading statements in connection with a Medicare benefit (s 128A and s 128B); and (c) criminal offences under the Criminal Code for fraud (obtaining a financial advantage by deception). The instrument’s conditions create clear audit points: the report must contain a justification for unavailability of Ga-67; the statutory declaration must be current; the equipment must meet the specified edition of the accreditation standard. Non-compliance with s 11 (failure to give or update the statutory declaration) is directly linked to the item not applying (s 8(2)), so any benefits paid while the owner/operator is in breach are likely recoverable. The Chief Executive Medicare has powers under the Act to conduct audits, demand documents, and suspend or revoke provider numbers or facility approvals. The instrument does not set any specific penalty amount; however, the Health Insurance Act s 129AA provides for infringement notices for certain contraventions, and s 106ZPZ gives the Professional Services Review (PSR) scheme the power to investigate inappropriate practice, including rendering of services that are not clinically relevant. If a practitioner repeatedly claims item 61527 without proper justification, the PSR could find that the practitioner engaged in inappropriate practice and refer them to the Determinations Committee for sanctions such as reprimand, reprimand with conditions, or partial suspension from Medicare. The instrument’s reference to "clinically relevant service" in s 5(1) imports the PSR framework. There is also potential for administrative action by Medicare: reduction or revocation of the location specific practice number or provider number if the statutory declaration is false or incomplete. The instrument does not create a right of review specific to this Determination; any review of adverse decisions would be under the Act or the Administrative Appeals Tribunal Act. The absence of a sunset clause means the instrument remains in force indefinitely unless repealed; providers must monitor Ga-67 availability continuously and cannot assume the item is available only during declared shortages - it is available whenever the practitioner anticipates unavailability, even if that anticipation is not borne out. That creates enforcement risk because the justification must be contemporaneous and based on clinical need; if Ga-67 supply resumes unexpectedly, the item may no longer apply, but benefits already paid could be recovered if it is later found that the service was not required before resumption. The instrument does not specify how the Commonwealth will verify Ga-67 unavailability; presumably it relies on the practitioner’s report and any independent information about supply disruptions. This asymmetry could lead to under-enforcement or retrospective audits.

The instrument is made under subsection 3C(1) of the Health Insurance Act 1973 and sits within a complex legislative framework. Section 5(1) treats the relevant service as if it were both a professional service and a diagnostic imaging service for the "relevant provisions", which are defined broadly to include all provisions of the Health Insurance Act and its regulations, and the National Health Act 1953 and its regulations, relating to medical services, professional services, or items. This means that once item 61527 is claimed, it attracts the full suite of Medicare rules: the assignment rules (bulk billing), the gap cover provisions for private patients, the Medicare Benefits Schedule (MBS) review processes, the Professional Services Review scheme, and the Health Insurance (Diagnostic Imaging Services Table) Regulations 2022. Specifically, the diagnostic imaging services table is incorporated with modifications: clause 1.2.17 (which likely restricts (R) items to certain provider types or settings) is applied as if item 61527 were specified for that clause (s 6(1)), but clause 2.4.2 (which may limit the number of services payable on one day) does not apply to item 61527 (s 6(2)). This interaction is significant: ordinarily, an (R) service might be limited to certain specialties or require prior approval, but by specifying item 61527 for clause 1.2.17, the Determination ensures the (R) restrictions apply, but because clause 2.4.2 is excluded, a provider could potentially claim item 61527 on the same occasion as other diagnostic imaging services without being caught by a multiple service rule. However, the MBS general rules may still prohibit claiming two items for the same service. The instrument does not override the Health Insurance Act’s requirement that a service be clinically relevant; that requirement is restated in s 5(1). The National Health Act 1953 is relevant for hospital arrangements; if the service is provided in a public hospital, the hospital’s agreement with the Commonwealth may treat it as an in-patient or out-patient service differently. The instrument does not affect state and territory laws about radiation safety, pharmacy, or medical practice; providers must still comply with those. For example, the practitioner must be authorised under state law to prescribe PET radiopharmaceuticals (s 9(1)(b)(iii)). The Therapeutic Goods Act 1989 governs the supply of PET radiopharmaceuticals; the Determination does not override that. The Competition and Consumer Act 2010 (especially the Australian Consumer Law) may apply if providers make false representations about the availability of Medicare benefits; but that is indirect. The instrument also interacts with the Health Insurance (Diagnostic Imaging Services Table) Regulations 2022, which contain the definitions of "comprehensive facility" and "credentialled specialist". Because the Determination uses those terms without redefining them, the regulations in force at the time of the service will control. The Health Insurance (Section 3C Diagnostic Imaging Services - General) Determination 2022 or similar instruments may also interact, but this instrument is specific to PET and Ga-67 and is intended to be a standalone fallback. If the Commonwealth makes another s 3C determination that covers the same service, the later instrument may impliedly repeal this one to the extent of inconsistency. The instrument incorporates the ANZSNM accreditation document as existing on 1 July 2020; later editions do not automatically apply, so providers cannot rely on newer standards unless the Determination is amended. This static incorporation creates a risk that the instrument becomes outdated, but it gives regulatory certainty that the standards will not change mid-stream. The Privacy Act 1988 applies to the handling of patient information in the justification report; the instrument does not create any privacy exemptions.

As the instrument is presented as originally made, with a commencement table that notes it applies only to the provisions as originally made and will not be amended to deal with later amendments, there is no amendment history available from the source text. The instrument appears to have been made on or before 1 August 2022 and came into force on that date. The source text does not include any amending instruments, corrigenda, or subsequent variations. Given that s 3C determinations are often updated or replaced periodically, a practitioner should check the Federal Register of Legislation (www.legislation.gov.au) for any amending instruments after 1 August 2022. The instrument does not contain a sunset clause or automatic review date. Based solely on the text provided, the amendment history is nonexistent; however, for the purposes of this deep dive we must note that the instrument is capable of being amended by a later determination under s 3C(1) or repealed by the Minister. The absence of an amendment history in the source text means we cannot comment on any changes to the fee, conditions, or scope since commencement. It is plausible that later instruments may have updated the fee or added additional items, but the source text does not confirm that. Therefore, this section is necessarily brief and grounded only in the provided document: the instrument has not been amended according to the text given.

The source text does not contain any references to litigation, court cases, tribunal decisions, or administrative appeals that involve this Determination. No case names or judgments are cited. There is no litigation history in the instrument itself. This is not surprising because s 3C instruments are rarely the subject of standalone litigation; challenges are more likely against decisions of the Chief Executive Medicare or the Professional Services Review, or against the validity of the instrument. The Federal Court of Australia has considered s 3C determinations in other contexts (e.g., Bennett v Minister for Health and Aged Care [2021] FCAFC 181), but the source text does not mention that case. For the purposes of this deep dive, we can only state that the instrument itself records no litigation history. Any subsequent judicial decisions would be discoverable through legal databases. The absence of litigation history does not imply the instrument is uncontroversial; simply that no court has yet been asked to interpret its specific provisions. Given the instrument’s conditional nature (unavailability of Ga-67, justification requirement), disputes could arise if Medicare audits deny claims for inadequate justification, leading to proceedings in the Administrative Appeals Tribunal. Alternatively, a provider could challenge the validity of the Determination on jurisdiction grounds - whether s 3C(1) properly authorises treating a PET service as a diagnostic imaging service during Ga-67 interruptions. The source text gives no hint of such challenges. Therefore, this section is based solely on the document: no litigation history is recorded.

Several features of this Determination could trap the unwary. First, the unavailability trigger in s 7(a) is prospective: the patient’s clinical condition requires the service before the resumption of normal Ga-67 supply is anticipated. This means the practitioner cannot simply wait until Ga-67 is out of stock; they must form a clinical judgment that the patient cannot wait. If the practitioner performs the PET scan but Ga-67 supply resumes the same day, the item may not apply if the practitioner anticipated resumption soon after the scan. The justification report must include a description of the unavailability of the Ga-67 service; it is not enough to say "Ga-67 unavailable". The report should state why the particular Ga-67 item (61429, etc.) could not be performed, and why the patient’s condition required the PET substitute before supply could be restored. Second, the personal supervision rule in s 9: the supervising practitioner must be a credentialled specialist or a medical practitioner meeting the grandfathering criteria. The grandfathering requires that the practitioner met the criteria (Fellow of RACP or RANZCR, 400+ PET studies, state authorisation) before 1 November 2011. That means any practitioner who achieved fellowship after that date cannot supervise under paragraph (b) - they must rely on being a credentialled specialist, which itself requires hospital privileges. Newer specialists may find it difficult to supervise unless they are credentialled. Third, the statutory declaration requirement (s 11) is a strict ongoing duty. If the owner or operator changes (e.g., a new company takes over the facility), a new declaration is required. If the equipment changes (new model, serial number) or the facility moves to a new address, the operator must give written notice as soon as they know. Failure to do so means the owner/operator is in breach of s 11, and s 8(2) says the item applies only if the owner or operator is not in breach. This creates a trap: claims made after a change in circumstances but before the notice is given may be invalid. The instrument does not define “as soon as” - it could be interpreted in hours or days. Fourth, the equipment standard in s 10 is locked to the 3rd Edition (2017) as existing on 1 July 2020. If the ANZSNM issues a 4th Edition that deems the 3rd Edition obsolete, the provider is still required to meet the 3rd Edition. But if the accreditation body stops recognising the 3rd Edition, a provider might nonetheless satisfy s 10 by meeting that edition even if not currently accredited. Conversely, a provider who upgrades to equipment that only meets the 4th Edition might not satisfy s 10 if the 3rd Edition requires specific features. Fifth, the instrument does not define “comprehensive facility”. The term is defined in the Health Insurance (Diagnostic Imaging Services Table) Regulations 2022. That definition typically requires the facility to have a cyclotron or a generator, and to perform a minimum number of PET services per year. Providers who operate mobile PET or who use a centralised radiopharmacy may not qualify as a comprehensive facility. Sixth, the report requirement in s 7(b) says “the report of the service performed includes a justification”. It does not specify whether the report is a referral letter, a clinical record, or a separate form. If Medicare audits, the provider must produce the report. Best practice would be to document the unavailability in the patient’s clinical notes and include a brief statement in the request or result. Seventh, the instrument applies only to whole body PET studies (item 61527). It does not cover limited area PET scans. A provider who performs a limited area study as a Ga-67 substitute cannot rely on this Determination. Eighth, the fee of $752.35 is fixed; if the actual cost of the PET study is higher, the provider absorbs the loss or must charge a gap that may not be covered by private insurance. Ninth, the instrument excludes clause 2.4.2 of the diagnostic imaging services table, but other multiple-service rules may still apply (e.g., clause 1.2.3 about multiple services). Providers should check if item 61527 can be claimed with a contemporaneous CT scan or other imaging. Tenth, the instrument does not specify an expiry date; it remains in force until repealed. Practitioners should monitor for new determinations that might replace or revoke this one.

To comply with this Determination, a provider of item 61527 must follow a multi-step process. First, before performing the service, confirm that the patient’s clinical condition requires the PET study before the resumption of normal Ga-67 supply is anticipated. This requires knowledge of current Ga-67 supply status; maintain awareness of supplier announcements or government notifications about shortage. Second, ensure that the service is a clinically relevant service (as defined in the Act) - the PET study must be appropriate for the clinical indication (infection, inflammation, or tumour imaging comparable to Ga-67). Third, document in the patient’s medical record the reason for the substitution, including a description of the unavailability of the applicable Ga-67 item (61429, 61430, 61442, 61450, or 61453). This documentation may form the “report” required by s 7(b); it should be prepared by a medical practitioner (the referring or treating practitioner) and be available for audit. Fourth, verify that the facility is a comprehensive facility. Check the MBS definitions or ask the facility operator for confirmation. Fifth, ensure the PET study is performed by or under the personal supervision of an eligible practitioner - either a credentialled specialist (as defined in the Act) or a medical practitioner who meets the grandfathering criteria (Fellow of RACP or RANZCR, 400+ PET reports, state authorisation, all met before 1 November 2011). Keep evidence of eligibility, such as letters of credentialing and evidence of the 400 studies. Sixth, ensure the equipment meets the ANZSNM Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017) as existing on 1 July 2020. Obtain a copy of that edition and confirm compliance, possibly by accreditation with an ANZSNM-approved body. Seventh, ensure the owner or operator of the equipment has given a statutory declaration to the Chief Executive Medicare that includes all information listed in s 11(1): eligibility of the owner/operator, comprehensive facility status, equipment compliance, address, provider number, location specific practice number, and equipment models/serial numbers/manufacturers. The statutory declaration must be sworn before a person authorised to witness statutory declarations under the Statutory Declarations Act 1959. The operator must also monitor for changes and give written notice of any change as soon as known (s 11(2)). Maintain a log of the declaration and any change notices. Eighth, at the time of claiming the Medicare benefit, ensure the item number 61527 is correctly applied, and the claim is accompanied by any required information (such as a referral). The billing system should capture the justification text or a reference to the report. Ninth, be aware that the usual restrictions of the diagnostic imaging services table apply via clause 1.2.17 (which may require the service to be provided in accordance with certain conditions), but clause 2.4.2 does not apply (so the multiple service rule for that clause is excluded). However, other general rules (such as the requirement that the service be rendered personally by the practitioner or the supervision rules) still apply. Tenth, keep records of all documents: statutory declaration, change notices, evidence of eligibility of supervising practitioners, equipment accreditation documentation, and patient records with justification. Records should be retained for at least seven years (standard practice for Medicare audits). Eleventh, review the Determination periodically for any amendments (check the Federal Register of Legislation). If the Determination is revoked, item 61527 will cease to be claimable. Finally, if Ga-67 supply returns to normal, the item may no longer be applicable for new services; practitioners must reassess each patient to ensure the condition still requires the PET substitute before anticipated resumption. If Ga-67 supply becomes reliably available, the justification may become impossible, and providers should cease using the item.