The instrument directly affects providers of PET nuclear medicine services who wish to claim Medicare benefits for the three specified substitute services. This includes credentialed specialists (as defined under State or Territory credentialing processes) and a grandfathered group of medical practitioners who are Fellows of the Royal Australasian College of Physicians (RACP) or the Royal Australian and New Zealand College of Radiologists (RANZCR), who have reported 400 or more PET studies for which a Medicare benefit was payable, who are authorised under State or Territory law to prescribe and administer PET radiopharmaceuticals, and who met these requirements before 1 November 2011 (s 9(1)(b)). That grandfathered group cannot be expanded. The instrument also affects the owners or operators of PET equipment used in comprehensive facilities: they must provide a statutory declaration to the Chief Executive Medicare with specific information about credentialing, facility details, provider numbers, and equipment serial numbers. If any of those matters change, they must notify in writing as soon as they become aware (s 11(2)). Patients are affected insofar as they can access PET substitutes during technetium‑99m shortages only if the practitioner determines the clinical need is urgent enough to require the service before normal supply resumes. This creates a potential inequality of access depending on the practitioner’s willingness to document the justification. The compliance burden falls primarily on the providers and operators, who must ensure personal supervision by the narrow class of eligible practitioners, equipment certifications, and ongoing declaration accuracy. There is no direct effect on referring practitioners, except that the requesting practitioner cannot supervise the service unless they meet the s 9 criteria (s 9(1)(b) excludes the requesting practitioner).

The primary duty on a provider seeking to bill items 61333, 61336, or 61341 is to ensure that the service meets all conditions set out in ss 7-11. Under s 7, the practitioner must make a clinical judgment that the patient’s condition requires the service before the resumption of normal technetium‑99m supply, and the report of the service must include a justification describing the unavailability of the equivalent standard service (items 61348, 61402, 61421, or 61425). This imposes a documentary duty that goes beyond a standard clinical note. Under s 8, the service must be performed in a comprehensive facility and in accordance with ss 9 and 10. Section 9 imposes a duty of personal supervision: the service must be performed by or under the personal supervision of either a credentialled specialist or a qualifying medical practitioner from the grandfathered group. The supervisor cannot be the requesting practitioner. Section 10 requires the equipment to meet the ANZSNM’s 3rd Edition accreditation requirements as at 1 July 2020. The owner or operator has a duty under s 11 to provide a statutory declaration to the Chief Executive Medicare containing seven specified categories of information. That declaration must be current; if any matter changes, the owner or operator must give written notice as soon as they become aware. Providers have the right to claim the fees specified in the Schedule ($443.35, $605.05, $600.70) but those fees are fixed for the instrument’s life. The instrument does not confer a right to appeal refusal of a benefit; such rights exist under the broader Health Insurance Act. In practice, if a provider fails to comply with any condition, the service will be treated as not being an item and no benefit will be payable, potentially exposing the provider to overpayment recovery or professional sanctions.

The instrument itself does not set out penalty amounts or criminal offences. Instead, it operates within the enforcement framework of the Health Insurance Act 1973. Because s 5 deems the relevant service to be an item in the diagnostic imaging services table, the usual rules for incorrect claims, false statements, and overpayments apply. Under the Act, knowingly making a false or misleading statement in connection with a Medicare benefit can lead to civil penalty provisions, criminal prosecution, and administrative action including suspension from Medicare. The statutory declaration required by s 11 is given to the Chief Executive Medicare; if it contains false information, the provider could face penalties under the Criminal Code for giving false or misleading information to a Commonwealth officer, which carries a maximum penalty of 12 months imprisonment (Criminal Code s 137.1) or potentially higher if fraud is proven. Additionally, the Professional Services Review scheme can investigate whether the service was “clinically relevant” and whether the practitioner engaged in inappropriate practice. Because the instrument requires a written justification in the report (s 7(b)), a failure to include that justification or inclusion of a false justification would be a breach of the item conditions, making the service non‑claimable and potentially triggering recovery of benefits paid. The Chief Executive Medicare also has powers to direct repayment of incorrectly paid benefits. There is no specific penalty in the instrument for failing to notify changes to the statutory declaration (s 11(2)), but the failure could result in the operator being in breach of s 8(2) (the condition that the owner or operator not be in breach of s 11), which would disentitle the service from being an item. The practical risk is that retrospective audits uncover non‑compliance years later, leading to large debts and possible referral to the Director of Public Prosecutions.

The instrument is expressly made under s 3C(1) of the Health Insurance Act 1973, which allows the Minister to determine that a health service is to be treated as a professional service and a medical service, and to specify fees. The definition of “relevant provisions” in s 4 sweeps in all provisions of the Health Insurance Act, its regulations, the National Health Act 1953, and the National Health Act regulations that relate to medical services, professional services or items. This means that once a service satisfies the instrument’s conditions, it is treated exactly as if it were a scheduled item for all purposes: assignment of benefit, bulk‑billing rules, safety net thresholds, and the Medicare Benefits Schedule (Diagnostic Imaging Services) Table. Section 6(1) applies clause 1.2.17 of the diagnostic imaging services table to the Schedule 1 items, which likely deals with reporting requirements. Section 6(2) expressly disapplies clause 2.4.2, which in the main table restricts the circumstances in which multiple imaging services can be claimed. The interaction with the National Health Act 1953 is significant because that Act governs pharmaceutical benefits and the supply of radiopharmaceuticals. The instrument does not itself authorise the supply of PET radiopharmaceuticals; that authority comes from State and Territory law (s 9(1)(b)(iii)). The instrument also interacts with the Health Insurance (Diagnostic Imaging Services Table) Regulation 2020 (or its successor) because the items are treated as if part of that table. There is potential interaction with state radiation safety laws for equipment accreditation - the instrument adopts the ANZSNM requirements, which themselves may reference state licensing. The instrument does not override the Privacy Act 1988; patient consent for the statutory declaration’s information is an operational matter. Importantly, the instrument does not interact with the Competition and Consumer Act 2010 directly, but the restriction on who can perform services (grandfathered practitioners only) may raise competition issues if challenged. The instrument is silent on any relationship with private health insurance; presumably the Medicare benefit is the primary benefit.

The provided text of the instrument shows no amendment history. The instrument is titled the Health Insurance (Section 3C Diagnostic Imaging - Nuclear Medicine Services) Determination 2019, suggesting it was originally made in 2019. The version supplied contains an incorporation reference in s 10 to the ANZSNM requirements “as existing on 1 July 2020”, which implies that the instrument may have been amended or at least updated to that reference date after its original making. However, no amending instruments are included. Section 4(2) provides that references to provisions of the Acts or regulations as applied, adopted or incorporated for specifying a matter are references to those provisions as in force from time to time - that is, a dynamic reference for the substantive Acts. But the equipment standard in s 10 is static, frozen at 1 July 2020. Without seeing the original determination or any subsequent amending determinations, it is not possible to state with certainty what changes have been made. Practitioners should check the Federal Register of Legislation for the current compilation of this instrument. The instrument does not contain any sunsetting date (s 3C determinations may have a limited life, but that is not stated). The absence of an amendment history in the source text means any amendments, if they exist, are not captured here. Users must verify the current version. This instrument may have been remade or varied after 2020, particularly if the ANZSNM issued a 4th edition or if technetium‑99m supply disruptions became more systematic.

The provided text contains no reference to any litigation or court decisions. This is not surprising for a narrow, time‑limited determination that creates substitute items during supply interruptions. Because the instrument has been in force since at least 2019, there may have been administrative appeals to the Administrative Appeals Tribunal or the Federal Court about refusal of benefits under these items, but no such cases are mentioned. The instrument’s conditions are detailed, which could give rise to disputes about whether a justification is sufficient, whether a patient’s clinical condition required the service before normal supply resumed, or whether a practitioner met the grandfathered criteria. The exclusion of the requesting practitioner from performing the service (s 9(1)(b)) could be challenged as an unreasonable restriction, but no litigation is recorded. The statutory declaration requirement could also attract litigation if changes were not notified in time and benefits were clawed back. Without any reported decisions, it is safe to say that this instrument has not yet generated significant judicial attention. However, that may change if the Commonwealth intensifies Medicare compliance audits. The instrument’s reliance on external standards (ANZSNM requirements) could also lead to litigation if equipment is deemed non‑compliant and the operator disputes the interpretation of those requirements. For now, the litigation history is a blank slate, and the instrument operates with little judicial gloss.

Several traps await unwary practitioners. First, the grandfathering provision in s 9(1)(b) is extremely narrow: the medical practitioner must have met all four subparagraphs before 1 November 2011. Anyone who became a Fellow, or completed 400 studies, or obtained authorisation after that date is permanently ineligible. There is no pathway for new practitioners to qualify. Second, the justification required by s 7(b) must describe the unavailability of the specific standard item (61348, 61402, 61421, or 61425). A generic statement that technetium‑99m is unavailable is insufficient - the report must name the unavailable item number. Third, the equipment requirement in s 10 adopts the ANZSNM 3rd Edition as at 1 July 2020, not any later edition. If the ANZSNM updates its requirements, the instrument will not automatically incorporate them, so equipment compliant with a newer edition may not necessarily satisfy the frozen standard. Operators should check that their accreditation matches the 2017 edition. Fourth, the statutory declaration under s 11 must be given to the Chief Executive Medicare before the service is performed. A failure to give the declaration, or a change in circumstances not promptly notified, means the owner or operator is in breach of s 11, and by s 8(2) that disentitles the service from item status. This creates strict liability: even an innocent failure to notify could result in denied benefits. Fifth, the definition of “comprehensive facility” is not defined in the instrument. Practitioners must look to other Medicare guidance or the Health Insurance Act to determine what qualifies. This ambiguity creates risk if the Chief Executive Medicare takes a restrictive view. Sixth, the fees in the Schedule are not indexed; they remain $443.35, $605.05, and $600.70. Inflation will erode their real value, but providers cannot claim more. Seventh, clause 2.4.2 of the diagnostic imaging services table is disapplied (s 6(2)), meaning the usual restrictions on claiming multiple imaging services on the same day may not apply. However, the instrument does not affirmatively allow multiple claims - providers must still comply with other table rules. Finally, the instrument only applies during technetium‑99m interruptions, but nowhere defines what constitutes an “interruption”. Practitioners must exercise clinical judgment, and the Chief Executive Medicare may later question whether a genuine interruption existed.

To claim a Medicare benefit for items 61333, 61336, or 61341, the provider must follow this compliance steps sequentially. First, confirm that technetium‑99m is genuinely unavailable and that the patient’s clinical condition requires the PET substitute service before normal supply resumes. The practitioner should document both facts in the patient’s clinical record and in the report. Second, ensure the service is performed in a “comprehensive facility”. If uncertain what that means, seek guidance from the Department of Health and Aged Care or Medicare’s provider liaison. Third, verify that the person performing or supervising the service qualifies under s 9: either a credentialled specialist or a grandfathered medical practitioner who was a Fellow of RACP or RANZCR, had reported 400+ PET studies, was authorised to administer PET radiopharmaceuticals, and met all those criteria before 1 November 2011. The supervisor cannot be the referring practitioner. Keep evidence of these qualifications on file. Fourth, confirm that the PET equipment meets the ANZSNM’s Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017) as at 1 July 2020. Obtain a current accreditation certificate referencing that edition. Fifth, the owner or operator must give a statutory declaration to the Chief Executive Medicare containing the information listed in s 11(1)(a)-(g). The declaration should be kept updated; any change in credentialing, facility, equipment serial numbers, or provider numbers must be notified in writing as soon as the owner or operator becomes aware. Sixth, when preparing the report for the service, include a clear justification that describes the unavailability of the relevant standard item (e.g., “cannot perform item 61348 due to technetium‑99m unavailability”). The report must also include any other information required by clause 1.2.17 of the diagnostic imaging services table (applied by s 6(1)). Seventh, bill using the relevant item number and the fee specified in Schedule 1. The fee is the scheduled benefit; the provider can bill the patient the gap if they choose not to bulk‑bill, subject to the usual Medicare rules. Eighth, maintain all records - the justification, supervision evidence, equipment accreditation, and the statutory declaration - for at least the period required under the Health Insurance Act (generally 5-7 years). Finally, if the supply of technetium‑99m resumes, the items cannot be used unless a separate new interruption occurs. The instrument does not confer ongoing entitlement; each service must independently satisfy all conditions.