Health Insurance (Section 3C – Diabetes Testing in Aboriginal and Torres Strait Islander Primary Health Care Sites) Determination 2025

This legislative instrument, made under subsection 3C(1) of the Health Insurance Act 1973, modifies the Medicare benefit framework for three specific diabetes testing services when provided within the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS) Program. It deems those testing services as if they were professional services and medical services, and as if there were an item in the pathology services table that is related to the service. That deeming operation means Medicare benefits become payable for these services even though no ordinary MBS item covers them in that context.

The instrument lists three pathology items in Schedule 1, under Group P9 - Simple Basic Pathology Tests: item 73839 (quantitation of HbA1c for diagnosis of diabetes in asymptomatic high risk patients, one test per 12 months, fee $16.80); item 73840 (quantitation of glycosylated haemoglobin in management of established diabetes, maximum four tests per 12 months, fee $17.00); and item 73844 (quantitation of urinary albumin/creatinine ratio in random spot collection in management of established diabetes or patients at risk of microalbuminuria, no stated frequency limit, fee $20.35). These fees are set at relatively low levels compared to typical pathology item fees, reflecting the point of care nature of the testing.

The instrument applies only when four cumulative circumstances are met (section 6): the service is rendered by or on behalf of a medical practitioner; that practitioner or their employing organisation participates in the QAAMS Program; the service is provided in accordance with that program; and the medical practitioner has determined the service to be necessary for their patient. It commences on 1 March 2026 and repeals the earlier 2015 determination of the same name (Schedule 2). The effect is a continuation and updating of the mechanism that permits these diabetes tests to attract Medicare benefits when performed at Aboriginal and Torres Strait Islander primary health care sites participating in the QAAMS Program, rather than requiring patients to attend external pathology laboratories.

The instrument does not itself create a Medicare benefit. Instead, it triggers the operation of the Health Insurance Act’s provisions that govern benefit payment. Section 7 uses the phrase “as a clinically relevant service” but does not define that term further, leaving clinical judgment to the medical practitioner making the necessity determination under section 6(d). The definition of “relevant provisions” (section 5(1)) is broad, encompassing 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 forces the instrument to interact with the entire Medicare regulatory architecture rather than operating in isolation.

Relevant service: This term is defined in section 5(1) as a health service (as defined in subsection 3C(8) of the Act) that is specified in the Schedule. The only services specified are the three pathology items in the table under Schedule 1. A health service under section 3C(8) of the Act has an extended meaning that goes beyond medical services to include a health service that is not a medical service but is performed by or on behalf of a medical practitioner. This is critical because the tests listed are pathology tests that would ordinarily be professional services but may not be medical services; the deeming in section 7 resolves that gap.

QAAMS Program: Defined in section 5(1) as the program known as the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services Program, funded by the Department of Health, Disability and Ageing, to provide a culturally appropriate and clinically effective diabetes diagnosis and management service for First Nations people. The definition is static - it does not incorporate future program documents by reference - but the requirement in section 6(c) that the service be provided “in accordance with the QAAMS Program” means operational rules of the program (such as testing protocols, quality assurance procedures, and participant requirements) become binding conditions through the instrument. Changes to the program rules by the Department will change the compliance burden without further legislative amendment, which introduces a risk of regulatory creep.

Relevant provisions: Defined broadly in section 5(1) as all provisions of the Health Insurance Act 1973 and regulations, and the National Health Act 1953 and regulations, relating to medical services, professional services or items. This is the entire regulatory corpus that governs Medicare billing. Section 7 then treats the relevant service as if it were a professional service and a medical service, and as if there were a related pathology item. That deeming is the machinery that unlocks Medicare benefits. The breadth means that the instrument does not merely create a narrow exception; it plugs the service into the full body of Medicare law, including rules on assignment, gap payments, and prohibition on certain billing practices.

Clinically relevant service: Appears in section 7 but is not defined in the instrument. It likely imposes a requirement that the service meet some threshold of clinical appropriateness beyond the medical practitioner’s necessity determination. Since the instrument is made under section 3C of the Act, which allows the Minister to specify services that are to be treated as professional services if they are “clinically relevant”, the phrase carries statutory weight. Its absence of definition creates interpretive uncertainty; a court might read it as requiring the service to be in accordance with accepted medical practice or supported by evidence of effectiveness. Providers cannot safely assume that meeting the four circumstances in section 6 automatically satisfies the clinically relevant condition.

Medical practitioners and organisations participating in the QAAMS Program: These are the immediate addressees of the instrument’s conditions. The instrument only applies if the service is rendered by or on behalf of a medical practitioner (section 6(a)), and that practitioner or their employing organisation participates in the QAAMS Program (section 6(b)). The QAAMS Program is primarily delivered through Aboriginal Community Controlled Health Services and other Aboriginal and Torres Strait Islander primary health care sites. Medical practitioners working in these settings, including general practitioners and possibly other doctors, are the ones who will determine necessity and order the tests. The instrument does not require the practitioner to perform the test personally; it says “rendered by or on behalf of a medical practitioner”, which could permit nurses or Aboriginal health workers to perform the test under the practitioner’s supervision, so long as the practitioner has made the necessity determination.

Aboriginal and Torres Strait Islander patients: The instrument is targeted through the QAAMS Program, which is described in the definition as providing a “culturally appropriate and clinically effective diabetes diagnosis and management service for First Nations people”. The instrument does not expressly limit the services to Aboriginal and Torres Strait Islander patients, but the program condition in section 6(b) and (c) effectively makes that limitation because the QAAMS Program is designed for that population. Patients gain access to these point of care diabetes tests at participating sites with Medicare benefits covering the service. The frequency limits on items 73839 and 73840 restrict how often a patient can receive each test on Medicare; exceeding those limits would require alternative funding or private payment.

The Department of Health, Disability and Ageing: Administers the QAAMS Program and will enforce compliance with program rules. The instrument puts the Department in a gatekeeping role: it controls program participation, which is a precondition for the instrument to apply. The Department can also change the QAAMS Program rules, thereby altering what it means to provide a service “in accordance with” the program without needing to amend the instrument. This gives the Department flexibility but also creates regulatory uncertainty for providers who must keep pace with program changes.

Pathology service providers: The instrument deems there to be an item in the pathology services table related to the service. This does not necessarily mean that a pathology laboratory performs the test; the tests are likely point of care tests conducted within the primary health care site. However, the deeming may bring the service within the broader pathology regulatory framework, including quality standards and accreditation requirements. Providers of point of care testing devices and reagents used in the QAAMS Program will see demand tied to the Medicare subsidy.

Duty to participate in QAAMS Program: Section 6(b) imposes a condition that the medical practitioner or their organisation must be participating in the QAAMS Program. This is not a duty created by the instrument itself; it is a condition precedent for the instrument to apply. Practitioners or organisations that are not participants cannot claim Medicare benefits for these services, even if they provide identical tests. The instrument does not create a right to participate; that is a matter of program administration by the Department. Practitioners who are participants therefore have an ongoing duty to maintain their participation and comply with program rules, as failure to do so would remove the basis for claiming.

Duty to provide service in accordance with QAAMS Program: Section 6(c) requires the service to be provided in accordance with the QAAMS Program. This incorporates whatever protocols, quality assurance procedures, and clinical guidelines the program prescribes. The duty is ongoing and may change as the program evolves. Because the instrument does not set out those rules, practitioners must refer to program documentation that is not part of the legislative instrument. This creates a compliance burden: a practitioner cannot simply read the instrument to know what is required; they must also obtain and follow the QAAMS Program rules, which may not be freely available or may be subject to change without notice.

Duty of the medical practitioner to determine necessity: Section 6(d) requires the medical practitioner to have determined the service to be necessary for their patient. This is a clinical judgment duty. The instrument does not prescribe factors for the determination or require documentation, though prudent compliance would involve recording the basis for necessity. The determination must be made by the medical practitioner who renders the service or on whose behalf it is rendered; it cannot be delegated to a nurse or other health worker, even if they perform the actual test. This duty imposes a real cost in consultation time; the practitioner must assess each patient individually rather than ordering tests on a routine or standing basis.

Right to have service treated as professional and medical service: Section 7(a) deems the relevant service to be both a professional service and a medical service for the relevant provisions. This is the core benefit: it unlocks Medicare benefits that would not otherwise be payable. The right attaches only to services that meet all the conditions in section 6; otherwise, the deeming does not apply and the service would need to qualify under ordinary MBS items or be privately funded.

The instrument itself does not create any penalties, but it operates within the enforcement framework of the Health Insurance Act 1973. The most relevant penalty provisions are those dealing with false or misleading claims. If a service is claimed under this instrument but does not meet the four circumstances in section 6, the claim would be improper and could attract liability under section 128A of the Act (false representations in relation to Medicare payments). That section imposes criminal penalties: a person who knowingly or recklessly makes a false representation in connection with a Medicare benefit claim may be liable to imprisonment for up to 12 months or a fine of up to 100 penalty units, currently $31,300 for an individual or $156,500 for a body corporate. Civil penalty provisions under Part IIB of the Act also apply, with penalties up to 500 penalty units for improper claiming.

Enforcement of the necessity determination (section 6(d)) would require evidence that the medical practitioner did not genuinely consider the test necessary. This is a subjective threshold, but if an audit reveals systematic overuse of item 73844 (which has no frequency limit) without documented clinical justification, the Department could argue the necessity condition was not met. The instrument requires the practitioner to have actually determined necessity; a retrospective claim that the test “would have been necessary” would not satisfy the condition if no determination was made at the time.

Non compliance with the QAAMS Program conditions (sections 6(b) and (c)) is also enforceable indirectly. If the Department determines that a service was not provided in accordance with QAAMS Program rules, it could raise a breach of the instrument, potentially leading to recovery of benefits paid. The Department can also remove a practitioner or organisation from participation in the QAAMS Program, which would prospectively prevent further claims under this instrument. That removal process is not governed by the instrument; it would be a matter of administrative action under the program, potentially subject to judicial review.

The Commonwealth can seek recovery of overpayments under section 129 of the Health Insurance Act, which allows recovery of benefits paid in excess of the amount properly payable. This is a civil debt, not requiring proof of fraud. An incorrect claim under this instrument would likely result in a recovery notice, and if not paid, the Commonwealth could sue. There is no internal review mechanism specified in the instrument for disputing recovery decisions; general administrative law remedies would apply.

Health Insurance Act 1973: This is the primary statute under which the instrument is made. Section 3C of the Act gives the Minister power to specify health services that are to be treated as professional services and medical services for Medicare purposes. The instrument exercises that power. It also interacts with the ordinary MBS provisions: section 7 deems there to be an item in the pathology services table, which means the service is treated as if it were covered by an existing item. That avoids the need for the instrument to create new items by amending the MBS. However, it means the instrument operates by legal fiction; the listed items (73839, 73840, 73844) are not actually in the pathology services table. This could cause confusion in billing systems or audit processes, where an item number may not exist in the official schedule.

National Health Act 1953: The definition of “relevant provisions” includes that Act and its regulations. The interaction is primarily through pharmaceutical benefits and related matters, but the instrument’s deeming of services as professional and medical services may affect eligibility for certain pharmaceutical benefits that require a medical service as a precondition. The instrument does not specify which provisions of the National Health Act are affected; the broad definition means any provision relating to medical services or items could be engaged.

Legislation Act 2003: The instrument is a legislative instrument subject to registration, tabling, and disallowance. It was made on an unspecified date but registered before commencement. The note in section 5(1) references the Legislative Instruments Act 2003 (now the Legislation Act 2003) regarding expressions having same meanings as in the Act. The parliamentary scrutiny committee may examine the instrument, and it is subject to disallowance for a period after registration. Practitioners should be aware that the instrument could be disallowed, which would mean the 2015 determination would remain in force (if not already repealed) or the field would be left without a section 3C determination for these services.

The repealed 2015 determination: Schedule 2 repeals the Health Insurance (Diabetes Testing in Aboriginal and Torres Strait Islander Primary Health Care Sites) Determination 2015. The 2025 Determination largely mirrors the structure of the 2015 determination, but with updated item fees and the addition of item 73844 (urinary albumin/creatinine ratio), which did not appear in the 2015 version. The repeal means any savings or transitional arrangements in the 2015 determination cease. There is no transitional provision in the 2025 Determination, so services provided before 1 March 2026 but claimed after that date would need to be made under the 2015 determination; conversely, services provided after 1 March 2026 must meet the 2025 Determination conditions.

The instrument is a new instrument that replaces the Health Insurance (Diabetes Testing in Aboriginal and Torres Strait Islander Primary Health Care Sites) Determination 2015. The 2015 determination was the previous section 3C instrument covering diabetes testing in this context. The 2025 Determination updates the item numbers and fees, adds the urinary albumin/creatinine ratio test (item 73844), and makes minor drafting changes.

The instrument itself has not been amended since its making; it is in its original form. The commencement table in section 2 is stated to relate only to the provisions as originally made and will not be amended to deal with any later amendments. This is standard wording but means that the table will become obsolete if the instrument is ever amended; those amendments would have their own commencement provisions.

Section 5(2) provides that references to provisions of Acts or regulations are references to those provisions as in force from time to time. This means that any future amendments to the Health Insurance Act, the National Health Act, or their regulations will automatically affect the operation of this instrument. For example, if the Act is amended to redefine “professional service” or to change the effect of section 3C, the deeming in section 7 may be altered, expanded, or restricted without any change to this instrument.

The instrument does not include any transitional provisions. That means there is no grace period for providers to adapt to the new instrument from the 2015 determination. The 2015 determination is repealed in full effective 1 March 2026 (section 2, Schedule 2). Any service provided on or after that date must satisfy the 2025 Determination conditions. Providers who fail to adjust their practices (e.g., by using old item numbers or failing to ensure QAAMS program participation as defined) risk making improper claims.

There is no amendment history for the 2015 determination recorded in this instrument. The source text does not provide that information, and we cannot assume any amendments were made to the old instrument. The 2025 Determination is a clean replacement, not an amendment of the 2015 instrument.

This instrument is new and has not been the subject of any reported litigation. The source text does not refer to any cases. The predecessor instrument, the 2015 determination, may have been litigated, but we have no source for that and cannot assume. The instrument is a minor and specific legislative instrument that does not create novel legal questions likely to generate litigation. However, there are potential grounds for future judicial review or disputes.

One potential area is the interpretation of “clinically relevant service” in section 7. If a claim is disputed, a court may need to determine what that phrase means, given it is not defined. The Administrative Appeals Tribunal or a federal court could consider whether a particular service met that threshold. Similarly, the meaning of “necessary for their patient” in section 6(d) could be litigated if the Department disputes a practitioner’s clinical judgment.

Another possible pathway is challenge to the Department’s administration of the QAAMS Program. If a practitioner is removed from the program, they lose the ability to claim under this instrument. That removal might be challenged under the Administrative Decisions (Judicial Review) Act 1977, arguing that the removal was procedurally unfair or that the program rules were applied unreasonably. Since the instrument depends on program participation, an adverse decision by the Department effectively terminates the practitioner’s rights under the instrument, which could be seen as a de facto revocation of a benefit.

The instrument could also be the subject of a disallowance motion in Parliament, which is a form of political review rather than litigation. If disallowed, the instrument would cease to have effect, which would eliminate the Medicare coverage for these testing services unless a replacement instrument were made. That would be a significant disruption for affected providers and patients.

Given the low monetary values involved and the niche application, significant litigation is unlikely. The instrument’s effect is to allocate modest fees for point of care tests within a specific program. Disputes are more likely to be handled administratively through Medicare compliance processes than through courts. The instrument’s clarity on conditions (section 6) should reduce interpretive disputes compared to some other section 3C determinations.

The definition of QAAMS Program is static but the requirement to provide services in accordance with it is dynamic. The definition in section 5(1) describes the program as one “funded by the Department of Health, Disability and Ageing” without incorporating any document. However section 6(c) requires the service to be provided “in accordance with the QAAMS Program”. If the Department changes the program’s clinical protocols, testing methods, or documentation requirements, those changes automatically become part of the condition for claiming. Providers cannot rely on the definition alone; they must keep up with program updates, which may not be published as legislative instruments or easily accessible.

Item 73844 has no frequency limit, but the necessity determination must be made each time. Unlike items 73839 and 73840, which state explicit maximums per 12 month period, item 73844 has no cap. This creates a risk of overuse. A doctor could theoretically order this test every visit if they deemed it necessary each time. That discretion may invite scrutiny by Medicare auditors, who could argue that the necessity determination was not genuine or that the test was not clinically relevant. The absence of a cap does not mean unlimited use; the medical practitioner must still satisfy section 6(d) each time.

The instrument does not state which MBS item is “related to the service” under section 7(b). It simply says there is an item “related to” the service. This could be read as creating a hypothetical item that is not actually in the pathology services table. In practice, the Department will treat the Schedule 1 items as the fictional item numbers for claiming purposes. But the legal uncertainty means that a court could interpret “related to” differently. If the item is not actually listed in the MBS, technical requirements of the Act relating to items (such as the requirement that an item specify the fee and conditions) might not be satisfied. The instrument avoids this problem by using the deeming power, but it is a potential weakness if challenged.

The instrument uses the phrase “by or on behalf of a medical practitioner” in section 6(a). This permits delegation of the actual performance of the test to someone else, such as a nurse or Aboriginal health worker, as long as it is on behalf of the medical practitioner. However, the necessity determination in section 6(d) must be made by the “practitioner referred to in paragraph (a)” - that is, the medical practitioner on whose behalf the service is rendered. If a nurse performs the test but no doctor has determined necessity, the condition fails. In busy clinics, this may be overlooked if the test is ordered by a nurse under a standing protocol. Standing orders are unlikely to satisfy the requirement for a specific determination for each patient.

For a medical practitioner or organisation participating in the QAAMS Program, compliance begins with ensuring ongoing participation in that program. The practitioner or organisation must be listed as a current participant with the Department of Health, Disability and Ageing before the service is rendered. Participation is not automatic; it requires application and meeting program eligibility criteria, which may include quality assurance accreditation, training requirements, and reporting obligations. Check with the Department’s QAAMS Program administration for current requirements, as these may change without legislative amendment.

When providing a relevant service, confirm that all four circumstances in section 6 are satisfied at the time of service. First, the service must be rendered by or on behalf of a medical practitioner; if a nurse or other health worker will perform the test, document that it is done under the supervision or delegation of a specific doctor. Second, confirm that the practitioner or their employing organisation is currently participating in QAAMS; maintain records of participation status, including any certificates or correspondence from the Department. Third, ensure the service is provided in accordance with the QAAMS Program; this means following the program’s clinical guidelines, using approved testing devices, adhering to quality assurance procedures, and completing any required documentation or data submission. Fourth, the medical practitioner must make an individual determination that the test is necessary for that particular patient; it is best practice to record the clinical basis for that determination in the patient’s health record, including factors such as diabetes risk, symptoms, or management needs.

Use the correct item number for claiming: 73839 for HbA1c diagnosis, 73840 for management HbA1c, or 73844 for urinary albumin/creatinine ratio. Ensure frequency limits are observed: item 73839 may be claimed only once in a 12 month period, and item 73840 up to four times in a 12 month period. For items 73839 and 73840, the 12 month period is not defined; it likely means a rolling 12 month period from the date of each test, not a calendar year. Maintain records to track all claims for each patient to avoid exceeding caps. For item 73844, there is no cap, but still record the necessity determination each time; auditors may query high frequency usage.

Ensure the service qualifies as a “clinically relevant service” as required by section 7. While that term is not defined, treat it as requiring the service to be supported by current medical evidence and appropriate for the patient’s clinical situation. Do not perform tests that are not indicated simply because the item exists.