Health Insurance (Section 3C Diagnostic Imaging Services – National Lung Cancer Screening Program) Determination 2025

The central concept is a relevant service, defined as a health service specified in a Schedule to the instrument. The only scheduled items are the two low dose CT scans under Subgroup 14. The instrument treats these services under the relevant provisions, which encompass all provisions of the Health Insurance Act, its regulations, the National Health Act 1953, and its regulations, insofar as they relate to medical services, professional services or items. This means the full Medicare compliance, claiming and enforcement framework applies to these services as if they were normal MBS items. The term low dose computed tomography (CT) and bulk billed are borrowed from the Diagnostic Imaging Services Table Regulations, so their meanings are those given in that existing instrument. Bulk billing is mandatory under paragraphs (c) of each item description: the service must be bulk billed. This removes any patient out of pocket cost but also removes the provider’s ability to charge a gap fee, which may affect viability for some providers. The eligibility criteria are defined in section 6. A patient is eligible only if they receive a request for the service as part of the National Lung Cancer Screening Program when aged between 50 years and 70 years and 364 days, are asymptomatic, currently smoke or have quit smoking in the past ten years, and have a history of cigarette tobacco smoking of at least 30 pack years. Pack years is defined as the number of cigarettes smoked per day multiplied by the number of years smoked. The instrument explicitly excludes other forms of tobacco or nicotine consumption, including vaping, from the definition of smoke or smoking. This means an electronic cigarette user, or a person who smokes only pipes or cigars, does not meet the smoking criterion regardless of risk profile. The concept of remote location is also taken from the DI table regulations and is relevant only for the mobile screening limitation. Finally, the instrument references an agreed nodule management protocol for standardised lung nodule identification, classification and reporting. The instrument does not identify who agrees this protocol, what body maintains it, or whether it is published; this lack of definition creates uncertainty for providers who must ensure compliance with an unspecified standard.

The primary affected group are patients within a narrow age band: 50 to 70 years and 364 days at the time the request is made, with a smoking history of at least 30 pack years and currently smoking or quit less than ten years ago, and without symptoms of lung cancer. For follow up scans (item 57413) the age cap extends to 71 years and 364 days provided eligibility was assessed at the initial screen. The instrument excludes anyone outside these criteria, regardless of clinical risk. Radiology providers (public and private) and mobile screening service operators are directly affected. They must decide whether to offer the service on a compulsory bulk billed basis at the set fee of $338.75. For mobile services operating more than 30 km from a fixed CT site, the instrument removes a potential table restriction, which may encourage expansion of mobile screening into rural areas. However, the bulk billing requirement may deter some providers if the fee does not cover the full cost of the scan, particularly for mobile units that have higher transport and setup costs. General practitioners and other referring practitioners must assess eligibility and confirm it in the request for the scan. The request must state that eligibility has been assessed and confirmed. This imposes a documentation and verification duty that may affect workflow and medicolegal risk if a subsequent audit finds an ineligible patient. The Department of Health and the operators of the National Lung Cancer Screening Program will be involved in monitoring uptake, managing the agreed nodule protocol, and auditing compliance. Private health insurers are not directly affected because the service is bulk billed under Medicare, but may see reduced demand for privately funded lung screening. The instrument may also affect state health services that provide CT scans, particularly if they are asked to bear costs not fully covered by the Medicare rebate. The narrow eligibility criteria mean only a fraction of current smokers will qualify; people over 71, those who quit more than ten years ago, and those with symptoms are excluded even if they face elevated lung cancer risk.

The instrument imposes several duties on providers of the service, but grants no explicit rights beyond the ability to claim the Medicare benefit (subject to compliance). The central duties are: (a) the service must be bulk billed (each item description paragraph (c)); (b) the service must utilise the agreed nodule management protocol for standardised lung nodule identification, classification and reporting (paragraph (b) of each item); (c) for item 57410, the request must state that the patient’s eligibility to participate in the National Lung Cancer Screening Program has been assessed and confirmed (paragraph (a)); (d) for item 57413, the scan must be a clinical follow up within two years of a screening 57410 scan, or a follow up of a previous interval 57413 scan that itself was linked to a 57410; (e) the patient must meet the criteria in section 6, which imposes on the provider an obligation to verify age, smoking history, pack years, symptom status, and that the request is part of the National Lung Cancer Screening Program. The instrument does not specify who conducts the eligibility assessment, but the request must state it has been done, which implies the referrer has that duty; the provider performing the scan relies on that statement but may bear residual risk if the statement is false. Providers also have the duty to apply the limitation in section 7: if the service is provided as part of a mobile screening service more than 30 km from a hospital that provides CT or fixed radiology, they cannot rely on clause 2.2.1(1)(a) of the DI table to prohibit the service; this is effectively a permission rather than a duty, but a provider must ensure they satisfy the distance criterion to access the exemption. Patients have the right to access the Medicare benefit for the service if the conditions are met, but no right to demand the service from any particular provider (the instrument does not oblige any provider to offer the service). The Commonwealth has the right to recover incorrectly paid benefits if conditions are later found not satisfied, through the enforcement mechanisms of the Health Insurance Act.

The instrument itself does not create penalties. However, because the services are treated as if there were items in the diagnostic imaging services table, the full enforcement apparatus of the Health Insurance Act 1973 and the National Health Act 1953 applies. Section 128A of the Health Insurance Act deals with false or misleading statements in connection with Medicare benefits, carrying maximum penalties of imprisonment for 12 months or 120 penalty units. Section 129 covers obtaining payment when not entitled; section 129AA covers improper claiming. The Criminal Code provisions on fraud (s 134.2 obtaining a financial advantage by deception) may also apply for serious cases. Providers who claim for a scan that does not meet all conditions (for example, the patient was symptomatic, or the nodule protocol was not used, or the scan was not bulk billed) may be liable to repay the benefit and face administrative penalties. The Professional Services Review scheme under Part VAA of the Health Insurance Act applies; a provider who engages in inappropriate practice in connection with these items (including failing to meet the clinical requirements) may face referral to the Professional Services Review Committee, which can reprimand, disqualify from Medicare, or impose conditions. Enforcement likely will focus on verification of eligibility, particularly the pack years calculation and the asymptomatic requirement. The mandatory bulk billing condition is easily auditable by checking patient invoices. The requirement to use the agreed nodule management protocol may be harder to enforce without clear published standards; the instrument does not specify which protocol is agreed, so a provider could be found non compliant if the protocol is varied or unpublished. The limitation on mobile services (section 7) is a provision for the provider’s benefit, not a penalty imposition; however, incorrectly claiming the exemption (e.g., if the mobile service is within 30 km of a hospital with CT) could lead to a claim that does not satisfy the item conditions. The onus is on the provider to ensure all conditions are satisfied.

The instrument sits within a web of existing federal health legislation. It is made under subsection 3C(1) of the Health Insurance Act 1973, which permits the Minister to determine that a health service is to be treated as a professional service even though it is not covered by a determination under section 3A (the usual MBS table). The effect is that for the relevant provisions (broadly, all Medicare and PBS rules in the HIA and National Health Act), the service is treated as if it were an item in the diagnostic imaging services table. This means the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020 are the primary table regulations, and this determination operates as a special supplement to them. The instrument explicitly does not apply clause 2.2.1(1)(a) of those regulations for mobile services more than 30 km from a hospital with CT; this is the only override. All other table provisions (e.g., provider registration, location rules, restrictions on frequency of scans, record keeping) presumably still apply unless inconsistent. The definition of bulk billed is taken from the DI table regulations, so the meaning is that given by that instrument: a service is bulk billed if the Medicare benefit is accepted as full payment for the service. The definition of CT and remote location are also from those regulations. The instrument interacts with the National Health Act 1953 only insofar as that Act’s provisions on pharmaceutical benefits may apply if the service leads to medication, but no direct link is stated. The National Lung Cancer Screening Program itself is a policy program established outside this instrument; the instrument merely provides the MBS funding mechanism. There may be interaction with state and territory radiation safety laws regarding CT scanning, but the instrument does not affect those. The instrument also may interact with the Health Insurance (General Medical Services Table) Regulations if any other MBS items are claimed in conjunction, but the items here are exclusive for the screening program. Providers must be aware that the instrument does not operate in isolation: the full legislative framework of Part II, Part IIA, and Part VAA of the HIA applies, including assignment of benefits, Medicare provider numbers, and professional review.

The instrument is newly made, with a commencement date of 1 July 2025. There are no amendments to date. As a legislative instrument under the Legislation Act 2003, it is subject to disallowance by either House of Parliament within 15 sitting days of tabling, which could occur if a future parliament objects to the policy or cost. The instrument may be amended by the Minister by making a new determination under s 3C(1) (or amending this one, though typically a fresh determination is made). Potential future amendments could adjust the fee, expand or contract eligibility criteria (e.g., lower the age, alter pack year threshold, include ex smokers beyond ten years, include vaping, or remove asymptomatic requirement), change the bulk billing condition, modify the nodule protocol reference, or add new items (e.g., for intermediate follow up or for non contrast CT with contrast). The instrument may also be repealed if the National Lung Cancer Screening Program is discontinued or if the services are migrated into the main Diagnostic Imaging Services Table through an amendment to the regulations. Practitioners should monitor the Federal Register of Legislation for any amending instruments. The note in the commencement table says that any information in column 3 is not part of the instrument, so future published versions may include editorial date insertions without legal effect.

As the instrument commences on 1 July 2025, there is no litigation history. However, several potential legal disputes can be anticipated. The eligibility criteria are tightly drawn and may give rise to disputes over what constitutes smoking (the instrument excludes vaping, pipes, cigars, and other tobacco products) and what constitutes asymptomatic. A patient with a chronic cough who is later found to have lung cancer could argue they were asymptomatic, or conversely a provider could be penalised for performing a scan on a patient with mild symptoms that turned out not to be lung cancer. The definition of pack years is straightforward mathematically but may lead to disputes over self reported versus verified smoking history. The requirement that the service be part of the National Lung Cancer Screening Program is ambiguous: is it enough that the patient is participating, or must the program have formally invited them? The instrument does not require an invitation, only that the request is part of the program. The agreed nodule management protocol is not defined; if no single protocol is agreed upon, or if different jurisdictions adopt different protocols, providers may be uncertain which to follow. A challenge to a refusal of a benefit could involve judicial review under the Administrative Decisions (Judicial Review) Act 1977, arguing that the conditions were applied incorrectly. The bulk billing condition may be challenged as an unconstitutional acquisition of property (if providers argue they are forced to accept a fee below cost), but such a challenge would face the strong presumption of validity of Medicare conditions. There may also be disputes about the distance measurement for the mobile service exemption (more than 30 km from a hospital that provides CT radiology or fixed radiology infrastructure) - the precise measurement method (road distance, straight line, from which point of the service) is not specified, creating ambiguity.

Several features of the instrument create traps for the unwary. First, the definition of smoke or smoking is exclusive: only cigarette tobacco (packaged or roll your own) counts. A patient who vapes daily but has never smoked cigarettes has zero pack years under this definition, regardless of lung cancer risk. A patient who smoked cigarettes heavily but quit 11 years ago does not meet the “quit in the past ten years” criterion, even if still at elevated risk. The age threshold operates at the time of the request, not the scan: if a patient turns 71 between the request and the scan, they may still be eligible for 57410 if the request was when they were under 71? The wording is “when they are aged between 50 years and 70 years and 364 days”; it does not specify whether the age at the time of the request or the service controls, but the natural reading is at the time they receive the request. However, paragraph 6(2) says that if assessed eligible for 57410 and 57413, the patient remains eligible for those services until they turn 71 years and 364 days. This suggests the initial eligibility is assessed before the first scan, but the follow up eligibility is extended. So a patient first screened at age 70 years and 300 days is eligible for the follow up even if they turn 71 in the interim, but only for the follow up items linked to that initial screen. If the initial request is made after the patient turns 71, no eligibility. The asymptomatic requirement is strict: a patient with any signs or symptoms of lung cancer (e.g., persistent cough, chest pain, weight loss) is ineligible for screening under this determination, even if the symptoms are mild or due to other causes. This could create a perverse incentive for patients to downplay symptoms to get the screening, which undermines clinical safety. The bulk billing requirement is absolute; the provider cannot charge any gap for this service. For mobile services, the $338.75 fee may not cover the cost of transport, set up, and interpretation, particularly in very remote areas. Providers offering the service may need to cross subsidise from other revenue. The nodule management protocol is not identified; providers must identify which protocol is “agreed” and may need to enter into agreements with the program administrators. If the protocol changes, providers must update their procedures to remain compliant. The limitation in section 7 only overrides clause 2.2.1(1)(a) of the DI table; there may be other table restrictions that still apply to mobile services (e.g., requirements about supervision, equipment standards). The instrument does not define mobile screening service, so a provider may need to rely on the ordinary meaning and any program guidelines. Finally, the instrument does not specify frequency limits between screens beyond the two year follow up window; but the National Lung Cancer Screening Program may impose additional rules, and the general MBS antichattering provisions may still apply to limit excessive claims.

Providers offering CT scans under items 57410 and 57413 should implement a structured compliance process. First, verify patient eligibility at the time the request is received. Confirm the patient is aged 50 to 70 years and 364 days for initial screening, or up to 71 years and 364 days for follow up if previously assessed. Confirm the patient is asymptomatic, currently smokes cigarette tobacco or has quit within the last ten years, and has a cigarette smoking history of at least 30 pack years (calculated as average cigarettes per day times years smoked). Retain a record of the pack years calculation and the basis for the patient’s self report (e.g., questionnaire). Ensure the referring practitioner’s request explicitly states that the patient’s eligibility to participate in the National Lung Cancer Screening Program has been assessed and confirmed. The scan must be a low dose CT of the chest without intravenous contrast medium. The scan must use the agreed nodule management protocol for standardised lung nodule identification, classification and reporting; the provider must obtain a copy of the current protocol from the program administrators and train staff accordingly. The service must be bulk billed: the Medicare benefit of $338.75 must be accepted as full payment; no additional fee may be charged to the patient or any third party. For mobile screening services, verify whether the service location is more than 30 km from a hospital that provides CT radiology or fixed radiology infrastructure. If so, clause 2.2.1(1)(a) of the DI table regulations does not apply, but other table requirements still do. Keep records of the distance calculation and the basis for the exemption. For follow up scans (item 57413), confirm that the scan is a clinical follow up within two years of a previous 57410 scan, or a follow up of a previous 57413 that itself was linked to a 57410. Document the link. All records must be retained for at least the usual Medicare audit period (generally five years). Providers should also monitor any amendments to the determination or updates to the nodule protocol, as conditions may change. Because the instrument cross references definitions from the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020, providers should be familiar with that instrument, particularly the definitions of bulk billed, CT, and remote location. Bulk billing means the Medicare benefit is accepted as full payment, so no account is sent to the patient for any amount. The instrument does not specify how the benefit is paid; standard Medicare claiming processes apply.