National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025

EXPLANATORY STATEMENT

National Cancer Screening Register Act 2016

National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025

Purpose and operation

The National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025 (the Instrument) amend the National Cancer Screening Register Rules 2017 to include mandatory and optional reporting requirements for the National Lung Cancer Screening Program (NLCSP). Specifically, these amendments will mandate reporting for radiologists for low-dose computed tomography scans in the NLCSP and authorise healthcare providers to collect smoking cessation advice on a non-mandatory basis.

Background

The National Cancer Screening Register Act 2016 (the Act) creates a legislative framework for the establishment and ongoing operation of the National Cancer Screening Register (the Register).

The Act authorises the collection, use and disclosure of information for the purposes of the Register to:

-          support the renewed National Cervical Screening Program;

-          the expansion of the National Bowel Cancer Screening Program and the newly established NLCSP; and

-          mandates the reporting of prescribed cancer screening information to the Register.

The routine collection of this information is crucial for screening processes and clinical pathways.

In line with the Medical Services Advisory Committee recommendations, the Register will also collect information on whether an NLCSP participant has received smoking cessation advice as part of the NLCSP enrolment process and participant management, noting the completion of this information will not be mandatory.

Smoking cessation advice questions fall under paragraph 11(g) of the Act and thus can only be collected by the Register if they are prescribed in the National Cancer Screening Register Rules 2017 (NCSR Rules). As per paragraph 11(g), the Minister has consulted with the Australian Information Commissioner to support this prescription.

Authority

Section 28 of the Act provides that the Minister may make rules prescribing matters required or permitted by the Act to be prescribed or which are necessary or convenient to be prescribed in order to carry out or give effect to the Act.

The NCSR Rules were made pursuant to section 28 of the Act.

 The Instrument amends the NCSR Rules. The Instrument is made for the purposes of subsection 13(1) and paragraph 11(g) of the Act. The information under paragraph11(g) is made under the purposes of paragraphs 12(1)(i) and 12(1)(j) of the Act.

The Instrument is a legislative instrument for the purposes of the Legislation Act 2003 and will be added to the Federal Register of Legislation (FRL).

Reliance on subsection 33(3) of the Acts Interpretation Act 1901

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

Incorporation by reference

Schedule 1, Item 1 amends section 4 of the NSCR Rules to include a new definition of nodule management protocol. The definition refers to, and incorporates by reference, the NLCSP nodule management protocol published by the Department of Health, Disability and Ageing, published on 29 April 2025 and as it exists on 1 July 2025. The document is incorporated as of 1 July 2025.

This protocol can be freely accessed and viewed on the Department's website, ensuring transparency and accessibility.

The note provides a link to the Department’s website for the purposes of s 14(1)(b) of the Legislation Act 2003. The link to the document is <<https://www.health.gov.au/resources/publications/nlcsp-nodule-management-protocol>>. There, a Portable Document Format (PDF) or Word Document (.docx) version of the document can be freely accessed by health practitioners and the public.

The document forms part of the Screening Tool and is a compilation of derivative and original work. It is subject to licenses set out on page 11 of that document. It is provided for use as part of the NLCSP. Any commercial use is strictly prohibited.

Members of the public, in particular relevant health practitioners, are able to access the work through the website indicated above free of charge, without risk of breaching copyright. The licence does not limit the ability of the public to access and understand the law; rather it restricts commercial reproduction of the document.

Commencement

This instrument commences on the later of: 1 July 2025, or the day after the instrument is registered.

Consultation

Radiologists and healthcare providers were consulted in relation to this amendment. Additionally, the Office of Australian Information Commissioner was consulted on inclusion of information that falls under paragraph 11(g) of the Act.

General

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

Details of this instrument are set out in Attachment A.

This instrument is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

ATTACHMENT A

National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025

Section 1 – Name

Section 1 provides that the name of the instrument is the National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025.

Section 2 – Commencement

Section 2 provides that the instrument commences on the later of: 1 July 2025, or the day after the instrument is registered.

Section 3 – Authority

Section 3 provides that the instrument is made under Section 28 of the National Cancer Screening Register Act 2016.

Section 4 – Schedules

Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1 – Amendments

National Cancer Screening Register Rules 2017

Item 1 – Section 4

Item 1 inserts a number of definitions to section 4 of the NSCR Rules.

comparison test: This term refers to a previous lung cancer screening test conducted on the same individual, where a lung nodule was observed, and the diagnostic radiologist has access to the results of this previous test.

Department of Health, Disability and Ageing: The definition clarifies that the Department of Health, Disability and Ageing is the Department administered by the Minister responsible for the National Cancer Screening Register Act 2016.

diagnostic radiologist: This definition specifies that a diagnostic radiologist must be registered under the Health Practitioner Regulation National Law in the specialty of radiology, with a field of specialty practice in diagnostic radiology.

episode number: The term episode number is defined as the unique identifier (comprising numbers, letters or both) attributed to an instance or event of healthcare during which a lung cancer screening test is conducted.

National Lung Cancer Screening Program MBS item: This definition refers to items in Schedule 1 to the Health Insurance (Section 3C General Medical Services – National Lung Cancer Screening Program) Determination 2025. The note clarifies that these items are treated as if they are in the diagnostic imaging services table under section 4AA of the Health Insurance Act 1973.

nodule management protocol: The nodule management protocol refers to the NLCSP nodule management protocol published by the Department of Health, Disability and Ageing, as existing on 1 July 2025. This protocol can be viewed on the Department's website: <<https://www.health.gov.au/resources/publications/nlcsp-nodule-management-protocol>>. The note provides a link to the Department of Health, Disability and Ageing’s website for the purposes of s 14(1)(b) of the Legislation Act 2003.

smoking cessation advice: This term is defined as advice intended to help an individual stop smoking tobacco products.

target lung nodule: The definition of target lung nodule is provided by section 11A.

Item 2 – Insert Parts 3 and 4

Item 2 inserts new Parts 3 and 4 to the instrument following section 9 of the current instrument.

Part 3—Requirement to notify—lung cancer screening

Part 3 prescribes the requirements for notifying the Commonwealth Chief Medical Officer about lung cancer screening tests. The amendments specify the type of screening test, the information that must be notified, the individual healthcare provider responsible for the notification, and the timeframe within which the notification must occur.

Section 10 - Simplified Outline of this Part

Section 10 provides a simplified outline of Part 3, explaining that it prescribes the type of lung cancer screening test and the necessary information to be notified to the Commonwealth Chief Medical Officer, the individual healthcare provider who must notify the information, and the time by which the information must be notified.

Section 11 - Purposes of this Part

Section 11 states that Part 3 is made for the purposes of subsection 13(1) of the National Cancer Screening Register Act 2016.

Section 11A - Meaning of Target Lung Nodule

Subsection 11A(1) defines a "target lung nodule" in relation to a lung screening test that is carried out by or on behalf of a diagnostic radiologist (the diagnostic radiologist). The provision provides that a “target lung nodule” means a lung nodule that:

(a) is observed by the diagnostic radiologist from the screening test, and

(b) is considered by the diagnostic radiologist not to be caused by an infectious or inflammatory process.

This definition is subject to subsection 11A(2).

Subsection 11A(2) provides that if the diagnostic radiologist observes more than four lung nodules from the lung screening test that would, apart from the operation of subsection 11A(2), be “target lung nodules”, then:

(a) the diagnostic radiologist must select four of those lung nodules; and

(b) the diagnostic radiologist must ensure that no lung nodule that is selected belongs to a lower risk category under the nodule management protocol than any lung nodule that is not selected; and

(c) only the four lung nodules that are selected are taken to be target lung nodules in relation to the screening test under section 12 for the purposes of this instrument.

Section 12 - Lung Cancer Screening Tests

Subsection 12(1) sets out the conditions under which this section applies. It provides that section 12 applies to a type of screening test to which all of the following paragraphs apply:

• (a) the screening test is associated with lung cancer;
• (b) the screening test involves the use of low dose computed tomography;
• (c) a National Lung Cancer Screening Program MBS item applies to the screening test;
• (d) the screening test is carried out by or on behalf of a diagnostic radiologist who is an individual healthcare provider;
• (e) the screening test is carried out other than as part of a clinical trial approved by an ethics committee (within the meaning of the Therapeutic Goods Act 1989).

A note provides that section 4 of the Act defines screening test to mean a test or procedure as part of screening.

Subsection 12(2) provides for a notification requirement for the purposes of subsection 13(1) of the Act.

Subsection 12(2) provides that if a screening test of the type described in subsection 12(1) is carried out, the diagnostic radiologist must notify the Commonwealth Chief Medical Officer, by the end of 30 days after the day the screening test is completed, of the information specified in the table for the screening test.

Column 1 of the table in subsection 12(2) sets out the information that must be notified to the Commonwealth Chief Medical Officer under subsection 13(1) of the Act, in relation to a lung cancer screening test of the type described in subsection 12(1).

Following the table, Note 1 states that a notice given under subsection 13(1) of the Act must be in the approved form. Note 2 states that an individual may request that information relating to them that is notified under subsection 13(1) of the Act not be included in the register.

Subsection 12(3) – Determination and Calculation of Information

Subsection 12(3) specifies that the information specified in the table must be determined or calculated in accordance with the nodule management protocol, where applicable.

For example, paragraph (i) of table item 7 requires the diagnostic radiologist to notify the total volume of each target lung nodule observed in the screening test. The diagnostic radiologist must determine or calculate this information as specified by the nodule management protocol.

Subsection 12(4) – Notification of Comparison Test Information

Subsection 12(4) states that if there is more than one comparison test in relation to a nodule observed in a lung cancer screening test (the current test), for the purpose of notifying the Chief Medical Officer of information about the current test, the diagnostic radiologist is only required to notify information about one comparison test that they are satisfied is relevant.

Part 4—Contents of the register—other information

Section 13 - Simplified outline of this Part

Section 13 provides a simplified outline of Part 4, explaining that it prescribes other information relevant to the purposes of the register that may be included on the register.

Section 14 - Purposes of this Part

Section 14 states that Part 4 is made for the purposes of paragraph 11(g) of the National Cancer Screening Register Act 2016.

Section 15 - Register may include other information

Smoking cessation advice

Section 15 applies to smoking cessation advice offered or provided to an individual in connection with a lung cancer screening test that the individual may undergo, will undergo, or has undergone.

For the purposes of paragraph 11(g) of the Act, the prescribed information is whether the individual was offered smoking cessation advice, whether smoking cessation advice was provided to the individual, and the type of smoking cessation advice offered or provided to the individual.

Notes following subsection 15(2) clarify that paragraph 11(g) of the Act allows the register to include any other information relevant to the purposes of the register and prescribed by the rules, and that section 17 of the Act authorises certain dealings in relation to the information.

ATTACHMENT B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Cancer Screening Register Act 2016

This Disallowable Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the National Cancer Screening Register Act 2016

The National Cancer Screening Register Act 2016 (the Act) creates a legislative framework for the establishment and ongoing operation of the National Cancer Screening Register (the Register).

The Act authorises the collection, use, and disclosure of information for the purposes of the Register to support the renewed National Cervical Screening Program; the expansion of the National Bowel Cancer Screening Program and the newly established National Lung Cancer Screening Program; and mandates the reporting of prescribed cancer screening information to the Register. The routine collection of this information is crucial for screening processes and clinical pathways.

Overview of the National Cancer Screening Register Rules 2017

For the purposes of subsection 13(1) of the Act, the National Cancer Screening Register Rules 2017 (the NCSR Rules) prescribe:

• types of cancer screening tests; and
• for each of those types of screening tests -

-       the information that must be notified to the Commonwealth Chief Medical Officer (CMO) in the approved form;

-       the individual healthcare provider who must notify the information; and

-       the time by which the information must be notified.

The prescribed screening tests are as follows:

        low-dose computed tomography scan

        colposcopy;

        human papillomavirus test;

        cytology test; and

         histopathology.

Overview of this Instrument

This Instrument is made under section 28 of the Act and deals with an amendment to the NCSR Rules regarding the requirement to notify an individual’s Indigenous status, country of birth and languages spoken at home to the CMO after a low-dose computed tomography scan has been carried out on the individual.

Where a colposcopy is carried out on an individual in accordance with subsection 12(1) of the NCSR Rules, subsection 12(2) of the NCSR Rules requires the notification of prescribed information about the individual, including the individual’s Indigenous status, country of birth and languages spoken at home, to the CMO by the end of 30 days after the day the low-dose computed tomography scan is completed. This information is only required to be provided if it is known by the diagnostic radiologist.

Human rights implications

The Act and NCSR Rules engage the following rights:

Protection of privacy and reputation

Article 17 of the ICCPR prohibits arbitrary or unlawful interference with an individual’s privacy, family, home and correspondence. For interferences with privacy not to be arbitrary, they must be reasonable in the particular circumstances. Reasonableness, in this context, incorporates notions of proportionality to the end sought and necessity in the circumstances.

The Act

The Act engages Article 17 of the ICCPR by the provisions that allow the Register to collect, record, use, and disclose personal information for various purposes associated with the Register.

There are various safeguards included in the Act to protect an individual’s right to privacy.

Safeguards include imposing limitations on the collection, recording, disclosure, or use of information in the Register.  The Act describes when collection, recording, disclosure, and use are authorised.  The purposes for which information can be used or disclosed are a reasonable and proportionate limitation on an individual’s right to privacy since the authorised disclosures are for specific legitimate purposes and limited to what is required to achieve the purposes of the National Cervical Screening Program, National Bowel Cancer Screening Program and more recently, the National Lung Cancer Screening Program.

In addition, participation in the Register is voluntary. The Act allows individuals to opt out of participating in the Register and/or screening programs, including requesting that their screening test results not be included in the Register. When an individual opts out in accordance with the Act, the individual’s personal information continues to be protected under the Act.

The offence provision for unauthorised use or disclosure aims to provide appropriate safeguards to protect against arbitrary and unlawful interference with privacy.

The NCSR Rules

The NCSR Rules, including as amended by the Instrument, engage Article 17 of the ICCPR by provisions that prescribe the collection of individuals’ cervical and/or lung cancer screening test results, results of relevant follow-up procedures up to and including the diagnosis (or clearance) of cancer. For lung cancer screening, information about the provision of smoking cessation advice and an individual’s family history of lung cancer and for cervical screening, treatment in relation to pre-cancerous abnormalities to be notified to the CMO through the Register. Information on history of lung cancer is collected to support an individual’s diagnosis.

Information notified to the CMO pursuant to the NCSR Rules is afforded the safeguards provided in the Act.

The Instrument

The Instrument amends subsection 8(3) of the NCSR Rules, which relate to subsection 13(1) of the Act.

Subsection 13(1) of the Act provides for rules to be made prescribing the individual healthcare providers who are required to notify prescribed information for a type of screening test or diagnosis by the prescribed timeframe. 

The amendment in the Instrument relates to the notification of a particular type of information – an individual’s indigenous status, country of birth and languages spoken at home (if the diagnostic radiologist knows this information). The amendment does not affect the privacy protections in the Act nor the reporting of other screening test information.

The purposes of requiring an individual’s Indigenous status, country of birth and languages spoken at home to be notified to the CMO are to:

• Accurately measure the screening participation rates in these subgroups;
• Enable greater understanding of screening behaviours in these sub-groups; and
• Inform targeted strategies to increase the screening participation of individuals in these subgroups to reduce the rate of morbidity and/or mortality from lung cancer in Indigenous and culturally and linguistically diverse (CALD) communities.

The identification and recording of the cultural background of all patients can be an important indication of clinical risk factors and can assist health professions in providing relevant care.

Recording a patient’s preferred language and whether an interpreter is required is helpful for information provision. The National Lung Cancer Screening Program is being co-designed with the National Aboriginal Community Controlled Health Organisation. Collection of the Indigenous status helps Aboriginal and Torres Strait Islander people access indigenous-specific health interventions, and helps achieve equity in cancer outcomes to overcome the health disparities between Indigenous and non-Indigenous people.

Right to health

The Act

The Act engages Articles 2 and 12 of the ICESCR by establishing the Register for the purpose of supporting early detection and prevention of cancer through screening. 

According to the World Health Organisation, the aim of screening for a disease or a risk marker for a disease is “to reduce the burden of the disease in the community, including incidence of disease, morbidity from the disease or mortality.  This is achieved by intervening to reduce individual risk of the disease or detecting the disease earlier on average than is usually the case in the absence of screening and thereby improving disease outcome.”

The requirement in the Act to notify to the Register will allow individuals’ screening test results/outcome data and results of relevant follow-up procedures up to and including the diagnosis (or clearance) of cancer (collectively referred to as screening test or diagnosis) to be routinely notified to the Register.   Complete and accurate data will allow the screening processes and clinical pathways to operate safely, efficiently and effectively.   

The NCSR Rules

The NCSR Rules, including as amended by the Instrument, provide a legislative basis for the collection of individuals’ cervical and/or lung screening test results. Low-dose computed tomography results are classified into one or more of the following categories:

For incomplete, very low risk, low risk, low to moderate risk, and moderate risk, people will be recommended to have a follow-up screening test at a shorter interval as required in the NLCSP Nodule Management Protocol. People with a high risk and very high risk finding will be referred to a respiratory physician linked to a lung cancer multidisciplinary team as they are at increased likelihood of having the condition and who require further investigation to determine whether or not they have the disease or condition.

People with additional actionable findings (findings unrelated to lung cancer) will be managed as per usual care arrangements by the referring healthcare provider.

The notification requirement in the NCSR Rules supports the screening processes and clinical pathways; and the monitoring of effectiveness of program quality, safety and effectiveness, particularly as it is a new program. The lung cancer screening test information notified by prescribed individual healthcare providers for the purpose of subsection 13(1) of the Act will be used to manage the participant and their clinical pathway, facilitate screening invitations, recall and clinical decision-making, thereby supporting early detection and prevention of cancer through screening.

The reporting requirement in the NCSR Rules made under 11(g) of the Act facilitates improved participant health outcomes, reduced mortality, increased program cost effectiveness, and will provide information about the NLCSP and provide an indication of the NLCSP’s success.

Conclusion

The Instrument is compatible with human rights and any interference with privacy is proportional and the minimum necessary to achieve the purposes of collecting the relevant information.

• The Instrument sets out an amendment changing the date when an individual’s Indigenous status, country of birth and languages spoken at home must be notified to the CMO in relation to low-dose CT scan.

• The Instrument does not affect the reporting of other screening test information.

• The Instrument does not affect the privacy protections in the Act as referred to above. Information about an individual’s Indigenous status, country of birth and languages spoken at home (if known to the individual healthcare provider) will have to be notified to the CMO from the commencement of the instrument. Once notified to the CMO, the information will be afforded the same privacy protections in the Act as other information already being notified.

• The healthcare provider can report whether smoking cessation advice has been provided to the participant from the commencement of the instrument.

• The healthcare provider is only required to notify the CMO of an individual’s, Indigenous status, country of birth and languages spoken at home if the information is available to the healthcare provider at the time of the service.

Hon Mark Butler MP

Minister for Health and Ageing

Minister for Disability and the National Disability Insurance Scheme