National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025
I, Mark Butler, Minister for Health and Ageing, Minister for Disability and the National Disability Insurance Scheme, make the following rules.
Dated 16 June 2025
Mark Butler
Minister for Health and Ageing, Minister for Disability and the National Disability Insurance Scheme
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
National Cancer Screening Register Rules 2017
This instrument is the National Cancer Screening Register Amendment (National Lung Cancer Screening Program) Rules 2025.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | The later of: (a) 1 July 2025; and (b) the day after this instrument is registered. |
|
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under the National Cancer Screening Register Act 2016.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
1 Section 4
Insert:
comparison test, in relation to a lung nodule observed in a lung cancer screening test conducted on an individual by or on behalf of a diagnostic radiologist, means a previous lung cancer screening test (if any) that satisfies both of the following conditions:
(a) the lung nodule was observed in the previous screening test;
(b) the diagnostic radiologist has access to the results of the previous screening test.
diagnostic radiologist means an individual who is registered:
(a) in the specialty of radiology; and
(b) with a field of speciality practice of diagnostic radiology;
under the Health Practitioner Regulation National Law set out in the Schedule to the Health Practitioner Regulation National Law Act 2009 of Queensland, as it applies (with or without modification) as a law of a State or Territory.
episode number means the unique identifier (comprising numbers, letters or both) that is attributed to an instance or event of healthcare during which a screening test is conducted.
lung cancer screening category means the category of risk for a target lung nodule determined in accordance with the nodule management protocol.
lung cancer screening test means a screening test to which section 12 applies.
National Lung Cancer Screening Program MBS item means an item in Schedule 1 to the Health Insurance (Section 3C General Medical Services – National Lung Cancer Screening Program) Determination 2025.
Note: By the operation of section 3C of the Health Insurance Act 1973, National Lung Cancer Screening Program MBS items are treated as if they are items in the diagnostic imaging services table made under section 4AA of that Act.
nodule management protocol means the NLCSP nodule management protocol, published by the Department, as existing on 1 July 2025.
Note: The nodule management protocol could in 2025 be viewed on the Department’s website (see https://www.health.gov.au/resources/publications/nlcsp-nodule-management-protocol).
Pan-Canadian Early Detection of Lung Cancer risk rating or PanCan risk rating means the malignancy risk of lung nodules calculated in accordance with the Brock University solitary pulmonary nodule malignancy risk in adults cancer prediction equation, as existing on 1 July 2025.
Note: The Brock University solitary pulmonary nodule malignancy risk in adults cancer prediction equation could in 2025 be viewed at the following website: https://www.uptodate.com/contents/calculator-solitary-pulmonary-nodule-malignancy-risk-in-adults-brock-university-cancer-prediction-equation.
smoking cessation advice means advice that is intended to help an individual stop smoking tobacco products.
target lung nodule has the meaning given by section 11A.
2 At the end of the instrument
Add:
For the purposes of subsection 13(1) of the Act, this Part prescribes a type of lung cancer screening test and, for each screening test of that type:
(a) the information that must be notified to the Commonwealth Chief Medical Officer; and
(b) the individual healthcare provider who must notify the information; and
(c) the time by which the information must be notified.
This Part is made for the purposes of subsection 13(1) of the Act.
(1) Subject to subsection (2), target lung nodule, in relation to a lung cancer screening test that is carried out by or on behalf of a diagnostic radiologist, 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.
(2) If the diagnostic radiologist observes more than 4 lung nodules from the screening test that would (apart from this subsection) be target lung nodules, then:
(a) the diagnostic radiologist must select 4 of those lung nodules; and
(b) the diagnostic radiologist must ensure that no lung nodule that is selected belongs to a lower risk lung cancer screening category under the nodule management protocol than a lung nodule that is not selected; and
(c) only the 4 lung nodules that are selected are taken to be target lung nodules in relation to the screening test for the purposes of this instrument.
(1) This section 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).
Note: Section 4 of the Act defines screening test to mean a test or procedure as part of screening.
(2) If a screening test of that type is carried out, the diagnostic radiologist must, under subsection 13(1) of the Act, 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 following table for the screening test.
Information for lung cancer screening tests | |
Item | Column 1 Information |
1 | The following information about the individual who undergoes the screening test: (a) given name (if known by the diagnostic radiologist); (b) family name; (c) medicare number or the number (if any) allocated to the individual by the Veterans’ Affairs Department (if known by the diagnostic radiologist); (d) gender; (e) date of birth; (f) Indigenous status (if known by the diagnostic radiologist); (g) country of birth (if known by the diagnostic radiologist); (h) languages spoken at home (if known by the diagnostic radiologist); (i) address; (j) personal phone number (if known by the diagnostic radiologist); (k) alternative phone number (if known by the diagnostic radiologist); (l) whether the individual has a family history of lung cancer (if known by the diagnostic radiologist) |
2 | The healthcare identifier (if any) of the diagnostic radiologist |
3 | If the screening test was carried out at a radiology practice, the following information about the practice: (a) healthcare identifier; (b) name; (c) address |
4 | If the screening test was carried out following a request by an individual healthcare provider for the screening test to be carried out—the following information about the individual healthcare provider who made the request: (a) provider number (if known by the diagnostic radiologist); (b) given name (if known by the diagnostic radiologist); (c) family name (if known by the diagnostic radiologist); (d) the date on which the individual healthcare provider made the request; (e) if the individual healthcare provider works at a medical practice—the following information about the medical practice: (i) healthcare identifier (if known by the diagnostic radiologist); (ii) name; (iii) address |
5 | The following information in relation to the screening test: (a) date the screening test was conducted; (b) date of any reports in relation to the screening test; (c) episode number; (d) radiation dose from the low dose computed tomography procedure expressed in CT dose index volume (milligray); (e) name (if known) of any computer aided diagnosis, artificial intelligence, or volumetry software used to carry out or support the low dose computed tomography procedure used in the screening test; (f) National Lung Cancer Screening Program MBS item number that applies to the screening test; (g) date of the comparison test (if any); (h) image quality of each scan produced from the screening test; (i) whether there are any additional actionable findings (within the meaning of the nodule management protocol) from the screening test |
6 | The following information: (a) whether the diagnostic radiologist considers that at least one lung nodule observed in the screening test is a target lung nodule; (b) whether the diagnostic radiologist considers that at least one lung nodule observed in the screening test is likely to be caused by infection or inflammation; (c) whether the diagnostic radiologist considers that at least one lung nodule observed in the screening test is likely to be benign (excluding any lung nodules that the radiologist considers likely to be caused by infection or inflammation) |
7 | The following information (if known by the diagnostic radiologist) in relation to each target lung nodule observed in the screening test: (a) the nodule’s assigned nodule number; (b) date the nodule was first visible on a screening test; (c) series in which the target lung nodule was observed; (d) image in which the target lung nodule was observed; (e) anatomical location of the nodule; (f) type of the nodule; (g) whether the border of the nodule is spiculated; (h) other descriptions of the nodule; (i) total volume of the nodule (expressed in cubic millimetres); (j) if the nodule is a subsolid nodule—the volume of the solid component of the nodule (expressed in cubic millimetres); (k) mean diameter of the nodule (expressed in millimetres); (l) if the nodule is a subsolid nodule—the mean diameter of the solid component of the nodule (expressed in millimetres); (m) if the mean diameter of the nodule is measured using a measurement plane—which measurement plane was used; (n) thickness of the wall of the nodule (expressed in millimetres); (o) if there is no comparison test for the nodule—the Pan‑Canadian Early Detection of Lung Cancer (PanCan) risk rating for the nodule (expressed as a percentage); (p) lung cancer screening category for the nodule as determined in accordance with the nodule management protocol Note: See also subsection 11A(2), which relates to selecting up to 4 lung nodules to be target lung nodules. |
8 | The following information (if known by the diagnostic radiologist) in relation to each target lung nodule observed in the screening test for which there is a comparison test: (a) change in the total volume of the nodule compared to the total volume of the nodule observed in the comparison test for the nodule (expressed as a percentage); (b) based on the information referred to in paragraph (a) of this table item—the volume doubling time (expressed in days); (c) if the nodule is a subsolid nodule—change in the total volume of the solid component of the nodule compared to the total volume of the solid component of the nodule observed in the comparison test for the nodule (expressed as a percentage); (d) based on the information referred to in paragraph (c) of this table item—the volume doubling time (expressed in days); (e) change in the mean diameter of the nodule compared to the mean diameter of the nodule observed in the comparison test for the nodule (expressed in millimetres); (f) if the nodule is a subsolid nodule—change in the mean diameter of the solid component of the nodule compared to the mean diameter of the solid component of the nodule observed in the comparison test for the nodule (expressed in millimetres); (g) change in the thickness of the wall of the nodule compared to the thickness of the wall of the nodule observed in the comparison test for the nodule (expressed in millimetres); (h) description of the type of change to the nodule compared to the nodule observed in the comparison test for the nodule |
9 | Information on any findings or observations made by the diagnostic radiologist from the screening test in relation to the following body parts of the individual who underwent the screening test: (a) lungs; (b) pleura; (c) mediastinum; (d) cardiovascular; (e) abdomen; (f) thyroid; (g) breasts; (h) bones; (i) other body parts |
Note 1: A notice given under subsection 13(1) of the Act must be in the approved form: see subsection 13(1) of the Act.
Note 2: An individual may request that information relating to the individual that is notified under subsection 13(1) of the Act not be included in the register: see section 14 of the Act.
(3) The information specified in the table in subsection (2) must be determined or calculated in accordance with the nodule management protocol (where applicable).
Example: Paragraph (i) of table item 7 of the table in subsection (2) requires the diagnostic radiologist to notify the total volume of each target lung nodule observed in the screening test (if this information is known by the diagnostic radiologist). In determining or calculating this information, the diagnostic radiologist must consider whether the nodule management protocol provides for the information to be determined or calculated in a certain way. If the nodule management does so, then the diagnostic radiologist must determine or calculate the information in that way.
(4) If there is more than one comparison test in relation to a nodule observed in a lung cancer screening test (the current test) conducted on an individual by or on behalf of a diagnostic radiologist, 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 the diagnostic radiologist is satisfied is relevant.
For the purposes of paragraph 11(g) of the Act, this Part prescribes, for each individual, other information relevant to the purposes of the register that may be included on the register.
This Part is made for the purposes of paragraph 11(g) of the Act.
(1) This section applies to smoking cessation advice offered or provided to an individual in connection with a lung cancer screening test that the individual:
(a) may undergo; or
(b) will undergo; or
(c) has undergone.
(2) For the purposes of paragraph 11(g) of the Act, the following information is prescribed:
(a) whether the individual was offered smoking cessation advice;
(b) whether smoking cessation advice was provided to the individual;
(c) the type of smoking cessation advice offered or provided to the individual.
Note 1: Paragraph 11(g) of the Act provides that the register may include, for each individual, any other information relevant to the purposes of the register and prescribed by the rules. Section 12 of the Act sets out the purposes of the register.
Note 2: As the information prescribed by this subsection may be included on the register, section 17 of the Act authorises certain dealings in relation to the information.