EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment Determination 2023
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, determine that a health service not specified in an item in the diagnostic imaging services table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the Table.
The Table is set out in the regulations made under subsection 4AA of the Act. The most recent version of the regulations is the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020 (DIST).
This instrument relies on subsection 33(3) of the Acts Interpretation Act 1901 (AIA). Subsection 33(3) of the AIA 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.
Purpose
The Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Determination 2022 (the Principle Determination) introduced item 61644 for a closed period to provide patients with access to item 61644 as an alternative positron emission tomography service to item 61325 services during shortages in the supply of the required imported radioisotope, thallous chloride 201 (T1-201). The services are for cardiac investigation to assess the extent and severity of non-viable myocardium and therefore patient suitability for cardiac surgery during supply shortages of T1‑201.
Access to item 61644 was introduced with a fixed period of application from 1 April 2022 to 30 September 2022 and was later extended until 30 June 2023 by the Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment (Extension of Access) Determination 2022.
The Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment Determination 2023 (the Determination) amends the Nuclear Medicine Determination to repeal the schedule containing the closed period of application, which contains the end date of 30 June 2023. This amendment means services under item 61644 will be available on an ongoing basis. The item descriptor will remain the same and item 61644 will continue to be available only where the patient’s clinical condition requires the service to be performed before the resumption of T1-201 supply is anticipated by the practitioner who provides the service.
The Determination will also insert a new section which reiterates this requirement and also specifies that the practitioner’s report of the service must justify using the substitute service by describing the unavailability of T1-201 for service item 61325.
Policy authority for the continuation of the service item 61644 was provided through the 2023‑24 Budget under the A Modern and Clinically Appropriate Medicare Benefits Schedule measure.
Consultation
The changes have been developed in consultation with the Australasian Association of Nuclear Medicine Specialists (AANMS).
The Determination makes no substantive changes to the requirements determined under the Former Determination. As the substantive requirements have not changed, the Determination is considered minor and machinery in nature and no formal consultation was undertaken regarding this item.
Details of the Determination are set out in the Attachment.
The Determination commences on the day after the instrument is registered.
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Subsection 3C(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment Determination 2023
Section 1 – Name
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment Determination 2023.
Section 2 – Commencement
Section 2 provides that the whole of the Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment Determination 2023 commences immediately after the instrument is registered.
Section 3 – Authority
Section 3 provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Schedules
Section 4 of the Determination provides that 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.
Schedule 1 – Amendments to Diagnostic Imaging Services
Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Determination 2022
Item 1 repeals and replaces the existing Section 7 of the of the Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Determination 2022 (the Nuclear Medicine Determination) which contains information about the closed period of application to ensure ongoing access to the services under item 61644 during supply disruptions of thallous chloride 201 (T1-201), from 1 July 2023.
The replaced Section 7 describes service requirements for services provided under item 61644.
Subsection 7(1)(a) provides that services rendered under item 61644 will continue to be available as an alternate positron emission tomography service to 61325 for cardiac investigation during shortages of radioisotope T1-201, provided the patient’s clinical condition requires cardiac investigations to be performed before the resumption of T1-201 supply is anticipated by the practitioner providing the service.
Subsection 7(1)(b) requires that services under item 61644 are accompanied by a report written by the practitioner detailing a justification for the substitute service, including the unavailability of a service to which item 61325 applies.
Item 2 inserts a new Section 8 which provides that 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.
Item 3 repeals Schedule 2 of the Nuclear Medicine Determination which contains the closed period of application for item 61644 from 1 April 2022 to 30 June 2023. This change is administrative in nature to ensure ongoing access to the services under item 61644 during supply disruptions of thallous chloride 201 (T1-201), from 1 July 2023.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Determination 2023
This 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 Determination
The Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Determination 2022 (the Principle Determination) introduced item 61644 for a closed period to provide patients with access to item 61644 as an alternative positron emission tomography service to item 61325 services during shortages in the supply of the required imported radioisotope, thallous chloride 201 (T1-201). The services are for cardiac investigation to assess the extent and severity of non-viable myocardium and therefore patient suitability for cardiac surgery during supply shortages of T1‑201.
Access to item 61644 was introduced with a fixed period of application from 1 April 2022 to 30 September 2022 and was later extended until 30 June 2023 by the Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment (Extension of Access) Determination 2022.
The Health Insurance (Section 3C Diagnostic Imaging – Additional Nuclear Medicine Services) Amendment Determination 2023 (the Determination) amends the Nuclear Medicine Determination to repeal the schedule containing the closed period of application, which contains the end date of 30 June 2023. This amendment means services under item 61644 will be available on an ongoing basis. The item descriptor will remain the same and item 61644 will continue to be available only where the patient’s clinical condition requires the service to be performed before the resumption of T1-201 supply is anticipated by the practitioner who provides the service.
The Determination will also insert a new section which reiterates this requirement and also specifies that the practitioner’s report of the service must justify using the substitute service by describing the unavailability of T1-201 for service item 61325.
Policy authority for the continuation of the service item 61644 was provided through the 2023‑24 Budget under the A Modern and Clinically Appropriate Medicare Benefits Schedule measure.
Human rights implications
This instrument engages Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to health and social security.
The Right to Health
The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The UN Committee on Economic Social and Cultural Rights (the Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.
The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.
The Right to Social Security
The right to social security is contained in Article 9 of the ICESCR. It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
The Committee reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
The right of equality and non-discrimination
The rights of equality and non-discrimination are contained in articles 2, 16 and 26 of the International Covenant on Civil and Political Rights (ICCPR). Article 26 of the ICCPR requires that all persons are equal before the law, are entitled without any discrimination to the equal protection of the law and in this respect, the law shall prohibit any discrimination and guarantee to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.
Analysis
This instrument maintains the right to health and social security and the right of equality and non-discrimination, providing continued access for patients to nuclear medicine services for cardiac investigations to assess the extent and severity of non-viable myocardium, and therefore patient suitability for cardiac surgery. This item will allow patients time-sensitive access to appropriate diagnostic imaging services and reduce the increased risk of morbidity caused by service delays during the supply shortage of Tl-201.
Conclusion
This instrument is compatible with human rights as it maintains the right to health, the right to social security and the right of equality and non-discrimination by providing patient with continued access to critical nuclear medicine services.
Daniel McCabe
First Assistant Secretary
Medicare Benefits and Digital Health Division
Health Resourcing Group
Department of Health and Aged Care