Federal Register of Legislation - Australian Government

Primary content

Determinations/Health as made
This instrument creates a new item to enable patient access to an alternative positron emission tomography (PET) imaging service during supply disruptions of the radiopharmaceutical gallium-67 (Ga-67).
Administered by: Health and Aged Care
Registered 21 Jul 2022
Tabling HistoryDate
Tabled HR26-Jul-2022
Tabled Senate27-Jul-2022

EXPLANATORY STATEMENT

                                                       

Health Insurance Act 1973

 

Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022

 

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 Section 4AA of the Act. The most recent version of the regulations is the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020 (DIST Regulations).

  

Purpose

The purpose of the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 (the Determination) is to introduce one new item (61527) to enable patient access to an alternative positron emission tomography (PET) imaging service during supply disruptions of the radiopharmaceutical gallium-67 (Ga-67). This new item will enable continuity of patient care by ensuring patients continue to have affordable access to an appropriate diagnostic imaging service. New item 61527 will commence on 1 August 2022.

 

The current Ga-67 supply interruptions will likely continue to affect patient access to these services until at least early 2023. It is further anticipated that supply will remain intermittent and unstable for several years. The Determination will enable providers to substitute a PET imaging scan when a preferred Ga-67 based scan under item 61429, 61430, 61442, 61450 or 61453 has been requested and is not available due to the supply interruption.

 

Consultation

The Department of Health and Aged Care has consulted with key stakeholders including members of the Australasian Association of Nuclear Medicine Specialists (AANMS), the Royal Australian and New Zealand College of Radiologists (RANZCR), the Australian Diagnostic Imaging Association (ADIA), the Australian and New Zealand Society of Nuclear Medicine (ANZSNM) and the Rural Alliance in Nuclear Scintigraphy (RAINS).

 

Details of the Determination are set out in the Attachment.

The Determination commences on 1 August 2022.

 

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 Services – PET and Gallium-67 Services) Determination 2022

 

Section 1 – Name

 

Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022.

 

Section 2 – Commencement

 

Section 2 provides that the Determination commences on 1 August 2022.

 

Section 3 – Authority

 

Section 3 provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.

 

Section 4 – Definitions  

 

Section 4 defines terms used in the Determination.

 

Section 5 – Treatment of Relevant Services

 

Section 5 provides that a clinically relevant service provided in accordance with the Determination shall be treated, for relevant provisions of the Health Insurance Act 1973 and National Health Act 1953, and regulations made under those Acts, as if it were both a professional service and a diagnostic imaging service and as if there were an item specified in the diagnostic imaging services table for the service.

 

Section 6 – Application of provisions of the diagnostic imaging services table

 

Subsection 6(1) specifies the provision of the diagnostic imaging services table that applies as if item 61527 was specified in the relevant provision in the diagnostic imaging services table.

 

Subsection 6(2) of the Determination provides that item 61527 will be treated as if it was specified in subclause 2.4.2(1). Clause 2.4.2 provides the requirement PET nuclear scanning services.

 

Section 7 – Restriction on items – services connected with provision of PET nuclear scanning during Gallium-67 interruptions

 

Section 7(a) of the Determination provides that an item in Schedule 1 of this instrument only applies to a service described in the item, if the patient’s clinical condition requires the service to be performed before the resumption of normal gallium-67 (Ga-67) supply is anticipated by the practitioner who provides the service on a case-by-case basis.

 

Section 7(b) of the Determination provides that an item in Schedule 1 of this instrument only applies to a service described in the item if the report of the service performed includes a justification for the substitute service, which describes the unavailability of a service to which item 61429, 61430, 61442, 61450 or 61453 applies.

 

Schedule 1 – Relevant services

 

The Schedule specifies the service and the associated fee for the new item 61527.


 

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 Services – PET and Gallium-67 Services) Determination 2022

 

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 purpose of the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 (the Determination) is to introduce one new item (61527) to enable patient access to an alternative positron emission tomography (PET) imaging service during supply disruptions of the radiopharmaceutical gallium-67 (Ga-67). This new item will enable continuity of patient care by ensuring patients continue to have affordable access to an appropriate diagnostic imaging service. New item 61527 will commence on 1 August 2022.

 

The current Ga-67 supply interruptions will likely continue to affect patient access to these services until at least early 2023. It is further anticipated that supply will remain intermittent and unstable for several years. The Determination will enable providers to substitute a PET imaging scan when a preferred Ga-67 based scan under item 61429, 61430, 61442, 61450 or 61453 has been requested and is not available due to the supply interruption.

 

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 advances the existing rights to health, the right to social security and the right of equality and non-discrimination by enabling patient access to alternative positron emission tomography (PET) imaging services during supply disruptions of the radiopharmaceutical gallium-67 (Ga-67). This new item will enable continuity of patient care by ensuring patients continue to have affordable access to this diagnosis service.

Conclusion

This instrument is compatible with human rights as it advances the right to health, the right to social security and the right of equality and non-discrimination, by having a positive effect on human rights issues.

 

 

Travis Haslam

Acting First Assistant Secretary

Medical Benefits Division

Health Resourcing Group

Department of Health and Aged Care