Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022

Administered by Department of Health, Disability and Ageing

Legislation au F2022L01239 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Health Insurance Act 1973

 

Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) 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 subsection 4AA of the Act.  The most recent version of the regulations is the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020.

 

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 purpose of the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022 (the Amendment Determination) is to amend the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 (the Principal Determination) to allow an alternative positron emission tomography (PET) service to be provided under item 61527 where a service under item 61429, 61430, 61442, 61450 or 61453 was requested by a medical practitioner other than a specialist or consultant physician but unable to be provided due to supply disruptions of the radiopharmaceutical gallium-67 (Ga-67). This change will ensure patients continue to have affordable access to diagnostic imaging services under item 61527 during supply disruptions.

Consultation

Consultation was not undertaken regarding this change as it will align the Principal Determination with the policy intention for the introduction of item 61527.

 

Details of the Amendment Determination are set out in the Attachment.

The Amendment Determination commences the day after registration of this instrument.

 

The Amendment 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) Amendment (No. 1) Determination 2022

 

Section 1 – Name

 

Section 1 provides for the Amendment Determination to be referred to as the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022.

 

Section 2 – Commencement

 

Section 2 provides that the Amendment Determination commences the day after registration of this instrument.

 

Section 3 – Authority

 

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

 

Section 4 – Schedules

 

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

 

Schedule 1 – Amendments

 

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

 

Amendment item 1 amends subsection 6(2) to specify that clause 2.4.2 of the diagnostic imaging services table does not apply to items in Schedule 1 of the Principal Determination. Clause 2.4.2 of the diagnostic imaging services table provides the referral requirements for positron emission tomography (PET) services.

 

Amendment item 2 inserts new sections 8 to 11 after section 7 in the Principal Determination. These new sections will provide the requirements for PET services under item 61527. Section 8 provides that the service must be performed in a comprehensive facility.

 

 

 


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) Amendment (No. 1) 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) Amendment (No. 1) Determination 2022 (the Amendment Determination) is to amend the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 (the Principal Determination) to allow an alternative positron emission tomography (PET) service to be provided under item 61527 where a service under item 61429, 61430, 61442, 61450 or 61453 was requested by a medical practitioner other than a specialist or consultant physician but unable to be provided due to supply disruptions of the radiopharmaceutical gallium-67 (Ga-67). This change will ensure patients continue to have affordable access to diagnostic imaging services under item 61527 during supply disruptions.

 

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 rights to health and social security and the right of equality and non-discrimination by ensuring patients continue to have affordable access to diagnostic imaging services under item 61527 during supply disruptions of the radiopharmaceutical gallium-67 (Ga-67) where a service under item 61429, 61430, 61442, 61450 or 61453 was requested by a medical practitioner other than a specialist or consultant physician.

Conclusion

This instrument is compatible with human rights as it maintains the right to health, the right to social security and the right to equality and social security.

 

 

Travis Haslam

Acting First Assistant Secretary

Medical Benefits Division

Health Resourcing Group

Department of Health and Aged Care

Overview

The Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022 was enacted to address disruptions in the supply of the radiopharmaceutical gallium-67 (Ga-67) that hindered the provision of certain positron emission tomography (PET) services under the Health Insurance Act 1973. This legislation, determined by the Minister for Health under subsection 3C(1) of the Act, aims to ensure patients continue to have affordable access to essential diagnostic imaging services during these supply disruptions. The Amendment Determination modifies the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022, allowing an alternative PET service to be provided under item 61527 when specific services under items 61429, 61430, 61442, 61450, or 61453 cannot be performed due to Ga-67 shortages, particularly when requested by medical practitioners other than specialists or consultant physicians. This amendment was introduced without consultation as it aligns with the initial policy intention for the introduction of item 61527, and it is set to commence the day after its registration as a legislative instrument under the Legislation Act 2003. The policy objective of the Amendment Determination is to uphold the rights to health, social security, and equality by maintaining access to necessary diagnostic services amidst supply chain challenges, thereby ensuring compliance with human rights standards as articulated in the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the International Covenant on Civil and Political Rights (ICCPR).

Scope and Application

The Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022 applies to the provision of diagnostic imaging services under the Health Insurance Act 1973. Specifically, it targets health services, particularly positron emission tomography (PET) services, and is relevant to medical practitioners, patients, and health insurers. The Amendment Determination aims to address supply disruptions of the radiopharmaceutical gallium-67 (Ga-67) that affect the provision of certain PET services. It ensures that patients maintain access to affordable diagnostic imaging services by allowing an alternative PET service to be provided under item 61527 when specific services under items 61429, 61430, 61442, 61450, or 61453 are requested by a medical practitioner other than a specialist or consultant physician but cannot be provided due to supply disruptions. This Amendment Determination operates nationally and is applicable to all jurisdictions within Australia. It does not specify any exclusions, exemptions, or thresholds beyond the conditions outlined for the provision of alternative PET services. The application of this Act may be further defined or extended through subordinate instruments, such as regulations, which may detail specific procedural or operational requirements for the implementation of the Amendment Determination.

Key Provisions

The main operative sections of the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022 (the Amendment Determination) are primarily found in Schedule 1, which specifies amendments to the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 (the Principal Determination). The key changes include altering subsection 6(2) to exempt certain PET services from the referral requirements set out in clause 2.4.2 of the diagnostic imaging services table, and inserting new sections 8 to 11, which detail the conditions under which an alternative PET service can be provided under item 61527. These changes ensure that patients can continue to access necessary diagnostic imaging services during supply disruptions of gallium-67 (Ga-67), provided the service was initially requested by a medical practitioner other than a specialist or consultant physician. The Amendment Determination imposes specific obligations and requirements on the parties and entities it governs. Firstly, it mandates that the alternative PET service under item 61527 must be performed in a comprehensive facility, as specified in section 8 of the Amendment Determination. Additionally, the Amendment Determination requires that the alternative PET service must be provided in circumstances where there is a supply disruption of the radiopharmaceutical gallium-67 (Ga-67), and the service was initially requested by a medical practitioner other than a specialist or consultant physician. These conditions ensure that the alternative service is only provided in specific, necessary circumstances and maintains the integrity of the diagnostic imaging services table. Breach of the provisions set out in the Amendment Determination could result in civil or criminal consequences, though specific penalties are not detailed within the explanatory statement. Under Australian law, breaches of legislative instruments can lead to fines or other legal penalties, depending on the severity and intent of the breach. The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003, and as such, any failure to comply with its provisions could result in legal action being taken against the offending party or entity. It is also worth noting that the Amendment Determination is compatible with human rights as it maintains the right to health, the right to social security, and the right to equality and non-discrimination, ensuring that patients can continue to access necessary diagnostic imaging services during supply disruptions.

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