EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
Health Insurance Act 1973
Health Insurance (LeukoScan) Determination 2010
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by writing, determine that a health service not listed in the diagnostic imaging services table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were so listed. The Table is set out in the Health Insurance (Diagnostic Imaging Services Table) Regulations, which is remade each year.
A determination made under subsection 3C(4) is a legislative instrument (see subsection 3C(4) of the Act and paragraph 6(d) of the Legislative Instruments Act 2003)
In 2003, the Medical Services Advisory Committee (MSAC) undertook a review of the use of LeukoScan, which is a diagnostic test used to detect osteomyelitis (an infection of the bone). MSAC found that LeukoScan was safe, effective and more costly than other methods of white blood cell scanning. MSAC recommended LeukoScan funding for patients who do not have access to conventional white blood cell scanning, or for whom conventional scanning is contra-indicated. The then Minister for Health and Ageing approved the MSAC recommendation in August 2003.
LeukoScan was first introduced in 2004 under a 3C Determination because it was unclear what the impact on overall nuclear medicine outlays or level of usage would be. The Health Insurance (LeukoScan) Determination HS/02/2004 (the 2004 Determination) provided that the LeukoScan diagnostic imaging service specified in the Determination is to be treated as if it were listed in the Table.
The 2004 Determination was revoked and remade by the Health Insurance (LeukoScan) Determination HS/08/2006 (the 2006 Determination). The 2006 Determination: (i) revised the wording of various provisions in the Determination to reflect updated drafting practices; (ii) clarify the operation of certain provisions in the Determination; and (iii) provide for an increase in the fee in line with the fee increase that was applied to nuclear medicine services in the Table from 1 November 2006.
The Health Insurance (LeukoScan) Determination 2010 revokes the 2006 Determination because the service specified in the 2006 Determination is added to the Table from 1 July 2010. The service is added to the Table as a result of low usage and no anomalies in the service. The addition of the LeukoScan service to the Table will also ensure that the service is managed in the same way as all other Medicare eligible nuclear medicine services from 1 July 2010.
Consultation
No consultation was undertaken in the making of this Determination as the instrument is machinery in nature and does not substantially alter existing arrangements.
Details of the Determination are set out in the Attachment.
This Determination commences on 1 July 2010.
ATTACHMENT
DETAILS OF THE HEALTH INSURANCE (LEUKOSCAN) DETERMINATION 2010
Section 1 Name of Determination
Section 1 provides that the name of the Determnation is the Health Insurance (LeukoScan) Determination 2010.
Section 2 Commencement
Section 2 provides that the Determination commences on 1 July 2010.
Section 3 Revocation
Section 3 provides that the Determination revokes the Health Insurance (LeukoScan) Determination HS/08/2006.
Overview
The Health Insurance (LeukoScan) Determination 2010 was enacted in 2010 by the Minister for Health and Ageing to address the management of LeukoScan services within the Medicare system. The Health Insurance Act 1973 allows the Minister to determine that certain health services not listed in the diagnostic imaging services table be treated as if they were listed, provided specific conditions are met. The 2010 Determination was necessitated by the previous 2006 Determination which had been in place to manage LeukoScan services, but was set to be revoked as these services would be formally included in the diagnostic imaging services table from 1 July 2010. This formal inclusion aimed to ensure consistent management of LeukoScan services alongside other Medicare-eligible nuclear medicine services, following a review by the Medical Services Advisory Committee in 2003 that found the service to be safe and effective.
Scope and Application
The Health Insurance (LeukoScan) Determination 2010 applies to the specified circumstances and statutory provisions related to the LeukoScan diagnostic imaging service, which is used to detect osteomyelitis. This Determination is made under subsection 3C(1) of the Health Insurance Act 1973 and serves to treat the LeukoScan service as if it were listed in the diagnostic imaging services table from 1 July 2010. The Determination revokes the previous Health Insurance (LeukoScan) Determination HS/08/2006, which had been in place to manage the service since 2006. This current Determination incorporates revisions to the wording and operational clarifications, and it reflects the low usage and absence of anomalies in the service, leading to its addition to the diagnostic imaging services table. The scope of this Act pertains to the specified diagnostic imaging service and its treatment under the Health Insurance Act 1973, with no consultation undertaken as the instrument is considered machinery in nature and does not substantially alter existing arrangements.
Key Provisions
The Health Insurance (LeukoScan) Determination 2010 (section 1) provides the specific name of the Determination, clarifying that it is a legislative instrument designed to govern the use of LeukoScan, a diagnostic imaging service. Section 2 of the Determination sets the commencement date as 1 July 2010, indicating when the provisions of this instrument will take effect. Section 3 revokes the previous Health Insurance (LeukoScan) Determination HS/08/2006, effectively replacing it with the 2010 version. This revocation is necessary as the LeukoScan service has been added to the diagnostic imaging services table (section 3C(1) of the Health Insurance Act 1973).
The Act imposes several obligations on the parties involved. Firstly, it mandates that the LeukoScan diagnostic imaging service be treated as if it were listed in the diagnostic imaging services table from 1 July 2010 (section 3). This ensures that the service is managed uniformly with other Medicare-eligible nuclear medicine services. Additionally, the Act requires that the service be provided in specified circumstances, as recommended by the Medical Services Advisory Committee (MSAC) and approved by the Minister for Health and Ageing. These circumstances include situations where patients do not have access to conventional white blood cell scanning or for whom such scanning is contraindicated.
Failure to comply with the provisions of the Determination may lead to civil or criminal consequences. However, the Determination itself does not specify any particular offences or penalties. It is likely that any breaches of the Act or associated regulations would be subject to the general provisions of the Health Insurance Act 1973 and other relevant legislation. These provisions typically include fines and, in severe cases, imprisonment. The specific penalties would depend on the nature and severity of the breach, as well as any applicable regulations or guidelines.
Overall, the Health Insurance (LeukoScan) Determination 2010 serves to integrate LeukoScan into the Medicare system, ensuring that it is provided under the same conditions and guidelines as other nuclear medicine services. The Determination aims to maintain the integrity and uniformity of the Medicare system while facilitating access to necessary diagnostic services for eligible patients.