Explanatory Statement

Health Insurance Act 1973

Health Insurance (Positron Emission Tomography) Determination HS/05/07

Issued by the authority of the Minister for Health and Ageing

Background

Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides, in part, 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 2006 which are remade each year.

A determination made under subsection 3C(1) is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (see subsection 3C(4) of the Act and paragraph 6(d) of the Legislative Instruments Act 2003).

• Health Insurance (Positron Emission Tomography) Determination HS/07/05

On 6 December 2005, the Minister for Health and Ageing made Health Insurance (Positron Emission Tomography) Determination HS/07/05 (the 2005 Determination) under subsection 3C(1) of the Act.  The 2005 Determination permitted the payment of Medicare benefits in relation to the Positron Emission Tomography (PET) diagnostic imaging services specified in the Schedule to the 2005 Determination.

PET is a form of nuclear medicine used mainly to determine the presence and severity of cancers, neurological conditions and cardiovascular disease.  PET images reveal the chemistry of organs and other tissues such as tumours.  A radiopharmaceutical that gives off signals is injected into the patient and its emissions are measured by a PET scanner.

An original determination (HS/6/01) was made under subsection 3C(1) in 2002 for PET services provided by a limited number of providers with eligibility agreements with the Commonwealth.  The 2005 Determination allowed for the payment of Medicare benefits in relation to PET services provided at additional facilities without eligibility agreements provided that they met the criteria in section 4 of the 2005 Determination. 

Section 4 of the 2005 Determination detailed the circumstances where the Determination applied.  These circumstances included that the service was a referred service; performed by or under the personal supervision of a credentialled specialist; at an accredited and comprehensive facility; and that the equipment met identified technical standards.  The facility providing the service also needed to meet the minimum quarterly throughput targets which were specified in the 2005 Determination.

• Health Insurance (Positron Emission Tomography) Determination HS/05/07

Health Insurance (Positron Emission Tomography) Determination HS/05/07 (the Determination) revokes and effectively replaces the 2005 Determination. 

The Determination provides for the payment of Medicare benefits for PET services under the same circumstances as the 2005 Determination.  However, the Determination also provides an additional pathway for recognition as a practitioner who may render, or personally supervise the rendering of, the relevant services other than being a credentialled specialist under the Joint Nuclear Medicine Specialist Credentialling Program for the Recognition of the Credentials of Nuclear Medicine Specialists for Positron Emission Tomography.  The new path prescribes the qualifications and experience needed by practitioners, including that they have reported 400 or more PET services where a Medicare benefit was payable. 

The Determination also clarifies the meaning of an accredited site and comprehensive facility by defining both terms.  An accredited site is one that is accredited by ANZAPNM as a site for advanced training in PET.  A comprehensive facility is a building or part of a building or multiple buildings with covered access where a defined set of services are provided.  The Determination also removes the requirement for neurosurgery to be provided at the facility where the PET service is being provided. 

The Determination has also been extended to 30 June 2008.

Details of the Determination are set out in the Attachment.

Consultation

Consultation was undertaken with provider, referrer, consumer groups, and State Governments in the re-making of the Determination.

The Determination commences on the day after it is registered on the Federal Register of Legislative Instruments and remains in force until midnight on 30 June 2008.

ATTACHMENT

Notes on sections

Section 1

Section 1 provides for the name of the Determination.

Section 2

Section 2 provides that the Determination is to commence on the day after it is registered and shall remain in force until midnight on 30 June 2008. 

Section 3

Section 3 provides that the Determination revokes Health Insurance Determination HS/07/05.

Section 4

Subsection 4(1) defines terms used in the Determination.

A key term is ‘accredited site’ which means one that is accredited by ANZAPNM as a site for advanced training in PET.

Another key term is ’comprehensive facility’ which means either one building or a part of a building, or buildings that are joined by a covered pedestrian walkway, where each of the following services is provided: PET, computed tomography, x-ray, diagnostic ultrasound, medical oncology, surgical oncology, radiation oncology and neurology services.  Neurosurgery is no longer required to be provided at the relevant facility where the PET service is being provided.

Another key term is ‘relevant service’ which means a health service as defined in subsection 3C(8) of the Act that is specified in the Schedule to the Determination.  There are three such relevant services in the Schedule.

Subsection 4(2) provides that a reference to a provision of an Act or regulations, is a reference to the provision as in force from time to time (as authorised by subsection 3C(3) of the Act).

Section 5

Subsection 5(1) specifies the circumstances in which the Determination applies.  These circumstances include that:

• the service is a service referred by a specialist or consultant physician;
• the service is performed by or under the personal supervision of a credentialled specialist or a practitioner possessing prescribed qualifications and experience;
• the service is performed at an accredited site in a comprehensive facility; 
• the equipment used to render the service meets identified technical standards; and 
• the facility providing the service has met the minimum quarterly throughput targets specified in the Determination.

The intention is that an “accredited site in a comprehensive facility" is one that can provide a full range of cancer treatment services (including chemotherapy, radiation oncology and surgical oncology) at the one site.  That is, a facility that is providing services under the following sections of the general medical services table:

Group T2 - Radiation Oncology;

Group T1 - Miscellaneous Therapeutic Procedures, Subgroup 11; and

Group T8 - Surgical Operations."

Subsection 5(2) defines a “credentialled specialist” as a specialist or consultant physician credentialled under the “Joint Nuclear Medicine Specialist Credentialling Program for the Recognition of the Credentials of Nuclear Medicine Specialists for Positron Emission Tomography”.  Information on this program and the standards can be viewed on the website of the Australian and New Zealand Association of Physicians in Nuclear Medicine Inc (ANZAPNM) at: www.anzapnm.org.au/qaprograms/credentialling.htm

Subsection 5(2A) prescribes the appropriate “qualifications and experience” for an additional pathway for recognition as a practitioner who may render, or personally supervise the rendering of, the relevant services as being: a Fellow of the RACP or RANZCR, having reported 400 or more studies forming part of PET services in respect of which a Medicare benefit was payable and holding a current licence to prescribe and administer PET radiopharmaceuticals to humans from the relevant State radiation licensing body.

Subsection 5(3) specifies the technical standards which the equipment must meet.  The first of these is the “Interim Recommendations for PET Accreditation (Technical Aspects)” dated 16 May 2001 and issued by the Australian and New Zealand Society of Nuclear Medicine, but not including the NEMA NU 2-2000 standard referred to in that document.  These standards can be viewed on the website of the Department of Health and Ageing at: www.health.gov.au.  The equipment must also meet the NEMA NU 2-2001 referred to in the “Interim Recommendations for PET accreditation (Technical Aspects)” which is a standard published on 20 June 2001 and issued by the National Electrical Manufacturers Association, a non-stock corporation organized under the General Corporation Law of the State of Delaware in the United States of America.  These standards can be purchased through the website of the National Electrical Manufacturers Association at: www.nema.org .

Subsection 5(4) specifies the minimum throughput requirements as at least 20 relevant services per PET scanner per quarter.  A quarter is the three months beginning on 1 January, 1 April, 1 July or 1 October of each year. 

Subsection 5(5) describes the circumstances where an authorised officer from Medicare Australia or an APS employee authorised by the Secretary may revoke a notice issued under paragraph 5(1)(b) which identifies that a PET scanner has failed to meet the throughput requirements. 

Section 6

Paragraph 6(a) provides that the relevant service specified in the Schedule to the Determination shall be treated for the purposes of all provisions of the Act, regulations made under the Act, the National Health Act 1953 and regulations made under the National Health Act 1953 as if it were both a professional service and a medical service.

Paragraph 6(b) provides that each PET service specified in the Schedule to the Determination shall be treated as if there were an R-type diagnostic imaging service in the diagnostic imaging services table that related to the service and specified a fee in respect of that service.

Section 7

Section 7 provides that the specified provisions shall have effect as if a relevant service and the items that relate to a relevant service were also specified in those specified provisions.

Schedule

The Schedule sets out the relevant services and assigns to the services the applicable item number, item descriptor and fee.