EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health and Ageing

Health Insurance Act 1973

Health Insurance (Positron Emission Tomography) Determination 2009

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 2008 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).

The Health Insurance (Positron Emission Tomography) Determination 2009 (the Determination) revokes and replaces the Health Insurance (Positron Emission Tomography) Determination 2008 (No. 2) (the Previous Determination).

This Determination allows Medicare benefits to be paid for PET services provided in the circumstances set out in section 5 of the Determination, including that PET services are carried out on equipment meeting standards specified by the Australian and New Zealand Association of Physicians in Nuclear Medicine (ANZAPNM).  ANZAPNM’s specified standards have recently changed from those set out in the Interim Recommendations for PET Accreditation (Instrumentation and Safety) to those set out in the Requirements for PET Accreditation (Instrumentation and Radiation Safety).  This change is reflected in the Determination.  ANZAPNM also specifies the standards set out in the NEMA NU 2-2001 Standard.

The Determination includes six new items to claim against.  The new items are for PET services relating to oesophageal and head and neck cancer. 

In substance the Determination ensures that facilities which provide PET services in the specified circumstances, including the new equipment standards, can provide an expanded number of Medicare-eligible PET services until 30 June 2010.

Details of the Determination are set out in Attachment A.

Consultation

The Department has consulted with expert clinicians in PET nominated by the ANZAPNM and the Royal Australian and New Zealand College of Radiologists for input into the design of the six new item descriptors, which are being implemented through this Determination.

The Determination commences on 1 September 2009 and remains in force until midnight on 30 June 2010.

DIAGNOSTIC SERVICES BRANCH

DEPARTMENT OF HEALTH AND AGEING

JULY 2009

ATTACHMENT A

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 1 September 2009 and shall remain in force until midnight on 30 June 2010. 

Section 3

Section 3 provides that this Determination revokes Health Insurance (Positron Emission Tomography Determination) 2008 (No. 2).

Section 4

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

A key term is ‘accredited site’ which means one that is accredited by the Australian and New Zealand Association of Physicians in Nuclear Medicine (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. 

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 fifteen such relevant services in the Schedule.

Subsection 3(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 in writing 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 equivalent to those provided by facilities under the following sections of Part 3 of Schedule 1 to the Health Insurance (General Medical Services Table) Regulations 2008:

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”. 

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 Royal Australasian College of Physicians or the Royal Australian and New Zealand College of Radiologists, 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, as specified by ANZPANM, which the equipment must meet.  These requirements are as set out in the Requirements for PET Accreditation (Instrumentation and Radiation Safety) dated May 2007 issued by the Australian and New Zealand Society of Nuclear Medicine and the NEMA NU 2-2001 Standard referred to in the Requirements for PET Accreditation (Instrumentation and Radiation Safety) document. 

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 Australian Public Service 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

Subsection 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 that make provision in respect of professional services or medical services, as if it were both a professional service and a medical service.

Subsection 6(b) 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 that make provision in respect of professional services or medical services, as if there were an R-type diagnostic imaging service in the Table that related to the service and specified a fee in respect of that service being the fee specified in the Schedule.

Section 7

Section 7 provides that the provisions specified in section 7 shall have effect as if a relevant service and the items that relate to a relevant service by virtue of section 6(b) were also specified in those provisions specified in section 7.

Schedule

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