Health Insurance Determination HS/7/1999

Administered by Department of Health, Disability and Ageing

Legislation au F2007B00444 Not in force Legislative Instrument

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EXPLANATORY STATEMENT HS/7/1999

 

 

SUBJECT: HEALTH INSURANCE ACT 1973

DETERMINATION UNDER SUBSECTION 3C(1) TO PROVIDE MEDICARE BENEFITS FOR 153SM-LEXIDRONAM THERAPY FOR BONE PAIN

 

 

Subsection 3C(1) of the Health Insurance Act (the Act) provides that the Minister may, by instrument in writing, determine that a health service not already included in the General Medical Services Table (the table) is to be treated as if it were included in the table. Such a determination specifies a fee in respect of the health service and is subject to the provisions, as specified in the determination, of the Act, the National Health Act 1953, and regulations under these Acts, as if it were a health service included in the table.

 

The table, which is prescribed by regulations under section 4 and section 133 of the Act, contains item numbers for, descriptions of and fees in respect of medical services which are, among other things, recognised for the purposes of payment of Medicare benefits.

 

The Medicare Services Advisory Committee (MSAC) recently completed a systematic review of the evidence on the use of the radiopharmaceutical 153Sm-lexidronam therapy for

the treatment of metastatic bone lesions.  Medicare benefits are currently payable only for the

treatment of painful bony metastases from carcinoma of the prostate using 89Strontium.

 

MSAC recommended public funding for 153Sm-lexidronam therapy for the relief of bone pain in patients with skeletal metastases (as indicated by a positive bone scan) from the following malignancies: ­

(i) carcinoma of the prostate, where hormonal therapy has failed; or

(ii) carcinoma of the breast, where hormonal therapy and chemotherapy have failed; and either:

(a) the disease is poorly controlled by conventional radiotherapy; or

(b) conventional radiotherapy is inappropriate, due to the wide distribution of sites

     of pain.

 

Following the Minister's endorsement of MSAC's recommendation, an appropriate Medicare Benefits Schedule item descriptor and fee for 153Sm-lexidronam therapy has been negotiated through the Medicare Benefits Consultative Committee process, in consultation with the Australian and New Zealand Association of Physicians in Nuclear Medicine and the Australian Medical Association.

 

This determination in effect introduces a new item for this health service to enable cancer patients who require this therapy for relief of intractable bone pain to have access to a Medicare rebate as quickly as possible. It will provide for the payment of benefits for 153 Sm­-lexidronam therapy pending its proposed inclusion in the table when revisions are made to the table by amendment of the relevant regulations.

 

 

Overview

The Health Insurance Act 1973 was enacted by the Parliament of Australia to provide a framework for the administration of Medicare, the country's universal health care scheme. The Act was introduced to address the need for a coordinated and equitable system for providing healthcare services to all Australians. Under subsection 3C(1) of the Act, the Minister for Health has the authority to determine that a health service not currently listed in the General Medical Services Table is to be treated as if it were included in the table, thereby enabling the payment of Medicare benefits for that service. This provision allows for the timely inclusion of new and emerging treatments into the Medicare scheme. The explanatory statement for the determination under subsection 3C(1) to provide Medicare benefits for 153Sm-lexidronam therapy for bone pain, issued in 1999, highlights the policy objective of ensuring that cancer patients with intractable bone pain have access to this therapy through a Medicare rebate. This was achieved following a recommendation by the Medicare Services Advisory Committee and consultation with relevant medical associations.

Scope and Application

The Health Insurance Act 1973 applies to persons in Australia who are eligible for Medicare benefits, as well as entities such as hospitals and medical practitioners that provide services to those eligible for Medicare. The Act facilitates the payment of benefits for medical services through the General Medical Services Table, which includes item numbers and fees for recognised services. Under the provisions of the Act, the Minister for Health can determine that a specific health service not currently listed in the General Medical Services Table can be treated as if it were included, thereby making it eligible for Medicare benefits. This is exemplified by the determination to provide Medicare benefits for 153Sm-lexidronam therapy for bone pain in patients with skeletal metastases from specific malignancies, pending its formal inclusion in the table through regulatory amendments. This determination is applicable nationally, as it extends across the Commonwealth of Australia and applies to all relevant parties within the health sector who provide or receive the specified therapy. There are no specific exclusions or exemptions mentioned in the determination, but it is subject to the broader provisions of the Health Insurance Act and the National Health Act 1953, as well as any related regulations.

Key Provisions

The main operative sections of the Health Insurance Act (the Act) involved in this determination are section 3C(1) and section 4, which together facilitate the inclusion of new health services in the General Medical Services Table (the table). Section 3C(1) allows the Minister to determine, through a written instrument, that a health service not already listed in the table should be treated as if it were included, thereby specifying a fee for that service. This determination must adhere to the provisions of the Act, the National Health Act 1953, and any regulations under these Acts. Section 4 outlines the process by which the table is prescribed through regulations, detailing the item numbers, descriptions, and fees of medical services eligible for Medicare benefits. The obligations imposed by the Act on the parties or entities it governs are primarily centred around ensuring that the newly determined health service is recognised for Medicare benefits. The Minister is required to make the determination based on the recommendations and evidence provided by the Medicare Services Advisory Committee (MSAC). Furthermore, the Australian and New Zealand Association of Physicians in Nuclear Medicine and the Australian Medical Association are consulted to negotiate an appropriate Medicare Benefits Schedule item descriptor and fee for the new service. Once the determination is made, the relevant authorities must facilitate the payment of benefits for 153Sm-lexidronam therapy to eligible patients, pending its formal inclusion in the table through regulatory amendments. There are no explicit offences, penalties, or civil/criminal consequences outlined in the determination for breaches of the Health Insurance Act in this context. However, the Act, as a whole, provides for various enforcement mechanisms to ensure compliance with its provisions. These could include fines, penalties, and other legal actions for non-compliance with Medicare regulations, although specific penalties are not detailed in this determination. The focus here is on the procedural compliance and the timely provision of Medicare benefits to eligible patients for 153Sm-lexidronam therapy, pending its formal inclusion in the General Medical Services Table.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.