Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00071 Rules Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

Private Health Insurance Act 2007

 

Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021

 

Authority

Section 333-20 of the Private Health Insurance Act 2007 (the Act) provides that the Minister may make Private Health Insurance (Prostheses) Rules, providing for matters required or permitted by Part 3-3 of the Act, or necessary or convenient in order to carry out or give effect to Part 3-3 of the Act.

In addition to the power to make this instrument under section 333-20 of the Act, subsection 33(3) of the Acts Interpretation Act 1901 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.

Subsection 72-10(6) of the Act provides that the Private Health Insurance (Prostheses) Rules may set out listing criteria that must be satisfied in order for an application for a prosthesis to be listed to be granted.

Background

The table in subsection 72-1(2) of Part 3-3 of the Act provides for benefit requirements that a complying health insurance policy that covers hospital treatment must meet. Under item 4 of that table there must be a benefit for the provision of a prosthesis, of a kind listed in the Private Health Insurance (Prostheses) Rules (i.e. a listed prosthesis), in specified circumstances and under any specified conditions. The specified circumstances are that the listed prosthesis is provided in circumstances in which a medicare benefit is payable or in other circumstances which may be set out in the Private Health Insurance (Prostheses) Rules. The specified conditions are any that may be set out in the Private Health Insurance (Prostheses) Rules.

If the complying health insurance policy also covers hospital-substitute treatment, under item 4 of the table in subsection 72-1(2) of Part 3-3 of the Act the same requirements apply.

The Private Health Insurance (Prostheses) Rules (No. 3) 2020 (Prostheses Rules) are made for the purposes of section 333-20(1) of the Act. Listed prostheses and their minimum benefits are set out in the Schedule to the Prostheses Rules. The list of prostheses in the Schedule is commonly referred to as the Prostheses List.


Purpose

The purpose of the Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021 (the Amending Rules) is to remove 12 urogynaecological mesh prostheses from ‘Part 1 – Prostheses List – Part A’ of the Schedule.

The 12 prostheses in Part A of the Prostheses List are being removed as a result of the cancellation of their entries from the Australian Register of Therapeutic Goods (ARTG). As these prostheses are no longer included in the ARTG they cannot be lawfully supplied in Australia.

Consultation

The Amending Rules have been made following consultation with the sponsors of the prostheses affected.

According to the Therapeutic Goods (Medical Devices) Regulations 2002, all surgical mesh devices have been reclassified from Class IIb to Class III (high-risk). In order to meet the transitional arrangements [and be able to continue to legally supply their products], sponsors of the surgical mesh devices on the ARTG as Class IIb had to submit applications to the Therapeutic Goods Administration (TGA) to include their meshes in the ARTG as Class III devices. For urogynaecological mesh devices, the deadline for submitting such an application was 1 December 2020.

Some sponsors did not reclassify their urogynaecological meshes prior to the specified date, and requested the TGA cancel their Class IIb ARTG entries.

The Department of Health contacted sponsors whose entries were no longer on the ARTG, advising that given their devices were no longer on the ARTG, the Department would be recommending to the Minister’s delegate to remove the respective billing codes for the urogynaecological mesh devices from the Prostheses List.

The sponsors’ responses had been given due consideration prior to making the decision.

Details of the Amending Rules are set out in the Attachment.

The Amending Rules commence the day following registration.

The Amending Rules is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

 

Details of the Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021

 

Rule 1 Name

 

Rule 1 provides that the title of the Amending Rules is the Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021.

 

Rule 2 Commencement

 

Rule 2 provides that the Amending Rules commence the day after the instrument is registered on the Federal Register of Legislation.

 

Rule 3 Authority

 

Rule 3 provides that the Amending Rules is made under item 4 of the table in section 333-20 of the Private Health Insurance Act 2007.

 

Rule 4 Schedules

 

Rule 4 provides that each instrument that is specified in Schedule 1 to the Amending Rules is amended or repealed as set out in the applicable items in the Schedule, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedules 1 – Amendments

Private Health Insurance (Prostheses) Rules (No. 3) 2020

Items 1 to 12 remove 12 billing codes for prostheses that are no longer included in the ARTG and cannot be lawfully supplied in Australia.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021
 

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 Legislative Instrument

The table in subsection 72-1(2) of Part 3-3 of the Private Health Insurance Act 2007 (the Act) provides for benefit requirements that a complying health insurance policy that covers hospital treatment must meet. Under item 4 of that table there must be a benefit for the provision of a prosthesis, of a kind listed in Private Health Insurance (Prostheses) Rules (i.e. a listed prosthesis), in specified circumstances and under any specified conditions.

The Private Health Insurance (Prostheses) Rules (No. 3) 2020 (Prostheses Rules) were made for the purposes of section 333-20 of the Act. Listed prostheses and their minimum benefits are set out in the Schedule to the Rules. The list of prostheses in the Schedule is commonly referred to as the Prostheses List.

The Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021 amends the Prostheses Rules by removing 12 prostheses from ‘Part 1 – Prostheses List – Part A’ of the Schedule.

Human rights implications

This instrument engages article 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the right to health.

Right to Health

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. Whilst the UN Committee on Economic Social and Cultural Rights has stated that the right to health is not to be understood as a right to be healthy, it does entail a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health. In addition, the right to health must meet certain key requirements, including that health care must be scientifically and medically appropriate and of good quality.

Analysis

The removal of 12 prostheses reflects that they are no longer included in the Australian Register of Therapeutic Goods (ARTG) and cannot be lawfully supplied in Australia. This impacts positively on the right to health of insured persons by preventing them from being exposed to prostheses that have not been adequately assessed for safety and performance.

Conclusion

The instrument is compatible with human rights because it enables advances in the protection of human rights, in particular the right to health.

 

Natasha Ryan

Assistant Secretary

Office of Health Technology Assessment

Technology Assessment and Access Division

Department of Health

Overview

The Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021 were introduced to address the issue of certain urogynaecological mesh prostheses that were removed from the Australian Register of Therapeutic Goods (ARTG) and therefore could no longer be lawfully supplied in Australia. These rules amend the Private Health Insurance (Prostheses) Rules (No. 3) 2020 by removing 12 such prostheses from the Prostheses List, ensuring that insured persons are not exposed to prostheses that have not been adequately assessed for safety and performance. The rules were made under section 333-20 of the Private Health Insurance Act 2007 and were enacted by the Minister for Health. The policy objective is to enhance patient safety by ensuring that only prostheses that meet necessary safety and quality standards are covered by private health insurance policies. The Amending Rules were developed following consultation with the sponsors of the affected prostheses and are in line with the reclassification of surgical mesh devices from Class IIb to Class III under the Therapeutic Goods (Medical Devices) Regulations 2002. By removing these prostheses from the Prostheses List, the rules aim to safeguard the right to health of insured persons by preventing them from being exposed to potentially unsafe or ineffective medical devices. The removal of these prostheses is also compatible with human rights, particularly the right to health as outlined in article 12 of the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021 apply to the Prostheses List, which is a component of the Private Health Insurance (Prostheses) Rules (No. 3) 2020, made under the Private Health Insurance Act 2007. This Act governs the regulation of private health insurance in Australia and applies to health insurance providers, policyholders, and prostheses suppliers within the Commonwealth. The Amending Rules specifically target the removal of 12 urogynaecological mesh prostheses from the Prostheses List due to their cancellation from the Australian Register of Therapeutic Goods (ARTG). As these prostheses are no longer lawfully supplied in Australia, their exclusion from the Prostheses List ensures compliance with health and safety standards. The geographic reach of the Act is national, applying across all states and territories of Australia. Any exclusions or exemptions would be determined by the specific terms of the Prostheses List and any amendments thereto, with subordinate instruments such as the Amending Rules extending or restricting the application of the Act.

Key Provisions

The Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021 primarily involve the removal of 12 specific urogynaecological mesh prostheses from the Prostheses List in the Private Health Insurance (Prostheses) Rules (No. 3) 2020. The removal of these prostheses is due to their cancellation from the Australian Register of Therapeutic Goods (ARTG), meaning they can no longer be lawfully supplied in Australia (Rule 4 and Schedule 1). This amendment ensures that only prostheses that meet safety and performance standards are included in the Prostheses List, thereby protecting the health of insured individuals. The Amending Rules impose several obligations on the parties involved. Health insurers must ensure that any prostheses listed in their policies comply with the updated Prostheses List. Prosthesis manufacturers and suppliers must also adhere to the updated regulatory standards by ensuring their products meet the requirements for inclusion in the ARTG. Furthermore, the Department of Health is responsible for monitoring and advising on the removal of prostheses from the Prostheses List based on their status in the ARTG. There are no specific offences, penalties, or civil/criminal consequences outlined in the Amending Rules for breach of the provisions. However, non-compliance with the updated Prostheses List could result in legal ramifications for health insurers if they continue to offer coverage for prostheses that are no longer lawfully supplied in Australia. This could include regulatory action, fines, or other penalties imposed by the relevant authorities. The overarching goal of these amendments is to uphold the safety and quality standards of prostheses available to insured individuals, thereby safeguarding their right to health.

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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.