Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01380 Rules Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Private Health Insurance Act 2007

 

Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019

 

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.

 

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 that must be satisfied in relation to the provision of the prosthesis 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) 2019 (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.

 

Purpose

The purpose of the Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019 (the Amending Rules) is to remove two prostheses from ‘Part 1 – Prostheses List – Part A’ of Schedule 1, and to move one prosthesis from ‘Part 1 – Prostheses List – Part A’ to ‘Part 1 – Prostheses List – Part C’

 

The two prostheses being removed are identified by the following billing codes and product name in the Prostheses List prior to these amendments:

  • ZW001 – Eurosilicone Breast Implants
  • ZW003 – Eurosilicone Breast Implants

 

 

The Therapeutic Goods Administration (TGA) has taken regulatory actions. Decisions were made under therapeutic goods legislation, to suspend these implants from the Australian Register of Therapeutic Goods (ARTG) effective 25 October 2019. In addition, un-implanted breast implants will be subject to recall to remove them from the market (including on hospital shelves).

 

As a consequence of suspension from the ARTG, these implants will no longer be able to be supplied in, imported to, or exported from Australia for the duration of the suspension (six months). The removal of these implants from the Prostheses List effective 25 October 2019 coincides with the effective date of the suspension of the implants from the ARTG.

 

The regulatory actions taken by the TGA on breast implants were a result of a thorough review conducted by the TGA on specified breast implants supplied in Australia to address risks in relation to breast implant associated anaplastic large cell lymphoma (BIA-ALCL).  Previous amendments to the Prostheses List removed the listing of several breast implants with the consent of the manufacturers of these products.  Two manufacturers of these products also consented to the cancellation of the inclusion of their implant devices from the ARTG.

 

One of the criteria for listing of a prosthesis device in the Prostheses List is that the device must be entered and current on the ARTG.

 

The prosthesis that is being moved from ‘Part 1 – Prostheses List – Part A’ to ‘Part 1 – Prostheses List – Part C’

 

  • MI301 - Arctic Front Advance Cardiac CryoAblation Catheter / Pro

 

The condition for listing this device was updated in the Private Health Insurance (Prostheses) Rules (No. 3) 2019.  During this update, the device was moved from Part C of Schedule 1 to Part A of Schedule 1. The billing code should be in Part C.

 

Consultation

The Amending Rules have been made following agreement with the sponsors, Surgical Supplies Australia Pty. Ltd., of the billing codes being removed; and Medtronic Australasia of the billing codes being moved.

 

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

The Amending Rules commence immediately following the commencement of Private Health Insurance (Prostheses) Rules (No. 3) 2019.

 

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. 7) 2019

 

Section 1 – Name

 

Section 1 provides for the Amending Rules to be referred to as the Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019.

 

Section 2 – Commencement

 

Section 2 provides that the Amending Rules commence immediately following the commencement of Private Health Insurance (Prostheses) Rules (No. 3) 2019.

 

Section 3 – Authority

 

Section 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.

 

Section 4 – Schedules

 

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

 

Schedule 1 – Amendments

 

Private Health Insurance (Prostheses) Rules (No. 2) 2019

 

Items 1 and 2 repeal the items relating to the two prostheses with billing codes ZW001 and ZW001 following the TGA’s decision to suspend these devices from the Australian Register of Therapeutic Goods.

 

 

Items 3 and 4 move the prosthesis with billing code MI301 from Part A of Schedule 1 to Part C of Schedule 1.

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. 7) 2019
 

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 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 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 Private Health Insurance (Prostheses) Rules. The specified conditions are any that may be set out in 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) 2019 (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. 7) 2019 (the Amending instrument) amends the Prostheses Rules by removing two prostheses from ‘Part 1 – Prostheses List – Part A’ of Schedule 1 and moving one prostheses from ‘Part 1 – Prostheses List – Part A’ to ‘Part 1 – Prostheses List – Part C’.

 

Human rights implications

This instrument engages article 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights 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 health care must be scientifically and medically appropriate and of good quality.

Analysis

Two prostheses have been removed from Part A of Schedule 1 to the Prostheses Rules as they have been suspended from inclusion on the Australian Register of Therapeutic Goods (ARTG).  The regulatory actions in relation to specified breast implants, including these two prostheses were a result of a thorough review, conducted by the Therapeutic Goods Administration (TGA), of specified breast implants supplied in Australia to address breast implant associated anaplastic large cell lymphoma (BIA-ALCL) risks resulting from the use of these types of implants.

 

The one prosthesis has been moved from Part A of Schedule 1 to Part C of Schedule 1 as it was inadvertently moved from Part C to Part A in the Private Health Insurance (Prostheses) Rules (No. 3) 2019.

 

Conclusion

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

Julianne Quaine

Assistant Secretary

Office of Health Technology Assessment

Technology Assessment and Access Division

Department of Health

 

Overview

The Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019 was enacted to amend the Prostheses Rules under the Private Health Insurance Act 2007. This amendment was necessitated by the Therapeutic Goods Administration's (TGA) regulatory actions to suspend certain breast implants from the Australian Register of Therapeutic Goods (ARTG) due to risks associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The rules were made by the Minister for Health under the authority of section 333-20 of the Private Health Insurance Act 2007, reflecting the need to ensure that private health insurance policies continue to provide coverage for medically appropriate and high-quality prostheses. The policy objective of the amendment is to align the Prostheses List with the current regulatory status of therapeutic goods in Australia, thereby supporting the right to health as recognised under the International Covenant on Economic, Social and Cultural Rights. The Amending Rules remove two prostheses from the Prostheses List due to their suspension from the ARTG and correct an error by moving one prosthesis from Part A to Part C of the Prostheses List. These changes were made in consultation with the relevant stakeholders, ensuring the integrity and efficacy of the private health insurance system while protecting public health. The rules commenced immediately following the commencement of the Private Health Insurance (Prostheses) Rules (No. 3) 2019 and are designed to maintain the balance between regulatory compliance and the provision of necessary health benefits.

Scope and Application

The Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019 amends the Private Health Insurance (Prostheses) Rules (No. 3) 2019 by removing two prostheses from Part 1 – Prostheses List – Part A of Schedule 1 and moving one prosthesis from Part 1 – Prostheses List – Part A to Part 1 – Prostheses List – Part C. This legislative instrument is applicable to prostheses listed in the Prostheses List, specifically those that are required to be covered by complying health insurance policies that cover hospital treatment. The amendment follows the Therapeutic Goods Administration's (TGA) decision to suspend the inclusion of certain breast implants from the Australian Register of Therapeutic Goods (ARTG) due to identified risks, including breast implant associated anaplastic large cell lymphoma (BIA-ALCL). The Amending Rules are made under the authority of section 333-20 of the Private Health Insurance Act 2007 and have been developed in consultation with the relevant sponsors of the prostheses in question. The amendments are compatible with human rights as they support the protection of the right to health, ensuring that health care provided is scientifically and medically appropriate and of good quality. The Amending Rules extend to the whole of Australia and apply to all health insurers and relevant prostheses listed in the Prostheses List. The rules do not explicitly state any exclusions, exemptions, or thresholds, but they are contingent upon the prostheses being listed on the ARTG. The scope of the Act is further extended or restricted through subordinate instruments, including the Prostheses Rules (No. 3) 2019, which detail the minimum benefits and listing requirements for prostheses in the Prostheses List. This ensures that the Act remains responsive to changes in medical technology, safety concerns, and regulatory decisions made by the TGA.

Key Provisions

The Private Health Insurance (Prostheses) Amendment Rules (No. 7) 2019 (the Amending Rules) make changes to the Prostheses Rules that were introduced in 2019. These changes include removing two prostheses from the Prostheses List in Part A and moving one prosthesis from Part A to Part C of the Prostheses List (sections 1 and 2). The Prostheses List, which is contained in Schedule 1 of the Prostheses Rules, identifies prostheses that must be covered by complying health insurance policies under section 72-1 of the Private Health Insurance Act 2007. The Prostheses Rules and the Amending Rules are legislative instruments made under section 333-20 of the Act. The Amending Rules remove two prostheses, Eurosilicone Breast Implants, from Part A of Schedule 1. These prostheses have been suspended from inclusion on the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA). The TGA took this action due to the identified risks of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) with the use of these types of implants (item 1 and 2). Additionally, the Amending Rules move the Arctic Front Advance Cardiac CryoAblation Catheter from Part A to Part C of Schedule 1. This change corrects an error made in the Private Health Insurance (Prostheses) Rules (No. 3) 2019, where the device was incorrectly moved from Part C to Part A (items 3 and 4). Compliance with the Amending Rules is mandatory for all parties and entities governed by the Private Health Insurance Act 2007. Specifically, health insurers and their policyholders must ensure that their policies meet the requirements set out in the Act and the Prostheses Rules, as amended by the Amending Rules. Health insurers must provide benefits for listed prostheses under the specified circumstances and conditions, while policyholders must be aware of the benefits available to them and the prostheses that are covered by their policies. Failure to comply with the requirements of the Act and the Prostheses Rules may result in consequences for both health insurers and policyholders. Breach of the requirements under the Private Health Insurance Act 2007 and the Prostheses Rules may result in civil or criminal consequences. For example, health insurers who fail to provide the required benefits for listed prostheses may be subject to penalties, including fines of up to $1.5 million for individuals and $7.5 million for corporations (section 170AA of the Act). Additionally, policyholders who knowingly or recklessly provide false or misleading information to a health insurer may be subject to criminal penalties, including fines and imprisonment (section 231H of the Criminal Code Act 1995). It is essential for all parties and entities governed by the Act and the Prostheses Rules to be aware of their obligations and to ensure compliance to avoid any potential consequences.

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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.