Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01033 Rules Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Private Health Insurance Act 2007

 

Private Health Insurance (Prostheses) Amendment Rules (No. 5) 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 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 that must be satisfied in relation to the provision of the prosthesis 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. 2) 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. 5) 2019 (the Amending Rules) is to remove five prostheses from ‘Part 1 – Prostheses List – Part A’ of Schedule 1 to the Prostheses Rules. The five prostheses are identified by the following billing codes and product name in the Prostheses List prior to these amendments:

  • AW004 - Natrelle® 510 TruForm™ Dual Gel Breast Prosthesis
  • AW005 - Natrelle® INSPIRA® TruForm Textured Mammary Implant
  • AW007 - Natrelle® 410 BioDIMENSIONAL™
  • AW012 - Natrelle® 150, 1-Stage BioDimensional™ Tissue Expander
  • AW013 - Natrelle® 133, 2-Stage BioDimensional™ Tissue Expander

 

On 30 July 2019, the Therapeutic Goods Administration (TGA) published a Recall Action Notification advising that the sponsor, Allergan Australia Pty Limited has voluntarily recalled these prostheses as a precautionary measure following notification of recently updated global safety information concerning the uncommon incidence of breast implanted-associated anaplastic large cell lymphoma (BIA-ALCL). The sponsor requested that the prostheses be removed from the Prostheses List following this action.

 

Consultation

The Amending Rules have been made following consultation with the TGA and Allergan Australia Pty Limited.

 

 

 

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

The Amending Rules commences the day after 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. 5) 2019

 

Section 1 – Name

 

Section 1 provides for the Amending Rules to be referred to as the Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019.

 

Section 2 – Commencement

 

Section 2 provides that the Amending Rules commence on the day after registration.

 

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.

 

Rule 4 – Schedules

 

Rule 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 to 4 revoke the listing of, and therefore remove the five prostheses supplied by Allergan Australia Pty Limited with billing codes AW004, AW007, AW005, AW012 and AW013 from the Prostheses List in Schedule 1 to these Rules.  Any provision of these prostheses during hospital treatment would no longer attract a benefit under the Private Health Insurance Act 2007.


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. 5) 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. 2) 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. 5) 2019 amends the Prostheses Rules by removing five prostheses from Part A of Schedule 1. These prostheses are being removed from the Prostheses List following a voluntary recall of these products. The prostheses being removed from the Prostheses List are five types of textured breast implants supplied by the specified sponsor.

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.

Analysis

The five prostheses have been deleted from Part A of Schedule 1 as the sponsor has voluntarily recalled stocks from hospitals.

There are other similar prostheses listed on the Prostheses List for persons to use and be reimbursed by private health insurance. Accordingly, this change will have no impact on the right to health of insured persons.

Conclusion

The instrument is compatible with human rights because it has no impact on the protection of human rights.

Karen Binnekamp

Acting Assistant Secretary

Office of Health Technology Assessment

Technology Assessment and Access Division

Department of Health

 

Overview

The Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019 were enacted to address an issue concerning specific prostheses that had been recalled due to safety concerns. This legislative instrument amends the Private Health Insurance (Prostheses) Rules (No. 2) 2019, made under the Private Health Insurance Act 2007. The purpose of these amendments is to remove five particular prostheses from the Prostheses List, which is a schedule to the Prostheses Rules. These prostheses were voluntarily recalled by the sponsor, Allergan Australia Pty Limited, in response to updated global safety information about the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The removal of these items from the Prostheses List ensures that these particular prostheses will no longer attract benefits under the Private Health Insurance Act 2007. The enactment of these rules was made possible under the authority granted by section 333-20 of the Private Health Insurance Act 2007, which allows the Minister to make rules concerning prostheses. The rules were developed following consultations with the Therapeutic Goods Administration and the sponsor, and they are designed to maintain the integrity and safety of the prostheses provided under private health insurance policies. The rules are compatible with human rights, as they do not adversely affect the right to health, given the availability of alternative prostheses listed in the Prostheses List. The rules commenced on the day after their registration, in accordance with the Legislation Act 2003.

Scope and Application

The Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019 is a legislative instrument made under the authority of the Private Health Insurance Act 2007. This Act applies to health insurers and insured persons within the Commonwealth of Australia. The Amending Rules specifically address the provision of prostheses covered by private health insurance policies. They amend the Prostheses Rules by removing five specific textured breast implants from the Prostheses List, a schedule that details the prostheses eligible for benefits under a complying health insurance policy. The removal follows a voluntary recall by the sponsor, Allergan Australia Pty Limited, in response to updated global safety information regarding the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The purpose of these rules is to ensure that the Prostheses List reflects current safety standards and recommendations, thereby maintaining the integrity and reliability of private health insurance coverage for prostheses. The Amending Rules do not introduce any new exclusions, exemptions, or thresholds but rather adjust the existing list of eligible prostheses to exclude certain products. The legislative instrument is compatible with human rights as it does not affect the overall right to health for insured persons, as alternative prostheses remain available and covered under the Act. The Amending Rules are a practical response to safety concerns and are designed to align the Prostheses List with current medical advice and industry standards.

Key Provisions

The Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019 amends the Private Health Insurance (Prostheses) Rules (No. 2) 2019, which establish a list of prostheses that are eligible for benefits under a complying health insurance policy that covers hospital treatment. Section 333-20 of the Private Health Insurance Act 2007 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. The Amending Rules, under section 3 of the Act, remove five specific prostheses from the Prostheses List in Schedule 1 to the Prostheses Rules, thereby altering the list of prostheses eligible for benefits under a complying health insurance policy. These prostheses are identified by the billing codes and product names: AW004 - Natrelle® 510 TruForm™ Dual Gel Breast Prosthesis, AW005 - Natrelle® INSPIRA® TruForm Textured Mammary Implant, AW007 - Natrelle® 410 BioDIMENSIONAL™, AW012 - Natrelle® 150, 1-Stage BioDimensional™ Tissue Expander, and AW013 - Natrelle® 133, 2-Stage BioDimensional™ Tissue Expander. The removal of these prostheses from the Prostheses List means that any provision of these prostheses during hospital treatment would no longer attract a benefit under the Private Health Insurance Act 2007. The obligations imposed by the Amending Rules primarily concern the removal of the specified prostheses from the Prostheses List, which directly affects the eligibility criteria for benefits under a complying health insurance policy. Health insurance providers must ensure that their policies do not offer benefits for the provision of the removed prostheses. These changes necessitate updates to policy documents, internal systems, and communication with policyholders to reflect the new eligibility criteria. The Amending Rules also require that any prostheses listed in the Prostheses List must meet the specified circumstances and conditions set out in the Act, which include being provided in circumstances in which a Medicare benefit is payable or under any specified conditions as outlined in the Prostheses Rules. The Amending Rules do not explicitly outline specific offences, penalties, or civil/criminal consequences for breach. However, the implications of non-compliance with the Act and its associated rules could lead to legal consequences. For instance, if a health insurance provider continues to offer benefits for the provision of the removed prostheses, this could be considered a breach of the rules and may result in enforcement actions by the relevant authorities. These actions could include fines, corrective measures, or other regulatory actions designed to ensure compliance with the Act and its associated rules. The exact penalties for non-compliance would be determined by the applicable laws and regulations governing the enforcement of the Private Health Insurance Act 2007.

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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.