Private Health Insurance (Prostheses) Amendment Rules (No. 6) 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01117 Rules Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Private Health Insurance Act 2007

 

Private Health Insurance (Prostheses) Amendment Rules (No. 6) 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. 6) 2019 (the Amending Rules) is to:

  • remove five prostheses from ‘Part 1 – Prostheses List – Part A’ of Schedule 1,
  • reinsert a sponsor name for a listing in ‘Part 1 – Prostheses List – Part A’ of Schedule 1, and
  • correct the benefit for one human tissue item in ‘Part 1 – Prostheses List – Part B’ of Schedule 1.

 

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

  • ER198 – Aeroform Patient Controlled Tissue Expander
  • ER199 – Aeroform Tissue Expander System Dosage Controller
  • SP047 - Gel Filled Mammary Prosthesis Models GFX-LP, GFX and GFX-EHP
  • SP049 - Gel Filled Mammary Prosthesis Models CoGel-XR, CoGel-XRH, CoGel-XL, CoGel- XM and CoGel XF
  • SP114 - Nagor Breast Implants

 

The sponsor of the Aeroform Tissue Expander and Dosage Controller requested that the prostheses be deleted from the Prostheses List as the products are no longer being sold.

The sponsor of the other three prostheses requested that they be removed from the Prostheses List as a precaution in light of an ongoing review by the Therapeutic Goods Administration (TGA) of textured breast implants.

An administrative error occurred in implementing Private Health Insurance (Prostheses) Amendment Rules (No. 5) 2019 whereby the sponsor name was deleted in respect of billing code AW019. The sponsor name is being reinserted.

The current listing for billing code RNB01 - a femoral head supplied by Hunter New England Bone Bank - is incorrect, due to an administrative error. The Amendment Rules correct the error to show that the minimum benefit for this human tissue item is $3,000.

 

Consultation

The Amending Rules have been made following consultation with the TGA, the sponsors of the billing codes being removed and the Hunter New England Bone Bank. The Office of Parliamentary Counsel advised on correcting the administrative error relating to the sponsor name.

 

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. 6) 2019

 

Section 1 – Name

 

Section 1 provides for the Amending Rules to be referred to as the Private Health Insurance (Prostheses) Amendment Rules (No. 6) 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.

 

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 delete the billing codes for two prostheses at the request of the sponsor.

 

Item 3 re-inserts the sponsor name for a billing code, which was deleted in error. This will assist in identifying the product.

 

Items 4 and 5 delete the billing codes for three prostheses at the request of the sponsor as a precaution in light of an ongoing TGA review.

 

Item 6 updates the benefit for one prosthesis supplied by Hunter New England Bone Bank with billing code RNB01 on the Prostheses List in Schedule 1 to these Rules.  Any provision of these prostheses to patients during hospital treatment from the commencement of the operation of the amendments implemented by the Amending Rule will attract the increased 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. 6) 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. 6) 2019 amends the Prostheses Rules by:

  • removing five prostheses from ‘Part 1 – Prostheses List – Part A’ of Schedule 1,
  • re-inserting a sponsor name for a listing in ‘Part 1 – Prostheses List – Part A’ of Schedule 1, and
  • correcting the benefit for one human tissue item in ‘Part 1 – Prostheses List – Part B’ of Schedule 1.

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

Two prostheses have been deleted from Part A of Schedule 1 as the sponsor no longer supplies them.

 

Three prostheses have been deleted from Part A of Schedule 1 at the request of the sponsor as a precaution in light of a review by the Therapeutic Goods Administration (TGA) of textured breast implants. There are other similar prostheses listed on the Prostheses List for persons to use and be reimbursed by private health insurance.

 

Re-inserting the sponsor name for a listing will assist in identifying the prosthesis for the purposes of paying a private health insurance benefit to insured persons.

 

Correcting the minimum benefit for the human tissue item will ensure that it continues to be available for insured persons and a private health insurance benefit will continue to be payable.

 

Accordingly, these changes 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. 6) 2019 were enacted to amend the Private Health Insurance (Prostheses) Rules (No. 2) 2019, which were made under the authority of the Private Health Insurance Act 2007. These rules were introduced to address the need for updating the Prostheses List, which specifies the types of prostheses that must be covered by complying health insurance policies. The Prostheses List is essential to ensure that insured persons have access to necessary medical devices and treatments during hospital treatment, as required by the Act. The rules were developed following consultation with relevant stakeholders, including the Therapeutic Goods Administration, sponsors of the prostheses, and the Hunter New England Bone Bank. The purpose of the amendment rules is to remove five prostheses from the Prostheses List due to requests from the sponsors and an ongoing review of textured breast implants by the Therapeutic Goods Administration. Additionally, the amendment rules correct an administrative error that led to the omission of a sponsor name and an incorrect minimum benefit for a human tissue item. The rules aim to ensure that the Prostheses List remains accurate and up-to-date, thereby protecting the rights of insured persons to access necessary medical treatments and devices. The amendment rules were made under the authority of the Private Health Insurance Act 2007 and are compatible with human rights as they do not impact the right to health of insured persons.

Scope and Application

The Private Health Insurance (Prostheses) Amendment Rules (No. 6) 2019 amends the Private Health Insurance (Prostheses) Rules (No. 2) 2019, which are made under section 333-20 of the Private Health Insurance Act 2007 (the Act). The Amending Rules apply to the list of prostheses specified in the Prostheses List, which is a schedule to the Prostheses Rules. The Prostheses List specifies the prostheses for which a benefit must be provided by complying health insurance policies that cover hospital treatment. The Act applies to private health insurance policies and providers in Australia, and the Amending Rules impact the specific prostheses listed in the Prostheses List. The Amending Rules remove five prostheses from the Prostheses List, reinsert a sponsor name that was deleted in error, and correct the minimum benefit for a human tissue item. These changes are made to reflect the current market offerings and correct administrative errors. The Amending Rules do not introduce any new exclusions, exemptions, or thresholds; rather, they amend existing entries in the Prostheses List. The scope of the Act and these rules is confined to the specific prostheses listed and does not extend to other health services or treatments.

Key Provisions

The Private Health Insurance (Prostheses) Amendment Rules (No. 6) 2019 (the Amending Rules) are an instrument under section 333-20 of the Private Health Insurance Act 2007 (the Act). The Amending Rules amend the Private Health Insurance (Prostheses) Rules (No. 2) 2019 by removing certain prostheses from the Prostheses List, correcting a sponsor name, and updating a benefit amount. The Prostheses List, as set out in the Schedule to the Prostheses Rules, lists prostheses that attract a benefit under a complying health insurance policy covering hospital treatment. The Amending Rules make three main amendments to the Prostheses List. First, they remove five prostheses from Part 1 – Prostheses List – Part A of Schedule 1 of the Prostheses Rules (items 1 to 5 of Schedule 1). This is done at the request of the sponsors of the prostheses, who either no longer supply the prostheses or have requested their removal as a precaution in light of a review of textured breast implants by the Therapeutic Goods Administration (TGA). Second, the Amending Rules re-insert a sponsor name for a listing in Part 1 – Prostheses List – Part A of Schedule 1 (item 3 of Schedule 1). This corrects an administrative error that occurred when the sponsor name was deleted in error. Third, the Amending Rules update the benefit for one human tissue item in Part 1 – Prostheses List – Part B of Schedule 1 (item 6 of Schedule 1). This corrects an administrative error that resulted in an incorrect benefit being listed for the item. The Amending Rules impose obligations on health insurance providers and sponsors of prostheses. Health insurance providers must ensure that they are offering a benefit for the provision of prostheses listed on the Prostheses List, in the circumstances and under the conditions set out in the Prostheses Rules. Sponsors of prostheses must ensure that they are supplying prostheses that are listed on the Prostheses List, and that they are meeting the minimum benefit requirements set out in the Prostheses Rules. The Amending Rules also impose obligations on the Department of Health, which must ensure that the Prostheses List is kept up to date and accurate. There are no offences, penalties, or civil or criminal consequences for breach of the Amending Rules. However, if a health insurance provider or sponsor of a prosthesis fails to meet their obligations under the Prostheses Rules, they may be subject to enforcement action by the Australian Prudential Regulation Authority (APRA) or the Australian Competition and Consumer Commission (ACCC). This may include fines, corrective notices, or other enforcement action. The maximum penalty for contravening a provision of the Act or the regulations made under the Act is 120 penalty units, or in the case of a corporation, 600 penalty units. In summary, the Amending Rules amend the Prostheses Rules by removing certain prostheses from the Prostheses List, correcting a sponsor name, and updating a benefit amount. The Amending Rules impose obligations on health insurance providers and sponsors of prostheses, and there are no offences, penalties, or civil or criminal consequences for breach of the Amending Rules. However, failure to meet the obligations imposed by the Prostheses Rules may result in enforcement action by APRA or the ACCC.

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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.