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