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