EXPLANATORY STATEMENT
Issued by the authority of the Minister for Health and Ageing
Private Health Insurance Act 2007
Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 3) 2025
Purpose
The Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 3) 2025 amends the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 (the MDHTP Rules) to insert the billing code QQ749 in Part D of the Schedule 1.
This billing code was omitted incorrectly as a result of an administrative error.
Legislative Authority
Item 4 of the Table in section 333-20 of the Act provides that the Minister may make the MDHTP 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.
Subsection 72-10(5) of the Act applies if the Minister grants the application and the applicant pays any cost-recovery fee that the applicant is liable to pay in relation to the initial listing of the kind of medical device or human tissue product to which the application relates. If the Minister grants the application and the applicant pays the cost-recovery fee, then the Minister must list the kind of medical device or human tissue product the next time the Minister makes or varies the MDHTP Rules.
Subsection 72-10(6) of the Act provides that the MDHTP Rules may set out criteria that must be satisfied in order for an application to be granted.
Section 72-15 of the Act provides for the MDHTP Rules to specify cost-recovery fees for activities carried out by, or on behalf of, the Commonwealth in connection with the performance of functions, or the exercise of powers, conferred by or under the Act in relation to the listing of kinds of medical devices and human tissue products in the MDHTP Rules.
Reliance on subsection 33(3) of the Acts Interpretation Act 1901
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.
Commencement
This instrument commences retrospectively on 1 November 2025.
Where a listed medical device is included in the Prescribed List in the Schedule to the MDHTP Rules, a private health insurer must pay a benefit must be paid, where the listed device is provided in the conditions and circumstances specified in the Private Health Insurance Act 2007.
In accordance section 12 of the Legislation Act 2003, the amendments to the MDHTP Rules made by this instrument do not apply to a person other than the Commonwealth or an authority of the Commonwealth to the extent that as a result of its retrospective commencement:
(a) the person’s rights as at the time the instrument is registered would be affected so as to disadvantage the person; or
(b) liabilities would be imposed on the person in respect of anything done or omitted to be done before the instrument is registered.
Accordingly, to the extent that this instrument would impose a new liability on a private health insurer under the Act to pay benefits in respect of billing code QQ749 where the device was provided before this instrument is registered, the amendments made by the instrument to add billing code QQ749 will not apply to the insurer.
Consultation
In making the amending instrument, the rule-maker consulted with the sponsor of the billing code QQ749.
General
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
Details of this instrument are set out in Attachment A.
This instrument is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
ATTACHMENT A
Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 3) 2025
Section 1 – Name
Section 1 provides that the name of the instrument is the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 3) 2025.
Section 2 – Commencement
Section 2 provides that the instrument is taken to have commenced retrospectively on 1 November 2025.
Section 3 – Authority
Section 3 provides that the instrument is made under item 4 of the table in section 333-20 of the Private Health Insurance Act 2007.
Schedule 1 – Amendments
Schedule 1 lists the listed items (billing codes) for kinds of medical devices and human tissue products and contains the ‘minimum benefit’ and conditions for provision of the kinds of medical devices and human tissue products for private and public hospital treatment, and hospital-substitute treatment. Schedule 1 is to be known as the Prescribed List.
Item 1 provides for the inclusion of billing code QQ749 that was omitted incorrectly as a result of an administrative error.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 3) 2025
This Disallowable Legislative 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 Disallowable Legislative Instrument
The Table in subsection 72-1(2) (the Table) of Part 3-3 of the Private Health Insurance Act 2007 (the Act) provides for benefit requirements a complying health insurance policy that covers hospital treatment must meet. Under item 4 of the Table, there must be a benefit for the provision of a medical device or human tissue product, of a kind listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, in specified circumstances and under any specified conditions. The specified circumstances are that the listed item 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 (Medical Devices and Human Tissue Products) Rules. The specified conditions are any that may be set out in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules.
Listed items and their minimum benefits are set out in Schedule 1 to the Private Health Insurance (Medical Devices and Human Tissue Products) Rules. Schedule 1 is known as the Prescribed List.
The MDHTP Rules also define circumstances in which fees for assessments in relation to listing and variation applications are required, and the associated fee for that assessment. The MDHTP Rules also prescribe cost-recovery arrangements, including the timing for when cost-recovery fees become due and payable, and when cost-recovery fees can be refunded, and waivers can be granted.
The Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 3) 2025 amend the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 (the MDHTP Rules) by inserting the billing code QQ749 in Part D of the Schedule 1.
Human rights implications
The MDHTP Rules engage article 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the right to health.
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 that health care must be scientifically and medically appropriate and of good quality.
Analysis
The addition of a new item in the Prescribed List will increase the amount of choice an insured person can have in relation to the kind of medical device or human tissue product for which they must receive a minimum private health insurance benefit. This will impact positively on the right to health of insured persons.
Conclusion
The MDHTP Rules is compatible with human rights because it enables advances in the protection of human rights, in particular the right to health.
This Disallowable Legislative Instrument is compatible with human rights because it enables advances in the protection of human rights, in particular the right to health.
Avi Rebera
Assistant Secretary
Medical Services and Devices Assessment Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health, Disability and Ageing