EXPLANATORY STATEMENT
Issued by the authority of the Minister for Disability and the National Disability Insurance Scheme, Minister for Health and Ageing
Private Health Insurance Act 2007
Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2026
Purpose
The purpose of the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No.1) 2026 (the MDHTP Amendment Rules) is to replace Schedule 1 to the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2026 (the MDHTP Rules) with a new Schedule. The MDHTP Rules set out the minimum benefit payable for each listed item.
Listed items and their minimum benefits are set out in Schedule 1 to the MDHTP Rules. Schedule 1 to the MDHTP Rules is known as the Prescribed List of medical devices and human tissue products (Prescribed List).
The Prescribed List has four parts:
Part 1 - Part A – Medical Devices
Part 2 - Part B – Human Tissue Products
Part 3 - Part C – Other Medical Devices
Part 4 - Part D – General Use Items (medical devices)
The MDHTP Amendment Rules amend the MDHTP Rules by making changes to the benefits of 58 billing codes in Part B to reflect whole dollar amounts rather than dollars and cents.
Background
The Table in subsection 72-1(2) of Part 3-3 of the Act (Table) 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 MDHTP 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 MDHTP Rules. The specified conditions are any that may be set out in the MDHTP Rules.
If the complying health insurance policy also covers hospital-substitute treatment then under item 4 of the Table, the same requirements apply.
Subsection 72-10(2) of the Act provides that a person may apply to the Minister to have the MDHTP Rules list a medical device or human tissue product of the kind to which the application relates to (listed item). The applicant for these applications is known as the ‘sponsor’. If the listing application is accepted, and the device or human tissue product is listed in Schedule 1 of the MDHTP Rules, the sponsor will be responsible for any obligations related to the billing code (listed item). The sponsor also has obligations to ensure the information in Schedule 1 relating to the billing code is accurate and up to date.
After the MDHTP Rules had been made, stakeholders advised, and the department became aware of, errors (including incorrect benefit amounts for 58 listed billing codes) in the Schedule of the MDHTP Rules. The MDHTP Amendment Rules are made to rectify these errors.
Personal information may be collected as part of the application for listing process. This is generally limited to the names and contact information for contact persons for sponsors. To the extent that any information collected in relation to an application is personal information within the meaning of the Privacy Act 1988, the department collects, stores, uses and discloses that information in accordance with the Privacy Act, including the Australian Privacy Principles. The department’s Privacy Policy also applies to personal information collected as part of the application process, which is available on the department’s website.
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
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.
Commencement
The MDHTP Amendment Rules commence on 27 March 2026.
Consultation
In making the MDHTP Amendment Rules and the billing codes in Schedule 1, the rule-maker had regard to feedback from stakeholders, including hospitals, private health insurers and sponsors of listed products.
General
The MDHTP Rules are a legislative instrument for the purposes of the Legislation Act 2003.
Details of the MDHTP Amendment Rules are set out in Attachment A.
The MDHTP Amendment Rules are 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
Details of the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2026
Part 1 Preliminary
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. 1) 2026.
Section 2 Commencement
Section 2 provides that the instrument commences on 27 March 2026.
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.
Section 4 Schedules
Section 4 provides that the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2026 is amended as set out in Schedule 1.
Schedule 1 – Amendments
Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2026
Item 1 Schedule 1
Item 1 repeals Schedule 1 of the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2026 and substitutes:
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. 1) 2026
This 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.
The purpose of the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2026 (MDHTP Amendment Rules) is to amend the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2026 (MDHTP Rules) to replace Schedule 1 with an updated Schedule 1.
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 Amendment Rules amend the MDHTP Rules by making changes to the benefits of 58 billing codes in Part B to reflect whole dollar amounts rather than dollars and cents.
After the MDHTP Rules had been made, stakeholders advised, and the department became aware of, errors (including incorrect benefit amounts for 58 listed billing codes) in the Schedule of the MDHTP Rules. The MDHTP Amendment Rules are made to rectify these errors.
Human rights implications
The MDHTP Amendment 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 correction to the benefit amounts of the 58 billing codes certifies that benefits are accurately listed on the Prescribed List, which ensures that privately insured patients are reimbursed appropriately for the human tissue products they receive. This will impact positively on the right to health of insured persons.
Conclusion
The MDHTP Amendment Rules is compatible with human rights because it promotes the protection of human rights, in particular the right to health.
Brian Kelleher
Assistant Secretary
Private Hospitals Branch
Portfolio Strategy Division
Systems Strategy Group
Department of Health, Disability and Ageing