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. 2) 2025
Purpose
The purpose of the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 2) 2025 (Amendment Rules) is to amend the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (MDHTP Rules) made under section 333-20 of the Private Health Insurance Act 2007 (the Act).
The Amendment Rules amend incorrectly listed billing codes in the list of medical devices and human tissue products, for which a benefit must be paid, where the listed item is provided in the conditions and circumstances specified in the Act. The incorrect billing codes where within the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2025 (Amendment Rules No. 1) that amended the MDHTP Rules on 1 July 2025. Listed items and their minimum benefits are set out in Schedule 1 to the MDHTP Rules, which is known as the Prescribed List of Medical Devices and Human Tissue Products (the Prescribed List).
Background
The Table in subsection 72-1(2) of Part 3-3 of the Act (the Table) provides for the benefit requirements a complying health insurance policy, that covers hospital treatment, must meet. Item 4 of the Table requires a benefit to be paid for the provision of a Prescribed List medical device or human tissue product in specified circumstances and under any specified conditions. A listed item meets the specified circumstances when a medicare benefit is payable, or, in other circumstances set out in the MDHTP Rules. The specified conditions are any that are set out in the MDHTP Rules.
If the complying health insurance policy also covers hospital-substitute treatment, then the same Item 4 requirements apply.
A person may apply to the Minister, under subsection 72-10(2) of the Act, to have the MDHTP Rules list a medical device or human tissue product. If the listing application is granted, the device or human tissue product becomes a ‘listed item’ and is added to the Prescribed List. The applicant is responsible for any obligations related to the listed item and must ensure accurate and up-to-date information is provided to the Department of Health, Disability and Ageing (the department) if circumstances relating to the listed item change.
The Amendment Rules are required to reflect changes to address 25 incorrect billing codes.
To the extent that any information collected as part of the application process 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. Personal information collected during this process is generally limited to applicant names and contact details. The department’s Privacy Policy, which is available on the department’s website, also applies.
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.
Section 72-15 of the Act enables 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.
Subsection 12(1A) of the Legislation Act 2003 states that a legislative instrument may commence before the instrument is registered. However, subsection 12(2) has the effect that a retrospectively commencing legislative instrument will not apply in relation to a person to the extent that the retrospective commencement would affect their rights as at the time the instrument is registered so as to disadvantage them, or impose additional liabilities on the person in respect of things done or omitted to be done at the time the instrument is registered.
The updated Schedule 1 to the MDHTP Rules will correct 25 billing codes incorrectly assigned to listed devices. The benefits payment will remain the same and therefore not disadvantage any person or impose additional liabilities on a person. Commencing the Amendment Rules retrospectively on 1 July 2025 ensures there is not time gap in applying benefits associated with the billing codes for listed devices that could affect claiming and reimbursement transactions.
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 Amendment Rules commence immediately after the commencement of the Amendment Rules (No. 1) 2025 on 1 July 2025.
Consultation
In making the Amendment Rules No. 1 and updating the Prescribed List, the rule-maker had regard to the advice received from stakeholders following the updating of their business systems. These stakeholders advised that 25 previously retired billing codes were assigned to new listings. These were manually adjusted in the Department’s online application system. The Amendment Rules amends the Schedule 1 to reflect these changes.
Impact Analysis
A Regulation Impact Statement was undertaken for the reforms to the Prescribed List (formerly known as the Prostheses List) which covers legislative implementation through the MDHTP Rules, including cost recovery (OBPR ID 43619).
General
The Amendment Rules are a legislative instrument for the purposes of the Legislation Act 2003.
Details of the Amendment Rules are set out in Attachment A.
The 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. 2) 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.2) 2025 (Amendment Rules).
Section 2 Commencement
Section 2 provides that the instrument commences immediately after the commencement of the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2025
Section 3 Authority
Section 3 provides that the Amendment Rules are 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 2025 (MDHTP Rules) are amended as set out in Schedule 1.
Schedule 1 – Amendments
Item 1
Schedule 1 contains a list of medical devices and human tissue products, as well as the ‘minimum benefit’ and conditions for provision of those medical devices and human tissue products when used in private and public hospital treatment, and hospital-substitute treatment. Schedule 1 is known as the Prescribed List of Medical Devices and Human Tissue Products (Prescribed List).
Item 1 repeals Schedule 1 and substitutes it with an updated list of medical devices and human tissue products to reflect changes to address 25 incorrect billing codes.
Schedule 1 of the Amendment Rules (the Prescribed List) differs from the previous Prescribed List (which commenced on 1 March 2025) by:
Addition of 198 new billing codes to Part A following accepted and granted new applications, 2 billing codes as the result of expansion applications and 348 new billing codes due to transfer of billing codes from one sponsor to another.
Changes to 345 billing codes in Part A following accepted amendment applications, correction of incorrectly listed billing codes, changes to the conditions, and changes to the Prescribed List benefits (due to the Prescribed List reforms or minor corrections).
Deletion of 348 billing codes from Part A following acceptance of applications for transfer of billing codes to the new sponsors, removing 1 billing code following completion of expansion application, and deletion of 395 billing codes following acceptance of deletion applications and other requests.
Addition of 9 new billing codes to Part B following accepted and granted new applications, and 8 new billing codes due to transfer of billing codes from one facility to another.
Changes to 52 billing codes in Part B following accepted amendment applications and minor corrections.
Deletion of 8 billing codes in Part B following acceptance of applications for transfer of the billing codes to the new sponsors, and deletion of 68 billing codes following acceptance of the deletion applications and other requests.
Addition of 1 new billing code to Part C following accepted and granted new application.
Changes to 4 billing codes in Part C following accepted amendment applications.
Deletion of 2 billing codes in Part C following acceptance of deletion applications.
Addition of 6 new billing codes to Part D following accepted and granted new applications, 2 billing codes as the result of expansion applications, and 5 new billing codes due to transfer of billing codes from one sponsor to another.
Changes to 10 billing codes in Part D following accepted amendment applications.
Deletion of 5 billing codes in Part D following acceptance of applications for transfer of billing codes to new sponsors, removing 1 billing code following completion of expansion application, and deletion of 19 billing codes following acceptance of deletion applications and other requests.
The numbers of Prescribed List billing codes were taken from reports produced by the Health Products Portal (HPP) when the list was run.
When Prescribed List billing codes are transferred from one sponsor to a different sponsor, or billing codes are compressed or expanded following the respective application, the Prescribed List billing codes that are transferred, expanded, or compressed are deleted.
Further, the Prescribed List differs from the previous (March 2025) Prescribed List by correcting the listing details of some of the billing codes that were identified as being listed in incorrect groupings (meaning category-subcategory-group-subgroup-suffix); that is, the devices do not have the attributes to fit in the groupings, they are currently listed in.
The changes also include benefit reductions for Cardiac Implantable Electronic Devices (CIEDs). One of the measures under the Prescribed List reforms was reducing the gap between the prices payable for medical devices in public hospitals and the Prescribed List benefits payable for the same devices for privately insured patients. The last scheduled reduction of the PL benefits under this measure occurred in 2024, however commencement of the benefit reductions for the Cardiac Implantable Electronic Devices (CIEDs) was delayed until July 2023 (with 3 reductions every 12 months).
The current Prescribed List benefits for CIEDs consist of two components, which are the benefits for devices and the reimbursement for the costs of technical support services for maintaining the CIED for the life of the device. In 2024 the Medical Services Advisory Committee (MSAC) advised on the rate between these two components, and it was agreed that the benefits reductions for CIED will only apply on the device component of the benefits. The Amendment Rules will give effect to the last reduction to the Prescribed List benefits payable for 248 billing codes for CIEDs.
The Prescribed List also differs to the previous (March 2025) Prescribed List by applying a change to the condition applying to 41 relevant billing codes, plus one new billing code, for surgical guides and biomodels devices. Following review of the existing condition, including the seeking of expert advice, it was decided to amend the condition and the restriction for the reimbursement. The current condition limits the reimbursement to 3 or less benefits for any billing codes for surgical guides or biomodels, and no more than 6 in total. The new condition will allow for reimbursement of 6 Prescribed List benefits for any combination of billing codes for surgical guides or biomodels used in a procedure.
Some of the conditions placed on the billing codes have been updated. The listed items and billing codes with conditions in the Prescribed List imposed under section 7 of the MDHTP Rules are:
Part A
BA313 (TissuePatchDural 100*100)
IJ022 (Regenerative Dural Repair Patch (ReDuraTM))
IJ023 (Regenerative Dural Repair Patch (ReDuraTM))
IJ024 (Regenerative Dural Repair Patch (ReDuraTM))
IJ025 (Regenerative Dural Repair Patch (ReDuraTM))
LH765 (Neodura Dural Repair Patch ≤10cm²)
SK494 (DuraMatrix)
HU397 ( Arthrex Universal Glenoid Baseplate)
BF031 (MixMax Bone Cement)
DE822 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament)
DE824 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament - AC30RA)
DE825 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament – LAC 20)
DE826 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament - LAC 30)
DE827 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament - MCL 32)
DE828 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament - Rotator Cuff CR 25)
DE829 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament - Rotator Cuff CR 30)
DE830 (Ligament Advanced Reinforcement System (LARS) Artificial Ligament)
HU267 ( Cerclage System)
HW785 (AutoPlex Mixer and Delivery System with VertaPlex HV)
HW856 (Augment Bone Graft - rhPDGF-BB component) )
KN004 (Invictus Spinal Cement System) )
MA545 (Ligamys DIS Suture with button)
FV015 (Simplant Surgical Guides)
HI001 (DDN Guide)
HI002 (DDN Biomodel)
HI005 (DDN Biomodel)
HI006 (DDN Guide)
HW544 (Stryker Anatomical Biomodel for Mandible)
HW546 (Stryker Anatomical Biomodel for PEEK)
HW650 (VSP Orthognathics Bundle (Surgical Guide and Implants))
HW651 (VSP Orthognathics Bundle (Custom Biomodel and Implants))
HW652 (VSP Reconstruction Maxillofacial Case Bundle)
HW653 (VSP Reconstruction Mandibular/Maxillary Case Bundle)
JN004 (ARDS Anatomic Biomodel)
KT004 (UNIQOS Patient Specific Anatomical Biomodel)
KT005 (UNIQOS Patient Specific Surgical guides)
MV007 (MGuide)
MV025 (MGuide)
OG001 (OMX Solutions patient Optimized Guide system)
OG004 (The OMX Solutions Biomodel)
OG006 (MAXONIQ Surgical Guide Dental (Southern Implants))
OG007 (MAXONIQ Surgical Guide Dental (STMN))
QQ001 (Anatomics Biomodel)
QQ008 (Anatomics Patient Specifc Surgical Guide)
QQ013 (Anatomics Patient Specific Surgical Guide)
QQ014 (Anatomics Surgical Guide)
QQ311 (Stryker Patient-Matched TMJ – Anatomic Biomodel)
QQ312 (AI Guide)
RV021 (ReconPILOT Biomodelled Patient Specific Surgical Guide for Craniofacial Surgery)
RV022 (ReconPILOT Biomodelled Patient Specific Surgical guide for Maxillofacial surgery)
SY777 (ProPlan)
SY778 (ProPlan)
SY779 (ProPlan)
SY829 (Custom made plates (including Megaplates) – Surgical Guides)
SY830 (Surgical Guide for OBL PorousiTi® PSI System – Orbital Floor)
UI001 (OsGuide)
UI002 (BIOMODEL)
UI003 (DGUIDE)
UI004 (OMF Model)
XU019 (OrthoTin Anatomic Biomodel)
XU020 (OrthoTin Surgical Guide)
XU022 (Lyka Smith Patient Specific Guides)
XU023 (Lyka-Smith Anatomical Biomodel)
ZZ108 (Materialise Titanium 3D Printed Guides)
MI407 (Cobalt™ XT VR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI408 (Cobalt™ VR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI409 (Crome™ VR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI410 (Cobalt™ XT VR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI411 (Cobalt™ VR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI412 (Crome™ VR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
QQ199 (NEUTRINO NxT VR ICD Model CDVRA600Q)
SJ417 (Gallant VR ICD Model CDVRA500Q)
MI402 (Cobalt™ XT DR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI403 (Cobalt™ DR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI404 (Crome™ DR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI405 (Cobalt™ XT DR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI406 (Cobalt™ DR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
MI413 (Crome™ DR ICD MRI SureScan™ with BlueSync mobile remote monitoring)
QQ200 (Neutrino NxT DR ICD Model CDDRA600Q)
SJ418 (Gallant DR ICD Model CDDRA500Q)
MI416 (Cobalt™ HF Quad CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI417 (Cobalt™ HF CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI418 (Crome™ HF Quad CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI419 (Crome™ HF CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI420 (Cobalt™ XT HF Quad CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI421 (Cobalt™ XT HF CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI422 (Crome™ HF Quad CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI423 (Crome™ HF CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI424 (Cobalt™ XT HF Quad CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI425 (Cobalt™ XT HF CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI426 (Cobalt™ HF Quad CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
MI427 (Cobalt™ HF CRT-D MRI SureScan™ with BlueSync mobile remote monitoring)
QQ164 (Neutrino NxT HF CRT-D Model CDHFA600Q)
SJ424 (Gallant HF CRT-D Model CDHFA500Q)
MI446 (Azure XT SR MRI SureScan with BlueSync mobile remote monitoring)
MI447 (Azure S SR MRI SureScanTM with BlueSync mobile remote monitoring)
MI448 (Azure XT DR MRI SureScan with BlueSync mobile remote monitoring)
MI449 (Azure S DR MRI SureScan with BlueSync mobile remote monitoring)
MI439 (Percepta Quad MRI SureScan CRT-P with BlueSync mobile remote monitoring)
MI440 (Percepta MRI SureScan CRT-P with BlueSync mobile remote monitoring)
MI441 (Serena Quad MRI SureScan CRT-P with BlueSync mobile remote monitoring)
MI442 (Serena MRI SureScan CRT-P with BlueSync mobile remote monitoring)
EL069 (PASCAL Precision System (PASCAL Implant and PASCAL ACE Implant)
SJ482 (Navitor™ Transcatheter Aortic Valve)
BF025 (Pedicle Screw)
BF026 (Pedicle Screw)
DE669 (icotec Pedicle System Polyaxial Screw)
DE678 (icotec Anterior Cervical Plate System - Screw)
LB089 (CREO Stabilization System Preassembled Monoaxial Screw)
BF027 (Locking Element)
DE671 (icotec Pedicle System Set Screw)
LB088 (CREO Stabilization System Locking Cap)
DE679 (icotec Anterior Cervical Plate)
DE680 (icotec Anterior Cervical Plate)
HW776 (Cayman United Plate)
BF028 (Rods, Curved)
BF029 (Rods)
DE670 (icotec Pedicle System Rod)
DE818 (BlackArmor Carbon Fibre/PEEK Curved / Multicurved Rods)
LB181 (REFLECT Staple)
Part C
II001 (Omnipod DASH® Insulin Management System - Personal Diabetes Manager (PDM) & Software only)
QQ717 (Omnipod 5 Automated Insulin Delivery System)
BS432 (LUX-Dx II, LUX-Dx II+)
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. 2) 2025
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 Legislative Instrument
The purpose of the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 2) 2025 (Amendment Rules) is to amend the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (MDHTP Rules) made under section 333-20 of the Private Health Insurance Act 2007 (the Act).
The Amendment Rules amend the list of medical devices and human tissue products A(correcting billing code errors in the previous amending instrument), for which a benefit must be paid, where the listed item is provided in the conditions and circumstances specified in the Act. Listed items and their minimum benefits are set out in Schedule 1 to the MDHTP Rules known as the Prescribed List of Medical Devices and Human Tissue Products (Prescribed List).
The Amendment Rules update the cost recovery fees that apply to applications to list a medical device or human tissue product or to make changes to a current listing. The amended fees are consistent with the Australian Government Cost Recovery Policy and ensure they accurately reflect the efficient costs of providing services. Fees are calculated using an activity-based cost model. This ensures that the contemporary costs incurred by the Department of Health, Disability and Ageing (the department) when providing services relating to the assessment of applications to list or vary the Prescribed List are accurately reflected in fees.
Human rights implications
The 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 addition of new items 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.
The removal of entries at the request of the sponsors of devices or products is usually because these devices or products are no longer being supplied for use to privately insured persons in Australia. Generally, the devices and products removed from the MDHTP Rules have been replaced by newer models due to upgraded technologies or advancements in surgical procedures, or are still available for privately insured patients, but are supplied by different sponsors.
The MDHTP Rules will continue to list medical devices in Part D and provide listing criteria for these devices. This will ensure that devices that have historically been included in Part D of
Schedule 1 will continue to be listed, and patients will continue to access these devices.
Conclusion
The Amendment Rules are compatible with human rights because it enables advances in the protection of human rights, in particular, the right to health.
Dr Anne-marie Boxall
Assistant Secretary
Medical Services and Devices Assessment Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health, Disability and Ageing