The Delegate for the Minister of Health and Aged Care has made the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2025 (the MDHTP Rules).
We expect the MDHTP Rules to be registered on the Federal Register of Legislation by 19 February 2025. It will replace the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment (No. 2) Rules 2024.
See the Prescribed List.
Changes effected in the MDHTP Rules
The MDHTP Rules give effect to all changes resulting from completion of the Prescribed List (PL) applications (new, amendment, expansion, compression, deletion, and transfer applications).
Billing code format
The billing code format for parts A, C and D of the PL was finalised and is effective from 1 March 2025. The XML schema has been updated to reflect the AXNNN billing code format. Please note that no devices were allocated a billing code with this format in the March 2025 PL.
All other XML elements and enumeration values in the XML schema remain unchanged as per the November 2023 PL. No further modifications to the XML schema are planned.
Incorrectly listed billing codes
Some billing codes on the PL were identified as listed in incorrect groupings (meaning category-subcategory-group-subgroup-suffix). This means that the devices did not have the attributes to fit in the groupings they were listed in.
The department sought advice and contacted the sponsors of these billing codes to seek required information for their respective devices. All available information was assessed and further advice was sought when required.
Following detailed consideration of the above, decisions were made to correct the details of the billing codes as of 1 March 2025.
Assessment fees
Minor edits have been made to section 4 of the MDHTP Rules that aim to clarify that the ‘clinical assessment fee’, ‘economic assessment fee’ and ‘full health assessment pathway fee’ mean the fees set out in their relevant subsections.
Other
Minor edits to subsection 26(4) seek to clarify that an applicant may apply in writing to the delegate or the Minister to review the initial review decision. References have also been updated to ensure correct cross-referencing of provisions. Notes have been included in sections 17, 18 and 19 to clarify that the type of application determines if an assessment is required to be subject to a cost recovery fee.