The Therapeutic Goods (Medical Devices) Regulations 2002 reclassified urogynaecological mesh devices from Class IIb to Class III. Some urogynaecological meshes were not reclassified by the required date of 1 December 2020, and sponsors of these devices respectively requested cancel their Class IIb entries from the Australian Register of Therapeutic Goods (ARTG).
One of the criteria for listing the product on the Prostheses List is that the product is entered and current on the ARTG. The billing codes where the entry is suspended or cancelled from the ARTG are required to be removed from the Prostheses List.
There are 12 billing codes for urogynaecological mesh devices that respectively should be removed from the Prostheses List. PHI Circular 89/20, published on 21 December 2020, provided further information on this matter and advised about incoming changes to the Prostheses Rules.
The removal of the billing codes may be achieved through an amendment to Schedule of the Private Health Insurance (Prostheses) Rules under section 333-20 of the Private Health Insurance Act 2007.
Respectively on 25 January 2021, the Private Health Insurance (Prostheses) Amendment Rules (No. 1) 2021 have been made to give effect to the removal of 12 urogynaecological mesh devices from the Prostheses List – Part A.
The Rules take effect on the day they are registered on the Federal Register of Legislation. The Amendment Rules have been registered on 25 January 2021 and can be found online.