Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (Cth)

Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025

I, Simon Singer, as delegate of the Minister for Health and Aged Care, make the following rules.

Dated 23 February 2025

Dr Simon Singer Acting Assistant Secretary Prescribed List Reform Taskforce Branch Technology Assessment and Access Division Health Resourcing Group Department of Health and Aged Care

Contents Part 1—Preliminary 1 1 Name ..................................................1 2 Commencement............................................1 3 Authority................................................1 4 Definitions...............................................1 Part 2—Benefit requirements for private health insurance policies that cover hospital treatment and hospital‑substitute treatment 4 5 Listing of medical devices and human tissue products......................4 6 Circumstances in which listed items are provided—other than circumstances in which a medicare benefit is payable......4 7 Conditions to be satisfied in relation to the provision of listed items..............4 8 Benefits for listed items provided as part of hospital treatment.................5 9 Benefits for listed items provided as part of hospital‑substitute treatment.....6 Part 3—Listing criteria 7 10 Purpose.................................................7 11 General listing criteria........................................7 12 Listing criteria for medical devices to be listed in Part A of Schedule 1...........7 13 Listing criteria for human tissue products to be listed in Part B of Schedule 1........8 14 Listing criteria for medical devices to be listed in Part C of Schedule 1...........8 15 Listing criteria for medical devices to be listed in Part D of Schedule 1...........9 Part 4—Cost‑recovery fees 10 Division 1—Cost‑recovery fees relating to medical devices 10 16 Cost‑recovery fees that may be charged.......................10 17 Clinical assessment fee.......................................10 18 Economic assessment fee.....................................11 19 Full health technology assessment pathway fee.........................12 Division 2—Payment of cost‑recovery fees 13 20 When cost‑recovery fee must be paid.........................13 21 Person liable to pay cost‑recovery fee.........................13 Division 3—Refunds and waiver of cost‑recovery fees 14 22 Refunds................................................14 23 Waiver of cost‑recovery fees..............................14 Division 4—Review 16 24 Reviewable decisions........................................16 25 Notice of review rights.......................................16 26 Internal review of decisions made by delegates.........................16 27 Notice of overpayment as a result of a review decision....................17 Part 5—Miscellaneous 18 28 Minister may have regard to recommendations and advice..................18