Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2025 (Cth)

Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2025

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

Dated 27 June 2025

Dr Simon Singer

Acting Assistant Secretary

Prescribed List Reform Taskforce Branch

Technology Assessment and Access Division

Health Resourcing Group

Department of Health, Disability and Ageing

Contents

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1Name

This instrument is the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 1) 2025.

2Commencement

1. (1)

   Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
The whole of this instrument	1 July 2025.	1 July 2025

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

1. (2)

   Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3Authority

This instrument is made under item 4 of the table in section 333-20 of the Private Health Insurance Act 2007.

4Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

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

1. 1

   Section 4 (definition of former Prescribed List)

   Repeal the definition.

2

Subsection 15(1) (heading)

Omit “former”.

3

Subsection 15(2)

Omit “the former Prescribed List”, substitute “of Schedule 1”.

4

Subsection 15(2) (note)

Repeal the note, substitute:

Note: The Prescribed List in Schedule 1 groups medical devices according to similarity in characteristics, functionality and clinical effectiveness. These grouping are, in descending order of generality: categories, subcategories, groups, subgroups and suffixes.

This criterion requires that listing and variation applications for Part D must seek listing of the medical device in an existing category, subcategory, group, subgroup or suffix (as applicable) in Part D of the Prescribed List in Schedule 1 and cannot seek establishment of a new category, subcategory, group, subgroup or suffix in Part D.

5

Paragraph 16(2)(a)

Omit “$1,420”, substitute “$1,460”.

6

Subsection 17(2)

Omit “$3,970”, substitute “$4,210”.

7

Paragraph 18(2)(a)

Omit “$9,250”, substitute “$12,150”.

8

Paragraph 18(2)(b)

Omit “$17,680”, substitute “$23,460”.

9

Paragraph 18(2)(c)

Omit “$28,920”, substitute “$34,770”.

10

Subsection 19(2)

Repeal the subsection, substitute:

1. (2)

   This subsection applies if the application is, or will be, the subject of any of the following requests to MSAC:

   1. (a)

      a request that an item be included in the table (within the meaning of the Health Insurance Act 1973) for a medical service involving the medical device;

   2. (b)

      a request that an item in the table (within the meaning of the Health Insurance Act 1973) be amended to cover a medical service involving the medical device;

   3. (c)

      a request for advice about the cost‑effectiveness or clinical‑effectiveness of the medical device.

   Note: The listing application is to identify that a full health technology assessment is required for the purposes of subsection (2).

11

Subsection 19(3)

Repeal the subsection, substitute:

1. (3)

   The full health technology assessment pathway fee is $3,100.

12

At the end of section 19

Add:

1. (4)

   A person is exempt from paying a full health technology assessment pathway fee in relation to an application if the person has paid, or is liable to pay, both a clinical assessment fee and an economic assessment fee in relation to the application.

13

Schedules 1 and 2

Repeal the Schedules, substitute: