Document ID: chunk:federal_register_of_legislation:F2025L00198:reg:19
Version: federal_register_of_legislation:F2025L00198
Segment Type: reg
Provision Reference: reg 19
Character Range: 30685–32335

19  Full health technology assessment pathway fee

When a full health technology assessment is required
 (1) A listing application or variation application relating to a medical device requires a full health technology assessment if:
 (a) subsection (2) applies; or
 (b) the Minister is satisfied on any other grounds that the application requires a full health technology assessment.
Note: Notice must be given of a decision that the Minister is satisfied as mentioned in paragraph (1)(b) of this section that an application requires a full health technology assessment (see subsection 25(1)). Such a decision made by a delegate of the Minister is reviewable (see section 26).
 (2) This subsection applies if:
 (a) the application is, or will be, the subject of any of the following requests to MSAC:
 (i) 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;
 (ii) 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;
 (iii) a request for advice about the cost‑effectiveness or clinical‑effectiveness of the medical device; and
 (b) the applicant has not paid both a clinical assessment fee and an economic assessment fee in relation to the application.
Note: The listing application is to identify that a full health assessment is required for the purposes of subsection (2).

Amount of full health technology assessment pathway fee
 (3) The full health technology assessment pathway fee is $2,990.

Division 2—Payment of cost‑recovery fees