About cost recovery
Before including medical devices or human tissue products on the Prescribed List, we carry out regulatory activities including:
- assessing applications (for new listings or variation of current listings)
- listing and undertaking ongoing administration of listed devices and products
- maintaining infrastructure
- undertaking compliance actions.
Under the Australian Government Charging Framework, we may charge for specific activities which we carry out, to recover some or all of the costs involved. These activities include providing:
- goods
- services
- regulation
- a combination of all 3.
New and variation applications (amendment, expansion or compression) for Part A, Part C and Part D of the Prescribed List require cost recovery fees. Cost Recovery fees are payable for each device within consolidated application, submitted via the Health Products Portal (HPP).
There are no cost recovery fees and charges for:
- Part B applications (human tissue products)
- applications to transfer a billing code to a different sponsor
- applications to delete a billing code.
Cost recovery arrangements and legislation
The legislative framework for the annual cost recovery fees and levy is provided through the below legislative instruments:
- the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (the MDHTP Rules), enabled by the Private Health Insurance Act 2007
- the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations, enabled by the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007
- Private Health Insurance (Levy Administration) Rules 2015, enabled by the Private Health Insurance Act 2007.
The Cost Recovery Implementation Statement (CRIS) sets out the Prescribed List fees and charges for a given financial year and:
- describes the legislative changes to support the administration of cost recovery arrangements for the Prescribed List
- provides financial forecasts for the next 3 financial years.
Cost recovery fees and levy for 2024-25
The table below lists the fees that apply to each application Tier, and the annual levy amount.
The fees for Tier 2 applications depend on the complexity of the required economic analysis.
See the CRIS for more information.
| Tier | Fee | Fee breakdown | Services provided |
|---|---|---|---|
| Tier 1 | $1,420 | Standard application fee $1,420 | A standard application process involving:
|
| Tier 2a | $5,390 | Standard application fee plus Clinical assessment fee | Standard application process plus:
|
| Tier 2b Simple | $14,640 | Standard application fee plus Clinical assessment fee plus Economic evaluation fee | Tier 2a process plus:
|
| Tier 2b Complex | $23,070 | Standard application fee plus Clinical assessment fee plus Economic evaluation fee | Same process as Tier 2b standard, but involving a complex HTA economic assessment. |
| Tier 2b Other | $34,310 | Standard application fee plus Clinical assessment fee plus Economic evaluation fee | Same process as Tier 2b standard, but involving a complex HTA assessment requiring further research and assessment. |
| Tier 3 | $4,670 | Standard application fee plus Clinical assessment fee plus Full HTA Medical Services Advisory Committee (MSAC) Pathway Assessment Fee (Please note this fee only includes the Prescribed List component of work and does not include any future fees that may be payable for MSAC assessment.) | Same process as Tier 2a standard plus consideration from the Medical Services Advisory Committee (MSAC). Costs for MSAC application consideration are not included in PL application cost recovery. |
| Annual cost recovery levy | Applicable to all listed billing codes | $150 per listed billing code | Cost recovery levy includes:
|
Payment of fees and levy
Invoices for fees and levy, including payment instructions, will be issued via the HPP. Invoices for standard applications fees will be issued within 7 business days from when the application is submitted in the HPP.
The annual cost recovery levy is payable for each billing code listed on the Prescribed List. The sponsor listed against the billing code on the levy imposition day is responsible for paying the levy. Billing codes listed under Part B are exempt from the levy.
All cost recovery fees and levy are non-refundable unless the applicant has overpaid, or under exceptional circumstances.
Fee waivers
A fee waiver may be granted for devices that are related, if a condensed clinical/economic assessment can be conducted for the related devices.
We consider medical devices in an application are related if they are designed to be used together (e.g., the main device and accessories) for an expected clinical outcome and the information is common for all devices. Information is common when the devices can be assessed based on the same product material such as product brochure, surgical technique, instructions for use and the clinical data is from the same source such as from the same clinical trial or registry.
You must request a fee waiver must be requested at the time of submitting an application in HPP. You must provide the rationale for requesting the waiver and include supporting documents.
The number of waivers granted is at the discretion of the Minister or a delegate. A waiver cannot be requested or provided for all devices in the application, as at least one clinical assessment or economic assessment fee must be paid.
Fee exemptions
A fee exemption may be granted for applications under Tier 3 Full HTA Pathway where an application has undergone a clinical assessment and/or economic evaluation before it was identified as requiring a Full HTA Pathway assessment. In this circumstance, for cost recovery purposes, the Full HTA Pathway assessment fee may be exempted on the basis that the assessment can be reduced. For more information on fee exemption requirements, see the Draft Prescribed List of Medical Devices and Human Tissue Products Guide.
Consultation
We consult with stakeholders through a draft CRIS annually. Read the final CRIS.
If you would like to participate in future CRIS consultations, please contact us to receive consultation updates through the Private Health Insurance Circular.
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