About cost recovery
Before including medical devices 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 an application, which is submitted via the Health Products Portal (HPP).
There are no cost recovery fees 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 from 1 July 2024
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.
The Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 1) 2024, which is enabled by the Private Health Insurance Act 2007, provide the legislative framework for the cost recovery fees and charges.
We have listed the fees and charges that apply to each application Tier in the table below. The applicant nominates the application assessment pathway.
The fees for Tier 2 applications depend on the complexity of the economic analysis.
From 1 July 2024, an annual cost recovery levy will apply. The table below will be updated prior to the payment date to advise the amount of the levy to be charged. 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. |
Cost recovery levy | Applicable to all listed items | TBA | Cost recovery levy includes:
|
Payment of fees
From 1 July 2024, the standard application fee must be paid by the end of 28 days of an invoice being issued by the department. A HPP correspondence with the invoice and payment instruction will be sent to applicants within 7 business days from when the HPP application is received by the department.
Applicants must pay all other fees by the end of 28 days of an invoice being issued by the department. We may not start assessing applications until all fees are paid in full. This may delay completion of the application.
All cost recovery fees are non-refundable unless the applicant has overpaid, or there are exceptional circumstances.
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.