Cost recovery fees and charges for the Prescribed List

To make sure privately insured patients in Australia can access safe and effective medical devices, we regulate the listing of devices and products on the Prescribed List. Learn about the cost recovery arrangements of fees and charges for these activities.

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. 

TierFeeFee breakdownServices provided
Tier 1$1,420Standard application fee
$1,420

A standard application process involving:

  • Departmental assessment and decision for each medical device listed in an application.
  • Administrative processing of the request following submission through the HPP.
  • Preparation of relevant legislation by the department.
  • Invoicing for application fees.
Tier 2a$5,390

Standard application fee
$1,420

plus

Clinical assessment fee
$3,970

Standard application process plus:

  • Clinical and expert advice sought to assess clinical aspects for each medical device listed under the application.
  • Consideration from the following committees:
    • Medical Devices and Human Tissue Advisory Committee (MDHTAC)
    • Expert Clinical Advisory Groups (ECAGs).
  • Administrative processing of the request following submission through the HPP.
  • Assessment of the application by the department, including a decision.
  • Preparation of relevant legislation by the department.
  • Invoicing for application fees.
Tier 2b Simple$14,640

Standard application fee
$1,420

plus

Clinical assessment fee
$3,970

plus

Economic evaluation fee
$9,250

Tier 2a process plus:

  • Development of an economic assessment of application.
  • Department’s liaison between the applicant and the Health Technology Assessment (HTA) contractor to inform the development of an economic assessment.
Tier 2b Complex$23,070

Standard application fee
$1,420

plus

Clinical assessment fee
$3,970

plus

Economic evaluation fee
$17,680

Same process as Tier 2b standard, but involving a complex HTA economic assessment.
Tier 2b Other$34,310

Standard application fee
$1,420

plus

Clinical assessment fee
$3,970

plus

Economic evaluation fee
$28,920

Same process as Tier 2b standard, but involving a complex HTA assessment requiring further research and assessment.
Tier 3$4,670

Standard application fee
$1,420

plus

Clinical assessment fee
$3,970

plus

Full HTA Medical Services Advisory Committee (MSAC) Pathway Assessment Fee
$2,990

(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 levyApplicable to all listed itemsTBA

Cost recovery levy includes:

  • List management services (transfer and deletion applications)
  • Prescribed List administration
  • IT system costs
  • compliance reviews
  • post-listing reviews.

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.

Contact

Prescribed List cost recovery contact

Please contact us if you have any questions about cost recovery arrangements for the Prescribed List.
Date last updated:

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