Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01323 Rules Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

 

Issued by the Authority of the Minister for Health

 

Private Health Insurance (Prostheses Application and Listing Fees) Act 2007

 

Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018

 

The Private Health Insurance (Prostheses Application and Listing Fees) Act 2007 (the Act) imposes, as a tax, fees in relation to applications for listing, and listing, of prostheses, and related purposes.

 

The table in subsection 72-1(2) of Part 3-3 of the Private Health Insurance Act 2007 (the PHI Act) provides for benefit requirements that a complying health insurance policy that covers hospital treatment must meet.  Under item 4 of that table there must be a benefit for the provision of a prosthesis, of a kind listed in Private Health Insurance (Prostheses) Rules (i.e. a listed prosthesis), in specified circumstances and under any specified conditions.

 

Section 8 of the Act provides that the Minister may, by legislative instrument, make Private Health Insurance (Prostheses Application and Listing Fee) Rules providing for matters required or permitted by the Act to be provided, or necessary or convenient to be provided in order to carry out or give effect to the Act. The Act does not specify any conditions that need to be met before the power to make the Rules under section 8 of the Act may be exercised.

 

Sections 3 and 4 of the Act provide that the Rules may specify:

  • an application fee for applications made under section 72-10 of the PHI Act (subsection 3(1) of the Act);
  • an initial listing fee for the purposes of subsection 72-10(5) of the PHI Act (subsection 4(4) of the Act);
  • an ongoing listing fee for the purposes of section 72-15 of the PHI Act (subsection 4(3) of the Act); and
  • the ongoing listing fee imposition days (subsections 4(4) and (5) of the Act).

 

These specified fees are imposed as taxes (see subsections 3(2), 4(2) and 4(4) of the Act).

 

Purpose of the Rules

 

The purpose of the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018 (the Rules) is to set the application fee, initial listing fee and ongoing listing fee to be paid by sponsors who wish to have a prosthesis listed on the Private Health Insurance (Prostheses) Rules.

 

The Rules are a substantive replication of the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No.1) (the Previous Rules)—which were due to be automatically repealed (sunset) on 1 October 2018 under section 50 of the Legislation Act 2003with a number of minor machinery changes. As part of the sunsetting process, a fit-for-purpose review of the Previous Rules was undertaken. The review determined that the instrument was still required. The Rules also repeal the Previous Rules.

 

Importantly, there has been no change in any of the fees from the Previous Rules. Section 5 and 6 of the Act specify the maximum amount of an application fee, initial listing fee and ongoing listing fee to be $2000 (indexed each financial year). The fees set out in the Rules range from nil to $600 and have not been increased since 2009. The purpose of these taxes is to recover the cost from industry for the administration of the prostheses list arrangements and for the clinical assessment of products using expert advisory groups established to advise on products placed on the list.

Consultation

 

The Rules have been made following consultation with Australia’s two leading industry associations, the Medical Technology Association of Australia and Ausbiotech.

 

The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry. MTAA represents manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability.

 

AusBiotech is Australia’s life sciences organisation, with a network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), digital health, food technology and agricultural, environmental and industrial sectors.

 

Consultation with these relevant industry associations was undertaken via email in August 2018. Both MTAA and AusBiotech did not make any objections to the Rules on the basis that the Rules are a substantive replication of the Previous Rules and have not increased the amount of any fees.

 

Details of the Rules are set out in the Attachment.

 

These Rules are a legislative instrument for the purposes of the Legislation Act 2003.

 

The Rules commence on the day after registration.

 

 

ATTACHMENT

 

DETAILS OF THE PRIVATE HEALTH INSURANCE (PROSTHESES APPLICATION AND LISTING FEE) RULES 2018

 

Section 1 – Name

 

Section 1 provides that the name of the Rules is the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018 (the Rules).

 

Section 2 – Commencement

 

Section 2 of the Rules provides that the Rules commence on the day after registration.

 

Section 3 – Authority

 

Section 3 of the Rules provides that the Rules are made under section 8 of the Private Health Insurance (Prostheses Application and Listing Fees) Act 2007.

 

Section 4Definitions

 

Section 4 of the Rules provides the definitions of certain terms used in the Rules.

 

Section 5Schedules

 

Section 5 of the Rules provides that 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.

 

Section 6Application Fees

 

Section 6 of the Rules provides application fees for applications made to the Minister under subsection 72-10(2) of the Private Health Insurance Act 2007 (PHI Act).

 

Paragraph 6(1)(a) of the Rules provides that the application fee for an application made in relation to a human tissue prosthesis is nil.

 

Paragraph 6(1)(b) of the Rules provides that the application fee for an application made in relation to any other prosthesis, except where subsection 6(2) applies, is $600.

 

Subsection 6(2) of the Rules provides that the fee for applications that involve a ‘revocation and relisting’ or a duplicate listing is, and is taken always to have been, nil. The specific circumstances in which an application will result in a revocation and relisting are described in subsection 6(4) of the Rules. The definition of ‘duplicate listing’ is provided in subsection 6(5) of the Rules.

 

Subsection 6(3) of the Rules provides that if the approved form for an application permits more than one application for listing of a kind of prosthesis to be made on the same form, the application for each kind of prosthesis is a separate application and each listing, if granted, is a separate listing.

 

Section 7Initial Listing fee

 

Section 7 of the Rules provides the initial listing fees imposed for the purposes of subsection 72-10(5) of the PHI Act.

 

Paragraph 7(1)(a) of the Rules provides that the initial listing fee for a human tissue prosthesis is nil.

 

Paragraph 7(1)(b) of the Rules provides that the initial listing fee for any other prosthesis, except where subsection 7(2) applies or rule 9 applies, is $200.

 

Subsection 7(2) of the Rules concerns applications that involve a ‘revocation and relisting’ or a duplicate listing.

 

Section 8Ongoing Listing fee

 

Section 8 of the Rules provides the ongoing listing fee for the purposes of section 72-15 of the PHI Act.

 

Paragraph 8(a) of the Rules provides that the ongoing listing fee for a human tissue prosthesis is nil.

 

Paragraph 8(b) of the Principal Rules provides that the ongoing listing fee for any other prosthesis, except where section 9 applies, is $200.

 

Section 9 First ongoing listing fee following grant of application

 

Section 9 of the Rules provides that the first ongoing listing fee immediately following the granting of an application (other than an application for a revocation and relisting’ or a duplicate listing) is nil.

 

Section 10Ongoing listing fee imposition day

 

Section 10 of the Rules provides the ongoing listing fee imposition days of each year as 15 March and 15 September.

 

Schedule 1 – Repeals

 

Schedule 1 of the Rules specifies and repeals the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No.1).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018

 

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Legislative Instrument

The Private Health Insurance (Prostheses Application and Listing Fees) Act 2007 (the Act) imposes, as a tax, fees in relation to applications for listing, and listing, of prostheses, and related purposes. The purpose of the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018 (the Rules) is to set these fees.

The table in subsection 72-1(2) of Part 3-3 of the Private Health Insurance Act 2007 (the PHI Act) provides for benefit requirements that a complying health insurance policy that covers hospital treatment must meet.  Under item 4 of that table there must be a benefit for the provision of a prosthesis, of a kind listed in Private Health Insurance (Prostheses) Rules (i.e. a listed prosthesis), in specified circumstances and under any specified conditions.

 

The Rules are a substantive replication of the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No.1) (the Previous Rules)—which were due to be automatically repealed (sunset) on 1 October 2018with a number of minor machinery changes. Importantly, there has been no change in any of the fees from the Previous Rules. The Act specifies the maximum amount of an application fee, initial listing fee and ongoing listing fee to be $2000 (indexed each financial year). The fees set out in the Rules range from nil to $600 and have not been increased since 2009.

 

The purpose of these taxes is to recover the cost from industry for the administration of the prostheses list arrangements and for the clinical assessment of products using expert advisory groups established to advise on products placed on the list. The assessment process ensures that privately insured Australians have access to a range of medical devices that are clinically effective and value for money.

 

Human rights implications

Strictly speaking, the Rules do not raise any human rights issues. However, the Rules indirectly engage article 12(1) of the International Covenant on Economic Social and Cultural Rights by assisting with the progressive realisation of the right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

 

The collection of fees is associated with the listing of kinds of prostheses in the Private Health Insurance (Prostheses) Rules, which ensures that persons with appropriate private health insurance will receive a minimum benefit for the provision of the prosthesis as hospital treatment (or hospital-substitute treatment); and that the prosthesis is provided in circumstances where a medicare benefit is payable.

 

Conclusion

The Rules are compatible with human rights because it supports the protection of human rights.

 

Greg Hunt

Minister for Health

Overview

The Private Health Insurance (Prostheses Application and Listing Fees) Act 2007, enacted by the Australian Parliament, addresses the need for a structured and regulated approach to the listing of prostheses in private health insurance policies. The Act, overseen by the Minister for Health, introduces fees for the application and listing of prostheses, aiming to ensure that private health insurance policies provide adequate coverage for medically necessary prostheses. The policy objective behind the Act is to regulate the listing of prostheses in private health insurance policies, ensuring that these policies meet certain benefit requirements and that the process of listing prostheses is managed efficiently. The Act empowers the Minister to set fees through legislative instruments, ensuring that the costs of administering the prostheses list arrangements and the clinical assessment of prostheses are recovered from the industry. The Act was designed to create a balanced approach, allowing for the inclusion of necessary prostheses in private health insurance policies while also ensuring that the process is cost-effective and does not unduly burden the industry. The fees set under the Act are intended to cover the administrative costs and to fund the expert advisory groups responsible for assessing the clinical effectiveness and value of the prostheses. By imposing these fees, the Act aims to support the progressive realisation of the right to a system of health protection that provides equality of opportunity for people to enjoy the highest attainable level of health, as indirectly supported by the Act’s alignment with article 12(1) of the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The Private Health Insurance (Prostheses Application and Listing Fees) Act 2007 applies to entities involved in the submission and listing of prostheses for private health insurance purposes in Australia. Specifically, the Act targets sponsors who wish to have a prosthesis listed under the Private Health Insurance (Prostheses) Rules. The fees imposed by the Act function as a tax and are intended to cover the costs associated with the administration of prostheses list arrangements and the clinical assessment of prostheses by expert advisory groups. The Act applies across the Commonwealth of Australia and does not specify any exclusions or exemptions. However, the fees set by the Act are capped at $2000, indexed annually, although the actual fees implemented through the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018 range from nil to $600. The Rules, which are made under section 8 of the Act, replicate the previous rules with some minor amendments and maintain the same fee structure that has been in place since 2009. These Rules came into effect following consultation with relevant industry associations, which did not object to the replication of the previous fee structure.

Key Provisions

The Private Health Insurance (Prostheses Application and Listing Fees) Act 2007 (the Act) imposes fees as taxes for the listing of prostheses under private health insurance policies. These fees cover applications for listing prostheses and the ongoing listing of these devices. The Act allows the Minister to create rules that specify the fees for these applications and listings, as outlined in sections 3 and 4. The Private Health Insurance (Prostheses Application and Listing Fee) Rules 2018 (the Rules) replicate the 2008 rules with minor changes, ensuring consistency in fee structures without any increase since 2009. These fees are intended to cover the costs of administering the prostheses list and conducting clinical assessments to ensure that listed prostheses are both effective and cost-efficient. The Rules impose several obligations on parties involved in the application and listing of prostheses. Sponsors of prostheses must pay specified fees when applying for listing or when their listing is ongoing. The fees vary depending on the type of prosthesis and the nature of the application. For instance, human tissue prostheses have different fee structures compared to other types. Additionally, the Rules detail specific scenarios, such as revocation and relisting or duplicate listings, which may result in nil fees. Sponsors must also ensure they comply with the definitions and conditions set out in the Rules, particularly when submitting applications and paying the associated fees. Breaches of the Rules may lead to civil or criminal consequences, although the Act does not explicitly outline these consequences. Given that the fees are imposed as taxes, failure to pay the required fees could be considered tax evasion, which carries significant penalties under Australian tax law. The seriousness of the breach, the intent behind it, and any previous history of non-compliance would influence the penalties imposed. These penalties could include fines and, in severe cases, imprisonment. Additionally, ongoing non-compliance could result in the revocation of listing approvals, affecting the availability of prostheses under private health insurance policies. The Rules are designed to ensure that the administration of prostheses listings is financially sustainable while maintaining high standards for the clinical effectiveness of listed prostheses. By imposing these fees, the Act aims to recover costs from the industry, thereby supporting a system where private health insurance can provide necessary medical devices to policyholders. The consultation with relevant industry associations, such as the Medical Technology Association of Australia and AusBiotech, underscores the collaborative approach in setting these fees, ensuring that the industry's voice is considered in the regulatory framework.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.