Private Health Insurance (Prostheses Application and Listing Fee) Amendment Rules 2009 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L00074 Rules Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

 

Issued by the Authority of the Minister for Ageing

 

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

 

Private Health Insurance (Prostheses Application and Listing Fee) Amendment Rules 2009 (No.1)

 

Section 8 of the Private Health Insurance (Prostheses Application and Listing Fees) Act 2007 (the Act) provides that the Minister may 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.

 

Sections 3 and 4 of the Act provide that the Private Health Insurance (Prostheses Application and Listing Fee) Rules may specify:

  • an application fee for applications made under section 72-10 of the Private Health Insurance Act 2007 (the PHI Act);
  • an initial listing fee for the purposes of subsection 72-10(5) of the PHI Act;
  • an ongoing listing fee for the purposes of section 72-15 of the PHI Act; and
  • ongoing listing fee imposition days.

 

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

 

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 Act does not specify any conditions that need to be met before the power to make the Private Health Insurance (Prostheses Application and Listing Fee) Rules may be exercised.

 

The Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No.1) commenced on 14 July 2008 (the Principal Rules).

 

The Private Health Insurance (Prostheses Application and Listing Fee) Amendment Rules 2009 (No.1) (the Rules) amend the Principal Rules by:

 

(i)                 increasing the application fee, initial listing fee and ongoing listing fee(s) payable in respect of an application under section 72-10 of the PHI Act; and

(ii)               altering the “ongoing listing fee imposition days” pursuant to section 72-15 of the PHI Act.

 

CONSULTATION

 

Consultation with industry regarding the proposed increase to the application fee, initial listing fee and ongoing listing fee(s) payable in respect of an application under section 72-10 of the PHI Act and the proposed alteration to the current “ongoing listing fee imposition days” pursuant to section 72-15 of the PHI Act, occurred in the following three ways:

(i)                 liaison with the relevant industry association, the Medical Technology Association of Australia, including formal correspondence in October 2008;
 

(ii)               the circulation of the Prostheses and Devices Committee Bulletin Number 26 in October 2008, to all interested and affected stakeholders; and
 

(iii)            by presentation at the National Prostheses Congress, held in Sydney on 5 & 6 November 2008. 

 

A preliminary assessment of the regulatory impact of these amendments was conducted.  The impact of these amendments on the private health insurance industry and the economy were assessed as low and therefore no further regulatory analysis is required.

 

Details of the Rules are set out in the Attachment.

 

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

 

The Rules commence on the day after registration.

 

 

 

Authority: Section 8 of the Private Health Insurance (Prostheses Application and Listing Fees) Act 2007

ATTACHMENT

 

DETAILS OF THE PRIVATE HEALTH INSURANCE (PROSTHESES APPLICATION AND LISTING FEE) AMENDMENT RULES 2009 (No. 1)

 

1. Name of Rules

 

Rule 1 provides that the title of the Rules is the Private Health Insurance (Prostheses Application and Listing Fee) Amendment Rules 2009 (No. 1).

 

2. Commencement

 

Rule 2 provides that the Rules commence on the day after registration.

 

3. Amendment of the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No. 1)

 

Rule 3 provides that the Schedule to the Rules amends the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No. 1) (the Principal Rules).

 

Schedule – Amendments

 

Item 1 – Part 2, Paragraph 5(1)(b)

 

Rule 5 of the Principal Rules currently specifies application fees for applications made to the Minister under subsection 72-10(2) of the PHI Act.

 

Paragraph 5(1)(a) of the Principal Rules currently provides that the application fee for an application made in relation to a human tissue prosthesis is nil.

 

Paragraph 5(1)(b) of the Principal Rules currently provides that the application fee for an application made in relation to any other prosthesis, except where subrule 5(2) applies, is $400. (Subrule 5(2) concerns applications that involve a ‘revocation and relisting’ or a duplicate listing.  The specific circumstances in which an application will result in a revocation and relisting are described in subrule 5(4).)

 

Item [1] amends paragraph 5(1)(b) of the Principal Rules by increasing the application fee from $400 to $600.

 

Item 2 – Part 2, Paragraph 6(1)(b)

 

Rule 6 of the Principal Rules currently specifies the initial listing fees imposed for the purposes of subsection 72-10(5) of the PHI Act.

 

Paragraph 6(1)(a) of the Principal Rules currently provides that the initial listing fee for a human tissue prosthesis is nil.

 

Paragraph 6(1)(b) of the Principal Rules currently provides that the initial listing fee for any other prosthesis, except where subrule 6(2) applies or rule 8 applies, is $110. (Subrule 6(2) concerns applications that involve a ‘revocation and relisting’ or a duplicate listing.  Rule 8 concerns ‘transitioned applications’ (i.e. applications to which rule 7 of the Private Health Insurance (Transition) Rules 2007 applies.)).

 

Item [2] amends paragraph 6(1)(b) of the Principal Rules by increasing the initial listing fee from $110 to $200.

 

Item 3 – Part 2, Paragraph 7(b)

 

Rule 7 of the Principal Rules currently specifies the ongoing listing fee for the purposes of section 72-15 of the PHI Act.

 

Paragraph 7(a) of the Principal Rules currently provides that the ongoing listing fee for a human tissue prosthesis is nil.

 

Paragraph 7(b) of the Principal Rules currently provides that the ongoing listing fee for any other prosthesis, except where rule 9 applies, is $110. (Rule 9 operates as an exception to rule 7.  It 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.

 

Item [3] amends paragraph 7(b) of the Principal Rules by increasing the ongoing listing fee from $110 to $200.

 

Item 4 – Part 2, Rule 10

 

Rule 10 of the Principal Rules currently specifies the “ongoing listing fee imposition days” of each year.

 

Item [4] amends rule 10 of the Principal Rules by changing the specified “ongoing listing fee imposition days” of each year from 15 January and 15 July to 15 March and 15 September. 

 

 

 

 

 

 

Overview

The Private Health Insurance (Prostheses Application and Listing Fees) Amendment Rules 2009 (No. 1) were enacted to amend the Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No.1), responding to a gap identified in the administration and listing fees for prostheses under the Private Health Insurance (Prostheses Application and Listing Fees) Act 2007. This Act was introduced to ensure the costs associated with managing the prostheses list and the clinical assessment of products are recovered from the industry. The rules were developed by the Minister for Ageing and were designed to address the financial burden of administering the prostheses list, particularly in light of rising operational costs. The amendment increased application, initial, and ongoing listing fees, and altered the dates on which these fees are imposed. The policy objective was to ensure the fees reflected current economic conditions and the cost of clinical assessments while maintaining the integrity and efficiency of the prostheses list arrangements. These amendments were the result of consultations with the Medical Technology Association of Australia and other relevant stakeholders.

Scope and Application

The Private Health Insurance (Prostheses Application and Listing Fee) Act 2007, along with the accompanying Private Health Insurance (Prostheses Application and Listing Fee) Amendment Rules 2009 (No.1), applies to entities within the private health insurance sector in Australia, specifically those entities that involve the application and listing of prostheses under the Private Health Insurance Act 2007. This legislation is enacted at the Commonwealth level and mandates the imposition of fees for the administration and clinical assessment of prostheses listings. These fees are levied as taxes to cover the costs associated with maintaining the prostheses list and ensuring the quality and safety of the listed prostheses. The Act authorises the Minister for Ageing to establish rules regarding application fees, initial listing fees, and ongoing listing fees, which are necessary for the effective operation of the prostheses list arrangements. The amendment rules specifically increase the fees for applications and listings, and alter the days on which ongoing listing fees are imposed. The Act and its accompanying rules do not specify any prerequisites for exercising the power to make these rules, and the impact of these amendments on the industry and the economy has been assessed as low. The consultation process involved liaison with the Medical Technology Association of Australia, distribution of a bulletin to stakeholders, and a presentation at the National Prostheses Congress. The Rules are legislative instruments under the Legislative Instruments Act 2003 and come into effect on the day after registration.

Key Provisions

The Private Health Insurance (Prostheses Application and Listing Fee) Amendment Rules 2009 (No.1) amend the existing Private Health Insurance (Prostheses Application and Listing Fee) Rules 2008 (No.1) by adjusting the fees associated with applications and listings of prostheses under the Private Health Insurance Act 2007. These amendments are aimed at increasing the fees for application, initial listing, and ongoing listing of prostheses, as well as modifying the days on which ongoing listing fees are imposed. Specifically, the application fee for non-human tissue prostheses is increased from $400 to $600 (Item 1). The initial listing fee for non-human tissue prostheses is increased from $110 to $200 (Item 2). The ongoing listing fee for non-human tissue prostheses is increased from $110 to $200 (Item 3). Additionally, the days on which ongoing listing fees are imposed are changed from 15 January and 15 July to 15 March and 15 September (Item 4). These amendments introduce new obligations for parties involved in the application and listing of prostheses. Manufacturers and suppliers of prostheses must now account for the increased application and listing fees when submitting their applications to the Minister for approval. The changes also require the Minister and relevant stakeholders to adjust their financial planning and budgeting to accommodate these higher fees. Furthermore, the new imposition days for ongoing listing fees mean that entities must align their financial schedules to these specific dates, ensuring timely payment of the fees. Failure to comply with the amended fees and their imposition days may lead to non-compliance with the Act, potentially resulting in legal consequences. While the Explanatory Statement does not detail specific penalties for non-compliance, it is likely that breaches could be subject to civil or administrative penalties under the relevant sections of the Private Health Insurance Act 2007. The increased fees aim to recover costs from the industry for the administration of prostheses list arrangements and clinical assessments, making compliance essential to maintain the integrity of the regulatory framework.

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