Commonwealth Numbered Regulations - Explanatory Statements

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HEALTH INSURANCE (PATHOLOGY SERVICES TABLE) AMENDMENT REGULATION 2012 (NO. 3) (SLI NO 254 OF 2012)

EXPLANATORY STATEMENT

Select Legislative Instrument 2012 No. 254

Health Insurance Act 1973

Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 3)

Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides that the

Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The Act provides, in part, for payments of Medicare benefits in respect of professional services rendered to eligible persons.  Section 9 of the Act provides that Medicare benefits shall be calculated by reference to the fees for medical services, including pathology services, set out in prescribed tables.

Section 4A of the Act provides that the regulations may prescribe a table of pathology services that sets out items of pathology services, the amount of fees applicable in respect of each item, and rules for interpretation of the pathology services table.  The Health Insurance (Pathology Services Table) Regulation 2012 (the Principal Regulation) currently prescribes such a table. 

The regulation amends the current table of pathology services in the Principal Regulation, as part of the ongoing management of the table.  The descriptor of the genetic test item 73332 is amended to allow in situ hybridisation (ISH) testing for human epidermal growth factor receptor 2 (HER2) gene amplification to be carried out on tumour tissue taken from breast cancer patients prior to, and following, surgery. Currently, a Medicare benefit is only payable for this testing following surgery. The amendment reflects evidence-based best clinical practice and better value for money for both the Australian Government and the Australian people.

The amendment of the existing item has been recommended by the Medical Services Advisory Committee following consultation with the public and pathology stakeholders.  This genetic test is required to determine the patient's eligibility for the Pharmaceutical Benefits Scheme (PBS) subsidised medicine trastuzumab (Herceptin®).  The PBS listing will also be extended on 1 December 2012 to allow the prescription of trastuzumab following ISH testing for HER2 prior to surgery.

The Act specifies no conditions that need to be satisfied before the power to make the regulation may be exercised. 

Consultation

This change relates to the ongoing maintenance of the Pathology Services Table to reflect evidence-based best practice and appropriate funding.  It results from advice from the Medical Services Advisory Committee (MSAC). 

Where a change to the PST relates to an application for public funding for a new technology or procedure, the application went through a MSAC process which included consultation with craft groups, the public and clinical experts.  MSAC and its two sub-committees are composed of expert members from a wide range of fields including pathology.

The Department of Human Services was consulted concerning the impact of the change on their business operations.  The Department of Veterans' Affairs was advised of the change to ensure that their schedule of benefits for veterans could be amended if necessary.

It has been concluded that the change will have minimal impact on pathology practice in terms of costs to business and will lead to a closer correspondence between Medicare benefit structure and pathology practice.

The regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

The regulation commences on 1 December 2012.

               
                                                                      Authority:    Subsection 133(1) of the

                                                                                                                                                                                                Health Insurance Act 1973

Statement of Compatibility with Human Rights

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

Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 3)

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 Bill/Legislative Instrument

The regulation will amend the current table of pathology services in the Health Insurance (Pathology Services Table) Regulation 2012, as part of the ongoing management of the table.  An existing item will be amended to reflect evidence-based best clinical practice and better value for money for both the Australian Government and the Australian people.

Human rights implications

This Legislative Instrument does not engage any of the applicable rights or freedoms.

Conclusion

This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

Tanya Plibersek

Minister for Health

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