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

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02242 Regulations Not in force Legislative Instrument

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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

 

 

 

 

Overview

The Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 3) was enacted to address the need for updating the Pathology Services Table under the Health Insurance Act 1973. The regulation was introduced by the Commonwealth of Australia under the authority granted by subsection 133(1) of the Act, which allows for the making of regulations necessary for the implementation and effect of the Act. This particular regulation aims to align Medicare benefits with evidence-based best clinical practice and to ensure better value for money. It was recommended by the Medical Services Advisory Committee (MSAC) following extensive consultation with stakeholders and experts. The amendment allows for the testing of human epidermal growth factor receptor 2 (HER2) gene amplification in breast cancer patients both before and after surgery, reflecting the current clinical best practice and facilitating the prescription of trastuzumab (Herceptin®) under the Pharmaceutical Benefits Scheme (PBS). The regulation was designed to have minimal impact on pathology practice costs and aims to improve the correspondence between the Medicare benefit structure and pathology practice.

Scope and Application

The Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 3) applies to the pathology services provided in Australia, directly affecting the entities and individuals engaged in delivering these services. This amendment is made under the authority of Subsection 133(1) of the Health Insurance Act 1973, and it pertains specifically to the fees for medical services, including pathology services, set out in the prescribed tables. The regulation is designed to align the Medicare benefits more closely with evidence-based best clinical practice, particularly in the context of genetic testing for breast cancer patients. The amendment allows for the payment of Medicare benefits for in situ hybridisation (ISH) testing for human epidermal growth factor receptor 2 (HER2) gene amplification on tumour tissue taken from breast cancer patients both prior to and following surgery, thereby reflecting a shift towards pre-surgical testing in clinical practice. This change is expected to provide better value for money for both the Australian Government and the Australian people. There are no specific exclusions or exemptions outlined in this regulation, and it applies nationally, as it is a Commonwealth regulation. The regulation does not extend or restrict application through subordinate instruments.

Key Provisions

The Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 3) amends the existing table of pathology services under the Health Insurance Act 1973 (the Act) (sections 4A and 9). This amendment is designed to align Medicare benefits more closely with evidence-based best clinical practices. Specifically, the regulation modifies the descriptor for the genetic test item 73332 to allow in situ hybridisation (ISH) testing for human epidermal growth factor receptor 2 (HER2) gene amplification to be performed on tumour tissue taken from breast cancer patients both prior to and following surgery. This change ensures that a Medicare benefit is payable for this test regardless of the timing of the surgery, which was previously only available post-surgery. This amendment is intended to provide better value for money for both the Australian Government and the Australian people. The regulation imposes obligations on pathology providers to ensure they comply with the updated descriptors and fee structures as outlined in the amended table. Pathology providers must update their billing practices to reflect these changes, ensuring they adhere to the new descriptors for the genetic test item 73332. Additionally, the Department of Human Services and the Department of Veterans' Affairs must also adjust their schedules of benefits to accommodate the new billing practices, ensuring that all eligible patients receive the appropriate Medicare benefits. Failure to comply with the requirements set out in the amended table may result in civil or criminal penalties. The Act does not specify particular penalties for breaches related to these amendments, but general provisions within the Act may apply, including fines and potential prosecution for fraudulent claims. These penalties are designed to ensure that the integrity of the Medicare system is maintained and that benefits are only claimed for services that are properly documented and authorised under the Act. The regulation ensures that the Medicare benefits system remains effective and equitable, providing necessary services to patients while preventing misuse of the system.

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