EXPLANATORY STATEMENT
Select Legislative Instrument 2012 No. 58
Health Insurance Act 1973
Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 1)
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) Regulations 2011 (the Principal Regulations) currently prescribe such a table.
The regulation amends the current table of pathology services in the Principal Regulations, as part of the ongoing management of the table. New items are introduced and existing items amended to reflect evidence-based best clinical practice and better value for money for both the Australian Government and the Australian people.
The new items have been recommended by the Medicare Services Advisory Committee following consultation with the public and pathology stakeholders. The changes to the existing patient episode initiation (PEI) items, include reference to tissue pathology items that were omitted in error from the PEI items following their introduction to the Pathology Services Table on 1 November 2007 and 1 November 2008 respectively. These items were developed with the co-operation and support of the three peak pathology bodies, the Royal College of Pathologists of Australasia, the Australian Association of Pathology Practices and the National Coalition of Public Pathology, through the Pathology Services Table Committee.
Details of the regulation are set out in the Attachment.
Consultation
These changes relate to the ongoing maintenance of the Pathology Services Table (PST) to reflect evidence-based best practice and appropriate funding; and the listing of new items on the PST to reflect new procedures and technology. They result from advice from both the Pathology Services Table Committee (PSTC) and the Medical Services Advisory Committee (MSAC).
Where a change to the PST related 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 PSTC comprised members from the Royal College of Pathologists of Australasia, the Australian Association of Pathology Practices and the National Coalition of Public Pathology, the Australian Medical Association, Medicare Australia and the Department of Health and Ageing. The changes to the existing items are to reflect items that were listed in 2007 and 2008 and developed in consultation with these organisations.
Medicare Australia was consulted concerning the impact of the changes on their business operations. The Department of Veterans’ Affairs was advised of the changes to ensure that their schedule of benefits for veterans could be amended if necessary.
It has been concluded that the changes 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 Act specifies no conditions that need to be satisfied before the power to make the regulation may be exercised.
The regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The regulation commences on 1 May 2012.
Authority: Subsection 133(1) of the
Health Insurance Act 1973
ATTACHMENT
DETAILS OF THE HEALTH INSURANCE (PATHOLOGY SERVICES TABLE) AMENDMENT REGULATION 2012 (No. 1)
Section 1 – Name of Regulation
This section provides for the regulation to be referred to as the Health Insurance (Pathology Services Table) Amendment Regulation 2012 (No. 1).
Section 2 – Commencement
This section provides for the regulation to commence on 1 May 2012.
Section 3 – Amendment of the Health Insurance (Pathology Services Table) Regulations 2011
This section provides that Schedule 1 amends the Health Insurance (Pathology Services Table) Regulations 2011.
Item [1] - After item 73327
This item inserts the following three new genetic tests co-dependent to drugs listed on the Schedule of the Pharmaceutical Benefits Scheme and recommended by the Medical Services Advisory Committee after item 73327:
- item 73328 for the testing of tumour tissue from a patient with locally advanced or metastatic non-small cell lung cancer to determine epidermal growth factor receptor gene status for access to gefitinib;
- item 73330 for the testing of tumour tissue from a patient with metastatic colorectal cancer to determine Kirsten ras (KRAS) gene mutation status for access to cetuximab; and
- item 73332 for the in situ hybridization (ISH) testing of tumour tissue from a patient with breast cancer to determine human epidermal growth factor receptor 2 (HER2) gene mutation status for access to trastuzumab.
Item [2] - Subclause 2.10.1(7), note
This item deletes the Note appearing after paragraph 2.10.1(7) as the information is incorrect with item 73920 listed in Sub-group 1 in error when the item was introduced on 1 July 2008.
Item [3] – Group P10
This item deletes the Sub-group title of Subgroup 1 – “Initiation of a patient episode involving particular services” in order to have no division between the Patient Episode Initiation (PEI) items. Item 73920 was incorrectly listed in Sub-group 1 as it doesn’t involve particular services but rather where the specimen was collected.
Item [4] – Items 73924 to 73927
This item amends the wording of items 73324 to 73327 to include tissue pathology items 72838, 72827 and 72828 that were omitted in error from the PEI items, following their introduction to the Pathology Services Table on 1 November 2007 and 1 November 2008 respectively. This reflects the corrections made by the Health Insurance (Patient Episode Initiation) Determination 2011 (No. 1) that was registered on the Federal Register of Legislative Instruments on 5 December 2011. The Determination will be revoked, effective 30 April 2012.
Item [5] – Group P10
This item deletes the sub-group title Subgroup 2 – “Initiation of a patient episode involving other services” in order to have no division between the PEI items. Item 73920 was incorrectly listed in Sub-group 1 as it doesn’t involve particular services but rather where the specimen was collected.