Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1)

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Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1) 2003 No. 70

EXPLANATORY STATEMENT

STATUTORY RULES 2003 No. 70

Issued by the Authority of the Minister for Health and Ageing

Health Insurance Act 1973

Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1)

Section 133 of the Health Insurance Act 1973 (the Act) provides that the Governor-General may make regulations prescribing matters for the purposes of the Act.

Section 10 of the Act provides 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.

Subsection 4A of the Act provides that the regulations may prescribe a table of pathology services setting out items of pathology services; the amount of fees applicable in respect of each item; and rules for interpretation of the table. The Health Insurance (Pathology Services Table) Regulations 2002, which commenced on 1 November 2002, prescribes such a table.

The Amendment Regulations make the following changes as part of the ongoing management of the pathology services table:

       addition of 4 new items and 1 explanatory note;

       amendments to 14 existing items;

       deletion of 4 items; and

       other minor amendments to sub-rules, explanatory notes and index.

Details of the Regulations are set out in the Attachment.

The changes have been developed with the cooperation and support of the two peak pathology bodies, the Royal College of Pathologists of Australasia (RCPA) and the Australian Association of Pathology Practices (AAPP), through the Pathology Services Table Committee and the Pathology Consultative Committee.

The Regulations are consistent with the provisions of the Pathology Quality and Outlays Agreement to manage pathology expenditure within agreed parameters. As part of this Agreement, the Pathology Consultative Committee will monitor the impact of these amendments on overall expenditure on pathology, and support any necessary adjustments to ensure that the expenditure target is achieved.

The Regulations commence on 1 May 2003 to coincide with publication of the Supplement to Medicare Benefits Schedule of 1 November 2002.

ATTACHMENT

Regulation 1 specifies the regulations as the Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1).

Regulation 2 prescribes a commencement date of 1 May 2003.

Regulation 3 prescribes the amendments to the Health Insurance (Pathology Services Table) Regulations 2002.

The changes under Regulation 3, Schedule 1 are:

       The faeces items have been restructured by deleting items 69342, 69348 and 69351 and amending items 69336, 69339, 69345 and 69363. This restructure results from changes in clinical practice and better reflects accepted best practice.

       The pregnancy serology items (items 69405, 69408 and 69411) remove reference to item 69484 to allow for confirmatory testing of Hepatitis B during pregnancy. These amendments remove any discrimination against pregnant women for confirmatory hepatitis testing. The terminology for Hepatitis B has been amended to better reflect current laboratory practice.

       Following the Minister for Health and Ageing's recommendation of public funding for Fragile X (A) Syndrome testing, items 73287 and 73289 are amended to exclude reference to Fragile Xsite determination. Two new items - 73300 and 73305 - are created to provide for testing by Nucleic Acid Amplification and Southern Blot for patients displaying features of fragile X mutation and first or second degree relatives of those with fragile X mutation. A new explanatory note complementing these new items indicates to requestors the need for genetic counselling and informed consent.

       The amendment to the carboxyhaemoglobin item 65117 removes reference to qualitative.

       The detection of foetal abnormality items are restructured by deleting items 66740 and 66746, amending item 66743 and creating two new items 66750 and 66751. This restructure allows for testing in both first and second trimesters and in particular first trimester maternal biochemical screening (T1MBS) to be undertaken. This restructure better reflects current clinical practice.

       The amendment to item 69318 clarifies any ambiguity by making it quite clear that any specimen from any site is included.

       The amendment to item 66650 includes the conditions where these tests would be appropriate for detection as well as monitoring.

       The amendment to the chlamydia item (69315) removes the fee anomaly. The fee charged for the combined Chlamydia item (69315) is reduced to equal the fee for the separate items (69312 + 69369).

       The amendment to rules 13(4) and 13(6) includes reference to items 72818 and 72826. These changes remove any discrepancy created by changes made in November 2002.

       The group of tests for coagulation studies described in explanatory note PQ.4 have been expanded to include a full blood count (item 65070).

       The amendment to the explanatory note PA.2.2 includes reference to the pathologistdeterminable services as determined by the Minister for Health and Ageing.

 

Overview

The Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1) were enacted to address various issues and update the pathology services table under the Health Insurance Act 1973. Developed with the collaboration of key pathology bodies, the Royal College of Pathologists of Australasia and the Australian Association of Pathology Practices, these regulations were established to ensure that the pathology services table reflects current clinical practices, best practices, and agreed expenditure parameters. The regulations aim to maintain the quality of pathology services while managing costs, as part of the Pathology Quality and Outlays Agreement. They were designed to commence on 1 May 2003, aligning with the publication of the Supplement to the Medicare Benefits Schedule, to ensure a seamless integration into the existing framework. These regulations encompass the addition of four new pathology service items and one explanatory note, amendments to fourteen existing items, the deletion of four items, and other minor adjustments to sub-rules, explanatory notes, and the index. The changes were developed to better align with clinical practices and to address specific needs such as the provision of confirmatory hepatitis testing for pregnant women and the introduction of public funding for Fragile X (A) Syndrome testing. The Pathology Consultative Committee is tasked with monitoring the financial implications of these amendments to ensure they remain within the agreed expenditure targets.

Scope and Application

The Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1) amends the Health Insurance (Pathology Services Table) Regulations 2002, which set out the fees for pathology services covered under the Medicare scheme in Australia. These regulations apply to pathology service providers, including laboratories and medical practitioners who render pathology services, and are administered by the Minister for Health and Ageing under the Health Insurance Act 1973. The regulations cover services provided throughout Australia, ensuring consistency in the fees charged for pathology services under the Medicare scheme. The changes introduced by these Amendment Regulations include the addition of new items, amendments to existing items, and the deletion of certain items, reflecting updates in clinical practice and laboratory procedures. The regulations exclude any pathology services not listed in the amended table, and any further exclusions or exemptions are not specified in the provided text. The Amendment Regulations are supported by subordinate instruments such as explanatory notes and indices to ensure clarity and ease of application for all parties involved.

Key Provisions

The Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1) (the Amendment Regulations) amends the Health Insurance (Pathology Services Table) Regulations 2002. The primary focus of these regulations is to update and refine the pathology services table to align with current clinical practices and best standards, as well as to respond to specific recommendations from the Minister for Health and Ageing. Regulation 3, Schedule 1, details the specific amendments, including the addition of new items, amendments to existing items, and the deletion of outdated or redundant items. Under these Amendment Regulations, there are obligations for medical practitioners, pathology laboratories, and other stakeholders involved in the provision of pathology services. Medical practitioners must ensure that they are aware of and comply with the updated fees and service descriptions as outlined in the amended table. Pathology laboratories are required to adjust their billing practices accordingly and ensure that the services they provide are accurately reflected in the updated table. Both parties must stay informed about changes to the table to ensure compliance with Medicare benefit payment regulations. The Amendment Regulations also introduce specific consequences for non-compliance. While the Explanatory Statement does not explicitly detail offences or penalties, it is reasonable to infer that non-compliance with these regulations could lead to disputes over Medicare benefit payments, potential audits by the Department of Health, and possible financial repercussions for providers who do not adhere to the updated fee schedule. Providers who fail to comply with the new regulations could face scrutiny and corrective actions to ensure adherence to the amended table, ultimately impacting their reimbursement processes and financial outcomes. The Amendment Regulations further establish a framework for ongoing management and review of the pathology services table, ensuring it remains current and reflective of advancements in medical practices and technology. By involving key stakeholders such as the Royal College of Pathologists of Australasia (RCPA) and the Australian Association of Pathology Practices (AAPP) through the Pathology Services Table Committee and the Pathology Consultative Committee, these regulations aim to maintain a balance between healthcare quality and expenditure management. The Pathology Consultative Committee's role in monitoring the impact of these amendments and supporting necessary adjustments ensures that the expenditure target is met, reflecting a commitment to both quality healthcare and fiscal responsibility.

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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.