Commonwealth Numbered Regulations - Explanatory Statements

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HEALTH INSURANCE (PATHOLOGY SERVICES TABLE) REGULATIONS 2003 2003 NO. 256

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.

Subsection 4A(1) 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. Subsection 4A(2) provides that, unless sooner repealed, regulations made under section 4A cease to be in force and are taken to be repealed on the day next following the 15^th sitting day of the House of Representatives after the expiration of a period of 12 months commencing on the day on which the regulations are notified in the Gazette.

A table of pathology services is currently prescribed by the Health Insurance (Pathology Services Table) Regulations 2002 (the 2002 Regulations). The table was amended by the Health Insurance (Pathology Services Table) Amendment Regulations 2003 (No. 1).

The purpose of the Regulations is to repeal the 2002 Regulations and the amending Regulations, and to prescribe a new table of pathology services for the 12 month period commencing on 1 November 2003. The new table sets out the items of pathology services which are eligible for Medicare benefits, the amount of fees applicable in respect of each item and rules for interpretation of the table. The new table replaces the table contained in the 2002 Regulations.

Details of the Regulations are set out in the Attachment.

The changes have been developed with the co-operation 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 target benchmarks and parameters. As part of this Agreement, the Pathology Consultative Committee (PCC) will monitor the impact of the 1 November 2003 changes on overall expenditure on pathology, and support any necessary adjustments to ensure that the expenditure target is achieved. The Pathology Quality and Outlays Agreement is the second cooperative agreement between the Commonwealth Government and the two peak pathology professional bodies - the RCPA and the AAPP - to manage pathology expenditure under the Medicare benefits arrangements.

The Act specifies no conditions that need to be met before the power to make the proposed Regulations may be exercised.

The proposed Regulations would commence on 1 November 2003.

ATTACHMENT

DETAILS OF THE HEALTH INSURANCE (PATHOLOGY SERVICES TABLE) REGULATIONS 2003

Regulation 1 specifies the regulations as the Health Insurance (Pathology Services Table) Regulations 2003.

Regulation 2 prescribes a commencement date of 1 November 2003.

Regulation 3 repeals the statutory rules 2002 Nos. 245 and 2003 No. 70.

Regulation 4 prescribes definitions for the purpose of the regulations.

Regulation 5 prescribes the new table of pathology services and rules of interpretation as set out in Schedule 1.

The Pathology Services Table 2003 incorporates a number of changes as follows:

•       addition of 10 new items, 4 new rules and sub-rules;

•       amendments to 21 existing items, 4 rules and sub-rules; and

•       deletion of 8 items and 1 rule.

A new rule (24) is enabling laboratories to use information that has been previously supplied by the requester and stored by the Approved Pathology Authority. It is expected that this will alleviate problems where clinical notes have been lacking on request forms.

Group P1 - Haematology

The following two amendments remove anomalies and reflect current clinical practice. An amendment to item 65132 is proposed to clarify that the patient's personal history must indicate a history of venous thromboembolism to claim this item.

Amending item 65165 removes reference to surface antigens and allow laboratories to claim Medicare when markers that detect intracellular antigenic substances are used.

Group P2 - Chemical

A restructure of the therapeutic drug items splits the existing items into tests that are simpler to perform and the remainder - the more complex tests. The restructure enables appropriate remuneration for the more complex tests whilst maintaining overall cost neutrality for therapeutic drug testing. The restructure provides for the deletion of item 66617, the creation of 4 new items (66800 - 66809), the amendment and renumbering of existing items 66611, 66614 and 66620 (renumbered to 66812, 66815 and 66818), and consequent changes to the rules and explanatory notes.

Group P3 - Microbiology

Hepatitis C antibody testing included in the microbiology serology during pregnancy items (69405, 69408 and 69411). The proposal creates a new item (69413) for the determination of all 4 of the tests described in these items - rubella immune status, specific syphilis serology, carriage of Hepatitis B and the Hepatitis C antibody test and corresponding changes to items 69405, 69408 and 69411. This proposal is in line with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists recommendation for best practice of February 2003.

An amendment to Rule 18 excludes the confirmatory test for hepatitis B or C (item 69484) from the episode-coning rule. This exclusion enables the deletion of three hepatitis C items (69487, 69490 and 69493) and is in response to current clinical practice requiring a confirmatory test following a positive result.

In line with the continuing restructure of the faeces items, amended item 69336 acknowledges that immunoassay and immunofluorescent techniques are acceptable alternatives to fixed stain analysis for cryptosporidia and giardia. This proposal instigates a subsequent small increase in the Schedule fee.

Group P4 - Immunology

Further restructures to the coeliac items by deleting items 71160, 71161 and 71162 and rule 24 and creating items 71163 and 71164. These changes are made to simplify the items for coeliac diagnosis and monitoring and to rectify an inadvertent increase in expenditure created by the previous restructure (1 November 2002).

Group P5 - Tissue Pathology

Creating two new items (72848 and 73061) for the examination of biopsy material and amend items 72846 and 73059 to incorporates reference to these new items. The new items increase remuneration for the biological markers of oestrogen, progesterone and c-erb-B2 (HER2) acknowledging that these are more expensive than other biological markers. As a consequence of this proposal, amendments are necessary to rule 13 and a determination from the Minister for Health and Ageing identifies these proposed new items as pathologist determinable.

Addition of a new item (72857) for 5 or more separately identified specimens to the ladder for the examination of biopsy material by frozen section. This involves a consequential change to item 72856.

Group P7 - Cytogenetics

An increase the fees for the cytogenetics items (items 73287 and 73289) by 10% follows a submission from the Australasian Society of Cytogeneticists. Independent costings were obtained which support the increase in fees.

The current Cytogenetics Group (Group P7) will be renamed Genetics to enable broader consideration of applications in the field of genetics.

An amendment to the fragile X item (73300) removes ambiguity about the clinical features required for the use of item 73300 and removes reference to first or second degree relatives.