Commonwealth Numbered Regulations - Explanatory Statements

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HEALTH INSURANCE (PATHOLOGY SERVICES TABLE) REGULATIONS 2001 2001 NO. 281

STATUTORY RULES 2001 No. 281

Issued by the authority of the Minister for Health and Aged Care

Health Insurance Act 1973

Health Insurance (Pathology Services Table) Regulations 2001

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.

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 Subsection 4A(2) provides that, unless repealed sooner, regulations made under section 4A cease to be in force and are taken to be repealed on the day next following the 15^th sitting day of the House of Representatives after the expiration of a period of 12 months commencing on the day on which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

The purpose of the Health Insurance (Pathology Services Table) Regulations 2001 (the Regulations) is to prescribe a table of pathology services for the 12 month period commencing on 1 November 2001. The new table will replace the table contained in the Health Insurance (Pathology Services Table) Regulations 2000. The Regulations set 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 Regulations contain the following changes made as part of the ongoing management of the pathology services table:

•       three new items and three new histopathology complexity levels;

•       amendments to six existing items and two rules of interpretation; and

•       deletion of five items, one rule of interpretation and one histopathology complexity level.

These 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 the 1 November 2001 changes on overall expenditure on pathology, and support any necessary adjustments to ensure that the expenditure target is achieved.

Details of the Regulations are provided at the Attachment.

The Regulations commence on 1 November 2001.

ATTACHMENT

Regulation 1 specifies the regulations as the Health Insurance (Pathology Services Table) Regulations 2001.

Regulation 2 prescribes a commencement date of 1 November 2001.

Regulation 3 repeals the statutory rule for 2000 No. 293 and 2001 Nos. 4, 80 and 158.

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 2001 incorporates a number of changes including:

•       an additional item (66519) to cover the investigation of cardiac or skeletal muscle damage which allow for more than one test in a 24 hour period

-       in line with recently published guidelines for the management of unstable angina, which support additional testing for elevated troponin levels during the first 24 hours after presentation if the initial result is negative.

•       two new items (69472 and 69474) for the detection of Epstein Barr Virus

-       this test was previously covered under a general serology item. The new items allow the claiming of a Medicare benefit for 1 test and 2 or more tests respectively.

•       three new complexity levels for breast - microdochectomy (6); large bowel (including rectum), biopsy, and confirmation or exclusion of Hirschsprung's Disease (5); and lymph node - biopsy, for lymphoma or lymphoproliferative disorder (5). A number of complexity levels have also been amended or deleted, consistent with current clinical practice.

•       amendments to a number of existing items in Groups P2 (Chemical), P3 (Microbiology) and P5 (Tissue)

       - general chemistry item 66500 has been amended to include quantitation of total cholesterol and triglycerides following a review of the current specific lipid items. Consequently, lipid items 66521 - 66533 are no longer required and have been deleted;

       - the restrictions on HDL cholesterol item 66536 are removed to allow better access to the test which is consistent with current guidelines for the diagnosis and treatment of hyperlipidemia;

-       Herpes simplex virus, varicella zoster virus or cytomegalovirus item 69375 has been amended to include testing by `nucleic acid amplification technique' which is consistent with current laboratory practice;

-       Hepatitis C (HCV) genotype item 69443 has been amended to allow 1 test in a 12 month period. The item previously restricted testing to once in a lifetime, however, evidence indicates that it is not uncommon for a patient to be co-infected or to move from one HCV genotype to another. Also, additional testing may be required if the first genotype test was not definitive or gave a false positive result; and

-       tissue biopsy items 72855 and 72856 have been amended to include tissue imprint and smear to recognise that an intra-operative consultation may involve more than just a frozen section.

•       a number of Rules of Interpretation have been amended and deleted including:

-       rule 4 to include patients undergoing cyclosporin therapy as this drug may cause impaired renal function. This rule provides for exceptions to the 'Multiple Services' rule 3 which restricts the number of the same tests that can be requested in the one patient episode;

-       rule 8 has been amended to allow for claiming of creatinine ratio when testing for another substance in urine, consistent with current clinical practice; and

-       rule 9 is deleted which sets out the requirements for testing HDL cholesterol, given the restrictions on HDL cholesterol item 66536 have been removed.

•       a number of minor changes have been made to the current list of abbreviations.