EXPLANATORY STATEMENT

 

Select Legislative Instrument 2007 No. 340

 

Subject - Health Insurance Act 1973

Health Insurance (Pathology Services Table) Regulations 2007

 

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 2006 (the 2006 Regulations) currently prescribe such a table.

 

Subsection 4A(2) of the Act provides that, unless sooner repealed, regulations made under subsection 4A(1) cease to be in force and are taken to have been repealed on the day after the 15^th sitting day of the House of Representatives after the end of a period of 12 months, commencing on the day on which the regulations are notified on the Federal Register of Legislative Instruments. The 2006 Regulations were registered on the Federal Register of Legislative Instruments on 23 October 2006 and commenced on 1 November 2006.

 

The purpose of the Regulations is to repeal the 2006 Regulations and prescribe a new pathology services table for the 12 month period commencing on 1 November 2007. The new table effectively reproduces the table contained in the 2006 Regulations, with some changes to the rules of interpretation and to the schedule of services, fees and complexity levels. The Regulations set out 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.

 

These changes have been 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 Regulations are set out in the Attachment.

 

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

 

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commence on 1 November 2007.

 

ATTACHMENT

 

DETAILS OF THE HEALTH INSURANCE (PATHOLOGY SERVICES TABLE) REGULATIONS 2007

 

Regulation 1 – Name of Regulations

 

This regulation provides for the Regulations to be referred to as the Health Insurance (Pathology Services Table) Regulations 2007.

 

Regulation 2 – Commencement

 

This regulation provides for the Regulations to commence on 1 November 2007.

 

Regulation 3 – Repeal

 

This regulation repeals the Health Insurance (Pathology Services Table) Regulations 2006 (as amended).

 

Regulation 4 – Definitions

 

This regulation provides that for the purpose of the Regulations, Act means the Health Insurance Act 1973 and this table means these Regulations.

 

Regulation 5 – Pathology Services Table

 

This regulation provides that the table of pathology services in Schedule 1 is prescribed for the purposes of subsection 4A(1) of the Act.

 

Schedule 1 – Table of pathology services

 

Schedule 1 sets out a pathology services table which is similar to the table in the Health Insurance (Pathology Services Table) Regulations 2006, but with changes to the following provisions:

§         Part 2 – Rules of interpretation;

§         Part 3 – Services and fees; and

§         Part 5 – Complexity Levels.

 

Part 2 - Rules of interpretation

 

The Regulations incorporate the following changes:

 

Items [1] to [15] of the Regulations incorporate the following changes:

 

Rules 13, 14, and 25 have been changed. These changes are to reflect the addition of new items; to support clinical best practice for biochemical, immunology, genetic and tissue pathology tests.

 

Subrule 13 (4) has been amended to include the new item 73323 which determines a patients suitability to commence a particular drug therapy.

 

Subrule 13 (6) has been amended to include a new tissue pathology item 73838 which also gives reference to a new complexity level 7.

 

Subrule 14(8)(b) has been amended to incorporate exemptions around Rules 3 and 4 for the payment of a Patient Episode Initiation (PEI) fee.

 

Rule 25 has been amended to note that item 69482 is rebatable once only in a 12 month period and item 69483 – four times in a 12 month period.

 

Part 3 – Services and fees

 

The Regulations incorporate the following changes:

 

Items [16] to [42] of the Regulations incorporate the following changes:

 

The addition of 12 new items to support clinical best practice in biochemistry, immunology, genetics and tissue pathology (66517, 71180, 71183, 71186, 71189, 71192, 71195, 71198, 71200, 71203, 72838 and 73323).

 

Item 66517 is added to provide to provide a new item for the quantitation of bile acids in blood in pregnancy.

 

Items 66773 and 66776 have been amended to incorporate the words ‘in formation’ as the items currently refers to products of collagen breakdown but not products of collagen formation.

 

Item 69384 which relates to antibody testing, has been amended to delete the words ‘or exogenous’.

 

Item 71079 has been amended to delete the word ‘G’ to remove the ability for testing for IgG to non-inhalational (eg food) allergens in this item.

 

Item 71165 has been amended to delete the word ‘cardiolipin’ from this general descriptor and moved into new specific items; 71180, 71183 and 71186.

 

Items 71180, 71183, and 71186 have been added to provide new items for the detection of antibodies to cardiolipin and beta-2 glycoprotein I to contribute to the disease management and diagnosis of patients with prothrombotic autoimmune disease.

 

Items 71189, 71192 and 71195 have been added to provide new items for the detection of specific immunoglobulin G antibodies to environmental and occupational inhalational (non-food) allergens.

 

Item 71198 has been added to provide for clinical situations for unexplained acute hypotension or suspected anaphlylactic event.

 

Item 71200 has been added to provide for the detection and quantitation, if present, of free kappa or lambda light chains in serum for the diagnosis or monitoring of amyloidosis, meloma or plasma cell dyscrasias.

 

Items 71203 and 73323 have been added to provide for the testing in both the immunology and genetics sections of the table for the management of patients with HIV who are being considered for Abacavir antiretroviral therapy.

 

Item 72838 has been added to provide for the examination of complexity level 7 biopsy material with multiple tissue blocks.

 

Part 5 – Complexity Levels

 

Two new complexity levels have been added for complex breast and prostate cancer resections.

 

Breast - orientated wide local excision for carcinoma, weighing at least 70g,

with margin assessment 7

Prostate - radical prostatectomy or cystoprostatectomy for carcinoma 7