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SR 1998 No. 303 Regulations as made
Principal Regulations. These regulations repeal the Health Insurance (1997-98 Pathology Services Table) Regulations.
Tabling HistoryDate
Tabled HR10-Nov-1998
Tabled Senate10-Nov-1998
Gazetted 30 Oct 1998
Date of repeal 01 Nov 1999
Repealed by Health Insurance (1999-2000 Pathology Services Table) Regulations 1999

Health Insurance (1998-99 Pathology Services Table) Regulations 1998 1998 No. 303

EXPLANATORY STATEMENT

STATUTORY RULES 1998 No. 303

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

Health Insurance Act 1973

Health Insurance (1998-99 Pathology Services Table) Regulations 1998

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 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 the table (which includes the pathology services table),

Section 4A of the Act provides that the table of pathology services may be prescribed by the regulations. The Health Insurance (1998-99 Pathology Services Table) Regulations 1998 prescribe such a table.

As part of the annual renewal of the Pathology Services Table of the Medicare Benefits Schedule, a number of changes have been incorporated in the Health Insurance (1998-99 Pathology Services Table) Regulations 1998.

The changes to the Regulations include: new pathology test items; a restructuring of three Groups of the Table; other changes, such as to the Immunology and Tissue Pathology Groups and the Rules for the Interpretation of the Pathology Services Table (the Rules) and targeted fee adjustments.

The changes in the 1998-99 Pathology Services Table have been developed with the co-operation and support of the two peak pathology professional bodies, the Royal College of Pathologists of Australasia (RCPA) and the Australian Association of Pathology Practices (AAPP), through the Pathology Services Table Committee (PSTC) and the Pathology Consultative Committee (PCC).

A number of new test items were recommended for inclusion on the Table including a number of new tests developed following a review of evidence by the PSTC to establish their clinical utility and cost effectiveness. Where relevant, other professional bodies with particular expertise in the field were consulted.

The new test items include: oral glucose challenge and tolerance tests for gestational diabetes; a coagulation test for activated protein C resistance; a test for the detection of active tuberculosis or atypical mycobacterial infection in immunosuppressed or immunocompromised patients; a faecal antigen test for Helicobacter pylori, a supplementary test for Hepatitis C antibodies; and a test for enzyme histochemistry of skeletal muscle.

Three Groups of the Table, P1 (Haematology), P2 (Biochemistry), and P3 (Microbiology) were reviewed and have undergone a major restructuring to ensure that they reflect current clinical and laboratory practice. Test item numbers within the three Groups have been reordered and renumbered to accommodate the changes. As a result of the restructure, some changes have been made to Group P4 (Immunology).

Further changes include a review and subsequent changes to the complexity levels pertaining to Group P5 (Tissue Pathology), three new Sub-rules to he included in the Rules and a number of editorial changes have also been made to the Rules to encompass the new item numbers allocated to Groups P1, P2 and P3.

The 1998-99 expenditure target is $982m which represents a 6% growth on the 1997-98 target. This rate includes a 1 November 1998 fee increase of 1.6% (which equates to an estimated 59.9m for the remainder of the financial year and $14.9m for the full 12 month period).

The Pathology Agreement, which took effect from 1 July 1996, contains a series of measures to manage pathology expenditure, with adjustments being made as necessary to operate within the Agreement's agreed parameters. There has been an underspend of some $12m over the first two years of the Agreement, and on current projections, it was estimated that the target figure for 1998-99 would not be achieved. The PCC decided, based on current growth trends, that fee adjustments should be made to some eighty-two items,

Items targeted for a fee increase are those that incorporate more complex tests and consequently a higher resource use. These adjustments improve the relativities between items and the benefits of these fee increases will flow to both the public and private sectors.

Details of the changes to the regulations are set out in the Attachment.

The regulations come into effect from 1 November 1998.

ATTACHMENT A

Regulation 1 cites the regulations as the Health Insurance (1998-99 Pathology Services Table) Regulations 1998. Regulation 2 prescribes a commencement date of 1 November 1998 for the new regulations.

Regulation 3 prescribes the new pathology services table for 1998-99 which sets down the pathology services eligible for Medicare benefits, Regulation 4 repeals Statutory Rules 1997 No. 299 and Statutory Rules 1998 No. 203. The 1998-99 Pathology Services Table will differ from previous tables in the following ways:

*       two new items (66545 and 66548) to provide for the oral glucose challenge test for the detection of gestational diabetes and the oral glucose tolerance test for the diagnosis of gestational diabetes

-       both tests are currently claimable under two existing general Table items however the introduction of two specific items for gestational diabetes will allow for the monitoring of demand and provision of services;

*       one new item (65141) to provide for the test for activated protein C resistance (APC resistance) in patients with a history of venous thrombosis or pulmonary thromboembolism

-       APC resistance is a significant and independent risk factor for the development of idiopathic venous thrombosis and confirmation of this risk factor will assist in the appropriate management of venous thrombosis or pulmonary embolism

-       the medical practitioner requesting the test must specifically identify in writing that the patient has a history of venous thrombosis or pulmonary thromboembolism

-       the test is currently claimable under an existing general chemistry item however the introduction of a specific item for APC resistance will allow for the monitoring of demand and provision of services;

*       one new item (69471) to provide for the cell-mediated test for the detection of active tuberculosis or atypical mycobacterial infection in an immunosuppressed or immunocompromised patient

-       unlike existing blood based tests for tuberculosis which rely upon the detection of antibodies, the cell mediated test quantifies a specific marker, cytokine interferongamma, which is produced by T-lymphocytes stimulated by exposure to mycobacterial antigens

-       the test has a number of advantages over the Mantoux test including accuracy, convenience, earlier availability of results and well being of the patient (less invasive)

-       it is the only test available for the early diagnosis of atypical mycobacterial infection in an immunosuppressed or immunocompromised patient.,

*       one new item (69366) to provide for the faecal antigen test for Helicobacier pylori for either the confirmation of Helicobacter pylori colonisation or the monitoring of the success of eradication therapy for Helicobacter pylori in patients with peptic ulcer disease

-       the test has a number of advantages over existing tests for Helicobacter pylori in that it is noninvasive, requires a simple stool sample, is relatively inexpensive and allows GPs to diagnose and treat some patients with gastritis or ulcers without referral to a specialist

-       the item descriptor is similar to the urea breath test item and similarly the medical practitioner requesting the test must specifically identify in writing one or more of the clinical indications for the test;

*       one new item (69441) to provide for a Hepatitis C confirmatory test using a different Hepatitis C antibody assay on a specimen which has had a reactive result on the initial Hepatitis C antibody test

-       in accordance with established clinical practice, if the initial Hepatitis C antibody test has a positive or equivocal result, a second antibody test for a different antigenic specificity is undertaken;

*       one new item (72844) for a test for enzyme histochemistry of skeletal muscle for investigation of primary degenerative or metabolic muscle diseases or of muscle abnormalities secondary to disease of the central or peripheral nervous system;

*       a restructure of Groups P1 (Haematology), P2 (Chemical) and P3 (Microbiology) of the Table to ensure that their structure, item descriptions and fees are appropriate and that the test composition of each of the Groups reflect modem laboratory practice, including:

-       the provision of new series of item numbers for all three Groups to accommodate the changes

-       a revision and update of the descriptors of existing haematology items 65001 to 65007 (to replacement items 65060, 65063, 65066, 65069, 65072)

-       new test items for reticulocyte examination (65072), Bethesda assay (65159), urine acidification test (665 87), measurement of troponin and myoglobin (665 18), detection and quantitation of porphyrins (66782 to 6679 1) and examination for Varicella zoster virus and cytomegalovirus by culture (69375)

-       the inclusion in existing items of new tests including the Donath Landsteiner antibody test and the Echis, Stypven and Reptilase time tests

-       the replacement of existing compatibility test item 65023 with four new blood transfusion compatibility testing items

-       the transfer of tests between items including lithium to 66611, calcium (ionised) to 66566-81 (blood gas quantitation) and 66584, fructosamine to 66557, angiotensin converting enzymelcholinesterase to item 66758, acetoacetate, ammonia, betahydroxybutyrate, lactate and pyruvate to 66500, histamine, hydroxyindoleacetic acid and serotonin to 66779 and zinc to item 66668

-       the removal of skin bleeding time, coagulation time and Passovoy factor from the Table

-       the transfer of tests for cryoglobulins/cryofibrinogen, protein classes, paraprotein, total. protein, albumin and globulin to Group P4 (Immunology)

-       replacement of microscopy, and culture item 69207 by a ladder of three items (69306, 69312 and 693 18) covering skin sites, genital sites and sputum

-       replacement of mycobacteria microscopy item 69213 by a ladder of three items (693 24, 69327 and 693 30) covering 1, 2 and 3 specimens for mycobacteria two new sub-rules to cover the four new compatibility test items update of the rules in general to reflect the newly allocated item numbers;

*       amendments to Group P4 (Immunology) as a consequence of the restructure of Group P2 (items 71057, 71058, 71059, 71060, 71062 and 71064 in place of existing items 71061, 71063 and 71065);

*       the revision of the complexity levels pertaining to Group P5 (Tissue Pathology) as a result of feedback received on the tissue pathology items introduced in March 1997;

*       a new Sub-rule 17 (3) to not allow the specimen referred fee item to be claimable if certain common tests are referred (items 65060, 65063, 65069, 65120, 66500, 66503, 66506, 66509, 66512, 66515, 66521, 66524, 66527, 66530, 66533, 66536, 66596, 69300, 69303, 69333 and 73527)

-       this is intended to bring the claiming of this item back in line with its original intent. The item was originally developed to recompense small, specialised laboratories and reference laboratories which were requested to perform tests which other pathology providers were unable to do

In addition, the items selected for a fee increase include:

*       eighteen haematology items (items 65063, 65075, 65078, 65090, 65093, 65096, 65099, 65111, 65120, 65123, 65126, 65129, 65132, 65138, 65147, 65150, 65153 and 65156);

*       six chemical items (items 66608, 66650, 66653, 66669, 66671 and 66761),

*       thirty-three microbiology items (items 69300, 69315, 69336, 69339, 69342, 69369,

       69384, 69387, 69390, 69393, 69396, 69399, 69405, 69408, 69411, 69414, 69417, 69420,

       69423, 69426, 69429, 69432, 69435, 69438, 69447, 69450, 69453, 69456, 69459, 69462,

       69465, 69469 and 69444);

*       two immunology items (items 71079 and 71147);

*       ten tissue pathology items (items 72924, 72925, 72830. 72836, 72846, 72847, 72851,

       72852, 72855 and 72956);

*       two cytology items (items 73059 and 73060);

*       two cytogenetics items (73287 and 73289)

*       two infertility and pregnancy test items (items 73521 and 73523);

*       six patient episode initiation (PEI) items (items 73907, 73909, 73910, 73912, 73913 and

       73915) and the specimen referred fee item (item 73921).