Health Insurance (1996-97 Pathology Services Table) Regulations (Amendment)

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Health Insurance (1996-97 Pathology Services Table) Regulations (Amendment)
1997 No. 54
 

EXPLANATORY STATEMENT

Statutory Rules 1997 No. 54

issued by the Authority of the Minister for Health and Family Services

Health Insurance Act 1973

Health Insurance (1996-97 Pathology Services Table) Regulations (Amendment)

Section 133 of the Act provides that the Governor-General may make regulations 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 prescribed under Section 4A of the Act

Section 4A of the Act provides that the regulations may prescribe a table of pathology services that sets out the items of pathology services, the amount of fees applicable in respect of each item. and the rules for the interpretation of the table. The Health Insurance (1996-97 Pathology Services Table) Regulations prescribe such a table.

The changes incorporated in the 1996-97 Pathology Services Table by these Regulations 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 and the Pathology Consultative Committee.

The changes are in accordance with the aims of the Pathology Savings Agreement developed by the Government and the two peak professional bodies, and announced in the 1996-97 Budget. Under the Agreement. pathology expenditure under the Medicare benefits arrangements will be capped to targeted amounts over the period 1996-91 to 1999-99, equating to an annual Budget growth rate of around 6 per cent. It provides for adjustments (upwards or downwards) as necessary to operate within the cap's agreed parameters.

Upward adjustments are required in March 1997 to meet targets for 1996-97 and 1997-98, It is proposed that these adjustments will be achieved, via the Regulations, through the introduction of a new set of histopathology items (subregulation 3.32), and an increase in Schedule fees for some targeted items (subregulations 3.9, 3.11, 3,12, 3.13, 3.33. 3.34, 3.35, and 3.36). Medicare benefits are calculated with reference to the Schedule fee.

in addition, the Regulations prescribe changes relating to hepatitis items, tests for feto-maternal haemorrhage. diabetes in pregnancy. thyroid hormone and other hormone items, items for pregnancy in serology, patient episode initiation and the rules of the Pathology Services Table.

Details of the Regulations are set out in the Attachment. The regulations come into effect from 20 March 1997.

ATTACHMENT A

Regulation 1 prescribes a commencement date of 20 Match 1997 for the Regulations.

Regulation 2 provides that the Pathology Services Table be amended as set out in these Regulations.

Regulation 3 prescribes the amendments to the Table.

Subregulation 3.1 amends paragraph 4(2)(d) of Part 1 of the Table to include services in relation to clozaril and ticlopidine hydrochloride in exemptions to rule 3 of the Table. This change is in line with the recommendations of the Pharmaceutical Benefits Advisory Committee, established under Section 101 of the National Health Act 1953.

Subregulation 3.2 corrects a grammatical error in rule 4.

Subregulation 3.3 amends subrule 12 (1), which lists a number of items for testing for hepatitis and prescribes that Medicare benefits will be payable for only one of these in a patient episode, to include two new hepatitis items in the list. A "Patient episode" is defined in rule 1 in Part 1 of the Table.

Subregulations 3.4 and 3.5 amend subrule 12(2) to include a reference to new hepatitis item 69283, and to clarify the subrule's intention.

Subregulations 3.6 and 3.7 expand rule 14 to include additional provisions required by the introduction of a new set of histopathology items in Group P5 of the Pathology Services Table listed in subregulation 3.32:

*       new paragraph 14 (1)(d) defines a separately identified specimen, to prevent inappropriate claims being made for multiple unidentified specimens under new histopathology items inserted by subregulation 3.32;

*       new subrule 14(4) ensures that a Medicare benefit is payable for only one of the eight basic histopathology examination items (72813, 72816, 72817, 72823, 72824, 72825, 72830 and 72836) in a patient episode, it is the item which has the highest Schedule fee;

*       A new subrule 14(5) provides that if in a patient episode more than one histopathology examinations are performed on separate specimens of different complexity levels, so that more than one of the histopathology examination items relate to these services, a Medicare benefit is payable only for the service which has the highest schedule fee; and

*       new subrule 14(6) specifies that the complexity levels of the various types of histopathology specimens, referred to in the eight new basic histopathology items, are prescribed in Part 4 of the Pathology Services Table.

Subregulation 3.3 amends item 65005 to omit a reference to the Kleihauer test, which would be covered by the new item 65052. and adds reference to acid elution stains.

Subregulations 3.9, 3.11, 3.12, 3.13, 3.33, 3.34, 3.35, and 3.36 increase fees for eight items in the Pathology Services Table, to correct under-remuneration.

Subregulation 3.10 prescribes two new items (65052 and 65053) to cover tests used to detect Rh positive fetal cells in the maternal circulation to prevent the development of haemolytic disease in new born babies to sensitised Rh negative mothers:

*       Item 65052 provides for the Kleihauer test, which subregulation 3.8 removes from item 65005.,

*       Item 65053 makes provision for a new flow cytometric test to detect and quanritate red blood cell populations. It is more accurate than the existing Kleihauer rest, and would largely replace it.

Subregulation 3.14 prescribes a new item 66322, which would permit pregnant women with existing diabetes to obtain Medicare benefits for up to six glycosylated haemoglobin tests performed in the year which includes their pregnancy. This provision has been made on the recommendation of the relevant professional bodies to improve blood glucose control during pregnancy, reducing the risk of perinatal mortality.

Subregulations 3.15, 3.16 and 3.17 prescribe a restructure of the Thyroid Stimulating Hormone (66327) and hormone (66405) items to prevent inappropriate claims being made for combinations of these items.

Subregulations 3.18 to 3.20 amend the restriction in the three pregnancy serology items (69253, 69255 and 69257) to add item 69280, and omit items 69274 and 69279, thereby permitting claims to be made for tests for Hepatitis C and acute hepatitis, in the same patient episode.

Subregulations 3.21 to 3.31 amend the hepatitis items:

*       subregulations 3.21, 3.23, 3.24, and 3.25 make minor amendments to clarify hepatitis items;

*       subregulations 3.21. 3.26 3.27, 3.28, and 3.29 amend four item descriptors (69268, 69277, 69278, and 69279) to cover some clinical scenarios which were not adequately provided for when the revised hepatitis items were first included in the Pathology Services Table in 1996; and

*       subregulations 3.30 and 3.31 insert two new hepatitis items, 69280 and 692933:

-       item 69280 covers the determination of immune status to hepatitis B and testing for C. The item is needed for patients whose hepatitis C status and immunity to hepatitis B both need assessment, and

-       item 69283 cover the investigation for hepatitis A and C in a patient with currently elevated transaminase levels. The item is needed for patients with symptoms of acute hepatitis, and whose hepatitis C status needs assessment.

Subregulation 3.32 replaces the existing histopathology items (72801, 72803, 72805 and 72807) with a new set of histopathology items. There are eight new items for histopathology examinations (72813, 72816, 72817, 72823, 72824, 72825, 72830 and 72836), based on the number of separately identified specimens examined, and the complexity level of the specimens. There are also six new items covering additional procedures performed with the basic histopathology examinations (72946, 72847, 72851, 72852, 72855 and 72856). The complexity levels are prescribed by subregulation 3.39.

Subregulation 3.37 extends the Pap smear item 73053, to overcome difficulties experienced by laboratories. The amendment permits pathology laboratories to use the screening item 73053 when they have been supplied with insufficient clinical information on the request form to determine why the test had been ordered.

Subregulations 3.38 and 3.39 amend the Patient Episode Initiations items 73903 and 73905, which cover the collection of histopathology specimens. to reflect the replacement of the histopathology item 72801 by the new set of histopathology items (72813, 72816, 72817, 72823, 72824, 72825, 72830 and 72836).

Subregulation 3.40 replaces the Patient Episode Initiation item 73911, which covers the collection of specimens from patients in their own homes and from patients in nursing homes and institutions, with two separate items. One item covers the collection of specimens inpatients' homes (73910), and the other covers the collection of specimens in nursing homes and institutions (7391.2). This will provide more accurate data on where collections are occurring

Subregulation 3.41 sets out a Schedule of complexity levels for histopathology specimens. to be used in conjunction with the items specified in Subregulation 3.32.

 

Overview

The Health Insurance (1996-97 Pathology Services Table) Regulations (Amendment) 1997 No. 54 was enacted to amend the fees for pathology services under the Health Insurance Act 1973, thereby addressing discrepancies in remuneration and updating the services covered. The regulations were authorised by the Governor-General under Section 133 of the Act, which allows for the making of regulations for the purposes of the Act, and Section 9, which specifies that Medicare benefits for medical services, including pathology services, are to be calculated by reference to fees set out in a prescribed table. These amendments were developed in collaboration with peak pathology professional bodies and aim to align with the Pathology Savings Agreement, which caps pathology expenditure under Medicare to targeted amounts from 1996-97 to 1999-99, allowing for adjustments as necessary. The regulations introduce a new set of histopathology items and increase fees for certain targeted pathology services to meet these targets, while also incorporating recommendations from the relevant professional bodies to improve service coverage and accuracy. These changes are intended to ensure that the pathology services table remains reflective of current clinical practices and patient needs. The regulations were made under the authority of the Minister for Health and Family Services and come into effect on 20 March 1997. They include adjustments to the Pathology Services Table, such as the introduction of new items and amendments to existing ones to better reflect clinical scenarios and improve service delivery. The amendments are designed to prevent inappropriate claims and ensure that pathology services are appropriately remunerated, thereby supporting the objectives of the Pathology Savings Agreement. The regulations also correct grammatical errors and clarify certain rules to enhance the administration of Medicare benefits under the Health Insurance Act.

Scope and Application

The Health Insurance (1996-97 Pathology Services Table) Regulations (Amendment) 1997 No. 54 applies to the administration and operation of the Medicare benefits scheme in Australia, specifically focusing on the pathology services component. These regulations amend the fees and items covered under the Pathology Services Table, which is integral to the calculation of Medicare benefits for pathology services. They apply to all entities involved in the provision of pathology services and to Medicare recipients who utilise these services, as well as the pathology professional bodies that have collaborated in developing these changes. The regulations extend across the Commonwealth, as they are a direct amendment to the Health Insurance Act 1973, which operates nationally. The amendments include adjustments to fees for specific pathology services, the introduction of new items to cover additional pathology tests, and clarifications to existing rules to prevent misuse of the scheme. The changes aim to align with the Pathology Savings Agreement, which targets the capping of pathology expenditure under Medicare, and the Pathology Services Table Committee and Pathology Consultative Committee's recommendations. The regulations came into effect on 20 March 1997, and they do not explicitly state exclusions or thresholds but instead focus on specific amendments to the Pathology Services Table as outlined in the detailed provisions of the regulations.

Key Provisions

The Health Insurance (1996-97 Pathology Services Table) Regulations (Amendment) 1997 No. 54 (the Regulations) amend the 1996-97 Pathology Services Table under the Health Insurance Act 1973 (the Act). The Regulations introduce new pathology items, revise existing items, and correct errors in the Table, in accordance with the Pathology Savings Agreement between the Government and peak pathology professional bodies. The changes include new items for tests used to detect Rh positive fetal cells in the maternal circulation, histopathology examinations, and glycosylated haemoglobin tests for pregnant women with diabetes. The Regulations also increase fees for under-remunerated items and clarify rules around patient episodes, complexity levels, and specimen collection. The Regulations impose several obligations on parties and entities governed by the Act. Firstly, the amendments to the Pathology Services Table must be applied in calculating Medicare benefits for pathology services. Secondly, pathology providers and laboratories must ensure their claims comply with the new items, fees, and rules. Thirdly, professional bodies and committees involved in developing the amendments must cooperate with the Government to achieve the aims of the Pathology Savings Agreement. Fourthly, the Minister for Health and Family Services must ensure the Regulations are made and published in accordance with the Act. Finally, the Regulations require the Pathology Services Table to be amended as set out in the Regulations. Breach of the Regulations may result in civil or criminal consequences. Firstly, pathology providers and laboratories that submit claims in violation of the new items, fees, or rules may be subject to financial penalties or recoupment of Medicare benefits. Secondly, professional bodies and committees that fail to cooperate with the Government in developing the amendments may undermine the aims of the Pathology Savings Agreement. Thirdly, the Minister for Health and Family Services that fails to make and publish the Regulations in accordance with the Act may be subject to legal challenges or administrative penalties. The maximum penalties for civil or criminal breaches are not specified in the Explanatory Statement but would depend on the nature and severity of the breach. In summary, the Regulations amend the 1996-97 Pathology Services Table under the Act to introduce new items, revise existing items, and correct errors in the Table. The Regulations impose obligations on parties and entities governed by the Act, including pathology providers, laboratories, professional bodies, committees, and the Minister for Health and Family Services. Breach of the Regulations may result in civil or criminal consequences, although the maximum penalties are not specified in the Explanatory Statement. The Regulations come into effect on 20 March 1997.

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