Health Insurance (Pathology Services Table) Regulations 2003

2 Commencement

These Regulations commence on 1 November 2003.

3 Health Insurance (Pathology Services Table) Regulations 2002 — repeal

The following Statutory Rules are repealed:

 2002 No. 245

 2003 No. 70.

4 Definitions

In these Regulations:

Act means the Health Insurance Act 1973.

this table means these Regulations.

5 Pathology services table

The table of pathology services set out in Schedule 1 is prescribed for subsection 4A (1) of the Act.

Schedule 1 Table of pathology services

(regulation 5)

Part 1 Prescription of table

1A Prescription of table

For section 4A of the Act, these Regulations prescribe a table of pathology services that sets out:

(a) in Part 2 — rules for interpretation of the table; and

(b) in Part 3:

(i) items of pathology services; and

(ii) the amount of fees applicable for each item; and

(c) in Parts 4 and 5 — additional supporting information.

Part 2 Rules of interpretation

1 Interpretation of table

(1) In this table:

item means:

(a) an item mentioned, by number, in column 1 of:

(i) Part 3; or

(ii) Part 3 of the diagnostic imaging services table; or

(iii) Part 3 of the general medical services table; and

(b) in a reference immediately followed by a number — the item so numbered.

patient episode means:

(a) a pathology service or pathology services (other than a pathology service to which paragraph (b) refers) provided for a single patient whose need for the service or services was determined under section 16A of the Act:

(i) on the same day; or

(ii) if more than 1 test is performed on the 1 specimen within 14 days — on the same or different days;

whether the services:

(iii) are requested by 1 or more practitioners; or

(iv) are described in a single item or in more than 1 item; or

(v) are rendered by 1 approved pathology practitioner or more than 1 approved pathology practitioner; or

(vi) are rendered on the same or different days; or

(b) a pathology service to which rule 4 refers that is provided in the circumstances set out in that rule that relate to the service.

recognised pathologist means a medical practitioner recognised as a specialist in pathology by a determination under section 3D or subsection 61 (3) of the Act.

serial examinations means a series of examinations requested on 1 occasion whether or not:

(a) the materials are received on different days by the approved pathology practitioner; or

(b) the examinations or cultures were requested on 1 or more request forms by the treating practitioner.

(2) In these rules, a reference to a request to an approved pathology practitioner includes a reference to a request for a pathologist-determinable service to which subsection 16A (6) of the Act applies.

(3) A reference to a Group in the table includes every item in the Group and a reference to a Subgroup in the table includes every item in the Subgroup.

2 Precedence of items

(1) If a service is described:

(a) in an item in general terms; and

(b) in another item in specific terms;

only the item that describes the service in specific terms applies to the service.

(2) Subject to subrule (3), if:

(a) subrule (1) does not apply; and

(b) a service is described in 2 or more items;

only the item that provides the lower or lowest fee for the service applies to the service.

(3) If an item is expressed to include a pathology service that is described in another item, the other item does not apply to the service in addition to the first-mentioned item, whether or not the services described in the 2 items are requested separately.

Application of items 74990 and 74991

(4) Despite subrules (1), (2) and (3):

(a) if the pathology service described in item 74991 is provided to a person, either that item or item 74990, but not both those items, applies to the service; and

(b) if item 74990 or 74991 applies to a pathology service, the fee specified in that item applies in addition to the fee specified in any other item in this table that applies to the service.

(5) For items 74990 and 74991:

bulk-billed, in relation to a pathology service, means:

(a) a medicare benefit is payable to a person in respect of the service; and

(b) under an agreement entered into under section 20A of the Act:

(i) the person assigns to the practitioner by whom, or on whose behalf, the service is provided, his or her right to the payment of the medicare benefit; and

(ii) the practitioner accepts the assignment in full payment of his or her fee for the service provided.

Commonwealth concession card holder means a person who is a concessional beneficiary within the meaning given by subsection 84 (1) of the National Health Act 1953.

unreferred service means a pathology service that:

(a) is provided to a person by, or on behalf of, a medical practitioner, being a medical practitioner who is not a consultant physician, or specialist, in any speciality (other than a medical practitioner who is, for the purposes of the Act, both a general practitioner and a consultant physician, or specialist, in a particular speciality); and

(b) has not been referred to the medical practitioner by another medical practitioner or person with referring rights.

(6) For item 74991:

ASGC means the document titled Australian Standard Geographical Classification (ASGC) 2002, published by the Australian Bureau of Statistics, as in force on 1 July 2002.

practice location, in relation to the provision of a pathology service, means the place of practice in respect of which the practitioner by whom, or on whose behalf, the service is provided, has been allocated a provider number by the Commission.

regional, rural or remote area means an area classified as RRMAs 3-7 under the Rural, Remote and Metropolitan Areas Classification.

Rural, Remote and Metropolitan Areas Classification has the meaning given by subrule 3 (1) of Part 2 of Schedule 1 to the general medical services table.

SLA means a Statistical Local Area specified in the ASGC.

SSD means a Statistical Subdivision specified in the ASGC.

3 Circumstances in which services rendered following 2 requests to be taken to have been rendered following 1 request

(1) In subrule (2), service includes assay, estimation and test.

(2) Two or more pathology services (other than services to which, under rule 4, this rule does not apply) rendered for a patient following 2 or more requests are taken to have been rendered following a single request if:

(a) the services are listed in the same item; and

(ab) that item is not item 74990 or 74991; and

(b) the patient’s need for the services was determined under subsection 16A (1) of the Act on the same day even if the services are rendered by an approved pathology practitioner on more than 1 day.

4 Services to which rule 3 does not apply

(1) Rule 3 does not apply to a pathology service described in item 66500, 66503, 66506, 66509, 66512, 66515 or 66584 if:

(a) the service is rendered in relation to a single specimen taken on each of not more than 4 occasions in a period of 24 hours; and

(b) the service is rendered to a patient in a hospital unit where:

(i) the presence of 1 nurse is required for each group of not more than 4 patients; and

(ii) the condition of the patients is continuously observed in relevant respects; and

(c) in order to render the service, an approved pathology practitioner who is a recognised pathologist has to arrange for a member of the laboratory staff of the approved pathology authority concerned to undertake duties in respect of the service that are in addition to the usual duties of the staff member; and

(d) the account for the service is endorsed ‘Rule 3 Exemption’.

(2) Rule 3 does not apply to any of the following pathology services:

(a) estimation of prothrombin time (INR) for a patient undergoing anticoagulant therapy;

(b) quantitative estimation of lithium for a patient undergoing lithium therapy;

(c) a service described in item 65070 in relation to a patient undergoing chemotherapy for neoplastic disease or immunosuppressant therapy;

(d) a service described in item 65070 in relation to
clozaril, ticlopidine hydrochloride, methotrexate, gold, sulphasalazine or penicillamine therapy of a patient;

(e) a service described in any of items 66500 to 66515, in relation to methotrexate or leflunomide therapy of a patient;

(f) quantitative estimation of urea, creatinine and electrolytes in relation to:

(i) cis-platinum or cyclosporin therapy of a patient; or

(ii) chronic renal failure of a patient being treated
in a dialysis program conducted by a recognised hospital;

(g) quantitative estimation of albumin and calcium in relation to therapy of a patient with vitamin D, its metabolites or analogues;

if:

(h) under a request for a service, other than a request for a service described in paragraph (a), no more than 6 tests are requested; and

(i) the tests are performed within 6 months of the request; and

(j) the account for the service is endorsed ‘Rule 3 Exemption’.

5 Item taken to refer only to the first service of a particular kind

(1) For an item in Group P1 (Haematology):

(a) if pathology services of a kind referred to in item 65090 or 65093 are rendered for a patient during a period when the patient is in hospital, the item applies only to the first pathology service of that kind rendered for the patient during the period; and

(b) if:

(i) tests (except tests mentioned in item 65099, 65102, 65105 or 65108) are carried out in relation to a patient episode; and

(ii) specimen material from the patient episode is stored; and

(iii) in response to a request made within 14 days of the patient episode, further tests (except tests mentioned in item 65099, 65102, 65105 or 65108) are carried out on the stored material;

(2) Items 65102 and 65108 apply only if a minimum of 6 units are issued for a patient’s care in any 1 day.

(3) For items 65099 and 65102:

compatibility tests by crossmatch means that, in addition to all the tests described in paragraphs (a) and (b) of the item, donor red cells from each unit must have been tested directly against the serum of the patient by 1 or more accepted crossmatching techniques.

6 Certain items not to apply to a service referred by one pathology practitioner to another

(1) In this rule:

designated pathology service means a pathology service in respect of tests relating to a single patient episode that are:

(a) tests of the kind described in item 66695; or

(b) tests of the kind described in item 66722; or

(c) tests of the kind described in item 66800; or

(d) tests of the kind described in item 66812; or

(e) tests of the kind described in item 69384.

(2) This rule applies in respect of a designated pathology service where:

(a) an approved pathology practitioner (practitioner A) in an approved pathology authority:

(i) has been requested to render the designated pathology service; and

(ii) is unable, because of the lack of facilities in, or expertise or experience of the staff of, the laboratory of the authority, to render 1 or more (but not all) of the tests included in the service; and

(iii) requests an approved pathology practitioner (practitioner B) in another approved pathology authority to render the test or tests that practitioner A is unable to render; and

(iv) renders each test included in the service, other than the test or tests in respect of which the request mentioned in subparagraph (iii) is made; and

(b) the tests mentioned in subparagraph (a) (iv) that practitioner A renders are not tests constituting a service described in item 66710, 66734, 66806, 66815 or 69399.

(3) If this rule applies in respect of a designated pathology service:

(a) item 66695, 66698, 66701, 66704, 66707, 66722, 66725, 66728, 66731, 66800, 66803, 66812, 69384, 69387, 69390, 69393 or 69396 (as the case requires) applies in respect of the test or tests rendered by practitioner A; and

(b) where practitioner B renders a service under a request referred to in subparagraph (2) (a) (iii) — subject to subrule (4), the amount specified in item 66713, 66737, 66809, 66818 or 69402 (as the case requires) is payable for each test that the service comprises.

(4) For paragraph (3) (b), the maximum number of tests to which item 66713, 66737, 66809, 66818 or 69402 applies is:

(a) for item 66809:

3 – X; and

(b) for item 66818:

2 – X; and

(c) for item 66713, 66737 or 69402:

6 – X;

where X is the number of tests rendered by practitioner A in relation to the designated pathology service in respect of which the request mentioned in that paragraph is made.

(5) Items in Group P10 (Patient episode initiation) do not apply to the second-mentioned approved pathology practitioner in subrule (2).

7 Items not to be split

Except as stated in rule 6, the amount specified in an item is payable only to 1 approved pathology practitioner in respect of a single patient episode.

8 Creatinine ratios — Group P2 (Chemical)

A pathology service mentioned in an item in Group P2 (Chemical) (except item 66500) that:

(a) involves the measurement of a substance in urine; and

(b) requires calculation of a substance/creatinine ratio;

is taken to include the measurement of creatinine necessary for the calculation.

9 Thyroid function testing

(1) For item 66719:

abnormal level of TSH means a level of TSH that is outside the normal reference range in respect of the particular method of assay used to determine the level.

(2) Except where paragraph (a) of item 66719 is satisfied, the amount specified in the item is not payable for a pathology service described in the item unless the pathologist who renders the service has a written statement from the medical practitioner who requested the service that satisfies subrule (3).

(3) The written statement from the medical practitioner must indicate:

(a) that the tests are required for a particular purpose, being a purpose specified in paragraph (b) of item 66719; or

(b) that the medical practitioner who requested the tests suspects the patient has pituitary dysfunction; or

(c) that the patient is on drugs that interfere with thyroid hormone metabolism or function.

10 Meaning of serial examinations or cultures

For an item in Group P3 (Microbiology):

(a) serial examinations or cultures means a series of examinations or cultures requested on 1 occasion whether or not:

(i) the materials are received on different days by the approved pathology practitioner; or

(ii) the examinations or cultures were requested on 1 or more request forms by the treating practitioner; and

(b) if:

(i) tests are carried out in relation to a patient episode; and

(ii) specimen material from the patient episode is stored; and

(iii) in response to a request made within 14 days of the patient episode, further tests are carried out on the stored material;

11 Investigation for hepatitis serology

(1) The fee applying in a single patient episode that includes any of items 69475, 69478 and 69481 is the fee specified for 1 only of those items.

(2) Item 69478 applies to a service in relation to which:

(a) a practitioner requests 2 tests for immune status or viral carriage; or

(b) the clinical notes indicate that the service is required for:

(i) pre-operative assessment; or

(ii) post-exposure to blood or other body fluids assessment; or

(iii) assessment before blood or tissue donation.

(3) Item 69481 applies to a service in relation to a patient who displays 1 or more of the characteristics of acute or chronic hepatitis.

12 Tests in Group P4 (Immunology) relating to antibodies

For items in Group P4 (Immunology), in items 71119, 71121, 71123 and 71125, if:

(a) tests are carried out in relation to a patient episode; and

(b) specimen material from the patient episode is stored; and

(c) in response to a request made within 14 days of the patient episode, further tests are carried out on the stored material;

13 Tests on biopsy material — Group P5 (Tissue pathology) and Group P6 (Cytology)

(1) For items in Group P5 (Tissue pathology):

biopsy material means all tissue (other than a bone marrow biopsy) received by an approved pathology practitioner:

(a) from a medical procedure, or group of medical procedures, performed on a patient at the same time; or

(b) after being expelled spontaneously from a patient.

cytology means microscopic examination of 1 or more stained preparations of cells separated naturally or artificially from their normal environment by methods recognised as adequate to demonstrate their structure to a degree sufficient to enable an opinion to be formed about whether they are likely to be normal, abnormal but benign, or abnormal and malignant but, in accordance with customary laboratory practice, does not include examination of a blood film and a bone marrow aspirate.

separately identified specimen means an individual specimen collected, identified so that it is clearly distinguished from any other specimen, and sent for testing by or on behalf of the treating practitioner responsible for the procedure in which the specimen was taken.

(2) For Groups P5 and P6 of the pathology services table, services in Group P6 include any services described in Group P5 on the material submitted for a test in Group P6.

(3) For subrule (2), any sample submitted for cytology from which a cell block is prepared does not qualify for a Group P5 item.

(4) If more than 1 of the services mentioned in items 72813, 72816, 72817, 72818, 72823, 72824, 72825, 72826, 72830 and 72836 are performed in a single patient episode, only the fee for the item performed having the highest specified fee is applicable to the services.

(5) If more than 1 histopathological examinations are performed on separate specimens, of different complexity levels, from a single patient episode, only the fee for the examination having the highest specified fee is applicable to the examinations.

(6) In items 72813, 72816, 72817, 72818, 72823, 72824, 72825, 72826, 72830 and 72836 a reference to a complexity level is a reference to the level given to a specimen type mentioned in Part 5 of this table.

(7) If:

(a) more than 1 of the services mentioned in items 72846, 72847 and 72848; or

(b) more than 1 of the services mentioned in items 73059, 73060 and 73061;

are performed in a single patient episode, only the fee for the item performed having the higher or highest specified fee applies to the services.

14 Items in Groups P10 (Patient episode initiation) and P11 (Specimen referred) not to apply in certain circumstances

(1) For this rule and items in Groups P10 (Patient episode initiation) and P11 (Specimen referred):

approved collection centre has the same meaning as in Part IIA of the Act.

institution means a place at which residential accommodation or day care is, or both residential accommodation and day care are, made available to:

(a) disadvantaged children; or

(b) juvenile offenders; or

(c) aged persons; or

(d) chronically ill psychiatric patients; or

(e) homeless persons; or

(f) unemployed persons; or

(g) persons suffering from alcoholism; or

(h) persons addicted to drugs; or

(i) physically or mentally handicapped persons;

but does not include:

(j) a hospital; or

(k) a residential care facility; or

(l) accommodation for aged persons that is attached to a residential care facility or situated within a residential care facility complex.

prescribed laboratory means a laboratory operated by:

(a) the Commonwealth; or

(b) an authority of the Commonwealth; or

(c) a State or internal Territory; or

(d) an authority of a State or internal Territory; or

(e) an Australian tertiary education institution.

residential care facility means a facility in which residential care, within the meaning of section 41-3 of the Aged Care Act 1997, is provided.

specimen collection centre has the same meaning as in Part IIA of the Act.

treating practitioner has the same meaning as in paragraph 16A (1) (a) of the Act.

(2) If a service described in an item in Group P10 is rendered by, or on behalf of, an approved pathology practitioner who is a recognised pathologist, the relevant one of those items does not apply to the service if:

(a) the service is rendered upon a request made in the course of an out-patient service at a recognised hospital; or

(b) the service is rendered upon a request made for a patient who is a private patient in a recognised hospital when the request is made; or

(c) the pathology equipment of a recognised hospital, or a prescribed laboratory, is used rendering the service; or

(d) a member of the staff of a recognised hospital, or a prescribed laboratory, participates in the service in the course of the member’s employment with the hospital or laboratory.

(3) An item in Group P10 or P11 does not apply to a pathology service to which subsection 16A (7) of the Act applies.

(4) An item in Group P10 or P11 does not apply to a pathology service unless at least 1 item in Groups P1 to P8 also applies to the service.

(5) Subject to subrule (7), if 1 item in Group P10 applies to a patient episode, no other item in the Group applies to the patient episode.

(6) An item in Group P11 applies only to the approved pathology practitioner or approved pathology authority to whom the specimen mentioned in the item was referred.

(7) If, in respect of the same patient episode:

(a) services referred to in 1 or more items in Group P5 and 1 or more of Groups P1, P2, P3, P4, P6, P7 and P8 are rendered by an approved pathology practitioner in the laboratory of another approved pathology authority; or

(b) services referred to in 1 or more items in Group P6 and 1 or more of Groups P1, P2, P3, P4, P5, P7 and P8 are rendered by an approved pathology practitioner in the laboratory of another approved pathology authority;

the fee specified in the applicable item in Group P10 applies to both approved pathology practitioners.

(8) If more than one specimen is collected from a person on the same day for the provision of pathology services:

(a) in accordance with more than 1 request; and

(b) in or by a single approved pathology authority;

the fee specified in the applicable item in Group P10 applies once only to the services.

(9) The fee specified in item 73921 applies only once in respect of a single patient episode.

15 Application of an item in Group P11 (Specimen referred) to a service excludes certain other items

If item 73921 applies to a patient episode, none of the items in Group P10 applies to any pathology service rendered by the approved pathology authority or approved pathology practitioner who claimed item 73921 in respect of the patient episode.

16 Circumstances in which an item in Group P11 (Specimen referred) does not apply

(1) An item in Group P11 does not apply to a referral if:

(a) a service in respect of the same patient episode has been carried out by the referring approved pathology authority; and

(b) the approved pathology authority to which the referral is made is related to the referring approved pathology authority.

(2) An approved pathology authority is related to another approved pathology authority for subrule (1) if:

(a) both approved pathology authorities are employed (including employed under contract) by the same person, whether or not the person is also an approved pathology authority; or

(b) either of the approved pathology authorities is employed (including employed under contract) by the other; or

(c) both approved pathology authorities are corporations and are related corporations within the meaning of the Corporations Act 2001; or

(d) the approved pathology authorities are partners (whether or not either or both of the approved pathology authorities are individuals and whether or not other persons are in partnership with either or both of the approved pathology authorities); or

(e) both approved pathology authorities are operated by the Commonwealth or an authority of the Commonwealth; or

(f) both approved pathology authorities are operated by the same State or internal Territory or an authority of the same State or internal Territory.

(3) An item in Group P11 does not apply to a referral if the following common tests are referred either singly or in combination (except if the following items are referred in combination with other items not similarly specified): 65060, 65070, 65120, 66500, 66503, 66506, 66509, 66512, 66515, 66536, 66596, 69300, 69303, 69333 or 73527.

17 Abbreviations

(1) The abbreviations in Part 4 may be used to identify particular pathology services or groups of pathology services.

(2) The names of services or drugs not listed in Part 4 must be written in full.

18 Certain pathology services to be treated as 1 service

(1) In this rule:

general practitioner means a medical practitioner who:

(a) is not a consultant physician in any specialty; and

(b) is not a specialist in any specialty.

set of pathology services means a group of pathology services:

(a) that consists of services that are described in at least 4 different items; and

(b) all of which are requested in a single patient episode; and

(c) each of which relates to a patient who is not an admitted patient of a hospital; and

(d) none of which is referred to:

(i) in item 66713, 66737, 66809, 66818, 69402, 69484, 73053 or 73055; or

(ii) in an item in Group P10 (Patient episode initiation), Group P11 (Specimen referred) or Group P12 (Management of bulk-billed services).

(2) If a general practitioner requests a set of pathology services, the pathology services in the set are to be treated as individual pathology services in accordance with this rule.

(3) If the fee specified in 1 item that describes any of the services in the set of pathology services is higher than the fees specified in the other items that describe the services in the set:

(a) the pathology service described in the first-mentioned item is to be treated as 1 pathology service; and

(b) either:

(i) the pathology service in the set that is described in the item that specifies the second-highest fee is to be treated as 1 pathology service; or

(ii) if 2 or more items that describe any of those services specify the second-highest fee — the pathology service described in the item that specifies the second-highest fee, and has the lowest item number, is to be treated as 1 pathology service; and

(c) the pathology services in the set, other than the services that are to be treated as 1 pathology service under paragraphs (a) and (b), are to be treated as 1 pathology service.

(4) If the fees specified in 2 or more items that describe any of the services in the set of pathology services are the same, and higher than the fees specified in the other items that describe the services in the set:

(a) the pathology service in the set that is described in the item that specifies the highest fee, and has the lowest item number, is to be treated as 1 pathology service; and

(b) the pathology service in the set that is described in the item that specifies the highest fee, and has the second‑lowest item number, is to be treated as 1 pathology service; and

(c) the pathology services in the set, other than the services that are to be treated as 1 pathology service under paragraphs (a) and (b), are to be treated as 1 pathology service.

(5) If pathology services are to be treated as 1 pathology service under paragraph (3) (c) or (4) (c), the fee for the 1 pathology service is the highest fee specified in any of the items that describe the pathology services that are to be treated as the 1 pathology service.

19 Hepatitis C viral RNA testing

For items 69442, 69444 and 69445:

Hepatitis C sero-positive, for a patient, means 2 different assays of Hepatitis C antibodies are positive.

serological status is uncertain, for a patient, means any result where 2 different assays of Hepatitis C antibodies are inconclusive.

20 Haemochromatosis testing

For item 66794:

elevated serum ferritin, for a patient, means a level of ferritin above the normal reference range in respect of the particular method of assay used to determine the level.

21 Serum B12 and red cell folate testing

(1) Items 66599 and 66602 do not apply to more than 3 patient episodes that include a service described in item 66599 or 66602, or any combination of those items, in a 12 month period.

(2) Item 66599 does not apply to a service described in that item if the service was provided as part of the same patient episode as a service described in item 66602.

22 Nutritional and toxicity metals testing

(1) For this rule:

metal toxicity testing group means items 66672 and 66673.

nutritional metals testing group means items 66669 and 66670.

(2) An item in the nutritional metals testing group or the metal toxicity testing group does not apply in relation to a service performed if medicare benefits are paid or payable for tests that are performed for the same patient in 3 patient episodes requested within 6 months before the request for that service, under any of:

(a) that item; or

(b) the other item in the same group; or

(c) an item in the other group.

23 Antineutrophil cytoplasmic antibody tests

For subsection 16A (3) of the Act, a request for an antineutrophil cytoplasmic antibody immunofluorescence test is taken to include a request for an antineutrophil proteinase 3 antibody test and an antimyeloperoxidase antibody test if:

(a) the immunofluorescence test performed as a result of the request is abnormal; or

(b) a previous immunofluorescence test was abnormal; or

(c) those antibodies have been previously detected.

24 Satisfying requirements described in pathology service

Unless the contrary intention appears, a requirement contained in the description of a pathology service in Part 3 is satisfied if:

(a) in the case of a requirement for information, the information:

(i) is included in the request for the service; or

(ii) was supplied in writing on an earlier occasion to the approved pathology authority that rendered the service, and has been kept by the approved pathology authority; or

(b) in the case of a requirement for laboratory test results, the results are:

(i) included in the request for the service; or

(ii) obtained from another laboratory test performed in the same patient episode; or

(iii) included in results from an earlier laboratory test that have been kept by the approved pathology authority.