Health Insurance (Pathology Services Table) Regulations 2009

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.

receiving APP, for a patient episode, means an approved pathology practitioner in an approved pathology authority who:

(a) receives a request from a referring APP to render a designated test or tests; and

(b) renders each test included in the designated test that the referring APP has not performed.

recognised pathologist means:

(a) a medical practitioner recognised as a specialist in pathology under subsection 3D (1) of the Act; or

(b) a medical practitioner in relation to whom there is in force a determination under paragraph 3DB (4) (a) or subsection 3E (1) of the Act that the practitioner is recognised as a specialist in pathology.

referring APP, for a patient episode, means an approved pathology practitioner in an approved pathology authority who:

(a) has been requested to render 1 or more designated tests; and

(b) 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 of the tests included in the designated test; and

(c) requests a receiving APP in another approved pathology authority to render:

(i) the test or tests that the approved pathology practitioner is unable to render; or

(ii) all of the tests that are included in the designated test; and

(d) renders each test included in the designated test, other than the test or tests for which the request mentioned in paragraph (c) is made.

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 for 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 for which the practitioner by whom, or on whose behalf, the service is provided, has been allocated a provider number by the Medicare Australia CEO.

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

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

(c) 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 65060, 65070, 65120, 65123, 65126, 65129, 65150, 65153, 65156, 66500, 66503, 66506, 66509, 66512, 66584 or 66800 if:

(a) the service is rendered in relation to 1 or more specimens taken on any of not more than 6 occasions in a period of 24 hours; and

(b) the service is rendered to an inpatient of a hospital; and

(c) the service is rendered in relation to each specimen as soon as possible after the specimen is taken; and

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

(1A) Rule 3 does not apply to a pathology service described in item 65109 or 65110 if:

(a) the service is rendered:

(i) for a service described in item 65109 — on 1 of not more than 5 occasions in a period of 24 hours; and

(ii) for a service described in item 65110 — on 1 of not more than 2 occasions in a period of 24 hours; and

(b) the service was requested on a separate occasion to any other occasions on which the service was requested in the period of 24 hours; and

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

(2) Rule 3 does not apply to a pathology service described in subrule (3) if:

(a) under a request for a service, other than a request for a service described in paragraph (3) (a), no more than 6 tests are requested; and

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

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

(3) For subrule (2), the pathology services are:

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

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

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

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

(e) a service described in any of items 66500 to 66512, in relation to methotrexate or leflunomide therapy of a patient; and

(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; and

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

(h) quantitative estimation of calcium, phosphate, magnesium, urea, creatinine and electrolytes for a cancer patient receiving bisphosphonate infusions.

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 mentioned 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;

the later tests and the earlier tests are taken to be part of 1 patient episode.

(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 mentioned 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 Referral of designated tests by 1 pathology practitioner to another

(1) In this rule:

designated test means a pathology test relating to a patient episode that is a test of a kind mentioned in item 65150, 65175, 66650, 66695, 66711, 66722, 66785, 66800, 66812, 66819, 66825, 69384, 69494, 71089, 71153 or 77165.

(2) This rule applies if 1 or more designated tests are referred by a referring APP to a receiving APP in another approved pathology authority.

(3) If a referring APP has rendered 1 or more designated tests:

(a) the amount mentioned in item 65150, 65153, 65175, 65176, 65177, 65178, 66650, 66695, 66698, 66701, 66704, 66707, 66711, 66722, 66725, 66728, 66731, 66785, 66800, 66803, 66812, 66819, 66825, 69384, 69387, 69390, 69393, 69396, 69494, 69495, 71089, 71091, 71153, 71155, 71157, 77165, 71166 or 71167 (as the case may be) is payable for each designated test rendered by the referring APP; and

(b) subject to subrule (5), the amount mentioned in item 65158, 65181, 66652, 66697, 66715, 66724, 66790, 66805, 66817, 66821, 66827, 69401, 69498, 71092, 71156 or 71170 (as the case may be) is payable for each designated test rendered by the receiving APP.

(4) If a referring APP has not rendered a designated test:

(a) for the first designated test that is rendered by the receiving APP — the amount mentioned in item 65157 65180 66651 66696, 66714, 66723, 66789, 66804, 66816, 66820, 66826, 69400, 69497, 71090, 71154 or 71169 (as the case may be) is payable; and

(b) for each subsequent designated test (if any) that is rendered by the receiving APP — subject to subrule (6), the amount mentioned in item 65158, 65181, 66652, 66697, 66715, 66724, 66790, 66805, 66817, 66821, 66827, 69401, 69498, 71092, 71156 or 71170 (as the case may be) is payable for each test rendered.

(5) For paragraph (3) (b), the maximum number of designated tests for which the fee mentioned in the relevant item is payable is as follows:

(a) for item 66652, 66715, 66790, 66817, 66821 or 66827

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(b) for item 65158, 66805, 69498 or 71092

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(c) for item 71156 or 71170

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(d) for item 65181 or 66724

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where:

X is the number of designated tests rendered by a referring APP.

(6) For paragraph (4) (b), the maximum number of designated tests for which the fee mentioned in the relevant item is payable is as follows:

(a) for item 66652, 66715, 66790, 66817, 66821 or 66827 — 1;

(b) for item 65158, 66805, 69498 or 71092 — 2;

(c) for item 71156 or 71170 — 3;

(d) for item 65181 or 66724 — 4.

(7) Items in Group P10 (Patient episode initiation) do not apply to a receiving APP in subrule (2).

7 Items not to be split

Except as stated in rule 6, the amount mentioned in an item is payable only to 1 approved pathology practitioner for 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 for the particular method of assay used to determine the level.

(2) Unless paragraph (a) of item 66719 is satisfied, the amount mentioned in the item is not payable for a pathology service mentioned 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 mentioned 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;

the later tests and the earlier tests are taken to be part of 1 patient episode.

11 Investigation for hepatitis serology

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

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;

the later tests and the earlier tests are taken to be part of 1 patient episode.

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 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, 72827, 72828, 72830, 72836 and 72838 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 examination is 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, 72827, 72828, 72830, 72836 and 72838 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, 72848, 72849 and 72850; or

(b) more than 1 of the services mentioned in items 73059, 73060, 73061, 73064 and 73065;

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 mentioned in an item in Group P10 is rendered by, or on behalf of, an approved pathology practitioner who is a recognised pathologist, the relevant item 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 to a public patient at a recognised hospital.

(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, for the same patient episode:

(a) services mentioned 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 mentioned 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 mentioned in the applicable item in Group P10 applies to both approved pathology practitioners.

(8) If more than 1 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 mentioned in the applicable item in Group P10 applies once only to the services unless an exemption mentioned in rule 4 applies or the Minister has made a direction under subsection 4B (3) of the Act.

(9) The fee mentioned in item 73940 applies only once for a single patient episode.

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

If item 73940 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 73940 for 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 for 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 connected entities 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 mentioned in combination with other items not similarly specified): 65060, 65070, 65120, 66500, 66503, 66506, 66509, 66512, 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 has the meaning given by subrule 18A (1).

set of pathology services has the meaning given by subrule 18A (2).

(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 mentioned in 1 item that describes any of the services in the set of pathology services is higher than the fees mentioned 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 mentions 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 mentions the second‑highest fee — the pathology service described in the item that mentions 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 mentioned 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 mentioned 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 mentions 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 mentions 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 mentioned in any of the items that describe the pathology services that are to be treated as the 1 pathology service.

18A Meaning of general practitioner and set of pathology services

(1) In rule 18:

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.

(2) In rule 18 and subject to subrule (3):

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 in item 66900, 69484, 73053 or 73055.

(3) In rule 18, an item mentioned in this subrule is to be excluded from a set of pathology services:

(a) if a service is requested by an approved pathology practitioner of an approved pathology authority and rendered by another approved pathology practitioner of an approved pathology authority that is not related to the approved pathology authority of the first mentioned approved pathology practitioner — item 65079, 65082, 65157, 65158, 65166, 65180, 65181, 66606, 66609, 66639, 66642, 66651, 66652, 66663, 66666, 66696, 66697, 66714, 66715, 66723, 66724, 66780, 66783, 66789, 66790, 66792, 66804, 66805, 66816, 66817, 66820, 66821, 66826, 66827, 66832, 69325, 69328, 69331, 69379, 69383, 69400, 69401, 69419, 69451, 69489, 69492, 69497, 69498, 69500, 71076, 71090, 71092, 71096, 71148, 71154, 71156, 71169, 71170, 73309, 73312, 73315, 73318, 73321 or 73324; or

(b) an item in Group P10 (Patient episode initiation), Group P11 (Specimen referred), Group P12 (Management of bulk‑billed services) or Group P13 (Bulk billing incentive for episodes consisting of a P10 service).

(4) An approved pathology authority is related to another approved pathology authority for paragraph (3) (a) 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 connected entities 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.

19 Hepatitis C viral RNA testing

For items 69499 and 69500:

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 items 73317 and 73318:

elevated serum ferritin, for a patient, means a level of ferritin above the normal reference range for 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 mentioned 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 mentioned in that item if the service was provided as part of the same patient episode as a service mentioned in item 66602.

22 Nutritional and toxicity metals testing

(1) For this rule:

metal toxicity testing group means items 66825, 66826, 66827, 66828, 66831 and 66832.

nutritional metals testing group means items 66819, 66820, 66821 and 66822.

(2) An item in the nutritional metals testing group or the metal toxicity testing group does not apply 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) for 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) for 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.

25 Limitation on certain items

(1) For any particular patient, item 69336 is applicable not more than once in each period of 7 days.

(2) For any particular patient, each of items 66819, 66820, 66821, 66822, 66825, 66826, 66827 and 66828 is applicable not more than 3 times in a 6 month period.

(3) For any particular patient, the following items are applicable not more than once in a 12 month period:

(a) items 66655, 66659 and 69482;

(b) item 69491 or 69492;

(c) item 69499 or 69500.

(4) For any particular patient, the following items are applicable not more than twice in a 12 month period:

(a) items 66539, 66607, 71075, 71127, 71135 and 71137;

(b) item 66605 or 66606;

(c) item 69488 or 69489.

(5) For any particular patient, each of items 66551, 66660, 69445, 69451, 69483, 71079 and 73523 is applicable not more than 4 times in a 12 month period.

(6) For any particular patient, each of items 66554, 66830 and 71077 is applicable not more than 6 times in a 12 month period.

(7) For any particular patient, item 66626 is applicable not more than 36 times in a 12 month period.

(8) For any particular patient, item 69418 or 69419 is applicable not more than twice in a 24 month period.

(9) For any particular patient, item 66750 or 66751 is applicable not more than once in a pregnancy.

(10) For any particular patient, item 66517 is applicable not more than 3 times in a pregnancy.

26 Antigen detection

If a pathology service described in item 69316, 69317, 69319, 69494, 69495, 69496, 69497 or 69498 is rendered as a pathologist‑determinable service, the amount mentioned in the item is not payable for the service unless the recognised pathologist who renders the service records, in writing, the reasons for rendering the service.