5.Recommendations for endocrine-related pathology tests

5.1Thyroid stimulating hormone (TSH) tests and thyroid function tests (TFTs)

TSH tests and TFTs: items 66716, 66719, 66722–5, 66728, 66731 and 66734

In the 2014–15 financial year about one in four Australians (5.7 million patients) had either a TSH test or a TFT.7 A total of 7.6 million tests were charged to Medicare over the course of the year (this excludes TSH tests and TFTs that are coned out and tests done for public hospital patients). This figure has grown by an average of 6.1 per cent per year over the last 5 years.

Benefits paid for these items totalled $203 million in the 2014–15 financial year. This figure has grown by an average of 6.2 per cent per year over the last 5 years and accounts for around 1 per cent of the total MBS expenditure.8 This growth is largely explained by increase in the number of patients being tested, which has grown by an average of 5.7 per cent per year over the past 5 years9 (compared with population growth of 1.3 per cent per year).10

Service volumes in this group are concentrated in two large items: TSH quantitation (item 66716) and TFTs (item 66719). The total services for these items 66716 and 66719 have grown by 4.3 and 11.1 per cent, respectively, per year over the last 5 years.8

5.1.1 TSH test: Items 66716, 66722–5, 66728, 66731 and 66734

Table 3: Item introduction table for items 66716, 66722–5, 66728, 66731 and 66734

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66716 TSH quantitation. [1998] $25.05 4,642,841 $99,063,014 4.3%
66722 TSH quantitation described in item 66716 and 1 test described in item 66695. (This fee applies where 1 laboratory, or more than 1 laboratory belonging to the same APA, performs the only 2 tests specified on the request form or performs 2 tests and refers the rest to the laboratory of a separate APA.) (Item is subject to rule 6.) [1998] $37.90 257,252 $8,302,767 6.8%
66723 Tests described in item 66722, that is, TSH quantitation and 1 test described in 66695, if rendered by a receiving APP, where no tests in the item have been rendered by the referring APP – 1 test. (Item is subject to rule 6 and 18.) [2007] $37.90 17 $548 –6.7%
66724 Tests described in item 66722, if rendered by a receiving APP, other than that described in 66723. It is to include a quantitation of TSH – each test to a maximum of 4 tests described in item 66695. (Item is subject to rule 6 and 18.) [2007] $13.15 32 $357 –45.1%
66725 TSH quantitation described in item 66716 and 2 tests described in item 66695. (This fee applies where 1 laboratory, or more than 1 laboratory belonging to the same APA, performs the only 3 tests specified on the request form or performs 3 tests and refers the rest to the laboratory of a separate APA.) (Item is subject to rule 6.) [1998] $51.05 108,605 $4,727,365 3.6%
66728 TSH quantitation described in item 66716 and 3 tests described in item 66695. (This fee applies where 1 laboratory, or more than 1 laboratory belonging to the same APA, performs the only 4 tests specified on the request form or performs 4 tests and refers the rest to the laboratory of a separate APA.) (Item is subject to rule 6.) [1998] $64.20 88,184 $4,836,010 2.1%
66731 TSH quantitation described in item 66716 and 4 tests described in item 66695. (This fee applies where 1 laboratory, or more than 1 laboratory belonging to the same APA, performs the only 5 tests specified on the request form or performs 5 tests and refers the rest to the laboratory of a separate APA.) (Item is subject to rule 6.) [1998] $77.40 104,774 $6,924,385 3.4%
66734 TSH quantitation described in item 66716 and 5 tests described in item 66695. (This fee applies where 1 laboratory, or more than 1 laboratory belonging to the same APA, performs 6 or more tests specified on the request form.) (Item is subject to rule 6.) [1998] $90.55 166,829 $12,895,377 7.1%

Source: Department of Human Services, published data, date of processing.


The following observations have been made with regard to TSH tests:

  • Δ There is significant use of TSH items. In the 2014–15 financial year about one in five Australians (4.6 million patients)7 had a TSH test, amounting to a total of 5.4 million tests.8 Thirty-eight per cent of patients had a repeat TSH test (item 66716) within 12 months of their first test in 2014.11 As a result of these high service volumes, around $111 million was paid in benefits for TSH tests – 0.55 per cent of total MBS expenditure. This figure included benefits paid for item 66716 ($99 million) as well as benefits paid for other item numbers containing TSH tests (applying only the 66716 fee for a TSH test).8
  • Δ There is considerable variation in patterns of use among requesters, which suggests that standardising practice may benefit patients. In the 2014–15 financial year about 20 per cent of requesting doctors accounted for two-thirds of 66716 tests.8 GPs are critical partners in optimising and standardising practice, as they request around 90 per cent of TSH tests. An analysis of GP requesting patterns shows that there is a long tail of GPs who request far more TSH tests per 100 patients than their peers. For example, a group of about 310 GPs requested 40–173 TSH tests per 100 patients in FY 2014/15, compared with a median of 7.31 (Figure 3).12

Figure 3: Rates of TSH tests requested per 100 patients, 2014–15.

2029 GPs requested fewer than one test per 100 patients. Most GPs (2116) requested three tests per 100 patients.Requests for higher numbers of tests tapered off very slowly beyond the median of 1737 GPs requesting seven tests per 100 patients, ranging from 1486 GPs requesting eight tests per 100 patients, through, to 36 GPs requesting 39 tests per 100 patients; 310 GPs requested more than 40 tests per 100 patients, with the highest rate being 173 tests per 100 patients.

Source: Department of Health, unpublished data, date of processing, accessed on 10 October 2016

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Change all item descriptors (66716–66734) to preclude testing in asymptomatic patients and patients with non-specific symptoms, specifying the following indications for testing:
    • - The patient has known thyroid or pituitary disease.
    • - There is clinical suspicion of thyroid dysfunction.
    • - The patient is undergoing thyroid hormone replacement therapy and needs to be monitored.
    • - The patient is pregnant or planning pregnancy, and testing is clinically indicated.
  • Δ Add the following explanatory notes (explanatory notes are not currently provided):
    • - Repeat testing should not be conducted on patients within 12 months of a normal TSH without a change in their underlying thyroid condition or their thyroid hormone replacement treatment.
  • Δ Develop an education strategy to support this change. Recommended measures include working with NPS MedicineWise to promote awareness, using tools such as its NPS MedicineWise bulletin. This should inform requesters of the changes and the appropriate use of guidelines for testing, and should emphasise the important requirement to include clinical information on all request forms. NPS MedicineWise’s appropriate use guidelines should include what is written in the explanatory notes above. Producers of consumer literature should align their recommendations for doctors with this behavioural change.
  • Δ Engage NPS MedicineWise to develop a specific audit and feedback activity after the MBS changes have been implemented to complement other education activities. This would show requesters how many tests they are requesting relative to their peers, and could be implemented after item descriptor changes have had time to take effect. This activity should focus on doctors with higher requesting rates.
  • Δ Actively monitor the impact of the changes on service patterns and volumes. If anticipated impacts do not occur, consider a combination of Medicare compliance audits and/or sending letters and making phone calls to: (i) doctors with high requesting rates, using requests per consultation or patients seen as a guiding metric to identify outlier practices; and (ii) pathology practices to determine compliance with item requirements.
Recommendation 1

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee agrees that TSH should not be used as a screening test in asymptomatic patients, as recommended by the RACGP Choosing Wisely guidelines and international guidelines.
  • Δ The Pathology Clinical Committee generally supports the Endocrinology Clinical Committee’s recommendations regarding the appropriate indications for TSH testing and the limits on repeat testing, with modifications as follows.
  • Δ The Pathology Clinical Committee recommends changing ‘non-specific symptoms’ to ‘unrelated symptoms’ noting that ‘non-specific’ could be misunderstood to include symptoms such as fatigue or weight gain which may well be appropriate indications for testing. ‘Unrelated’ would refer to symptoms that are not associated with thyroid disease.
  • Δ The Pathology Clinical Committee recommends broadening the Endocrinology Clinical Committee’s proposals to allow testing in asymptomatic patients who are pregnant or at elevated risk of thyroid disease, including patients with type 1 diabetes mellitus.
  • Δ The Pathology Clinical Committee does not support including clinical indications in the item descriptor but instead recommends that clinical advice be included in explanatory notes. It notes that, following discussion, the Endocrinology Clinical Committee supports this approach.
  • Δ The Pathology Clinical Committee recommends that the explanatory note for TSH testing should state that testing is appropriate in the following circumstances:
    • - The patient has known thyroid disease.
    • - There is clinical suspicion of thyroid dysfunction.
    • - The patient is currently receiving thyroid hormone replacement therapy and needs to be monitored.
    • - The patient is pregnant or planning pregnancy, and testing is clinically indicated.
    • - The patient has an autoimmune condition (e.g. type 1 diabetes mellitus or adrenal insufficiency).
    • - The patient is taking medication known to affect thyroid function (e.g., lithium or amidarone).
  • Δ In agreement with the Endocrinology Clinical Committee, the Committee does not recommend that there should be a limit on the annual number of TSHs performed, but recommends that repeat testing should not be conducted on patients within 12 months of a normal TSH without a change in their underlying thyroid condition or their thyroid hormone replacement treatment. It recommended that this advice should be included in an explanatory note.
    • - Repeat testing should not be conducted within 12 months of a normal TSH without a change in the patient’s underlying condition or their thyroid hormone replacement treatment.
  • ΔThe Pathology Clinical Committee supports the Endocrinology Clinical Committee recommendation for a proposed education program, supported by NPS MedicineWise, on the clinical appropriateness of TSH testing. The proposed education program would inform requesters of the appropriate use of guidelines for testing, and should emphasise the important requirement to include clinical information on all request forms. NPS MedicineWise’s appropriate use guidelines should include the content of the explanatory notes above. Consumer products should align the recommendations for doctors with this behavioural change.

Rationale 1

The Pathology Clinical Committee recommendation that TSH not be used as a screening test aligns with the RACGP Choosing Wisely recommendations.

There was considerable discussion in the Pathology Clinical Committee around the proposal that item descriptors be amended to reflect agreed indications for testing. It was agreed that the increased testing is based on an increase in requesting and the best way to address this is by seeking to improve the quality of requesting, particularly in primary care settings, through education of the requesting clinicians.

A change in descriptor puts the onus of compliance on the laboratories. Given that up to 30–50 per cent of clinical requests have no relevant clinical notes on the question of thyroid disease (according to pathologists working in the private sector), it is difficult for the pathologists to ensure compliance.

Although the Pathology Clinical Committee were supportive of the need to improve the clinical value of testing, they were unable to support the recommendation to change the item descriptors to specify clinical indications, due to issues relating to governance and increased workload for pathology laboratories. Instead, the Committee proposes that there be guidance in the explanatory notes to promote the appropriate use of TSH testing.

The Pathology Clinical Committee was supportive of the Endocrinology Clinical Committee recommendation that some high-risk groups should have access to testing even when asymptomatic. These groups include pregnant women and those at elevated risk of thyroid disease (generally patients with autoimmune disease, and in particular type 1 diabetes mellitus). This approach is supported internationally.13

The Pathology Clinical Committee notes that 38 per cent of patients had a repeat TSH test (item 66716) within 12 months of their first test in 2014.11 The Committee supports the Endocrinology Clinical Committee recommendation as outlined, which seeks to remind clinicians that repeat testing is generally not indicated within 12 months of a normal TSH result. Including such advice in explanatory notes allows for repeat testing when it is appropriate and clinically indicated, noting that for relatively few patients, multiple tests can be indicated over short time period.

The Pathology Clinical Committee recommends amendments to item 66716 as follows.

Table 4: Current and proposed new item descriptor for item 66716

Current item descriptor Proposed new item descriptor
TSH quantitation TSH quantitation

Explanatory notes

TSH testing should not be performed as a screening test in asymptomatic patients. Indications for testing with TSH are:

  • – The patient has known thyroid disease.
  • – There is clinical suspicion of thyroid dysfunction.
  • – The patient is currently receiving thyroid hormone replacement therapy and needs to be monitored.
  • – The patient is pregnant or planning pregnancy, and testing is clinically indicated.
  • – The patient is at elevated risk because of an autoimmune condition (e.g. type 1 diabetes mellitus or adrenal insufficiency).
  • – The patient is taking medication known to affect thyroid function (e.g. lithium or amiodarone).
Repeat testing should not be conducted within 12 months of a normal TSH without a new clinical suspicion of thyroid dysfunction or a change in the patient’s underlying condition or their thyroid hormone replacement treatment.

5.1.2 TFTs: Item 66719

Table 5: Item introduction table for item 66719

Item number 66719
Descriptor [date last amended] Thyroid function tests (comprising the service described in item 66716 and 1 or more of the following tests – free thyroxine, free T3, for a patient, if at least 1 of the following conditions is satisfied: (a) the patient has an abnormal level of tsh; (b) the tests are performed: (i) for the purpose of monitoring thyroid disease in the patient; or (ii) to investigate the sick euthyroid syndrome if the patient is an admitted patient; or (iii) to investigate dementia or psychiatric illness of the patient; or (iv) to investigate amenorrhoea or infertility of the patient; (c) the medical practitioner who requested the tests suspects the patient has a pituitary dysfunction; (d) the patient is on drugs that interfere with thyroid hormone metabolism or function. (Item is subject to rule 9.) [2008]
Schedule fee $34.80
Volume of services FY2014/15 2,250,306
Total benefits paid FY2014/15 $66,534,461
Services 5 year (FY2009/10– FY2014/15) annual average growth (CAGR) 11.1%

Source: Department of Human Services, published data, date of processing.

The following observations have been made with regard to TFTs:

  • Δ During the last 5 years use of TFTs has grown by an average of 11 per cent per year.8 In the 2014–15 financial year about 1 in 16 Australians (1.4 million patients) had a TFT, amounting to a total of 2.3 million tests. This growth is driven by increases in the number of patients tested (which is growing by 11.8 per cent per year), rather than increased tests per patient (which is declining at –0.7 per cent per year).7 Around 57 per cent of patients had a repeat TFT within 12 months of their first test in 2014.11
  • ΔTwenty per cent of requesting doctors accounted for two-thirds of all tests in the 2014–15 financial year. GPs requested 75 per cent of tests, reinforcing that they are important partners in optimising and standardising practice.8
  • Δ It is possible that the clinical indications described in the current item descriptor do not adequately explain the volume of TFTs performed. It was noted that around 750,000 patients were dispensed PBS-listed thyroid replacement medication in the 2014–15 financial year,14 and these patients may have had multiple TFTs. Furthermore, an unknown number of TFTs were undertaken to investigate other indications listed in the item descriptor, such as dementia or psychiatric illness. Although the use of TFTs may be consistent with current item descriptors, which also allow TFTs for patients with abnormal TSH tests and those with known thyroid disease, it is possible that a significant number of TFTs were being requested when a TSH test would be more suitable.
  • Δ MBS data demonstrates that 380,000 patients (26 per cent) received a separate TSH test in the 12 months preceding a TFT in FY2014/15.15 The ECC had noted that an abnormal TSH test is an appropriate indication for a TFT, but suggested that it is often inefficient for patients to have a second distinctive test performed when the indication for TFT is an abnormal TSH test.

Advice from the Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Change the TFT item descriptor to reflect the most clinically relevant indications for testing, which includes removing the following: ‘To investigate the sick euthyroid syndrome if the patient is an admitted patient; or (iii) to investigate dementia or psychiatric illness of the patient.’
  • Δ Expand the current descriptor to discourage the use of TFTs for monitoring thyroid hormone replacement therapy. The proposed addition is as follows: ‘For monitoring of thyroid replacement therapy where hypothyroidism is due to pituitary disease.’
  • Δ Change the rules for this item to make it a pathology-determinable test. This would allow a pathologist to conduct a TFT without further instruction from the requesting doctor if a patient has a significantly abnormal TSH test. An abnormal TSH test that automatically prompts testing of fT3 and fT4 should be defined as follows: ‘a TSH quantitation of < 0.2 or > 5 mIU/L. When this occurs and TFTs are conducted, the pathologist should bill for TFT item 66719 alone.
  • Δ Include education on the proper use of TFTs, and the use of audit and feedback, following the education strategy described in Section 4.2.1.
  • Δ Perform Medicare compliance audits on high-volume requesters and pathology practices and/or contact them by letter or telephone, following the principles outlined in Section 4.2.1. The change to pathology-determinable testing may require particular scrutiny.
Recommendation 2

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee supports the Endocrinology Clinical Committee recommendation on the removal of the wording ‘(ii) to investigate the sick euthyroid syndrome if the patient is an admitted patient; or (iii) to investigate dementia or psychiatric illness of the patient’ from the current item descriptor of 66719.
  • Δ The Pathology Clinical Committee agrees with the Endocrinology Clinical Committee recommendation to add new wording of ‘For monitoring of thyroid replacement therapy where hypothyroidism is due to pituitary disease.’ in the explanatory notes, not the item descriptor as suggested by the Endocrinology Clinical Committee, as there is already mention of this situation in the descriptor.
  • Δ The Pathology Clinical Committee agrees that the use of TFT for monitoring thyroid hormone replacement therapy should be discouraged and that TSH should be used instead in most cases. This suggestion is based on the concern that there are cases of normal TSH tests where fT4 and/or fT3 tests will provide additional clinical information, especially in patients taking non-traditional thyroid hormone replacement (thyroid extract or T3).
  • Δ The Pathology Clinical Committee supports an education program aimed at requesters of TFTs as a way to discourage use in patients taking thyroid replacement therapy. The education program should include consumers.
  • Δ The Pathology Clinical Committee supports the proposal to change fT4 and fT3 testing to be a pathologist-determinable test after an abnormal TSH test result.

The Pathology Clinical Committee recommends amendments to item 66719 as follows.

Table 6: Current and proposed new item descriptor for item 66719

Current item descriptor Proposed new item descriptor
Thyroid function tests (comprising the service described in item 66716 and 1 or more of the following tests – free thyroxine, free t3, for a patient, if at least 1 of the following conditions is satisfied: (a) the patient has an abnormal level of TSH; (b) the tests are performed: (i) for the purpose of monitoring thyroid disease in the patient; or (ii) to investigate the sick euthyroid syndrome if the patient is an admitted patient; or (iii) to investigate dementia or psychiatric illness of the patient; or (iv) to investigate amenorrhoea or infertility of the patient; (c) the medical practitioner who requested the tests suspects the patient has a pituitary dysfunction; (d) the patient is on drugs that interfere with thyroid hormone metabolism or function. (Item is subject to rule 9.)

Thyroid function tests (comprising the service described in item 66716 and 1 of the following tests – free thyroxine or free T3, for a patient, if at least 1 of the following conditions is satisfied: (a) the patient has an abnormal level of TSH on this test or the most recently available test; (b) when TSH may be an unreliable indicator of thyroid function (Item is subject to rule 9.)

Explanatory notes

TFTs can be pathologist-determinable when, after a request for TSH or TFT, an abnormal TSH is detected as part of this service. TFTs can also be performed when requested in response to the most recent TSH being abnormal.

TFTs are an appropriate initial test when TSH alone may be an unreliable indicator of thyroid function, including:

  1. investigation of suspected pituitary dysfunction
  2. investigation of amenorrhoea or infertility
  3. monitoring of thyroid hormone replacement in patients with known pituitary dysfunction.
  4. monitoring of some patients in the initial management of thyrotoxicosis
  5. monitoring of patients with hypothyroidism who have documented intolerance or resistance to thyroxine.

For monitoring thyroid hormone replacement therapy TSH is usually the best test, but occasionally fT4 or fT3 can add information (e.g. in patients on T3 or thyroid extract).

Rationale 2

There is universal agreement that in severe illness both TSH and fT4 can be abnormal. There is no advantage to patients to start with TFT testing instead of a single TSH test. In the so-called ‘sick euthyroid state’, abnormal TFT results are due to the patient’s illness and will resolve after resolution of the non-thyroidal illness without thyroid-specific intervention.

Similarly, there is no clinical reason to require TFTs for patients with mental illness, as it is only in pituitary disease that the TSH test alone can be misleading.

In patients with hypothyroidism, TSH is the most valid test for the monitoring of thyroid hormone replacement therapy. TFTs might be misleading, as fT4 can be elevated, especially if the patient has recently taken the thyroxine supplementation. Therefore use of TFTs should be discouraged and TSH should be used instead in most cases.

The main benefit of education programs aimed at requesters on use of TFTs is to discourage use in patients taking thyroid replacement therapy. The education program should also include consumers.

The recommendation is that the new proposed wording: ‘For monitoring of thyroid replacement therapy when hypothyroidism is due to pituitary disease’ be included in the explanatory notes as opposed to the item descriptor as recommended by the Endocrinology Clinical Committee. In pituitary disease, TSH may be misleading despite the patient experiencing hypothyroidism. Therefore in this clinical setting TFT is the appropriate test.

The frequency of abnormal fT4 and fT3 levels is increased in patients with TSH outside the reference range, based on information from unpublished data and a recommendation from the chair of the endocrine testing subcommittee of the Endocrinology Clinical Committee.

When the initial TSH is outside the reference range, two scenarios are possible. In patients with suppressed levels of TSH, fT4 and fT3 can provide additional information about the degree of hyperthyroidism, while in patients with elevated TSH, fT4 can also provide additional information. In patients with mildly elevated TSH, the most helpful test is anti-TPO antibodies, as presence of these predicts future development of overt hypothyroidism.

About 25 per cent of requests have no additional clinical information on the request form about the type of test the laboratory needs to perform.

5.1.3 Proposed new item for TFTs

Recommendation 3

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee recommends adding a new item including the measurement of TSH, fT4 and fT3 in patients with totally suppressed TSH (< 0.05 mIU/L). This recognises that for most patients with TFT tests there is no indication to measure fT3, but for some with suppressed TSH the fT3 will offer additional information about the severity and prognosis of their hyperthyroidism and identify patients with T3-toxicosis.

Table 7: Proposed new item descriptor

New item descriptor

Thyroid function tests comprising TSH, free thyroxine and free T3, for a patient, if the following conditions are satisfied: (a) the patient has a suppressed level of TSH (to 0.05 mIU or less) on this occasion; and (b) TSH suppression is not due to thyroid treatment with the aim to suppress TSH.


Explanatory notes

When TSH is suppressed, free T3 can give helpful information on the severity of hyperthyroidism or can identify T3 toxicosis, when free thyroxine can be normal and only free T3 is elevated.


Many patients with a history of thyroid cancer are treated with thyroxine, and the thyroxine dose is aimed at suppressing TSH. Free T3 measurement is not indicated in these patients.

Rationale 3

Measurement of fT3 is currently not separately remunerated in the table. fT3 is the active form of the thyroid hormone and transmits its metabolic effects.16

While TSH and fT4 measurements suffice in most clinical scenarios, in clinical situations when the patient is hyperthyroid with a suppressed TSH, fT3 can add valuable information. In these situations an fT3 will add information about the rate of conversion from fT4, which allows clinicians to assess risk of ongoing disease; it will also diagnose patients with isolated T3 toxicosis, who have normal fT4 with suppressed TSH, but elevated fT3.

This should be limited to patients with suppressed TSH (< 0.05 mIU/L). A <0.05 mIU/L cut-off was selected based on unpublished laboratory data. Below this level the frequency of abnormal fT3 increased markedly. There was general agreement in the group that clinically valuable tests should be incentivised. The introduction of this item number is likely to increase MBS expenditure, with an estimated utilisation of 350,000 tests per year.

Further rationale: repeat TSH tests and TFTs

There was initial concern about repeat testing rates for both tests, and the Endocrinology Clinical Committee considered including a restriction in the item descriptor – specifically, a maximum of six tests within 12 months. Some of the considerations were as follows:

  • Δ Patients without thyroid or pituitary disease who have a normal TSH test do not require further testing unless clinical circumstances change.
  • Δ Patients who have unstable disease, particularly those with thyrotoxicosis, may need frequent testing.
  • Δ Patients who are taking thyroid replacement therapy may also require repeat testing, and the indications for whether a TSH test or TFT is most appropriate are outlined in the recommendations above.

However, MBS data showed that repeat testing resulting in more than six tests in 12 months did not account for a significant volume of tests: 0.04 per cent of TSH 66716 patients (about 1500) had more than six TSH tests, on average, within 12 months of their first test in 2014;11 and 1.4 per cent of TFT 66719 patients (about 19,000) had more than six TFTs, on average, within 12 months of their first test in 2014.11

As patients with repeat TFTs would include patients with new-onset hyperthyroidism, this group includes a significant population in which the tests are requested appropriately. The Endocrinology Clinical Committee therefore concluded that it was not necessary to restrict the maximum number of tests to six. However, it noted that guidelines should be provided specifying that a TSH test with normal results should generally preclude follow-up TSH tests for the next 12 months, and that this guidance should be provided in educational initiatives via NPS MedicineWise.

5.2Diabetes-related items: Items 66542, 66545, 66548, 66551, 66554, 66557, 66841 and 66560

Table 8: Item introduction table for items 66542, 66545, 66548, 66551, 66554, 66557, 66841 and 66560

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66542 Oral glucose tolerance test for the diagnosis of diabetes mellitus that includes: (a) administration of glucose; (b) at least 2 measurements of blood glucose; and if performed (c) any test described in item 66695. [1998] $18.95 292,924 $4,737,344 –0.2%
66545 Oral glucose challenge test in pregnancy for the detection of gestational diabetes that includes: (a) administration of glucose; and (b) 1 or 2 measurements of blood glucose; and (c) (if performed) any test in item 66695. [1998] $15.80 49,327 $684,953 –19.3%
66548 Oral glucose tolerance test in pregnancy for the diagnosis of gestational diabetes that includes: (a) administration of glucose; and (b) at least 3 measurements of blood glucose; and (c) any test in item 66695 (if performed). [1998] $19.90 138,051 $2,378,743 31.7%
66551 Quantitation of glycated haemoglobin performed in the management of established diabetes – (item is subject to rule 25). [1998] $16.80 1,138,075 $16,251,094 2.3%
66554 Quantitation of glycated haemoglobin performed in the management of pre-existing diabetes where the patient is pregnant – including a service in item 66551 (if performed). (Item is subject to rule 25.) [1998] $16.80 11,615 $167,040 23.0%
66557 Quantitation of fructosamine performed in the management of established diabetes – each test to a maximum of 4 tests in a 12-month period. [1998] $9.70 14,741 $121,415 –2.8%
66841 Quantitation of HbA1c (glycated haemoglobin) performed for the diagnosis of diabetes in asymptomatic patients at high risk. (Item is subject to rule 25.) [2014] $16.80 122,097 $1,738,994 N/A
66560 Microalbumin – quantitation in urine. [1998] $20.10 1,228,232 $21,032,232 6.9%

Source: Department of Human Services, published data, date of processing.

5.2.1 Oral glucose tolerance and challenge tests: Items 66542, 66545 and 66548

The following observations have been made in regards to OGTT tests:

  • Δ In the 2014–15 financial year a large number of OGTT diagnostic tests were performed on non-pregnant patients (292,000, or 61 per cent of OGTTs). While this figure has remained fairly constant looking at 2009–2015, declining by an average of only 0.2 per cent per year, it declined by 7 per cent in 2014–15 compared with 2013–14, and a further 14 per cent in 2015–16 compared with 2014–15 (251,250 tests).8
    The overall use of OGTTs should continue to decrease, given that HbA1c measurement is a more reliable test and simpler to perform. The large number of OGTT tests is most likely explained by low-value over testing, particularly in non-pregnant patients who do not have a clinical indication for the test and should undergo HbA1c measurement instead.17-19 The changes are designed to remind requesters and pathologists that for most patients HbA1c is the preferred diagnostic test. Given the inconvenience of the OGTT, there is an expectation that the number will rapidly decline in coming years.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Delete item 66545 and consolidate item 66548 under item 66542.
  • ΔChange the item descriptor for item 66542 to include pregnant patients, and highlight that it should be used when measurement of HbA1c is unreliable. The proposed item descriptor for item 66542 is as follows: ‘Oral glucose tolerance test (OGTT) for the diagnosis of diabetes mellitus in patients who are pregnant or in whom measurement of HbA1c is unreliable. The OGTT includes: (a) administration of glucose; and (b) at least two measurements of blood glucose; and (c) (if performed) any test described in item 66695.’
  • ΔAdd explanatory notes for item 66542 to provide guidance on when an OGTT is appropriate. (Explanatory notes are not currently provided for this item.) The proposed explanatory notes are as follows: ‘OGTT in non-pregnant patients is indicated when diabetes is suspected despite a non-diagnostic HbA1c OR when HbA1c measurement is unreliable. Conditions that may make HbA1c measurement unreliable include haemoglobinopathies, iron-deficiency anaemia and severe illnesses that may shorten red cell lifespan, such as chronic renal impairment.’ Women with a history of gestational diabetes are recommended to have an OGTT 6–12 weeks postpartum.
Recommendation 4

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee supports the proposal to delete the oral glucose challenge test item 66545, as this test no longer has a place in practice. The Working Group suggested that requesters and providers be provided with an adequate warning and lead time before the change is implemented.
  • ΔThe Pathology Clinical Committee recommends that item 66548 is not consolidated under item 66542, as proposed by the Endocrinology Clinical Committee. The Committee suggests keeping the items 66548 and 66542 separate. In pregnancy (item 66548) there is a requirement for three independent glucose levels, each of which can define gestational diabetes, while the glucose tolerance test in non-pregnant patients requires only two measurements with different cut-off levels (item 66542).
  • ΔThe Pathology Clinical Committee supports the Endocrinology Clinical Committee recommendation that the descriptor for item 66542 be revised to include patients with conditions in which HbA1c measurement is unreliable.
  • ΔThe Pathology Clinical Committee supports the Endocrinology Clinical Committee recommendation for complementary explanatory notes that provide more detail to requesters about the patient groups in which HbA1c may be unreliable.

Table 9: Current and proposed new item descriptor for item 66542

Current item descriptor Proposed new item descriptor
Oral glucose tolerance test for the diagnosis of diabetes mellitus that includes:
(a) administration of glucose; and
(b) at least 2 measurements of blood glucose; and
(c) (if performed) any test described in item 66695.
Oral glucose tolerance test (OGTT) for the diagnosis of diabetes mellitus in patients in whom measurement of HbA1c is unreliable. The OGTT includes:

(a) administration of glucose; and

(b) at least two measurements of blood glucose; and

(c) (if performed) any test described in item 66695.

Explanatory note

OGTT in non-pregnant patients is indicated when diabetes is suspected despite a non-diagnostic HbA1c or when HbA1c measurement is unreliable. Conditions that may make HbA1c measurement unreliable include haemoglobinopathies, iron-deficiency anaemia and illnesses that may shorten red cell lifespan, such as chronic renal impairment and haemolytic anaemia.

Rationale 4

In pregnancy the glucose challenge test has been superseded by the full glucose tolerance test. This has been recommended by the Australian Diabetes in Pregnancy Society.20

While there are still recommendations by the RACGP that women with a history of gestational diabetes have an OGTT 6–12 weeks postpartum,21there is a recognition that a shift to HbA1c might improve adherence with testing.

5.2.2 Quantitation of glycated haemoglobin: Items 66551 and 66554

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • ΔChange the item descriptors to explicitly include the maximum number of tests permitted under rule 25, which is four tests in a 12-month period for item 66551 and six tests for pregnant patients under item 66554. For example, the proposed item descriptor for item 66551 is as follows: ‘Quantitation of glycated haemoglobin performed in the management of pre-existing diabetes; maximum four tests in a 12-month period (Item is subject to rule 25).’
Recommendation 5

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee supports the proposal to change the item descriptor for items 66551 and 66554 by adding rule 25 that limits the number of tests in a 12-month period to four and six tests, respectively.

Rationale 5

Rule 25 of the Health Insurance (Pathology Services Table) Regulation 2015, states that for any particular patient, item 66551 is used not more than four times in a 12-month period and item 66554 is used not more than six times in a 12-month period. The current item descriptor does not specify how many tests can be ordered in a 12-month period, and making this explicit in the item descriptor may assist requesters.

5.2.3 Quantitation of glycated haemoglobin: Item 66841

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • ΔChange the item descriptor to include specific indications for asymptomatic patients tested for diabetes mellitus, and change the maximum number of tests permitted in a 12-month period (under rule 25) to two, including this explicitly in the item descriptor. The proposed item descriptor is as follows:
    • Quantitation of HbA1c (glycated haemoglobin) performed for the diagnosis of diabetes mellitus in asymptomatic patients at high risk because of:
      • (i) a medical condition or ethnic background associated with high rates of diabetes mellitus, or
      • (ii) an Australian type 2 diabetes risk (AUSDRISK) score ≥ 12.
    • – Tests limited to one test per year if result is < 48 mmol/mol (6.5%). A second test can be ordered to confirm the diagnosis of diabetes if the initial test is ≥ 48 mmol/mol (6.5%). (Item is subject to rule 25; maximum two tests per year.)
Recommendation 6

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee supports the Endocrinology Clinical Committee proposal to change the number of available tests from one to two in a 12-month period when the test is used to confirm diagnosis when HbA1c is ≥ 48 mmol/mol (6.5%).
  • ΔThe Pathology Clinical Committee recommends that the Endocrinology Clinical Committee proposal to change the item descriptor for item 66841 to include specific indications for asymptomatic patients tested for diabetes mellitus be moved to the explanatory notes. The proposed wording is:
    • – Quantitation of HbA1c is indicated in patients with:
    • – (i) a medical condition or ethnic background associated with high rates of diabetes mellitus, or
    • – (ii) an Australian type 2 diabetes risk (AUSDRISK) score ≥ 12.
  • Δ The Pathology Clinical Committee supports an education program aimed at requesters to help with the implementation of the changes to the item descriptor.

Table 10: Current and proposed new item descriptor for item 66841

Current item descriptor Proposed new item descriptor
Quantitation of HbA1c (glycated haemoglobin) performed for the diagnosis of diabetes in asymptomatic patients at high risk. (Item is subject to rule 25.) Quantitation of glycated haemoglobin (HbA1c) performed for the diagnosis of diabetes in asymptomatic patients at increased risk.

Tests limited to one test per year if result is < 48 mmol/mol (6.5%). A second test can be performed for confirmation of the diagnosis of diabetes if the initial result is ≥ 48 mmol/mol (6.5%). (Item is subject to rule 25; maximum two tests per year.)

Explanatory note

Quantitation of HbA1c is indicated in patients with:
(i) a medical condition or ethnic background associated with high rates of diabetes mellitus, or
(ii) an Australian type 2 diabetes risk (AUSDRISK) score ≥ 12.

Rationale 6

Currently, this item is restricted to one test in a 12-month period; this restriction is inconsistent with guidelines for diagnosing diabetes mellitus. The Australian Diabetes Society Position Statement 2015 states: ‘an HbA1c level ≥ 48 mmol/mol (6.5 per cent) suggests that the patient has diabetes mellitus, and a confirmatory test should be performed on another day, ideally as soon as possible and before any lifestyle or pharmacological interventions are commenced’.19 The RACGP,22 the World Health Organisation23 and the American Diabetes Association24 provide the same advice.

The Australian Diabetes Society Position Statement (2015) also states: ‘There is an apparent conflict between these practice guidelines and the Medicare regulations (one diagnostic HbA1c test in a 12-month period). Medicare recognises a single elevated HbA1c measurement as establishing a diabetes diagnosis; this entitles the patient to four monitoring HbA1c tests in each subsequent 12-month period.’25

The current MBS restriction requires the requesting health professional to state that a patient has an established diagnosis of diabetes for an asymptomatic patient with elevated HbA1c, when in fact the diagnosis is still to be established. This may have unintended consequences for insurance (e.g. for patients who are not found to have diabetes on this repeat testing).

It is acknowledged that there is inherent imprecision in pathology tests around any specified cut-off level, and that the implications of incorrect diagnosis are quite significant. To be sure of an established diagnosis rather than a suggested diagnosis, it therefore seems reasonable to allow for a confirmatory test to address any concerns of imprecision or error.

The item descriptor currently states ‘diabetes’ rather than ‘diabetes mellitus.’ HbA1c screening is not recommended for type 1 diabetes or gestational diabetes. It is acknowledged that other subtypes of diabetes exist.

5.2.4 Quantitation of fructosamine: Item 66557

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Change the item descriptor to highlight that the test should only be conducted when measurement of HbA1c is unreliable. The proposed item descriptor is as follows:
    • – Quantitation of fructosamine performed in the management of established diabetes, when measurement of HbA1c is unreliable, to a maximum of four tests in a 12-month period.
  • ΔAdd explanatory notes to guide clinicians in the appropriate use of the item. Explanatory notes are not currently provided for this item. The proposed explanatory notes are as follows:
    • – HbA1c measurement is unreliable in non-pregnant patients with:
    • – (i) a severe illness such as chronic renal impairment that may shorten the red cell lifespan or
    • – (ii) a haemoglobinopathy.
Recommendation 7

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee supports the Endocrinology Clinical Committee proposal to change the item descriptor to stipulate the test only be conducted when HbA1c is unreliable. The proposed item descriptor wording is as follows:
    • – Quantitation of fructosamine performed in the management of established diabetes, when measurement of HbA1c is unreliable, to a maximum of four tests in a 12-month period.
  • Δ The Pathology Clinical Committee supports the Endocrinology Clinical Committee proposal to add explanatory notes to the item descriptor to specify the clinical circumstances as follows:
    • – HbA1c measurement is unreliable in patients with:
    • – (i) a condition that will shorten the red cell lifespan or
    • – (ii) a haemoglobinopathy.
  • Δ The Pathology Clinical Committee proposed to remove the wording ‘non-pregnant’ from the explanatory notes suggested by the Endocrinology Clinical Committee, as HbA1c may also be unreliable in pregnancy.

Table 11: Current and proposed new item descriptor for item 66557

Current item descriptor Proposed new item descriptor
Quantitation of fructosamine performed in the management of established diabetes – each test to a maximum of 4 tests in a 12 month period. Quantitation of fructosamine performed in the management of established diabetes, when measurement of HbA1c is unreliable, to a maximum of four tests in a 12-month period.

Explanatory note

HbA1c measurement is unreliable in patients with
(i) a condition that will shorten the red cell lifespan or
(ii) a haemoglobinopathy.’

Rationale 7

The most reliable test for managing established diabetes is an HbA1c measurement. Relatively few fructosamine quantitation tests (14,741) were conducted in the 2014–15 financial year.8 There was concern that some patients may not be receiving the most reliable monitoring test for the management of their established diabetes. The easiest solution was to change the item descriptor and add explanatory notes to guide clinicians to use an HbA1c measurement instead, when appropriate. This aligns with other recommendations for diabetes-related items, outlined above.

5.2.5 Microalbumin: Item 66560

The following observations have been made with regard to microalbumin tests:

  • ΔThe MBS data show an increased uptake of microalbumin testing, with 1.23 million services in the 2014–15 financial year and an annual growth rate of 6.9% over the last 5 years. Given that Australia has a million people with known diabetes, more than 30% of adult Australians have hypertension, and metabolic syndrome is increasingly frequent, there is little evidence of over-testing.
  • ΔReview of the geographic distribution of microalbumin testing shows a higher frequency of testing in very remote areas compared with cities (8,815 per 100,000 populations in very remote areas versus 4,743 per 100,000 population in the city). This is appropriate, as the frequency of diabetes and renal failure is markedly increased in Aboriginal and Torres Strait Islander people.
    However, MBS data also suggests that the number of tests per patient in some people exceeds best practice: in the 2014–15 financial year, one per cent of patients had more than four tests. These figures have increased by an average of eight per cent and 17 per cent per year, respectively, over the last 5 years. In the same year, 65 patients had 20 or more tests. While very small, this figure has increased by an average of 25 per cent per year over the last five years.8

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • ΔConsider changing the item descriptor to incorporate the following suggestions:
    • – Microalbumin – quantitation in urine. One test annually for:
    • (i) patients with type 1 diabetes, starting 5 years after diagnosis
    • (ii) patients with type 2 diabetes mellitus, from diagnosis
    • (iii) patients with hypertension or metabolic syndrome, from diagnosis.
    • – In patients with previously established albuminuria (defined as a urinary albumin:creatinine ratio > 2.4 mg/mmol for men and > 3.4 mg/mmol for women) documented on a previous test and stated on the request form, up to a maximum of four tests per year for
    • (i) confirmation of albuminuria and
    • (ii) monitoring of progression of albuminuria.
  • ΔNote that these recommendations represent a diabetes and endocrine perspective, and other users such as nephrologists should be considered.
Recommendation 8

The Pathology Clinical Committee provides the following advice and recommendations.

  • ΔThe Pathology Clinical Committee agrees with the clinical recommendations made by the Endocrinology Clinical Committee but suggest that these detailed clinical requirements be contained in the explanatory notes.
  • ΔThe Pathology Clinical Committee suggests including ‘renal disease’ and that ‘testing is restricted to four times within a 12-month period’ is also contained within the notes.
  • ΔThe Pathology Clinical Committee recommends that this item should be accompanied by an explanatory note as follows:
    • – It is recommended that the following patients should be tested annually:
    • (i) patients with type 1 diabetes, starting 5 years after diagnosis
    • (ii) patients with type 2 diabetes mellitus, from diagnosis
    • (iii) patients with hypertension or metabolic syndrome, from diagnosis
    • (iv) patients with or at risk of renal disease.
    • – In patients with previously established albuminuria (defined as a urinary albumin:creatinine ratio > 2.4 mg/mmol for men and > 3.4 mg/mmol for women) documented on a previous test and stated on the request form; up to a maximum of four tests per year may be indicated for confirmation of albuminuria and monitoring of progression of albuminuria.
  • ΔThe Pathology Clinical Committee recommends changing the name of the item descriptor from microalbumin to albumin:creatinine ratio.

Table 12: Current and proposed new item descriptor for item 66560

Current item descriptor Proposed new item descriptor
Microalbumin – quantitation in urine. Albumin:creatinine ratio (ACR) – quantitation in urine.

Explanatory note

The following patients should be tested annually:
(i) patients with type 1 diabetes, starting 5 years after diagnosis
(ii) patients with type 2 diabetes mellitus, from diagnosis
(iii) patients with hypertension or metabolic syndrome, from diagnosis
(iv) patients with or at risk of renal disease.

Testing is restricted to four times within a 12-month period:

  • • in patients with previously established albuminuria (defined as a urinary albumin:creatinine ratio > 2.4 mg/mmol for men and > 3.4 mg/mmol for women) documented on a previous test and stated on the request form; up to a maximum of four tests per year may be indicated for confirmation of albuminuria and monitoring of progression of albuminuria.

Rationale 8

This test is primarily used for two clinical purposes: screening and diagnosis of patients who are at risk of developing albuminuria, and monitoring the progression of albuminuria.

The number of times a single patient is tested within a 12-month period depends on the purpose of the test. The position of the Committee is that the explanatory notes should include the appropriate indications for each test. These indications were determined based on the Committee’s clinical judgment and the relevant literature.26-28

The Pathology Clinical Committee also noted that this test was ordered by nephrologists and is also indicated in renal disease. The Committee recognised that the term ‘microalbumin’ is now an outdated term and that the preferred name is albumin:creatinine ratio, reflecting the measurement of albumin corrected for the excretion of creatinine in a random sample. It therefore suggested changing the name of the item descriptor to albumin:creatinine ratio. This also removes the link to absolute concentrations of albumin, which can range from very small amounts to grams per day.

5.3Quantitation of hormones and hormone-binding proteins: Items 66695–8, 66701, 66704 and 66707

Table 13: Item introduction table for items 66695–8, 66701, 66704 and 66707

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66695 Quantitation in blood or urine of hormones and hormone binding proteins – ACTH, aldosterone, androstenedione, C-peptide, calcitonin, cortisol, DHEAS, 11-deoxycortisol, dihydrotestosterone, FSH, gastrin, glucagon, growth hormone, hydroxyprogesterone, insulin, LH, oestradiol, oestrone, progesterone, prolactin, PTH, renin, sex hormone binding globulin, somatomedin C (IGF-1), free or total testosterone, urine steroid fraction or fractions, vasoactive intestinal peptide, – 1 test. (Item is subject to rule 6.) [1998] $30.50 602,001 $15,579,871 7.1%
66696 A test described in item 66695, if rendered by a receiving APP – where no tests in the item have been rendered by the referring APP. (Item is subject to rule 6 and 18.) [2007] $30.50 15,160 $390,842 0.0%
66697 Test described in item 66695, other than that described in 66696, if rendered by a receiving APP – each test to a maximum of 4 tests. (Item is subject to rule 6 and 18.) [2007] $13.20 43,783 $491,811 12.0%
66698 2 tests described in item 66695. (Item is subject to rule 6.) [1998] $43.70 171,416 $6,368,414 5.3%
66701 3 tests described in item 66695. (Item is subject to rule 6.) [1998] $56.90 180,259 $8,755,478 5.9%
66704 4 tests described in item 66695. (This fee applies where 1 laboratory, or more than 1 laboratory belonging to the same APA, performs the only 4 tests specified on the request form or performs 4 tests and refers the rest to the laboratory of a separate APA.) (Item is subject to rule 6.) [1998] $70.15 129,211 $7,724,653 6.9%
66707 5 or more tests described in item 66695. (Item is subject to rule 6.) [1998] $83.35 157,655 $11,191,602 9.8%

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Leave these items unchanged.
Recommendation 9

The Pathology Clinical Committee decided to review these items at a later stage and has put them on the work plan. No recommendations are made at this time.

5.4 Thyroid antibodies to tissue antigens: Items 71165–71170

Table 14: Item introduction table for items 71165–70

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
71165 Antibodies to tissue antigens (acetylcholine receptor, adrenal cortex, heart, histone, insulin, insulin receptor, intrinsic factor, islet cell, lymphocyte, neuron, ovary, parathyroid, platelet, salivary gland, skeletal muscle, skin basement membrane and intercellular substance, thyroglobulin, thyroid microsome or thyroid stimulating hormone receptor) – detection, including quantitation if required, of 1 antibody. (Item is subject to rule 6.) [2007] $34.55 128,207 $3,790,200 10.0%
71166 Detection of 2 antibodies described in item 71165. (Item is subject to rule 6.) [2007] $47.45 287,101 $11,658,177 11.3%
71167 Detection of 3 antibodies described in item 71165. (Item is subject to rule 6.) [2007] $60.30 40,198 $2,072,476 16.2%
71168 Detection of 4 or more antibodies described in item 71165. (Item is subject to rule 6.) [2007] $73.15 6,596 $408,989 18.5%
71169 A test described in item 71165, if rendered by a receiving APP, where no tests in the item have been rendered by the referring APP 1 test. (Item is subject to rule 6 and 18.) [2007] $34.55 18,588 $544,709 13.7%
71170 Tests described in item 71165, other than that described in 71169, if rendered by a receiving APP – each test to a maximum of 3 tests. (Item is subject to rule 6 and 18.) [2007] $12.85 15,399 $167,907 3.4%

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Remove the thyroid antibodies (thyroglobulin, thyroid microsome or thyroid stimulating hormone receptor) from the suite of tests currently covered under items 71165–71168 and create three new distinct thyroid antibodies items, proposed below:
  • ΔItem A: Thyroglobulin and thyroglobulin antibody (TgAb): for monitoring of patients with thyroid cancer.
  • ΔItem B: Thyroperoxidase antibody (TPOAb): for diagnosis of patients suspected to have autoimmune thyroid disease; if positive this test should not be repeated.
  • ΔItem C: TSH receptor antibody (TRAb or TSI): for diagnosis and monitoring of patients with Graves’ disease. Up to four tests annually.
Recommendation 10

While supportive of the proposals of the Endocrinology Clinical Committee, the Pathology Clinical Committee is awaiting input from the Immunology Working Group before finalising its proposals for the testing for thyroid antibodies.

There are no recommendations on these items. The Pathology Clinical Committee will further consider thyroid antibodies at a later date.

5.5 Quantitation of products of collagen breakdown or formation: Items 66773 and 66776

Table 15: Item introduction table for items 66773 and 66776

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66773 Quantitation of products of collagen breakdown or formation for the monitoring of patients with proven low bone mineral density, and if performed, a service described in item 66752 – 1 or more tests. (Low bone densitometry1 is defined in the explanatory notes to Category 2 – Diagnostic Procedures and Investigations of the Medicare Benefits Schedule.) [1998] $24.65 43,017 $906,370 15.5%
66776 Quantitation of products of collagen breakdown or formation for the monitoring of patients with metabolic bone disease or Paget's disease of bone, and if performed, a service described in item 66752 – 1 or more tests. [1998] $24.65 26,409 $562,509 10.3%

Source: Department of Human Services, published data, date of processing.

1 It was noted that this may be referred to as ‘low bone mineral density’ in the Schedule, section D1.19 pages 30 and 31, and may require the descriptor to be updated.


Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Leave these items unchanged.
Recommendation 11

The Pathology Clinical Committee provides the following advice and recommendation.

  • Δ The Pathology Clinical Committee supports the proposal to leave these items unchanged.

Rationale 11

The recommendation is based on the following observation. The MBS items provide clinically required tests, and the high growth rates in service volumes reflect the frequency of osteoporosis in the population and the recent introduction of medications used to treat bone-related disorders. These medications have a potent effect on bone turnover markers.29 This recommendation is to encourage best practice within this area.

A restriction on the maximum number of tests per year was considered; however, there is no consensus within the published literature about the appropriate number of tests per year.30 In the 2014–15 financial year, only 18 per cent and 13 per cent of patients had two or more tests under items 66773 and 66776, respectively.8

5.6 Adrenaline and other tests: Items 66779 and 66780

Table 16: Item introduction table for items 66779 and 66780

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66779 Adrenaline, noradrenaline, dopamine, histamine, hydroxyindoleacetic acid (5HIAA), hydroxymethoxymandelic acid (HMMA), homovanillic acid (HVA), metanephrines, methoxyhydroxyphenylethylene glycol (MHPG), phenylacetic acid (PAA) or serotonin quantitation – 1 or more tests. [1998] $39.95 42,115 $1,448,373 4.5%
66780 A test described in item 66779 if rendered by a receiving APP – 1 or more tests. (Item is subject to rule 18.) [2007] $39.95 22,010 $745,570 8.2%

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • ΔLeave these items unchanged.
Recommendation 12

Quantitation of adrenal hormones will require review by the Committee and has been put on the work plan. No recommendations are made at this time.

5.7 1, 25-dihydroxyvitamin D quantification: Items 66835–7

Table 17: Item introduction table for items 66835–7

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66835 1, 25-dihydroxyvitamin D – quantification in serum, if the request for the test is made by, or on advice of, the specialist or consultant physician managing the treatment of the patient. [2014] $ 39.05 7068 $234,845 N/A
66836 1, 25-dihydroxyvitamin D – quantification in serum, if: (a) the patient has hypercalcaemia; and (b) the request for the test is made by a general practitioner managing the treatment of the patient. [2014] $ 39.05 67 $2,155 N/A
66837 A test described in item 66835 or 66836 if rendered by a receiving APP. (Item is subject to rule 18.) [2014] $39.05 997 $33,025 N/A

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Leave these items unchanged.
Recommendation 13

The Pathology Clinical Committee provides the following advice and recommendation.

  • Δ The Pathology Clinical Committee supports the Endocrinology Clinical Committee proposal to leave these items unchanged.

Rationale 13

These items were recently reviewed and changed within the MBS Schedule; they do not require further revision at this stage.

5.8 Hormone and other tests: Item 66686

Table 18: Item introduction table for item 66686

Item number 66686
Descriptor [date last amended] Performance of 1 or more of the following procedures: (a) growth hormone suppression by glucose loading; (b) growth hormone stimulation by exercise; (c) dexamethasone suppression test; (d) sweat collection by iontophoresis for chloride analysis; (e) pharmacological stimulation of growth hormone. [1998]
Schedule fee $50.65
Volume of services FY2014/15 4,555
Total benefits paid FY2014/15 $196,662
Services 5-year (FY2009/10–FY2014/15) annual average growth (CAGR) 7.5%

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Leave this item unchanged.
Recommendation 14

The Pathology Clinical Committee provides the following advice and recommendation.

  • Δ The Pathology Clinical Committee supports the proposal to leave this item unchanged.

Rationale 14

  • Δ This item contains an unrelated bundle of tests; these tests are required and should remain unchanged on the MBS.

5.9 Quantification in saliva of cortisol: Items 66711–2 and 66714–5

Table 19: Item introduction table for items 66711–2 and 66714–5

Item Descriptor [date last amended] Schedule fee Services FY2014/15 Benefits FY2014/15 Services 5-year annual avg. growth
66711 Quantitation in saliva of cortisol in: (a) the investigation of Cushing's syndrome; or (b) the management of children with congenital adrenal hyperplasia. (Item is subject to rule 6.) [2005] $30.15 2286 $59,115 58.9%
66712 Two tests described in item 66711. (Item is subject to rule 6.) [2005] $43.05 201 $7,330 13.9%
66714 A test described in item 66711, if rendered by a receiving APP, where no tests in the item have been rendered by the referring APP. (Item is subject to rule 6 and 18.) [2007] $30.15 194 $4,967 62.7%
66715 Tests described in item 66711, other than that described in 66714, if rendered by a receiving APP, each test to a maximum of 1 test. (Item is subject to rule 6 and 18.) [2007] $12.85 151 $1,720 2.0%

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Leave these items unchanged.
Recommendation 15

The Pathology Clinical Committee provides the following advice and recommendation.

  • Δ The Chemical Working Group supports the proposal to leave these items unchanged.

Rationale 15

These tests are clinically relevant and should remain unchanged from their current form in the MBS Schedule.

5.10 Electrophoresis of serum: Item 66539

Table 20: Item introduction table for item 66539

Item number 66539
Descriptor [date last amended] Electrophoresis of serum for demonstration of lipoprotein subclasses, if the cholesterol is > 6.5 mmol/l and triglyceride >4.0 mmol/l or in the diagnosis of types iii and iv hyperlipidaemia. (Item is subject to rule 25.) [1998]
Schedule fee $30.60
Volume of services FY2014/15 559
Total benefits paid FY2014/15 $15,251
Services 5-year (FY2009/10–FY2014/15) annual average growth (CAGR) 3.8%

Source: Department of Human Services, published data, date of processing.

Advice from Endocrinology Clinical Committee

The Endocrinology Clinical Committee proposed the following:

  • Δ Delete this item from the MBS.
Recommendation 16

The Pathology Clinical Committee provides the following advice and recommendations.

  • Δ The Pathology Clinical Committee supports the proposal to remove the item 66539.
  • Δ The Pathology Clinical Committee recommends a new item for the investigation of familial hypercholesterolaemia be introduced into the table. This test should be a genetic test, including mutations of the LDL-receptor gene, PCSK9 gene or mutations of the apolipoprotein B gene, and should be reviewed by the genetics committee, including appropriate indications for testing.
  • Δ The Committee recommends a new item for the investigation of markedly high mixed hyperlipidaemia, investigating apoE genotype, be introduced into the table subsequent to genetics committee suggestions.

Rationale 16

The Committee noted that electrophoresis of lipoprotein E is now superseded by genotyping. The Committee also considered that there will be a small group of patients with hyperlipidaemia who will not be diagnosed with genotyping. In addition apolipoprotein E (apo E4) predicts an increased risk of Alzheimer’s disease. The evidence for a clinical benefit is not as strong as for the genetic testing for familial hypercholesterolaemia (see below) and is beyond the scope of the Committee’s review of the MBS Schedule for chemical-pathology items.

There is no item in the MBS Schedule for genotyping for patients with familial hypercholesterolaemia, the most common autosomal dominant lipid disorder (frequency 1:200 to 1:400). There is strong evidence to support the addition of new items for investigation of lipid disorders by genetic testing in Australia; this is beyond the scope of the Committee’s review of the MBS Schedule for chemical pathology items.

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_________________________________________

References

7. Department of Health. MBS data – Q210381-02. 2016. (accessed 26.10.2016).

8. Department of Health. MBS Data. 2016. Report No. (accessed 26.10.2016).

9. Medicare Australia Statistics. Standard MBS data. 2016. (accessed 26.10.2016).

10. Australian Bureau of Statistics. Australian Demographic Statistics. 2015. http://www.abs.gov.au/ausstats/abs@.nsf/Previousproducts/3101.0Main%20Features1Jun%202015?opendocument&tabname=Summary&prodno=3101.0&issue=Jun%202015&num=&view=. (accessed 25 October).

11. Department of Health. MBS data –Q203551. 2016. (accessed 26.10.2016).

12. Department of Health. MBS Data – Q20354-02. 2016. (accessed 26.10.2016).

13. Craig ME, Twigg SM, Donaghue KC, et al. National evidence-based clinical care guidelines for type 1 diabetes in children, adolescents and adults. Canberra: National Health and Medical Research Council, 2011. (accessed.

14. Department of Health. PBS data. 2016.

15. Department of Health. MBS data - Q20382-01. 2016.

16. Gereben B, Zavacki AM, Ribich S, et al. Cellular and Molecular Basis of Deiodinase-Regulated Thyroid Hormone Signaling. Endocrine Reviews 2008;29:898-938. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2647704/.

17. Colagiuri S. Time to move to a glycated haemoglobin-based algorithm for diabetes screening and diagnosis? Med J Aust 2015;203:7-9. http://www.ncbi.nlm.nih.gov/pubmed/26126553.

18. d'Emden MC, Shaw JE, Colman PG, et al. The role of HbA1c in the diagnosis of diabetes mellitus in Australia. Med J Aust 2012;197:220-1. http://www.ncbi.nlm.nih.gov/pubmed/22900870.

19. d'Emden MC, Shaw JE, Jones GR, et al. Guidance concerning the use of glycated haemoglobin (HbA1c) for the diagnosis of diabetes mellitus. Med J Aust 2015;203:89-90. http://www.ncbi.nlm.nih.gov/pubmed/26175248.

20. Nankervis A, McIntyre HD, Moses R, et al. ADIP Consensus Guidelines for the Testing and Diagnosis of Hyperglycaema in Pregnancy in Australia and New Zealand. Australasian Diabetes in Pregnancy Society 2014:1–8.

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