Medicare Benefits Schedule - Note PN.7.15

Prior to requesting or performing these tests, the requesting practitioner or pathologist should consider if the patient has already received equivalent testing under the same or another methodology in the same new diagnosis of non-small cell lung cancer (NSCLC).
Repeat testing by multiple methods in the same new diagnosis of NSCLC should only be performed if it is clinically relevant.

Items 73337, 73341, 73344 and 73436 support sequential single-gene testing for biomarkers in patients with NSCLC.

Item 73437 supports use of one next generation sequencing (NGS) panel for testing of all biomarkers supported under items 73337, 73341, 73344 and 73436.

Items 73438 and 73439 support sequential use of two NGS panels for testing of all biomarkers supported under 73337 and 73436, and 73341 and 73344 respectively.

Related Items: 73337 73341 73344 73436 73437 73438 73439

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A test of tumour tissue from a patient with a new diagnosis of non‑small cell lung cancer, shown to have non-squamous histology or histology not otherwise specified, requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)   to determine if requirements relating to epidermal growth factor receptor (EGFR) gene status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled; and

(b)   not associated with a service to which item 73437 or 73438 applies

Fee: $397.35 Benefit: 75% = $298.05 85% = $337.75

(See para PN.7.15 of explanatory notes to this Category)

Fluorescence in situ hybridisation (FISH) test of tumour tissue from a patient with a new diagnosis of locally advanced or metastatic non-small cell lung cancer, which is of non-squamous histology or histology not otherwise specified, with documented evidence of anaplastic lymphoma kinase (ALK) immunoreactivity by immunohistochemical (IHC) examination giving a staining intensity score > 0, and with documented absence of activating mutations of the epidermal growth factor receptor (EGFR) gene, requested by a specialist or consultant physician, if the test is:

(a)   to determine if requirements relating to ALK gene rearrangement status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled; and

(b)   not associated with a service to which item 73437 or 73439 applies

Fee: $400.00 Benefit: 75% = $300.00 85% = $340.00

(See para PN.7.15 of explanatory notes to this Category)

Fluorescence in situ hybridization (FISH) test of tumour tissue from a patient with a new diagnosis of locally advanced or metastatic non-small cell lung cancer, which is of non-squamous histology or histology not otherwise specified, with documented evidence of ROS proto-oncogene 1 (ROS1) immunoreactivity by immunohistochemical (IHC) examination giving a staining intensity score of 2+ or 3+; and with documented absence of both activating mutations of the epidermal growth factor receptor (EGFR) gene and anaplastic lymphoma kinase (ALK) immunoreactivity by IHC, requested by a specialist or consultant physician, if the test is:

(a)   to determine if requirements relating to ROS1 gene arrangement status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled: and

(b)   not associated with a service to which item 73437 or 73439 applies

Fee: $400.00 Benefit: 75% = $300.00 85% = $340.00

(See para PN.1.2, PN.7.15 of explanatory notes to this Category)

A test of tumour tissue from a patient with a new diagnosis of locally advanced or metastatic non-small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)   to determine if the requirements relating to MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping alterations (METex14sk) status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled: and

(b)   not associated with a service to which item 73437 or 73438 applies

Fee: $397.35 Benefit: 75% = $298.05 85% = $337.75

(See para PN.1.2, PN.7.15 of explanatory notes to this Category)

A nucleic acid-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)  to detect variants in at least EGFR, BRAF, KRAS and MET exon 14 to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS); and

(b)  to detect the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2 and NTRK3; and

          (i)   to determine access to specific therapies relevant to these variants listed on the PBS; or

         (ii)   determine if the requirements relating to EGFR, ALK and ROS1 status for access immunotherapies listed on the PBS are fulfilled; and

(c)  not associated with a service to which item 73438, 73439, 73337, 73341, 73344, 73436 or 73351 applies

Fee: $1,247.00 Benefit: 75% = $935.25 85% = $1,148.30

(See para PN.7.15 of explanatory notes to this Category)

A DNA-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)   to detect variants in at least EGFR, BRAF, KRAS and MET exon 14; and

(b)   to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS); or

(c)   to determine if the requirements relating to EGFR status for access to immunotherapies listed on the PBS are fulfilled; and

(d)   not associated with a service to which item 73437, 73337, 73436 or 73351 applies

Fee: $682.35 Benefit: 75% = $511.80 85% = $583.65

(See para PN.7.15 of explanatory notes to this Category)

A nucleic acid-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer and with documented absence of activating variants of the EGFR gene, KRAS, BRAF and MET exon14, requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a)   to determine the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2, and NTRK3 to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS) are fulfilled; or

(b)   to determine if the requirements relating to ALK and ROS1 status for access to immunotherapies listed on the PBS are fulfilled; and

(c)   not associated with a service to which item 73437, 73341, 73344 or 73351 applies

Fee: $682.35 Benefit: 75% = $511.80 85% = $583.65

(See para PN.7.15 of explanatory notes to this Category)