EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
SECTION 4BA
Health Insurance (Pathologist-Determinable Services) Amendment Determination 2014
Section 4BA of the Health Insurance 1973 (the Act) provides that the Minister may, following consultation with the Royal College of Pathologists of Australasia (RCPA), determine that a particular pathology service, or pathology services included in a class of pathology services, are pathologist-determinable services.
The Health Insurance (Pathologist-determinable Services) Amendment Determination 2014 (the Amendment Determination) amends the Health Insurance (Pathologist-determinable Services) Determination 2006 (No. 3) (the Principal Determination) to specify two new pathology services as pathologist-determinable services.
Section 16A of the Act specifies that certain requirements have to be met for the payment of Medicare benefits in relation to pathology services. Subsections 16A(1), (3) and (6) together provide that a Medicare benefit is not payable in respect of a pathology service unless the service was rendered pursuant to a request or is a pathologist-determinable service.
Determining a service as a pathologist-determinable service obviates the need for a request from a treating practitioner and allows for the payment of Medicare benefits to cover specific circumstances where:
- services are requested and performed by an Approved Pathology Practitioner (APP) for their own patients; or
- services are deemed necessary in the interest of the patient by the APP, in light of results obtained from earlier tests performed in response to a request from the treating practitioner.
An example of the former is a haematologist or immunologist performing pathology services for their own patients. An example of the latter is the receipt of a request by a histopathologist for the examination of a biopsy specimen and following examination the histopathologist determines that further tests are necessary to complete the diagnosis. The histopathologist would be able to undertake further testing without the need to seek another request from the treating practitioner.
The following determinations were made under section 3C of the Act:
- the Health Insurance (Pharmacogenetic Testing) Determination 2013 (No. 1), which from 1 December 2013 created new Medicare pathology item 73336 for the test of tumour tissue from a patient with unresectable stage III or stage IV metastatic cutaneous melanoma, in order to determine if the patient meets the requirements relating to BRAF V600 gene mutation status for access under the Pharmaceutical Benefits Scheme (PBS) to the drug dabrafenib;
- the Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013, which from 1 January 2014 created new Medicare pathology item 73337 for the testing of tumour tissue from a patient diagnosed with non-small lung cancer, shown to have non-squamous histology, in order to determine if the patient meets the requirements relating to epidermal growth factor receptor (EGFR) gene status for access to erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS).
Where not provided as a pathologist-determinable service, the services described in items 73336 and 73337 must be requested by a specialist or consultant physician.
The Amendment Determination amends the Principal Determination to allow the services described in items 73336 and 73337 to be performed as a pathologist-determinable service by, or on behalf of, an APP:
- to a patient of that APP; and
- where the APP considers it to be necessary on the basis of information the APP has learned as a result of providing one of a specified range of other pathology services requested by the patient’s treating practitioner.
Consultation
The RCPA has been consulted concerning the amendments, as required by section 4BA of the Act. The RCPA endorsed enabling the provision of the services described in items 73336 and 73337 as pathologist-determinable services.
The Amendment Determination commences retrospectively as follows:
- section 1 to 4 and Schedule 1 – 1 December 2013 (the date item 73336 was created);
- Schedule 2 - 1 January 2014 (the date item 73337 was created).
The retrospective start dates ensures that Medicare benefit will be payable for the new items when provided as a pathologist-determinable service from that date. The retrospective commencement will not retrospectively disadvantage or impose liabilities on any person other than the Commonwealth and therefore the Amendment Determination does not offend subsection 12(2) of the Legislative Instruments Act 2003.
The Amendment Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Pathologist-determinable Services) Amendment Determination 2014
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Health Insurance (Pathologist-determinable Services) Amendment Determination 2014 (the Amendment Determination) amends the Health Insurance (Pathologist-determinable Services) Determination 2006 (No. 3) (the Principal Determination) to specify two new Medicare pathology services (items 73336 and 73337) as pathologist-determinable services.
The Health Insurance Act 1973 ordinarily requires that a pathology service must be rendered pursuant to a request for Medicare benefit to be payable for the service.
Determining a service as a pathologist-determinable service obviates the need for a request from a treating practitioner and allows for the payment of Medicare benefits where:
- the service is requested and performed by an Approved Pathology Practitioner (APP) for their own patient; or
- the service is deemed necessary in the interest of the patient by the APP, in light of results obtained from earlier tests performed in response to a request from the treating practitioner.
Human rights implications
This Legislative Instrument positively impacts on the rights to health and social security by enabling patients to receive a Medicare benefit for the services described in items 73336 and 73337 in an expanded range of settings. In particular, the specification of items 73336 and 73337 as pathologist-determinable services will ensure that, where an APP considers that the results of a patient’s requested services indicate the need for the tests covered by the items to be performed, the APP can provide the follow-up test as a Medicare-eligible service. It also enables APPs to provide the services to their own patients as a Medicare-eligible service.
There are no patient eligibility criteria such as age or gender that must be met in order for items 73336 or 73337 to be provided as a pathologist-determinable service.
Conclusion
This Legislative Instrument is compatible with human rights because it impacts positively on the human rights to health and social security and does not limit any of the rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Peter Dutton
Minister for Health