EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health

Health Insurance Act 1973

Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2020

Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, determine that a health service not specified in an item in the pathology services table shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the pathology services table. 

The pathology services table is set out in the regulations made under subsection 4A(1) of the Act, which is repealed and re-made each year.  The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2019. This version will be remade on 1 May 2020 by the Health Insurance (Pathology Services Table) Regulations 2020.

This instrument relies on subsection 33(3) of the Acts Interpretation Act 1901 (AIA).  Subsection 33(3) of the AIA provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

Purpose

The purpose of the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2020 (the Amendment Determination) is to amend the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Determination 2019 (the Principal Determination) to clarify the intent of item 72860, and to align with the Health Insurance (Pathologist-determinable Services) Amendment Determination (No.2) 2020 (the Pathologist-determinable Amendment Determination), which will make item 72860 pathologist determinable from 1 May 2020.

On 1 May 2019, item 72860 was introduced for the retrieval and review of archival tissue by a pathologist for the purpose of identifying appropriate sample(s) for further genetic testing. Where a treating practitioner requests genetic testing on archived tissue following an initial tissue, cytology or genetic pathology test, and the accredited pathology laboratory where the archived tissue is retrieved is unable to perform the subsequent genetic test, item 72860 allows for the pathologist who rendered the initial service to retrieve and review the archived tissue to determine appropriate tissue sample(s) for referral to a different accredited pathology laboratory for testing.

While not changing the intended operation of MBS item 72860, the new and improved drafting follows consultation with the Royal College of Pathologists of Australasia.

From 1 May 2020, a service provided under item 72860 will be able to be rendered as a pathologist determinable service. This will allow a pathologist to render the service, without a requirement for the treating practitioner to specifically request item 72860. This will be implemented by the Pathologist-determinable Amendment Determination.

The Pathologist-determinable Amendment Determination will provide that a service provided under item 72860 will be pathologist determinable if following an initial service, which is a pathology service mentioned in an item in Group P5 (other than item 72860), P6 or P7 of the pathology services table, the treating practitioner determines a subsequent service under an item in Group P7 (subsequent P7 service) is clinically necessary for the patient. Following the request from the treating practitioner for the subsequent P7 service, the pathologist who rendered the initial service determines they are unable to perform the subsequent P7 service, and consequently retrieves and reviews the archival tissue to select appropriate tissue samples for referral to a different accredited pathology laboratory for testing, by or on behalf of, an approved pathology practitioner who is a recognised pathologist. The subsequent P7 service must be rendered in another patient episode, and the relevant service under item 72860 must also be rendered in the subsequent patient episode

The Amendment Determination will clarify that archival tissue item 72860 will be pathologist determinable from 1 May 2020, by removing the requirement for the treating practitioner to specifically request item 72860.

In April 2017, the Medical Services Advisory Committee (MSAC) supported the public funding of the retrieval and review of archival tissue by pathologists to select appropriate tissue samples for further testing or pathological review for further diagnostic testing (MSAC assessment 1331). The Determination is an administrative amendment which provides further clarity the item. 

Consultation

MSAC reviews new or existing medical services or technology, and the circumstances under which public funding should be supported through listing on the MBS. This includes the listing of new items, or amendments to existing items on the MBS.

As part of the MSAC process, consultation was undertaken with key stakeholders, clinical experts and providers, and consumer health representatives. The Royal College of Pathologists of Australasia was consulted in relation to the amendment to item 72860.

Details of the Determination are set out in the Attachment.

The Determination commences on 1 May 2020.

The Determination is a legislative instrument for the purposes of the Legislation Act 2003.

Authority:     Subsection 3C (1) of the

 Health Insurance Act 1973

ATTACHMENT

Details of the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2020

Section 1 – Name

Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2020.

Section 2 – Commencement

Section 2 provides that the instrument commences on 1 May 2020.

Section 3 – Authority

Section 3 provides that the instrument is made under subsection 3C (1) of the Health Insurance Act 1973.

Section 4 – Schedules

Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Determination has effect according to its terms.

Section 1 – Amendments

Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Determination 2019

Item 1 – Section 6 (below the heading)

Item 1 repeals and substitutes section 6 of the Principal Determination, which specifies the application of item 72860. 

Subsection 6(1) provides that item 72860 applies to a service (the relevant service) if an initial service that is described in an item in Group P5 (other than item 72860), P6 or P7 of the pathology services table was rendered in a patient episode for the patient, and following the initial service, the treating practitioner determines that one or more genetic tests in Group P7 (the subsequent P7 service) is clinically necessary for the patient. Following the request from the treating practitioner for the subsequent P7 service, the pathologist who rendered the initial service determines they are unable to perform the subsequent P7 service and consequently retrieves and reviews the archival tissue to select appropriate tissue samples for referral to a different accredited pathology laboratory for testing. The subsequent P7 service must be rendered in another patient episode, and the relevant service must also be rendered in the subsequent patient episode.

Tissue material must be collected from the initial service. The tissue material must be either biopsy material or sample submitted for cytology from which a tissue block was prepared, and the tissue material was archived in a formalin fixed paraffin embedded block.

Item 2 – Section 7 (below the heading)

Item 2 repeals and substitutes section 7 of the Principal Determination, which specifies the limitations for services provided under item 72860. 

Subsection 7(1) provides that item 72860 does not apply if it is rendered at the same ‘accredited pathology laboratory’ in which the subsequent P7 service is rendered, or if it is rendered in association with a service to which item 72858 or 72859 applies, or if it is rendered in association with, and in the same patient episode, as a service to which an item in Group P5, P6, P10 or P11 applies. Accredited laboratory means premises in respect of which there is in force an approval under section 23DN of the Health Insurance Act 1973.

Subsection 7(2) provides that item 72860 is applicable for one retrieval and review of an archived formalin fixed paraffin embedded block per subsequent patient episode.

Item 3 – Schedule 1 (below the heading)

Item 3 repeals and substitutes the table in Schedule 1 of the Principal Determination, to provide an updated item descriptor for item 72860. The updated descriptor specifies that the service is for the retrieval and review of one or more archived formalin fixed paraffin embedded block(s). The service provided under item 72860 has not changed.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2020
 

This 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 Determination

Item 72860 was listed on 1 May 2019 to allow pathologists to retrieve and identify tissue blocks which are suitable for conducting genetic testing. This service enables certain patients, who require urgent genetic testing as a result of initial tissue, cytology or genetic pathology test results, to avoid another invasive biopsy. Item 72860 is prescribed in the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Determination 2019 (the Principal Determination).

From 1 May 2020, a service provided under item 72860 will be able to be pathologist-determinable. This means that the service will be able to be rendered by a pathologist, without a request from the treating practitioner. This will be implemented by the Health Insurance (Pathologist-determinable Services) Amendment Determination (No. 2) 2020 (Pathologist-determinable Amendment Determination).

The Pathologist-determinable Amendment Determination will provide that a service provided under item 72860 will be pathologist determinable if:

• Following the initial service (a service described in an item in Group P5 (other than item 72860), Group P6 or Group P7 of the pathology services table), a treating practitioner or recognised pathologist, determines that a service described in an item in Group P7 (the subsequent P7 service) is clinically necessary for the patient and the subsequent P7 service requires the retrieval and review of archival tissue.
• The pathologist who rendered the initial service determines they are unable to perform the subsequent P7 service and consequently performs a service described under item 72860.
• The subsequent P7 service is rendered in a different accredited pathology laboratory.

The Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2020 amends the Principal Determination to clarify that archival tissue item 72860 will be pathologist determinable from 1 May 2020, by removing the requirement for the treating practitioner to request item 72860.

The Medical Services Advisory Committee (MSAC) supported the public funding of the retrieval and review of archival tissue by pathologists to select appropriate tissue samples for further testing or pathological review for further diagnostic testing (MSAC assessment 1331).  The Determination is an administrative amendment which provides further clarity on the service. 

Human rights implications

This instrument engages Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to health and social security.

The Right to Health

The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR.  The UN Committee on Economic Social and Cultural Rights (the Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources.  This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.

The Right to Social Security

The right to social security is contained in Article 9 of the ICESCR.  It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care.  Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.

The Committee reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them.  However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.

Analysis

This instrument will maintain patient access rights to health and social security by ensuring that patients are able to access further testing under item 72860, if required, by reducing administrative burden on the clinician. This is in line with the policy intent of the service.

Conclusion

This instrument is compatible with human rights as it expands a patient access right to health and the right to social security.

Renaye Lucchese

Assistant Secretary

Diagnostic Imaging and Pathology Branch 

Medical Benefits Division

Health Financing Group

Department of Health