EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health

Health Insurance Act 1973

Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Amendment Determination 2019

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 (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the Table.

The Table is set out in the regulations made under subsection 4A(1) of the Act, which is repealed and re-made each year.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.

Subsection 33(3) of the Acts Interpretation Act 1901 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 – Cystic fibrosis gene testing) Amendment Determination 2019 (the Amendment Determination) is to amend the Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Determination 2018 (the Principal Determination) to amend the descriptor of Medicare Benefits Schedule (MBS) item 73348 to allow medical practitioners to request item 73348. Currently, only consultant physicians and specialists can request MBS item 73348.

On 1 July 2018, six items (73345 to 73350) for a genetic pathology test for cystic fibrosis or mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene were introduced in target populations and settings.  Cystic fibrosis is usually clinically diagnosed with supporting evidence of a CFTR abnormality, either by sweat chloride measurement or through identification of mutations in the CFTR gene known to cause cystic fibrosis.

This policy was announced in the 2018-19 Budget under the Guaranteeing Medicare — Medicare Benefits Schedule — new and amended listings measure.

The Amendment Determination amends the descriptor of MBS item 73348 to allow all medical practitioners (primarily general practitioners) to request this test. MBS item 73348 is a ‘cascade test’ – meaning that the test is used for first degree relatives of a person who has had a laboratory confirm they have CFTR variants.  This change will allow all qualified medical practitioners of first degree relatives to request a CFTR cascade test (MBS item 73348) once their first degree family member has confirmed laboratory findings of pathogenic CFTR variants.

Consultation

Consultation was undertaken as part of the MSAC process, with key stakeholders, clinical experts and providers and consumer health representatives.  At this time consultation was also undertaken with the Royal College of Pathologists of Australasia in relation to the amended descriptor of MBS item 73348. 

Details of the Determination are set out in the Attachment.

The Determination commences on 1 January 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 – Cystic fibrosis gene testing) Amendment Determination 2019

Section 1 – Name

Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Amendment Determination 2019.

Section 2 – Commencement

Section 2 provides that the Determination commences on 1 January 2020.

Section 3 – Authority

Section 3 provides that the Determination 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 Determination 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.

Schedule 1 – Amendments

Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Determination 2018

Item 1 – Schedule 1 (item 73348, Column 2)

Item 1 amends MBS item 73348 by omitting the words “when requested by a specialist or consultant physician who manages the treatment of the patient”.

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 – Cystic fibrosis gene testing) Amendment Determination 2019
 

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

The purpose of the Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Amendment Determination 2019 (the Amendment Determination) is to amend the Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Determination 2018 (the Principal Determination) to amend the descriptor of Medicare Benefits Schedule (MBS) item 73348 to allow general practitioners to request this test.

On 1 July 2018, six MBS items (73345 to 73350) for a genetic pathology test for cystic fibrosis or mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene were introduced in target populations and settings. Cystic fibrosis is usually clinically diagnosed with supporting evidence of a CFTR abnormality, either by sweat chloride measurement or through identification of mutations in the CFTR gene known to cause cystic fibrosis.

This policy was announced in the 2018-19 Budget under the Guaranteeing Medicare — Medicare Benefits Schedule — new and amended listings measure.

The Amendment Determination amends the descriptor of MBS item 73348 to allow general practitioners to request this test. MBS item 73348 is a ‘cascade test’ – meaning that the test is used for first degree relatives of a person who has had a laboratory confirm they have CFTR variants.  This change will allow all medical practitioners of first degree relatives to request a CFTR cascade test (MBS item 73348) once their first degree family member has confirmed laboratory findings of pathogenic CFTR variants.

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 rights to health and social security by ensuring patients can continue to access subsidised cystic fibrosis testing services on the Medicare Benefits Schedule.

Conclusion

This instrument is compatible with human rights as it maintains the right to health and the right to social security.

Renaye Lucchese

Acting Assistant Secretary

Diagnostic Imaging and Pathology Branch

Medical Benefits Division

Health Financing Group

Department of Health