Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00044 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

Health Insurance Act 1973

 

Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2019

 

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

 

The PST is set out in the regulations made under subsection 4A(1) of the Act, and is repealed and remade each year.

 

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 Co-Dependent Pathology Services) Amendment Determination 2019 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to provide a legal basis for the payment of Medicare benefits for a test provided under new item 73351.  The effect of this amendment is to treat new item 73351 as if it is specified in the PST and attract Medicare benefit when the professional service is rendered to a particular patient when all specified statutory requirements are met.

 

The medical service is an additional epidermal growth factor receptor (EGFR) mutation test for the presence of the T790M mutation in patients with locally advanced (Stage IIIB) or metastatic (Stage IV), non-squamous or not otherwise specified EGFR mutation positive non-small cell lung cancer, who have received first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment, and whose disease has subsequently progressed. Patients with an EGFR T790M gene status will be eligible to access osimertinib under the Pharmaceutical Benefits Scheme (PBS).

 

This proposal was supported by the Medical Services Advisory Committee (MSAC) and agreed by Pharmaceutical Benefits Advisory Committee (PBAC) in
November 2018.

 

Consultation

As part of the MSAC process, consultation is undertaken with professional bodies, consumer groups, the public and clinical experts for proposals put forward for consideration by MSAC.

 

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

 

Details of the Determination are set out in the Attachment.

 

The Determination commences on 1 February 2019.

 

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 Co-Dependent Pathology Services) Amendment Determination 2019

 

Section 1 – Name

 

Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2019.

 

Section 2 – Commencement

 

Section 2 provides that the instrument commences on 1 February 2019.

 

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 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 – Amendment

 

This Determination amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to include new item 73351.

 

Item 1 prescribes the fee and item descriptor for new item 73351.

 

 


Statement of Compatibility with Human Rights

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

 

Health Insurance (Section 3C Co-Dependent Pathology Services) 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 Co-Dependent Pathology Services) Amendment Determination 2019 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to provide a legal basis for the payment of Medicare benefits for a test provided under new item 73351.

 

The medical service is an additional epidermal growth factor receptor (EGFR) mutation test for the presence of the T790M mutation in patients with locally advanced (Stage IIIB) or metastatic (Stage IV), non-squamous or not otherwise specified EGFR mutation positive non-small cell lung cancer, who have received first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment, and whose disease has subsequently progressed. Patients with an EGFR T790M gene status will be eligible to access osimertinib under the Pharmaceutical Benefits Scheme (PBS).

 

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 provides subsidised pathology testing to cancer patients with advanced lung cancer and positive test result for the presence of the particular genetic marker allowing them to access subsidised cancer drugs under the Commonwealth Pharmaceutical Benefits Scheme.  This Determination therefore advances the right to health and the right to social security by ensuring access to publicly subsidised health services which are clinically effective, safe and cost-effective.

Conclusion

This instrument is compatible with human rights as it has a positive effect on the right to health and the right to social security.

 

Angela Mikalauskas

Acting Assistant Secretary

Diagnostic Imaging and Pathology Branch 

Medical Benefits Division

Health Financing Group

Department of Health

 

Overview

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2019 was enacted to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018. This amendment was introduced to provide a legal basis for the payment of Medicare benefits for an additional epidermal growth factor receptor (EGFR) mutation test for the presence of the T790M mutation in patients with locally advanced (Stage IIIB) or metastatic (Stage IV), non-squamous or not otherwise specified EGFR mutation positive non-small cell lung cancer. The amendment was initiated by the Minister for Health under the authority conferred by subsection 3C(1) of the Health Insurance Act 1973. The policy objective of this Determination is to ensure that patients with specific genetic markers can access subsidised cancer drugs under the Pharmaceutical Benefits Scheme, thereby enhancing their access to effective and necessary health care services. This legislative instrument was developed following consultation with relevant professional bodies, consumer groups, and clinical experts, as part of the process overseen by the Medical Services Advisory Committee (MSAC) and agreed by the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2018. The amendment provides a legal framework for treating new item 73351 as if it is specified in the pathology services table, ensuring that Medicare benefits are available when the professional service is rendered under the specified statutory conditions. The Determination aims to support the right to health and social security by providing access to clinically effective, safe, and cost-effective health services for eligible patients.

Scope and Application

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2019 amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to provide a legal basis for the payment of Medicare benefits for a specified additional epidermal growth factor receptor (EGFR) mutation test for the presence of the T790M mutation in patients with locally advanced (Stage IIIB) or metastatic (Stage IV), non-squamous or not otherwise specified EGFR mutation positive non-small cell lung cancer, who have received first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment and whose disease has subsequently progressed. The amendment treats new item 73351 as if it is specified in the pathology services table (PST) and thus attracts Medicare benefit when the professional service is rendered to a particular patient when all specified statutory requirements are met. The Determination is made under subsection 3C(1) of the Health Insurance Act 1973 and is a legislative instrument for the purposes of the Legislation Act 2003. It commenced on 1 February 2019 and applies nationally. The Determination does not explicitly state any exclusions or exemptions, though it is subject to the conditions and requirements set out in the Health Insurance Act 1973 and the regulations made under it. The application of the Determination may be extended or restricted through subordinate instruments, including regulations made under the Act.

Key Provisions

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2019 amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 by adding new item 73351 to the pathology services table (PST) (Schedule 1). This amendment allows for the payment of Medicare benefits for a specific additional epidermal growth factor receptor (EGFR) mutation test for the presence of the T790M mutation in patients with locally advanced or metastatic non-small cell lung cancer, who have received first-line EGFR TKI treatment and whose disease has progressed (Section 1). The test is to be conducted under new item 73351, which is prescribed with a specific fee and item descriptor (Item 1). The Determination imposes certain statutory requirements that must be met for the Medicare benefit to be paid. The test must be provided to eligible patients under the specified circumstances, and the statutory requirements must be fulfilled. The new item 73351 is now considered specified in the PST, thereby attracting Medicare benefits when the professional service is rendered (Subsection 3C(1)). This ensures that the medical service is recognised under the Health Insurance Act 1973 and can be funded appropriately. There are no specific offences, penalties, or civil/criminal consequences outlined in the Determination itself for breaches of its provisions. However, any breaches of the Health Insurance Act 1973 or the regulations made under it could lead to civil or criminal penalties as prescribed by those respective laws. For example, under the Act, an entity or individual may be subject to financial penalties for fraudulent claims or misrepresentation of facts. The penalties can vary significantly depending on the nature and severity of the breach, but they can include substantial fines and, in some cases, criminal charges. The specifics of these penalties are detailed in other sections of the Health Insurance Act 1973 and the relevant regulations.

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