EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Pathology Services—BRAF Gene Testing) Determination 2017
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by writing, 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 re-made each year. The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulation 2016 (PST) which commenced on 19 August 2016.
Purpose
Medical Benefits Schedule (MBS) item 73336 funds a test of tumour tissue from a patient with unresectable stage III or stage IV metastatic cutaneous melanoma. The test is currently available under the MBS to determine the BRAF V600 gene status, in order to determine a patient’s eligibility for treatment with dabrafenib under the PBS.
In March 2016, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that vemurafenib (to be taken in combination with cobimetinib) be PBS listed for this same patient group. Following the PBAC recommendation to list vemurafenib, the Medical Services Advisory Committee (MSAC) supported the addition of vemurafenib to MBS item 73336.
The purpose of the Health Insurance (Section 3C Pathology Services—BRAF Gene Testing) Determination 2017 (the Determination) is to maintain the legal basis for the payment of Medicare benefits for the genetic pathology service provided under item 73336 following the repeal of the item from the PST on 1 May 2017 by the Health Insurance Legislation Amendment (2017 Measures No. 1) Regulations 2017. Item 73336 will also be expanded in scope to cover testing for access to the newly listed Pharmaceutical Benefits Scheme (PBS) medicine, vemurafenib.
All other conditions on eligibility for access to item 73336, including access as a pathologist-determinable service, remain unchanged.
Consultation
As part of the MSAC process, consultation was undertaken with professional bodies, consumer groups, the public and clinical experts for proposals put forward for consideration by the Committee.
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.
The Royal College of Pathologists Australasia was consulted about the specification of item 73336 as a pathologist-determinable service at the time it was first included in the PST.
Details of the Determination are set out in the Attachment.
The Determination commences on 1 May 2017.
The Determination is 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—BRAF Gene Testing) Determination 2017
Section 1 – Name of Determination
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Pathology Services—BRAF Gene Testing) Determination 2017.
Section 2 – Commencement
Section 2 provides that the Determination commences on 1 May 2017.
Section 3 – Authority
Section 3 provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Definitions
Section 4 defines terms used in the Determination.
Section 5 – Treatment of relevant services
Section 5 provides that a clinically relevant service provided in accordance with the Determination shall be treated, for relevant provisions of the Health Insurance Act 1973 and National Health Act 1953, and regulations made under those Acts, as if it were both a professional service and a medical service and as if there were an item specified in the pathology services table for the service. The pathology services table is a table of pathology services prescribed under section 4A of the Health Insurance Act 1973.
Section 6 – Effect of specified provisions
Subsection 6(1) provides that section 5 of the Health Insurance (Pathologist-determinable Services) Determination 2015 shall have effect as if the relevant service described in item 73336 was also specified in paragraph 5(a) and item 73336 was specified in item 1 of column 1 of the table to subparagraph 5(b)(iii).
Paragraph 5(a) of the Health Insurance (Pathologist-determinable Services) Determination 2015 provides that pathology services that are mentioned in the pathology services table and rendered by or on behalf of an approved pathology practitioner (APP) to their own patients are pathologist-determinable services, meaning that no request for the service is required.
An item specified in column 1 of an item to the table to subparagraph 5(b)(iii) is a pathologist-determinable service where:
(a) it is rendered by or on behalf of an APP;
(b) the APP considers the service is necessary because of the results of another pathology test requested for the patient; and
(c) the other pathology test is specified in column 2 of the same table item.
Schedule 1 – Relevant services
Prescribes the fee and item descriptor for service 73336.
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—BRAF Gene Testing) Determination 2017
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
Medical Benefits Schedule (MBS) item 73336 funds a test of tumour tissue from a patient with unresectable stage III or stage IV metastatic cutaneous melanoma. The test is currently available under the MBS to determine the BRAF V600 gene status, in order to determine a patient’s eligibility for treatment with dabrafenib under the PBS.
In March 2016, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended that vemurafenib (to be taken in combination with cobimetinib) be PBS listed for this same patient group. Following the PBAC recommendation to list vemurafenib, the Medical Services Advisory Committee (MSAC) supported the addition of vemurafenib to MBS item 73336.
The purpose of the Health Insurance (Section 3C Pathology Services—BRAF Gene Testing) Determination 2017 (the Determination) is to maintain the legal basis for the payment of Medicare benefits for the genetic pathology service provided under item 73336 following the repeal of the item from the PST on 1 May 2017 by the Health Insurance Legislation Amendment (2017 Measures No. 1) Regulations 2017. Item 73336 will also be expanded in scope to cover testing for access to the newly listed Pharmaceutical Benefits Scheme (PBS) medicine, vemurafenib.
All other conditions on eligibility for access to item 73336, including access as a pathologist-determinable service, remain unchanged.
Human rights implications
The Regulations engage 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 Determination will advance rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective.
Conclusion
This Legislative Instrument is compatible with human rights as it has a positive effect on human rights issues.
Teresa Gorondi
Acting Assistant Secretary
Medical Specialist Services Branch
Medical Benefits Division
Department of Health