EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Aged Care
Health Insurance Act 1973
Health Insurance (Extended Medicare Safety Net) Amendment (Repetitive Transcranial Magnetic Stimulation Capping) Determination 2021
Section 10B of the Health Insurance Act 1973 (the Act) provides that the Minister for Health may, by legislative instrument, determine to which Medicare items subsections 10ACA(7A) and 10ADA(8A) apply and the maximum increases in Medicare benefit payable for those items under the Extended Medicare Safety Net (EMSN).
The increase in the Medicare benefit payable under the EMSN is commonly referred to as the ‘EMSN benefit’ and the maximum increase amount is known as the ‘EMSN benefit cap’. The EMSN provides an additional benefit for Australian families and singles who incur high out-of-pocket costs for Medicare eligible out-of-hospital services.
Subsections 10ACA(7A) and 10ADA(8A) of the Act provide that where a Medicare item is listed in a determination made under section 10B, the EMSN benefit must not exceed the amount determined as the EMSN benefit cap.
Purpose
In the 2021-22 Budget under the Primary Care measure, the Government announced it would introduce four new items (14216, 14217, 14219 and 14220) for repetitive transcranial magnetic stimulation (rTMS) therapy for the treatment of medication resistant major depressive disorder.
From 1 November 2021, the new items will provide rTMS services for eligible adult patients (18 years old or older), who have not previously received rTMS services in the public or private setting, and who have trialled at least two different classes of antidepressant medicines but have not responded to this course of treatment. These items will be introduced in the Health Insurance Legislation Amendment (2021 Measures No. 2) Regulations 2021 (the Regulations).
rTMS therapy represents a non-invasive treatment option for patients with severe depression compared to electroconvulsive therapy currently offered under Medicare Benefits Schedule (MBS), which is commonly used as a last resort for many patients who do not respond to antidepressant medication.
The purpose of the Health Insurance (Extended Medicare Safety Net) Amendment (Repetitive Transcranial Magnetic Stimulation Capping) Determination 2021 (the EMSN Amendment Determination) is to amend the Health Insurance (Extended Medicare Safety Net) Determination 2017 (the Principal Determination) to apply an EMSN benefit cap to the rTMS items from
1 November 2021.
The rTMS items were supported by the Medical Services Advisory Committee (MSAC) at its August 2019 and November 2019 meetings (MSAC applications 1196.2 and 1196.3). MSAC supported applying an EMSN benefit cap on the new rTMS items.
The EMSN Amendment Determination will also remove item 32507, which is for varicose vein treatment, as this item will be amended in the Regulations to become an in-hospital service only from 1 November 2021. This is an administrative change as the EMSN benefit cap only applies to Medicare eligible out-of-hospital services, and therefore will no longer apply to item 32507.
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. Consultation was undertaken as part of consideration of the MSAC application for the new listing of the rTMS items. Consultation on the implementation of the rTMS items was undertaken with the Royal Australian and New Zealand College of Psychiatrists.
Consultation on the removal of an EMSN benefit cap for item 32507 was not undertaken as this change is administrative in nature.
Details of the Determination are set out in the Attachment.
The EMSN Amendment Determination will not commence until it has been approved by each House of Parliament. This instrument will commence the later of the day it is approved by each House of Parliament or the day after registration. Schedule 1 of the Determination will commence on 1 November 2021 or the day this instrument is approved by each House of Parliament, whichever occurs later.
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Section 10B of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Extended Medicare Safety Net) Amendment (Repetitive Transcranial Magnetic Stimulation Capping) Determination 2021
Section 1 – Name
Section 1 provides for the Determination to be referred to as the Health Insurance (Extended Medicare Safety Net) Amendment (Repetitive Transcranial Magnetic Stimulation Capping) Determination 2021.
Section 2 – Commencement
Section 2 provides that the Determination will not commence until it has been approved by each House of Parliament. Subject to Parliament’s approval, the Determination will commence the later of the day after registration or the day after the Determination has been approved by each House of Parliament.
Subject to Parliament’s approval, Schedule 1 of the Determination will commence on
1 November 2021. If Parliament approves the Determination after 1 November 2021, Schedule 1 will commence the day after it has been approved by each House of Parliament.
Section 3 – Authority
Section 3 provides that the Determination is made under section 10B of the Health Insurance Act 1973 (the Act).
Section 4 – Schedules
Section 4 provides that 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 (Extended Medicare Safety Net) Determination 2017 (Principal Determination)
Amendment 1 – Subsection 4(1) (after table item dealing with item 14202)
Amendment 1 inserts four items 14216, 14217, 14219 and 14220 for repetitive transcranial magnetic stimulation (rTMS) therapy to provide that an Extended Medicare Safety Net (EMSN) benefit cap of $500.00 will be applied to items 14216 and 14219, and an EMSN benefit cap of $316.65 will be applied to items 14217 and 14220.
Amendment 2 – Paragraph 4(2)(a)
Amendment 2 removes item 32507 from paragraph 2(a) of the Principal Determination, as this item will become an in-hospital service only and an EMSN benefit cap of 80 per cent of the schedule fee will no longer apply.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Extended Medicare Safety Net) Amendment Determination 2021
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
In the 2021-22 Budget under the Primary Care measure, the Government announced it would introduce four new items (14216, 14217, 14219 and 14220) for repetitive transcranial magnetic stimulation (rTMS) therapy for the treatment of medication resistant major depressive disorder.
From 1 November 2021, the new items will provide rTMS services for eligible adult patients (18 years old or older), who have not previously received rTMS services in the public or private setting, and who have trialled at least two different classes of antidepressant medicines but have not responded to this course of treatment. These items will be introduced in the Health Insurance Legislation Amendment (2021 Measures No. 2) Regulations 2021 (the Regulations).
rTMS therapy represents a non-invasive treatment option for patients with severe depression compared to electroconvulsive therapy currently offered under Medicare Benefits Schedule (MBS), which is commonly used as a last resort for many patients who do not respond to antidepressant medication.
The purpose of the Health Insurance (Extended Medicare Safety Net) Amendment (Repetitive Transcranial Magnetic Stimulation Capping) Determination 2021 (the EMSN Amendment Determination) is to amend the Health Insurance (Extended Medicare Safety Net) Determination 2017 (the Principal Determination) to apply an EMSN benefit cap to the rTMS items from
1 November 2021.
The rTMS items were supported by the Medical Services Advisory Committee (MSAC) at its August 2019 and November 2019 meetings (MSAC applications 1196.2 and 1196.3). MSAC supported applying an EMSN benefit cap on the new rTMS items.
The EMSN Amendment Determination will also remove item 32507, which is for varicose vein treatment, as this item will be amended in the Regulations to become an in-hospital service only from 1 November 2021. This is an administrative change as the EMSN benefit cap only applies to Medicare eligible out-of-hospital services, and therefore will no longer apply to item 32507.
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.
The right of equality and non-discrimination
The rights of equality and non-discrimination are contained in articles 2, 16 and 26 of the International Covenant on Civil and Political Rights (ICCPR). Article 26 of the ICCPR requires that all persons are equal before the law, are entitled without any discrimination to the equal protection of the law and in this respect, the law shall prohibit any discrimination and guarantee
to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.
Analysis
This instrument maintains rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective. The instrument will apply an EMSN benefit cap to the new rTMS items 14216, 14217, 14219 and 14220, as was supported by the Medical Services Advisory Committee.
The instrument will also make an administrative change by removing item 32507, as EMSN benefits cannot be paid on in-hospital services.
Conclusion
This instrument is compatible with human rights as it maintains the right to health and the right to social security.
Greg Hunt
Minister for Health and Aged Care