EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (IncobotulinumtoxinA) Determination 2015
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may determine in writing that a health service not specified in an item in the General Medical Services Table (the Table) shall, in specified circumstances and for the purposes of specified statutory provisions, be treated as if it were so specified. The Table is set out in the Health Insurance (General Medical Services Table) Regulations which are re-made each year.
A determination made under subsection 3C(1) of the Act is a legislative instrument (see subsection 3C(4) of the Act and paragraph 6(d) of the Legislative Instruments Act 2003).
Purpose
The purpose of the Determination is to introduce four new items to the Medicare Benefits Schedule (MBS) to enable Medicare benefits to be paid for the injection of IncobotulinumtoxinA (Xeomin®), for the treatment of cervical dystonia (a painful condition in which neck muscles contract involuntarily), blepharospasm (involuntary twitching, blinking, closure or squeezing of the eyelids) in adults and post-stroke spasticity of the upper limb in adults.
The new items are being introduced in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC) Executive.
At its July 2014 meeting, PBAC recommended the listing of Xeomin® under the Pharmaceutical Benefits Scheme (PBS) for the treatment of cervical dystonia, blepharospasm in adults and post-stroke spasticity of the upper limb in adults. This recommendation was made on the basis of a positive cost-minimisation analysis compared to Botox®.
In October 2014, the MSAC Executive supported the creation of new MBS items for the listing of professional service to inject Xeomin® in the above indications. The MSAC Executive advised that the eligible population and conditions of use for the MBS items should reflect the corresponding PBS restrictions.
Operation
The Determination creates four new MBS items (18353, 18365, 18369 and 19374) which will allow benefits to be paid for the injection of Xeomin®. The new items also allow benefits to be paid for the injection of the two existing brands of botulinum toxin currently listed in the PBS and MBS, Botox® and Dysport®. The purpose of creating these new MBS items for the injection of multiple brands of botulinum toxin is to make it simple for practitioners to claim one item for the treatment of the particular condition regardless of the brand of botulinum toxin used.
The Determination applies several provisions found in the Table to the four new MBS items:
- as for all other surgical services listed in subclauses 1.2.4(1) and 1.2.5(1) in the Table, the four new items will require personal attendance by a single medical practitioner on a single patient on a single occasion, and the attendance must be by a medical practitioner who is not employed at a public hospital or, if employed at a public hospital, is exercising his or her right of private practice;
- as for other botulinum toxin items listed in subclause 2.42A.1(1) in the Table, MBS items 18353, 18369 and 18374 do not apply to an injection of botulinum toxin provided in a service mentioned in the item if the botulinum toxin is not administered in accordance with the National Health (Botulinum Toxin Program) Special Arrangement 2011;
- as for other botulinum toxin items listed in subclause 2.42A1(2) of the Table, the four new items, if the cost of the botulinum toxin injection supplied in connection with the service described in the new item is not subsidised by the Commonwealth or a State, the service is not taken to include the supply of the botox;
- as for other botulinum toxin items listed for the treatment of upper limb spasticity in Clause 2.42A.2 of the Table item 18365 is only applicable to the first four treatments, not exceeding two for each limb, on any one day and the treatment may not be provided on the same occasion as a service mentioned in item 18364.
This Determination commences on 1 April 2015 and ceases to have effect at
23:59, 30 June 2015. It is intended that from 1 July 2015, MBS items 18353, 18365, 18369 and 18374 will be listed directly in the Health Insurance (General Medical Services Table) Regulations.
The Act specifies no conditions which need to be met before the power to make the determination may be exercised.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Consultation
During MSAC’s assessment of the listing of professional service for the injection of Xeomin® in the MBS, the application was made available for public comment. As part of this process, stakeholders and professional groups were given an opportunity to provide feedback on the application. No feedback was received opposing the introduction of the new Xeomin® items.
Authority: Subsection 3(1) of the
Health Insurance Act 1973
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (IncobotulinumtoxinA) Determination 2015
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
The purpose of the Health Insurance (IncobotulinumtoxinA) Determination 2015 (the Determination) is to introduce four new items to the Medicare Benefits Schedule (MBS) to enable Medicare benefits to be paid for the injection of a newly approved brand of Botox, IncobotulinumtoxinA (Xeomin®) for the treatment of cervical dystonia (a painful condition in which neck muscles contract involuntarily), blepharospasm (involuntary twitching, blinking, closure or squeezing of the eyelids) in adults and post-stroke spasticity of the upper limb in adults. The Determination will ensure that Medicare benefits can be paid for the provision of Xeomin® at the same time as Xeomin® is listed on the Pharmaceutical Benefits Scheme (PBS).
Human rights implications
The Determination engages Articles 2, 9 and 12 and 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 has also stated that the ‘highest attainable standard of health’ takes into account the country’s available resources. The 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 realization of the highest attainable standard of health.
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.
Analysis
The Determination advances rights to health and social security by increasing access to publicly subsidised health services which are safe, clinically effective and representative of best medical practice.
Kirsty Faichney
First Assistant Secretary
Medical Benefits Division
Department of Health