EXPLANATORY STATEMENT

Health Insurance Act 1973

Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013

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 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 (the Regulations), which are re-made each year.

The purpose of the Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (the Determination) is to introduce a new Medicare items (item 18375) for the injection of botulinum toxin for urinary incontinence due to neurogenic detrusor overactivity.

The new item is being introduced in accordance with recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC).             

At its March 2013 meeting, PBAC recommended extending the current Section 100 Botulinum Toxin Program listing for botulinum toxin type A (Botox) under the Pharmaceutical Benefits Scheme to include the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients with multiple sclerosis or spinal cord injury, or patients aged 18 years or older who have spina bifida and who meet certain criteria.  This recommendation was made on the basis of acceptable cost-effectiveness compared to best supportive care.

In April 2013, MSAC supported the creation of a new Medicare (MBS) item for intravesical injection of Botox for the treatment of certain patients with urinary incontinence due to neurogenic detrusor overactivity. MSAC advised that the eligible population and conditions of use for the Medicare item should reflect the corresponding Pharmaceutical Benefits Scheme restrictions under the Section 100 Botulinum Toxin Program listing.

The Determination applies several provisions found in the Table to new item 18375:

• as for all other items in the Table, Medicare will not be payable for the new Botox item if it is provided in contravention of a law of the Commonwealth, a State or a Territory (paragraph 7(1)(a) of the Determination).
• as for all other surgical services in the Table, the new Botox item 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 (paragraphs 7(1)(b) and (c) of the Determination);
• as for other botulinum toxin items 18350 – 18373 in the Table:
  • the new Botox item will only be claimable by a medical practitioner registered by the Chief Executive Medicare to participate in the arrangements made under paragraph 100(1)(b) of the National Health Act 1953 for the purpose of providing an adequate pharmaceutical service for individuals requiring treatment with botulinum toxin; and
  • if the cost of the Botox injection supplied in connection with the service described in new item is not subsidised by the Commonwealth or a State, the service is not taken to include the supply of the Botox (paragraph 7(1)(d) of the Determination).

Consultation

During MSAC’s assessment of the professional service, the application was made available for public comment.  As part of this process, specific stakeholders and professional groups where given an opportunity to provide feedback on the application.  Relevant professional groups who provided feedback included the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Uro-Gynaecological Association of Australia and Urological Society of Australia and New Zealand.  No feedback was received opposing the introduction of the new Botox item.  Ongoing consultation has also occurred with Allergan Australia Pty Ltd, the applicant and manufacturer of Botox.

The Determination commences on 1 October 2013 and ceases at midnight 31 October 2013.  From 1 November 2013 new item 18375 will the listed directly in the General Medical Services Table.  

This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Statement of Compatibility with Human Rights

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

Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013

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 Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (the Determination) creates a new Medicare item for the injection of botulinum toxin for urinary incontinence due to neurogenic detrusor overactivity.

Human rights implications

This 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

This new service will advance the human rights to health and social security by assisting private patients with financial costs associated with receiving this clinically relevant medical service.

Richard Bartlett

First Assistant Secretary

Medical Benefits Division