Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01840 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Health Insurance Act 1973

Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (No.2)

 

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) Regulation (the Regulation), which is re-made each year.

 

The purpose of the Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (No.2) (the Determination) is to
enable the ongoing listing of item 18375 for the injection of botulinum toxin for urinary incontinence due to neurogenic detrusor overactivity.  The Determination will remain in place until listing can occur through the Regulation. 

 

Item 18375 was introduced on 1 October 2013 by the Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (the Current Determination).  The Current Determination ceases on 31 October 2013, after which item 18375 was expected to be included in the re-make of the Regulation due to commence on 1 November 2013.  However, the 1 November 2013 re-make has been postponed and is now expected to occur in late November 2013.  The Determination is required to maintain listing of item 18375 until the new Regulation commences. 

 

The Determination continues to apply several provisions found in the Table to item 18375:

  • as for all other items in the Table, Medicare will not be payable for the 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 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 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 the 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).

 

These provisions are all applied under the Current Determination.

 

 

Consultation

No consultation has been undertaken in relation to the making of this Determination.  Its purpose is to maintain the current listing of item 18375 until it can be incorporated into the Regulation.  The Determination makes no changes to the rules applying to the use of item 18375.

The Determination commences on 1 November 2013 and ceases as if repealed on the date the Health Insurance (General Medical Services) Table Regulation 2012 ceases, or is earlier repealed as part of the annual remake of the Regulation.  The new Regulation, expected to be made in late November 2013, will list item 18375 directly in that Regulation.  

 

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 (No.2)

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 (No.2) (the Determination) enables the ongoing listing of item 18375 for the injection of botulinum toxin for urinary incontinence due to neurogenic detrusor overactivity.

Item 18375 was introduced on 1 October 2013 by the Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (the Current Determination).  The Current Determination ceases on 31 October 2013, after which time item 18375 was expected to be included in the annual re-make of the Health Insurance (General Medical Services Table) Regulation due to commence on 1 November 2013. 

 

However, the 1 November 2013 re-make was postponed and is now expected to occur in late November 2013.  The Determination is required to maintain Medicare access to item 18375 until the new Regulation commences. 

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

The Determination will advance the human rights to health and social security by maintaining current Commonwealth assistance to private patients with financial costs associated with receiving this clinically relevant medical service through the Medicare scheme.  

 

Richard Bartlett

First Assistant Secretary

Medical Benefits Division

Department of Health

 

Overview

The Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (No.2) was enacted by the Australian government to address the gap in the Health Insurance Act 1973 caused by the delay in the annual re-make of the Health Insurance (General Medical Services Table) Regulation. This Determination was introduced by the Minister for Health under the authority provided in Subsection 3C(1) of the Health Insurance Act 1973, allowing for the listing of specific health services that are not explicitly mentioned in the General Medical Services Table. The policy objective of this Determination is to ensure the continuity of Medicare coverage for the injection of botulinum toxin for urinary incontinence due to neurogenic detrusor overactivity, specifically item 18375, until it can be formally incorporated into the Regulation. This Determination maintains several provisions found in the General Medical Services Table, such as the requirement for personal attendance by a medical practitioner and the prohibition of payments for services provided in contravention of any law. Additionally, it ensures that the item remains claimable only by medical practitioners registered for providing botulinum toxin treatments and stipulates that the cost of the Botox injection must be subsidised by the Commonwealth or a State for the service to be claimable under Medicare. The Determination is set to cease when the Health Insurance (General Medical Services Table) Regulation 2012 is remade, expected in late November 2013, and it does not alter the existing rules for the use of item 18375. This interim measure is intended to uphold the rights to health and social security by ensuring continued access to necessary medical services for eligible patients.

Scope and Application

The Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (No.2) applies to the injection of botulinum toxin for urinary incontinence due to neurogenic detrusor overactivity and is administered under the Health Insurance Act 1973. This Determination is applicable to medical practitioners who provide the specified health service and patients who receive it, ensuring that the service continues to be listed under Medicare until the next annual re-make of the Health Insurance (General Medical Services Table) Regulation. The Determination also ensures that specific statutory provisions regarding the provision of this service are maintained, such as personal attendance by a single medical practitioner on a single patient and the requirement that the practitioner not be employed at a public hospital or be exercising their right of private practice if employed at one. This Determination applies across the Commonwealth of Australia, with no specific exclusions beyond the statutory conditions already outlined in the Health Insurance (General Medical Services Table) Regulation. It is effective until the next annual re-make of the Regulation, expected in late November 2013, at which point item 18375 will be directly incorporated into that Regulation. This Determination does not involve any consultation process, as its purpose is purely transitional until the new Regulation is in place.

Key Provisions

The Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (No. 2) (the Determination) is designed to ensure that the treatment for urinary incontinence due to neurogenic detrusor overactivity, specifically the injection of botulinum toxin, remains accessible under Medicare. This Determination, which aligns with Subsection 3C(1) of the Health Insurance Act 1973, allows for the ongoing listing of item 18375, which was initially introduced by the Health Insurance (Botulinum Toxin for Urinary Incontinence due to Neurogenic Detrusor Overactivity) Determination 2013 (the Current Determination). The Current Determination expired on 31 October 2013, and the new Determination continues the listing until the new Health Insurance (General Medical Services Table) Regulation is enacted, which has been postponed to late November 2013. Under the Determination, several key provisions from the General Medical Services Table apply to item 18375, ensuring that the service is provided in compliance with applicable laws and by qualified medical practitioners. For instance, paragraph 7(1)(a) of the Determination stipulates that Medicare will not cover the service if it contravenes any Commonwealth, State, or Territory laws. Additionally, paragraphs 7(1)(b) and (c) ensure that the service must be provided by a medical practitioner personally attending to the patient, who cannot be employed at a public hospital unless they are exercising their right to private practice. Furthermore, the service is only claimable by medical practitioners registered under the National Health Act 1953 to provide adequate pharmaceutical services for botulinum toxin treatment, as per paragraph 7(1)(d). These provisions maintain the same standards as those applied under the Current Determination. The Determination imposes specific obligations on medical practitioners and patients. Medical practitioners must ensure they are registered to provide this service and that they comply with all legal requirements when administering the treatment. Patients, on the other hand, should ensure their practitioners are appropriately registered and that the treatment is provided within the legal framework. Additionally, if the cost of the botulinum toxin is not subsidized by the Commonwealth or a State, the supply of the toxin is not considered part of the service, as outlined in paragraph 7(1)(d). Failure to comply with the provisions of the Determination could result in the service not being covered by Medicare. There are no specific penalties outlined in the Determination itself, but any contravention of laws mentioned in paragraph 7(1)(a) could lead to civil or criminal consequences under the applicable laws. This ensures that the service remains within the bounds of the law and that Medicare benefits are only used for legitimate and compliant services.

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