EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
Health Insurance Act 1973
Health Insurance (Deep Brain Stimulation for Parkinson’s Disease)
Determination HS/01/2005
Subsection 3C(1) of the Health Insurance Act 1973 (“the Act”) allows the Minister to determine in writing that a specified health service (which is not listed in the Medicare Benefits Schedule) shall, in specified circumstances and for specified statutory provisions, be treated as if it were so listed.
The effect of subsection 3C(4) is that a determination made under subsection 3C(1) is a disallowable instrument within the meaning of the Acts Interpretation Act 1901.
On 11 February 2001 the former Minister for Health and Ageing made Health Insurance Determination HS/07/2001 (“Determination HS/07/2001”) to allow the payment of Medicare benefits for deep brain stimulation for Parkinson’s disease. The Determination followed an assessment by the Medical Services Advisory Committee (MSAC) of the evidence supporting the safety, effectiveness and cost-effectiveness of the treatment. At that time, MSAC considered there was insufficient evidence to support permanent funding under Medicare, but recommended interim funding to allow further information on adverse events, longer-term patient outcomes and costs in the Australian setting to be collected. Accordingly, the Determination allowed the payment of benefits until 31 January 2005.
New evidence will now be assessed by MSAC.
Health Insurance (Deep Brain Stimulation for Parkinson’s Disease) Determination HS/01/2005 (“the Determination”) replaces Determination HS/07/2001 and incorporates all subsequent amendments, except that the cessation date is extended from 31 January 2005 until 30 April 2006. Extending the cessation date will mean that Medicare benefits can continue to be paid while MSAC undertakes its assessment of the latest available evidence for the treatment.
Details of the Determination are set out in the Attachment.
ATTACHMENT
NOTES ON CLAUSES
Clause 1 provides that the Amending Determination may be cited as the Health Insurance (Deep Brain Stimulation for Parkinson’s Disease) Determination HS/01/2005.
Clause 2 defines certain terms used in the Determination.
Clause 3 provides that the Determination commences on 1 February 2005.
Clause 4 provides that the Determination ceases on 30 April 2006.
Clause 5 provides that deep brain stimulation services for the treatment of Parkinson’s Disease shall be treated as if were both a professional service and a medical service for the purposes of the provisions of the Health Insurance Act 1973 and the National Health Act 1953 and regulations made under each Act that make provision in respect of professional services or medical services. Clause 5 also provides that each deep brain stimulation service shall be treated as if there were an item in the general medical services table that related to the service and specified a fee in respect of that service.
Clause 6 specifies the circumstances in which the Determination applies. The determination applies to services rendered in relevant centres in respect of a patient whose response to medical therapy is not sustained and is accompanied by unacceptable motor fluctuations.
Schedule 1 lists the relevant centres in which deep brain stimulation services must be provided.
Schedule 2 sets out the deep brain stimulation services to which the Determination relates and specifies the fee in respect of each service.
Overview
The Health Insurance (Deep Brain Stimulation for Parkinson’s Disease) Determination HS/01/2005 was introduced under the authority of the Health Insurance Act 1973 to address the need for continued Medicare funding for deep brain stimulation (DBS) treatments for Parkinson’s disease, while new evidence regarding the treatment's safety, effectiveness, and cost-effectiveness is being assessed. The former Minister for Health and Ageing, through this Determination, extended the cessation date of the previous interim funding arrangement, allowing Medicare benefits for DBS to continue until 30 April 2006. This extension ensures that further data on adverse events, patient outcomes, and treatment costs can be collected within the Australian healthcare setting. The Determination was made following a recommendation by the Medical Services Advisory Committee, which had previously considered the evidence insufficient for permanent funding but recommended interim funding to gather additional information. The Determination specifies that DBS services are to be treated as both professional and medical services, with a defined fee for each service, and applies to patients in designated centres who do not respond adequately to medical therapy and experience unacceptable motor fluctuations.
Scope and Application
The Health Insurance (Deep Brain Stimulation for Parkinson’s Disease) Determination HS/01/2005 applies to deep brain stimulation services for the treatment of Parkinson’s disease and is a specific application under the Health Insurance Act 1973. This Determination ensures that these services are treated as if they were both professional and medical services for the purposes of the Act and the National Health Act 1953, including the regulations made under these Acts. The Determination is applicable to services rendered in specified centres by professionals for patients whose response to medical therapy is not sustained and is accompanied by unacceptable motor fluctuations. It is a national instrument that applies across Australia, with the cessation date set for 30 April 2006. The Determination incorporates all subsequent amendments to the previous Health Insurance Determination HS/07/2005, extending the cessation date from 31 January 2005. Notably, this Determination is subject to disallowance under the Acts Interpretation Act 1901. The relevant centres and specific services, including the associated fees, are detailed in the attached schedules.
Key Provisions
The Health Insurance (Deep Brain Stimulation for Parkinson’s Disease) Determination HS/01/2005 (the Determination) is a legislative instrument made under subsection 3C(1) of the Health Insurance Act 1973 (the Act). It allows deep brain stimulation services for the treatment of Parkinson’s disease to be treated as if they were listed in the Medicare Benefits Schedule, thus enabling the payment of Medicare benefits for these services. Clause 2 of the Determination provides definitions for terms used, while Clause 3 specifies that the Determination commences on 1 February 2005, and Clause 4 states that it ceases on 30 April 2006. Clause 5 is crucial as it stipulates that deep brain stimulation services for Parkinson’s disease are to be treated as both professional and medical services for the purposes of the Act and the National Health Act 1953, with each service treated as if there were a specified item in the general medical services table with a corresponding fee.
The Determination imposes obligations on healthcare providers and patients. Healthcare providers must ensure that deep brain stimulation services are provided in one of the listed relevant centres, as detailed in Schedule 1. Patients must meet the criteria outlined in Clause 6, which requires that their response to medical therapy for Parkinson’s disease is not sustained and that they experience unacceptable motor fluctuations. Additionally, the services must be rendered within the specified period, from 1 February 2005 until 30 April 2006, as outlined in Clauses 3 and 4.
For breaches of the Determination, the Act does not specify particular offences or penalties within the text itself. However, it is pertinent to note that as a disallowable instrument, any failure to comply with the Determination could potentially result in civil or administrative consequences. Given that the Determination relates to Medicare benefits, non-compliance could lead to the withholding of benefits for the affected services. Additionally, given that the Determination is a legislative instrument, broader legal consequences may arise if the provisions are contravened, including possible actions under the Acts Interpretation Act 1901 for instruments made under the Act.