EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
Health Insurance Act 1973
Health Insurance (Facial Injections of Poly-L-lactic acid) Determination 2011
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by writing, determine that a health service not listed in the general medical services table (the Table) shall, in specified circumstance and for specified statutory provisions, be treated as if it were so listed. This Table is currently set out in the Health Insurance (General Medical Services Table) Regulations 2010.
The purpose of the Determination is to enable the payment of Medicare benefits for the medical procedure to inject poly-L-lactic acid (Sculptra®) for the treatment of severe facial lipoatrophy caused by antiretroviral therapy in HIV positive patients.
Two new Medicare Benefits Schedule (MBS) items will provide for the following services for eligible patients:
- the initiation of a course of treatment, limited to one injection session (item 14201);
- subsequent injection sessions, up to a maximum of four adjustment treatments, followed by one maintenance injection session every two years (item 14202).
Item descriptors are consistent with Pharmaceutical Benefits Scheme (PBS) restrictions, such as the maximum number of treatments. Authority is required to prescribe Sculptra under the PBS. Patients must be referred from the HIV physician to an accredited injector.
Details of this Determination are set out in the Attachment.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This Determination commences on 1 July 2011.
Consultation
The Department wrote to the Australian Medical Association and relevant professional and consumer representative stakeholders regarding the Medicare item structure and content for services, seeking their advice or comments in relation to the draft item descriptors and related explanatory notes. The stakeholder groups included the Australasian Society for HIV Medicine, Australian Society of Plastic Surgeons, the Australasian College of Dermatologists and the Royal Australian College of General Practitioners. The letters directed stakeholders to a link to the Medical Services Advisory Committee’s (MSAC) website at which details of the application for funding and MSAC’s Public Summary Document, which articulated MSAC’s recommendations on fees and the EMSN, could be found. All bodies supported the introduction of these items.
ATTACHMENT
Details of the Health Insurance (Facial Injections of Poly-L-lactic acid) Determination 2011
Section 1 – Name of Determination
Section 1 provides for the Determination to be referred to as the Health Insurance (Facial Injections of Poly-L-lactic acid) Determination 2011.
Section 2 – Commencement and term
Section 2 provides that the Determination commences on 1 July 2011 and shall remain in force until midnight 31 October 2011.
Section 3 – Interpretation
Section 3 defines specific terms used in this Determination.
Section 4 – Treatment of a relevant service
Subsection 4(a) provides that a relevant service specified in the Schedule to the Determination will be treated as if it were both a professional service and a medical service for the purposes of the provisions of the Act, the National Health Act 1953 and regulations made under each Act which provide for medical services or professional services.
Subsection 4(b) provides that a relevant service specified in the Schedule to the Determination is to be treated as if there were an item in the General Medical Services Table related to the service and specified a fee for that service, being the fee specified in the Schedule to the Determination in relation to the service.
Section 5– Application of items 14201 and 14202
This section provides that only accredited injectors are able to provide the services. Accreditation follows the completion of injection administration training with Sanofi-Aventis, the manufacturer of Sculptra®. Patients must be referred from the HIV physician to the accredited injector.
Section 6– Limitations on item 14202
This section sets out the limitations for item 14202.
Schedule
The Schedule sets out the relevant services and assigns to the services the applicable item number, item descriptor and fee.