Explanatory Statement
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Poly Implant Prosthese MRI) Amendment Determination 2012 (No. 1)
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 diagnostic imaging services table (the Table) shall, in specified circumstance and for specified statutory provisions, be treated as if it were so listed. This Table is set out in the Health Insurance (Diagnostic Imaging Services Table) Regulations, which is remade each year.
Purpose
The Health Insurance (Poly Implant Prosthese MRI) Amendment Determination 2012 (No. 1) (the Determination) amends the Health Insurance (Poly Implant Prosthese MRI) Determination 2012 (the Principal Determination) to expand the category of practitioners able to refer patients for Medicare-eligible MRI scans to assess the integrity of breast implants manufactured by French company Poly Implant Prosthese (PIP).
Background
In March 2010 the Australian Therapeutic Goods Administration (TGA) received advice from the French regulatory agency (AFSSAPS) that the marketing, distribution and export of silicone breast implants manufactured by PIP had been suspended. The suspension followed the AFSSAPS’ detection of deficiencies in the manufacturing process for the implants, including PIP’s alleged use of a gel different to that which it was authorised to use, and an apparent increase in reports of PIP implant rupture. The TGA recalled all unused PIP implants the implants were withdrawn from the Australian market in April 2010.
The Government made the Principal Determination to enable patients with PIP breast implants to receive Medicare benefits for MRI scans performed to check the integrity of their implants, where the scan was requested by a specialist, consultant physician or general practitioner.
However, cosmetic surgery is not recognised as a specialty for the purposes of medical registration or for Medicare purposes. Accordingly, patients who had received their implants from a cosmetic surgeon were not able to be referred for a Medicare-eligible PIP MRI scan by their treating surgeon.
The Determination amends the Principal Determination to allow all medical practitioners, including cosmetic surgeons, to request PIP MRI scans for their patients.
Details of this Determination are set out in the Attachment.
Commencement
This Determination will be taken to have commenced immediately after the commencement of the Principal Determination. The Principal Determination commenced on 12 March 2012.
The retrospective commencement of this Determination is to ensure that patients who have already received a PIP MRI scan, for which they were referred by a cosmetic surgeon, will be eligible to claim Medicare benefits for the scan.
The retrospective commencement does not contravene subsection 12(2) of the Legislative Instruments Act 2003. Subsection 3C(2) of the Act provides that a determination made under that section may be expressed to take effect on a day earlier than the date the determination is made. Further, the Commonwealth is the only person who is disadvantaged by the retrospective commencement date.
Consultation
Extensive formal and informal consultation occurred with MSAC, the TGA and the Department of Human Services in the development of the six Medicare rebatable MRI PIP items in the Determination. Further consultation has been undertaken with the Department of Human Services and industry to refine the implementation aspects of this initiative.
A determination made under subsection 3C(1) of the Act is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Attachment
Details of the health insurance (POLY IMPLANT PROSTHESE MRI) AMENDMENT determination 2012 (NO. 1)
Section 1 Name of Determination
Section 1 provides that the name of the Determination is the Health Insurance (Poly Implant Prosthese MRI) Amendment Determination 2012 (No. 1).
Section 2 Commencement
Section 2 provides that the Determination will be taken to have commenced immediately after the commencement of the Health Insurance (Poly Implant Prosthese MRI) Determination 2012 (the Principal Determination). The Principal Determination took effect on 12 March 2012.
Section 3 Amendment of Health Insurance (Poly Implant Prosthese MRI) Determination 2012
Section 3 provides that Schedule 1 to the Determination amends the Principal Determination.
Schedule 1 Amendments
Item 1
Item 1 makes consequential amendments to the Note to subsection 3(1), removing reference to ‘consultant physician’ and ‘general practitioner’, as these terms are no longer used in the Determination. A reference to ‘medical practitioner’ has been inserted.
Item 2
Item 2 amends subsection 7(1) of the Determination. That subsection previously provided that requests for PIP MRI scans must be made by specialists, consultant physicians and general practitioners.
Subsection 7(1) as amended enables all medical practitioners to request PIP MRI scans for those patients who have, or are suspected of having, PIP breast implants.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Poly Implant Prosthese MRI) Amendment Determination 2012 (No. 1)
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 (Poly Implant Prosthese MRI) Determination 2012 (the Principal Determination) enables the payment of Medicare benefits for MRI scans to check the integrity of silicone breast implants manufactured by French company, Poly Implant Prosthese (PIP).
This Determination amends the Principal Determination to expand the category of practitioners who are able to request Medicare-eligible PIP MRI scans to all medical practitioners. Previously, only specialists, consultant physicians and general practitioners could request PIP MRI scans. As a result, cosmetic surgeons, who are not recognised as specialists under their medical registration or for Medicare purposes, were not able to refer their patients for PIP MRI scans.
This Determination increases patient access to Medicare-eligible PIP MRI scans, and patients who received their implants as a cosmetic procedure are now able to be referred for a PIP MRI scan by their treating surgeon.
Human rights implications
The Determination engages the following human rights:
Right to Health
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 International Covenant on Economic Social and Cultural Rights (ICESCR). Whilst the UN Committee on Economic Social and Cultural Rights (the Committee) has stated that the right to health is not to be understood as a right to be healthy, it does entail 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 stated that the notion of ‘the highest attainable standard of health’ takes into account both the conditions of the individual and 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 realisation of the highest attainable standard of health.
The amendment of the Principal Determination to broaden the category of practitioners able to refer patients to for Medicare-eligible PIP MRI scans results in increased access to Commonwealth Government subsidised MRI services by patients who have, or are suspected of having, PIP breast implants. It also improves ease of access to PIP MRI scans, as patients who received PIP implants from a cosmetic surgeon will not be required to consult a different practitioner in order to be referred for a scan. As such, the Determination advances the right to health.
Right to Social Security
The right to social security is contained in Article 9 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The right 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.
For the reasons discussed in relation to the right to health, the amendments made by the Determination impact positively on the right to social security by increasing access of Australians to Commonwealth benefits promoting health care.
Conclusion
The Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Richard Bartlett, Delegate of the Minister for Health