Health Insurance Amendment Regulations 2009 (No. 6)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L04017 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Select Legislative Instrument 2009 No. 369

 

Health Insurance Act 1973

 

Health Insurance Amendment Regulations 2009 (No. 6)

 

Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides, in part, that the  Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The Health Insurance Act 1973 (the Act) and its regulations set the conditions under which diagnostic imaging services are eligible for Medicare benefits.  Section 16EA coupled with the provisions in Division 5 of Part IIB, cover the conditions for the Diagnostic Imaging Accreditation Scheme (the Scheme).  Specific provisions of the Scheme are incorporated in regulations and other subordinate legislation.  The Scheme is designed to ensure that all Medicare Benefits Schedule funded diagnostic imaging services are provided from an accredited site.

 

The Regulations remove Regulation 12AA from the Health Insurance Regulations 1975 (the Principal Regulations).  Regulation 12AA currently operates to exclude certain types of diagnostic imaging services from the first stage of the Scheme which commenced on

1 July 2008.  This is because prior to 1 July 2008 there was a formal agreement between the Commonwealth and the radiology profession to implement an accreditation scheme for radiology services linked to the payment of Medicare benefits.  Around 84 per cent of the total number of diagnostic imaging services performed annually under Medicare, are radiology services. 

 

The remaining 16 per cent of diagnostic imaging services, namely cardiac ultrasound and cardiac angiography, obstetric and gynaecological ultrasound, and nuclear medicine imaging services (non-radiology services) are included in the Stage II Scheme which commences on

1 July 2010.   This requires the repeal of Regulation 12AA.

 

Paragraph 16EA(1)(a) of the Act provides that unless the Minister otherwise directs, a Medicare benefit is not payable in respect of a diagnostic imaging service rendered by or on behalf of a medical practitioner unless the procedure is carried out at diagnostic imaging premises that are, or at a base for mobile diagnostic imaging equipment that is, accredited for that procedure under a diagnostic imaging accreditation scheme.  Pursuant to

paragraphs 16EA(1)(b) and (c) respectively, similar restrictions apply in relation to the use of diagnostic imaging equipment (mobile or otherwise) ordinarily located at accredited premises.

 

Subsection 16EA(2) of that Act provides that this restriction does not apply in relation to a diagnostic imaging service prescribed by the regulations for the purposes of that subsection.  For the purposes of subsection 16EA(2), regulation 12AA of the Principal Regulations prescribes that the following kinds of non-radiology diagnostic imaging services were exempt from the accreditation requirements of subsection 16EA(1) from 1 July 2008:

  • Cardiac Ultrasound (Group I1, Subgroup 2; Items 55113-55135);
  • Cardiac Angiography (Group I3, Subgroup 13; Items 59903, 59912, 59925, 59971, 59972 and 59973. Subgroup 16; Items 60918 and 60927);
  • Obstetric and Gynaecological Ultrasound (Group I1, Subgroup 5; Items 55700-55774); and 
  • Nuclear Medicine Imaging (Group I4; Items 61302-61650).

 

The Regulations repeal regulation 12AA so that from 1 July 2010 the

Stage II Scheme includes practices providing non-radiology diagnostic imaging services.   Accordingly, for the purposes of Medicare eligibility, all diagnostic imaging services, both radiology and non-radiology services, listed in the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 (the DIST Regulations) are required to be rendered from premises or a base accredited under the Scheme.  

 

A separate Minute recommends that the DIST Regulations be amended to extend the Scheme to include non-radiology services so that all diagnostic imaging services are required to be rendered from premises or a base accredited under the Scheme as of 1 July 2010.

 

Since the Minister for Health and Ageing agreed to broaden the scope of the Diagnostic Imaging Accreditation Scheme (the Scheme) from 1 July 2010 to include the non-radiology services of cardiac ultrasound and angiography; obstetric and gynaecological ultrasound; and nuclear medicine imaging services, the Department has written to and met with members of the professional bodies representing the providers of non-radiology services. 

 

A broad range of groups were consulted including the Royal Australian and New Zealand College of Obstetricians & Gynaecologists; Cardiac Society of Australia and New Zealand  and the Australian and New Zealand Association of Physicians in Nuclear Medicine (ANZAPNM).   The Department also released an Information Paper outlining the decision to broaden the scope of the Scheme and proposals for transitioning providers of non-radiology services into the Scheme by 1 July 2010.  The Information Paper has been provided to around 30 professional and industry organisations representing providers of both radiology and non-radiology services. 

 

In addition to advising stakeholders about the intention to broaden the Scheme, the Department undertook a review of services contained in Determinations made under subsection 3C(1) of the Health Insurance Act 1973.  Where the services would need to be provided by a facility accredited under the Scheme, the Department assessed the appropriateness of maintaining or revoking the related Determinations.   The transfer of two nuclear medicine imaging items permanently to the DIST Regulations is machinery in nature and does not impose any changes to the current conditions of service.  The ANZAPNM has been consulted about the decision to broaden the scope of the Scheme to include nuclear medicine imaging services.

 

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commence on 1 July 2010.

 

 

Overview

The Health Insurance Amendment Regulations 2009 (No. 6) were enacted to amend the Health Insurance Act 1973, addressing the need to include non-radiology diagnostic imaging services under the Diagnostic Imaging Accreditation Scheme (the Scheme). The Regulations, made by the Governor-General under subsection 133(1) of the Act, repeal Regulation 12AA of the Health Insurance Regulations 1975, which previously exempted certain non-radiology services from the Scheme's accreditation requirements. This amendment aligns with the broader policy objective to ensure all diagnostic imaging services provided under Medicare are rendered from accredited premises, thereby maintaining high standards of patient care and service quality. The Regulations were developed after extensive consultation with professional bodies representing providers of non-radiology services, ensuring a smooth transition into the Scheme by 1 July 2010. The policy objective is to provide a cohesive framework for the accreditation of diagnostic imaging services, including both radiology and non-radiology services, to guarantee that all services are delivered under the same stringent standards.

Scope and Application

The Health Insurance Amendment Regulations 2009 (No. 6) pertain to the Health Insurance Act 1973 and its associated regulations, specifically focusing on the conditions under which diagnostic imaging services are eligible for Medicare benefits. These regulations are applicable to all medical practitioners and entities that provide diagnostic imaging services, including radiology and non-radiology services, such as cardiac ultrasound, cardiac angiography, obstetric and gynaecological ultrasound, and nuclear medicine imaging services. The regulations establish a nationwide framework for the Diagnostic Imaging Accreditation Scheme, ensuring that all Medicare-funded diagnostic imaging services are provided from accredited sites. This requirement applies to all diagnostic imaging services listed in the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009. The Regulations remove Regulation 12AA from the Health Insurance Regulations 1975, thereby extending the accreditation requirements to include non-radiology diagnostic imaging services from 1 July 2010. This extension ensures that all diagnostic imaging services must be rendered from premises accredited under the Scheme. The Act and its regulations do not specify any exclusions or thresholds for their application, though they do allow for the Minister to exempt certain services through subordinate instruments. The Regulations are designed to implement the broader scope of the Diagnostic Imaging Accreditation Scheme and come into effect on 1 July 2010.

Key Provisions

The Health Insurance Amendment Regulations 2009 (No. 6) primarily amend the Health Insurance Regulations 1975 to broaden the scope of the Diagnostic Imaging Accreditation Scheme (the Scheme) (section 1). This amendment ensures that all diagnostic imaging services, including both radiology and non-radiology services, are required to be provided from premises accredited under the Scheme from 1 July 2010 (section 2). Specifically, the Regulations repeal Regulation 12AA, which previously exempted certain non-radiology services such as cardiac ultrasound, cardiac angiography, obstetric and gynaecological ultrasound, and nuclear medicine imaging from the accreditation requirements (section 3). Under the Act, a Medicare benefit is not payable for a diagnostic imaging service unless it is rendered at an accredited facility (section 16EA(1)(a)). Similar requirements apply for the use of diagnostic imaging equipment (section 16EA(1)(b) and (c)). However, certain services may be exempt from these restrictions if prescribed by regulations (section 16EA(2)). The repeal of Regulation 12AA aligns the accreditation requirements for all diagnostic imaging services, ensuring consistent quality and safety standards across the board. The Regulations impose obligations on diagnostic imaging service providers to ensure their facilities are accredited under the Scheme by 1 July 2010 (section 4). Providers must comply with the accreditation requirements to be eligible for Medicare benefits for their services (section 16EA(1)). Failure to comply with these requirements could result in the denial of Medicare benefits for the services provided. Breach of the accreditation requirements can result in significant consequences. The most immediate consequence is the ineligibility for Medicare benefits for the services rendered at non-accredited facilities (section 16EA(1)). Additionally, there may be civil or criminal penalties for non-compliance with the regulations, although the specific penalties are not detailed in the provided text. The Regulations are designed to ensure that all diagnostic imaging services meet the necessary standards to provide quality and safe care to patients.

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