Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L00840 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Select Legislative Instrument 2009 No. 60

 

    Health Insurance Act 1973

 

Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1)

 

Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides 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 Act provides, in part, for payments of Medicare benefits in respect of professional services rendered to eligible persons. 

 

Subsection 4AA(1) of the Act provides that the regulations may prescribe a table of diagnostic imaging services, the amount of fees applicable in respect of each item and the rules for interpretation of the table.  Schedule 1 to the Health Insurance (Diagnostic Imaging Services Table) Regulations 2008 (the Principal Regulations) prescribes such a table.

 

The purpose of the Regulations is to amend the Principal Regulations to enable Medicare benefits to be paid for Magnetic Resonance Imaging (MRI) services conducted using specified equipment at seven locations in New South Wales, Victoria, Queensland and Western Australia and set out the conditions under which Medicare benefits are paid for these MRI services.

 

The Regulations also clarify an existing item to enable Medicare benefits to be paid for MRI services used in the diagnosis of breast cancer in asymptomatic women less than 50 years of age with a high risk of developing breast cancer.

 

The Department of Health and Ageing undertook a competitive application process to select the specified equipment being granted Medicare-eligibility.  The Department consulted with the seven successful applicants about the requirements for the MRI units to be granted Medicare-eligibility in order to finalise the amendments to the Principal Regulations.  The relevant local communities are keen to see the introduction of Medicare-eligible MRI services at the seven locations as soon as possible.

 

The Department consulted with the Royal Australian and New Zealand College of Radiologists, the Australian Diagnostic Imaging Association, and the National Breast and Ovarian Cancer Centre regarding the patient eligibility requirements prior to the introduction of Medicare benefits for breast MRI services for certain women from February 2009. 

 

Details of the Regulations are provided in the Attachment.

 

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 the day after registration on the Federal Register of Legislative Instruments.

 

      

ATTACHMENT

 

Details of the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1)

 

Regulation 1 – Name of Regulations

 

This regulation provides that the title of the Regulations is the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1).

 

Regulation 2 - Commencement

 

This Regulation provides for the Regulations to commence on the day after registration on the Federal Register of Legislative Instruments.

 

Regulation 3 – Amendment of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2008

 

This regulation provides that the Health Insurance (Diagnostic Imaging Services Table) Regulations 2008 (the Principal Regulations) are amended as set out in Schedule 1.

 

Schedule 1 – Amendments

 

Item [1]

This item inserts a reference to new subrule 31(2B) into Schedule 1, Part 2, subrule 31(1).  The new subrule 31(2B) is inserted by item [2] below.

 

Item [2]

This item inserts into Schedule 1, Part 2, a new subrule 31(2B) which includes a reference to:

-           (i)               Monash Medical Centre, Clayton, Victoria;

-           (ii)    Suite 1, 38-40 Urunga Parade, Miranda, New South Wales;

-           (iii)   Bundaberg Mater Misericordiae Hospital, Bundaberg, Queensland;

-           (iv)   Radiology Department of the Royal Melbourne Hospital, Parkville, Victoria;

-           (v)    Suite 1, Maitland Specialist Centre, Maitland Private Hospital, East Maitland,  
New South Wales;

-           (vi)   SKG Radiology Kelmscott, Kelmscott, Western Australia; and

-           (vii)  SKG Radiology Duncraig, Duncraig, Western Australia..

 

New subrule 31(2B) provides that a Medicare benefit is only payable for an MRI service performed with the specified equipment under the following circumstances:

-          for services to patients who are concessional beneficiaries or children under 16 – the maximum charge is the sum of the medicare benefit and any private health insurance benefit payable for the service; and

-          where all of the conditions of the agreement, set out in the table, that applies to the eligible equipment are met. 

 

Item [3]

This item inserts a reference to a new paragraph 36(1)(f) into Schedule 1, Part 2, subrule 34(2).  The new paragraph 36(1)(f) is inserted by item [6] below.

 

 

 

 

Item [4]

For Schedule 1, Part 2, rule 36, the reference to ‘For rule 31’ is replaced by a reference to

‘(1) For rule 31’ as a result of the inclusion of a new subrule 36(2).  The new subrule 36(2) is inserted by item [7] below.  

 

Item [5]

This item makes a grammatical change to allow item [6] to be inserted.

 

Item [6]

This item inserts a new paragraph 36(1)(f) into rule 36, Schedule 1, Part 2 of the Principal Regulations.  This amendment provides that each of the seven new specified pieces of equipment, set out in item [8] below, are Medicare eligible if the equipment:

(a)   is located at the place specified in the regulations;

(b)   is described by reference to the manufacturer, scanner model and magnet strength in the regulations;

(c)   forms part of a comprehensive radiology department, or a medical practice, at the relevant location that provides x-ray, computed tomography and ultrasound services; and

(d)   is available for use at least from 9 am to 5 pm each Monday to Friday (excluding public holidays), except for periods reasonably required for necessary maintenance, repairs and upgrades.

 

Item [7]

This item inserts a new subrule 36(2) into rule 36, Schedule 1, Part 2 of the Principal Regulations, which defines the term “medical practice”.  This term is used in the new paragraph 36(1)(f) being inserted by item [6] above.

 

Item [8]

This item inserts the details of the seven new MRI units into a new table (referred to as ‘Table 3 Eligible equipment - paragraph 36 (1)(f)) in rule 36 of Schedule 1, Part 2 to the Principal Regulations.

 

The new Table 3 in subrule 36(1) of Schedule 1, Part 2 describes: (i) the locations of the seven new MRI units; (ii) the manufacturer and scanner model of the MRI units; and (iii) the magnet strength of the seven new MRI units.  The conditions under which Medicare benefits are paid for the seven new MRI units prescribed in Table 3 are set out in item [2] and item [6] above.  

 

Item [9]

This item clarifies in the descriptor for item 63464 that the MRI service applies to asymptomatic women.

 

Item [10]

This item amends the following rules as a consequence of the inclusion of new subrule 36(2) by item [7] above:

(i)                 subrule 31(2), 31(2A) and 34(1) of  Schedule 1, Part 2 of the Principal Regulations; and

(ii)               Table 1 and Table 2 of rule 36 of Schedule 1, Part 2 of the Principal Regulations.

Overview

The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1) were enacted to address the problem of limited access to Medicare-funded Magnetic Resonance Imaging (MRI) services in certain regions of Australia. These Regulations amend the Health Insurance (Diagnostic Imaging Services Table) Regulations 2008 to enable Medicare benefits to be paid for MRI services conducted using specified equipment at seven locations across New South Wales, Victoria, Queensland, and Western Australia. Furthermore, the Regulations clarify an existing item to allow Medicare benefits for MRI services used in the diagnosis of breast cancer in asymptomatic women less than 50 years of age who are at high risk of developing breast cancer. The Department of Health and Ageing conducted a competitive application process to select the MRI equipment eligible for Medicare benefits and consulted with relevant stakeholders to finalise the amendments. The Regulations are a legislative instrument under the Legislative Instruments Act 2003 and commence the day after registration on the Federal Register of Legislative Instruments.

Scope and Application

The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1) apply to the Health Insurance Act 1973 and are concerned with the provision of Medicare benefits for Magnetic Resonance Imaging (MRI) services in Australia. These regulations amend the existing Health Insurance (Diagnostic Imaging Services Table) Regulations 2008 to specify the conditions under which Medicare benefits can be paid for MRI services provided by specified equipment at seven locations across New South Wales, Victoria, Queensland, and Western Australia. Additionally, the regulations clarify eligibility criteria for MRI services used in diagnosing breast cancer in asymptomatic women under 50 years of age who are at high risk of developing breast cancer. The regulations outline specific requirements for the MRI units to be Medicare-eligible, including their location, manufacturer, scanner model, magnet strength, and availability for use during specified hours, excluding maintenance periods. The regulations are applicable to the relevant entities and individuals involved in the provision and receipt of these services within the specified locations. There are no stated exclusions, exemptions, or thresholds in the regulations themselves, though the conditions for eligibility are stringent and must be met for Medicare benefits to be applicable. The regulations are subordinate instruments of the Health Insurance Act 1973, and their implementation is subject to the legislative authority granted under the Act.

Key Provisions

The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 1) introduce several key provisions to the existing Health Insurance (Diagnostic Imaging Services Table) Regulations 2008. Primarily, these amendments aim to enable Medicare benefits to be paid for Magnetic Resonance Imaging (MRI) services conducted using specified equipment at seven locations across New South Wales, Victoria, Queensland, and Western Australia. Additionally, the regulations clarify the criteria for MRI services used in diagnosing breast cancer in asymptomatic women under 50 years of age who are at a high risk of developing breast cancer (Regulation 3, Schedule 1, Item [9]). These amendments are set out in Schedule 1, which details the specific locations, equipment specifications, and operational conditions for the new MRI units (Schedule 1, Items [1], [2], [6], [8]). The regulations impose specific obligations and requirements on the parties involved. For instance, the MRI equipment must be located at the specified locations, detailed in the new Table 3 of Schedule 1, Part 2 (Schedule 1, Item [8]). The equipment must also be described by reference to the manufacturer, scanner model, and magnet strength as outlined in the regulations. Furthermore, the MRI units must be part of a comprehensive radiology department or a medical practice that provides x-ray, computed tomography, and ultrasound services, and they must be operational from 9 am to 5 pm, Monday to Friday, excluding public holidays, except for necessary maintenance, repairs, and upgrades (Schedule 1, Item [6]). The new subrule 36(2) inserted by Item [7] defines the term "medical practice" for these purposes. Failure to comply with the conditions specified in the regulations could result in legal consequences. While the explanatory statement does not detail specific offences or penalties, non-compliance with the requirements for Medicare eligibility could potentially lead to the denial of Medicare benefits for services rendered using the specified MRI equipment. This could have significant financial implications for both the service providers and the patients relying on these benefits. The regulations ensure that only MRI services conducted under the specified conditions and using the eligible equipment will qualify for Medicare benefits, thus maintaining the integrity of the Medicare system.

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