Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2001 (No. 2) 2001 No. 122
EXPLANATORY STATEMENT
STATUTORY RULES 2001 No. 122
Issued by the Authority of the Minister for Health and Aged Care
Health Insurance Act 1973
Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2001 (No. 2)
Section 133 of the Health Insurance Act 1973 (the Act) provides that the Governor-General may make Regulations for the purposes of the Act.
Section 4AA of the Act provides that the regulations may prescribe a table of diagnostic imaging services that sets out. the items of diagnostic imaging services, the amount of fees applicable in respect of each item and rules for interpretation of the table.
The Health Insurance (Diagnostic Imaging Services Table) Regulations 2000 (the Principal Regulations) are regulations made for the purposes of section 4AA of the Act.
The Principal Regulations contain items of diagnostic imaging services, including magnetic resonance imaging (MRI) services. The rules of interpretation provide that Medicare benefits in respect of MRI services are only payable where the services are performed with 'eligible equipment'. 'Eligible equipment' is defined in rule 27 as equipment located in Australia in a medical practice, or the radiology department of a hospital, that offers a comprehensive range of diagnostic imaging procedures, that is, procedures that include x-ray, ultrasound and computed tomography procedures. Moreover, to be 'eligible equipment' the equipment must satisfy certain 'time of installation' requirements.
The purpose of the Amending Regulations is to provide for an additional category of 'eligible equipment'. This additional category of MRI units will be units registered under the MRI Additional Units Eligibility Scheme (the eligibility scheme) following a competitive tender process. A copy of the eligibility scheme, which will be referred to in the proposed Regulations, is attached.
Details of the Amending Regulations are set out in the Attachment.
The Amending Regulations commenced on gazettal.
ATTACHMENT
NOTES ON CLAUSES
Regulation 1 provides that the Regulations may be cited as the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2001 (No. 2).
Regulation 2 provides that the Regulations commence on gazettal.
Regulation 3 provides that the Health Insurance (Diagnostic Imaging Services Table) Regulations 2000 are amended by Schedule 1.
Item 1 of Schedule 1 amends paragraph 27(c) by including a reference to new rule 31A. The effect of this amendment is to provide that eligible services many only be performed with eligible equipment in accordance with rule 31 or 31A.
Item 2 of Schedule 1 amends paragraph 30(1)(b) by including a reference to new rule 31A. The effect of this amendment is to provide that an eligible provider must satisfy the Health Insurance Commission that he or she proposes to render eligible services with eligible equipment in accordance with rule 31 or 31A.
Item 3 of Schedule 1 amends subrule 30(2) to clarify that a statutory declaration is only required in relation to equipment which is eligible equipment in accordance with rule 31. There is no requirement to provide a statutory declaration in relation to equipment which is eligible equipment in accordance with rule 31A.
Item 4 of Schedule 1 substitutes a new subrule 31(1). The effect of this substitution is to clarify that rule 31 is not the only rule dealing with eligible equipment.
Item 5 of Schedule 1 amends paragraph 31(3)(c) to correct a minor drafting error in the Principal regulations.
Item 6 of Schedule 1 inserts a new subrule 31A which provides that equipment registered under the 'MRI Additional Units Eligibility Scheme' published in Gazette, No. GN20 on 23 May 2001 will be 'eligible equipment'.
Department of Health and Aged Care
MRI ADDITIONAL UNITS ELIGIBILITY SCHEME
1. Background
1.1 The Commonwealth Government seeks to make Medicare benefits available under the Health Insurance Act 1973 ("Health Insurance Act") in respect of services (the "MRI Services") to be provided by additional MRI units ("additional MRI units") in areas identified as under-serviced ("Areas of Need").
1.2 Additional MRI units will be units registered under this MRI Additional Units Eligibility Scheme ("this Eligibility Scheme") following a competitive tender process.
1.3 Additional MRI units will be eligible equipment for the purposes of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2000 as amended.
2. Process Prior to Registration
2.1 The Department of Health and Aged Care ("Health") will issue one or more Requests for Tenders ("RFT"), which will set out in detail the tender process for those seeking registration of one or more additional MRI units under this Eligibility Scheme.
2.2 Persons/organisations seeking to provide MRI Services will be invited to respond to an RFT within specified timeframes.
2.3 The tenders received in response to an RFT will be evaluated by a Health-appointed panel according to mandatory and weighted criteria and the other matters or processes specified in the RFT.
2.4 Having regard to the evaluation, Health may negotiate with all or any of the tenderers who have satisfied the mandatory criteria and weighted criteria, the object of such negotiation with a tenderer being to reach agreement with the tenderer on the terms and conditions of an undertaking for the purposes of this Eligibility Scheme in respect of the tenderer's proposed additional MRI unit or units.
2.5 Health may invite each of one or more of the tenderers with whom it has reached such an agreement to provide Health, in a specified timeframe, with a written undertaking (an "Undertaking") that, upon registration under this Eligibility Scheme, the tenderer will provide MRI services, by means of the additional MRI unit or any substituted unit registered under this Eligibility Scheme, in accordance with the terms and conditions agreed with Health. The Under-taking will also provide that Health or its nominee will have access to premises and documents in order to monitor compliance with the Undertaking.
3. Areas of Need for Initial RFT Process
3.1 The Areas of Need (not listed in any order of priority) for the initial RFT process are:
(a) South-Western Sydney, NSW, which means the statistical subdivisions of Fairfield-Liverpool and Outer South Western Sydney;
(b) Nepean area, NSW, which means the statistical subdivision of Blacktown-Baulkham Hills and the Statistical Local Area (SLA) of Hawkesbury;
(c) Dubbo/Orange/Bathurst, NSW, which means the statistical division of North Western NSW and Central West NSW;
(d) Mornington Peninsula, outer eastern suburban Melbourne and the Gippsland region, which means the Vie statistical division of Gippsland and the Mowing Vie statistical subdivisions: Mornington Peninsula Shire (SLAs Mornington Peninsula East, Mornington Peninsula South, Mornington Peninsula West) Frankston City
(SLAs Frankston East, Frankston West) Greater Dandenong City (SLAs Dandenong, Dandenong-Balance) South Eastern Outer Melbourne (SLAs CardiniaNorth, Cardinia-Pakenham, Cardinia-South, Casey-Berwick, Casey-Cranbourne, Casey-Hallam, Casey-South);
(e) North of Brisbane to Gladstone, Queensland, which means the QLD statistical division of Wide Bay/Burnett; the QLD statistical subdivision of Sunshine Coast, and the following Queensland SLAs of the statistical division of Moreton: Caboolture, Caloundra-Hinterland, Caloundra-Rail Corridor, Esk, Kilcoy, Maroochy, and Noosa;
(f) Gold Coast, Queensland, which means the QLD statistical subdivision of Gold Coast City Part A and the QLD statistical subdivision of Gold Coast City Part B, and the following Queensland SLAs of the statistical division of Moreton: Beaudesert Part B, Boonah, Gatton, Ipswich-South West, Ipswich-West, Laidley and the NSW statistical division of Richmond-Tweed.
3.2 In any subsequent RFT process after the initial RFT process, Health will identify in the RFT the Areas of Need for additional MRI units.
4. Mandatory Criteria in RFT Process
4.1 In assessing tenders, Health will reject any that do not meet the following criteria:
(a) substantive compliance with the requirements and intent of the RFT;
(b) location within an Area of Need (see clause 3 above);
(c) compliance with the Medicare benefits legislative arrangements, including that the MRI services are:
(i) to be provided following a written request by a specialist or consultant physician who identified the clinical indications for the service;
(ii) to be provided within a comprehensive imaging practice; and
(iii) to be provided under the professional supervision of an eligible provider;
(d) the MRI unit to be delivered and fully operational within 18 months of the date of registration under this Eligibility Scheme;
(e) the MRI unit is to have a minimum size of 0.5 tesla;
(f) corporate capability and integrity;
(g) financial capacity;
(h) changes to corporate structure ownership and support;
(i) for newly formed organisations, additional assurances and information on the entities in the organisation.
5. Weighted Criteria
5.1 In assessing tenders that comply with the mandatory criteria in clause 4.1, Health will apply the following criteria which are weighted and listed in order of importance:
(a) comparative advantage in terms of patient access within an Area of Need;
(b) patient affordability. The tenderer's policy on patient charging for Medicare-eligible MRI services: the tenderer is required to provide information on its proposed charging policy for MRI services. The tender that provides the greatest patient affordability within an Area of Need is preferred in this criterion. This should be expressed as the average patient payment per service expressed as fee charged less the relevant MRI Medicare rebate.
(c) location in or collocation/proximity with a Tertiary Referral Centre/Hospital if there is a Tertiary Referral Centre/Hospital in the Area of Need. Collocation or proximity means where the location allows safe, appropriate and convenient transport of patients between the Tertiary Referral Centre/Hospital and the MRI unit. Tertiary Referral Centre/Hospital means a centre/hospital that provides a comprehensive specialist diagnostic and treatment service, and advanced training;
(d) location of relevant specialist referral base relative to the proposed location of the MRI; and
(e) hours of operation - emergency services or after hours availability.
6. Registration
6.1 If a preferred/successful tenderer is invited to provide an Undertaking to Health and does so within the timeframe specified by Health, Health will as soon as practicable inform that tenderer (from this stage, called the "Unit Provider") by letter that the Unit Provider's tendered MRI unit is registered under this Eligibility Scheme from the date stated in the letter. The letter will also state:
(a) details of the relevant MRI unit registered under this Eligibility Scheme;
(b) the name, address and relevant identification numbers of the Unit Provider (such as ACN, ABN);
(c) the Area of Need to be serviced;
(d) that registration under this Eligibility Scheme is conditional on the Unit Provider:
(i) not breaching the Undertaking; and
(ii) providing all reasonable assistance to Health or its nominee to facilitate monitoring of compliance with the Undertaking; and
(e) any other requirement Health considers necessary.
6.2 Health will provide a copy of the letter referred to in 6.1 and the Undertaking to the Health Insurance Commission and to any person who requests one. Copies may be made available on Health's website.
6.3 Upon application by a Unit Provider, an, MRI unit may be registered in substitution for its registered unit if Health is satisfied and agrees in writing that:
(a) the substituted unit is of at least the same capacity and quality as the registered unit; and
(b) the Undertaking otherwise is complied with.
7. Revocation of Registration
7.1 If a Unit Provider does not comply with its Undertaking, Health may revoke the registration of the Unit Provider's MRI unit, but will not do so until after it has given reasonable notice in writing to the Unit Provider of Health's intention and considered written comments, if any, of the Unit Provider provided to Health on or before a date specified in the notice.
7.2 Without limiting clause 7.1, Health may revoke the Unit Provider's registration under this Eligibility Scheme if a registered MRI unit (other than a replacement MRI unit referred to in 6.3) is not fully operational within 18 months of its registration under this Eligibility Scheme.
7.3 If the registration, of the MRI unit is to be revoked, Health will give written notice to the Provider that the revocation will take effect on a date specified in the notice (not earlier than 14 days from the date of Health's notice) and on that date the MRI unit will no longer be registered under this Eligibility Scheme from that date.
7.4 Health will revoke the Unit Provider's registration if asked to do so by the Provider and without compliance with clause 7.3.
8. Amendment of Undertaking
8.1 Health may, in its sole discretion and by written notice given to the Unit Provider, agree that a Unit Providers Undertaking be amended as requested by the Unit Provider with the amendment to be effective from a date specified in the notice.
Authorised by
MICHAEL WOOLDRIDGE
Minister for Health and Aged Care.
Dated this 9 day of May 2001