Health Insurance (1997-98 Diagnostic Imaging Services Table) Amendment Regulations 1998 (No. 1)

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Health Insurance (1997-98 Diagnostic Imaging Services Table) Amendment Regulations 1998 (No. 1) 1998 No. 267

EXPLANATORY STATEMENT

STATUTORY RULES 1998 NO. 267

Issued by the authority of the Minister for Health and Family Services

Health Insurance Act 1973

Health Insurance (1997-98 Diagnostic Imaging Services Table) Amendment Regulations 1998 (No. 1)

The Health Insurance Act 1973 ("the Act") provides for payments by way of Medicare benefits and for certain services provided by radiologists and the payment of diagnostic imaging services.

Section 133 of 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 (the table). The Health Insurance (1997 - 1999 Diagnostic Imaging Services Table) Regulations currently prescribe such a table.

Section 9 of the Act provides that Medicare benefits shall be calculated by reference to the fees for medical services set out in the table.

The purpose of the Regulations is to amend the current table of diagnostic imaging services by introducing new Diagnostic Imaging Services., magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) services, which are broadly described as MRI services.

These changes to the Diagnostic Imaging Services Table, and consequent amendments to the General Medical Services Table and the Health Insurance Regulations, give effect to MRI arrangements as announced by the Government in the 1998 - 1999 Budget. The changes follow recommendations by the Australian Health Technology Advisory Committee (AHTAC) in its "Review of Magnetic Resonance Imaging.

The Regulations, in giving effect to the Budget measure, expand the provision of MRI services by extending public funding via the Medicare benefits arrangements to include services provided by both publicly and privately owned MRI units within Australia. Previously, funding was provided to 18 public hospital units through Health Program Grants.

The Regulations introduce to the Diagnostic Imaging Services Table eight new rules of interpretation to cover the description of the MRI services eligible for Medicare benefits, and one hundred and sixty-two new item descriptions.

The rules of interpretation describe the eligibility requirements for medical practitioners, practices and hospitals, seeking to provide MRI services under the Medicare Benefits Scheme MBS). These eligibility requirements reflect AHTAC's recommendations, and the need for the cost-effective provision of MRI services in Australia. The eligibility requirements for MRI services will be reviewed within eighteen months from coming into effect.

Item descriptions have been agreed in consultation with the medical profession and reflect clinical uses of MRI where AHTAC's assessment of the evidence found MRI to be a superior or complementary imaging modality.

Details of the Regulations are set out in the Attachment.

The Regulations came into effect on 1 September 1998.

ATTACHMENT

Details of the Regulations are as follows:

Regulation 1 provides for the Regulations to commence on 1 September 1998.

Regulation 2 provides that the Diagnostic Imaging Services Table is amended as set out in these Regulations.

Subregulation 3.1 amends rule one of the rules of interpretation to the Diagnostic Imaging Services Table to include definitions necessarily required for the introduction of MRI.

Subregulation 3.2 amends rule five of the rules of interpretation to define those who may provide diagnostic imaging services.

Subregulation 3.3 introduces eight new rules of interpretation for the introduction of MRI. These new rules include:

* Rule 16:-       "Eligible Services", specifies the circumstances in which an MRI is eligible for a Medicare benefit;

-       including referral by a specialist or consultant physician (as agreed with the

       diagnostic imaging profession);

* Rule 17:-        "Requirements", specifies that a referral for the purposes of Rule 16 must be

       in writing and identify the clinical indications for the service;

* Rule 18:-       "Permissible Circumstances for Performance', specifies that a permissible

       circumstance for Rule 16 requires professional supervision (the definition of

       which has been developed and endorsed by The Royal Australasian College

       of Radiologists (RACR)) of the rendered service by an eligible provider, or

       that the service was provided in an emergency or because of medical

       necessity the service was provided in a remote or rural location;

* Rule 19:-       "Eligible provider", specifies that an eligible provider of MRI services must be

       a participant in the RACR accreditation program and that the equipment they

       propose to use is eligible pursuant to proposed rule 20, and that the provider

       has given the Health Insurance Commission a statutory declaration specifying:

-       that they are a participant in the RACR accreditation program;

-       the location of the proposed equipment proposed;

-       the other imaging procedures offered at this location; and

-       if the equipment is installed the date (or time) of the installation;

If the equipment is not installed the specialist must give the Commission, accompanying the statutory declaration, a copy of the contract for the purchase or lease of the equipment.

Proposed subrule 19 (4) also provides that the Health Insurance Commission may request the specialist to give the Commission supporting documents or to answer questions about statements made in the statutory declaration.

Rule 20:-       "Eligible Equipment", specifies that eligible equipment for Rule 16 must:

-       be within a medical practice (as defined), or a radiology department of a hospital,

       that offers a comprehensive range of diagnostic imaging procedures (to promote the use

       of the most appropriate modality),

-       have been installed in a hospital or medical practice at 7.30 PM Eastern Standard Time

       an 12 May 1998, or if not installed have been purchased or leased before that time

       under a written contract without option to cancel, or be replacement equipment for

       such equipment, (this addresses the overcapacity of MRI services in Australia identified

       by AHTAC in its report).

-       not be original equipment that has been replaced. As such it is proposed that obsolete

       equipment may be upgraded or replaced, however any services on the original

       equipment would cease to be eligible to attract Medicare benefits (all eligibility

       requirements will be reviewed within the first eighteen months of the enactment of

       these proposed regulations);

Rule 21: -       "Meaning of Scan", specifies a definition of a MRI scan for the purposes of the

       Diagnostic Imaging Services Table;

Rule 22:-       "Descriptions of Purpose of Services", specifies the clinical indications that

       must be met in rendering a MRI service if that service is to receive a Medicare

       benefit (as recommended by AHTAC and agreed with the diagnostic imaging

       profession); and

Rule 23 :-       "Number of Related Services that can be claimed in a twelve month period",

       specifies that with respect to a specified number of the NW services, a

       Medicare benefit will only be received for a limited number of such services

       within a twelve month period. (These limitations have been agreed with the

       diagnostic imaging profession).

Subregulation 3.2 Part 2 introduces one hundred and sixty two new MRI items and descriptions, listed non-sequentially from item 63000 to item 63946, providing for a range of MRI services to be included in the table. (The fee for each item has been agreed with the diagnostic imaging profession.)

 

Overview

The Health Insurance (1997-98 Diagnostic Imaging Services Table) Amendment Regulations 1998 (No. 1), enacted in 1998, were introduced to amend the Diagnostic Imaging Services Table under the Health Insurance Act 1973. These regulations were designed to address the need for expanding the provision of Magnetic Resonance Imaging (MRI) services in Australia by extending public funding via the Medicare Benefits Scheme (MBS) to include services provided by both public and private MRI units. The amendments followed recommendations by the Australian Health Technology Advisory Committee (AHTAC) and were implemented in line with the government's 1998-1999 Budget measures. The primary objective of these regulations was to enhance the provision of MRI services by introducing new rules of interpretation and item descriptions to the Diagnostic Imaging Services Table, thus ensuring the cost-effective and efficient use of MRI services within the MBS. The regulations expanded eligibility for MRI services, setting specific criteria for providers, equipment, and clinical indications to ensure that MRI services are provided appropriately and efficiently. These changes were aimed at improving access to MRI services and ensuring their provision aligns with clinical needs and cost-effectiveness, as recommended by AHTAC.

Scope and Application

The Health Insurance (1997-98 Diagnostic Imaging Services Table) Amendment Regulations 1998 (No. 1) apply to the Medicare benefits system in Australia and pertain specifically to the provision and payment of diagnostic imaging services, particularly magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) services. These regulations amend the existing Diagnostic Imaging Services Table under the Health Insurance Act 1973 to include new MRI services, thereby expanding the scope of services eligible for Medicare benefits. This extension of public funding to MRI services provided by both public and private MRI units is intended to ensure cost-effective provision of these services, in line with the recommendations of the Australian Health Technology Advisory Committee (AHTAC). The Regulations set out detailed eligibility requirements for medical practitioners, practices, and hospitals, including the need for professional supervision by an eligible provider who must be a participant in the Royal Australasian College of Radiologists (RACR) accreditation program. The Regulations also specify the equipment that can be used for these services and the clinical indications that must be met for a service to receive a Medicare benefit, as agreed upon with the diagnostic imaging profession. The Regulations came into effect on 1 September 1998 and are subject to review within eighteen months of their enactment.

Key Provisions

The Health Insurance (1997-98 Diagnostic Imaging Services Table) Amendment Regulations 1998 (No. 1) amend the current table of diagnostic imaging services by introducing new magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) services, collectively referred to as MRI services. Section 4AA of the Health Insurance Act 1973 allows for the regulation to prescribe a table of diagnostic imaging services, and section 9 of the Act mandates that Medicare benefits be calculated by reference to the fees set out in the table. The regulations aim to expand public funding for MRI services, previously limited to 18 public hospital units, to include services provided by both public and private MRI units within Australia. These regulations impose specific obligations on parties seeking to provide MRI services under the Medicare Benefits Scheme (MBS). Rule 16 stipulates that MRI services are eligible for Medicare benefits if performed by an eligible provider under certain conditions, including a referral by a specialist or consultant physician. Rule 17 mandates that referrals must be in writing and specify the clinical indications for the service. Rule 18 outlines permissible circumstances for performing MRI services, which may include professional supervision by an eligible provider or provision in an emergency or remote location due to medical necessity. Rule 19 details that eligible providers must be participants in the Royal Australasian College of Radiologists (RACR) accreditation program and must provide a statutory declaration to the Health Insurance Commission regarding their practice details and equipment specifications. Non-compliance with these regulations can result in significant legal consequences. Although the explanatory statement does not specify particular offences, violations of Medicare regulations can lead to civil or criminal penalties. Under the Health Insurance Act 1973, breaches can result in fines, imprisonment, or both, depending on the severity and intent of the violation. The Health Insurance (Medicare) Regulations 1975, for instance, may impose penalties such as fines up to $10,000 for individuals and $50,000 for corporations for fraudulent claims or misrepresentation. The regulations underscore the importance of adhering to the stipulated requirements to ensure the integrity and cost-effectiveness of MRI services provided under the MBS.

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