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Health Insurance Amendment (Diagnostic Imaging Accreditation) Bill 2007

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2004-2005-2006-2007

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

HEALTH INSURANCE AMENDMENT (DIAGNOSTIC IMAGING ACCREDITATION) BILL 2007

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Minister for Health and Ageing,

the Honourable Tony Abbott MP)

 



HEALTH INSURANCE AMENDMENT (DIAGNOSTIC IMAGING ACCREDITATION) BILL 2007

 

OUTLINE

 

The purpose of this Bill is to amend the Health Insurance Act 1973 (the Act) to establish a legislative framework that will enable the introduction of an accreditation scheme for practices providing diagnostic imaging services covered by the Radiology Quality and Outlays Memorandum of Understanding (Radiology MoU). 

 

The Radiology MoU is one of four collaborative agreements between the Government and diagnostic imaging representative organisations made as part of the 2003-04 Budget process for managing Medicare funded diagnostic imaging services.  It is managed jointly by the Australian Government (as represented by the Department of Health and Ageing), the Royal Australian and New Zealand College of Radiologists and the Australian Diagnostic Imaging Association.

 

The Radiology MoU covers all diagnostic imaging services except cardiac imaging, nuclear medicine imaging, and obstetrical and gynaecological ultrasound.  It is the largest of the MoUs, representing about 80% of all Medicare funded diagnostic imaging services. 

 

Accreditation is a process of externally reviewing an organisation’s performance against a defined set of standards.  Accreditation is generally recognised as a tool which assists the health care industry to review and improve systems that support the delivery of safe and high quality health care. The accreditation process provides:

 

·          a means of ensuring that minimum standards of practice operation are met;

·          a benchmark for maintaining that competence; and

·          feedback to enhance overall quality in a professional discipline over time.

 

Accreditation is considered the longest established and most widely known process for the external evaluation of health care services.  It is based on standards and processes devised and developed by, or in association with, health care professionals for health care services.

 

Under the accreditation scheme, all practices providing diagnostic imaging services covered by the Radiology MoU will need to be accredited by an approved accreditation provider in order for Medicare benefits to be payable for the services they provide.

 

As mentioned earlier, the Bill creates a framework for the introduction of the accreditation scheme for services covered by the Radiology MoU.  However, it has been designed to allow for the introduction of accreditation schemes for other diagnostic imagingservices should the Parliament support a future decision to extend accreditation to those services.

 

FINANCIAL IMPACT

 

The amendments in this Bill will require enhancements to Medicare Australia’s Medicare processing systems.  These costs have not been quantified as they depend on the extent of the operational requirements of the accreditation scheme when these are developed.  However, based on previous similar enhancements, estimated costs would be in the order of $1.2 million.  Full costings will be provided in the Regulation Impact Statement that will accompany the subordinate legislation when this is developed.

 

These costs will be funded from existing budgetary measures for the provision of diagnostic imaging services.

 

REGULATION IMPACT STATEMENT

 

 

ACCREDITATION OF PRACTICES PROVIDING DIAGNOSTIC IMAGING SERVICES UNDER THE RADIOLOGY QUALITY AND OUTLAYS MEMORANDUM OF UNDERSTANDING

 

 

1.       BACKGROUND

 

Accreditation is a process of externally reviewing an organisation’s performance against a defined set of standards.  Accreditation schemes are usually characterised by both quality assurance and quality improvement processes.  They involve some form of award of accreditation to indicate that an organisation has demonstrated compliance with externally set standards.

 

Accreditation is generally recognised as a tool which assists the health care industry to review and improve systems that support the delivery of safe and high quality health care.  The accreditation process provides:



·          a means of ensuring that minimum standards of practice operation are met;

·          a benchmark for maintaining that competence; and

·          feedback to enhance overall quality in a professional discipline over time.

 

Accreditation is considered the longest established and most widely known process for the external evaluation of health care services.  It is based on standards and processes devised and developed by health care professionals for health care services. 

 

The Australian Government (as represented by the Department of Health and Ageing), the Royal Australian and New Zealand College of Radiologists (RANZCR) and the Australian Diagnostic Imaging Association (ADIA) made a joint commitment to introduce an accreditation scheme for radiology practices linked to the payment of Medicare benefits in negotiating the Radiology Quality and Outlays Memorandum of Understanding (Radiology MoU) in 2003.  The Radiology MoU is one of four collaborative agreements between the Government and diagnostic imaging representative organisations as part of the 2003-04 Budget process for managing Medicare funded diagnostic imaging services.

 

The Radiology MoU covers all diagnostic imaging services except cardiac imaging, nuclear medicine imaging and obstetrical and gynaecological ultrasound.  It is the largest of the MoUs, covering about 80% of all Medicare funded diagnostic imaging services. 

 

In the 2005-06 financial year there were approximately 12.6 million services claimed under the Radiology MoU.  These services were rendered from around 3,100 practice sites.

 

Around 12 million of these services, or approximately 95%, were rendered by specialist radiologists.  Eighty five percent (85%) of services were provided at private specialist radiology/nuclear imaging/radiation oncology sites.  Eleven percent (11%) of services were rendered at public facilities. 

 

The remaining services were rendered at non specialist radiology practices, such as primary, cardiology and vascular surgery practices.

 

It has been estimated that there are 170 multi-site practices, representing about 950 sites.  Of these, the largest number of sites are part of the three major corporate diagnostic imaging providers: I-Med/MIA; Sonic Health Care; and Symbion Health.

 

Under the new scheme, practice sites will be accredited against a set of standards developed specifically for the provision of radiology services.  Subject to appropriate transitional arrangements, Medicare benefits will only be payable when practice sites providing diagnostic imaging services, covered by the Radiology MoU, can demonstrate through accreditation that they comply with these standards.

 

2.       REGULATORY Problem

 

Beyond the requirement that all staff in a radiology practice be appropriately qualified, there are many other factors that impact on the ability of a practice to provide a quality service. 

 

Effective management, available resources, information systems capable of monitoring patient progress, and multi-disciplinary teamwork contribute to a high quality service being provided.  In other words, health outcomes are impacted by each element/activity carried out by the practice when delivering a diagnostic imaging service.

 

In addition, there have been major technological advances in diagnostic imaging over the past decade, including the development of powerful multislice computed tomography equipment, the introduction of magnetic resonance imaging and the increasing use of teleradiology.

 

There is currently no regulatory mechanism that helps to ensure all the elements involved in the delivery of diagnostic imaging services work together.

 

As such, there is no guarantee to patients that optimal radiology services are being provided.  In addition, the Government provides more than $1.3 billion per annum in Medicare benefits for services covered by the Radiology MoU.  Accreditation provides assurance that this large amount of money is spent on services of an appropriate standard.

 

Radiology services are provided, and are increasingly being provided, by a diverse range of provider groups, including specialist radiologists, vascular surgeons, cardiologists, general practitioners, obstetricians and gynaecologists, and sports physicians.  Radiology services can also be provided in a range of practice settings and circumstances, including hospitals, single practitioner practices and multisite corporate practices, or in conjunction with surgical procedures.

 

In such a diverse industry, there is the potential for inconsistency in the delivery of radiology services.  Variations in the qualifications and experience of practitioners, standards of supervision, equipment standards, practice protocols and administrative procedures could lead to inconsistencies, which have been shown to increase the likelihood of adverse events resulting in patient harm.

 

Consumers should expect to receive quality services irrespective of who provides the services and the facilities in which they are provided.

 

 

3.       Objectives

 

The objectives of an accreditation scheme for radiology services are to:

 

·          support practices in the provision of safe, quality radiology services to healthcare consumers

·          foster a culture of continuous quality improvement

·          provide practices with regular and objective advice regarding their performance against agreed accreditation standards

·          provide benchmarks for the monitoring and maintenance of industry performance.

 

Ultimately, accreditation should ensure that high quality radiology services are provided to patients.

 

4.       Options

 

The Health Insurance Act 1973 (the Act) and its regulations set the conditions under which services provided by the diagnostic imaging industry are eligible for Medicare benefits, including the professional qualifications required of medical practitioners providing those services.  This Act also requires practice sites to comply with State and Territory licensing and registration legislation for staff and equipment using ionising radiation (such as x-rays) in order for Medicare benefits to be payable. 

 

In addition to the regulatory requirements, many professional groups encourage their members to comply with voluntary standards of practice and quality related protocols which they have developed.  For example:

 

·          the Royal Australian and New Zealand College of Radiologists (RANZCR) has developed Standards of Practice for Diagnostic and Interventional Radiology, to support its voluntary accreditation scheme in association with the National Association of Testing Authorities (NATA);

·          the Australasian Society for Ultrasound in Medicine has a number of guidelines and policies for the delivery of diagnostic ultrasound; and

·          the Australian Institute of Radiography has competency standards.

 

It could be argued that the current requirements adequately ensure the delivery of high quality diagnostic imaging services to consumers.  This is because there is no evidence of any public health and safety risk arising from the current legislative arrangements. 

 

Equally, there is no evidence that consumers are receiving optimal diagnostic imaging services under the current arrangements because there is no external measure of the extent to which professional and technical requirements as prescribed in the Act are being met.

 

There are therefore two options for ensuring the delivery of high quality radiology services to patients. 

 

Option A:  Maintain the status quo (ie. retain the current regulatory requirements and a voluntary framework)

 

This option would require no change to the current legislative provisions.  Practices would be expected to comply with the existing regulations and any voluntary standards and protocols developed by their professional and industry groups.

 

Option B Amend the Health Insurance Act (HIA) and associated regulations to introduce an accreditation scheme linked to Medicare benefits

 

This option would involve amendments to the HIA and its associated regulations requiring practices providing services covered by the Radiology MoU to be accredited under an approved accreditation scheme in order for Medicare benefits to be payable for those services.

 

This option would introduce similar requirements as the accreditation arrangements for pathology laboratories, which have been in existence for some 20 years now. 

 

5.       Impact analysis

 

The following are considered to be the key groups affected by the options outlined above:

 

·          Australian Government

·          Practices providing radiology services

·          Accreditation providers

·          Healthcare consumers

 

5.1     Option A Maintain the status quo (ie. retain the current regulatory requirements and a voluntary framework

 

Australian Government

 

The costs and benefits of Option A to the Australian Government are as follows:

 

Costs/disadvantages

 

·          The absence of a legislative requirement for practice sites to be accredited provides no assurance to government that public money is supporting the provision of quality services and that the health and safety needs and expectations of consumers are being met; 

·          The experience of the voluntary RANZCR/NATA accreditation scheme indicates that without financial incentives or regulatory imperatives the rate of participation in accreditation is likely to be low.  Since its introduction in 2004, less than 20 sites have gained accreditation; and 

·          In addition, a post implementation review of the voluntary RANZCR/NATA program undertaken in September 2005 found that participating practices indicated that future benefits linked to the payment of Medicare would need to underpin the program for their continued participation in accreditation.

 

Benefits

 

·          The Government does not have to develop and administer an accreditation scheme. 

 

Practices providing radiology services

 

The costs and benefits of Option A to practices providing radiology services are as follows:

 



Costs

 

There are existing compliance costs for practices (whether or not they participate in RANZCR/NATA voluntary program).  These costs result from compliance with mainly State and Territory legislation and cover such things as:

·          Radiation equipment testing

·          Radiation equipment registration

·          Licensing and monitoring of personnel involved in using radiation equipment

·          Sonographer accreditation

 

It has been estimated that the annual costs for a practice site in New South Wales offering x-ray, fluoroscopy, mammography, computed tomography and orthopantomography with a staffing of four radiographers, two sonographers and a radiologist would be in the order of $2500.

 

It is important to note, however, that these costs would still apply under an accreditation scheme. 

 

For those practices participating in the RANZCR/NATA program, there are costs associated with such things as:

 

Initial costs

 

·          Establishing compliant management processes

·          Staff training

·          Application fees

·          Initial site assessments

 

Ongoing costs

 

·          Dedicated personnel to maintain management systems

·          Annual membership fees (these cover subsequent site visits every three years)

 

For a single site practice with general radiography (2 rooms), ultrasound (2 rooms), mammography (1 room) and computed tomography, it has been estimated that the initial costs of accreditation under the RANZCR/NATA program are in the order of $60,000 to $100,000, and the ongoing costs would be around $25,000 per annum. [1]

 

Practices who participate in the voluntary program incur the costs, but are disadvantaged in that non-accredited practices still have access to Medicare benefits without having proven their competency under an accreditation scheme.

 

Benefits

 

·          Providers would not incur the direct and indirect costs of accreditation because Medicare eligibility would not be linked to accreditation.

·          While there are costs involved for practices accredited under the RANZCR/NATA voluntary program, the post implementation review of this scheme in 2005 found that there were economic efficiencies and financial benefits in accreditation, these may not be realised in the early years of implementation.

 

Accreditation providers

 

Costs

 

·          The accreditation provider for the current voluntary scheme, NATA, will have a smaller market than if accreditation was linked to Medicare benefits.  Therefore, the cost of providing the infrastructure for accreditation may not be matched by the income stream.  These costs need to be passed onto practices, resulting in higher up front costs; and

·          There is no market for other providers.

 

Benefits

 

There are considered to be no benefits to accreditation providers in maintaining the current regulatory and voluntary arrangements

 

Consumers of radiology services

 

Maintaining the status quo is considered to have the following costs and benefits to consumers.

 

Costs

 

·          there is no assurance that radiology services meet or exceed minimum industry standards;

·          there is no assurance that the same level of service quality is provided irrespective of where the radiology service is rendered from or who renders the radiology service; and

·          appropriate processes may not be in place to protect their privacy, the handling of complaints and physical safety.

 

Benefits

 

·          Consumers would continue have access to Medicare benefits if practices do not comply with the voluntary standards.

 

5.2     Option B:  Amend the Health Insurance Act and associated regulations to introduce an accreditation scheme linked to Medicare benefits

 

The Australian Government

 

Costs

 

·          infrastructure and administrative costs by Medicare Australia to assure the payment of Medicare benefits  to accredited sites; and

·          managing the legislative framework for the accreditation scheme, including the approvals process for accreditation providers.

 

These costs have not been quantified as they depend on the extent of the operational requirements of the scheme when these are developed.  However, based on previous similar enhancements to Medicare Australia’s processing systems, estimated costs would be the order of $1.2 million.  Ongoing costs would be in the order of $200,000 per year.  Full costings will be provided in the Regulation Impact Statement that will accompany the subordinate legislation when this is developed.

 

Benefits

 

·          certainty that all accredited practices conform to the same set of practice standards;

·          reassurance that government funding is expended on services which meet both quality standards and consumer expectations; and

·          reduced outlays for less than optimal services because providers who do not fulfil the requirements of accreditation are identified and therefore no Medicare benefits are payable.

 

Practices providing radiology services

 

Linking the payment of Medicare benefits to accreditation is considered to have the following costs and benefits to practices providing radiology services:

 

Costs

 

·          the indirect cost of up-skilling or employing staff to develop and implement systems and business processes to support the requirements of the accreditation standards;

·          the direct cost of registration/application fees, site visits and on-going membership fees for accreditation; and

·          loss of staff resources to support the assessment component of practice accreditation.

 

As identified under the impact on radiology practice in maintaining the status quo, there are costs of compliance whether or a not an accreditation scheme linked to Medicare benefits is introduced.

 

The costs of accreditation to practices cannot be readily quantified until the operational elements of the scheme are fully developed in association with industry stakeholders.  The Department is working with stakeholders to build an accreditation scheme that will keep costs to a minimum, for example, we are examining ways in which frequency of site visits can be reduced, for example, through a self-assessment and targeted audit mechanism

 

In comparing the costs of accreditation to the amount of Medicare benefits payable for services rendered by the practice site, in general, the benefits would exceed the accreditation costs.  In many instances, and particularly for comprehensive practices, the costs can represent a very small percentage of the Medicare benefits paid in respect of the practice.

 

Using the practice example provided for the voluntary scheme earlier, for sites with

·          x-ray;

·          ultrasound;

·          mammography;  and

·          computed tomography equipment,

 

the average Medicare benefits paid in 2005/06 were around $1.4 million per site.  Just under 75% of these sites are drawing $1 million or more in Medicare benefits.  Using figures from the voluntary accreditation scheme, the ongoing accreditation costs would represent approximately 2% of the total practice income from Medicare benefits, where Medicare revenue is in the order of $1 million.

 

However, the post implementation review of the voluntary accreditation in 2005 found that those practices who had gained accreditation were operating more efficiently, potentially leading to increased productivity.  This would help off-set these costs.

 

Benefits

 

The following benefits of accreditation linked to Medicare benefits accrue to practices providing radiology services:

 

·          confidence that their practice has implemented systems to support the delivery of high quality radiology services;

·          assurance that legislative and technical requirements are met or exceeded;

·          assurance that staff are technically competent and confident to provide quality radiology services;

·          economic benefits through the implementation of robust, streamlined and efficient administrative processes;

·          savings from reduced outlays for less than optimal services redistributed to the providers of high quality services; and

·          potential savings in medical indemnity insurance.

 

Accreditation providers

 

Costs

 

·          There will be normal business set up costs for those providers wishing to enter the market. 

 

Benefits

 

·          The market will be much larger than under a voluntary arrangement.

 

Consumers of radiology services

 

Linking accreditation to eligibility for Medicare benefits is considered to have the following costs and benefits to consumers of radiology services:

 

Costs

 

The costs of accreditation to consumers could be described as follows:

 

·          potential increased out of pocket expenses if the direct and indirect costs of accreditation to service providers are passed onto consumers; and

·          if practice sites fail to become accredited, consumer access to Medicare funded radiology services may be reduced

 

Benefits

 

Accreditation linked to Medicare benefits is considered to have the following benefits to consumers:

 

·          assurance that radiology services meet or exceed minimum industry standards;

·          assurance that the same level of service quality is provided irrespective of where the radiology service is rendered from or who renders the radiology service; and

·          confidence in the health care system because appropriate processes are in place to protect their privacy, the handling of complaints and physical safety.

 



Summary of costs and benefits

 

Stakeholder

Option 1

Option 2

Australian

Government

Costs

·          no assurance public money is supporting quality services. 

·          participation in accreditation likely to be low. 

 

Costs

·          infrastructure and administrative costs to Medicare Australia

·          management of the legislative framework for the accreditation scheme

 

Benefits

·          does not have to develop and administer an accreditation scheme. 

Benefits

·          certainty that all accredited practices conform to the same set of practice standards

·          reassurance that government funding is expended on quality services

·          reduced Medicare outlays for less than optimal services

Practices

Costs

·          cost of compliance with existing regulatory provisions

·          cost of the voluntary scheme for those who participate.

Costs

·          up-skilling or employing staff to support the requirements of the accreditation standards

·          registration/application fees, site visits and on-going membership fees for accreditation

·          potential loss of staff resources to support assessment

 

Benefits

 

·          no direct and indirect costs of accreditation

·          potential economic efficiencies and financial benefits in accreditation

 

Benefits

·          confidence that they can deliver high quality services;

·          assurance that legislative and technical requirements are met or exceeded;

·          economic benefits through robust, streamlined and efficient administrative processes;

 

Accreditors

Costs

·          will have a smaller market then if accreditation was linked to Medicare benefits.

·          there is no market for other providers

 

Costs

·          normal business set up costs for those providers wishing to enter the market 

 

Benefits

·          none

Benefits

·          market will be much larger than under a voluntary arrangement.

Consumers

Costs

·          no assurance re quality

·          no confidence that there are processes to protect privacy, the handling of complaints and physical safety.

Costs

·          potential increased out of pocket

·          access to Medicare funded radiology services may be reduced

 

Benefits

·          continue have access to Medicare benefits if practices do not comply with the voluntary standards.

 

Benefits

·          receive high quality services

·          confidence that there are processes to protect their privacy, the handling of complaints and physical safety.

 

6.       Consultation

 

Intensive consultation with stakeholders was undertaken during July to September 2006 on how an accreditation scheme linked to Medicare benefits might operate.  These included workshops in Adelaide, Sydney and Melbourne during August 2006. 

 

A Consultation Paper was distributed to peak diagnostic imaging professional and industry organisations, State and Territory Governments and major accreditation bodies inviting comments on the proposed accreditation scheme.  Ninety two submissions were received in response to the consultation paper.

 

A full list of the organisations consulted is shown in Attachment A.  A list of organisations and individuals who provided submissions to the consultation paper is shown in Attachment B.

 

6.1     Views of stakeholders

 

There was general support for the accreditation scheme but some stakeholders, particularly vascular surgeons, are concerned about limited consultation and the ambitious implementation timetable. 

 

The Consultation Paper sought comments from stakeholder in four key areas:

 

·          Standards Development;

·          Development of the scheme rules;

·          Accreditation providers; and

·          Implementation options and transitional arrangements.

 

A brief analysis of the stakeholder views on these areas follows.  A more detailed analysis will form part of the Regulation Impact Statement for the accreditation scheme rules when they have been fully developed.

 

Standards

 

Stakeholders generally felt that:

 

·          all relevant stakeholders should be involved in the standards development and review processes; and

·          existing professional and other standards should be integrated into the Accreditation standards.

 



Development of the scheme rules

 

The Consultation Paper put forward a model for accreditation based on a five-step assessment process and a three year accreditation cycle.  It also discussed possible appeal and complaint handling processes.

 

Stakeholders generally supported a five-step assessment process and a three year accreditation cycle model.  However, the peak industry body for private specialist diagnostic imaging practices, ADIA, opposed this model primarily on cost.  ADIA put forward an alternative model based on off-site assessment, annual declaration of compliance, supported by random on-site audits. 

 

The Department, ADIA and RANZCR, which are the signatories to the Radiology MoU have been having regular meetings to discuss and develop a suitable model that is acceptable to all parties.

 

Stakeholders also supported continuing the payment of benefits for the duration of any appeals against unfavourable assessment decisions or the resolution of complaints against accredited practices, unless the issue to be resolved involved patient safety

 

Accreditation providers

 

Stakeholders were asked whether:

 

·          there should be a single or multiple accreditation providers to assess practices; and

·          if it was appropriate for an international accreditation body to inform the Government whether an accreditation provider is competent to assess practices against the standards.

 

Stakeholders supported:

 

·          a system of multiple accreditation providers to assess practices, but noted the need for consistency of accreditation decisions; and

·          allowing accreditation providers operating in other domains, e.g. hospital and GP accreditation, to extend the scope of their assessments to encompass the new radiology standards, providing they are fully competent to assess all aspects of the new standards.

 

In recent discussions with RANZCR and ADIA, these matters have been agreed in principle, together with using a single international accreditation body to determine the capability of providers to accredit practices.

 

Implementation options and transitional arrangements

 

Because of the large number of sites rendering diagnostic imaging services in a vast range of clinical settings, a number of implementation options were put forward.  These included:

 

·          low volume sites not to be subject to accreditation site visits; 

·          site visit concessions for multiple sites; and

·          deeming provisions for practices accredited under other health care programs, eg general practices and hospitals be deemed to be accredited until their next site visit

 

Most stakeholders did not support low volume sites being deemed to be accredited.  They felt practice providing services infrequently could not maintain a quality service. 

 

Concessions for multiple site practices and mutual recognition of other accreditation programs were generally supported.

 

7        Conclusion and recommended option

 

The quality of an imaging service is dependent on the interplay of a number of factors.  These include:

 

·          the knowledge, expertise and experience of the reporting medical practitioner and other team members, such as radiographers and sonographers

·          the equipment and facilities used;

·          the capabilities of the imaging modality and test, ie x-ray , ultrasound, computed tomography and so on;

·          the quality assurance systems in place; and

·          the level of communication between members, with requesting practitioners and patients.

 

It could be said that the existing regulatory and voluntary arrangements provide the Government, practices and consumers with some degree of assurance that practices are providing a quality service under Medicare. 

 

However, accreditation is the only mechanism that ensures that all elements of providing a quality service are brought together in the practice environment.

 

Making accreditation a pre-requisite for Medicare eligibility will ensure that all practices providing services under Medicare will become accredited.

 

Therefore, Option B is the preferred option.

 

8        Implementation and review

 

Implementation

 

It is proposed that overarching provisions giving a head of power for accreditation and setting out the general principles for the scheme will be contained in the Act itself (the primary legislation) .  The general operative provisions would be contained in regulations and other subordinate legislation. 

 

The primary legislation would include broad guiding principles around the aim of accreditation, ie:

 

·          to support practices in the provision of safe, quality radiology services to healthcare consumers;

·          to foster a culture of continuous quality improvement;

·          to provide practices with regular and objective advice regarding their performance against agreed accreditation standards; and

·          to provide benchmarks for the monitoring and maintenance of industry performance.

 

The legislation would also require that:

·          there are consistent and credible rules and transparent processes for the conduct of assessments of practices providing radiology services;

·          approved accreditation providers will have fair and transparent appeal mechanisms in place which incorporate ‘natural justice’ principles; and .

·          the outcome of an adverse accreditation assessment decision can be contested by the practice without removal of Medicare benefits until there has been a review.

 

The subordinate legislation would cover such things as:

 

·          the standards against which practices would be assessed;

·          the accreditation process assessing bodies would need to follow, including the length of the accreditation cycle;

·          the organisations approved to accredit practices, and their responsibilities; and

·          transitional arrangements.

 

Further Regulation Impact Statements will be prepared to support the subordinate legislation when the operational details of the scheme are fully developed.  .

 

It is expected that the primary legislation will be introduced in the Autumn 2007 sittings of Parliament. Subject to passage through Parliament, the scheme would come into effect from 1 July 2008.  The subordinate legislation would be put forward for consideration following passage of the Bill.

 

By 30 June 2008, practices will need to have applied for accreditation with an approved accreditation provider in order to retain eligibility for Medicare benefits.  At this point, practices will be ‘provisionally accredited.  Practices will gain full accreditation once they are assessed and meet the accreditation requirements.

 

Practices accredited under the current RANZCR/NATA scheme will be deemed to be accredited under the mandatory scheme until their next site assessment is due.

 

Review

 

It is proposed that there will be ongoing monitoring and review of the standards and operation of the scheme through an industry representative committee established for that purpose.

 

It is expected that a comprehensive review of the scheme will undertaken after it has been in operation for five years.



Attachment A

 

Organisations Consulted

The following is list of organisations the Department originally wrote to in July 2006, and those that either registered as an interested party and/or were represented at one of the August 2006 Radiology Workshops.

6 East Vascular Laboratory, New South Wales

ACPSEM (Australian College of Physical Scientists and Engineers in Medicine)

ACPSEM Radiology Physics Special Interest Group

ANZSVS (Australian and New Zealand Society of Vascular Surgery)

Austin Health, Victoria

Australian Healthcare Associates

Australian Medical Imaging, New South Wales

Australian Radiation Services Pty Ltd, Victoria

Ballarat Surgical Clinic, Victoria

Balmoral Naval Hospital, New South Wales

Barwon Health , Victoria

Bendigo Radiology, Victoria

Benson Radiology, South Australia

Bondi Junction Radiology, New South Wales

Booragoon Radiology , Western Australia

Breast Imaging Victoria

Breastscreen WA

Bundaberg Radiology , Queensland

Canberra Imaging Group, ACT

Canterbury Hospital, Sydney

Castlereagh Imaging, New South Wales

Caulfield X-Ray , Victoria

Central Sydney Imaging, New South Wales

Chelmer Imaging Group, Victoria

Clayray X-Ray Services, Victoria

Clinical and State Wide Services, Queensland

Concord Repatriation General Hospital , New South Wales

Cooma Health Service, New South Wales

Dandenong Hospital , Victoria

Eastern Health Medical Imaging, Victoria

Flinders Medical Centre, South Australia

Future Medicine Imaging Group, Victoria

Geelong Medical Imaging, Victoria

Gold Coast Hospital , Queensland

Gralee Business Services, New South Wales

Health System and Improvement Reform, South Australian Department of Health

Hobart Private Hospital , Tasmania

Hunter Radiology, New South Wales

Illawarra Radiology Group, New South Wales

Imaging Management Services

I-Med

Inner West Imaging, New South Wales

Lake Imaging , Victoria

Malvern Diagnostic Imaging, Victoria

MAS Management Consultancy Services

Mather Townsend & Associates

Medical Imaging Eurobodalla, New South Wales

Medical Imaging Services Redcliffe, Caboolture Health Service District, Queensland

MIA Victoria

NATA (National Association of Testing Authorities)

North Shore Vascular Laboratory Pty Ltd, New South Wales

Northam Hospital , Western Australia

Northcote Radiology Clinic, Victoria

Orange Base Hospital , New South Wales

Penisula Vascular Diagnostics Pty Ltd, Victoria

Perth Radiological Clinic, Western Australia

Peter MacCallum Cancer Centre, Victoria

Peter Quinn Management Consulting Pty Ltd

Prince of Wales and Sydney Children’s Hospital

Princess Alexandra Hospital, Queensland

Princess Margaret Hospital for Children, Western Australia

Proprietor Monitor X-Ray, Victoria

Queanbeyan District Hospital , New South Wales

Queensland Vascular Diagnostics Pty Ltd

Queensland X-Ray

Radar Medical Imaging

Radiology South Australia

RANZCR (Royal Australian and New Zealand College of Radiologists)

Royal Children’s Hospital, Victoria

Royal Perth Hospital , Western Australia

Royal Women’s Hospital, Victoria

Shimadzu Medical Systems (Oceania) Pty Ltd

SKG Radiology, Western Australia

South Coast Radiology, Queensland

South East Radiology, New South Wales

South Eastern Sydney and Illawarra Area Health Service, New South Wales

South Gippsland Radiology, Victoria

South West Radiology, New South Wales

Southcoast X-Ray , New South Wales

Southern Radiology, New South Wales

St Vincent’s Clinic Vascular Lab, New South Wales

St Vincent’s Medical Imaging, New South Wales

Statewide Medical Physics Services, Queensland

Sterling Radiology, Western Australia

Sunshine Vascular Imaging, Queensland

Symbion Health

The Alfred Hospital, Victoria

The Geelong Hospital, Victoria

Uniradiology , Victoria

Vascular Diagnostic Service, New South Wales

Vascular Specialists Investigations & Management, New South Wales

West Wyalong District Hospital , New South Wales

Western Australia Country Health Service

Western District Radiology, Victoria

Western Hospital , Victoria

Western Imaging Group, New South Wales

Westmead Vascular Laboratory, New South Wales

William Harvey Vascular Laboratory, South Australia,

Wodonga Medical Imaging, Victoria



Attachment B

 

Organisations and Individuals who lodged submission to Consultation Paper

 

IDENTIFIER: AS.

ORGANISATION/SUBMITTER

DATE RECEIVED

AS.01:

Radar Medical Imaging

30 August 2006

 

AS.02:

 

Gosford District Vascular Diagnostic Laboratories (Dr Bernard Bourke)

3 September 2006

AS.03:

 

Zane Healy Royal Dental Hospital

4 September 2006

AS.04:

 

Royal Perth Hospital/Breast Screen WA (Dr Elizabeth Wylie)

5 September 2006

AS.05:

 

International Society for Quality in Health Care, ISQua

 

6 September 2006

AS.06:

 

South Gippsland Radiology (Francis Sullivan)

6 September 2006

AS.07:

 

Flinders Medical Centre (Dr P R Downey)

7 September 2006

AS.08:

 

Peninsula Vascular Diagnostics Pty Ltd (Ms Claire Johnston)

9 September 2006

AS.09:

 

Australian and New Zealand Society of Vascular Surgery (Mr Noel Atkinson)

9 September 2006

AS.10:

 

Dr Fiona Bettenay MBBS FRANZCR

11 September 2006

AS.11:

 

Goulburn Valley Health

11 September 2006

AS.12:

 

Ballarat Health Services Radiology Department (Richard van Dreven, Craig Wilding)

12 September 2006

AS.13:

 

Dr Stephen Etheredge

12 September 2006

AS.14:

 

Dr David Lipp FRANZCR

12 September 2006

AS.15:

 

Australian Commission on Safety and Quality in Health Care (Dr Diana Horvath)

11 September 2006

AS.16:

Radiology Accreditation Services (Mr Paul O’Keefe)

 

13 September 2006

AS.17:

 

Dr Fraser Brown Ethical Imaging Services Pty Ltd (Dr Fraser Brown)

13 September 2006

AS.18:

 

Sunshine Vascular Imaging Pty Ltd (Dr Schulze)

13 September 2006

AS.19:

 

Australian Council on Healthcare Standards (Dr Marjorie Pawsey)

13 September 2006

AS.20:

 

Mr Charles Barry Beiles

13 September 2006

AS.21:

 

Adelaide Vascular Ultrasound Pty Ltd, Vascular Ultrasound Laboratory (Mr Glen Benveniste)

13 September 2006

AS.22:

 

Royal Australian and New Zealand College of Obstetricians and Gynaecologists (Ann Robertson)

13 September 2006

AS.23:

 

The Liverpool Vascular Laboratory (Wayne Milligan, Eric Farmer and Robert van Den Dolder)

13 September 2006

AS.24:

 

Lakes Diagnostic Imaging Victoria (Dr Greg Filewood)

13 September 2006

AS.25:

 

X-Ray Hobart (Mr Paul Edwards)

13 September 2006

AS.26:

 

Canberra Imaging Group (Mr Jim Percival)

14 September 2006

AS.27:

 

Mr John Cooper

14 September 2006

AS.28:

 

Pennant Hills Diagnostic Centre (Dr Louis Shulman)

14 September 2006

AS.29:

 

Radiology Planning Consultants Pty Ltd (Mr Peter Condon)

13 September 2006

AS.30:

 

National Association of Testing Authorities (Mr John Styzinski)

14 September 2006

AS.31:

 

Penrith Vascular Ultrasound Laboratory

14 September 2006

AS.32:

 

Bendigo Health Care Group (Luke Adorni)

14 September 2006

AS.33:

 

Australian and New Zealand Society for Vascular Surgery (A/Prof Peter Woodruff)

14 September 2006

AS.34:

 

Austin Radiology, Austin Health (Ms Deb Elks)

14 September 2006

AS.35:

Queensland Vascular Diagnostics Pty Ltd (Dr Stephen Gett)

15 September 2006

AS.36:

Vascular Ultrasound Laboratory (Dr Deepak Williams)

 

15 September 2006

AS.37:

 

Australian College of Rural and Remote Medicine (Ms Adrena Doyle)

15 September 2006

AS.38:

 

South Coast Vascular Laboratory (Dr Stephen Etheredge - he is a consultant physician.  Same answers as submitted in AS.13 - independent submission)

15 September 2006

AS.39:

Dr Rodney James Lane

15 September 2006

 

AS.40:

 

Dr Nigel Ackroyd

15 September 2006

AS.41:

 

St. Vincent’s Clinic Vascular Lab (Ms Debbie Hamilton)

15 September 2006

AS.42:

Dr Fraser M McK Brown

 

15 September 2006

AS.43:

Imaging Management Services (Mr Ian Smalley

15 September 2006

 

AS.44:

 

Australian Sonographers Association Ltd (Ms Elaine Trevaskis)

15 September 2006

AS.45:

 

Hunter New England Imaging Service (Mr Phillip McConnell)

15 September 2006

AS.46:

 

Imaging Partners Online Limited (Mr Bob Sheraton)

15 September 2006

AS.47:

 

The Alfred Radiology Department (Ms Gillian Tickall)

15 September 2006

AS.48:

 

NSW Health - Statewide Services Development Branch (Ms Cathryn Cox)

15 September 2006

AS.49:

 

Eastern Health (Ms Jennifer Errey)

15 September 2006

AS.50:

 

Medical Imaging Department, St.Vincent’s Hospital Sydney (Ms Pat Buick)

15 September 2006

AS.51:

 

Joint Accreditation Scheme of Australia and New Zealand Australia (Mr Brett Abraham)

15 September 2006

AS.52:

 

Mather-Townsend & Associates (Ms Marilyn Townsend-Mather)

15 September 2006

AS.53:

 

Victorian Medical Imaging Quality Network (C/- Ms J. Errey)

15 September 2006

AS.54:

 

Ms Janine Horton

15 September 2006

AS.55:

 

Dr F G Quigley Pty Ltd (Vascular Ultrasound Laboratory)

17 September 2006

AS.56:

Dr G Mark Malouf ( Australian and New Zealand Society of Phlebology)

18 September 2006

 

AS.57:

Australian Institute of Radiography (Emile Badawy)

 

18 September 2006

AS.58:

 

Australian Diagnostic Imaging Association (Ms Pattie Beerens)

15 September 2006

AS.59:

 

Australian and New Zealand College of Anaesthetists (Prof Garry Phillips)

18 September 2006

AS.60:

 

Royal Prince Alfred Hospital Radiology (Ms K. Fisher and Ms K. Cook)

18 September 2006

AS.61:

 

Vascular Investigations (Mr George Somjen, Mr Graeme Lass and Mrs Eva Tarjan)

18 September 2006

AS.62:

 

Hastings Vascular Laboratory (Dr Jennifer Chambers)

18 September 2006

AS.63:

 

Royal North Shore Hospital (Ms Ingrid Egan)

18 September 2006

AS.64:

 

Dr Phillip Colman (Vascular Ultrasound Laboratory)

18 September 2006

AS.65:

 

Vermont Radiology (Ms Toni Jones)

19 September 2006

AS.66:

 

Medical Imaging Department, St.Vincent’s Hospital Sydney (Ms Elizabeth Silverstone)

21 September 2006

AS.67:

 

Dr Charles Fisher (Department of Vascular Surgery)

21 September 2006

AS.68:

 

Dr John Anderson and Dr Peter Bray (Ashford Specialist Centre)

21 September 2006

AS.69:

 

Dr John Teasdale (WA Vascular Centre)

21 September 2006

AS.70:

 

Western Vascular Diagnostics (Gary Frydman)

21 September 2006

AS.71:

Geelong Regional Vascular Service (Mr David McClure)

21 September 2006

 

AS.72:

 

Australian Dental Association (Mr W J O’Reilly)

22 September 2006

AS.73:

A/Professor John Gurry (Vascular Ultrasound Laboratory)

22 September 2006

 

AS.74:

 

Melbourne Vascular Surgery Unit (Mr Peter Milne)

22 September 2006

AS.75:

 

Australian and New Zealand Association of Physicians in Nuclear Medicine (Inc) (Prof Wong)

 

22 September 2006

AS.76:

Dr Nick Ferris

15 September 2006

AS.77:

Department of Health South Australia (Dr T. Sherbon)

22 September 2006

AS.78

Dr Arvind Deshpande

25 September 2006

AS.79

ADIA Proposal on Accreditation

25 September 2006

AS.80:

Royal Australia and New Zealand College of Radiologists (Lisa Penlington)

26 September 2006

AS.81:

Radiation Health Branch, Department of Health WA (Dr Neale Fonge)

25 September 2006

AS.82:

Pittwater Radiology Partnership (Dr Peter Duffy)

14 September 2006

 

AS.83:

Symbion Imaging (Dr Ronald Shnier)

15 September 2006

 

AS.84:

Sydney West Area Health Service (A/Prof Gilhotra for Ms Gloria Olivieri, Mr Ian Lambert)

27 September 2006

AS.85:

Mr Nick Vertes (Intellicorp Australia Pty Ltd)

27 September 2006

 

AS.86:

Royal Australian College of General Practitioners (Richard Lawrence for Prof Michael Kidd, President)

28 September 2006

AS.87:

Rural Doctors Association of Australia (Mr Steve Sant)

29 September 2006

 

AS.88:

Conformance and Standards Services Pty Ltd (Mr Peter Walsh)

19 September 2006

AS.89:

Department of Human Services VIC (Dr Mary B Turner)

Amended submission & covering letter submitted & received 19 October.

6 October 2006

 

AS.90:

Medicare Australia (Doug Marshall, Kellie Flanagan; Tina Crawford, Claire Ruskin)

19 September 2006

AS.91:

GPA Accreditation PLUS

3 October 2006

 

AS.92:

Australian General Practice Accreditation Limited/Quality In Practice Pty Ltd (Ms Marisa Vecchio)

 

17 October 2006

 

 



NOTES ON CLAUSES

 

Clause 1—Short title

 

This clause provides that this Bill, when enacted, will be known and cited in official documents as the Health Insurance Amendment (Diagnostic Imaging Accreditation) Act 2007.

 

Clause 2—Commencement

 

This clause provides that sections 1 to 3 and Items 1 to 4 and 6 to 13 of Schedule 1 of the Bill commence on the day the Bill receives Royal Assent. 

 

Item 5 of Schedule 1 to the Bill commences on 1 July 2008.  This will allow time for the necessary infrastructure for accreditation to be put in place before Medicare benefits cease to be payable.

 

Clause 3—Schedule(s)

 

This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out in the applicable items in the Schedule concerned and any other item has effect according to its terms.  In this Bill, Schedule 1 amends the Health Insurance Act 1973.

 

SCHEDULE 1—AMENDMENTS

 

In accordance with Clause 2, the amendments in items 1 to 4 and 6 to 13 detailed below commence Royal Assent.  Item 5 commences on 1 July 2008.  Item 13 restricts the application of sections 23DZZIAE and DZZIAF so that they only apply in relation to services provided on or after 1 July 2008.

 

Health Insurance Act 1973

 

Item 1

 

This item inserts into the Act a definition of ‘approved accreditor’ in relation to the accreditation of practices under a diagnostic imaging accreditation scheme.  This term is discussed further under paragraph 23DZZIAA(1)(b) at Item 11. 

 

Item 2

 

This item inserts a definition of ‘diagnostic imaging accreditation scheme’ into the Act.  This term is discussed further under section 23DZZIAA of this Bill introduced by Item 11.  

 



Items 3 and 4

 

Item 11 of this Bill inserts new Division into the Act - ‘Division 5—Diagnostic imaging accreditation’.  These items reference this new Division in existing subsections 16D(7) and 16D(9).  Those subsections define the concept of ‘equipment being ordinarily located at a practice site’.  The amendments being made to these subjections are consequential amendments as the ‘ordinarily located’ concept applying in those subsections is also used in Division 5.

 

The heading section 16D will also be altered to read ‘Medicare benefits not payable for certain diagnostic imaging services: registration’.  This is a consequential change because of the introduction of new section 16EA - see Item 5 below.

 

Item 5

 

This item would add a new section 16EA into the Act.

 

New subsection 16EA(1) precludes the payment of Medicare benefits (except where the Minister otherwise directs) for diagnostic imaging services, unless the diagnostic imaging procedures (that is, the capture of the images used in the service, e.g. the x-ray, ultrasound scan, computed tomography scan etc.) are carried out:

 

·          at premises that are accredited under a diagnostic imaging accreditation scheme to undertake the particular type of diagnostic imaging procedure - paragraph 16EA(1)(a); or

·          in the case where the images are captured off-site, for example mobile services, on equipment that is ordinarily located at a base for mobile diagnostic imaging equipment or diagnostic imaging premises accredited to undertake the procedure - paragraphs 16EA(1)(b) and (c).

 

The terms ‘base for mobile diagnostic imaging equipment’ and ‘diagnostic imaging premises’ are currently defined in the Act by sections 23DZL and 23DZM.  The term ‘diagnostic imaging procedure’ is currently defined in subsection 3(1) of the Act.

 

Proposed new section 23DZZIAA, at Item 11 of Schedule 1 provides the framework for the establishment of diagnostic imaging accreditation schemes, including the approval of accrediting organisations. 

 

It will be the responsibility of the practices site to apply for and maintain accreditation with an approved accreditation provider.

 

This new subsection allows the Minister to direct that a Medicare benefit be paid in respect of a diagnostic imaging service where the practice site was not accredited.  The intention of this power is so that the Minister can give consideration as to whether a patient has or would be disadvantaged in a particular case through no fault of their own and provide for the payment of medicare benefit where appropriate.  An example of when it would be envisaged that this power would be exercised is when the patient was unable to use an accredited practice to have the service, which in similar circumstances would be eligible for a Medicare benefit.  The Minister may also use this power to direct that a benefit be paid where the patient was not notified by the practice that no Medicare benefit would be payable in accordance with its obligations under proposed new section at 23DZZIAE (introduced by Item 11).

 

Where the Minister does direct that this provision will not prevent the payment of a Medicare benefit and the proprietor has failed to notify the patient that the site was not accredited, the benefit paid is a debt recoverable from the proprietor of the premises or mobile base under proposed new section 23DZZIAF (discussed under Item 11).

 

Subsection 16EA(2) allows for regulations to be made to exclude certain types of procedures from the accreditation requirements.  The accreditation arrangements will only apply to diagnostic imaging services covered by the Radiology Quality and Outlays Memorandum of Understanding, that is, all services except cardiac imaging, nuclear medicine imaging, and obstetrical and gynaecological ultrasound.  Cardiac, nuclear medicine and obstetrical and gynaecological services will be excluded from the arrangements by such regulations until such time as Parliament supports a future decision to extend accreditation to those services.

 

Coupled with the provisions in proposed new section 23DZZIAA, this allows for flexibility in introducing further diagnostic imaging accreditation schemes via delegated legislation, rather than as changes to the Act, should accreditation be extended to those services in the future.

 

Subsection 16EA(3) is included to assist readers as the direction under subsection 16EA(1) is not a legislative instrument within the meaning of section 5 the Legislative Instruments Act 2003.

 

This provision commences on 1 July 2008 to allow time for the necessary infrastructure for accreditation to be put in place before Medicare benefits cease to be payable.

 

Item 6

 

Existing section 23DZL defines a ‘base for mobile diagnostic imaging equipment’ for the purpose of the Diagnostic Imaging Register, commonly known as the Location Specific Practice Number (LSPN) arrangements.  This definition will be amended to also apply to the proposed accreditation provisions. 

 

To differentiate these practices from diagnostic imaging premises (i.e. fixed practice sites), paragraph 23DZL(b) of the definition currently requires that the imaging equipment needs to be used at a place other than the base.

 

The proposed amendment to paragraph 23DZL(b) addresses an unintended consequence of the provision that, if applied literally, does not allow for circumstances where images are occasionally captured at the home base. 

 

The use of the phrase ‘frequently carried out off the premises’ is intended distinguish mobile bases from practice sites where procedures are generally carried out on site.

 

Items 7 and 8

 

These items are consequential amendments because of the amendment to paragraph 23DZL(b).  They amend the current definition of diagnostic imaging premises to make it clear that a base for mobile diagnostic imaging equipment is not a diagnostic imaging premises.

 

They are technical amendments to clarify the distinction between mobile bases and diagnostic imaging premises.

 

 

Items 9 and 10

 

Subsections 23DZT and 23DZU allow the Minister to release extracts of the Diagnostic Imaging Register (commonly known as the LSPN Register) in certain circumstances, and to publish extracts of the Register on the internet. 

 

Proposed new section 23DZZIAB, discussed under Item 11, will require details about the accreditation status of a practice site to be kept on the Diagnostic Imaging Register.

 

The amendments to these sections provide that information about whether a practice site is accredited or not is included in the extracts.

 

Item 11

 

This item inserts new Division 5 titled ‘Diagnostic imaging accreditation’ into Part IIB of the Act.  Part IIB of the Act contains special provisions relating to diagnostic imaging services.  This new Division sets out the framework for the establishment and operation of diagnostic imaging accreditation schemes.

 

Section 23DZZIAA - Diagnostic imaging accreditation

 

Subsection 23DZZIAA(1) allows the Minister to establish, via legislative instruments, a diagnostic imaging accreditation scheme or schemes and approve persons (accreditors) who will be able to accredit practices for the purposes of the scheme.  The purpose of allowing the Minister to establish more than one scheme is for situations where there may be a need for accreditation schemes with different rules to cater for the diverse range of clinical settings in which diagnostic imaging services are rendered. 

 

Subsection 23DZZIAA(2) allows a legislative instrument establishing a scheme to specify the conditions with which accreditation organisations would need to comply in order to become approved or maintain their approval.

 

Subsection 23DZZIAA(3) provides that the instrument establishing a scheme may provide for any matters needed to create and administer the scheme.  The matters contained in the instrument will become the scheme rules.  Subsection 23DZZIAA(4) elaborates on subsection 23DZZIAA(3) by listing the types of matters that may be included in the instrument.  This is not an exhaustive list. 

 

If the legislative instrument establishing a scheme confers a power or function on the Minister in administering the scheme, subsection 23DZZIAA(5) allows the Minister to delegate these powers or functions to an officer as defined in existing section 131 of the Act.  Under section 131, an officer is:

 

·          an officer of the Department; or

·          a person performing the duties of an office in the Department; or

·          the Chief Executive Officer of Medicare Australia CEO; or

·          an employee of Medicare Australia.

 

Section 23DZZIAB - Diagnostic Imaging Register to include accreditation status

 

The Diagnostic Imaging Register (LSPN Register as it is commonly known) will be the mechanism for recording the accreditation status of accredited practices for Medicare benefits purposes.

 

Section 23DZZIAB requires the accreditation status of practice to be recorded on the Diagnostic Imaging Register.  The type of information that will be recorded will be prescribed by regulations when the legislative instrument for the scheme is made.

 

Subsection 23DZZIAB(1) applies to the granting and renewal of accreditation.  Subsection 23DZZIAB(2) covers revocation and variation of accreditation status.

 

Section 23DZZIAC - Reconsideration of accreditation decisions

 

Approved accreditation providers will need to comply with the conditions imposed on them by the scheme rules which will be provided for in the legislative instrument under section 23DZZIAA. 

 

One of these conditions will be for the scheme to have full and proper review mechanisms for practices where the accreditation provider has made a decision to revoke or vary the accreditation status of a practice.

 

Subsection 23DZZIAC(1) creates an obligation of the Minister when determining the scheme rules to include in the rules a process for reconsideration of an accreditation decision [paragraph  23DZZIAC(1)(b)].  It also requires the proprietor of the practice to be notified of the result of the reconsideration and the review rights available to the proprietor under section 23DZZIAD [paragraph 23DZZIAC(1)(b)].  It is envisaged that the scheme will provide that first reconsiderations will be undertaken by the accreditation providers themselves.

 

Subsection 23DZZIAC(2) provides that the scheme rules determined by the Minister must provide that the practice generally maintains its existing accreditation status until such time as their rights for reconsideration under the Scheme and under section 23DZZIAD (discussed below) are exhausted or after 28 days from the date of the accreditation provider’s decision if the practice does not apply for a review.  There is an exception to this where accreditation has been revoked on the grounds that there is potential risk to public health and safety.  In this instance, the decision is not stayed pending a first reconsideration or a review by the Minister.  This subsection only applies where practices have current accreditation.  It does not apply where a practice is seeking accreditation for the first time or seeks to be accredited for additional procedures. 

 

Section 23DZZIAD - Reconsideration by the Minister of accreditation decisions

 

This section applies where an accreditation provider does not grant accreditation, renew accreditation, revokes accreditation or varies an existing accreditation status such that there would be a reduction of Medicare benefit entitlements.

 

Subsection 23DZZIAD(1) allows a practice to apply to the Minister for a review of the accreditation provider’s decision if they receive an unfavourable first reconsideration decision.  The practice can only apply after the first reconsideration has been made as required by section 23DZZIAC. 

 

The application for a review must be made within 28 days of the date of the first reconsideration decision notice and set out the reasons the proprietor believes that a review should be undertaken [subsection 23DZZIAD(2)].

 

Subsection 23DZZIAD(3) allows the Minister to seek further information from the practice in relation to the review.

 

Subsection 23DZZIAD(4) requires the Minister to make a decision to affirm or set aside the first decision and make a new decision instead.

 

Subsection 23DZZIAD(5) allows the Minister to specify when the decision takes effect.  Subject to subsection 23DZZIAD(6) this may be earlier than the date of the notice of decision to the practice.

 

Subsection 23DZZIAD(6) specifies that the date of effect of the Minister’s decision cannot be backdated where accreditation wasn’t renewed, it was revoked or varied so as to reduce the procedures for which the premises are accredited, i.e. where this would adversely affect the existing Medicare entitlements of the practice.

 

The following examples may help to illustrate how these provisions operate.

 

Example 1 (No existing accreditation - refusal to grant accreditation)

 

An accreditation provider refuses to grant accreditation to a practice.

 

After the practice has sought and obtained a first review of the decision, under the scheme rules, the practice can apply to the Minister for a review of that decision within 28 days of the date of the first review decision.

 

The Minister must make a decision within 28 days of the date of receipt of the practice’s review application to either affirm the decision or set aside the decision and substitute a new decision.  If the Minister affirms the decision, the decision would apply from the date of the decision by the accreditation provider. If the Minister sets aside the decision, the new decision could apply from any date the Minister specifies in the notice.  This date may or may not be earlier than the date of the Minister’s decision.

 

Example 2 (Existing accreditation - renewal of accreditation refused)

 

An accreditation provider refuses to renew accreditation for a practice. 

 

After the practice has sought and obtained a first review of the decision under the sheme rules, the practice can apply to the Minister for a review of that decision within 28 days of the date of the first review decision.

 

The Minister must make a decision within 28 days of the date of receipt of the practice’s review application to either affirm or set aside the decision. 

 

If the Minister affirms the decision (ie accreditation is not renewed), by contrast to Example 1, the Minister cannot backdate the decision as this would affect existing Medicare entitlements.

 

The Minister’s decision will not be reviewable by the Administrative Appeals Tribunal.  This is because the Minister’s decision is a review of a decision of an approved accreditation provider, which itself will be required to have a full and proper review mechanism in place for practices as described under section 23DZZIAC.

 

Section 23DZZIAE - Proprietor of unaccredited premises or base must notify patients that Medicare benefit not payable

 

This section makes it an offence by the proprietor of premises or mobile base if the patient is not informed before undertaking the diagnostic imaging procedure that Medicare benefit is not payable if the premises or base is not accredited in respect of that procedure.  The proprietor must also advise the patient the reason no Medicare benefits are payable, i.e. that the premises is not accredited for the procedure the patient is having.

 

Subsection 23DZZIAE(1) applies to diagnostic imaging premises and subsection 23DZZIAE(2) applies to bases for mobile diagnostic imaging equipment.

 

A proprietor may discharge their obligations under this section by either providing an individual notice in writing to the patient or displaying a suitable sign in a prominent position at the premises.

 

Similar offence provisions exist for proprietors of unregistered diagnostic imaging premises and mobile bases under section 23DZZF and 23DZZG.

 

Like the offences under section 23DZZF and 23DZZG, the offence for unaccredited sites is a strict liability offence, carrying a fine of 10 penalty units (currently $1,100) for an individual and 30 penalty units ($3,300) for a corporation.

 

An offence is necessary to ensure the integrity of the accreditation regime through patients being made aware that the practice is not accredited.  Patients may then choose to seek services from an accredited practice.

 

Strict liability is considered appropriate in these circumstances based on the following considerations:

·          the penalty is relatively small (10 penalty units) and the offence itself is a straight forward one;

·          Non-compliance with the notification requirement would be to the potential detriment of patients attending the non-accredited practice. For this reason it is considered justified to impose strict liability on the proprietor of the practice encourage proprietor to take active steps to ensure compliance with the requirement; and

·          There needs to be a credible threat of prosecution of non-compliance to encourage proprietors to comply.  To this, the strict liability nature of the offence will help to facilitate speedy prosecution of cases of non-compliance.

 

As discussed in Item 13, this provision will only apply in relation to diagnostic imaging procedures carried out on or after 1 July 2008, to coincide with the date of commencement of new section 16EA (discussed under Item 5).

 

Section 23DZZIAF - Debt recovery if proprietor fails to inform patient that premises or base not accredited

 

This section provides that the amount of a Medicare benefit paid to a patient in respect of a diagnostic imaging service is recoverable from the proprietor of diagnostic imaging premises where:

 

·          the proprietor has failed to notify the patient that the premises or mobile base is not accredited for the procedure provided, and that therefore no medicare benefit would be payable for the service; and

·          the Minister has directed the benefit be paid under the discretionary power given to the Minister by new subsection 16EA(1).

 

This debt will be in addition to any fine imposed on the proprietor for failure to notify the patient that no Medicare benefit is payable because the practice is not accredited for the particular procedure.

 

This provision mirrors a current provision for unregistered premises and bases in section 23DZZH.

 

This item will only apply in relation to diagnostic imaging procedures carried out on or after 1 July 2008.  This is to coincide with the date of commencement of new section 16EA which prevents the payment of Medicare benefit in relation to procedures carried out by a practice which is not accredited under a diagnostic imaging accreditation scheme.

 

Section 23DZZIAG - Application of this Division to partnerships

 

Existing section 23DZO defines a proprietor of a diagnostic imaging premises or mobile base.  Under that section, a proprietor can be a natural person, a corporate entity or state or federal agency or statutory authority.

 

Section 23DZZI covers the circumstances in which a partnership is the proprietor of the premises or mobile base.  That section provides that that each partner in a partnership are equally responsible for the obligations imposed on a proprietor of a registered diagnostic imaging premises or a mobile base, notwithstanding anything contained in a partnership agreement to the contrary.  It also provides that any of the partners can discharge an obligation or exercise a right on behalf of the other partners. 

 

Section 23DZIAG has the effect of imposing the same rights and responsibilities on partnerships for the purposes of the accreditation arrangements.

 

As an example of how this might operate, should a patient have an x-ray at a premises that was not accredited and the patient was not informed that a Medicare benefit would not be payable, a fine could be imposed any one of the partners.  However, no more than one partner may be fined for the one offence.

 

Similarly, any one of the partners could exercise (on behalf of other partners) the right to apply to the Minister for reconsideration of an unfavourable decision of an approved accreditation provider under proposed new section 23DZZIAD.

 

Item 12

 

Item 12 contains the transitional arrangements for practices in operation at the time the diagnostic imaging scheme comes into effect.

 

In summary, these arrangements provide that as long as a practice has registered for accreditation before 1 July 2008, services rendered by the practice will continue to be eligible for Medicare benefits until such time as the practice goes through the accreditation process, or until the date by which the practice must apply for accreditation under subitem (3).  In other words, they will have ‘provisional accreditation’.

 

Subitem 1 of the transitional provisions provides for the proprietor to register the practice with a person designated by the Minister.  It is intended that these persons will be the approved accreditation providers when the scheme comes into operation to avoid unnecessary administrative burdens on practices.

 

Subitem 2 is the operative provision that deems a practice to be accredited for the purpose of subsection 16EA(1) once they have registered with a designated person.  In other words, once they have registered, they remain eligible for Medicare benefits until the transitional arrangements cease under subitem 4.

.

Subitems 3 and 4 provide for when ‘deemed’ accreditation for practices ceases.  Subitem 3 provides that practices who are deemed to be accredited must apply for accreditation before 1 July 2009 (that is 12 months after effective date of accreditation), or by such other date as is prescribed in the legislative instrument describing the scheme.  Allowing the legislative instrument to specify an earlier or later date provides flexibility regarding the deadline for practices to apply for accreditation in case unforeseen circumstances arise when the scheme is operational.  If no date is specified in the legislative instrument, practices will need to apply under the scheme by 1 July 2009..  Subitem 4 provides that deemed accreditation ceases:

 

·          on the day after the period specified in subitem 3 (i.e 1 July 2009 or such other date provided for in the legislative instrument

·          on the day the practice has been granted accreditation under the scheme

·          if accreditation has been refused, on the day after the proprietor’s rights to have the decision reconsidered are exhausted or have expired.

 

Subitem 5 allows the Minister to designate the persons able to accept applications under the transitional arrangements.  As mentioned earlier, it is intended that these persons will be the organisations who will become approved accreditation providers.

 

Subitem 6 allows the Minister to delegate to the Secretary of the Department or to an APS employee in the Department his power under subitem 5 to designate the persons who will be able to accept applications for deemed accreditation pursuant to subitem 1.

 

Subitem 7 allows the designated person to charge registration fees.  They may also charge different fees for different kinds of applications, for example, they might have an incremental fee schedule based on the range of imaging procedures offered. 

 

Subitem 8 provides that a practice cannot register under the transitional arrangements after 1 July 2008.  Practices requiring accreditation after that date would need to apply to an approved accreditation provider to become accredited under the scheme.

 

Subitem 9 provides that any term defined in the Health Insurance Act 1973 that is used in this Item 12 has the same meaning as defined in the Act. 

 

Item 13

 

This item provides that new sections 23DZZIAE and 23DZZIAF apply only in relation to diagnostic imaging procedures carried out on or after 1 July 2008. 




[1] QUDI Project - Post Implementation Review of Accreditation of Radiology Practices - September 2005.