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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 imaging services 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.
1
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.
2
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
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.
4
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:
5
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.
1
QUDI Project - Post Implementation Review of Accreditation of Radiology Practices - September 2005.
6
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.
7
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.
8
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.
9
Summary of costs and benefits
Stakeholder Option 1 Option 2
Australian Costs Costs
· no assurance public money is · infrastructure and administrative
Government
supporting quality services. costs to Medicare Australia
· participation in accreditation · management of the legislative
likely to be low. framework for the accreditation
scheme
Benefits Benefits
· does not have to develop and · certainty that all accredited
administer an accreditation practices conform to the same set of
scheme. practice standards
· reassurance that government
funding is expended on quality
services
· reduced Medicare outlays for less
than optimal services
Practices Costs Costs
· cost of compliance with · up-skilling or employing staff to
existing regulatory provisions support the requirements of the
· cost of the voluntary scheme accreditation standards
· registration/application fees, site
for those who participate.
visits and on-going membership
fees for accreditation
· potential loss of staff resources to
support assessment
Benefits Benefits
· confidence that they can deliver
· no direct and indirect costs of high quality services;
· assurance that legislative and
accreditation
· potential economic efficiencies technical requirements are met or
and financial benefits in exceeded;
· economic benefits through robust,
accreditation
streamlined and efficient
administrative processes;
Accreditors Costs Costs
· will have a smaller market then · normal business set up costs for
if accreditation was linked to those providers wishing to enter the
Medicare benefits. market
· there is no market for other
providers
Benefits Benefits
· none · market will be much larger than
under a voluntary arrangement.
Consumers Costs Costs
· no assurance re quality · potential increased out of pocket
· no confidence that there are · access to Medicare funded
10
Stakeholder Option 1 Option 2
processes to protect privacy, radiology services may be reduced
the handling of complaints
and physical safety.
Benefits Benefits
· continue have access to · receive high quality services
· confidence that there are processes
Medicare benefits if practices
do not comply with the to protect their privacy, the
voluntary standards. 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.
11
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.
12
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 .
13
· 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.
14
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
16
Attachment B
Organisations and Individuals who lodged submission to Consultation Paper
IDENTIFIER: ORGANISATION/SUBMITTER DATE
AS. RECEIVED
AS.01: Radar Medical Imaging 30 August 2006
AS.02: Gosford District Vascular Diagnostic Laboratories 3 September 2006
(Dr Bernard Bourke)
AS.03: Zane Healy Royal Dental Hospital 4 September 2006
AS.04: Royal Perth Hospital/Breast Screen WA (Dr 5 September 2006
Elizabeth Wylie)
AS.05: International Society for Quality in Health Care, 6 September 2006
ISQua
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 9 September 2006
Johnston)
AS.09: Australian and New Zealand Society of Vascular 9 September 2006
Surgery (Mr Noel Atkinson)
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 12 September 2006
(Richard van Dreven, Craig Wilding)
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 11 September 2006
Health Care (Dr Diana Horvath)
AS.16: Radiology Accreditation Services (Mr Paul O'Keefe) 13 September 2006
AS.17: Dr Fraser Brown Ethical Imaging Services Pty Ltd 13 September 2006
(Dr Fraser Brown)
AS.18: Sunshine Vascular Imaging Pty Ltd (Dr Schulze) 13 September 2006
AS.19: Australian Council on Healthcare Standards (Dr 13 September 2006
Marjorie Pawsey)
AS.20: Mr Charles Barry Beiles 13 September 2006
AS.21: Adelaide Vascular Ultrasound Pty Ltd, Vascular 13 September 2006
Ultrasound Laboratory (Mr Glen Benveniste)
AS.22: Royal Australian and New Zealand College of 13 September 2006
Obstetricians and Gynaecologists (Ann Robertson)
AS.23: The Liverpool Vascular Laboratory (Wayne Milligan, 13 September 2006
Eric Farmer and Robert van Den Dolder)
AS.24: Lakes Diagnostic Imaging Victoria (Dr Greg 13 September 2006
Filewood)
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 13 September 2006
Condon)
AS.30: National Association of Testing Authorities (Mr John 14 September 2006
Styzinski)
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 14 September 2006
Surgery (A/Prof Peter Woodruff)
AS.34: Austin Radiology, Austin Health (Ms Deb Elks) 14 September 2006
AS.35: Queensland Vascular Diagnostics Pty Ltd (Dr 15 September 2006
Stephen Gett)
AS.36: Vascular Ultrasound Laboratory (Dr Deepak 15 September 2006
Williams)
AS.37: Australian College of Rural and Remote Medicine 15 September 2006
(Ms Adrena Doyle)
AS.38: South Coast Vascular Laboratory (Dr Stephen 15 September 2006
Etheredge - he is a consultant physician. Same
answers as submitted in AS.13 - independent
submission)
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 15 September 2006
Hamilton)
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 15 September 2006
Trevaskis)
18
AS.45: Hunter New England Imaging Service (Mr Phillip 15 September 2006
McConnell)
AS.46: Imaging Partners Online Limited (Mr Bob Sheraton) 15 September 2006
AS.47: The Alfred Radiology Department (Ms Gillian 15 September 2006
Tickall)
AS.48: NSW Health - Statewide Services Development 15 September 2006
Branch (Ms Cathryn Cox)
AS.49: Eastern Health (Ms Jennifer Errey) 15 September 2006
AS.50: Medical Imaging Department, St.Vincent's Hospital 15 September 2006
Sydney (Ms Pat Buick)
AS.51: Joint Accreditation Scheme of Australia and New 15 September 2006
Zealand Australia (Mr Brett Abraham)
AS.52: Mather-Townsend & Associates (Ms Marilyn 15 September 2006
Townsend-Mather)
AS.53: Victorian Medical Imaging Quality Network (C/- Ms 15 September 2006
J. Errey)
AS.54: Ms Janine Horton 15 September 2006
AS.55: Dr F G Quigley Pty Ltd (Vascular Ultrasound 17 September 2006
Laboratory)
AS.56: Dr G Mark Malouf (Australian and New Zealand 18 September 2006
Society of Phlebology)
AS.57: Australian Institute of Radiography (Emile Badawy) 18 September 2006
AS.58: Australian Diagnostic Imaging Association (Ms 15 September 2006
Pattie Beerens)
AS.59: Australian and New Zealand College of Anaesthetists 18 September 2006
(Prof Garry Phillips)
AS.60: Royal Prince Alfred Hospital Radiology (Ms K. 18 September 2006
Fisher and Ms K. Cook)
AS.61: Vascular Investigations (Mr George Somjen, Mr 18 September 2006
Graeme Lass and Mrs Eva Tarjan)
AS.62: Hastings Vascular Laboratory (Dr Jennifer 18 September 2006
Chambers)
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 21 September 2006
Sydney (Ms Elizabeth Silverstone)
AS.67: Dr Charles Fisher (Department of Vascular Surgery) 21 September 2006
AS.68: Dr John Anderson and Dr Peter Bray (Ashford 21 September 2006
Specialist Centre)
AS.69: Dr John Teasdale (WA Vascular Centre) 21 September 2006
19
AS.70: Western Vascular Diagnostics (Gary Frydman) 21 September 2006
AS.71: Geelong Regional Vascular Service (Mr David 21 September 2006
McClure)
AS.72: Australian Dental Association (Mr W J O'Reilly) 22 September 2006
AS.73: A/Professor John Gurry (Vascular Ultrasound 22 September 2006
Laboratory)
AS.74: Melbourne Vascular Surgery Unit (Mr Peter Milne) 22 September 2006
AS.75: Australian and New Zealand Association of 22 September 2006
Physicians in Nuclear Medicine (Inc) (Prof Wong)
Dr Nick Ferris
AS.76: 15 September 2006
Department of Health South Australia (Dr T. Sherbon)
AS.77: 22 September 2006
Dr Arvind Deshpande
AS.78 25 September 2006
ADIA Proposal on Accreditation
AS.79 25 September 2006
Royal Australia and New Zealand College of Radiologists (Lisa
AS.80: 26 September 2006
Penlington)
Radiation Health Branch, Department of Health WA (Dr Neale
AS.81: 25 September 2006
Fonge)
Pittwater Radiology Partnership (Dr Peter Duffy)
AS.82: 14 September 2006
Symbion Imaging (Dr Ronald Shnier)
AS.83: 15 September 2006
Sydney West Area Health Service (A/Prof Gilhotra for Ms
AS.84: 27 September 2006
Gloria Olivieri, Mr Ian Lambert)
AS.85: Mr Nick Vertes (Intellicorp Australia Pty Ltd) 27 September 2006
AS.86: Royal Australian College of General Practitioners 28 September 2006
(Richard Lawrence for Prof Michael Kidd, President)
AS.87: Rural Doctors Association of Australia (Mr Steve 29 September 2006
Sant)
AS.88: Conformance and Standards Services Pty Ltd (Mr 19 September 2006
Peter Walsh)
AS.89: Department of Human Services VIC (Dr Mary B 6 October 2006
Turner)
Amended submission & covering letter submitted &
received 19 October.
AS.90: Medicare Australia (Doug Marshall, Kellie Flanagan; 19 September 2006
Tina Crawford, Claire Ruskin)
AS.91: GPA Accreditation PLUS 3 October 2006
AS.92: Australian General Practice Accreditation 17 October 2006
Limited/Quality In Practice Pty Ltd (Ms Marisa
Vecchio)
20
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.
21
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).
22
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.
23
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
24
· 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.
25
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.
26
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
27
· 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.
28
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.
29
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.
30
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