EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
Health Insurance (Accredited Pathology Laboratories – Approval)
Amendment Instrument (No. 1) 2019
Section 23DNA of the Health Insurance Act 1973 (‘the Act’) provides for the Minister for Health to determine the principles to be applied in exercising his or her powers under section 23DN of the Act to approve in principle, or refuse to approve, premises as an accredited pathology laboratory. The current principles determined under section 23DNA are provided for under the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017 (the Principles).
With the exception of some basic tests conducted by some medical practitioners within their own medical practice, medicare benefits for pathology services are only payable when they are rendered by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority. The Principles approved under section 23DNA operate to ensure that appropriate standards are met and maintained in pathology laboratories at which Medicare eligible pathology services can be provided.
The Principles set out the criteria for different categories of accredited pathology laboratories and specify the standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in that laboratory. The overarching objectives of the Principles include promoting the delivery of reliable test results and reducing the risk of misdiagnosis in the provision of pathology services.
The Schedule to the Principles specifies accreditation materials that set out relevant standards against which applicants for accreditation are to be assessed. These documents are developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC) or endorsed by NPAAC as supplementary accreditation materials. The accreditation process of pathology laboratories is administered by the Department of Human Services, while the National Association of Testing Authorities (NATA) is the current independent assessment body that conducts the accreditation assessment of pathology laboratories, in conjunction with the Royal College of Pathologists of Australasia, in accordance with the specified accreditation standards.
The supervision standards set out in the document titled “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018)” (the 2018 supervision accreditation standards) comes into effect on 1 August 2019 as a pathology accreditation standards for all pathology laboratories. The purpose of the Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Instrument (No. 1) 2019 (the Amendment Instrument) is to amend the Principles to include a transition period whereby certain specified laboratories and specialised S category laboratories that perform In-vitro Fertilisation (IVF) testing related to the diagnosis and treatment of fertility issues can be assessed under either the supervision standards set out in the document titled “Requirements for the Supervision of Pathology Laboratories 2007” (superseded supervision accreditation standards) or the 2018 supervision accreditation standards until 31 December 2020. The extended transition period for these specific laboratories will allow them to continue operations whilst making arrangements to meet the 2018 supervision accreditation standards by 1 January 2021.
The extended transition period is in response to concerns raised by IVF laboratories, and a number of other laboratories, with the Minister for Health. As it is important that these specialised laboratories, including those providing fertility tests, continue the provision of specified services set out in the approval under section 23DN of the Act, the transition period has been provided to these laboratories to enable their medical specialists be given adequate time to have their scope of practice to be credentialed for the purposes of supervision of testing rendered in their pathology laboratories. These laboratories will be expected to make arrangements to meet the 2018 supervision accreditation standards by 1 January 2021.
Copies of pathology accreditation materials listed in the Schedule to the Principles are published on the NPAAC website and can be accessed from -http://www.health.gov.au/internet/main/publishing.nsf/ Content/health-npaac-publication.htm. The pathology accreditation framework is aimed at assuring the quality of Australian pathology services.
CONSULTATIONS
The usual established standards development protocol includes a public consultation phase. However, the amendments to the Principles were in response to concerns raised by some members of the pathology sector and there has been communication between NPAAC and the pathology sector on the proposed modifications to the extended transition period for IVF laboratories and other specified laboratories.
The Amendment Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Details of the legislative instrument are set out in Attachment A.
ATTACHMENT A
Details of the Health Insurance (Accredited Pathology Laboratories-Approval) Amendment Instrument (No. 1) 2019
1. Name of legislative instrument
Section 1 provides that the title of the legislative instrument is the Health Insurance (Accredited Pathology Laboratories-Approval) Amendment Instrument (No. 1) 2019 (the Amendment Instrument).
2. Commencement
Subsection 2(1) provides for commencement dates of each of the provisions specified in Column 1 of the table, in accordance with Column 2 of the table. Item 1 of the table in subsection 2(1) provides that sections 1 to 4 and anything in the instrument not elsewhere covered by the table commence the day after this instrument is registered. Item 2 of the table in subsection 2(1) provides that the amendments listed in Schedule 1 commence on 1 August 2019.
3. Authority
Section 3 provides for the authority for the Amendment Instrument and that it is made under subsection 23DNA(1) of the Health Insurance Act 1973 (the Act).
Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
4. Schedules
Section 4 provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the instrument has effect according to its terms.
There is one Schedule in the instrument. This Schedule provides for the transitional arrangements applying to Category S specialised pathology laboratories that perform IVF testing related to the diagnosis and treatment of fertility services and a number of other laboratories identified in the Schedule 1 to which the transitional arrangements apply.
Schedule 1 – Transitional arrangements
Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017 (the Primary Principles)
Item 1
Item 1 inserts new section 19 after Part 4 of the Primary Principles that provides for transitional arrangements to specified premises covering the period 1 August 2019 to 31 December 2020 in relation to the application of the supervision accreditation standards.
New section 19 provides that the supervision accreditation standards, set out in the document titled “Requirements for the Supervision of Pathology Laboratories (2007 Edition) (the 2007 supervision accreditation standards), continue to apply to specified approvals of premises under section 23DN of the Health Insurance Act 1973 (the Act) that were granted and were in force before 1 August 2019. This arrangement only applies to premises specified in the instrument (refer to subsection 19(1)) and for laboratories whose category of accreditation specified in the approval was, immediately before 1 August 2019, specialised Category S laboratories that perform IVF specialised testing for a target population related to the diagnosis and treatment of fertility issues.
Subject to other provisions under section 19, applications for new approvals of premises under section 23DN of the Act, sought by these Category S IVF testing laboratories and specified laboratories, during the transition period (from 1 August 2019 to 31 December 2020) will be assessed and approved against the 2007 supervision accreditation standards. In relation to Category S IVF testing laboratories, the transitional arrangements allowing for their applications for approval to be assessed and approved against the 2007 supervision accreditation standards include those laboratories that had an approval that is in effect at any time in the three months before 1 August 2019.
On 1 February 2020 and under the operation of section 15 of the Primary Principles, these specialised Category S IVF testing laboratories and specified laboratories that are covered by section 19 will need to be compliant with the 2018 supervision accreditation standards that commenced operation on 1 August 2019, otherwise the Minister of Health could revoke their approval under section 23DN of the Act.
These specialised Category S IVF testing laboratories and specified laboratories can elect to be approved under the 2018 supervision accreditation standards at any time leading up to 1 January 2021, if approval under section 23DN of the Act is sought during the transition period.
The specified transitional arrangements also apply with regard to variation of approvals of premises specified in this instrument.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Accredited Pathology Laboratories – Approval)
Amendment Instrument (No.1) 2019
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Minister determines the principles to be applied in exercising his or her powers under section 23DN of the Act to approve in principle, or refuse to approve, premises as an accredited pathology laboratory. The current principles determined under section 23DNA are the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017 (‘Pathology Principles 2017’).
With the exception of some basic tests conducted by some medical practitioners within their own medical practice, Medicare benefits for pathology services are only payable when they are rendered by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority. The Principles approved under section 23DNA operate to ensure that appropriate standards are met and maintained in pathology laboratories at which Medicare eligible pathology services can be provided.
The Principles set out the criteria for different categories of accredited pathology laboratories and specify the standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in that laboratory. The overarching objectives of the Principles include promoting the delivery of reliable test results and reducing the risk of misdiagnosis in the provision of pathology services.
The Schedule to the Principles specifies accreditation materials that set out relevant standards against which applicants for accreditation are to be assessed. These documents are developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC) or endorsed by NPAAC as supplementary accreditation materials. The accreditation process of pathology laboratories is administered by the Department of Human Services, while the National Association of Testing Authorities (NATA) is the currently recognised independent assessment body that conducts the accreditation assessment of pathology laboratories, in conjunction with the Royal College of Pathologists of Australasia.
The primary purpose of the Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Instrument (No. 1) 2019 (the Amendment Instrument) is to amend the Principles to delay the commencement date for application of the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018) (the 2018 Supervision Standard) for specialised pathology laboratories that perform testing related to the diagnosis and treatment of fertility issues, as well as a number of other specified laboratories, until 1 January 2021. The extended transition period for these specific laboratories is to ensure they can continue operations in the interim of making arrangements to meet the 2018 Supervision Standard by 1 January 2021.
The date of effect of the 2018 Supervision Standard is 1 August 2019. However, to address concerns from these specialised laboratories, an extended transition date has been provided for these laboratories to make arrangements to meet the accreditation requirements.
The Requirements for the Supervision of Pathology Laboratories 2007 Edition will continue to remain as an applicable accreditation material for specialised laboratories until 1 January 2021 when it is expected that these laboratories will meet the 2018 Supervision Standard.
The review of these pathology accreditation standards is part of the ongoing process of refining the pathology accreditation requirements to maintain their currency and to ensure they reflect contemporary clinical best practice. They should be read in conjunction with the NPAAC overarching document, the Requirements for Medical Pathology Services, which sets out the core elements of good laboratory practice, in addition to the other materials that form the national pathology accreditation framework. Copies of the pathology accreditation materials are published on the NPAAC website and can be accessed from - http://www.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-publication.htm. The pathology accreditation standards are aimed at assuring the quality of Australian pathology services.
This Legislative Instrument does not make any substantive changes to the law.
Human rights implications
The International Covenant on Economic, Social and Cultural Rights recognises that individuals have the right to the enjoyment of the highest attainable standard of health, including a right to a system of health protection.
The Amendment to the Pathology Principles 2017 will maintain rights to access quality, safe, clinically relevant and cost effective Medicare eligible pathology services.
Although majority of Pathology premises will be assessed to the current accreditation standards for the purposes of accreditation assessments, specialised Category S IVF testing laboratories and a small number of other specified laboratories, will be allowed to be assessed and comply with the previous supervision accreditation standards until 1 February 2020. This would not have an effect on the Australian public’s access to Commonwealth subsidised pathology services nor impact on people’s right to quality health services and social security.
The Amendment Instrument promotes the right to health as the accreditation standards are aimed at ensuring pathology laboratories providing Medicare-eligible pathology services deliver high quality services.
Conclusion
This Legislative Instrument is compatible with human rights as it maintains existing arrangements and the protection of human rights.
Greg Hunt
Minister for Health