Health Insurance (Pathology Services) Regulations 2018

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00223 Regulations Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Health Insurance Act 1973

 

Health Insurance (Pathology Services) Regulations 2018

 

Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides that the Governor‑General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

Part II of the Act provides for the payment of Medicare benefits for professional services rendered to eligible persons. Section 16A of the Act sets out the requirements that pathology services must meet to allow Medicare benefits to be paid.

 

Paragraph 16A(4)(b) of the Act provides that a request for pathology services must be made in accordance with the Health Insurance (Pathology Services) Regulations 1989 (the current Regulations) in order for Medicare benefits to be payable in respect of that pathology service.

 

Section 50 of the Legislation Act 2003 causes the current Regulations to sunset from 1 April 2018.

 

Purpose

The purpose of the Health Insurance (Pathology Services) Regulations 2018 (the proposed Regulations) is to remake the current Regulations before they sunset.  The proposed Regulations are a remake of existing government policy and do not change the status quo for industry.

 

Consultation

As the Regulations are a remake of the existing regulations and do not change the status quo for government policy, industry has not been consulted regarding the proposed Regulations.

However, the proposed Regulations support ongoing Government policy and generally industry is supportive of retaining status quo.

 

Industry continues to be consulted more generally on an ongoing basis and is largely supportive of retaining status quo.

 

Details of the Regulations are set out in the Attachment.

 

The Act specifies no conditions which need to be met before the power to make the Regulations may be exercised. 

 

The Regulations are a legislative instrument for the purposes of the Legislation Act 2003.

 

The proposed Regulations would commence on the day after registration.

 

 

 Authority:         Subsection 133(1) of the

                                                                                                   Health Insurance Act 1973 


 

ATTACHMENT

 

Details of the proposed Health Insurance (Pathology Services) Regulations 2018

 

Section 1 – Name

 

This section provides for the proposed Regulations to be referred to as the Health Insurance (Pathology Services) Regulations 2018.

 

Section 2 – Commencement

 

This section provides that the proposed Regulations would commence on the day after registration. 

 

Section 3 – Authority 

 

This section provides that the proposed Regulations are made under the Health Insurance Act 1973.

 

Section 4 – Schedule(s)

 

This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Section 5 – Definitions

This section provides the defined terms specific to the proposed Regulations and makes reference to a number of expressions which would be used in the proposed Regulations and are defined under the Health Insurance Act 1973.

 

Section 6 – Purpose of this Part

This section sets out that the purpose of this Part, being to provide the requirements that a request for pathology services must meet in order for Medicare benefits to be payable for that service.

 

Section 7 – Information about requesting practitioner

This section sets out the information which must be included in a request for a pathology service to a treating practitioner or approved pathology practitioner. For example, their surname and initials, address for their place of practice and their provider number.

 

This section also states the requirement that the requesting practitioner must have a provider number.

 

Section 8 – Information about patient

This section provides the information which must be included about the patient in a request for pathology services, and the requirement to seek the patient’s consent to include their information on the request if they are a private patient in relation to a hospital.

 

This section further clarifies that if the patient’s consent is not granted then the inclusion of their information must not be disclosed on the request for pathology services. This would not affect the patient’s entitlement to Medicare benefits and/or private health insurance benefits for that service.

 

This section updates terminology by removing references to ‘day hospital facility’. Private day hospitals are captured under section 8(1)(d) for private hospitals.

 

This section updates terminology of ‘private health fund’ to ‘private health insurer’ as reflected within the Private Health Insurance Act 2007.

 

Section 9 – Information about pathology service

This section sets out the information which a request for a pathology service must contain (subject to the requirements applying to further requests under section 11) in respect of the service. For example, pathology service requests are required to include:

a)      a description of the service;

b)     the date when it was determined to be necessary; and

c)      whether the service relates to a bodily specimen obtained from a person while they were an in-patient of a hospital and is to be performed after the person ceases to be an in-patient of a hospital.

 

This section also updates the reference from ‘medical practitioner’ to ‘practitioner’.

 

Section 10 – Requirements applying to requests that specify an approved pathology practitioner

This section requires the treating practitioner to provide the clinical grounds, or a statement that the specification is on clinical grounds, if an approved pathology practitioner is specified on the request for pathology services.

 

Section 11 – Requirements applying to further requests

This section defines ‘further requests’ for pathology services. A further request is a request for pathology services which is made by an approved pathology practitioner who received the first request.

 

This section also clarifies that further requests must include the same information which was included in the first request, unless it relates to the same pathology service and the first request is attached to the further request.

 

Section 12 – Terminating undertakings

This section provides the particulars for submitting an application for an approved pathology authority undertaking, and terminating an undertaking, for the purposes of sections 23DF and 23DH of the Health Insurance Act 1973. This section now includes the additional option of submitting a terminating undertaking electronically.

 

Schedule 1 – Repeals

 

Health Insurance (Pathology Services) Regulations 1989

 

Item 1

This item repeals in whole the Health Insurance (Pathology Services) Regulations 1989.

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Health Insurance (Pathology Services) Regulations 2018
 

This Disallowable 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 Disallowable Legislative Instrument

The Health Insurance Act 1973 (the Act) sets out the principles and definitions governing the Medicare Benefits Schedule. Part II of the Act provides for the payment of Medicare benefits for professional services rendered to eligible persons, including section 16A of the Act which sets out the requirements that pathology services must meet to allow Medicare benefits to be paid.

 

Paragraph 16A(4)(b) of the Act provides that a request for pathology services must be made in accordance with the Health Insurance (Pathology Services) Regulations 1989 (the current Regulations) in order for Medicare benefits to be payable in respect of that pathology service.

 

The purpose of the Health Insurance (Pathology Services) Regulations 2018 (the proposed Regulations) is to remake the current Regulations before they sunset.  The proposed Regulations are a remake of existing government policy and do not change the status quo for industry.

 

As the Regulations are a remake of the existing regulations and do not change the status quo for government policy, industry has not been consulted specifically regarding the proposed Regulations. However, industry continues to be consulted more generally on an ongoing basis and is largely supportive of retaining status quo.

Human rights implications

The Regulations engage Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to health and social security.

The Right to Health

The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR.  The UN Committee on Economic Social and Cultural Rights (the Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources.  This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.

 

 

The Right to Social Security

The right to social security is contained in Article 9 of the ICESCR.  It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care.  Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.

The Committee reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR.  In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them.  However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.

Analysis

The Regulations will maintain rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective.

The requirements of pathology services which attract a Medicare benefit have not be amended, but rather clarified to ensure they best reflect existing government policy.

Conclusion

This Disallowable Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

 

Greg Hunt

Minister for Health

 

Overview

The Health Insurance (Pathology Services) Regulations 2018 were enacted to address the impending sunset of the Health Insurance (Pathology Services) Regulations 1989, as specified under section 50 of the Legislation Act 2003. These Regulations were introduced to ensure the continuity of Medicare benefits for pathology services by maintaining existing policy and requirements without altering the status quo for industry. The purpose of these Regulations is to remake the outdated regulations and to support ongoing government policy. Although industry was not specifically consulted regarding these Regulations, they are largely supportive of retaining the current framework as it does not introduce new changes. These Regulations are made under subsection 133(1) of the Health Insurance Act 1973 and would commence on the day after registration. The Regulations aim to uphold the rights to health and social security as outlined in the International Covenant on Economic, Social and Cultural Rights (ICESCR). By maintaining access to publicly subsidised health services that are clinically effective and cost-effective, these Regulations ensure that the requirements for pathology services eligible for Medicare benefits remain unchanged, thereby safeguarding existing entitlements. This approach ensures that the Regulations do not raise any human rights issues, as they align with the fundamental rights to health and social security.

Scope and Application

The Health Insurance Act 1973, as amended by the Health Insurance (Pathology Services) Regulations 2018, governs the provision and reimbursement of Medicare benefits for pathology services in Australia. The Act applies to all medical practitioners, pathology providers, and patients eligible for Medicare benefits, as well as any entities involved in the provision or administration of such services. It encompasses the conduct and transactions related to pathology services that are eligible for Medicare reimbursement, ensuring that these services meet specific criteria to qualify for government funding. The Regulations extend to the entire Commonwealth, ensuring a uniform approach across Australia. There are no stated exclusions or exemptions within the scope of the Act, although thresholds may apply to specific services or items. The Act and its subordinate instruments allow for the continuous refinement of the criteria and conditions for pathology services, ensuring that the system remains effective and equitable. The Regulations are made under the authority of Subsection 133(1) of the Health Insurance Act 1973, with the purpose of maintaining the existing government policy and ensuring the continuity of the Medicare benefits scheme for pathology services. The Health Insurance (Pathology Services) Regulations 2018 serve to update and replace the previous Health Insurance (Pathology Services) Regulations 1989, ensuring that the legislative framework remains current and operational. The Regulations specify the detailed requirements for pathology service requests, including information about the requesting practitioner, the patient, and the specific pathology service. These requirements are designed to maintain the integrity and effectiveness of the Medicare benefits system while ensuring that pathology services are clinically justified and appropriately documented. The Regulations provide for the electronic submission of terminating undertakings, reflecting modern administrative practices. Overall, the Act and its Regulations ensure that pathology services attracting Medicare benefits are provided in a manner that is consistent with public health objectives and resource availability.

Key Provisions

The Health Insurance (Pathology Services) Regulations 2018 (the Regulations) primarily serve to remake the Health Insurance (Pathology Services) Regulations 1989, which were set to sunset on 1 April 2018, as per Section 50 of the Legislation Act 2003. The Regulations are made under Subsection 133(1) of the Health Insurance Act 1973 (the Act) and aim to retain the status quo of existing government policy concerning pathology services that attract Medicare benefits. Section 1 of the Regulations provides the name, while Section 2 specifies that they would commence on the day after registration. Section 3 confirms the Regulations' authority under the Health Insurance Act 1973, and Section 4 details the Schedule, which outlines amendments and repeals of existing regulations. Under these Regulations, various obligations and requirements are imposed on parties involved in requesting pathology services. Section 7 mandates that requests for pathology services must include specific information about the requesting practitioner, such as their surname and initials, address for their place of practice, and provider number. Section 8 requires information about the patient, including seeking the patient’s consent for their information to be included if they are a private patient in relation to a hospital. Section 9 outlines the essential information that must be included in a request for pathology services, such as a description of the service, the date when it was determined to be necessary, and whether the service relates to a bodily specimen obtained from an in-patient of a hospital. Section 10 requires treating practitioners to provide clinical grounds or a statement that the specification of an approved pathology practitioner is on clinical grounds. Section 11 specifies requirements for further requests made by approved pathology practitioners, ensuring consistency with the initial request unless it pertains to the same pathology service and the first request is attached. The Regulations also address the consequences of non-compliance, though they do not explicitly state criminal or civil penalties. However, failure to comply with the requirements set forth in the Regulations may result in the denial of Medicare benefits for the pathology services in question. Specifically, under Section 16A(4)(b) of the Act, a request for pathology services must meet the criteria outlined in the Regulations for Medicare benefits to be payable. Non-compliance with the Regulations may thus indirectly result in financial implications for practitioners and patients, as it would mean the services are not eligible for Medicare reimbursement. In summary, the Health Insurance (Pathology Services) Regulations 2018 are designed to ensure that requests for pathology services meet specific requirements, thereby maintaining the eligibility of these services for Medicare benefits. The Regulations impose clear obligations on practitioners and patients, ensuring that all necessary information is included in requests for pathology services. While the Regulations themselves do not stipulate specific penalties for non-compliance, the failure to adhere to them would result in the denial of Medicare benefits, thereby impacting the financial aspects of healthcare delivery.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.