EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Pathologist-determinable Services) Amendment Determination 2022
Section 16A of the Health Insurance Act 1973 (the Act) specifies that certain requirements have to be met for the payment of Medicare benefits in relation to pathology services, including the requirement for a pathology service to be requested (subsection 16A(3)). Pathologist-determinable services allow Medicare benefits to be paid for pathology services which are requested and performed by an approved pathology practitioner for their own patients, or for certain tests which are not requested, but are performed on the basis of information learned from an originally requested service.
Section 4BA of the Act provides that the Minister for Health may determine by legislative instrument, that a particular pathology service, or pathology services included in a class of pathology services, are pathologist-determinable services after consultation with Royal College of Pathologists of Australasia (RCPA).
This instrument relies on subsection 33(3) of the Acts Interpretation Act 1901 (AIA). Subsection 33(3) of the AIA 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.
Purpose
The purpose of the Health Insurance (Pathologist-determinable Services) Amendment Determination 2022 (the Amendment Determination) is to amend the Health Insurance (Pathologist-determinable Services) Determination 2015 (the Principal Determination) from 1 July 2022 to allow items 73411, 73412 and 73413 to be performed as a pathologist-determinable service based on the results of a service performed under item 73410.
Item 73410 is for genetic testing for the diagnosis of alpha thalassemia in patients of reproductive age who have abnormal red cell indices, for whom thalassemia screening for beta-thalassemia was not conclusive, who do not have a concurrent iron deficiency or who are pregnant, and who have no historic normal cell indices. This service is also available for the determination of carrier status in reproductive partners of a person with diagnosed alpha thalassaemia, where the reproductive partner has abnormal red cell indices and does not have a concurrent iron deficiency.
Items 73411, 73412 and 73413 are also for the diagnosis of alpha thalassemia, however, may only be conducted where the results of testing described in item 73410 were inconclusive. Patients will benefit from these items being pathologist-determinable as the pathologist will be able to undertake further genetic testing for the diagnosis, or determination of carrier status, of alpha thalassaemia where the results of genetic testing described in item 73410 are inconclusive without the need for the patient to obtain a further pathology request from their treating practitioner. This will prevent delays in test turnaround times for the patient.
By including items 73411, 73412 and 73413 in the Principal Determination, a service under these items may be rendered by a pathologist, without a request, if the pathologist determines that the service is necessary on the basis of the results of a service performed under item 73410.
Items 73410, 73411, 73412, and 73413 were announced under the 2021-22 Mid-Year Economic and Fiscal Outlook measure Guaranteeing Medicare – Medicare Benefits Schedule new and amended listings and introduced through the Health Insurance Legislation Amendment (2022 Measures No. 1) Regulations 2022.
Consultation
Section 4BA of the Act requires that the RCPA is consulted on pathology services being made pathologist-determinable services. The RCPA was consulted on the inclusion of items 73411, 73412 and 73413. The RCPA was supportive of items 73411, 73412 and 73413 being made pathologist-determinable services.
Details of the Amendment Determination are set out in the Attachment.
The Amendment Determination commences on 1 July 2022.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Section 4BA of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Pathologist-determinable Services) Amendment Determination 2022
Section 1 – Name
Section 1 provides for the Amendment Determination to be referred to as the Health Insurance (Pathologist-determinable Services) Amendment Determination 2022.
Section 2 – Commencement
Section 2 provides that the Amendment Determination commences on 1 July 2021.
Section 3 – Authority
Section 3 provides that the Amendment Determination is made under section 4BA of the Health Insurance Act 1973.
Section 4 – Schedules
Section 4 provides that each instrument that is specified in a Schedule to this Amendment Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Amendment Determination has effect according to its terms.
Schedule 1 – Amendments
Health Insurance (Pathologist-determinable Services) Determination 2015
Amendment item 1 repeals and replaces the table under subparagraph 5(b)(iii) to insert items 73411, 73412, and 73413 as pathologist-determinable services. These items will be inserted into new item row 6 which may be performed as a pathologist-determinable service if:
- an approved pathology practitioner receives a request to render a service to which item 73410 would apply; and
- the approved pathology practitioner, or a person on their behalf, renders a service to which item 73410 applies; and
- based on the information learned from the results of that service, the approved pathology practitioner considers it necessary to perform a service to which items 73411, 73412 or 73413 apply. For example, the approved pathology practitioner may consider it necessary to perform another test to confirm a diagnosis of alpha thalassemia if the results in the original test under item 73410 were inconclusive.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Pathologist-determinable Services) Amendment Determination 2021
This 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 Determination
The purpose of the Health Insurance (Pathologist-determinable Services) Amendment Determination 2022 (the Amendment Determination) is to amend the Health Insurance (Pathologist-determinable Services) Determination 2015 (the Principal Determination) from 1 July 2022 to allow items 73411, 73412 and 73413 to be performed as a pathologist-determinable service based on the results of a service performed under item 73410.
Item 73410 is for genetic testing for the diagnosis of alpha thalassemia in patients of reproductive age who have abnormal red cell indices, for whom thalassemia screening for beta-thalassemia was not conclusive, who do not have a concurrent iron deficiency or who are pregnant, and who have no historic normal cell indices. This service is also available for the determination of carrier status in reproductive partners of a person with diagnosed alpha thalassaemia, where the reproductive partner has abnormal red cell indices and does not have a concurrent iron deficiency.
Items 73411, 73412 and 73413 are also for the diagnosis of alpha thalassemia, however, may only be conducted where the results of testing described in item 73410 were inconclusive. Patients will benefit from these items being pathologist determinable as the pathologist will be able to undertake further genetic testing for the diagnosis, or determination of carrier status, of alpha thalassaemia where the results of genetic testing described in item 73410 are inconclusive without the need for the patient to obtain a further pathology request from their treating practitioner. This will prevent delays in test turnaround times for the patient.
By including items 73411, 73412 and 73413 in the Principal Determination, a service under these items may be rendered by a pathologist, without a request, if the pathologist determines that the service is necessary on the basis of the results of a service performed under item 73410.
Items 73410, 73411, 73412, and 73413 were announced under the 2021-22 Mid-Year Economic and Fiscal Outlook measure Guaranteeing Medicare – Medicare Benefits Schedule new and amended listings and introduced through the Health Insurance Legislation Amendment (2022 Measures No. 1) Regulations 2022.
Human rights implications
This instrument engages 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.
The right of equality and non-discrimination
The rights of equality and non-discrimination are contained in articles 2, 16 and 26 of the International Covenant on Civil and Political Rights (ICCPR). Article 26 of the ICCPR requires that all persons are equal before the law, are entitled without any discrimination to the equal protection of the law and in this respect, the law shall prohibit any discrimination and guarantee to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.
Analysis
This instrument maintains the right to health, the right to social security and the right of equality and non-discrimination by ensuring access to publicly subsidised health services which are clinically effective, safe and cost-effective.
Conclusion
This instrument is compatible with human rights as it maintains the right to health, the right to social security and the right to equality and non-discrimination.
Travis Haslam
Acting First Assistant Secretary
Medical Benefits Division
Health Resourcing Group
Department of Health