Health Insurance Legislation Amendment (2026 Measures No. 2) Regulations 2026

EXPLANATORY STATEMENT

Health Insurance Act 1973

Health Insurance Legislation Amendment (2026 Measures No. 2) Regulations 2026

The Health Insurance Act 1973 (the Act) sets out the principles and definitions governing the Medicare Benefits Schedule (MBS). The Act provides for payments by way of medical benefits and for other purposes.

Subsection 133(1) of 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 9 of the Act provides that Medicare benefits be calculated by reference to the fees for medical services set out in prescribed tables.

Section 4AA of the Act provides that regulations may prescribe a table of diagnostic imaging services which sets out items of diagnostic imaging services, the fees applicable for each item, and rules for interpreting the table. The table made under this section is referred to as the diagnostic imaging services table (DIST).  The most recent version of the regulations is the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020 (DIST Regulations).

Subsection 4(1) of the Act provides that regulations may prescribe a table of general medical services which sets out items of general medical services, the fees applicable for each item, and rules for interpreting the table. The table made under this subsection is referred to as the general medical services table (GMST). The most recent version of the regulations is the Health Insurance (General Medical Services Table) Regulations 2021 (GMST Regulations).

Section 4A of the Act provides that regulations may prescribe a table of pathology services which set out items of pathology services, the fees applicable for each item, and rules for interpreting the table. The table made under this section is referred to as the pathology services table (PST). The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2020 (PST Regulations).

The Health Insurance Regulations 2018 (HIR) provide the overarching policy framework supporting the provision of appropriate Medicare services. For the purposes of paragraph 10(2)(aa) of the Act, section 28 of the HIR prescribes items that have a Medicare benefit equal to 100 per cent of the fee in respect of the service.

Purpose

The purpose of the Health Insurance Legislation Amendment (2026 Measures No. 2) Regulations 2026 (the Regulations) is to amend the DIST, GMST and PST Regulations and the HIR from 1 July 2026, including to implement annual fee indexation from 1 July 2026 by increasing the schedule fee by 2.6 per cent for most general medical services in the GMST and diagnostic imaging services in the DIST, and for specified groups of pathology services in the PST.

The Regulations will implement changes to introduce and amend MBS services as agreed to in the 2025-26 Budget, the 2023-24 and 2025-26 Mid-Year and Economic Fiscal Outlook, as recommended by the Medical Services Advisory Committee, and make administrative and machinery changes. Further details on the changes can be found below and at the Attachment.

The Regulations will:

• remove reference to specified non-requested type items in section 44 of the HIR;
• remove restrictions on claiming breast ultrasound items with chest or abdominal wall ultrasound item 55812 and with breast magnetic resonance imaging item 63464, and remove the multiple services rule when breast imaging items apply together;
• increase fees for nuclear medicine imaging items that use gallium-67 or thallium-201;
• expand echocardiogram item 55133 to include the monitoring of patients taking cardiac Pharmaceutical Benefits Scheme listed medicines that have cardiotoxic side effects;
• insert a new item 73400 for human leukocyte antigen testing for hypersensitivity to carbamazepine and oxcarbazepine;
• amend item 65150 for quantitation of von Willebrand factor antigen and activity to remove reference to specific test methodology and update outdated terminology;
• amend hepatitis C testing item 69499 to remove the requirement for two different serology tests to have been completed before the service can be performed;
• introduce three new items for unilateral correction of developmental breast abnormality;
• amend genioplasty item 45761 to include the indication that the deformity is the result of a diagnosed craniofacial disorder;
• amend colonoscopy item 32222 by removing the positive faecal occult blood test indication and making it into a new standalone item 32119, and amend colonoscopy item 32150 to remove reference to injection with botulinum toxin;
• amend burn wound closure items to include the option of treatment using autologous skin cell suspension, and to account for treatment involving multiple surgeons;
• insert two new paediatric sleep study items 12218 and 12219 and amend claiming and frequency restrictions in specified items to reflect these new items;
• amend items 45888, 45939 and 45891 to include anaesthesia and use of an assistant; and
• clarify frequency restrictions for items 50200 and 50201, and amend frequency restriction for item 15944 to allow for treatment of up to two tumour sites per day.

Consultation

The Department of Health, Disability and Ageing (the department) consulted with relevant stakeholders on the changes in the Regulations by way of public consultation and targeted consultation with individual stakeholders. Stakeholders were largely supportive of the changes.

For changes to the DIST Regulations, the consulted stakeholders included:

• Australasian Association of Nuclear Medicine Specialists
• Australasian Society for Ultrasound in Medicine
• Australasian Society of Breast Physicians
• Australasian Sonographers Association
• Australian Association of Obstetrical and Gynaecological Ultrasonologists
• Australian College of Midwives
• Australian College of Nurse Practitioners
• Australian College of Nursing
• Australian College of Rural and Remote Medicine
• Australian Diagnostic Imaging Association
• Australian Medical Association
• Australian Women’s Health Alliance
• Breast Cancer Network Australia
• Bristol Myers Squibb
• Cancer Council Australia
• Cardiac Society of Australia and New Zealand
• Consumer Health Forum Australia
• EndoActive
• Endometriosis Australia
• Global Medical Solutions Australia
• Medical Oncology Group of Australia
• National Association of Specialist Obstetricians and Gynaecologists
• National Breast Cancer Foundation
• National Rural Women’s Coalition
• Royal Australian College of General Practitioners
• Royal Australasian College of Physicians
• Royal Australasian College of Surgeons
• Royal Australian and New Zealand College of Obstetricians and Gynaecologists
• Royal Australian and New Zealand College of Radiologists
• Society of Obstetric Medicine of Australia and New Zealand
• Urological Society of Australian and New Zealand

For changes to the GMST Regulations, the consulted stakeholders included:

• Australia and New Zealand Sleep Science Association
• Australian and New Zealand Association of Oral and Maxillofacial Surgeons
• Australian and New Zealand Burn Association
• Australian Society of Otolaryngology Head and Neck Surgery
• Australian Society of Plastic Surgeons
• BreastSurgANZ
• Cancer Australia
• Colorectal Surgical Society of Australia and New Zealand
• Gastroenterological Society of Australia
• Plastic and Reconstructive Surgery Clinical Improvement Committee
• Prader Willi Research Foundation Australia
• Private Healthcare Australia
• Royal Australian and New Zealand College of Radiologists
• Sleep Health Foundation
• Thoracic Society of Australia and New Zealand

The Colorectal Surgical Society of Australia and New Zealand (CSSANZ) raised as an initial concern that the removal of the benefit for the injection of botulinum toxin under item 32150 may increase patient out of pocket costs or pressure patients into surgical treatment. However, following discussions with the department, CSSANZ accepted the change.

The Gastroenterological Society of Australia (GSA) supported the creation of new item 32219 but suggested limiting the item to participants in the National Bowel Cancer Screening Program only. The department has since advised the GSA that the item should provide for all patients with a positive faecal occult blood test, enhancing patient access to this item.

For the change involving the insertion of two new paediatric sleep study items 12218 and 12219 (and corresponding changes to other items to reflect the insertion of the new items), stakeholders were largely supportive of the change. The MSAC application for this change was progressed by the Australasian Sleep Association. During the consultation process, the Thoracic Society of Australia and New Zealand and the Prader Willi Research Foundation Australia raised considerations related to technical aspects of implementing the changes in practice – for example, accessibility of services in regional and remote areas of Australia and giving priority consideration for children and adolescents with disability, rare conditions or complex needs. However, concerns were not raised about these new items themselves.

For changes to the PST Regulations, the consulted stakeholders include:

• Australasian College of Dermatologists
• Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists
• Australian Pathology
• Epilepsy Society of Australia
• National Pathology Accreditation Advisory Council
• Public Pathology Australia
• Royal Australian & New Zealand College of Psychiatrists
• Royal College of Pathologists of Australasia
• Royal College of Pathologists of Australasia Haematology Advisory Committee 
• Society of Hospital Pharmacists

No consultation was undertaken for change to the HIR, as this change is administrative and machinery in nature.

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

Details of the Regulations are set out in the Attachment.

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

The Regulations will commence on 1 July 2026.

Authority:  Subsection 133(1) of the

Health Insurance Act 1973 

ATTACHMENT

Details of the Health Insurance Legislation Amendment (2026 Measures No. 2) Regulations 2026

Section 1 – Name

This section provides for the instrument to be referred to as the Health Insurance Legislation Amendment (2026 Measures No. 2) Regulations 2026 (the Regulations).

Section 2 – Commencement

This section provides that table items 1-3, 5-6, 8 and 10 of the Regulations are to commence on 1 July 2026. It also provides that table items 4, 7 and 9 of the Regulations are to commence immediately after the commencement of the provisions covered by table item 2.

Section 3 – Authority 

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

Section 4 – Schedules

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.

Schedule 1—Indexation

Schedule 1 of the Regulations applies annual indexation to the schedule fees of most Medicare Benefits Schedule (MBS) items from 1 July 2026. This will increase the benefit paid to patients for these services, which is calculated as a percentage of the fee per section 10 of the Act. Indexation will be applied at a rate of 2.6 per cent, which is represented as 1.026 in the diagnostic imaging services table (clause 2.7.1), general medical services table (clause 1.3.1) and the pathology services table (clause 2.14.1).

Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020 (DIST)

Items 1 and 2 apply indexation to all items in the DIST other than positron emission tomography items in Group I4 (Subgroup 2) and nuclear medicine modifier items in Group I4 (Subgroup 3). There is no change to the range of items indexed in the DIST.

Health Insurance (General Medical Services Table) Regulations 2021 (GMST)

Items 3 to 19 apply indexation to most items in the GMST. There is no change to the range of items indexed in the GMST.

Health Insurance (Pathology Services Table) Regulations 2020 (PST)

Items 20 and 21 apply indexation to specified items in the PST. That is, indexation will be applied to each item in Group P1, P4, P5, P6, P8 and P12. There is no change to the range of items indexed in the PST.

Schedule 2—Other diagnostic imaging services amendments

Part 1—Amendments relating to breast imaging services

Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020

Item 1 repeals subclause 1.2.21(10) and substitutes new subclauses 1.2.21(10) and (10A).

This amendment expands the range of items that are exempt from the operation of the multiple services rule set out in clause 1.2.21 of the DIST to include item numbers 55066, 55070, 55071, 55073, 55076, 55079, 59300, 59302, 59303, 59305, 59312, 59314, 59318 and 63464. The rule provides for a reduction of fees where multiple services are rendered by a medical practitioner to the same patient on the same day.

Items 2 and 3 repeal and substitute paragraphs (b) in item descriptors 55066 and 55071 to remove existing co-claiming restrictions with specified items in Group I1 of the DIST. Specifically, this change will remove the restriction on claiming item 55066 together with item 55070, 55071, 55073, 55076, 55079 or 55812, and the restriction on claiming item 55071 with item 55066, 55070, 55073, 55076, 55079 or 55812.

Item 4 amends the descriptor for item 55812 to remove the current restriction that prevents this item from applying where the service is performed in conjunction with a service mentioned in item 55070, 55073, 55076 or 55079.

Items 5 and 6 amend the descriptor for 63464 by repealing paragraph (d) and removing “and” from subparagraph (c)(v), to remove the restriction that item 63464 does not apply where the service is performed in conjunction with items 55076 or 55079.

Part 2—Other amendments

Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020

Item 7 amends the descriptor for item 55133 by amending subparagraph (a)(ii) to remove the limitation that the item is only available for a patient who has commenced medication for non-cardiac purposes. This will expand access under item 55133 to include patients prescribed Pharmaceutical Benefits Scheme listed cardiac medicines that have cardiotoxic side effects, where continued and safe prescribing requires frequent echocardiograms.

Items 8 to 15 amend the schedule fees for items 61325, 61429, 61430, 61438, 61442, 61450, 61453 and 61461 to increase the fees, accounting for ongoing supply shortages and price pressures affecting gallium‑67 and thallium‑201. As Australia relies on a single domestic supplier and global production is limited, embedding these higher costs into existing fees will provide certainty for patients and maintain access to essential nuclear medicine imaging services.

Schedule 3—Other pathology services amendments

Health Insurance (Pathology Services Table) Regulations 2020

Item 1 repeals and substitutes the descriptor for item 65150 to provide flexibility in assay selection by allowing for the use of both qualitative and quantitative testing methods for assessment of von Willebrand factor, which will enable practitioners to choose the most clinically appropriate testing methodology. References to “Fletcher factor” and “Fitzgerald factor” are also replaced with “prekallikrein” and “high-molecular-weight kininogen” to update outdated terminology.

Item 2 repeals paragraph (a) of the descriptor for item 69499 and substitutes new paragraphs (a) and (aa). This removes the requirement for two different serology tests to be performed for hepatitis C virus (HCV) RNA testing in patients with suspected HCV with either positive or inconclusive results. This reflects advancements in contemporary HCV assay technologies and current clinical guidelines. This will also apply in practice to item 69500, which is not being amended, but refers to a test described in item 69499 if the test is performed by an approved pathology practitioner.

Item 3 inserts new item 73400 for human leukocyte antigen genotyping to predict the risk of carbamazepine or oxcarbazepine–related drug hypersensitivity reactions, enabling clinicians to identify at‑risk patients before or during initiation of treatment and to choose alternative therapies to prevent serious adverse reactions, if necessary.

Schedule 4—Other general medical services amendments

Part 1—Amendments relating to treatment of acute burn wounds

Health Insurance (General Medical Services Table) Regulations 2021

Item 1 amends the descriptor for item 46100 by setting out the range of items in paragraph (b) in a different format to provide clarity to providers on the items to which item 46100 can apply. Item 46100 is a modifier item that applies in addition to an item specified in paragraph (b), and operates to increase the fee for the relevant item in paragraph (b). This amendment does not change the list of items set out under paragraph (b) of item 46100, but instead is intended to set them out more clearly.

Item 2 amends the descriptor for item 46100 by expanding the current restriction on the application of this item to include whole of face items 46112 and 46124 (in addition to item 46136). This has the effect that item 46100 does not apply to a service to which any of items 46112, 46126 or 46136 apply.

Item 3 amends the descriptor for item 46112 by removing the current restriction which provides that item 46112 does not apply to a service associated with a service to which item 46100 applies. This will ensure that item 46112 may apply (and therefore be claimed) regardless of whether a service is performed that is associated with a service to which item 46100 applies.

Items 4 to 9 amend the descriptors for items 46113, 46114 and 46115 to allow for the use of autologous skin cell suspension (ASCS), or a combination of ASCS and autologous skin grafting, as a treatment option for immediate definitive burn wound closure where the treatment involves multiple surgeons where the total area being treated is at least 10% of total body surface for paediatric patients and at least 20% of total body surface for adult patients.

Items 10 to 25 amend the descriptors for items 46116, 46117, 46118, 46119, 46120, 46121, 46122, 46123 and 46124 to include the option of treatment for definitive closure using ASCS, or a combination of ASCS and autologous skin grafting for immediate definitive burn wound closure. This expands the choice of techniques available for treatment.

Item 26 amends the descriptor for item 46124 by removing the current restriction which provides that item 46124 does not apply to a service associated with a service to which item 46100 applies. This will ensure that item 46124 may apply (and therefore be claimed) regardless of whether a service is performed that is associated with a service to which item 46100 applies.

Items 27 to 29 amend the descriptors for items 46130, 46131 and 46132 to allow the use of ASCS, or a combination of ASCS and autologous skin grafting, as a treatment option for delayed definitive burn wound closure where the treatment involves multiple surgeons where the total area being treated is at least 10% of total body surface for paediatric patients and at least 20% of total body surface for adult patients.

Items 30 to 33 amend the descriptors for items 46133, 46134, 46135 and 46136 relating to immediate and delayed burn wound closure to include the option of treatment for definitive closure using ASCS, or a combination of ASCS and autologous skin grafting. This expands the choice of techniques available for treatment.

Part 2—Amendments relating to sleep investigations

Health Insurance (General Medical Services Table) Regulations 2021

Item 34 amends subclause 1.2.11(1) of Schedule 1 by inserting reference to new paediatric sleep study items 12218 and 12219 (see item 57). This provides that elements of the services described in items 12218 and 12219 may be provided by persons other than medical practitioners.

Items 35 to 48 amend the descriptors for existing items 11000, 11003, 11004, 11005, 11503, 11704, 11705, 11707, 11713, 11714, 11716, 11717, 11723 and 11735 by inserting restrictions on the application of these items where new sleep study items 12218 or 12219 apply (see item 57). This has the effect that where a service to which item 12218 or 12219 applies is provided, none of items 11000, 11003, 11004, 11005, 11503, 11704, 11705, 11707, 11713, 11714, 11716, 11717, 11723 or 11735 will apply and therefore cannot be claimed where the only service rendered is the sleep study service to which item 12218 or 12219 applies.

Items 49, 50, 53 and 56 amend the descriptors for existing sleep study items 12210, 12213, 12215 and 12217 to include reference to new paediatric sleep study items 12218 and 12219, as relevant, in the restrictions on how frequently sleep study investigations may be performed.

As part of these amendments, item 49 will amend the frequency restriction in the descriptor for item 12210 to insert reference to item 12218, and item 53 will amend the frequency restriction in the descriptor for item 12215 to refer to a study mentioned in subparagraph (g)(i) or (ii) of that item (see item 52 – that is, a study under item 12210 or 12218), as these frequency restrictions only relate to studies provided to children aged under 12 years.

In contrast, item 50 will amend the frequency restriction in the descriptor for item 12213 to insert reference to items 12210, 12218 and 12219, and item 56 will amend the frequency restriction in the descriptor for item 12217 to insert reference to a study mentioned in subparagraph (g)(i) or (ii) of that item (see item 55 – that is, a study under item 12210, 12213, 12218 or 12219). This will have the effect that the frequency restrictions in items 12213 and 12217, which are items for sleep studies for adolescents between 12 and 17 years, can include investigations that were performed during the relevant 12-month period for an individual who is aged under 12 years old when they have a study (or studies) performed under item 12210 or 12215, and subsequently turn 12 during that 12-month period such that the appropriate items become items 12213, 12217 or 12219.

Items 51 and 52 amend the descriptor for existing sleep study item 12215 to include reference to new item 12218 in paragraph (g) and subparagraphs (g)(i) and (ii). As item 12215 is for a further investigation after three prior services, this amendment ensures that item 12215 is available where a further investigation is indicated in the same 12-month period that services to which either or both item 12210 or 12218 took place as prior investigations, for a child who is less than 12 years old.

Item 54 and 55 amend the descriptor for existing sleep study item 12217 to include reference to new items 12210, 12218 and 12219 in paragraph (g) and subparagraphs (g)(i) and (ii). As item 12217 is for a further investigation after three prior services, this amendment ensures that item 12217 is available where a further investigation is indicated in the same 12-month period that a service to which any of items 12210, 12213, 12218 and 12219 took place as prior investigations. This also takes into account a circumstance where an individual who was less than 12 years old and had a service under item 12210 or 12218, and then subsequently turned 12 during that 12-month period and became eligible for a service under item 12213, 12217 or 12219.

Item 57 inserts new paediatric sleep study items 12218 and 12219. These new services provide for Level 2 polysomnography out-of-laboratory sleep studies for the investigation of sleep disordered breathing in children aged between 3 and 11 years and adolescents aged between 12 and 18 years.

Part 3—Other amendments

Division 1—Amendments commencing at the same time as Schedule 1

Health Insurance (General Medical Services Table) Regulations 2021

Items 58 and 59 make administrative amendments to clause 2.11.3 to remove reference to item 92436, which had been erroneously included in clause 2.11.3, and to item 294 to remove reference to items 92436 and 92444, which had been erroneously included in item 294.

Items 60 and 61 make administrative amendments to clause 2.16.11 to correct the erroneous reference to item number 9206, replacing it with the correct item number 92060.

Items 62 and 63 make administrative amendments to clause 2.31.7 to remove reference to repealed items 92115, 92121, 92127 and 92133 from subclause 2.31.7(3), and to repeal subclause 2.31.7(5) which has no operation as it only deals with these repealed items.

Item 64 amends the descriptor for item 15944 to clarify that the item applies once per day per site for a maximum of two sites, aligning the service with the original policy intent.

Item 65 amends the descriptor for item 32150 to remove reference to injection of Botulinum toxin.

Item 66 makes an administrative amendment to the descriptor for item 38511, moving the terms “(H) (Anaes.) (Assist.)” to appear at the end of the descriptor.

Item 67 repeals and substitutes paragraphs (a) and (b) in the descriptor for item 45761 to provide that the item also applies where the deformity is the result of a diagnosed craniofacial disorder and to remove the requirement that the service is required for maintaining lip competency, broadening eligibility for this service.

Items 68, 69 and 70 amend the descriptors for items 45888, 45891 and 45939 to include “(Anaes.) (Assist.)” to include indication for anaesthesia and the use of an assistant.

Items 71 and 72 clarify the frequency restrictions for items 50200 and 50201 by repealing clause 5.10.25, which currently contains the frequency restriction for these items, and inserting clarified frequency restrictions into the descriptors for items 50200 and 50201.

Division 2—Amendments commencing after Schedule 1 commences

Health Insurance (General Medical Services Table) Regulations 2021

Items 73 to 76 amend existing colonoscopy item 32222 by removing the indication for positive faecal occult blood test and moving this indication into a new item 32219. Specifically, item 74 inserts new item 32219, and item 95 repeals and replaces paragraphs (a) to (h) of item 32222 to remove the relevant indication. Items 73 and 76 make consequential changes to insert reference to new item 32219 into the descriptors for items 32084, 32087, 32228 and 32229.

Item 77 inserts new items 45070, 45071 and 45072, which relate to developmental breast abnormalities.

Schedule 5—Amendments to Health Insurance Regulations 2018

Health Insurance Regulations 2018

Item 1 repeals and substitutes the cell at table item 1, column 2 in the table to section 44. This removes reference to items 55857, 55859, 55861, 55863, 55865, 55867, 55869, 55871, 55873, 55875, 55877, 55879, 55881, 55883, 55885, 55887, 55889, 55891, 55893 and 55895. These items were incorrectly included in the table, as they are non-requested type diagnostic imaging items, whereas section 44 sets out items that may be requested by participating nurse practitioners.

Statement of Compatibility with Human Rights

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

Health Insurance Legislation Amendment (2025 Measures No. 1) Regulations 2026

These Regulations are 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 purpose of the Health Insurance Legislation Amendment (2026 Measures No. 2) Regulations 2026 (the Regulations) is to amend the DIST, GMST and PST Regulations and the HIR from 1 July 2026, including to implement annual fee indexation from 1 July 2026 by increasing the schedule fee by 2.6 per cent for most general medical services in the GMST and diagnostic imaging services in the DIST, and for specified groups of pathology services in the PST.

The Regulations will implement changes to introduce and amend MBS services as agreed to in the 2025-26 Budget, the 2023-24 and 2025-26 Mid-Year and Economic Fiscal Outlook, and through the Minister’s delegation to approve certain Medical Services Advisory Committee recommendations outside a budget process, and will implement administrative and machinery changes. Further details on the changes can be found below and at the Attachment.

The Regulations will:

• remove reference to specified non requested type items in section 44 of the HIR;
• remove restrictions on claiming breast ultrasound items with chest or abdominal wall ultrasound item 55812 and with breast magnetic resonance imaging item 63464, and remove the multiple services rule when breast imaging items apply together;
• increase fees for nuclear medicine imaging items that use gallium-67 or thallium-201;
• expand echocardiogram item 55133 to include the monitoring of patients taking cardiac Pharmaceutical Benefits Scheme listed medicines that have cardiotoxic side effects;
• insert a new item 73400 for human leukocyte antigen testing for hypersensitivity to carbamazepine and oxcarbazepine;
• amend item 65150 for quantitation of von Willebrand factor antigen and activity to remove reference to specific test methodology and update outdated terminology;
• amend hepatitis C testing item 69499 to remove the requirement for two different serology tests to have been completed before the service can be performed;
• introduce three new items for unilateral correction of developmental breast abnormality;
• amend genioplasty item 45761 to include the indication that the deformity is the result of a diagnosed craniofacial disorder;
• amend colonoscopy item 32222 by removing the positive faecal occult blood test indication and making it into a new standalone item 32119, and amend colonoscopy item 32150 to remove reference to injection with botulinum toxin;
• amend burn wound closure items to include the option of treatment using autologous skin cell suspension, and to account for treatment involving multiple surgeons;
• insert two new paediatric sleep study items 12218 and 12219 and amend claiming and frequency restrictions in specified items to reflect these new items;
• amend items 45888, 45939 and 45891 to include anaesthesia and use of an assistant; and
• clarify frequency restrictions for items 50200 and 50201, and amend frequency restriction for item 15944 to allow for treatment of up to two tumour sites per day.

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.

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

The Regulations maintain the rights to health and social security and the right of equality and non-discrimination by ensuring access to publicly subsidised medical services that are clinically relevant and cost-effective consistent with a universal health insurance program. The Regulations also advance these rights by introducing new services which will be available as publicly subsidised medical services.

Conclusion

This instrument is compatible with human rights because it maintains and advances arrangements for publicly subsidised medical services.

Mark Butler

Minister for Health and Ageing