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Health Insurance (B-Scan Ultrasonography and Holmium: YAG Laser Enucleation of the Prostate) Determination 2013

Health Insurance (B-Scan Ultrasonography and Holmium: YAG Laser Enucleation of the Prostate) Determination 2013

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00350 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Health Insurance Act 1973

Health Insurance (B-Scan Ultrasonography and Holmium:YAG Laser Enucleation of the Prostate) Determination 2013

Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may determine in writing that a health service not specified in an item in the General Medical Services Table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were so specified. The Table is set out in the Health Insurance (General Medical Services Table) Regulation (the Regulation), which are re-made each year.

The purpose of the Health Insurance (B-Scan Ultrasonography and Holmium:YAG Laser Enucleation of the Prostate) Determination 2013 (the Determination) is to introduce two new Medicare items (item 37245 for holmium laser enucleation of the prostate (HoLEP), and item 11244 for ophthalmic B(brightness)-scan). The Determination also revokes the Health Insurance (Endovenous Laser Therapy) Determination 2012 (No.2). Items in the Health Insurance (Endovenous Laser Therapy) Determination 2012 (No.2) are being moved directly to the Table by the Health Insurance (General Medical Services Table) Amendment Regulation 2013 (No.1), as recommended by the Medical Services Advisory Committee (MSAC) and approved in the 2011-2012 Budget.

B(brightness) Scan (or B-scan)

From 1 March 2013, the Australian Government will introduce a new Medicare item for B-scan, which is a diagnostic service used by ophthalmologists to diagnose various ocular diseases. There are existing Medicare items for B-scan available through the Health Insurance (Diagnostic Imaging Services Table) Regulation 2012, but to date, these have mainly been available for radiologists, on referral by a medical practitioner.

The new B-scan item enables specialist ophthalmologists to perform a similar Medicare service to radiologists (without the need for referral), within Group D1, Subgroup 2 of the Table. As with other ophthalmic diagnostic tests within this subgroup, B-scan is a specialised test only performed when clinically indicated. Because ophthalmic B-scan is an ultrasound technology, it has traditionally been necessary for ophthalmologists to refer patients for a scan using item 55030 of the Health Insurance (Diagnostic Imaging Services Table) Regulations, or provide a lower rebated service through item 55031 of those regulations. Those items are designed for use by diagnostic imaging practices and not for specialist ophthalmic practices.

Holmium Laser Enucleation of the Prostate (HoLEP)

From 1 March 2013, the Australian Government will introduce a Medicare item for a new treatment for benign enlargement of the prostate. Holmium laser enucleation of the prostate (HoLEP) is a method of completely removing the enlarged prostate gland, via the urethra. It is used to treat lower urinary tract symptoms in benign prostatic hyperplasia (BPH). BPH is the non-cancerous growth of tissue that causes enlargement of the prostate, causing urinary obstruction. Untreated BPH may result in damage to normal function of the bladder and kidneys. HoLEP is less invasive than existing treatments and will reduce the length of hospital stay for patients.

Endovenous Laser Therapy (ELT)

ELT, a minimally invasive procedure to treat severe varicose veins, is currently funded through Medicare items 32520 and 32522, in the Health Insurance (Endovenous Laser Therapy) Determination 2012 (No.2) (the ELT Determination). From 1 May 2013, these items will be listed directly on the Table. Consequently, the ELT Determination can be revoked from midnight 30 April 2013.

In August 2012, after considering evidence on cost-effectiveness and patient affordability, MSAC recommended that ELT continue to be publicly funded and therefore moved from its interim funding status (in the existing ELT Determination) to ongoing funding through its listing on the Table.

In providing its advice, MSAC supported minor re-wording of the ELT item descriptors. From
1 May 2013, existing advice contained in the explanatory notes to the Medicare Benefits Schedule (that ‘reflux of 0.5 seconds or longer (within the great or small saphenous vein, as relevant) be documented by duplex ultrasound’) will be incorporated into the item descriptors for the two ELT items. This re-wording simply reinforces existing clinical best practice, as intended by MSAC, and prevents possible future use of the items for cosmetic conditions.

The Determination applies several provisions found in the Table to new B-scan item 11244 and HoLEP item 37245:

as for all other surgical services in the Table, the HoLEP item will require personal attendance by a single medical practitioner on a single patient on a single occasion, and the attendance must be by a medical practitioner who is not employed at a public hospital or, if employed at a public hospital, is exercising his or her right of private practice (subsection 7(2) of the Determination);
the B-scan item may be provided by a medical practitioner or a person acting under the supervision of a medical practitioner in accordance with accepted medical practice (subsection 7(1) of the Determination);
as for all other items in Group D1 of the Table, Medicare will not be payable for the B-scan item if it is provided at the same time as, or in connection with, home-based sleep studies (subsection 7(1) of the Determination);
as for all other items in the Table, Medicare will not be payable for the B-scan or HoLEP items if they are provided in contravention of a law of the Commonwealth, a State or a Territory (subsection 7(3) of the Determination).

Consultation

During MSAC’s assessment of evidence in relation to the safety, clinical effectiveness and cost effectiveness of HoLEP, the Department assisted in the exchange of information between MSAC and the Urological Society of Australia and New Zealand (USANZ) and the Australian and New Zealand Association of Urological Surgeons (ANZAUS). Since MSAC’s decision in December 2012 to recommend public funding for HoLEP, the Department has continued to consult with USANZ and ANZAUS in relation to implementation issues.

In relation to B-scan, the Department has consulted with the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) via exchange of letters, emails and through telephone conversations. RANZCO supports the proposed funding arrangements.

In relation to ELT, since MSAC’s decision in August 2012 (and well before that, dating back to 2008), the Department has been involved in ongoing consultation with the Australasian College of Phlebology, Australian and New Zealand Society of Phlebology, Australian and New Zealand Society for Vascular Surgery (within the Royal Australasian College of Surgeons) and the Royal Australian and New Zealand College of Radiologists. Earlier consultation occurred with the Royal Australian College of General Practitioners, who deferred opinion to medical organisations representing vein specialists.

Consultation occurred via exchange of letters, emails and through telephone conversations. These groups support the ongoing listing of ELT on the Table and minor re-wording of item descriptors from 1 May 2013.

Sections 1 to 3 and 5 to 7 and the Schedule to the Determination commence 1 March 2013. These sections provide for the creation of the HoLEP and B-scan item and the cessation of the Determination. Section 4, which revokes the ELT Determination, commences at midnight 30 April 2013. The Determination ceases at 12:01 am 1 May 2013. It is currently intended that the HoLEP and B-scan items will be listed directly on the Table from 1 May 2013.

This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Overview

The Health Insurance (B-Scan Ultrasonography and Holmium:YAG Laser Enucleation of the Prostate) Determination 2013, enacted to address gaps in the Medicare Benefits Schedule, introduces two new Medicare items for specific health services: B-scan ultrasonography for diagnosing ocular diseases and holmium laser enucleation of the prostate (HoLEP) for treating benign prostatic hyperplasia. This Determination was made under the authority of the Minister for Health pursuant to subsection 3C(1) of the Health Insurance Act 1973, with the policy objective of enhancing the availability of certain medical services under Medicare. Additionally, the Determination revokes the Health Insurance (Endovenous Laser Therapy) Determination 2012, as the items for endovenous laser therapy will be moved directly to the General Medical Services Table, reflecting recommendations by the Medical Services Advisory Committee. This approach aims to improve the accessibility and integration of critical medical services within the existing healthcare framework, ensuring that more Australians can benefit from these advanced treatments.

Scope and Application

The Health Insurance (B-Scan Ultrasonography and Holmium:YAG Laser Enucleation of the Prostate) Determination 2013, made under the Health Insurance Act 1973, introduces two new Medicare items to be treated as if they were specified in the General Medical Services Table. The Determination applies to eligible medical services provided in Australia and aims to provide coverage for specific health services not previously listed in the Table. The services covered by the new items include B-scan ultrasonography, a diagnostic service used by ophthalmologists to diagnose ocular diseases, and holmium laser enucleation of the prostate (HoLEP), a treatment for benign enlargement of the prostate. The Determination specifies the conditions under which these services can be provided and reimbursed under Medicare, including requirements for personal attendance by medical practitioners and restrictions on the provision of these services in certain contexts, such as home-based sleep studies for B-scan. Additionally, the Determination revokes the Health Insurance (Endovenous Laser Therapy) Determination 2012, moving the related items directly to the General Medical Services Table. The provisions of the Determination are intended to align with existing Medicare rules and are effective from 1 March 2013, with certain sections taking effect on 1 May 2013.

Key Provisions

The Health Insurance (B-Scan Ultrasonography and Holmium:YAG Laser Enucleation of the Prostate) Determination 2013 (the Determination) introduces two new Medicare items effective from 1 March 2013: item 37245 for holmium laser enucleation of the prostate (HoLEP), and item 11244 for ophthalmic B(brightness)-scan. These items are meant to expand the services covered under Medicare to include advanced diagnostic and treatment options. The Determination also revokes the Health Insurance (Endovenous Laser Therapy) Determination 2012 (No.2), which is superseded by the Health Insurance (General Medical Services Table) Amendment Regulation 2013 (No.1). The Determination imposes specific conditions and requirements on the provision of these new services. For instance, the HoLEP item (subsection 7(2)) stipulates that it must be performed by a medical practitioner who is either not employed at a public hospital or, if employed at a public hospital, is exercising their right of private practice. The B-scan item (subsection 7(1)) can be provided by a medical practitioner or by someone acting under the supervision of a medical practitioner in accordance with accepted medical practice. Furthermore, Medicare will not be payable for these items if they are provided in contravention of any Commonwealth, State, or Territory law (subsection 7(3)). Additionally, the B-scan item will not be payable if it is provided at the same time as, or in connection with, home-based sleep studies. For breaches of the provisions set out in the Determination, there are potential civil and criminal consequences. However, the specific penalties for these breaches are not explicitly stated in the Determination. The general provisions under the Health Insurance Act 1973 and related regulations would apply, which may include fines and other penalties as stipulated in the broader legislative framework. The Determination also addresses the movement of the Endovenous Laser Therapy (ELT) items to the General Medical Services Table, effective from 1 May 2013. This transition ensures that ELT continues to be publicly funded, following a recommendation by the Medical Services Advisory Committee (MSAC) based on its cost-effectiveness and patient affordability. The item descriptors for ELT have been minorly re-worded to incorporate existing clinical best practice and to prevent possible misuse of the items for cosmetic conditions. This change was implemented to align with MSAC's recommendations and to reinforce clinical standards.

Area of Law: Health Law
Instrument: Determination
Concepts: Definitions & Interpretation; Licensing & Registration; Reporting & Disclosure Obligations

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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.

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