EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
National Health Act 1953
Determination under subsections 73AAG (6) and (7)
(HIB 05/2006)
Subsection 73AAG(6) of the National Health Act 1953 (the Act) provides that the Minister may determine in writing the prostheses that are no gap prostheses and the benefit amount for each no gap prosthesis.
Subsection 73AAG(7) provides that the Minister may determine in writing the prostheses that are gap permitted prostheses, and the minimum and maximum benefit amounts for each gap permitted prosthesis.
The Schedule to this determination has two parts:
- Part A – Prostheses; and
- Part B – Human Tissue List.
The Schedule to this determination is known as the “Prostheses List”.
This determination commences on 14 March 2006. It replaces, in its entirety, the determination dated 19 October 2005 (HIB18/2005), as amended (by HIB23/2005).
This determination updates the previous Prostheses List by:
- adding a number of new products as no gap prostheses or gap permitted prostheses;
- changing some existing products including: amending the descriptions of products, allocating new billing codes in respect of new sizes or models of products, compressing billing codes to cover a range of products offered at the same cost, changing supplier names to reflect new supplier arrangements, changing the minimum benefit amount and/or maximum benefit amount; and
- deleting other products.
The determination is consistent with the recommendations of the Prostheses and Devices Committee.
In Part A of the Prostheses List, some products are grouped according to their clinical effectiveness, as assessed by Clinical Advisory Groups (CAGs). The purpose of the groupings is to identify products of similar clinical effectiveness or clinical design, in order to assist in determining the benefits payable for the products and to assist with clinical choice. To date, CAGs have assessed and grouped products for the Prostheses List in the following categories:
- cardiac pacemakers and leads;
- implantable cardioverter defibrillators and leads;
- cardiac stents;
- intraocular lenses;
- hip prostheses; and
- knee prostheses.
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Other products have been grouped according to their product type, as determined by the Emergency Care Research Institute (ECRI) or Global Medical Devices Nomenclature System (GMDNS) descriptor allocated by the Therapeutic Goods Administration. This is to allow for greater ease of comparison of products listed.
Benefits payable in respect of the products that have been assessed and grouped by CAGs, and new products, have been negotiated with the suppliers. Benefits payable in respect of products that have not yet been assessed and grouped by CAGs have been determined by application of a formula taking into account the benefits payable in respect of each product as at 1 October 2004 and, where available, the utilisation of each product.
CONSULTATION
This Determination has been made having regard to advice provided by the Prostheses and Devices Committee (PDC), a ministerially appointed committee comprised of nominees from health funds, hospitals, clinicians, prostheses and devices suppliers, the Commonwealth, and consumer representatives. In making their recommendations, the PDC were advised by CAGs, other clinical experts, and benefits negotiators, all appointed by the PDC.
This determination and this Explanatory Statement have been registered on the Federal Register of Legislative Instruments.
PRIVATE HEALTH INSURANCE BRANCH
DEPARTMENT OF HEALTH AND AGEING
FEBRUARY 2006
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves to regulate the provision of health services and public health initiatives across the nation. The Act was introduced to address the need for a cohesive legislative framework that would standardise health services, ensure quality care, and manage public health effectively. The 2006 Determination under subsections 73AAG (6) and (7) of the Act, issued by the Minister for Health and Ageing, aims to update the Prostheses List by adding new products as no gap or gap permitted prostheses, modifying existing products, and removing outdated ones. This update aligns with recommendations from the Prostheses and Devices Committee and ensures that benefits payable for prostheses are determined fairly, taking into account clinical effectiveness and supplier negotiations. The overarching policy objective is to maintain a current, clinically effective, and economically viable list of prostheses, ensuring patients have access to necessary medical devices with appropriate benefits.
Scope and Application
The determination under subsections 73AAG (6) and (7) of the National Health Act 1953 outlines the prostheses that are classified as no gap prostheses and gap permitted prostheses, along with the associated benefit amounts. This determination applies to all entities involved in the provision of prostheses within Australia, including private health insurers, hospitals, and suppliers. The determination is designed to standardise the benefits payable for certain prostheses, ensuring consistency in the coverage provided by health funds. It operates on a national level, with the benefits payable determined by the Minister for Health and Ageing, as advised by the Prostheses and Devices Committee. The determination is comprehensive, including both the addition of new prostheses and adjustments to existing ones, with benefits negotiated based on clinical effectiveness and product type. The benefits for prostheses not yet assessed by Clinical Advisory Groups are determined by a formula considering previous benefits and utilisation rates. This legislation does not specify any exclusions or thresholds but rather extends its application to all relevant prostheses as defined in the Prostheses List.
Key Provisions
The key provisions of the determination under the National Health Act 1953, specifically subsections 73AAG(6) and 73AAG(7), pertain to the classification of prostheses into "no gap prostheses" and "gap permitted prostheses." These classifications, along with the benefit amounts for each type, are determined in writing by the Minister for Health and Ageing. The Prostheses List, which is the Schedule to this determination, is divided into two parts: Part A, which details the prostheses, and Part B, which lists human tissue. This list, effective from 14 March 2006, replaces the previous determinations and updates the Prostheses List by adding new products, modifying existing ones, and removing others. The list is structured to assist in determining benefits payable and to facilitate clinical choices by grouping products based on clinical effectiveness or product type.
Under this determination, certain obligations and requirements are imposed on the entities it governs. These include suppliers of prostheses and devices, health funds, and other relevant stakeholders. Suppliers must comply with the updated descriptions, billing codes, and benefit amounts as specified in the Prostheses List. Health funds, in turn, are required to adhere to the benefit amounts set out for each prosthesis to ensure consistent and fair coverage for beneficiaries. The Prostheses and Devices Committee plays a crucial role in advising the Minister on these matters, ensuring that the list is consistent with clinical effectiveness and industry standards.
Non-compliance with the provisions of this determination can result in various civil and criminal consequences. While the Act itself does not explicitly detail specific offences or penalties within this determination, breaches of health-related regulations generally may lead to enforcement actions, fines, or other legal repercussions. The precise nature and extent of penalties would be determined in accordance with other applicable laws and regulations governing health services and benefits. It is important for all parties involved to adhere strictly to the provisions of the Prostheses List to avoid any potential legal ramifications.