EXPLANATORY STATEMENT
STATUTORY RULES 1985 NO. 36
ISSUED BY AUTHORITY OF THE MINISTER FOR HEALTH
HEALTH INSURANCE ACT 1973 HEALTH INSURANCE REGULATIONS (AMENDMENT)
Section 133 of the Health Insurance Act 1973 (‘the Act’) provides that the Governor-General may make regulations 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.
Sub-section 19A(1) of the Act provides that, subject to sub-section 19A(2) of the Act, the regulations may provide that, unless the Minister otherwise directs, medicare benefits are not payable under the Act in respect of professional services rendered in prescribed circumstances.
Sub-section 19A(2) of the Act provides that regulations shall not be made for the purposes of sub-section 19A(1) except in accordance with a recommendation made to the Minister by the Medicare Benefits Advisory Committee under paragraph 67(1)(aa) of the Act. Paragraph 67(1)(aa) provides
that included in the functions of the Medicare Benefits Advisory Committee, established under section 66 of the Act, is to consider, in pursuance of a reference to it by the Minister for Health, whether medicare benefits should continue to be payable in circumstances specified by the Minister and to make recommendations arising from that consideration in writing to the Minister.
On 1 November 1983, in pursuance of paragraph 67(1)(aa) of the Act, the Minister for Health referred for consideration to the then Medical Benefits Advisory Committee the question of whether medical benefits should continue to be payable in respect of professional services rendered for the purposes of chelation therapy. Following amendments by the Health Legislation Amendment Act 1983, the Medical Benefits Advisory Committee became the Medicare Benefits Advisory Committee and, as provided for by sub-section 49(2) of that Act, continued its existence as though it had originally been established as the Medicare Benefits Advisory Committee under section 66 of the
Act as amended. In response, the Medicare Benefits Advisory Committee made recommendations, subsequently accepted by the Minister for Health, that medical benefits should not be payable for professional services performed in connection with chelation therapy.
The technique of chelation therapy involves the repeated intravenous administration of ethylenediamine tetra-acetic acid or its salts which has been claimed to remove calcium from the walls of human arteries and therefore to be effective in the treatment of arterioscelerosis. In its consideration, the Committee had regard to the lack of acceptable evidence of chelation therapy as an effective treatment, its wide range of undesirable side-effects, and the views of the Australian Drug Evaluation Committee, the Royal Australian College of Physicians and the Cardiac Society of Australia and New Zealand.
The regulations prescribe circumstances for the purposes of sub-section 19A(1) of the Act in which medicare benefits are not payable in respect
of professional services unless the Minister otherwise directs. These prescribed circumstances are, in accordance with the recommendation of the Medicare Benefits Advisory Committee, where professional services are rendered in relation to the provision of chelation therapy, being the intravenous administration of ethylenediamine tetra-acetic acid or any of its salts, otherwise than for the treatment of heavy-metal poisoning.
The regulations came into effect on the date of their notification in the Commonwealth of Australia Gazette.
Overview
The Health Insurance Regulations (Amendment) 1985 were enacted under the authority of the Minister for Health and issued in accordance with the Health Insurance Act 1973. These regulations were introduced to address the specific issue of whether Medicare benefits should be payable for professional services related to chelation therapy. The problem identified was the lack of substantial evidence supporting the effectiveness of chelation therapy as a treatment, coupled with its numerous adverse side effects. The policy objective was to align Medicare benefits with treatments that have demonstrated efficacy and safety, thereby ensuring that public funds are used responsibly and effectively. The enacting body, the Parliament, authorised the Minister for Health to make these regulations based on recommendations from the Medicare Benefits Advisory Committee, which considered the clinical and scientific evidence and consulted with relevant medical bodies.
Scope and Application
The Health Insurance Regulations (Amendment), issued under the authority of the Minister for Health, pertain to the Health Insurance Act 1973, impacting the scope and application of Medicare benefits within Australia. These regulations, made pursuant to section 133 of the Act, specify that unless the Minister directs otherwise, Medicare benefits will not be payable for professional services rendered in prescribed circumstances. Specifically, the regulations address professional services related to chelation therapy, excluding the treatment of heavy-metal poisoning, and follow recommendations from the Medicare Benefits Advisory Committee. The application of these regulations is nationwide, affecting all entities and individuals subject to the Health Insurance Act 1973, thereby impacting medical practitioners and patients across Australia. The regulations came into effect on the date of their notification in the Commonwealth of Australia Gazette, ensuring immediate enforcement of the prescribed changes.
Key Provisions
The primary operative sections of the Health Insurance Regulations (Amendment) are sections that pertain to the conditions under which medicare benefits are not payable for professional services. Specifically, section 19A(1) of the Health Insurance Act 1973 provides that, unless the Minister directs otherwise, medicare benefits will not be payable for professional services rendered in certain prescribed circumstances. This is further elaborated in the regulations, which detail that benefits are not payable for services related to chelation therapy unless it is for the treatment of heavy-metal poisoning. The regulations are made pursuant to section 133 of the Act, which empowers the Governor-General to prescribe matters necessary for the Act’s implementation.
These regulations impose specific obligations on healthcare providers and patients. Healthcare providers must ensure that professional services rendered are not for the purpose of chelation therapy unless it pertains to the treatment of heavy-metal poisoning. Patients seeking chelation therapy must be aware that medicare benefits will not be applicable for such treatments, except under the circumstances of treating heavy-metal poisoning. The regulations also require adherence to the recommendations of the Medicare Benefits Advisory Committee, which assessed the efficacy and side-effects of chelation therapy.
Failure to comply with these regulations may result in civil or criminal consequences. For instance, healthcare providers who bill for services rendered for chelation therapy in non-compliant circumstances may face penalties. The Act does not specify maximum penalties for these breaches, but violations can lead to financial penalties, legal actions, or other regulatory consequences as deemed appropriate by the relevant authorities. The seriousness of the offence, including potential fines and other legal repercussions, would be determined based on the specific circumstances and the extent of non-compliance.