EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health

Health Insurance Act 1973

Health Insurance (Section 3C General Medical Services - Transcatheter Aortic Valve Implantation) Determination 2017

Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, determine 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 specified in the Table.  The Table is set out in the regulations made under subsection 4(1) of the Act, which is re-made each year.  The most recent version of the regulations is the Health Insurance (General Medical Services Table) Regulation 2017 which commenced on 1 July 2017.

Purpose

In March 2016, the Medical Services Advisory Committee (MSAC) recommended the listing of Medicare Benefits Schedule items for transcatheter aortic valve implantation (TAVI) and associated services for use in patients who are symptomatic with severe aortic stenosis, and who are deemed to be at high risk for surgical aortic valve replacement or who would otherwise be inoperable.

The purpose of the Health Insurance (Section 3C General Medical Services - Transcatheter Aortic Valve Implantation) Determination 2017 (the Determination) is to implement a Government decision in the 2016-17 Mid-Year Economic and Fiscal Outlook (MYEFO) by providing a legal basis for the payment of Medicare benefits for services provided under items 6080, 6081 and 38495, from 1 November 2017.

The new item for the performance of a TAVI, 38495, only applies to a service that is provided in a TAVI Hospital by a TAVI Practitioner, on a patient who has been assessed as suitable to receive the procedure.  A TAVI Practitioner is either a cardiothoracic surgeon or an interventional cardiologist who is accredited by Cardiac Accreditation Services Limited (ACN622113004).

A TAVI Hospital is a hospital, as defined by subsection 121-5(5) of the Private Health Insurance Act 2007, that is clinically accepted as being a suitable hospital at which TAVI procedures may be performed.  The Transcatheter Aortic Valve Implantation - Rules for the Accreditation of TAVI Practitioners, issued by Cardiac Accreditation Services Limited in October 2017, provides guidance regarding clinically acceptable TAVI facilities.   This document is publicly available from the website www.tavi.org.au, or can be obtained directly from Cardiac Accreditation Services Limited.

Medicare benefit for the service specified in item 38495 is only payable once per patient in a five year period.

The new items 6080 and 6081 apply in relation to a TAVI Case Conference, which is a process undertaken by a number of medical practitioners to assess and make recommendations regarding a patient’s suitability to receive the service described in item 38495. 

Item 6080 provides for the coordination of the TAVI Case Conference by a TAVI Practitioner and is only payable once per patient in a five year period.

Item 6081 provides for attendance at a TAVI case conference by a specialist or consultant physician who attended but did not coordinate the conference.  This item is only payable twice per patient in a five year period.

Consultation

MSAC reviews new or existing medical services or technology, and the circumstances under which public funding should be supported through listing on the MBS.  As part of the MSAC process, consultation was undertaken with professional bodies, consumer groups, the public and clinical experts for proposals put forward for consideration by the Committee.

The Cardiac Society of Australia and New Zealand and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons were consulted in relation to items 6080, 6081 and 38495. 

Details of the Determination are set out in the Attachment.

The Determination commences on 1 November 2017.

The Determination is a legislative instrument for the purposes of the
Legislation Act 2003.

Authority:     Subsection 3C(1) of the

 Health Insurance Act 1973

ATTACHMENT

Details of the Health Insurance (Section 3C General Medical Services - Transcatheter Aortic Valve Implantation) Determination 2017

Section 1 – Name of Determination

Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C General Medical Services - Transcatheter Aortic Valve Implantation) Determination 2017.

Section 2 – Commencement

Section 2 provides that the Determination is taken to have commenced on 1 November 2017.

Section 3 – Authority

Section 3 provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.

Section 4 – Definitions

Section 4 defines terms used in the Determination.

Section 5 – Treatment of relevant services

Section 5 provides that a clinically relevant service provided in accordance with the Determination shall be treated, for relevant provisions of the Health Insurance Act 1973 and National Health Act 1953, and regulations made under those Acts, as if it were both a professional service and a medical service and as if there were an item specified in the medical general services table for the service. The general medical services table is a table of medical services prescribed under section 4 of the Health Insurance Act 1973. 

Section 6 – Application of item 38495

Section 6 provides that Medicare benefit is not payable in respect of item 38495 if, the service is provided at the same time as, or in connection with, the provision of a pain pump for post – surgical pain management.

Schedule 1 – Relevant services

Schedule 1 specifies the health services and prescribes the associated fees for items 6080, 6081 and 38495.

Statement of Compatibility with Human Rights

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

Health Insurance (Section 3C General Medical Services - Transcatheter Aortic Valve Implantation) Determination 2017

This Determination 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 Legislative Instrument

In March 2016, the Medical Services Advisory Committee (MSAC) recommended the listing of Medicare Benefit Schedule items for transcatheter aortic valve implantation (TAVI) and associated services for use in patients who are symptomatic with severe aortic stenosis, and who are deemed to be at high risk for surgical aortic valve replacement or who would otherwise be inoperable.

The purpose of the Health Insurance (Section 3C General Medical  Services - Transcatheter Aortic Valve Implantation) Determination 2017 (the Determination) is to provide a legal basis for the payment of Medicare benefits for services provided under items 6080, 6081 and 38495 from 1 November 2017.

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.

Analysis

This Determination will advance rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective.

Conclusion

This Determination is compatible with human rights as it has a positive effect on human rights issues.

Natasha Ryan

Assistant Secretary

MBS Policy and Specialist Services Branch

Medical Benefits Division

Department of Health