EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (RET Gene Testing) Revocation Determination 2015
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by writing, determine that a health service not listed in the Pathology Services Table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were so listed. The Table is set out in the regulations made under subsection 4(A)(1) of the Act, which is re-made each year. The most recent version of the regulations is the
Health Insurance (Pathology Services Table) Regulation 2015 (the regulation) which commences on 1 July 2015.
The Health Insurance (RET Gene Testing) Revocation Determination 2015 revokes the Health Insurance (RET Gene Testing) Determination 2014 as the two item numbers (73339 and 73340) contained in the 2014 Determination have been incorporated into the Regulation to commence on 1 July 2015, and will continue as items within the Regulation.
Consultation
RET mutation testing, and the associated genetic counselling, of patients suspected of having multiple endocrine neoplasia type II (MEN2) and their close family members is currently standard clinical practice offered in state and territory hospitals and private facilities. An application for public funding for RET gene test was received in October 2010. This application was sponsored by the Royal College of Pathologists of Australasia (RCPA) and considered by the Medical Services Advisory Committee (MSAC) in August 2013.
After considering the evidence relating to the safety, effectiveness and cost-effectiveness, MSAC made a recommendation to the Australian Government to publicly fund these services.
Details of the Determination are set out in the Attachment.
The Act specifies no conditions which need to be met before the power to make the Determination may be exercised.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This Determination commences on 1 July 2015.
ATTACHMENT
DETAILS OF THE HEALTH INSURANCE (RET GENE TESTING) REVOCATION DETERMINATION 2015
Section 1 Name of Determination
Section 1 provides that the name of the Determination is the Health Insurance (RET Gene Testing) Revocation Determination 2015.
Section 2 Commencement
Section 2 provides that the Determination commences on 1 July 2015.
Section 3 Revocation
Section 3 provides that the Determination revokes the Health Insurance (RET Gene Testing) Determination 2014.
Overview
The Health Insurance (RET Gene Testing) Revocation Determination 2015, issued under subsection 3C(1) of the Health Insurance Act 1973, revokes the previous Health Insurance (RET Gene Testing) Determination 2014. This revocation was necessary because the two item numbers (73339 and 73340) pertaining to RET gene testing, which were previously determined to be funded under the Act, have been incorporated into the Health Insurance (Pathology Services Table) Regulation 2015. This incorporation ensures that these services continue to be recognised and funded within the Regulation, effective from 1 July 2015. The revocation determination was made by the Minister for Health, aligning with the policy objective to streamline and update the health services funding provisions in line with clinical practice and cost-effectiveness recommendations.
Scope and Application
The Health Insurance (RET Gene Testing) Revocation Determination 2015 applies to the Health Insurance Act 1973, which governs the regulation of private health insurance in Australia. The Determination itself specifically revokes the previous Health Insurance (RET Gene Testing) Determination 2014, as the services it covered are now incorporated into the Health Insurance (Pathology Services Table) Regulation 2015. This means that the Determination impacts entities and individuals who may have previously been covered under the 2014 Determination, which concerned the genetic testing for RET mutations and associated genetic counselling for patients suspected of having multiple endocrine neoplasia type II (MEN2) and their close family members. This process is a standard clinical practice offered in both state and territory hospitals and private facilities. The revocation and incorporation of these services into the Pathology Services Table means that they will continue to be covered under the regulation from 1 July 2015 onwards. There are no exclusions or thresholds specified in this Determination, and it applies nationally across Australia, as it concerns the regulation of private health insurance services under Commonwealth legislation.
Key Provisions
The Health Insurance (RET Gene Testing) Revocation Determination 2015 (section 1) operates under the Health Insurance Act 1973 to revoke the previous Health Insurance (RET Gene Testing) Determination 2014. This revocation occurs because the specific item numbers (73339 and 73340) for RET gene testing have been incorporated into the Health Insurance (Pathology Services Table) Regulation 2015 (section 3), effective from 1 July 2015. Consequently, these services will continue to be recognised and funded under the new Regulation rather than the Determination.
The Act imposes obligations on parties such as the Minister for Health, who has the authority to determine that certain health services, not listed in the Pathology Services Table, can be treated as if they were listed under specified circumstances (subsection 3C(1)). The Act also mandates that the Pathology Services Table is updated annually, with the latest version being the Health Insurance (Pathology Services Table) Regulation 2015. This ensures that the services covered by health insurance are kept current with medical advancements and clinical practices.
In terms of compliance and consequences, the Act does not specify particular conditions that must be met before the power to make the Determination can be exercised. However, the Determination itself is a legislative instrument governed by the Legislative Instruments Act 2003. Any failure to comply with the requirements set forth in the Act or the Regulations could potentially lead to legal repercussions, although specific penalties are not detailed in the Act itself. It is crucial for all stakeholders, including healthcare providers and patients, to stay updated with the latest regulations to ensure continued coverage and compliance with health insurance provisions.