Attachment E
EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health and Ageing
Health Insurance Act 1973
Health Insurance (Endoscopic and Endobronchial Ultrasound for Sampling and Diagnosis of Lung Cancer) Determination 2009
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may determine in writing that a health service not listed 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 listed. The Table is set out in the Health Insurance (General Medical Services Table) Regulations 2008 which are re-made each year.
A determination made under subsection 3C(1) of the Act is a legislative instrument (see subsection 3C(4) of the Act and paragraph 6(d) of the Legislative Instruments Act 2003).
The Health Insurance (Endoscopic and Endobronchial Ultrasound for Sampling and Diagnosis of Lung Cancer) Determination 2009 (the Determination) will permit the payment of Medicare benefits for endoscopic ultrasound plus fine needle aspiration for the sampling and diagnosis of patients with presumed or known non-small cell lung cancer or mediastinal masses; and endobronchial ultrasound guided procedures for the sampling and diagnosis of patients with non-small cell lung cancer, mediastinal/hilar masses or peripheral lung lesions.
The Determination provides for two new items (item 30696 and 30710). Item 30696 will provide a service for the sampling and diagnosis of presumed or known non-small cell lung cancer or mediastinal masses. Item 30710 will provide a service for the sampling and diagnosis of non-small cell lung cancer, mediastinal/hilar masses or peripheral lung lesions.
This Determination has been made following evaluations of endoscopic and endobronchial ultrasound guided procedures for sampling and diagnosis of lung cancer by the Medical Services Advisory Committee (MSAC). The MSAC recommended that public funding be supported for these services. The MSAC provides advice to the Australian Government on evidence relating to the safety, effectiveness and cost-effectiveness of new medical technology and procedures.
The Determination will cease on 31 October 2009.
Details of the Determination are set out in the Attachment.
Consultation
Consultations took place between November 2008 and April 2009 with Medicare Australia, the Australian Medical Association (AMA), the Gastroenterological Society of Australia, the Thoracic Society of Australia & New Zealand, the Royal Australasian College of Surgeons and the Royal Australasian College of Physicians. All parties support the introduction of the new items. However, the AMA brought to the Department’s attention that the new items may lead to some confusion and that some practitioners may attempt to claim associated imaging items in association with Endoscopic Ultrasound (EUS)-Fine Needle Aspiration (FNA). The Department has agreed to consult further with the AMA should this become an issue.
ATTACHMENT
Notes on sections in the Determination
Section 1
Section 1 provides the name of the Determination.
Section 2
Section 2 provides that the Determination commences on 1 July 2009 and will cease to have effect at the end of 31 October 2009.
Section 3
Section 3 defines terms used in this Determination. These terms are referred to in section 4 of the Determination.
Subsection 3(2) provides that a reference to a provision of an Act or regulations, is a reference to the provision as in force from time to time (as authorised by subsection 3C(3) of the Act).
Section 4
Subsection 4(a) provides that a relevant service specified in the Schedule to the Determination will be treated as if it were both a professional service and a medical service for the purposes of the provisions of the Act, the National Health Act 1953 and regulations made under each Act which provide for medical services or professional services.
Subsection 4(b) provides that a relevant service specified in the Schedule to the Determination is to be treated as if there were an item in the General Medical Services Table related to the service and specified a fee for that service, being the fee specified in the Schedule to the Determination in relation to the service.
Schedule
The Schedule to the Determination sets out the relevant services, assigning the applicable item number, item descriptor and fee for each service.
Overview
The Health Insurance (Endoscopic and Endobronchial Ultrasound for Sampling and Diagnosis of Lung Cancer) Determination 2009 was enacted to address the need for public funding of specific medical procedures for the diagnosis of lung cancer. This Determination was made under the authority of the Health Insurance Act 1973, which empowers the Minister to determine that certain health services not listed in the General Medical Services Table can be treated as if they were listed, thus qualifying for Medicare benefits. The Determination introduces two new items (30696 and 30710) related to endoscopic and endobronchial ultrasound procedures, following recommendations from the Medical Services Advisory Committee (MSAC) that these services should receive public funding due to their effectiveness and cost-effectiveness. The Determination was subject to consultation with various medical associations and bodies, including the Australian Medical Association and the Gastroenterological Society of Australia, all of whom supported the introduction of the new items, although some concerns were raised about potential confusion and improper claims which the Department agreed to address through further consultation.
Scope and Application
The Health Insurance (Endoscopic and Endobronchial Ultrasound for Sampling and Diagnosis of Lung Cancer) Determination 2009 applies to health services provided under the Health Insurance Act 1973. It specifically addresses the treatment of endoscopic and endobronchial ultrasound procedures for the sampling and diagnosis of lung cancer. These procedures are to be treated as if they were listed items in the General Medical Services Table, thereby enabling Medicare benefits for these services. The Determination applies to medical practitioners and patients in Australia and is in effect from 1 July 2009 until 31 October 2009. The new services are designated by specific item numbers and descriptors, with corresponding fees outlined in the schedule attached to the Determination. This legislative instrument was made following recommendations by the Medical Services Advisory Committee, which evaluated the safety, effectiveness, and cost-effectiveness of these procedures. The Determination also acknowledges potential confusion regarding the claiming of associated imaging items alongside endoscopic ultrasound services and commits to further consultation with relevant parties if necessary.
Key Provisions
The main operative sections of the Health Insurance (Endoscopic and Endobronchial Ultrasound for Sampling and Diagnosis of Lung Cancer) Determination 2009 (the Determination) establish two new items (item 30696 and item 30710) for the purposes of Medicare benefits. Section 4(a) of the Determination specifies that these services will be treated as if they were both professional and medical services under the Health Insurance Act 1973 (the Act), the National Health Act 1953, and regulations made under each Act. Furthermore, section 4(b) states that these services will be treated as if there were an item in the General Medical Services Table (the Table) related to the service, with the fee specified in the Schedule to the Determination. These services are designed to facilitate the sampling and diagnosis of patients with presumed or known non-small cell lung cancer or mediastinal masses, and non-small cell lung cancer, mediastinal/hilar masses, or peripheral lung lesions.
The Determination imposes obligations on parties such as healthcare providers, patients, and Medicare Australia. Healthcare providers must ensure that the services provided meet the criteria specified in the Determination to be eligible for Medicare benefits. This includes ensuring that the services are provided in specified circumstances and for specified statutory provisions. Patients must be aware that these services are available for the specified conditions and must obtain the services from providers who are eligible to claim the Medicare benefits. Medicare Australia, on the other hand, is obligated to process claims for the new services as if they were listed in the General Medical Services Table and to pay the specified fees.
Breach of the provisions in the Determination can lead to civil and criminal consequences. Healthcare providers who fraudulently claim Medicare benefits for services not covered by the Determination can face civil penalties, including fines. In more severe cases, such conduct may also lead to criminal charges, with potential penalties including imprisonment. The maximum penalties for civil and criminal offences are not specified in the Determination but would be in line with the relevant provisions of the Health Insurance Act 1973 and other applicable laws. It is also worth noting that the Australian Medical Association has raised concerns about potential confusion and improper claims related to these new services, and the Department has agreed to further consultation should such issues arise.