The Prostheses List is the list of surgically implanted devices, human tissue items and other medical devices that Australian private health insurers must pay benefits for. Inclusion on the Prostheses List is critical for commercial success for many medical devices in Australia.
While Australia has a free public hospital system, about half of all Australians have private health insurance which covers private hospital admissions. 60% of surgical hospitalisations occur in private hospitals. If a device is implanted during a surgical procedure, then it must be included on the Prostheses List for the supplier to be paid in the private system.
Providing there is existing physician reimbursement for the procedure, an application can be made to be included on the Prostheses List. Physician reimbursement in Australia requires that the procedure be included on the Medical Benefits Schedule (MBS). Click here for a searchable version of the MBS.
Applications can be made online through the Prostheses List Management System (PLMS). To access the system, you must have an AUSkey. An AUSkey is a secure login that identifies you, when you use some Australian Government services on behalf of a business. Acquiring an AUSkey can sometimes be an administrative hurdle but is essential if you need to lodge a Prostheses List application.
The Prostheses List application is designed to assess the comparative clinical and cost-effectiveness of your device. In most cases this will require a comparison with a device that is already included on the Prostheses List. If your device is very similar to an existing device (a ‘me too’), then an application may be relatively straight forward. You merely have to demonstrate that your device is likely to have similar clinical outcomes to the currently listed device. This may be done by providing brochures, surgical technique guides and detailed images.
There are some devices, that regardless of whether there are similar devices already listed, will require more clinical evidence. These include nearly all joint replacements, anything that may be considered high risk such as a heart valve, or anything that is considered ‘novel’. Most of these applications will require published evidence of the clinical performance of the device over a significant time period. This requirement is quite challenging for some sponsors. At times the requirement for clinical evidence of some devices may seem unreasonable or there may be inconsistencies in how the requirement is applied. This can be quite frustrating. If a device is novel, an economic justification of the price requested will be necessary.
A common error of many sponsors is to take a regulatory approach to the Prostheses List application stating that the device is similar in design and function of another device and using the Clinical Evaluation Report from the regulatory filing as evidence. This won’t work. Evidence of the performance of the specific device in question will be required.
Another common error is to provide superfluous information in the mistaken belief that ‘more is better’. Applications are assessed by clinicians working in the field. An application will be looked at more favourably if it is succinct, information is clear and easy to find and only relevant to the device in question. For example, evidence of the success of a procedure in general is irrelevant. Evidence of the performance of the specific device is relevant.
Decisions by the Clinical Assessment Groups can at times appear to be illogical, lack transparency or be very poorly communicated. This is extremely frustrating. However, decisions can sometimes be changed, although it may take some time. It is imperative that any written communication querying a decision is very clear, succinct and overall very polite. While there may be a temptation to vent, this should be avoided.
Prostheses List applications can be straight forward, but often require specialised expertise and experience which most companies will not have available in-house. This is particularly true of applications with an economic component which will require the expertise of a health economist.
MedTechnique Consulting has helped many organisations to navigate the Australian health financing landscape and submit successful reimbursement applications. Contact us (email: email@example.com or phone:+ 61 448 058 600) if you have any questions or would like to learn more about how we can help your organisation submit a successful reimbursement application.