The Prostheses List is an unusual arrangement in the world of medical device reimbursement. The Australian Government Prostheses List Arrangements allow for a defined benefit to be paid for implantable medical devices. This arrangement applies only to patients with private health insurance (PHI). At the end of 2013 46.7% of the Australian population was covered by PHI. (http://phiac.gov.au/industry/industry-statistics/data-tables-membership-and-coverage/)
While the arrangements have some serious drawbacks, such as lack of indexation, opaque assessment arrangements and some governance issues, they do provide a level of certainty for insurers, hospitals and suppliers of medical devices.
If you plan to sell an implantable medical device in Australia it is crucial to your commercial success that your device is included on the Commonwealth Prostheses List. While the process to be included on the Prostheses List has improved in recent years, there are still some serious pitfalls for the uninitiated. There are a complex set of criteria that must be met. These can be found in the Prostheses List Guide documents. http://www.health.gov.au/internet/main/publishing.nsf/Content/health-privatehealth-prostheseslistforms#ProsthesesGuide
If your device is very similar to a predicate device, and you are prepared to accept the same price, an application may be relatively straight forward. If your device is at all ‘novel’, involves a new procedure or is seen as ‘high risk’ an application will have to be very carefully thought through.
The Prostheses List is issued in February and August each year, with the cut off dates for various clinical groups up to 5 months earlier. If an error is made in an application listing may be delayed for a minimum of 6 months.