Australian Regulators Plan Improved Patient Access, Reimbursement for Prosthetic Medical Devices
| Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Australian Department of Health (DoH) to publish Prostheses List three times per year starting in 2019
- Private insurers as well as prosthetic device manufacturers and active in Australia as well as their distributors will be impacted
The Australian Department of Health (DoH) will begin publishing its Prostheses List of prosthetic medical devices more frequently starting in 2019 in an effort to address patient access to new devices and respond to manufacturers' concerns regarding reimbursement delays.
The DoH announced plans to publish the Prostheses List three times per year (March, July and November), up from twice per year currently. More frequent list updates will improve privately insured patients’ access to new prosthetic devices and technologies, according to the Australian government, as well as help accelerate reimbursement timeframes for companies marketing these devices.
Additional updates to the Prostheses List also have implications for private insurance providers operating in Australia, as they must pay mandatory benefits for any device included in the list.
Changes to Prostheses List Clinical Advisory Group review committees and Panel of Clinical Experts schedules
To facilitate more frequent Prostheses List publication schedules, the DoH is also changing meeting schedules and requirements for committees involved in the listing process.
- For the March 2019 Prostheses List, there are two meetings scheduled for each of the Clinical Advisory Groups (CAGs). Prostheses List applications for new billing codes or to amend existing billing codes may be submitted at any time, but both now need to be submitted no later than six weeks prior to scheduled meetings.
- For the March 2019 Prostheses List, applications to create new billing codes or amend existing ones must be submitted for consideration by the Panel of Clinical Experts no later than nine weeks prior to the meeting of the Prostheses List Advisory Committee, currently scheduled for December, 13, 2018.
- Applications for transferring, duplicating or deleting listings for the March 2019 publication must be submitted before February 11, 2019.
- Where Prostheses List Applications were submitted with Australian Register of Therapeutic Goods (ARTG) applications still pending, the DoH must receive TGA certificates by February 11, 2019 in order for approved billing codes to be eligible for the March 2019 publication of the Prostheses List.
- An indicative meeting schedule for the March 2019 Prostheses List cycle was issued with two CAG meetings per cycle as is current practice. Beyond the March 19 cycle, the DoH is likely to maintain two scheduled meetings per cycle for the CAGs with larger application volumes (Specialist Orthopaedic and Spinal) and have only one meeting per cycle for the other CAG’s. Specific details and schedules will be advised in due course.