For medical device companies seeking reimbursement in the Australian private hospital system, inclusion on the Prescribed List (PL) remains critical. What has changed is that the Prescribed List is no longer a static or purely administrative reimbursement mechanism.
Recent reforms have modernised how applications are assessed, how evidence is scrutinised and how listed devices are monitored over time. For international manufacturers and Australian medtech companies, understanding these changes is essential to avoid delays, rejected applications or unexpected post-listing scrutiny.
Below are the eight most important things device companies need to know following the Prescribed List reforms.
1. The reforms are about modernisation, not simplification
The Prescribed List reforms are often described as “streamlining”, but their real purpose is modernisation.
The Department has redesigned the PL framework to:
- reduce unnecessary red tape
- ensure assessment pathways are fit for purpose
- direct more resources to applications that require deeper scrutiny
- align listed devices with contemporary health technology assessment (HTA) principles
In practice, this means clearer structure and proportionality, but also less tolerance for poorly framed or speculative applications. Sponsors should expect a more disciplined system, not a more permissive one.
2. Start with the fundamentals: which part of the Prescribed List applies?
Before considering evidence or assessment pathways, sponsors must first confirm which part of the Prescribed List their product belongs to. This is a critical early decision and a common source of avoidable delay.
At a high level:
- Part A covers implantable medical devices used for specific therapy, including devices integral to implantation or critical to the ongoing function of an implant.
- Part B covers human tissue products regulated under state and territory legislation.
- Part C covers specified groups of medical devices that do not meet Part A criteria but are considered suitable for private health insurance benefits.
- Part D covers general use items. Despite earlier policy signals, Part D remains active and new products continue to be added.
Some requirements apply across all Parts, while others are Part-specific. Selecting the wrong Part can undermine an application regardless of evidence quality.
3. Eligibility is assessed strictly against the Rules
Eligibility for inclusion on the Prescribed List is interpreted narrowly and deliberately, in line with Private Health Insurance (Medical Devices and Human Tissue Products) Rules and the Prescribed List Guide.
In practical terms, devices listed in Parts A, C and D must generally:
- be used as part of a hospital or hospital-substitute admission
- have at least one relevant Medicare Benefits Schedule (MBS) item describing the associated professional service
- meet the eligibility criteria for the relevant Part
Eligibility should be confirmed early, before significant time and resources are invested.
4. Tiered assessment pathways determine the level of scrutiny
A central feature of the reforms is the introduction of tiered assessment pathways, which align the depth of assessment with the nature of the device and the claims made.
Sponsors may choose any pathway for Part A applications. For Part C applications, Tier 2 or Tier 3 pathways are generally expected.
The three pathways are:
- Tier 1 – Departmental assessment, for well-established, low-risk devices (classified by the TGA as Class IIb or lower) that are clearly interchangeable with existing listings.
- Tier 2 – Clinical / focused HTA assessment, used where clinical assessment is required, with some applications also requiring focused economic consideration.
- Tier 3 – Full HTA assessment, including consideration by the Medical Services Advisory Committee (MSAC).
The pathway applied depends largely on the claims made in the application. Overstating novelty or benefit can trigger a higher tier than intended, with implications for timelines, evidence requirements and cost.
5. Application cut-off dates are fixed
The Prescribed List is updated three times per year, on 1 March, 1 July and 1 November. Application cut-off dates are fixed and submissions close at midnight on:
| Submission closes | PL update |
| 2nd Sunday in January | July |
| 2nd Sunday in May | November |
| 2nd Sunday in September | March (following year) |
Late or incomplete submissions are not accepted.
6. Applications are reviewed by expert clinical and policy committees
Tier 2 and Tier 3 applications are assessed with input from expert bodies:
- Expert Clinical Advisory Groups (ECAGs) assess clinical function, clinical effectiveness and comparator suitability.
- Medical Devices and Human Tissue Advisory Committee (MDHTAC) considers eligibility, grouping, comparative effectiveness and financial implications and makes recommendations to the Minister.
These committees assess applications through a clinical and policy lens, not a marketing one. Clear comparator logic, disciplined language and proportionate claims are essential.
7. Evidence must be proportionate and device-specific
The Prescribed List does not mandate a single study design. Evidence is assessed in context, taking into account device risk, novelty and claims.
Depending on the application, acceptable evidence may include:
- observational studies (cohort studies or case series)
- registry data (preferably Australian, where available)
- clinical trial data
Evidence must relate directly to the device being listed and support the claims made. Promotional material does not substitute for clinical evidence and stronger claims require stronger data.
8. Listing is not the end of the process
Post-listing review and compliance activity is now a routine part of Prescribed List administration.
The Prescribed List Assessment Section may contact sponsors to:
- clarify eligibility or grouping rationale
- validate original claims
- review utilisation patterns
Sponsors should view listing as the start of ongoing product life cycle management, rather than the end of the reimbursement process.
Final thoughts
The Prescribed List reforms have created a more structured and transparent system. Success now depends on understanding eligibility, selecting the appropriate assessment pathway and aligning evidence and claims with Australian clinical practice.
Sponsors who approach the Prescribed List strategically, rather than administratively, are best placed to achieve sustainable reimbursement outcomes.
How Pulse Economics can help
Pulse Economics supports medical device sponsors across the Prescribed List lifecycle, from early eligibility and strategy through to application support and responses to post-listing reviews. Our focus is on helping sponsors navigate the system with clarity, proportionality and confidence.
If you would like to discuss the Prescribed List, application strategy, or broader market access considerations for your medical device, please contact us. We are here to provide guidance and provide the support you need to succeed.
Contact and Connect with us
Email us: contact@pulse-economics.com.au
Call us: 02 7240 6738
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