Regulatory & Market Intelligence Update: Prescribed List Group Definition Review

Executive Summary

The Australian Government has confirmed that the formal Prescribed List (PL) Reform Program concluded in June 2025. However, a range of post-reform activities continue, including post-listing reviews, assurance activities, compliance initiatives, and ongoing reviews of Prescribed List grouping definitions.

Recent industry discussion has focused on proposed changes to Prescribed List group definitions and descriptors. While the Department has generally characterised these activities as clarification and maintenance of the existing grouping framework, some industry stakeholders have expressed concern that changes to group definitions may have unintended reimbursement consequences for certain device categories.

According to industry reports published by Life Sciences Australia, modelling undertaken by stakeholders suggests that some proposed definition changes could have a significant financial impact on parts of the orthopaedic sector. Life Sciences Australia reported that one example could reduce a benefit from approximately $1,200 to $300 and that the broader impact on orthopaedics could be as much as $30 million annually. We have not independently verified these figures and they should be considered industry estimates rather than official Government projections.

This update provides our assessment of the current regulatory landscape and highlights areas medical device sponsors, manufacturers and distributors should continue to monitor.

Has the Prescribed List Reform Program Restarted?

Based on current Department publications, the answer appears to be no.

The Department of Health, Disability and Ageing has publicly stated that:

"Recent reforms to improve the Prescribed List have been completed."

The Department further confirms that the reform program operated from 1 July 2021 to 30 June 2025 and is currently undergoing independent evaluation, with a final report expected in 2026.

In our assessment, the current environment should not be viewed as the launch of a new Prescribed List reform program. Rather, it appears to represent a transition into an ongoing management, assurance and review phase established through the previous reforms.

What Is Continuing?

Although the formal reform program has concluded, several significant activities remain active. These include:

• Post-listing reviews of existing Prescribed List products and groupings
• Ongoing assurance activities
• Grouping definition reviews and clarification exercises
• Compliance and integrity initiatives
• Independent evaluation of reform outcomes and future priorities

Importantly, these activities provide mechanisms through which the Department can continue to review existing reimbursement arrangements without initiating a new large-scale reform program.

Group Definition Reviews

One area receiving increased attention is the review and clarification of Prescribed List group definitions.

Historically, grouping reviews formed part of the broader reform agenda. However, in May 2025 the Department announced that the proposed regrouping of Part A of the Prescribed List would not proceed as a reform measure. The Department stated that the proposed grouping structure developed during the reforms would instead be used to guide future reviews of specific groupings through post-listing review and assurance activities.

This distinction is important.

While large-scale regrouping was discontinued, individual group reviews and definition changes remain possible through other established review processes.

Industry Concerns

A key issue raised by industry stakeholders is whether apparently administrative changes could have broader commercial implications.

Life Sciences Australia has reported concerns from the orthopaedic sector that some proposed definition changes may result in products being reassigned to different reimbursement categories, potentially affecting benefit levels and market dynamics.

We have not reviewed the underlying economic modelling referenced in those reports and therefore cannot verify the projected financial impacts. However, the concerns illustrate a broader principle that is well recognised within reimbursement systems:

Changes to definitions can influence how products are grouped, and changes to grouping arrangements can influence reimbursement outcomes.

This does not mean that every definition change will result in reduced benefits. However, it highlights why industry participants closely scrutinise proposed amendments to group descriptors and eligibility criteria.

Reports of Delayed Implementation

Industry reports have indicated that Assistant Secretary Brian Kelleher paused a planned implementation timetable to allow further discussion with stakeholders.

If accurate, this would suggest that stakeholder feedback has played a meaningful role in the consultation process and that further dialogue may occur before any final decisions are implemented.

Readers should note that this information originates from industry reporting and has not been independently verified by Servi-Star through official Government publications.

Our Assessment

Based on currently available information, we believe several observations can reasonably be made.

1. The reform program itself has concluded. The Department has been clear that the formal reform program finished in June 2025.

2. Review activity remains significant. The Department continues to maintain active review, assurance and evaluation processes. These activities are expected to continue influencing the operation of the Prescribed List over coming years.

3. Group definitions remain strategically important. Even where proposed changes are described as clarifications, stakeholders will continue to assess whether revised definitions alter grouping outcomes, reimbursement eligibility or market access pathways.

4. Future changes are likely to be incremental. In our view, the greater likelihood is not the return of a broad Prescribed List reform package, but rather ongoing category-by-category reviews, post-listing assessments and targeted definition updates.

What Medical Device Companies Should Monitor

Manufacturers, sponsors and distributors should continue monitoring:

• Department consultation papers
• Post-listing review workplans
• Grouping scheme updates
• Clinical advisory recommendations
• Independent evaluation findings
• Industry association updates and consultation outcomes

Particular attention should be paid to any proposal affecting device categories where reimbursement outcomes may be influenced by changes to grouping definitions or benefit structures.

Conclusion

While the Prescribed List Reform Program has officially concluded, the policy environment remains active.

Current developments suggest that the Department is continuing to refine and review elements of the Prescribed List through established post-reform mechanisms. Industry stakeholders remain engaged in discussions regarding the potential impact of group definition changes, particularly where those changes may influence reimbursement arrangements.

At this stage, the most prudent approach for sponsors and manufacturers is continued engagement with consultation processes and close monitoring of developments that may affect product classification, reimbursement pathways and market access strategies.

This publication is provided for general information purposes only and does not constitute legal, regulatory, reimbursement, financial or commercial advice. Information is based on publicly available Government publications, consultation documents and industry reports available at the time of publication. While every effort has been made to ensure accuracy, Servi-Star makes no representation or warranty regarding the completeness or accuracy of the information contained in this publication. Readers should obtain independent professional advice before making business, regulatory or commercial decisions.