Health Department’s proposed reporting rules face industry pushback over costs and confidentiality

MedTech News: The Department of Health has unveiled stakeholder feedback on the reporting requirements for the Prescribed List (PL), sparking a mix of reactions.

Consultation Paper 8a proposed expanding reporting measures to include gifts, benefits, and discounts related to PL items. Concerns have been raised about benefits claimed for devices on the PL when no expenditure was incurred, such as hospitals receiving free medical devices but claiming PL benefits.

However, stakeholders have voiced significant concerns. The primary issue raised is the increased regulatory burden and administrative costs. Most stakeholders indicated they currently lack systems to record gifts, benefits, or discounts, with some only tracking rebates or samples provided during training or education. Implementing new mechanisms to comply with the proposed requirements would, they argue, demand substantial resources and time.

One of the central fears is that the added complexity could drive up the cost of delivering medical technology to Australian patients. With hospitals already facing escalating operational costs, many believe this new measure could push them further into financial strain. Hospitals, in particular, argue that medtech companies should be responsible for maintaining and reporting any gifts or discounts.

Private health insurers, however, take a different stance. They are pushing for reporting from both hospitals and device sponsors, suggesting it would facilitate cross-referencing and validation, ultimately benefiting transparency.

A key point of contention remains who would bear the responsibility for reporting. While the consultation paper proposes that medical device sponsors should have the legal obligation, challenges arise when sponsors rely on third-party distributors and may lack oversight on data required for reporting. Additionally, sponsors may not always know which items hospitals ultimately claim under the PL.

The proposed reporting has also raised privacy concerns. Many stakeholders worry that disclosing commercial arrangements between medtech companies and hospitals could conflict with the confidentiality these private entities rely on. Stakeholders are particularly concerned about the publication of sensitive information and have requested protections against Freedom of Information requests.

Despite these concerns, some stakeholders believe that the measure could improve the integrity of the PL pricing, promote fair competition, and curb unethical practices. Smaller businesses, in particular, may benefit from a more level playing field.

Still, the majority of stakeholders remain sceptical, arguing that the proposal lacks a robust evidence base to justify such sweeping changes.

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