INTRODUCTION

Copayment

Could Single Use Device Regulation be the cause of the rise in out-of-pocket payments on appliances?

Medical aid members are feeling the pinch of rising healthcare costs. In fact, out-of-pocket expenses have surged by 55% over the past five years. A substantial chunk of these costs—33%—goes towards dispensed medicine. But another significant portion is spent on allied healthcare services, including assistive devices like wheelchairs and crutches.

This article aims to shed light on these costs, particularly focusing on the financial burden associated with Single Use Device Regulation on assistive devices and how we can address this issue.

PROBLEM

Understanding the Current Landscape

Regulatory Framework: Single Use Device Regulation

Picture showing linear economy

Assistive devices such as wheelchairs, crutches, and walkers are vital for many of us. These devices fall under the regulation of the South African Health Product Regulating Authority (SAHPRA), which mandates that all medical devices be classified as Single Use Devices (SUDs) See Figure 2 on the right. This regulation is intended to ensure patient safety by reducing infection risks and maintaining device efficacy. However, this well-intentioned policy has unintended financial consequences for medical aid members.

Medical Aid Funding Policy: Frequency Limitations

On the other hand, medical aid schemes fund these appliances based on a frequency limitation policy. This means that there are specific time frames within which a member can receive funding for a new appliance. For example, Discovery frequency limitation policy will only fund a wheelchair once every three years, while GEMS frequency appliance list (Government Employee Medical Scheme) will fund every two years. To illustrate this phenomenon, we purposely selected 4 different medical aid schemes to identify different frequency limitations by medical aid schemes and by type of appliances. See Table 1 below

The Financial Burden of Single Use Device Regulation

The clash between the regulatory framework and medical aid funding policies creates a significant financial burden for medical aid members. The SUD regulation promotes a “take, make, use, and dispose” approach, which means a new device is needed every time, regardless of its condition. This leads to wastefulness and inefficiency, putting members in a position where they must pay out of pocket for devices that fall outside the medical aid’s frequency limitations. For instance, if a patients need a new wheelchair before the three-year period is up, they will have to cover the entire cost yourself. This is not just an inconvenience; it’s a substantial financial strain that forces members to pay-out-pocket. In fact, out-of-pocket expenses have surged by 55% over the past five years.

Lack access to appliances with Single Use Device Regulation

Failure to pay or commitment to pay out-of-pocket leads to members failing to have access to needed appliances.

SOLUTION 

A Path Towards Sustainability

The world is moving towards sustainability through Sustainable Development Goals SDG by 2030 and healthcare should not be left behind. Therefore, Sustainable Development Goal 12 of responsible production and consumption on appliances will ensure a more sustainable and patient-friendly approach that is needed. Here are some potential multi-stakeholder sustainability solutions:

Sustainability Regulatory Policy Revisions:

Reselling of moonboot in dark market

• Transition to Individual Use Device regulation: This change would mean that devices are not automatically considered waste after a single use. Instead, they can be evaluated and potentially reused by the same individual based on the condition of the device.
• Reprocessing for Individual Reuse: Devices can be cleaned and refurbished, ensuring they are safe and effective for individual reuse.
•  Individual Reuse of Appliances: Allowing devices to be reused by the same individual within standard limits to be set by regulating authority to alleviate some of the financial burdens indicated above.
• Recollection of used appliances: A wasteful Single Use Device regulation ought to be supported with sustainable recollection and reprocessing site of appliances. To prevent potential dark market of sourcing appliances without professional consultation, fitting and education see image on the right. Unregulated dark market poses risk of infection and treatment efficacy that regulating authority seek to prevent with Single Use Device regulation.

Sustainability Funding Policies:

Assistive Device Storage

• Recollection and Reprocessing Costs: Medical aid schemes should cover the costs of refurbishing devices, making them ready for individual reuse
• Storage Costs: Funding should also be provided for the storage of reprocessed devices in medically approved facilities.
• Reuse Costs: Covering the costs of reusing own devices would be more economical than purchasing new ones.
• Product as a Service Funding: Would be welcomed sustainability practice in the medical aid scheme as it would save the medical aid schemes 61% with 0% out of pocket payment for its members. For example, we have supplied rented wheelchairs for 6-12 weeks to the Department of Labour through compensation of injury on duty COIDA, for their members with temporary impairment.

CONCLUSION

The current system, with its conflicting regulatory and funding policies, places an undue financial burden on medical aid members.

The linear economy model mandated by SAHPRA clashes with the circular economy funding approach which aims to maximize resource use. This misalignment leads to increased out-of-pocket expenses for assistive devices. A synergistic approach is essential, on revising regulatory policies to adopt an Individual Use Device approach and introducing sustainable funding policies.

We can create a more sustainable and patient-friendly system. This cooperation between regulatory bodies and medical aid schemes is crucial for reducing financial burdens and ensuring the long-term sustainability of healthcare in South Africa. Together, we can pave the way for a healthcare system that balances safety, efficiency, and affordability, ultimately benefiting everyone.