Sequana Medical, a Swiss medical device company, has recently announced that it has received Current Procedural Terminology (CPT®) III reimbursement codes for its alfapump® System in the United States. This development is a significant milestone for the company as it will enable healthcare providers to bill and receive reimbursement for procedures involving the alfapump® System.
The alfapump® System is a unique and innovative solution for the management of fluid overload in patients with liver disease. It is a fully implantable, programmable pump that automatically and continuously removes excess fluid from the abdominal cavity and delivers it to the bladder, where it is naturally eliminated from the body. This system offers a minimally invasive alternative to traditional methods of fluid removal, such as paracentesis, which require repeated hospital visits and can be associated with complications.
The CPT® III codes assigned to the alfapump® System by the American Medical Association (AMA) are specific to emerging technologies that are not yet widely used but have the potential to significantly impact patient care. These codes are temporary and are intended to facilitate data collection and analysis for future consideration of permanent CPT® codes. The assignment of these codes for the alfapump® System reflects the recognition of its potential clinical value and the need for reimbursement mechanisms to support its adoption.
Receiving CPT® III codes for the alfapump® System is a crucial step towards commercialization in the US market. It allows healthcare providers to bill for procedures involving the device, ensuring that patients have access to this innovative technology. The reimbursement codes will also facilitate data collection on the clinical outcomes and cost-effectiveness of the alfapump® System, which will be essential for securing permanent CPT® codes in the future.
The alfapump® System has already been granted CE Mark approval in Europe and has been successfully used in over 800 patients across the continent. It has demonstrated significant clinical benefits, including a reduction in the need for paracentesis procedures, improved quality of life, and increased survival rates. With the receipt of CPT® III reimbursement codes in the US, Sequana Medical aims to replicate this success and provide a much-needed solution for patients suffering from fluid overload due to liver disease.
Sequana Medical is now focused on commercializing the alfapump® System in the US market. The company plans to initiate a pivotal study to gather additional clinical evidence and support a submission for pre-market approval from the US Food and Drug Administration (FDA). The availability of reimbursement codes will not only facilitate patient access but also attract potential investors and strategic partners, further accelerating the commercialization process.
In conclusion, Sequana Medical’s receipt of CPT® III reimbursement codes for the alfapump® System is a significant achievement that paves the way for its commercialization in the United States. This innovative medical device offers a minimally invasive solution for fluid overload management in patients with liver disease. The reimbursement codes will enable healthcare providers to bill and receive reimbursement for procedures involving the alfapump® System, ensuring patient access and facilitating data collection for future consideration of permanent CPT® codes. With its proven clinical benefits and growing market presence in Europe, Sequana Medical is well-positioned to bring this life-changing technology to patients in the US.
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/sequana-medical-granted-us-cpt-iii-reimbursement-codes-for-alfapump-system-biospace/
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States The Food and...