#South Korea #Seoul #Mezzion Pharmaceuticals #Fontan #ICD-10 Codes

Advancing Care for Fontan Patients: New ICD-10 Codes Introduced

In a significant development for patients with single ventricle heart disease, Mezzion Pharmaceuticals has unveiled new ICD-10 codes tailored specifically to address Fontan-associated conditions. This important milestone was announced in a recent statement regarding the U.S. Centers for Medicare & Medicaid Services (CMS) FY 2026 IPPS Proposed Rule.

The newly introduced codes are:

• - I27.840 – Fontan-associated liver disease (FALD)
• - I27.841 – Fontan-associated lymphatic dysfunction
• - I27.848 – Other Fontan-associated condition
• - I27.849 – Fontan-related circulation, unspecified

These codes represent the first-ever official classification of complications related to the Fontan circulation, enabling better documentation, reimbursement processes, and acknowledgment of the unique challenges faced by this patient demographic. Dean Park, the Chairman and CEO of Mezzion Pharmaceuticals, emphasized the significance of this advancement, stating, "The introduction of ICD-10 codes dedicated to Fontan-associated conditions represents long-overdue validation of the challenges faced by these patients and their families."

These diagnostic codes will not only empower healthcare professionals to better monitor and manage complications linked to Fontan physiology, but they will also facilitate more precise epidemiological studies. By categorizing the Fontan patient population as a distinct group with specific healthcare requirements, both public and private insurers can tailor their coverage to meet these needs more effectively.

A Milestone for Clinical Developments
For Mezzion, these codes are particularly critical in the context of their research on udenafil, a novel treatment currently under investigation to improve exercise capacity for individuals with Fontan circulation. Udenafil is presently featured in the FUEL-2 trial, a Phase 3 confirmatory study being executed across multiple regions, including the U.S., Europe, and Asia-Pacific.

As noted by Park, "These codes provide clarity and structure in a medical field that has long been lacking. They strengthen our foundation for continued development and future market access opportunities."

The opportunity for public feedback concerning the proposed ICD-10 codes is available until June 10, 2025, with the final decisions expected to be made by August of the same year, followed by anticipated implementation in September.

Mezzion Pharmaceuticals' Commitment
Mezzion Pharmaceuticals has dedicated its efforts to improving the fate of patients harboring rare congenital heart diseases. With their innovative solutions, including the ongoing research into udenafil, the company continues to set itself apart as a leader in addressing the needs of patients with Fontan physiology. For those interested in further details, more information can be found on their official website.

As the Fontan patient community gains acknowledgement and specialized categorization within the healthcare system, Mezzion's initiative acts as a beacon of hope, paving the way for better care delivery and support for families battling the intricacies of congenital heart conditions.