Biomerica Announces CMS Medicare Payment Rate of $300 for Revolutionary inFoods® IBS Test

Core Insights - Biomerica, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has set a national Medicare payment rate of $300 for its inFoods® IBS test, effective January 1, 2026, under the Clinical Laboratory Fee Schedule (CLFS) [1][9] - The establishment of a dedicated CPT® Proprietary Laboratory Analyses (PLA) code for inFoods® IBS, effective October 1, 2025, enhances the test's market position and patient access [2] Commercial Milestone - The $300 payment rate from CMS provides a foundation for negotiations with private insurers, as CMS is the largest payer in the U.S. healthcare system, accounting for approximately 21% of total healthcare expenditure [3][9] - The CEO of Biomerica emphasized that the pricing determination is a significant milestone for both the company and patients suffering from IBS, positioning the company for commercial growth in 2026 and beyond [4] Market Need - Irritable bowel syndrome (IBS) affects about 10% to 15% of adults in the U.S., translating to over 30 million potential patients, highlighting a significant unmet medical need [4] - Current treatment options for IBS often provide inconsistent relief and may involve side effects, with no FDA-approved drugs for the IBS-M subtype, which represents about one-third of the IBS market [4] Product Efficacy - The inFoods® IBS test utilizes a personalized diagnostic approach to identify food triggers for IBS symptoms, allowing for targeted dietary recommendations [5] - Clinical trials demonstrated that 59.6% of patients who eliminated identified trigger foods met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group [6] - Notable efficacy was observed in difficult-to-treat populations, with 67.1% of IBS-C patients and 66% of IBS-M patients achieving FDA-target pain reduction [7] Strategic Positioning - The combination of clinical evidence, a dedicated PLA code, and a national CLFS price represents a pivotal moment for inFoods® IBS [8] - The company plans to work with Medicare Administrative Contractors to secure coverage for the inFoods® IBS test and leverage the established pricing to negotiate with private insurers [10] Value Proposition - The CMS pricing announcement enhances Biomerica's market opportunity by providing a differentiated offering, a large patient population, a personalized medicine approach, and platform potential for additional gastrointestinal conditions [11]