CMS announced a final Medicare payment rate of $300 for Biomerica, Inc.’s inFoods® IBS test, effective for claims submitted on or after January 1 2026. The rate applies nationwide under the Clinical Laboratory Fee Schedule and provides a predictable, national benchmark for the company’s diagnostic‑guided therapy platform.
Medicare accounts for roughly 21% of total U.S. health‑care spending, so a national payment rate establishes a clear revenue source for Biomerica and sets a reference point for negotiations with private insurers. The decision follows the approval of a proprietary CPT® PLA code for the test on October 1 2025, giving the company a dedicated billing code and further legitimizing the product in the payer ecosystem.
Biomerica’s financials underscore the importance of this milestone. In fiscal 2025 the company reported a net loss of $5.0 million on revenue of $5.3 million, with a gross margin of 9%. Liquidity challenges have prompted cost‑control initiatives, and the Medicare payment rate is expected to provide a stable, recurring revenue stream that can help the company move toward profitability and support its expansion plans.
The inFoods® IBS test is backed by a randomized, multi‑center trial that showed a 59.6% response rate versus 42.2% for the control group. Irritable Bowel Syndrome affects 10–15% of the U.S. population—over 30 million people—including a significant share of Medicare‑eligible adults. The test’s clinical evidence, combined with the new payment rate, positions Biomerica to accelerate adoption and potentially extend the platform to other gastrointestinal indications.
CEO Zack Irani said the CMS pricing determination is a major milestone for both Biomerica and patients suffering from IBS. “With both a dedicated PLA code and established Medicare pricing, we are well positioned for continued commercial growth in 2026 and beyond,” he added. The announcement was positively received by investors, reflecting confidence in the company’s ability to monetize its diagnostic‑guided therapy platform and to broaden its market reach beyond IBS.
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