1. CMS establishes $300 nationwide Medicare payment rate for inFoods® IBS test. 2. AMA approved a unique CPT code for inFoods® effective October 2025. 3. IBS affects 10-15% of U.S. adults, presenting a large patient opportunity. 4. inFoods® IBS offers a personalized dietary approach, addressing unmet medical needs. 5. Commercial growth prospects are expected with Medicare coverage and negotiated rates.
FAQ
Why Bullish?
The establishment of a set Medicare payment rate enhances market access. Historical examples show that similar announcements have led to short-term price increases for diagnostic companies.
How important is it?
This Medicare pricing determination is crucial for BMRA's commercial success and growth potential. The implications of a clear payment structure cannot be underestimated for future profitability.
Why Long Term?
Medicare coverage ensures ongoing revenue starting January 2026, fostering sustained growth. Successful negotiations with private insurers can further solidify BMRA's market position.
Biomerica Secures $300 Medicare Payment Rate for inFoods® IBS Test
IRVINE, Calif., Dec. 23, 2025 — Biomerica, Inc. (NASDAQ: BMRA), a leader in advanced diagnostic solutions, has announced a significant milestone with the Centers for Medicare & Medicaid Services (CMS) finalizing a national Medicare payment rate of $300 for its inFoods® IBS test. This validation will apply to claims with dates of service on or after January 1, 2026, reinforcing the importance of Medicare as a critical payer for patients with irritable bowel syndrome (IBS).
Impact of the CMS Decision
The CMS decision to establish a payment rate under the Clinical Laboratory Fee Schedule (CLFS) offers crucial clarity, significantly enhancing patient access to the inFoods® IBS test. This development follows the earlier approval of a unique CPT® Proprietary Laboratory Analyses (PLA) code by the American Medical Association, which took effect on October 1, 2025.
This payment rate by CMS, the largest payer in the U.S. healthcare system, accounts for nearly 21% of overall healthcare expenditures. This sets the stage for negotiations with private insurers, making it easier for Biomerica to expand its reach within the healthcare market.
Addressing the IBS Patient Population
IBS affects approximately 10% to 15% of adults in the United States, equating to over 30 million potential patients. Current treatment options often yield inconsistent relief, and many patients experience chronic symptoms such as abdominal pain and bloating. Notably, there are no FDA-approved medications for IBS-M, a subtype representing about one-third of the IBS market.
The inFoods® IBS test provides a tailored diagnostic approach that identifies specific food triggers, allowing physicians to offer personalized dietary recommendations focused on mitigating the underlying causes of IBS rather than solely managing symptoms.
Clinical Validation and Evidence
The efficacy of inFoods® IBS has been validated through a rigorous, randomized, multicenter study involving reputable institutions such as the Mayo Clinic and Harvard. Published in the journal *Gastroenterology*, the study indicated that 59.6% of patients who eliminated identified trigger foods met FDA standards for abdominal pain reduction, in contrast to 42.2% in the control group.
Remarkably, among IBS-C patients, 67.1% achieved pain reduction compared to 35.8% in the control group. Similarly, 66% of IBS-M patients reached FDA-targeted pain reduction versus 29.5% in the control group.
Biomerica's Future Strategy and Market Access
With a concrete payment rate established, Biomerica plans to collaborate with Medicare Administrative Contractors to secure coverage for the inFoods® IBS test. The company will leverage the CMS pricing as a benchmark for discussions with private insurers like Aetna and United Healthcare, while also aiming to expand partnerships with gastroenterology practices and clinical trial relationships at major medical institutions.
As stated by Biomerica's CEO Zack Irani, “The CMS pricing determination is a major milestone for Biomerica and for 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.”
Key Advantages of inFoods® IBS
- Differentiated Offering: The only IBS-specific diagnostic guided dietary intervention backed by extensive clinical trials.
- Large Patient Population: Access to a significant market of over 30 million IBS sufferers in the U.S.
- Personalized Medicine Approach: Responding to the demand for non-pharmaceutical treatment alternatives.
- Platform Potential: The technology used in inFoods® has applications for additional gastrointestinal conditions.
About Biomerica
Biomerica, Inc. (NASDAQ: BMRA) develops innovative diagnostic and therapeutic products for use in home care, physician offices, and clinical laboratories. Their focus primarily includes solutions for gastrointestinal and inflammatory diseases designed to improve patient health and reduce healthcare costs.