Announcement • Apr 17
Biomerica Inc Announces Medicare Administrative Contractor Confirmation of Individual Claim Review For Infoods Ibs Test
Biomerica, Inc. announced that the Medicare Administrative Contractor (MAC) responsible for processing inFoods IBS claims has confirmed to the Company’s CLIA-certified laboratory partner, Ethos Laboratories, that the test is eligible for Medicare coverage on an individual, claim-by-claim basis. The MAC responsible for adjudicating all inFoods IBS Medicare claims confirmed in writing to Ethos, Biomerica’s CLIA-certified laboratory partner, that, consistent with standard Medicare practice for tests without a formal coverage policy, claims for inFoods IBS “may be considered on an individual basis for coverage consideration.” The MAC further recommended that providers document medical necessity as part of the patient record when ordering the test, as with other diagnostic tests. Under Medicare’s established framework, when no formal coverage policy has been issued for a test, the MAC evaluates each submitted claim individually against Medicare’s reasonable and necessary standard. According to the Centers for Medicare & Medicaid Services: “In the absence of an LCD or NCD, claims are reviewed on a claim-by-claim basis by the MACs. In such cases, the MACs review the claim on an individual basis to ensure that all CMS requirements have been met prior to paying the claim.” All inFoods IBS Medicare claims will be processed through the single MAC jurisdiction where Biomerica’s certified laboratory partner operates, providing a clear, centralized pathway for coverage adjudication and claim submission. The previously established $300 CMS payment rate, combined with a dedicated billing code and Level 1 clinical evidence from a landmark randomized controlled trial published in Gastroenterology, positions us well for successful claim adjudication. The inFoods IBS test holds a dedicated CPT Proprietary Laboratory Analyses (PLA) code and a CMS-established national payment rate of $300, prerequisites for Medicare claims submissions. Payment rates apply to claims approved by Medicare with dates of service on or after January 1, 2026. Biomerica and Ethos believe that claims submitted with proper documentation, including appropriate ICD-10 diagnosis codes, physician orders, and supporting evidence of medical necessity, are positioned for Medicare payment. The Company and Ethos are actively implementing compliance protocols to ensure all claims meet MAC requirements at the time of submission. The inFoods IBS test’s strong clinical and regulatory foundation further supports coverage consideration on a claim-by-claim basis: Level 1 Clinical Evidence: Clinical efficacy was demonstrated in a rigorous, randomized, multicenter, double-blind, placebo-controlled trial published in Gastroenterology, one of the most respected journals in the field, involving leading institutions including Mayo Clinic, Cleveland Clinic, University of Michigan, and others. Established CPT Billing Code: A unique Proprietary Laboratory Analyses (PLA) code, approved by the American Medical Association and effective October 1, 2025, provides the billing infrastructure required for Medicare claims submission. $300 CMS National Payment Rate: CMS established a $300 national payment rate effective January 1, 2026, providing a clear, pre-established reimbursement amount for approved claims. Significant Unmet Medical Need: IBS affects an estimated 10–15% of U.S. adults — over 30 million potential patients. Adults of Medicare age comprise over 20% of U.S. adults and a substantial portion of IBS sufferers, providing strong clinical rationale for test utilization and medical necessity determinations. With the individual claim review pathway now confirmed with Ethos, Biomerica’s laboratory partner, the Company is positioned to begin generating revenue from inFoods IBS claim submissions with dates of service on or after January 1, 2026. The Company will also work on establishing claims experience across private insurance companies (commercial payers) to support the expansion of reimbursement pathways beyond Medicare. inFoods IBS is the only IBS-specific diagnostic-guided dietary intervention supported by a large-scale randomized, multicenter clinical trial published in a leading peer-reviewed journal. The test identifies patient-specific food triggers contributing to IBS symptoms by measuring immune responses to IBS trigger foods, enabling physicians to provide targeted dietary recommendations that address underlying causes rather than merely managing symptoms. Using a simple finger-stick blood sample, the test enables physicians to recommend targeted dietary changes tailored to the patient’s immune response—offering a non-pharmaceutical, precision-based approach to symptom relief. A multicenter, double-blinded clinical study on the inFoods IBS test was published in the June issue of Gastroenterology, the top peer-reviewed GI journal. As the largest study of its kind, it demonstrated statistically significant outcomes: 59.6% of patients in the treatment group (who eliminated identified trigger foods) achieved the FDA’s endpoint for abdominal pain reduction, compared to 42.2% in the control group. Among IBS-C patients, 67.1% of patients in the treatment group vs. 35.8% in the control group. Among IBS-M patients, 66% of patients in the treatment group vs. 29.5% in the control group. The study was conducted at leading U.S. institutions including Cleveland Clinic, Mayo Clinic, and University of Michigan.
