Biomerica Announces Medicare Administrative Contractor Confirmation of Individual Claim Review for inFoods® IBS, Opening a Scalable Medicare Commercialization Pathway
- The Medicare Administrative Contractor (MAC) responsible for processing inFoods® IBS claims has confirmed to Biomerica's certified laboratory partner that the test will be reviewed on an individual, claim-by-claim basis under Medicare's standard claims approval process.
- The Company's laboratory partner believes that properly documented claims — with appropriate diagnosis codes and evidence of medical necessity — are eligible for payment under existing $300 CMS payment rate.
- 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.
IRVINE, Calif., April 16, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ:BMRA), a global provider of advanced diagnostic solutions, today 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. This confirmation is consistent with established CMS policy for other similar diagnostic tests, which provides that in the absence of a formal Medicare coverage policy, claims are reviewed individually by the MAC to determine whether all coverage requirements have been met. This development represents an important step toward scalable, near-term revenue for Biomerica.
MAC Confirmation: Medicare Billing Pathway Now Open
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." This development represents an important step toward accelerating broad access to inFoods® IBS for medically necessary Medicare patients, subject to claim-level adjudication
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 confirmation received from the Medicare Administrative Contractor that inFoods® IBS claims can now be submitted and evaluated for payment is a meaningful and actionable milestone for Biomerica. 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. We are working closely with our laboratory partner to ensure every claim is submitted with comprehensive documentation to support payment. We are moving quickly toward initial claim submissions, and expect this to begin translating into revenue for the Company in the near term." Zack Irani, Chief Executive Officer, Biomerica, Inc.
"As a gastroenterologist in high-volume clinical practice, I see firsthand the profound impact that IBS has on my patients' quality of life and the frustration that often accompanies broad, restrictive dietary interventions and the cycle of drug therapies that carry burdensome side-effect profiles. The clinical evidence behind InFoods® IBS is compelling; it transitions us from a 'trial and error' model to one of clinical precision.
With a Medicare payment pathway now open, I see no reason why eligible patients should not have immediate access to this technology. In my experience, this test is a vital additive to our existing treatment algorithms. By identifying a patient's specific, statistically significant food triggers, we can move away from the broad, often unsustainable 'shotgun' elimination diets and toward a more surgical, targeted approach. This not only improves patient adherence but may also allow us to rebalance or even reduce the need for pharmacological interventions over time.
The AGA has long recognized dietary modification as a primary pillar of IBS management. InFoods® IBS is the practical tool that finally allows us to execute that goal with the specificity our patients deserve."
— Daksesh B. Patel, DO Gastroenterologist, GI Alliance of Illinois
Strong Foundation for Coverage Consideration: Documentation and Clinical Evidence
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.
Near-Term Revenue Opportunity
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.
About inFoods® IBS
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.
For more information about inFoods® IBS, visit www.inFoodsibs.com.
About Biomerica (NASDAQ:BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures, and markets advanced diagnostic and therapeutic products used at the point-of-care and in hospital/clinical laboratories. The Company primarily focuses on gastrointestinal and inflammatory diseases where it has multiple diagnostic and therapeutic products in development.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company's current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company's products and tests including the inFoods IBS Test, FDA, CMS, Medicaid and/or international regulatory authorization for the Company's products to be marketed and sold, including the inFoods IBS Test, the ability to receive Medicare payment for inFoods® IBS test claims, the Company's expectations regarding MAC claim adjudication outcomes, anticipated near-term Medicare revenues, the Company's ability to obtain a formal Medicare coverage policy, and continued commercial growth, the possible current or future payment coverage by CMS, Medicare or other government agencies in the US and in other markets for the inFoods IBS test or other Company tests provided to patients, the possible future payment coverage or reimbursement of the inFoods IBS test by private medical insurance companies, expansion in to other markets, uniqueness of the Company's products, accuracy of the Company's tests and products, pricing of the Company's test kits, domestic and/or international market adoption and acceptance and demand for the Company's products including the inFoods IBS Test, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: Medicare and MAC coverage decisions, which are made on a claim-by-claim basis and are not guaranteed; CMS or MAC regulatory actions that may affect coverage or reimbursement; the Company's ability to ensure proper claim documentation; actual claim approval rates, which may differ materially from expectations; competition from other products and from competitors with greater financial resources; and other risks described in the Company's filings with the Securities and Exchange Commission. These included earnings and other financial results; results of studies testing the efficacy of the Company's inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company's products; availability of the Company's test kits and other products; capacity, shipping logistics, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulatory compliance and oversight, and the Company's ability to obtain patent protection on any aspects of its diagnostic or therapeutic technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.
Corporate Contact
Zack Irani | CEO, Biomerica, Inc.
p. 949.645.2111
Source: Biomerica, Inc.
