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

Biomerica (Nasdaq: BMRA) announced that CMS set a national Medicare payment rate of $300 for the inFoods® IBS test under the CLFS, effective for services paid with dates of service on or after January 1, 2026.

Rhea-AI Summary

Biomerica (Nasdaq: BMRA) announced that CMS set a national Medicare payment rate of $300 for the inFoods® IBS test under the CLFS, effective for services paid with dates of service on or after January 1, 2026. The test secured a dedicated CPT® PLA code effective October 1, 2025. Medicare represents roughly 21% of US healthcare spending and Medicare-age adults are a meaningful share of IBS patients, supporting potential access expansion.

Clinical data from a randomized, multicenter trial showed 59.6% response for trigger-food elimination versus 42.2% control; subgroup results included 67.1% (IBS-C) and 66% (IBS-M) meeting FDA pain-reduction targets.

Positive

• $300 national Medicare CLFS payment rate effective Jan 1, 2026
• Dedicated CPT PLA code effective Oct 1, 2025
• Randomized trial: 59.6% response vs 42.2% control
• IBS-C subgroup: 67.1% met FDA pain-reduction target
• IBS-M subgroup: 66% met FDA pain-reduction target
• Medicare covers ~21% of US healthcare spend (payer leverage)

Negative

• None.

Argus Dec 23 session

+10.55% close to close Open Argus

Details

News Market Reaction – BMRA

On Dec 23, the day this news came out, BMRA closed 10.55% above the previous close.

Data tracked by StockTitan Argus for the Dec 23 session.

Key Figures

Medicare payment rate: $300 Medicare share of spend: 21% Adults of Medicare age: Over 20% +5 more

Medicare payment rate

$300

National CMS CLFS rate for inFoods IBS from Jan 1, 2026

Medicare share of spend

21%

Portion of total U.S. healthcare expenditure

Adults of Medicare age

Over 20%

Share of U.S. adults, key IBS population segment

IBS prevalence

10–15%

Estimated share of U.S. adults with IBS

IBS patient population

Over 30 million

Estimated U.S. adults with IBS symptoms

Abdominal pain responder rate

59.6% vs 42.2%

Treatment vs control meeting FDA pain target

IBS-C responder rate

67.1% vs 35.8%

IBS-C patients meeting FDA pain reduction target

IBS-M responder rate

66% vs 29.5%

IBS-M patients meeting FDA pain reduction target

Historical Context

5 past events · Latest: Dec 11

5 events

1. Dec 11

   Regulatory authorization

   24h Move

   +3.2%

   Egyptian Drug Authority authorized full rapid screening test portfolio.

2. Nov 25

   Clinical data highlight

   24h Move

   +4.4%

   InFoods IBS trial results featured in Biotherapeutics Quarterly.

3. Nov 06

   CDMO expansion

   24h Move

   -1.2%

   Expansion of CDMO services to meet higher diagnostic demand.

4. Oct 16

   Commercial partnership

   24h Move

   +5.2%

   Henry Schein agreement to market inFoods IBS across U.S.

5. Oct 15

   Earnings update

   24h Move

   -0.7%

   Improved margins and small net profit aided by tax credit.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cms, medicare, clinical laboratory fee schedule (clfs), cpt, +4 more

8 terms

cms regulatory

"Centers for Medicare & Medicaid Services (CMS) has issued its final pricing"

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that sets rules, payment rates and coverage decisions for major public health insurance programs; think of it as both a giant insurer and the rulebook maker for how many healthcare providers and drug makers get paid by government programs. Its policy changes and reimbursement decisions can materially affect revenue, profit forecasts and valuations for hospitals, insurers, device makers and drug companies, so investors watch CMS announcements closely.

medicare regulatory

"claims approved and paid by Medicare with dates of service on or after"

Medicare is a large government-run health insurance program that primarily covers people aged 65 and older and certain younger people with disabilities. For investors it matters because Medicare acts like a huge customer and rule-maker for hospitals, drugmakers and medical-device companies—its coverage decisions, payment rates and regulatory policies can change demand, revenue and profit margins across the healthcare sector, similar to how a major client or regulator can shape a business’s prospects.

clinical laboratory fee schedule (clfs) regulatory

"payment rate of $300 under the Clinical Laboratory Fee Schedule (CLFS)"

The Clinical Laboratory Fee Schedule (CLFS) is a government-set list of payment rates for clinical lab tests that determines how much public health programs will reimburse laboratories and diagnostic companies. Think of it as a large customer’s approved price list — changes to the CLFS directly affect a lab’s revenue, profit margins and cash flow, so investors watch updates closely as they can alter future earnings and competitiveness in the diagnostics market.

cpt regulatory

"American Medical Association's (AMA) approval of a unique CPT® Proprietary"

CPT stands for Current Procedural Terminology, a standardized set of codes used to describe medical procedures and services for billing and insurance purposes. For investors, CPT codes determine how and whether healthcare providers get paid for treatments, affecting revenue streams and reimbursement risk; think of them like product barcodes that decide price and payment for clinical services. Changes to codes or coverage policies can directly alter a healthcare company's cash flow and profitability.

proprietary laboratory analyses (pla) code regulatory

"approval of a unique CPT® Proprietary Laboratory Analyses (PLA) code for inFoods"

A proprietary laboratory analyses (PLA) code is an internal identifier assigned to a company’s own lab test, measurement method, or dataset, much like a recipe name that points to a specific way a lab produces results. For investors it signals that the underlying test or process is company-owned and may be a source of competitive advantage, licensing revenue, or regulatory scrutiny; knowing a PLA code helps track the uniqueness, reproducibility and potential commercial value of a firm’s scientific outputs.

randomized medical

"rigorous randomized, multicenter (Mayo Clinic, Harvard Beth Israel"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"double-blind, placebo-controlled trial published in Gastroenterology"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"double-blind, placebo-controlled trial published in Gastroenterology"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• CMS is the single largest payer for healthcare in the United States, with Medicare responsible for approximately 21% of total healthcare expenditure.
• The $300 rate will apply to claims approved and paid by Medicare with dates of service on or after January 1, 2026.
• Adults of Medicare age comprise over 20% of US adults and a substantial portion of patients with IBS symptoms, making Medicare a critical payer for inFoods® IBS.
  
  

IRVINE, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued its final pricing determination for the company's inFoods® IBS test, establishing a national Medicare payment rate of $300 under the Clinical Laboratory Fee Schedule (CLFS). The pricing will apply to claims for InFoods IBS tests that Medicare approves and pays with dates of service on or after January 1, 2026.

This milestone follows the American Medical Association's (AMA) approval of a unique CPT® Proprietary Laboratory Analyses (PLA) code for inFoods® IBS, which became effective October 1, 2025. The CMS pricing determination establishes a clear national payment rate for the test and this pricing clarity should expand patient access.

Significant Commercial Milestone

The $300 CLFS payment rate provides a foundation for negotiations with private insurers. CMS is the single largest payer for healthcare in the United States, with Medicare responsible for approximately 21% of total healthcare expenditure.

"The CMS pricing determination is a major milestone for Biomerica and for patients suffering from IBS," said Zack Irani, CEO of Biomerica. " With both a dedicated PLA code and established Medicare pricing, we are well-positioned for continued commercial growth in 2026 and beyond."

Addressing a Significant Unmet Need

Irritable bowel syndrome affects approximately 10% to 15% of adults in the United States, representing over 30 million potential patients. The condition significantly reduces quality of life and work productivity, with patients experiencing chronic symptoms including abdominal pain, bloating, diarrhea, and constipation. Current treatment options often provide inconsistent relief and may involve side effects or compliance challenges that many patients find difficult to sustain. In addition, there no FDA-approved drugs for IBS-M (mixed constipation and diarrhea), IBS subtype which is represents approximately 1/3 of the IBS market.

The inFoods® IBS test addresses this unmet need through a personalized diagnostic approach that identifies patient-specific food triggers contributing to IBS symptoms. By measuring immune responses to IBS trigger foods, the test enables physicians to provide targeted dietary recommendations that address underlying causes rather than merely managing symptoms.

Clinical Validation and Evidence

The clinical efficacy of inFoods® IBS was demonstrated in a rigorous randomized, multicenter (Mayo Clinic, Harvard Beth Israel Deaconess, University of Michigan, etc.), double-blind, placebo-controlled trial published in Gastroenterology, a leading medical journal in the field. The study found that 59.6% of patients who eliminated trigger foods identified by the inFoods IBS test, met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group.

The benefits were particularly notable in difficult-to-treat patient populations: 67.1% of IBS-C (constipation) patients in the treatment group met the FDA target for pain reduction versus 35.8% in the control group, while 66% of IBS-M (mixed constipation and diarrhea) patients experienced FDA-target pain reduction compared to 29.5% in the control group.

"The convergence of Level 1 clinical evidence, a dedicated PLA code, and a national CLFS price represents an important inflection point for InFoods IBS," said Scott Madel, Chief Commercial Officer of Biomerica.

Commercial Strategy and Market Access

With the CMS payment rate now established, the Company and its lab partner will work with Medicare Administrative Contractors to attain Medicare coverage for the inFoods® IBS test. Biomerica will also work to use the CMS pricing as a benchmark to begin negotiations with private commercial insurers such as Aetna, United Healthcare, Blue Cross and others. The Company will also continue working to expand relationships with gastroenterology practices and leverage clinical trial relationships with institutions including Mayo Clinic, Harvard, University of Michigan, and University of Texas Medical Center. Biomerica will seek to expand distribution of the test in the US with partners similar-to the previously announced distribution relationship with Henry Schein.

Key Value Propositions

The CMS pricing announcement strengthens several aspects of Biomerica's market opportunity:

Differentiated Offering: inFoods IBS is the only IBS specific diagnostic guided dietary intervention supported by the largest of its kind randomized, multi-center clinical trial published in a leading peer-reviewed journal

Large Patient Population: Substantial market opportunity with over 30 million IBS patients in the US

Personalized Medicine Approach: Aligns with growing demand for non-pharmaceutical treatment alternatives

Platform Potential: inFoods® technology applicable to, and holds patents for, additional gastrointestinal conditions

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 (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

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, and the Company’s other current and future products, 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: 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 oversite, 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
p. 949.645.2111
www.biomerica.com

Source: Biomerica

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What Medicare payment rate did CMS set for Biomerica's inFoods IBS test (BMRA) and when does it take effect?

CMS set a national Medicare CLFS payment rate of $300, effective for claims with dates of service on or after January 1, 2026.

When did inFoods IBS receive its dedicated CPT PLA code and why does it matter for BMRA (BMRA)?

inFoods IBS received a dedicated CPT PLA code effective October 1, 2025, which helps enable distinct billing and supports payer reimbursement discussions.

How strong was the clinical evidence cited by Biomerica for inFoods IBS and what were the main trial results?

A randomized, multicenter, double-blind trial reported 59.6% of treated patients met FDA pain-reduction targets versus 42.2% control, with 67.1% for IBS-C and 66% for IBS-M subgroups.

How could the $300 Medicare rate affect Biomerica's commercial strategy for inFoods IBS (BMRA)?

The company plans to use the Medicare CLFS price as a benchmark in negotiations with private insurers and to expand Medicare coverage via MAC engagement, aiming to broaden patient access.

What patient population size does Biomerica cite for inFoods IBS in the US?

Biomerica cites an estimated US IBS population of roughly 30 million adults (about 10–15% of adults).

Will the CMS price automatically guarantee private insurer coverage for inFoods IBS (BMRA)?

No; the company plans to use the CMS price as a benchmark while separately negotiating coverage and reimbursement with private insurers.