Insight Molecular Diagnostics Inc.

Current report

Our ability to commercialize our products is dependent on availability and sufficiency of third-party payer coverage and our ability to ensure our tests remain reimbursed or attain reimbursement by Medicare, and the loss of, or a significant reduction in, reimbursement from Medicare or the CMS would have a material adverse impact on our business.

Current report

Our ability to successfully commercialize our current diagnostic tests and any product candidates we receive regulatory approval to market will depend, in significant part, on the extent to which appropriate reimbursement levels can be obtained for patients. Physicians will be hesitant to order a diagnostic test for a patient when they may be left with a large out-of-pocket fee through co-payments or co-insurance or unreimbursed balances. Third-party payers, including Medicare, Medicaid and private insurers, are increasingly challenging the prices charged for healthcare products and services. In addition, legislative proposals to reform health care or reduce government insurance programs may result in lower prices or the actual inability of prospective customers to purchase our tests. Furthermore, even if reimbursement is available, it may not be available at price levels sufficient for us to realize a positive return on our investment.

Current report

For diagnostics tests, Medicare or CMS reimbursement approval is critical. CMS relies on a network of MACs to make LCDs approving test for reimbursements. The MolDx Program was developed by Palmetto GBA (the previous MAC for California) to identify and establish coverage and reimbursement for molecular diagnostics tests. The program has developed guidelines for the level of evidence of efficacy required to be obtained through clinical trials. Palmetto, which contracted with CMS to administer the MolDx, issues LCDs that affect coverage, coding, and billing of many molecular tests and several MACs including the MAC for California, Noridian Healthcare Solutions, LLC, participate in the MolDX program. MACs also serve as the primary operational contact between the Medicare Fee-For-Service program, for paying Medicare claims, and approximately 1.5 million health care providers enrolled in the program. Delays in obtaining MAC approval, or any changes made related to any favorable LCDs, could have a material adverse impact on our business.

Current report

Our primary near-term strategic market is organ transplant. We received a positive coverage decision from MolDx for GraftAssureCore (Kidney) in August of 2023, and it became commercially available for ordering in January 2024. In December 2024, we confirmed Medicare reimbursement for also monitoring certain high-risk patients, that is, those with newly developed donor-specific antibodies.

Current report

On July 16, 2026, MolDX revised its foundational LCD, “MolDX Molecular Testing for Solid Organ Allograft Rejection” (L40062), which supports expanded coverage for certain dd-cfDNA testing in transplant care. Compared to its predecessor, the revised LCD supports a higher testing frequency through the allowance of surveillance coverage in addition to the already-covered for-cause testing. iMDx believes the favorable policy establishes a baseline for long-term surveillance testing for transplanted organ patients; provides additional clarity for hospitals, clinicians, and laboratories; supports patient access to reimbursable dd-cfDNA testing; and further aligns with the company's strategy to enable in-house dd-cfDNA testing. Additionally, we believe the revised LCD may support broader commercial adoption of our GraftAssure™ family by reinforcing and expanding the Medicare reimbursement framework for dd-cfDNA testing.

Current report

However, we may not be able to ensure our tests remain reimbursed or attain reimbursement by Medicare for future tests for a variety of reasons, including changes in reimbursement practices, general policy shifts, or reductions in reimbursement amounts or breadth of coverage. We cannot predict whether Medicare reimbursements will continue at the same payment amount or with the same breadth of coverage in the future, if at all. If future reimbursement price levels are lower than their current levels, or if the scope of coverage becomes more limited, our revenues and our ability to achieve profitability could be impaired, and the market price of our common stock could decline. Any additional changes in the MACs’ practices in processing Medicare claims could also impact the coverage determinations or payments amounts or payment for our tests and our ability to obtain Medicare coverage for any products we may launch in the future.

Current report

Any decision by CMS or its local contractors to reduce or deny coverage for our tests would have a significant adverse effect on our revenue, ability to operate, and access to capital. Any such decision could also cause affected clinicians treating Medicare-covered patients to reduce or discontinue the use of our tests. Further, third‑party payers often follow Medicare coverage policy and payment limitations in setting their own coverage and payment rates and therefore their coverage and payment determinations may likewise be affected by any such decisions.

Current report

Even if a diagnostic test receives coverage and reimbursement from third-party payers, such coverage policies and reimbursement rates may change at any time, might not be adequate, or less favorable coverage policies and reimbursement rates may be implemented in the future. We may need to conduct additional studies in order to demonstrate the cost-effectiveness of our diagnostic tests to the satisfaction of our target customers and their third-party payers. Such studies might require us to commit a significant amount of management time and financial and other resources. If we are unable to obtain and maintain sufficient third-party coverage and adequate reimbursement for a diagnostic test, its commercial success may be greatly hindered, and our financial condition and results of operations may be materially and adversely affected.