Comment on CMS-2026-1256-0002

We appreciate this opportunity to respond to CMS's proposed denial of Glytec's NTAP application. Glytec has developed something genuinely new: a cloud-based, EMR-integrated clinical decision support platform that helps hospitals identify and manage glycemic risk across entire patient populations, not just at the bedside. It is the kind of technology the NTAP program was designed to support. CMS's proposed denial turns largely on the newness criterion under 42 CFR 412.87(b)(2), and we believe that determination deserves a closer look. The regulation ties newness to when billing data begins to reflect inpatient hospital codes, per SSA Section 1886(d)(5)(K)(iii). For Glytec, no such data exists, not because the technology is old, but because it has never had a code to generate them. That is precisely the situation the framework was designed to address, and we urge CMS to apply it accordingly. We also demonstrate below that Glytec satisfies the substantial clinical improvement criterion under 42 CFR 412.87(b)(1) and the cost criterion under 42 CFR 412.87(b)(3). The newness case rests on several reinforcing points. The Glytec product historically has had no billing code, precisely the state the regulation's framework was designed to evaluate. Technology implementation currently is indirect via hospital software licensing, and reimbursement is uncovered. No systematically available patient billing data exist that would enable the calculation of newness according to prior rulemaking in FY 2005 and FY 2022. Additionally, SSA Section 1886(d)(5)(K)(iii) defines inpatient hospital code as including ICD codes and subsequent revisions. Hospital claims reflecting a new ICD-10-PCS code will not become available until after the code is implemented, which is in 2026 for this technology. CMS has explained that the 2 to 3 year newness period generally begins when a technology becomes available on the market for sale. In the case of complex software, this can result in real delays of several years before a technology can integrate commercially into standing EMR systems such as EPIC and Cerner. The Glytec product first appeared in EPIC in 2024. The Glytec product today is not the device cleared in 2017. That 510(k) covered Glytec Glucommander as a dosing calculator. Command Center as it exists today is a cloud-based, EMR-integrated platform with capabilities that did not exist in 2017, including predictive analytics, system-wide benchmarking, surveillance, and workflow management. The 510(k) was the regulatory vehicle, not the product definition. Glucommander's predictive analytics, system-wide Glucosurveillance, and EMR-native workflow integration represent capabilities that do not exist in legacy glycemic management tools, and lumping them together as equivalent would mischaracterize both the technology and the clinical problem it solves. Critically, the FDA issued a new 510(k) clearance for this technology this quarter, K254102. This is not a minor update. A new FDA clearance reflects a determination by the agency that the current product is sufficiently distinct to warrant independent review and authorization. If the FDA treats this as a new device, CMS should as well. We respectfully urge CMS to weigh this clearance as direct, concurrent federal agency evidence that Glytec's current platform meets the newness standard under 42 CFR 412.87(b)(2). Glytec meets the substantial clinical improvement criterion under 42 CFR 412.87(b)(1). Published research consistently demonstrates that automated, algorithm-driven glycemic management reduces hypoglycemic events, improves time-in-range outcomes, and delivers measurable patient safety gains over manual protocols. Command Center extends this foundation with Glucosurveillance, system-wide risk identification, and predictive workflow tools that no currently reimbursed alternative offers. The attached bibliography documents this evidence in full. Glytec's cost methodology is consistent with the statute and has been updated in response to CMS staff questions; we are confident it supports approval under the applicable cost criterion under 42 CFR 412.87(b)(3). The NTAP program exists precisely for technologies like this one, innovative enough to matter clinically but too new to have generated the billing history CMS typically relies on. Approval rates hovering around 30 to 41% per cycle suggest the current framework may be filtering out the very technologies it was designed to support. Glytec is a clear example: the absence of prior billing data is not evidence that the product is not new. It is evidence that it is. We respectfully urge CMS to reconsider its proposed denial. Glytec meets all three criteria under 42 CFR 412.87, and its approval would reflect both the letter and the spirit of the NTAP program. We welcome any opportunity to provide additional information in support of this application.