Comment on CMS-2026-1256-0002
Wellsense, IncSupportBusiness
Summary: Wellsense, Inc. is requesting a specific amendment to 42 CFR 412.87 to create a third "pathway" for New Technology Add-on Payment (NTAP) eligibility. They argue that the current regulations create a jurisdictional gap that excludes clinical procedures using FDA Class I 510(k)-exempt devices, and they propose a high-evidence-threshold alternative to allow these procedures to qualify for reimbursement.
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Please see the attached document for Wellsense, Inc.'s public comment on CMS-1849-P. The comment proposes a narrow amendment to 42 CFR 412.87 to address a structural jurisdictional gap in the NTAP program that categorically excludes clinically validated procedures performed using FDA Class I, 510(k)-exempt medical devices. The CMS Division of New Technology confirmed this gap in writing and directed Wellsense to address it through notice-and-comment rulemaking under the IPPS rule. Exhibits A, B, and C contain the three CMS Division of New Technology emails confirming the gap. Respectfully submitted, Roman Ferber, President and Chief Technology Officer, Wellsense, Inc.