CMS proposes reclassification of digital breast tomosynthesis to Class II

HHS issued a proposed rule to reclassify digital breast tomosynthesis (DBT) systems from Class III to Class II devices. This move, if finalized, would shift the regulatory pathway for new DBT systems, potentially affecting future coding and reimbursement as these devices become subject to less stringent pre-market approval requirements. The change reflects an evolving stance on the risk profile of this established imaging technology. The comment period is now open; billing teams should track the docket (CMS-2026-16209) as the reclassification could influence future coverage determinations and payment policies for DBT services.