Monday, August 10, 2026

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.

A Florida Medicare provider has agreed to pay $14.1 million to resolve allegations of a fraudulent billing scheme. The settlement, announced August 9, resolves claims that the provider submitted false claims to Medicare. The details serve as a reminder of the continuing enforcement focus on Medicare billing compliance, particularly in regions flagged for high utilization. While not requiring direct action, this settlement reinforces the necessity for rigorous internal audits and documentation practices to avoid similar scrutiny.

Medicare will not cover thousands of dollars in home-modification costs, like ramps, rails, and widened doorways, for patients discharged after a stroke. These items are deemed 'not medical' equipment, forcing patients to pay out-of-pocket for essential modifications required for safe return home. This coverage gap creates a significant financial cliff post-discharge and can delay or complicate transitions from inpatient rehabilitation or skilled nursing facilities. Billing teams should advise patients and case managers on this limitation early in the discharge-planning process to prevent billing surprises and facilitate timely access to alternative funding sources.

Researchers from KFF are proposing a new social-risk-weighted scoring system to improve equity in Medicare Advantage star ratings. The current system penalizes plans serving disadvantaged populations for lower performance on clinical and patient-experience metrics, which are influenced by social determinants of health. The proposed adjustment aims to level the playing field and more accurately reflect plan quality. This change, if adopted by CMS, could shift plan bonuses and market competition. Practices should track the CMS-2026-XXXX rulemaking process, as changes to star ratings can affect plan reimbursement and network participation strategies.