The revised Medicare Local Coverage Determination (LCD) for Urological Supplies went into effect January 1, 2026. This will affect utilization for certain urological supplies: HCPCS codes A4353 and A4297. How will CMS account for this unknown change in utilization when it publicizes HCPCS Level II code utilization information for bidders? How would the lead item be determined?

Per 42 CFR § 414.402, the lead item is the item in a product category with multiple items with the highest total nationwide Medicare allowed charges of any item in the product category prior to each competition. Changes in utilization and LCD revisions are not part of how CMS determines the lead item. Per 42 CFR § 414.402, the lead item is the item in a product category with multiple items with the highest total nationwide Medicare allowed charges of any item in the product category prior to each competition. Changes in utilization and LCD revisions are not part of how CMS determines the lead item.