CMS Proposed Rule Clarifies Criteria for Pass-Through Payment

Responding to continuing industry uncertainty about the Centers for Medicare & Medicaid Services’ transitional “pass-through” payment policy, the agency last week issued a proposed rule clarifying one of the criteria for device eligibility. Pass-through payments help to cover the use of new technologies or services while CMS determines the appropriate payment rate for the long term. Under the proposed rule, the agency is amending the requirement that an eligible device be “an integral and subordinate part of the service furnished,” because devicemakers have raised questions about the meaning of the terms “integral” and “subordinate.”
Devices & Diagnostics Letter