CMS Statement on Reimbursement
CMS reimburses for reprocessed devices, in the same way it reimburses for all eligible “single- use” devices. The CMS Manual Publication 100-04 for Medicare Claims Processing (Transmittal 1336, September 2007) includes specific language on devices eligible for transitional pass-through payments. Regarding reprocessed devices, (Section 60.4, Effective 10-01-07) it says:
Reprocessed devices – Hospitals may bill for transitional pass-through payments only for those devices that are “single use.” Reprocessed devices may be considered “single use” if they are reprocessed in compliance with enforcement guidance of the Food and Drug Administration (FDA) relating to the reprocessing of devices applicable at the time the service is delivered. The FDA phased in new enforcement guidance relating to reprocessing during 2001 & 2002. For further information see FDA’s guidance document entitled “Enforcement Priorities for Single-Use Device Reprocessed by Third Parties and Hospitals” published August 14, 2000, or any later FDA guidance or enforcement document currently in effect. For a complete list of currently and previously payable device categories related to pass-through payments and specific definitions of such device categories, refer to CMS Manual
Don’t be fooled by incomplete or inaccurate references to current CMS reimbursement practice: FDA-regulated third-party reprocessed devices are reimbursed by the federal Medicare/Medicaid system like any other FDA cleared “single-use” device.