Explanations of Terms

60.4.1 - Explanations of Terms (Rev. 11150; Issued: 12-10-21; Effective: 01-01-22; Implementation: 01-03-22) Reporting Multiple Units of Pass-Through Device Categories Hospitals must bill for multiple units of items that qualify for transitional pass-through payments when such items are used with a single procedure by entering the number of units used on the bill. Reporting of Multiple Device Categories For items with multiple component devices that fall in more than one category (e.g., kits or systems other than those explicitly identified in the long descriptors), hospitals should code the appropriate category separately for each component. For example, the “Rotablator Rotational Angioplasty System (with catheter and advancer)” consists of both a catheter and an advancer/sheath. Hospitals should report category C1724 for the catheter and C1894 for the advancer/sheath. Also, for items packaged as kits that contain a catheter and an introducer, hospitals should report both appropriate categories. For example, the “Clinicath 16G Peripherally Inserted Central Catheter (PICC) Dual-Lumen PolyFlow Polyurethane” contains a catheter and an introducer. To appropriately bill for this item, hospitals should report category C1751 for the catheter and C1894 for the introducer. (Please note that the device categories C1724, C1894 and C1751 are no longer eligible for pass-through payments, but are used here for illustrative purposes for reporting multiple categories. However, hospitals should continue to report devices on claims in this manner even after the category is no longer eligible for pass-through payment.) 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 and 2002. For further information, see FDA’s guidance document entitled “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals,” published August 14, 2000, or any later FDA guidance or enforcement documents currently in effect.