CMS Pub. 100-04, ch. 4, § 60.4.1

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.