Due to the interest shown regarding these devices, we will list a few questions and answers regarding transitional pass-through devices. These frequently asked questions and more can be found on HCFA’s website at: http://www.hcfa.gov
QUESTION 2: When may hospitals bill for transitional passthrough payments for reprocessed devices?
ANSWER 3: The regulations defining a device eligible for transitional pass-through payments require that a device meet a number of criteria, including that they be for “single use.” Hospitals may thus bill for transitional passthrough 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 is phasing in new enforcement guidance relating to reprocessing during 2001 and 2002. See FDA’s guidance document entitled “Enforcement Priorities for Single- Use Devices Reprocessed by Third Parties and Hospitals,” published August 14, 2000.
QUESTION 10: If an item is on the pass-through list, does it automatically mean that the item is covered by Medicare?
ANSWER 10: No. The passthrough list is only for payment purposes and does not imply a coverage decision. Coverage determinations are made only through HCFA’s National Coverage Decision or by action of a local Fiscal Intermediary (FI) or carrier medical director.
QUESTION 35: I understand that pass-through payments for drugs and biologicals are not affected by the categories. Does this mean that hospitals can still report the associated C-codes for radiopharmaceuticals and biologicals?
ANSWER 35: Yes. Hospitals can still bill the designated C-codes for drugs and biologicals.
QUESTION 37: In the past the pass-through payments were only available for item specific (brand/trade name) devices. The long descriptors for the new category C-codes do not indicate a vendor name or model number. Does this mean that any device, regardless of manufacturer name or model number, are eligible for pass-through payment if they fit into a category?
ANSWER 37: Yes. Regardless of manufacturer name or model number, a device is eligible for passthrough payment if it fits into a category and meets the passthrough criteria.