(Medicare Claims Processing Manual)

The regulations regarding transitional pass-through payment for devices are compiled at 42 CFR 419.66.  Additionally, the eligibility criteria for CMS to establish a new ca tegory for pass-through payment are discussed on the CMS Web site at https://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/passthrough_payment.html   60.4 - General Coding and Billing Instructions and Explanations  (Rev. 11150; Issued: 12-10-21; Effective: 01-01-22; Implementation: 01-03-22)  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 Cathet er (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 FDAs 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.   60.4.2 - Complete List of Device Pass -through Category Codes  (Rev. 11150; Issued: 12-10-21; Effective: 01-01-22; Implementation: 01-03-22)  List of Device Category Codes for Present or Previous Pass -Through Payment and Related          Definitions The table below shows the complete list  of the device  category HCPCS codes used presently  or previously  for pass -through payment, along  with their expiration  dates, and definitions . This list does not include all device codes  reportable under  the OPPS;  there are additional  HCPCS  codes  for devices  that were not eligible  for pass-through payment. See section  61, Chapter  4 of the IOM,  pub. 100-4, currently  available at  https://www.cms.gov/Regulations -and-Guidance/Guidance/Manuals/downloads/clm104c04.pdf , for detailed information  on requirements  for reporting  device codes  and satisfying  device edits  in the OPPS.   Section  402(a) of the Benefits  Improvement  and Protection Act of 2000 (BIPA), which  was enacted on December 21, 2000, required the creation of categories for pass -through devices  under  the hospital  OPPS.  As a result  of BIPA,  new category codes  were  created  for pass-through  devices  that became effective April  1, 2001.     As indicated  in section  1833(t)(6)  of the Social  Security  Act, payments  for pass -through  devices  are limited  to at least two years but  no more than three years. Starting  on January 1, 2017, we  changed  our policy  to allow  for quarterly  expiration  of pass-through  payment status  for devices,  beginning  with pass -through  devices approved  in CY 2017 and subsequent calendar years, to afford a pass -through payment period that is as close to a full  3 years as possible for all pass- through payment  devices. Note that payment for pass -through devices is based on the charge on  the individua l  bill, converted to cost by application  of a hospital -specific  cost-to-charge ratio, and subject  (in some instances) to a reduction  that offsets the cost of similar  devices  already  included in the APC  payment  rate for the associated procedure.   When the category codes became effective April 1, 2001, many of the item -specific C -codes that were cross -walked in Transmittal A -01-41 and Transmittal A-01- 97 to the new category codes were approved for pass-through status before April 1, 2001. In determining the expiration dates for those initial pass -through device category codes listed below, we determined when specific devices that are described by the categories were paid as pass -through devices through their item- specific C -codes prior to the creatio n of the categories, pursuant to the statute, section 1833(t)(6)(iii)(I). These dates are listed in the column below entitled "Date First Populated." Thus, many of the category codes that were made effective April 1, 2001 expired on December 31, 2002. Desp ite the expiration of pass-through payment status for device category codes, hospitals are still required to report the device category C -codes on claims when such devices are used in conjunction with procedures billed and paid under the OPPS.  In the CY 2 015 final rule, we finalized a policy and implemented claims processing edits  that require any of the device codes used in the previous device -to-procedure edits to be  present  on the claim  whenever  a procedure code assigned to any of the APCs  listed  in Table    H1 (the formerly  device dependent  APCs)  is reported  on the claim  (79 FR 66795).  List of Device Category  HCPCS  Code  s and Definitions  Used  for Present  and Previous  Pass - Through  Payment  ***