(Medicare Claims Processing Manual)

OPPS considers any HCPCS code assigned to the above APCs to be a new technology procedure or service.   Application procedures for consideration as a New Technology procedure or service may be found on the CMS Web site, currently at https://www.cms.gov/Medicare/Medicare -Fee-for-Service -Payment/HospitalOutpatientPPS/passthrough_payment.html .  Under the Downloads section, refer to the document titled For a New Technology Ambulatory Payment Classification (APC) Designation under the Hospital Outpatient Prospective Payment System (OPPS) for information on the requirements for submitting an application.  The list of HCPCS codes and payment rates assigned to New Technology APCs can be found in Addendum B of the latest OPPS update regulation each year at  https://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum -A-and-Addendum -B-Updates.html. Please note that this link may change depending on CMS Web design requirements   61 - Billing for Devices Under the OPPS  (Rev. 1657, Issued: 12- 31-08, Effective: 01 -01-09, Implementation: 01 -05-09)  Future updates will be issued in a Recurring Update Notification.   61.1 - Requirement that Hospitals Report Device Codes on Claims on Which They Report Specified Procedures  (Rev. 11305; Issued: 03- 24-22; Effective: 04-01-22; Implementation: 04 -04-22) Effective January 1, 2005, hospitals paid under the OPPS (bill types 12X and 13X) that report procedure codes that require the use of devices must also report the applicable HCPCS codes and charges for all devices that are used to perform the procedures where such codes exist and are designated with a status indicator of N (for packaged payment) or H (for pass -through device payment) in the OPPS Addendum B that applies to the date of service. If there are device HCPCS codes with status indicators other than  N or H that describe devices that are used to perform the procedure or that are furnished because they are necessary for the function of an implanted device, hospitals should report the charges for those other devices on an uncoded revenue code line, but should not report the HCPCS codes for those items. Typically, payment for the costs of all internal and external components required for the function of a nonpass -through device is packaged into the APC payment for the associated procedure in which the  device is used. Accurate reporting of HCPCS codes and charges for these internal and external device components is necessary so that the OPPS payment for the associated procedures will be correct in future years in which the claims are used to set the APC  payment rates.  For procedure codes that require the use of devices that are not described by a specific HCPCS code, hospitals should report HCPCS code C1889 (Implantable/insertable device, not otherwise classified) and charges for all devices that are used to perform the  procedures. Such devices must:   Have received FDA marketing authorization, have received an FDA investigational device exemption (IDE) and have been classified as a Category B device by FDA in accordance with 405.203 through 405.207 and 405.211 through 405.215, or meets another appropr iate FDA exemption from premarket review;   Be an integral part of the service furnished;   Be used for one patient only;   Come in contact with human tissue;   Be surgically implanted or inserted (either permanently or temporarily); and   Not be either of the following:  (a) Equipment, an instrument, apparatus, implement, or item of the type for which depreciation and financing expenses are recovered as depreciable assets as defined in Chapter 1 of the Medicare Provider Reimbursement Manual (CMS Pub. 15-1); or  (b) A material or supply furnished to a service (for example, a suture, customized surgical kit, scalpel, or clip, other than a radiological site marker).  Manufacturers frequently package a number of individual items used with a device in a particular procedure. In cases of devices that are described by device category HCPCS codes whose pass -through status has expired, or HCPCS codes that describe devices without pass -through status, and that are packaged in kits with other items used in a particular procedure, hospitals may consider all kit costs in their line -item charge for the associated device/device category HCPCS code that is assigned status indicator N for packaged payment. That is, hospitals may report the total charge for the whole kit with the associated device/device category HCPCS code. Payment for device/device category HCPCS codes without pass -through status is packaged into payment for the procedures in which they are used, and these codes are assigned status indicator N. In the case of a device kit, should a hospital choose to report the device charge alone under a device/device category HCPCS code with SI=N, the hospital should report charges for other items that may be included in the kit on a separate line on the clai m. Hospitals may use the same revenue code to report all components of the kit.  61.2 - Edits for Claims on Which Specified Procedures are to be Reported With Device Codes and For Which Specific Devices are to be Reported With Procedure Codes  (Rev. 3685, Issued: 12- 22-16, Effective: 01 -01-17, Implementation: 01- 03-17)  The OCE will return to the provider any claim that reports a HCPCS code for a device -intensive procedure that does not also report at least one device HCPCS code required for that procedure.  If the claim is returned to the provider for failure to pass the  edit, the hospital will need to modify the claim by either correcting the procedure code or ensuring that one of the required device codes is on the claim before resubmission.  While all devices that have device HCPCS codes and that were used in a given p rocedure should be reported on the claim, only one of the possible device codes is required to be on the claim for payment to be made, unless otherwise specified.  The device edit does not apply to the specified procedure code if the provider reports one of the following modifiers with the procedure code:   52 - Reduced Services;  73 - Discontinued outpatient procedure prior to anesthesia administration; and 74 - Discontinued outpatient procedure after anesthesia administration.  Where a procedure that normally requires a device is interrupted, either before or after the administration of anesthesia if anesthesia is required or at any point if anesthesia is not required, and the device is not used, hospitals should report modifier 52, 73 or 74 as applicable.  The device edit is not applied in these cases.   The OCE will also return to the provider claims for which specified devices are billed without the procedure code that is necessary for the device to have therapeutic benefit to the patient.  If the claim is returned to the provider for failure to pass the edi t, the hospital will need to modify the claim by either correcting the device code or ensuring that one of the required procedure codes is on the claim before resubmission.      61.2.1  Bypass Edit Modifier CG for Claims on Which Specified Procedures are to be Reported With Device Codes                            (Rev.4513, Issued: 02- 04-2020, Effective: 01 -01- 2020, Implementation: 01- 06-2020)   For certain device -intensive procedures, providers may bypass the device edit requiring at least one device HCPCS code for the procedure. For situations where no device was performed with certain device -intensive procedures, providers may bypass the edit b y reporting modifier CG.   61.3 - Billing for Devices Furnished Without Cost to an OPPS Hospital or Beneficiary or for Which the Hospital Receives a Full or Partial Credit and Payment for OPPS Services Required to Furnish the Device  (Rev. 1657, Issued: 12- 31-08, Effective: 01 -01-09, Implementation: 01- 05-09)  61.3.1 - Reporting and Charging Requirements When a Device is Furnished Without Cost to the Hospital Prior to January 1, 2014  (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  Effective January 1, 2007, the definition of modifier - FB is  Item Provided Without Cost to Provider, Supplier or Practitioner, or Credit Received for Replacement Device (Examples, but not Limited to:  Covered Under Warranty, Replaced Due to Defect, Free Samples).   When a hospital furnishes a device received without cost or with full credit from a manufacturer, the hospital must append modifier - FB to the procedure code (not the device code) that reports the service provided to furnish the device.  The hospital must report a token charge for the device (less than $1.01) in the covered charge field.  This includes circumstances in which the cost of a replacement device is less than the cost of the device being replaced, such that the hospital incurs no net cost for the device being inserted.  For example, if a device that originally cost $20,000 fails and is replaced by a device that costs $16,000 and for which the manufacturer gives a credit of $16,000, there is no cost to the hospital for the device being inserted and the hospital would append modifier - FB to the procedure code and report a token char ge for the device.   61.3.2 - Reporting and Charging Requirements When the Hospital Receives Full Credit for the Replaced Device against the Cost of a More Expensive Replacement Device Prior to January 1, 2014  (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  When a hospital replaces a device with a more expensive device and receives a credit in the amount that the device being replaced would otherwise cost, the hospital must append modifier - FB to the procedure code (not on the device code) that reports the se rvice provided to replace the device.  The hospital must charge the difference between its usual charge for the device being implanted and its usual charge for the device for which it received credit.  This charge should be billed in the covered charge field.   Hospitals should not report modifier - FB when the hospital receives a partial credit for a replacement device when the amount of the credit is less than the amount that the device would otherwise cost the hospital.  For example, a device fails in the 6th month of a 1 year warranty and under the terms of the warranty, the hospital receives a credit of 50 percent of the cost of a replacement device.  The hospital should not append modifier - FB to the procedure code in which the device is implanted.  See the  Medicare Claims Processing Manual, Pub 100- 04, Chapter 4, 61.3.3 for billing instructions pertaining to partial credit situations.   61.3.3 - Reporting Requirements When the Hospital Receives Partial Credit for the Replacement Device Prior to January 1, 2014  (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  When a hospital receives a partial credit of 50 percent or more of the cost of a new replacement device due to warranty, recall, or field action, the hospital must append modifier - FC to the procedure code (not on the device code) that reports the service provided to replace the device.   61.3.4 - Medicare Payment Adjustment Prior to January 1, 2014  (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  Effective January 1, 2007, Medicare payment is reduced by the full offset amount for specified procedure codes reported with modifier -FB.  Effective January 1, 2008, Medicare payment is reduced by the partial offset amount for specified procedure codes reported with modifier -FC.  Effective January 1, 2009, payment is only reduced for procedure codes that map to the Ambulatory Payment Classification groups (APCs) on the list of APCs subject to the adjustment that are reported with modifier -FB or - FC and that are present on claims with specified device HCPCS codes.   The Integrated Code Editor (I/OCE) assigns a payment adjustment flag when a procedure code in an APC subject to an offset adjustment is billed with modifier - FB or -FC and a specified device HCPCS code.  The payment adjustment flag communicates to the OPPS  PRICER that the payment for the procedure code line is to be reduced by the established full or partial offset amount for the APC to which the procedure code is assigned.  The I/OCE uses the offset APC payment rate (APC payment amount minus the establishe d offset amount) as the rate used in the I/OCEs determination of which multiple procedure line(s) will be discounted.