(Medicare Claims Processing Manual)

Morcellator (C1782)  - Used for cutting, coring, and extracting tissue in laparoscopic procedures. These are distinct from biopsy devices because morcellators are used for t he laparoscopic removal of tissue.   Pacemaker, other than single or dual chamber (C2621)  - Includes cardiac resynchronization devices as well as other pacemakers that are neither single or dual chamber.   Patient programmer (C1787) -  Programmer that allows the patient to operate their neurostimulator, for example, programming the amplitude and rate of stimulation of a neurostimulator system. Only a non- console patient programmer is eligible for transitional pass- through payments.   Peel-away introducer/sheat h (C1892) -  A non- absorbable sheath or introducer that separates into two pieces. This device is used primarily when removal of the sheath is required after a catheter or lead is in the desired position.   Retinal tamponade device, silicone oil (C1814)   A device used as a permanent/prolonged retinal tamponade in the treatment of complex retinal detachments. This is used as a post -operative retinal tamponade following vitreoretinal surgery.    Retrieval device, insertable (C1773)  - A device designed to retriev e other devices or portions thereof (e.g., fractured catheters, leads) lodged within the vascular system. This can also be used to retrieve fractured medical devices or to exchange introducers/sheaths.   Septal defect implant system (C1817)  - An intracardia c metallic implant used for closure of various septal defects within the heart. The septal defect implant system includes a delivery catheter. The category code for the septal defect implant system (C1817) includes the delivery catheter; therefore, the del ivery catheter should not be reported separately.   Stents with delivery system (C1874, C1876, C2625) -  Stents packaged with delivery systems generally include the following components: stent mounted or unmounted on a balloon angioplasty catheter, introduce r, and sheath. These components should not be reported separately.   Temporary non -coronary stent (C2617, C2625)  - Usually composed of a substance, such as plastic or other non -absorbable material, designed to permit removal. Typically, this type of stent is placed for a period of less than one year.  Tissue marker (C1879)  - A material that is placed in subcutaneous  or parenchymal tissue (may also include bone) for radiopaque identification of an anatomic site. These markers are distinct from topical skin markers, which are positioned on the surface of the skin to serve as anatomical landmarks.   Transluminal angioplasty catheter (C1725, C1885) -  Designed to dilate stenotic blood vessels (arteries and veins). For vascular use, the terms balloon dilatation catheter and translumina l angioplasty catheter are frequently used interchangeably. [For the reporting of non- vascular balloon dilatation catheters, see the category "Balloon dilatation catheter" (C1726).]   Transvenous VDD single pass pacemaker lead (C1779) -  A transvenous pacemaker lead that paces and senses in the ventricle and senses in the atrium.   Urinary incontinence repair device (C1771, C2631) -  Used to attach or insert a sling graft for the purpose of strengthening the pelvic floor. It consists of the device components used to deliver (suprapubically or transvaginally) and/or fixate (via permanent sutures or bone anchors) the sling graft. The device may or may not be packaged with a sling graft. Report the appropriate category for a device with or without a sling graft. NOTE: For reporting connective tissue (human or non-  human) when used to treat urinary i ncontinence, see the category Connective tissue, human (C1762) or Connective tissue, non- human (C1763). For reporting mesh when used to treat urinary incontinence, see the category Mesh (C1781).   Vascular closure device (implantable /insertable) (C17 60) - Used to achieve hemostasis at arterial puncture sites following invasive or interventional procedures using biologic substances (e.g., collagen) or suture through the tissue tract.    Vector mapping catheter (C1732)  - Refers to an electrophysiology catheter with an "in-plane" orthogonal array of electrodes. This catheter is used to locate the source of a focal arrhythmia.    60.5 - Services Eligible for New Technology APC Assignment and Payments  (Rev. 3941; Issued: 12- 22-17; Effective: 01- 01- 18; Implementation: 01 -02-18) Under OPPS, services eligible for payment through New Technology APCs are those codes that are assigned to the series of New Technology APCs published in Addendum A of the latest OPPS update.  As of January 1, 2018, the range of New Technology APCs include    APCs 1491 through 1500  APCs 1502 through 1537  APCs 1539 through 1585  APCs 1589 through 1599, and  APCs 1901 through 1908   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/Hosp italOutpatientPPS/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) Effec tive 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 appropriate 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 p ermanently 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 Medi care 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 i ndividual 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 packag ed 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 m ay 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 claim. 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 F or 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 procedure 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 s pecified 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 edit, 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 sit uations where no device was performed with certain device -intensive procedures, providers may bypass the edit by reporting modifier CG.