Article - Urological Supplies - Policy Article (A52521)

A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies; orA sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies; orA sterile no-touch type of catheter system.The insertion kit (A4353) described in #1 and #2 above contains an intermittent urinary catheter (packaged separately from the other components in #2), lubricant, gloves, antiseptic solution, applicators, a drape, and a collection tray/bag in a sterile package intended for single use. The collection tray/bag is a separate item included within the kit; therefore, materials that serve as non-sterile packaging to contain all of the items in the kit do not meet this requirement. Except as noted in #2 above, code A4353 must not be billed if individual insertion kit components are provided as separate items. When providing a sterile kit, all components are included and packaged as a kit. Separate billing of individual components is considered as unbundling.The product described in #3 is a single-catheter system that is functionally equivalent to a complete sterile insertion kit (A4353) containing a catheter and the additional components as described in the previous paragraph. In order to be coded as A4353, a no-touch type of catheter system must be a sterile, all-inclusive, self-contained system capable of accomplishing intermittent catheterization with sterile technique without the use of additional supplies such as gloves, lubricant, collection chamber, etc. Additional individual components must not be separately billed. Separate billing of additional supply items is considered as unbundling.Therapeutic agent for urinary irrigation (A4321) is defined as a solution containing agents in addition to saline or sterile water (for example acetic acid or hydrogen peroxide) which is used for the treatment or prevention of urinary catheter obstruction.Code A5105 should be used when billing for a urinary suspensory with leg bag.A4326 is a male external catheter with an integrated collection chamber that does not require the use of an additional leg bag.Irrigation solutions containing antibiotics and chemotherapeutic agents should be coded A9270. Irrigating solutions, such as acetic acid or hydrogen peroxide, which is used for the treatment or prevention of urinary obstruction, should be coded A4321.Adhesive strips or tape used with code A4349 (MALE EXTERNAL CATHETER, WITH OR WITHOUT ADHESIVE, DISPOSABLE, EACH) should not be billed separately.Adhesive catheter anchoring devices that are used with indwelling urethral catheters are billed using codes A4333 and A4334, respectively. An anchoring device used with a percutaneous catheter/tube (e.g., suprapubic tube, nephrostomy tube) is billed using code A5200.Replacement leg straps (A5113, A5114) are used with a urinary leg bag (A4358, A5105, or A5112). These codes are not used for a leg strap for an indwelling catheter.When codes A4217, A4450, and A4452 are used with Urological Supplies, they must be billed with the AU modifier. For this policy, codes A4217, A4450, and A4452 are the only three codes for which the AU modifier may be used.An external catheter that contains a barrier for attachment should be coded using A4335.Codes for ostomy barriers (A4369 and A4371) should not be used for skin care products used in the management of urinary incontinence.A percutaneous catheter/tube anchoring device (A5200) is a dressing with adhesive that is designed to be applied directly over the cutaneous opening through which the catheter/tube passes. This dressing has a hole through which the catheter/tube passes and a mechanism for firmly anchoring the catheter/tube to the dressing.For claims with date of service (DOS) July 26, 2020 through September 30, 2020, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1 unit of service (UOS) at initial issue, and is all inclusive (catheter, activator, charging base). Code A4335 must also be used on separate claim lines for replacement of any of the individual components of the inFlow Intraurethral Valve-Pump system (catheter, activator, charging base).For claims with DOS October 1, 2020 through March 31, 2021, the inFlow system must be billed using HCPCS code(s): K1010 (Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each), K1011 (Activation device for intraurethral drainage device with valve, replacement only, each) and/or K1012 (Charger and base station for intraurethral activation device, replacement only).For claims with DOS April 1, 2021 through March 31, 2023, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4335 (INCONTINENCE SUPPLY; MISCELLANEOUS). Code A4335 is billed as 1 unit of service (UOS) at initial issue (see below), and is all-inclusive (catheter, activator, charging base). For replacement of individual components, code A4335 must be used on separate claim lines for any of the individual components of the inFlow Intraurethral Valve-Pump system (catheter, activator, charging base).For claims with DOS on or after April 1, 2023, the inFlow Intraurethral Valve-Pump system (Vesiflo, Inc.) must be billed using HCPCS code A4341 (INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, PATIENT INSERTED, REPLACEMENT ONLY, EACH).The initial sizing and insertion of the inFlow device is performed by the treating practitioner in their office. Claims for these services must be billed to the Part B MAC. Replacement of the indwelling intraurethral drainage device with valve is done by a trained caregiver or the beneficiary at home and may be billed on a monthly basis. If a replacement of the indwelling intraurethral drainage device with valve is performed by the treating practitioner, claims for this service must be billed to the Part B MAC.Since the activator and charging base are provided at the time of initial issue in the treating practitioner's office to the beneficiary, these may only be billed to the DME MAC as a replacement using HCPCS code A4342 (ACCESSORIES FOR PATIENT INSERTED INDWELLING INTRAURETHRAL DRAINAGE DEVICE WITH VALVE, REPLACEMENT ONLY, EACH).Payment for items listed in Column II are included in the payment for the Column I code. In the following table, when providing the items listed in Column II, the Column I code must be used instead of billing separate Column II codes when the items are provided at the same time.Column IColumn IIA4310A4332A4311A4310, A4332, A4338A4312A4310, A4332, A4344A4313A4310, A4332, A4346A4314A4310, A4311, A4331, A4332, A4338, A4354, A4357A4315A4310, A4312, A4331, A4332, A4344, A4354, A4357A4316A4310, A4313, A4331, A4332, A4346, A4354, A4357A4354A4310, A4331, A4332, A4357A4357A4331A4358A4331, A5113, A5114A5105A4331, A4358, A5112, A5113, A5114A5112A5113, A5114If a code exists that includes multiple products, that code should be used in lieu of the individual codes.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.