Urological Supplies
Number: 0533
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses urological supplies.
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Medical Necessity
Aetna considers urinary catheters and external urinary collection devices medically necessary prosthetics for members who have permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that person within 3 months.
Note: The general term "external urinary collection devices" used in this policy includes male external catheters and female pouches or meatal cups. This term does not include diapers or other types of absorptive pads.
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Indwelling Catheters
- Aetna considers 1 catheter per month medically necessary for routine catheter maintenance. Non-routine catheter changes are considered medically necessary in exceptional circumstances, such as the following:
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Catheter is accidentally removed (e.g., pulled out by member); or
- Catheter is obstructed by encrustation, mucous plug, or blood clot; or
- Catheter malfunctions (e.g., balloon does not stay inflated, hole in catheter); or
- Member has history of recurrent obstruction or urinary tract infection for which it has been established that an acute event is prevented by a scheduled change at intervals of less than once per month.
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- TuckSpecialty indwelling catheters and all silicone catheters are considered medically necessary where the member is unable to use a straight Foley type catheter with coating (such as recurrent encrustation, inability to pass a straight catheter, or sensitivity to latex). For example, use of a Coude (curved) tip indwelling catheter in female members is rarely medically necessary.
- A 3-way indwelling catheter either alone or with other components is considered medically necessary only if continuous catheter irrigation is medically necessary.
- Aetna considers 1 catheter per month medically necessary for routine catheter maintenance. Non-routine catheter changes are considered medically necessary in exceptional circumstances, such as the following:
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Catheter Insertion Trays
One insertion tray is considered medically necessary per episode of indwelling catheter insertion. One intermittent catheter with insertion supplies is considered medically necessary per episode of medically necessary sterile intermittent catheterization (see below). Catheter insertion trays are of no proven benefit for clean, non-sterile intermittent catheterization.
Catheter insertion trays that contain component parts of the urinary collection system, (e.g., drainage bags and tubing) are inclusive sets and additional component parts are considered medically necessary only per the stated criteria in each section of this policy.
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Urinary Drainage Collection Systems
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The following table indicates the quantity of supplies that are considered medically necessary for routine changes of the urinary drainage collection system. Additional supplies for non-routine changes are considered medically necessary only under exceptional circumstances (e.g., for obstruction, sludging, clotting of blood, or chronic, recurrent urinary tract infections).
Table: Usual Maximum Medically Necessary Quantity of Supplies Description Number per month Number per 3 months Insertion tray with drainage bag with indwelling catheter, Foley-type, 2-way, latex with coating 1 Insertion tray with drainage bag with indwelling catheter, Foley-type, 2-way, all silicone 1 Insertion tray with drainage bag with indwelling catheter, Foley-type, 3-way, for continuous irrigation 1 Insertion tray with drainage bag but without catheter 1 Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each 2 Urinary leg bag; vinyl, with or without tube, each 2 Bedside drainage bottle with or without tubing, rigid or expandable, each 1 Urinary leg bag; latex 1 - Leg bags are considered medically necessary for members who are ambulatory or are chair- or wheelchair-bound. The use of leg bags for bedridden members is not considered medically necessary.
- Either a vinyl leg bag or a latex leg bag is considered medically necessary; the use of both is not considered medically necessary.
- If there is a catheter change and an additional drainage bag change within a month, the combined utilization for catheters and drainage bags should be considered when determining if additional documentation should be submitted with the claim. For example, if one insertion tray with drainage bag and indwelling foley-type catheter and one bedside drainage bag are provided, this should be considered as two drainage bags, which is the usual maximum quantity of drainage bags needed for routine changes.
- The value drainage bags containing absorbent material such as gel matrix or other material, which are intended to be disposed of on a daily basis, has not been proven.
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Intermittent Irrigation of Indwelling Catheter
Supplies for the intermittent irrigation of an indwelling catheter are considered medically necessary when they are used on an as needed (non-routine) basis in the presence of acute obstruction of the catheter. Routine intermittent irrigations of a catheter (i.e., catheterizations performed at pre-determined intervals) are of no proven value.
Medically necessary supplies for medically necessary non-routine irrigation of a catheter include either an irrigation tray or an irrigation syringe, and sterile saline or sterile water. When syringes, trays, sterile saline, or water are used for routine irrigation, they will be considered not medically necessary.
Note: Irrigation supplies that are used for care of the skin or perineum of incontinent members are not covered.
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Continuous Irrigation of Indwelling Catheter
Supplies for continuous irrigation of a catheter are considered medically necessary if there is a history of obstruction of the catheter and the patency of the catheter can not be maintained by intermittent irrigation and catheter changes. Continuous irrigation has not been proven to be of benefit as a primary preventative measure (i.e., no history of obstruction).
Medically necessary supplies for medically necessary continuous bladder irrigation include a 3-way Foley catheter, irrigation tubing set, and sterile saline or sterile water. More than one irrigation tubing set per day for continuous catheter irrigation is not considered medically necessary.
Sterile water or sterile saline are considered medically necessary for use as irrigation solutions.
Continuous irrigation is a temporary measure; continuous irrigation for more than 2 weeks is rarely considered medically necessary.
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Intermittent Catheterization
Intermittent catheterization is considered medically necessary when basic medical necessity criteria are met and the member or caregiver can perform the procedure.
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Intermittent catheterization using sterile technique is considered medically necessary when the member requires catheterization and the member meets any of the following criteria:
- The member resides in a nursing facility; or
- The member is immunosuppressed, for example (not all inclusive):
- Has AIDS,
- Has a drug-induced state such as chronic oral corticosteroid use,
- On a regimen of immunosuppressive drugs post-transplant,
- On cancer chemotherapy; or
- The member has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or
- The member is a spinal cord-injured female with neurogenic bladder who is pregnant (for duration of pregnancy only); or
- The member has had distinct, recurrent urinary tract infections, while on a program of clean intermittent catheterization with sterile lubricant, twice within the 12-month period prior to the initiation of sterile intermittent catheterization.
Note: A member would be considered to have a urinary tract infection if they have a urine culture with greater than 10,000 colony forming units of a urinary pathogen and concurrent presence of any of the following signs, symptoms or laboratory findings:
- Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation)
- Change in urinary urgency, frequency, or incontinence
- Fever (oral temperature over 38º C [100.4º F])
- Increased muscle spasms
- Physical signs of prostatitis, epididymitis, orchitis
- Pyuria (greater than 5 white blood cells (WBCs) per high-powered field)
- Systemic leukocytosis
Intermittent catheterization using sterile technique is of no proven benefit for other indications. Requests for sterile intermittent catheterization for members who fail to meet the above criteria are subject to medical review.
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The following table lists usual medically necessary quantity of supplies for intermittent catheterization.
Table: Medically Necessary Quantity of Supplies for Intermittent Catheterization Description Number per month Lubricant, individual sterile packet, each 200 Intermittent urinary catheter; straight tip, with or without coating (teflon, silicone, silicone elastomer, or hydrophilic, etc.), each 200 Intermittent urinary catheter; coude (curved) tip, with or without coating (teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each 200 Intermittent urinary catheter, with insertion supplies 200 Note: The code for an intermittent urinary catheter with insertion supplies should not be used for billing if the components are packaged separately rather than together as a kit. Separately provided components do not provide the equivalent degree of sterility achieved with an intermittent urinary catheter with insertion supplies kit.
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For each episode of medically necessary sterile catheterization, Aetna considers medically necessary either
- catheter plus an individual packet of lubricant, or
- an intermittent catheter kit if medical necessity criteria above are met.
A urinary intermittent catheter with insertion supplies is a kit, which includes a catheter, lubricant, gloves, antiseptic solution, applicators, drape, and a tray or bag in a sterile package intended for single use.
Use of a Coude (curved) tip catheter in female members is rarely medically necessary. A Coude tip catheter is considered medically necessary for either male or female members only when a straight tip catheter can not be used. An example would be the inability to catheterize with a straight tip catheter.
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External Catheters/Urinary Collection Devices
Male external catheters (condom-type) or female external urinary collection devices are considered medically necessary for members who have permanent urinary incontinence when used as an alternative to an indwelling catheter.
- Generally, no more than 35 male external catheters are considered medically necessary per month.
- Adhesive strips or tape used with male external catheters with adhesive strips or adhesive coating are included in the allowance for that code and are not separately payable.
- Male external catheters (condom-type) or female external urinary collection devices are not considered medically necessary when ordered for members who also use an indwelling catheter.
- Specialty-type male external catheters such as those that inflate or that include a faceplate are considered medically necessary where the clinical situation justifies their need.
- For female external urinary collection devices, more than 1 meatal cup per week or more than 1 pouch per day are not considered medically necessary.
A meatal cup female external urinary collection device is a plastic cup, which is held in place around the female urethra by suction or pressure and is connected to a urinary drainage container such as a bag or bottle. A pouch type female external collection device is a plastic pouch which is attached to the peri-urethral area with adhesive and which can be connected to a urinary drainage container such as a bag or bottle.
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Aetna considers the PureWick urine collection system unproven and not medically necessary for the management of urinary incontinence.
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The inFlow Device
Aetna considers the inFlow device medically necessary as an alternative to intermittent catheterization for members with permanent urinary retention (PUR) due to impaired detrusor contractility. Note: One inFlow device is considered medically necessary no more than once every 29 days.
Documentation of the continued medical necessity of the inFlow device beyond the first 3 months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner conduct a clinical re-evaluation and document that the member continues to use and is benefiting from the inFlow device.
Documentation of use and clinical benefit is demonstrated by:
- An in-person encounter by the treating practitioner with documentation that urinary symptoms are improved; and
- The treating practitioner verifies the member’s adherence to use of the inFlow device.
If the above criteria are not met, continued use of the inFlow device and related accessories will be considered not medically necessary.
If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the member is benefiting from the inFlow device as defined in criteria 1 and 2 above, continued coverage of the inFlow device will commence with the date of that re-evaluation.
Note: If there is discontinuation of usage of the inFlow device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.
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Miscellaneous Supplies
- Appliance cleaner is considered medically necessary when used to clean the inside of certain urinary collecting appliances. More than 16 oz. per month is rarely considered medically necessary.
- One external urethral clamp or compression device is considered medically necessary every 3 months or sooner if the rubber/foam casing deteriorates.
- Tape that is used to secure an indwelling catheter to the member’s body is considered medically necessary. More than 5 yards of 1-inch tape per month is usually not considered medically necessary.
- Adhesive catheter anchoring devices and catheter leg straps for indwelling urethral catheters are considered medically necessary.
A urinary catheter anchoring device with an adhesive skin attachment has an adhesive surface, which attaches to the member's skin and a mechanism for releasing and re-anchoring the catheter multiple times without changing the device. A urinary catheter anchoring device with a leg strap has a strap, which goes around a member's leg and has a mechanism for releasing and re-anchoring the catheter multiple times without changing the device.
- More than 3 per week of adhesive catheter anchoring devices or 1 catheter leg strap per month is usually not considered medically necessary.
- A catheter/tube anchoring device is considered medically necessary when it is used to anchor a covered suprapubic tube or nephrostomy tube. A catheter/tube anchoring device is considered not medically necessary to anchor an indwelling catheter.
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Urethral inserts are considered medically necessary for adult women with stress incontinence when basic medical necessity criteria are met and the member or caregiver can perform the procedure. They are not indicated for women:
- With bladder or other urinary tract infections (UTI)
- With a history of urethral stricture, bladder augmentation, pelvic radiation or other conditions where urethral catheterization is not clinically advisable
- Who are immunocompromised, at significant risk from UTI, interstitial cystitis, or pyleonephritis, or who have severely compromised urinary mucosa
- Unable to tolerate antibiotic therapy
- On anticoagulants
- With overflow incontinence or neurogenic bladder.
- Extension tubing is considered medically necessary for use with a latex urinary leg bag. Note: Extension tubing is included in the allowance for insertion trays with drainage bags, bedside drainage bags, vinyl urinary drainage bags, and urinary suspensories with leg bags, and should not be separately billed with these items.
- Aetna considers ureteral stents medically necessary for the following indications:
- Before surgery (e.g., gynecologic surgery, rectosigmoid surgery, aortoiliac surgery) to assist with intra-operative identification of the ureter; or
- Following ureteroscopy for ureteral stone disease, ureteral stricture, or treatment of transitional cell carcinoma of the ureter or kidney; or
- Management of ureteral obstruction due to nephrolithiasis, tumor, or retroperitoneal fibrosis; or
- Following the creation of a ureteral anastomosis (i.e., ureteroureterostomy) for repair of ureteral injury (e.g., trauma, iatrogenic), kidney surgery (e.g., pyeloplasty), or renal transplant (i.e., neo-ureterostomy); or
- Protection of a ureteral anastomosis prophylactically before extracorporeal shock wave lithotripsy.
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Experimental, Investigational, or Unproven
Aetna considers the following procedures experimental, investigational, or unproven because the effectiveness of these approaches has not been established:
- Implantation of an absorbable urethral scaffold
- Irrigation solutions containing antibiotics and chemotherapeutic agents
- Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction
- Tibbe Female External Urinary Device (EUD)
- Ureteral stents for all other indications (except for those listed in the "Medical Necessity" section above).
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Policy Limitations and Exclusions
Notes on Non-Covered Supplies
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The following supplies used in the management of incontinence are not covered, other than for home care suppliers who bill for the supplies as part of the home health care visit, because they are not prosthetic devices and are not required for the effective use of a prosthetic device:
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Adhesive remover (Note: these are considered medically necessary for ostomy supplies)
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Catheter care kits
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Catheter clamp or plug
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Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products
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Diapers, drip collectors, or incontinent garments, disposable or reusable
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Disposable underpads (e.g., Chux)
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Drainage bag holder or stand
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Gauze pads and other dressings (may be covered under other benefits, e.g., surgical dressings)
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Measuring container
- Urinary drainage tray
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Urinary suspensory without leg bag
- Other incontinence products not directly related to the use of medically necessary urinary catheter or external urinary collection device.
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The following items are not covered other than for home care suppliers because they are not medical supplies and/or they could be used by the member or the member's family for purposes other than to replace the urine collection and retention function of the bladder:
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Rubber bands
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Rubber gloves
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Scissors
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Sheets.
Note: These lists are not all-inclusive.
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Consistent with DME MAC policy:
Treating practitioner means physician (MD or DO) or physician assistant, nurse practitioner, or clinical nurse specialist. A prosthetist, orthotist, orthotic fitter, pedorthotist, physical therapist, or occupational therapist is not considered a treating practitioner.
A new prescription from the treating practitioner is required each time a new device or repair is requisitioned.
There must be sufficient medical information included in the medical record to demonstrate that all applicable coverage criteria are met.
Consistent with DME MAC policy:
Supplier prepared statements and physician attestations by themselves do not provide sufficient documentation of medical necessity, even if signed by the ordering physician.
"Neither a practitioner’s order, nor a supplier-prepared statement, nor a practitioner’s attestation by itself provides sufficient documentation of medical necessity, even though it is signed by the treating practitioner or supplier. There must be information in the member’s medical record that supports the medical necessity for the item and substantiates the information on a supplier-prepared statement or treating practitioner’s attestation (if applicable)."
"Forms are subject to corroboration with information in the medical record."
Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.
Consistent with DME MAC Policy:
A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not medically necessary.
The SWO must contain all the following elements:
- Member's name or identification number
- Order date
- General description of the item
- The description can be either a HCPCS code, a HCPCS code narrative, or a brand name/model number
- In addition to the description of the base item, the SWO must include all concurrently ordered options, accessories or additional features that are separately billed or require an upgraded code (List each separately).
- For supplies -- In addition to the description of the base item, the order/prescription must include all concurrently ordered supplies that are separately billed (List each separately)
- Each item or service requested must individually list the HCPCS code (Procedure code) and quantity to be dispensed
- Treating practitioner name and national provider identifier (NPI)
- Treating practitioner's signature.
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Background
Urinary drainage systems are used to replace the urine collection, urine retention function and bladder emptying function in individuals with permanent urinary incontinence, urinary obstruction or neurogenic bladder dysfunction resulting from disease, accidental injury, or surgery.
External systems are worn by incontinent male patients in situations where injury to the urethra prohibits use of an indwelling catheter. The external system consists of a latex sheath fitted over the penis and connects directly or with a drainage tube to a urine collection bag strapped to the patient's leg.
Internal systems consist of an indwelling urethral catheter attached to a bag for collection and retention of urine. This system requires flushing or irrigation of the catheter.
Intermittent systems are used for intermittent catheterization of patients who require regularly performed, periodic bladder catheterizations as an alternative to indwelling catheters. An example of one type of intermittent system is a catheter enclosed in a plastic bag permitting lubrication and insertion without touching. The urine is collected in a calibrated lower chamber eliminating the need for a sterile field and gloves. Intermittent systems are identical for male and female patients. When the bladder is emptied, the catheter is withdrawn and the kit is discarded after emptying the urine into a urinal or toilet.
Sterile catheterization technique involves the use of a new, sterile packaged catheter and sterile lubricant for each catheterization. It may also involve use of sterile gloves and drape and use of an antiseptic solution to cleanse the peri-urethral area. Clean, non-sterile intermittent catheterization technique involves the use of soap and water for cleansing of the periurethral area, a reusable catheter that is cleansed between episodes, and non-sterile lubricant.
The inFlow Device
The inFlow Intra-urethral valve pump system is a urinary "prosthesis" comprised of the inFlow device, and the Activator. The inFlow device is a sterile, single-use, intra-urethral valve-pump that is inserted into the female urethra. As a prosthetic device, the inFlow compensates for the inability of women with impaired detrusor contractility (IDC) to generate bladder pressure by pumping the urine out of the urinary bladder, allowing almost normal use of a toilet. Other benefits include reduced rates of infection and encrustation, as well as improved quality of life (QOL). The inFlow urinary prosthesis device is indicated for use by women with permanently impaired detrusor contractility of neurologic origin - a condition where patients care unable to empty their bladder. The inFlow device is a 3- to 7-cm long magnetic pump encased in a silicone tube that has flexible stays to anchor the device at the bladder neck. The pump is packaged with a disposable introducer. Device sizing and initial insertion is performed by a physician. Device insertion is similar to that of a urinary catheter. The device is replaced every 29 days (essentially monthly) by the patient or a care-giver. The activator is a hand-held, patient-operated remote control that operates the internal valve-pump mechanism in the InFlow device. The activator comes with a base station for charging its internal battery. The user sits on the commode, uses the remote control activator to activate the valve-pump, which pumps urine from the bladder through the urethra to empty the bladder.
In a prospective, single-arm, cross-over, multi-center study, Chen and colleagues (2005) compared the safety, effectiveness and patient satisfaction of an intra-urethral valve-pump catheter (In-Flow) versus the current standard of care, clean intermittent catheterization (CIC), for women with hypo-contractile or a-contractile bladder. Eligible patients underwent a 1-week In-Flow tolerability trial. Successful patients then continued through an 8-week baseline phase using CIC, followed by a 16-week In-Flow treatment phase, and a final 4-week treatment withdrawal phase. Outcome measures included post-void residual (PVR), Wagner incontinence-specific QOL (I-QOL), rate of urinary tract infection and adverse events (AEs). At study completion, open enrollment was offered. A total of 273 women with a mean age of 48.9 years using CIC entered the study in 18 centers under either the original (n = 88) or revised protocols (n = 185). The revised protocol included the addition of a 1-week tolerability trial. The reasons for the large early withdrawal of subjects (169/273) were mainly related to initial discomfort and leakage. A total of 77 patients completed the In-Flow treatment phase. PVR was comparable during baseline CIC phase and In-Flow treatment phase (20.3 ml versus 16.1 ml), with significantly improved QOL (mean improvement of I-QOL score +25.9; p < 0.001). The authors concluded that the In-Flow catheter appeared to be a viable alternative to CIC. A subgroup of patients, mainly those unsatisfied with the currently available treatments, was more likely to tolerate In-Flow catheters, and they may achieve enhanced independence and QOL.
Bayrak and Dmochowski (2019) noted that the inflow Intra-urethral Valve-Pump and Activator (collectively called inFlow) device was approved by the Food and Drug Administration (FDA) since 2014. inFlow assists urine drainage in patients who have urinary retention due to underactive bladder (UAB). It is inserted into the urethra and replaced after 29 days. It is a short self-retaining silicone catheter including an internal valve and pump mechanism that uses a miniature magnetically coupled pump activated by a hand-held remote control. When the patient activates the remote control by holding it over her pelvis and pushing the button, urine is actively pumped from the bladder to mimic normal voiding. When the button is released at the end of micturition, a valve is engaged within the device that stops further flow of urine. In a multi-center study of intra-urethral valve-pump catheter in women with a hypo-contractile or a-contractile bladder, Chen et al (2005) compared inFlow versus CIC. A total of 273 women performing CIC were included in the study in 18 centers; with 77 patients completed the inFlow treatment phase. This study showed that inFlow was significantly superior to CIC in its effect on the QOL. More importantly, urinary tract infections (UTIs) rates for inFlow started off slightly lower than those for CIC and reduced with continued usage. inFlow has already been in use in Europe for more than 20 years. It is possible that the decreased UTI rate related to the ability of the inFlow to mimic normal micturition acts by providing periodic, powerful, and total emptying of urine. Furthermore, inFlow is a sterile device that is placed only once-monthly, whereas CIC requires 4 to 6 times daily, each of which increases the risk of bacterial infection.
PureWick Urine Collection System
The PureWick system is a urine collection system that includes the PureWick female external catheter, a flexible, disposable "wick", which is attached to a continuous low-pressure pump, the PureWick urine collection system. The system is designed to gently pull the urine from the external catheter into the sealed collection canister. The female external catheter works outside the body to absorb and wick urine. The wick is replaced every 8-12 hours or if it’s soiled with feces or blood.
Medina et al. (2025) reported the results of a post‑market, prospective, open‑label randomized trial comparing the PureWick external female catheter system with the Hollister Female Urinary Pouch for managing nocturnal urinary incontinence in the home setting. The study aimed to evaluate safety, efficacy, and patient experience. A total of 165 women, most of whom were 65 years or older, were randomized 2:1 to use PureWick or Hollister nightly for four weeks. Nurses conducted home visits to measure urine capture and skin irritation, while participants completed logs and questionnaires on comfort, ease of use, quality of life, and sleep. PureWick achieved noninferiority for both primary endpoints: urine capture rate and skin irritation. Mean capture rates were similar between groups (90.9 percent PureWick vs 87.9 percent Hollister), and skin irritation was minimal in both arms. Participants reported greater comfort and ease of use with PureWick, including easier placement and removal, although these comparisons were exploratory. Both devices were associated with improvements in sleep and quality‑of‑life measures. Limitations included the unblinded design, the reliance on home nurses and participants to adhere to study procedures, protocol deviations reflective of decentralized study conduct, and incomplete data from one site that led to missing primary endpoint measurements. Variability in caregiver assistance, training fidelity, and subjective reporting may also have influenced patient‑reported outcomes. Overall, the authors concluded that this study supports PureWick as a safe, effective, and user‑friendly option for home management of nocturnal urinary incontinence.
A systematic review and meta analysis evaluated the clinical risks and benefits of female external urine wicking devices as alternatives to indwelling urinary catheters in preventing catheter associated urinary tract infections and related complications (Pryor et al., 2024). The authors conducted a comprehensive search of multiple databases including MEDLINE, Embase, Scopus, Web of Science, CINAHL, and ClinicalTrials.gov from inception through July 2023, including randomized and nonrandomized studies that reported urinary tract infection outcomes or secondary measures of incontinence management. Fifty studies met inclusion criteria for qualitative synthesis and a subset of seven studies contributed to meta analyses using random effects models to estimate the impact of device implementation on catheter associated urinary tract infection rates and indwelling catheter utilization. The results demonstrated that implementation of female external urine wicking devices was associated with a statistically significant 14 percent reduction in indwelling catheter utilization, but reductions in catheter associated urinary tract infection rates were not statistically significant overall despite a trend toward decreased incidence. However, among studies with more rigorous implementation protocols, significant reductions in infection rates up to 54 percent were observed, suggesting that structured deployment strategies may be critical to achieving benefit. Secondary outcomes such as skin complications, antibiotic use, mobility related complications, and patient satisfaction were inconsistently reported, although available data suggested generally favorable satisfaction and potential cost savings with device use. The review was limited by the predominance of nonrandomized studies with moderate to serious risk of bias, substantial heterogeneity in study design and implementation protocols, and frequent cointerventions aimed at reducing catheter use that confounded attribution of effect. Additional limitations included inconsistent outcome definitions, sparse reporting of non catheter associated urinary tract infections, potential publication bias, and insufficient adjustment for clustering and sex specific exposure in some analyses. Overall, the evidence suggests that female external urine wicking devices may reduce catheter use and potentially lower infection rates when implemented within structured protocols, but higher quality, standardized research is needed to confirm their effectiveness.
Tibbe Female External Urinary Device (EUD)
The Tibbe™ Female External Urinary Device (EUD) is described as a female external urinary management product intended to collect urine externally without insertion into the body. It is designed to be positioned externally over the female perineal area and connected to a urine collection system, allowing for noninvasive urine diversion and management (CMS, 2026). The device is intended for use by individuals who require assistance with urinary incontinence management or urine collection and is classified as an external urinary device specifically for female anatomy. There are a lack of peer-reviewed published studies of this device.
Implantation of an Absorbable Urologic Scaffold
Implantation of an absorbable urologic scaffold is a surgical technique used during robot-assisted radical prostatectomy (RARP) to immediately support the newly reconstructed bladder neck and urethra, aiming to reduce post-operative stress urinary incontinence (SUI). The scaffold, such as the Voro Urologic Scaffold (Levee Medical), acts as a temporary framework, providing radial support and lengthening the urethra at the site of the anastomosis.
A first-in-human early feasibility study evaluated the safety and preliminary effectiveness of an absorbable urologic scaffold placed during robot-assisted radical prostatectomy (RARP) to reduce post-operative stress urinary incontinence (SUI) (Gahan et al., 2026). The study’s objective was to assess whether an implantable, fully absorbable scaffold could improve early continence outcomes by providing structural support to the bladder neck and urethral stump following prostate removal. The investigators conducted a prospective, single-center, non-randomized, single-arm early feasibility trial (ARID study), enrolling adult men with localized prostate cancer undergoing RARP. The scaffold was implanted intraoperatively, and patients were followed for up to 6 months. Safety endpoints included adverse events classified using CTCAE criteria, while efficacy was primarily assessed using rigorous 24-hour pad weight testing to define continence (return to baseline pad weight within predefined error margins), with additional 1-hour pad weight testing as a secondary measure. Among 24 evaluable patients (mean age ~63 years), no device-related adverse events or unanticipated safety concerns were observed, and all reported adverse events were attributed either to the surgical procedure or unrelated causes. Continence outcomes were favorable, with approximately 47% of patients continent at catheter removal, 52% at 6 weeks, and 72–76% at 6 months using 24-hour pad weight criteria. Notably, a sub-analysis demonstrated substantially higher continence rates among patients with optimal scaffold placement, reaching up to 92.9% at 6 months, whereas suboptimal placement resulted in markedly poorer outcomes. These findings suggest that the device may reduce early SUI compared with historical outcomes when properly deployed, although the study was not powered for definitive efficacy conclusions. Several important limitations temper interpretation of these results. The study lacked a randomized control group and had a small sample size typical of feasibility trials, limiting statistical power and generalizability. The non-randomized design introduces potential selection bias, and strict inclusion/exclusion criteria further reduce applicability to broader clinical populations. Variability in device placement technique affected outcomes, and missing data at certain time points may have influenced reported continence rates. Additionally, follow-up was limited to 6 months, precluding assessment of long-term durability and safety.
Appendix
Payment for items listed in Column II are included in the payment for the Column I. In the following table, when providing the items listed in Column II, the item in Column I must be billed instead of billing items in Column II separately when the items are provided at the same time.
| Column I | Column II |
|---|---|
| Insertion tray without drainage bag and without catheter (accessories only) | Lubricant, individual sterile packet, each |
| Insertion tray without drainage bag with indwelling catheter, foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophylic, etc.) | Insertion tray without drainage bag and without catheter (accessories only) Lubricant, individual sterile packet, each Indwelling catheter; foley type, two-way latex with coating (Teflon, silicone, silicone elastomer, or hydrophilic, etc.), each |
| Insertion tray without drainage bag with indwelling catheter, foley type, two-way, all silicone | Insertion tray without drainage bag and without catheter (accessories only)
Lubricant, individual sterile packet, each Urinary catheter anchoring device, leg strap, each |
| Insertion tray without drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation | Insertion tray without drainage bag and without catheter (accessories only)
Lubricant, individual sterile packet, each Indwelling catheter; foley type, three way for continuous irrigation, each |
| Insertion tray with drainage bag with indwelling catheter, foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) | Insertion tray without drainage bag and without catheter (accessories only) Lubricant, individual sterile packet, each |
| Insertion tray with drainage bag with indwelling catheter, foley type, two-way, all silicone | Insertion tray without drainage bag and without catheter (accessories only)
Insertion tray without drainage bag with indwelling catheter, foley type, two-way, all silicone Lubricant, individual sterile packet, each Urinary catheter anchoring device, leg strap, each Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each Insertion tray with drainage bag but without catheter Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each |
| Insertion tray with drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation | Insertion tray without drainage bag and without catheter (accessories only)
Insertion tray without drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation Lubricant, individual sterile packet, each Indwelling catheter; foley type, three way for continuous irrigation, each Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each Insertion tray with drainage bag but without catheter Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each |
| Insertion tray with drainage bag but without catheter | Insertion tray without drainage bag and without catheter (accessories only)
Lubricant, individual sterile packet, each Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each |
| Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each | Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each |
| Urinary drainage bag, leg or abdomen, vinyl, with or without tube, with straps, each | Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each
Leg strap; latex, replacement only, per set Leg strap; foam or fabric, replacement only, per set |
|
Urinary suspensory with leg bag, with or without tube, each |
Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each
Urinary drainage bag, leg or abdomen, vinyl, with or without tube, with straps, each Urinary drainage bag, leg or abdomen, latex, with or without tube, with straps, each Leg strap; latex, replacement only, per set Leg strap; foam or fabric, replacement only, per set |
| Urinary drainage bag, leg or abdomen, latex, with or without tube, with straps, each | Leg strap; latex, replacement only, per set Leg strap; foam or fabric, replacement only, per set |
References
The above policy is based on the following references:
- Bayrak O, Dmochowski RR. Underactive bladder: A review of the current treatment concepts. Turk J Urol. 2019;45(6):401-409.
- Becton, Dickinson and Company (BD). PureWick Urine Collection System [website]. Franklin Lakes, NJ: BD; 2020. Available at: https://www.purewickathome.com/how-does-purewick-work.html?srsltid=AfmBOoqL0bwjGi4zJMWGVu9hL36s0eCRtCCsCUqDtaft2L4sxZXGqZq8. Accessed May 11, 2026.
- Belsfield PW. Urinary catheters. Br Med J. 1988;296(6625):837-837.
- Centers for Medicare & Medicaid Services (CMS). Future local coverage determination (LCD): Urological supplies (L33803). Baltimore, MD: CMS; revision effective date July 26, 2020.
- Centers for Medicare & Medicaid Services (CMS). Future local coverage article: Urological supplies (A52521). Baltimore, MD: CMS; revision effective date July 26, 2020.
- Chen T Y-H, Ponsot Y, Carmel M, et al. Multi-centre study of intraurethral valve-pump catheter in women with a hypocontractile or acontractile bladder. Eur Urol. 2005;48(4):628-633.
- Cravens DD, Zweig S. Urinary catheter management. Am Fam Physician. 2000;61(2):369-376.
- Gahan JC, Espino G, Young M, et al. Initial results with an absorbable urologic scaffold to mitigate early urinary incontinence following radical prostatectomy: The ARID study. World J Urol. 2026;44:106.
- Johnson JR. Safer urinary catheterization. Contemp Intern Med. 1992;4(1):47-54.
- Medina JC, Fakih M, Khalsa S, et al. Safety, efficacy, and patient‑reported outcomes of the PureWick System versus comparator for nocturnal urinary incontinence in the home setting: Results of a randomized trial. J Clin Med. 2025;14:8699.
- NHIC, Corp. Urologic supplies. Policy Article No. A25230. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdication A. Hingham, MA: NHIC; revised February 4, 2011.
- NHIC, Corp. Urological supplies. Local Carrier Determination (LCD) No. L5080. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A. Hingham, MA: NHIC; revised February 4, 2011.
- Niel-Weise BS, Arend SM, van den Broek PJ. Is there evidence for recommending silver-coated urinary catheters in guidelines? J Hosp Infect. 2002;52(2):81-87.
- Noridian Medicare. Local coverage determination (LCD): Urological supplies (L33803). Fargo, ND: Noridian; 2020.
- Pryor N, Wang JC, Young J, et al. Clinical outcomes of female external urine wicking devices as alternatives to indwelling catheters: a systematic review and meta-analysis. Infect Control Hosp Epidemiol. 2024;45(9):1121-1129.
- Resnick NM. Geriatric incontinence. Urol Clin North Am. 1996;23(1):55-74.
- Shandera KC, Thompson IM. Urologic prostheses. Emerg Med Clin North Am. 1994;12(3):729-748.
- U.S. Department of Health and Human Services, Agency for Healthcare Policy and Research (AHCPR). Urinary incontinence in adults: Acute and chronic management. Clinical Practice Guideline No. 2. Rockville, MD: AHCPR; March 1996.
- U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Prosthetic devices. Medicare Carriers Manual §2130. Baltimore, MD: HCFA; 1999.
- Warren JW. Catheter-associated urinary tract infections. Infect Dis Clin North Am. 1997;11(3):609-622.
- Warren JW. Catheters and catheter care. Clin Geriatr Med. 1986;2(4):857-871.
- White HM. Choosing continence aids. Br J Nurs. 1994;3(22):1158, 1160, 1162-1163.
- Winn C, Thompson J. Urinary catheters for intermittent use. Prof Nurse. 1999;14(12):859-865.
- Wyndaele JJ. Complications of intermittent catheterization: Their prevention and treatment. Spinal Cord. 2002;40(10):536-541.
