Urological Supplies

Number: 0533

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses urological supplies.

1. 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.

   1. Indwelling Catheters

      1. 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:
         
         
         1. Catheter is accidentally removed (e.g., pulled out by member); or
         2. Catheter is obstructed by encrustation, mucous plug, or blood clot;or
         3. Catheter malfunctions (e.g., balloon does not stay inflated, hole in catheter);or
         4. 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.
      2. 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.
      3. A 3-way indwelling catheter either alone or with other components is considered medically necessary only if continuous catheter irrigation is medically necessary.

   2. 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.

   3. Urinary Drainage Collection Systems

      1. 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

      2. 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.
      3. Either a vinyl leg bag or a latex leg bag is considered medically necessary; the use of both is not considered medically necessary.
      4. 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.
      5. The value drainage bags containing absorbant material such as gel matrix or other material, which are intended to be disposed of on a daily basis, has not been proven.

   4. 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.

   5. 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.

   6. Intermittent Catheterization

      Intermittent catheterization is considered medically necessary when basic medical necessity criteria are met and the member or caregiver can perform the procedure.

      1. Intermittent catheterization using sterile technique is considered medically necessary when the member requires catheterization and the member meets any of the following criteria:
         
         
         1. The member resides in a nursing facility; or
         2. The member is immunosuppressed, for example (not all inclusive):
            
            
            1. Has AIDS,
            2. Has a drug-induced state such as chronic oral corticosteroid use,
            3. On a regimen of immunosuppressive drugs post-transplant,
            4. On cancer chemotherapy; or
               
         3. The member has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or
         4. The member is a spinal cord-injured female with neurogenic bladder who is pregnant (for duration of pregnancy only); or
         5. 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.

      2. 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, indiividual 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 cather with inseration supplies kit.

      3. For each episode of medically necessary sterile catheterization, Aetna considers medically necessary either
         1. catheter plus an individual packet of lubricant, or
         2. 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.

   7. 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.

      1. Generally, no more than 35 male external catheters are considered medically necessary per month.
      2. Note: 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.
      3. 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.
      4. 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.
      5. 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.

      6. Aetna considers the PureWick urine collection system unproven and not medically necessary for the management of urinary incontinence.

   8. 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:

      1. An in-person encounter by the treating practitioner with documentation that urinary symptoms are improved; and
      2. 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.

   9. Miscellaneous Supplies

      1. 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.
      2. One external urethral clamp or compression device is considered medically necessary every 3 months or sooner if the rubber/foam casing deteriorates.
      3. 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.
      4. 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.

         1. More than 3 per week of adhesive catheter anchoring devices or 1 catheter leg strap per month is usually not considered medically necessary. 
         2. A catheter/tube anchoring device is considered medically necessary when it is used to anchor a covered suprapubic tube or nephrostomy tube. A cather/tube anchoring device is considered not medically necessary to anchor an indwelling catheter.
      5. 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.
      6. 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.
      7. Aetna considers ureteral stents medically necessary for the following indications:
         
         
         • Before surgery (eg, 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 (ie, ureteroureterostomy) for repair of ureteral injury (eg, trauma, iatrogenic), kidney surgery (eg, pyeloplasty), or renal transplant (ie, neo-ureterostomy); or
         • Protection of a ureteral anastomosis prophylactically before extracorporeal shock wave lithotripsy.

2. Experimental and Investigational

   The following procedures are considered experimental and investigational because the effectiveness of these approaches has not been established:

   1. Irrigation solutions containing antibiotics and chemotherapeutic agents
   2. Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction
   3. Ureteral stents for all other indications (except for those listed in the "Medical Necessity" section above).

3. Policy Limitations and Exclusions

   Notes on Non-Covered Supplies

   1. 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:
      
      
      1. Adhesive remover (Note: these are considered medically necessary for ostomy supplies)
      2. Catheter care kits
      3. Catheter clamp or plug
      4. Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products
      5. Diapers, drip collectors, or incontinent garments, disposable or reusable
      6. Disposable underpads (e.g., Chux)
      7. Drainage bag holder or stand
      8. Gauze pads and other dressings (may be covered under other benefits, e.g., surgical dressings)
      9. Measuring container
      10. Urinary drainage tray
      11. Urinary suspensory without leg bag
      12. Other incontinence products not directly related to the use of medically necessary urinary catheter or external urinary collection device.
   2. 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:
      
      
      1. Rubber bands
      2. Rubber gloves
      3. Scissors
      4. Sheets.

      Note: These lists are not all-inclusive.

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
HCPCS codes covered if selection criteria are met::
A4310	Insertion tray without drainage bag and without catheter (accessories only) [maximum 1 per month for indwelling, not medically necessary for CIC] [includes A4332]
A4311	Insertion tray without drainage bag with indwelling catheter, Foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4332, A4338]
A4312	Insertion tray without drainage bag with indwelling catheter, Foley type, two-way, all silicone [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4332, A4344]
A4313	Insertion tray without drainage bag with indwelling catheter, Foley type, three-way, for continuous irrigation [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4332, A4346]
A4314	Insertion tray with drainage bag with indwelling catheter, Foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4311, A4331, A4332, A4338, A4354, A4357]
A4315	Insertion tray with drainage bag with indwelling catheter, Foley type, two-way, all silicone [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4312, A4331, A4332, A4344, A4354, A4357]
A4316	Insertion tray with drainage bag with indwelling catheter, Foley type, three-way, for continuous irrigation [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4313, A4331, A4332, A4346, A4354, A4357]
A4326	Male external catheter with integral collection chamber, any type, each [alternative to indwelling only - for members with permanent incontinence]
A4327	Female external urinary collection device; metal cup, each [alternative to indwelling only - for members with permanent incontinence] [maximum 1 cup per week]
A4328	Female external urinary collection device; pouch, each [alternative to indwelling only - for members with permanent incontinence] [maximum 1 pouch per day]
A4331	Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each [included in allowance for insertion trays with drainage bags, bedside drainage bags, vinyl urinary drainage bags, and urinary suspensorys with leg bags]
A4333	Urinary catheter anchoring device, adhesive skin attachment, each [maximum 3 per week]
A4334	Urinary catheter anchoring device, leg strap, each [maximum 3 per week]
A4338	Indwelling catheter; Foley type; two-way latex with coating (Teflon, silicone, silicone elastomer, or hydrophilic, etc.), each [maximum 1 per month]
A4340	Indwelling catheter; specialty type (e.g., Coude, mushroom, wing, etc.), each [maximum 1 per month] [when member is unable to use a straight foley type catheter with coating due to encrustation, inability to pass, or latex sensitivity, etc.] [Coude for females is rarely medically necessary]
A4344	Indwelling catheter; Foley type, two-way, all silicone, each [when member is unable to use a straight foley type catheter with coating due to encrustation, inability to pass, or latex sensitivity, etc.]
A4346	Indwelling catheter; Foley type, three-way for continuous irrigation, each [only when continuous catheter irrigation is medically necessary]
A4349	Male external catheter, with or without adhesive, disposable, each [alternative to indwelling only - for members with permanent incontinence] [maximum 35 per month] [includes adhesive strips]
A4351	Intermittent urinary catheter; straight tip, with or without coating (Teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each [see criteria]
A4352	Intermittent urinary catheter; Coude (curved) tip, with or without coating (Teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each [see criteria] [rarely necessary for females]
A4353	Intermittent urinary catheter, with insertion supplies [see criteria] [includes A4310, A4332, A4351, A4352]
A4354	Insertion tray with drainage bag but without catheter [maximum 1 per month] [includes A4310, A4331, A4332, A4357]
A4355	Irrigation tubing set for continuous bladder irrigation through a three-way indwelling Foley catheter, each [see criteria] [maximum 1 per day, up to 2 weeks total]
A4356	External urethral clamp or compression device (not to be used for catheter clamp), each [maximum 1 per 3 months unless the rubber/foam casing deteriorates]
A4357	Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each [maximum 2 per month] [includes A4331]
A4358	Urinary drainage bag, leg or abdomen, vinyl, with or without tube, with straps, each [for members who are ambulatory or chair or wheelchair bound-not bedridden] [maximum 2 per month] [either vinyl or latex-not both] [includes A4331, A5113, A5114]
A4452	Tape, waterproof, per 18 square inches [included with male external catheters with adhesive strips or adhesive coating] [maximum 5 yards per month]
A5102	Bedside drainage bottle, with or without tubing, rigid or expandable, each [maximum 1 per 3 months]
A5105	Urinary suspensory; with or without leg bag, with or without tube, each [includes A4331, A4358, A4359, A5112, A5113, A5114]
A5112	Urinary leg bag; latex [for members who are ambulatory or chair or wheelchair bound-not bedridden] [maximum 1 per month] [either vinyl or latex-not both] [includes A5113, A5114]
A5113	Leg strap; latex, replacement only, per set [maximum 1 per month]
A5114	Leg strap; foam or fabric, replacement only, per set [maximum 1 per month]
A5131	Appliance cleaner, incontinence and ostomy appliances, per 16 oz. [maximum 1 per month]
T4545	Incontinence product, disposable, penile wrap, each
HCPCS codes not covered for indications listed in the CPB [other than for home care suppliers]:
A4245	Alcohol wipes, per box
A4247	Betadine or iodine swabs/wipes, per box
A4321	Therapeutic agent for urinary catheter irrigation [acetic acid, hydrogen peroxide, or other agent for urinary irrigation solution]
A4335	Incontinence supply; miscellaneous [creams, salves, lotions, spray, powders, pastes, catheter care kits, catheter clamps or plugs, drip collectors, drainage bag holders or stands, measuring containers, rubber bands, sheets, scissors]
A4455	Adhesive remover or solvent (for tape, cement or other adhesive), per oz. [except for ostomies]
A4520	Incontinence garment, any type, (e.g., brief, diaper), each
A4554	Disposable underpads, all sizes (e.g., Chux's)
A4649	Surgical supply; miscellaneous [except cream, salves, lotions, spray, powders, pastes, catheter care kits, catheter clamps or plugs, drip collectors, drainage bag holders or stands, measuring containers, rubber bands, sheets, scissors]
A4927	Gloves, non-sterile, per 100
A4930	Gloves, sterile, per pair
A5120	Skin barrier, wipes or swabs, each
A5121	Skin barrier, solid, 6 x 6 or equivalent, each
A5122	Skin barrier, solid, 8 x 8 or equivalent, each
A5126	Adhesive or non-adhesive; disk or foam pad
A5200	Percutaneous catheter/tube anchoring device, adhesive skin attachment [maximum 3 per week] [not medically necessary to anchor an indwelling catheter]
A6216 - A6233	Gauze pads [may be covered under other benefits]
A6250	Skin sealants, protectants, moisturizers, ointments, any type, any size
A6266 - A6404	Gauze [may be covered under other benefits]
A6441	Padding bandage, non-elastic, non-woven/non-knitted, width greater than or equal to 3 in. and less than 5 in., per yard [may be covered under other benefits]
A6442 - A6447	Conforming bandage [may be covered under other benefits]
A6448 - A6452	Compression bandage [may be covered under other benefits]
A6453 - A6455	Self-adherent bandage [may be covered under other benefits]
A6456	Zinc paste impregnated bandage, non-elastic, knitted/woven, width greater than or equal to 3 in. and less than 5 in., per yard
A6590	External urinary catheters; disposable, with wicking material, for use with suction pump, per month
A6591	External urinary catheter; non-disposable, for use with suction pump, per month
A9270	Non-covered item or service [irrigation solutions containing antibiotics and chemotherapeutic agents]
A9999	Miscellaneous DME supply or accessory, not otherwise specified [catheter care kits, catheter clamps or plugs, drip collectors, drainage bag holders or stands, measuring containers, rubber bands, sheets, scissors]
C1765	Adhesion barrier
K1006	Suction pump, home model, portable or stationary, electric, any type, for use with external urine management system
T4521	Adult sized disposable incontinence product, brief/diaper, small, each
T4522	Adult sized disposable incontinence product, brief/diaper, medium, each
T4523	Adult sized disposable incontinence product, brief/diaper, large, each
T4524	Adult sized disposable incontinence product, brief/diaper, extra large, each
T4525	Adult sized disposable incontinence product, protective underwear/pull-on, small size, each
T4526	Adult sized disposable incontinence product, protective underwear/pull-on, medium size, each
T4527	Adult sized disposable incontinence product, protective underwear/pull-on, large size, each
T4528	Adult sized disposable incontinence product, protective underwear/pull-on, extra large size, each
T4529	Pediatric sized disposable incontinence product, brief/diaper, small/medium size, each
T4530	Pediatric sized disposable incontinence product, brief/diaper, large size, each
T4531	Pediatric sized disposable incontinence product, protective underwear/pull-on, small/medium size, each
T4532	Pediatric sized disposable incontinence product, protective underwear/pull-on, large size, each
T4533	Youth sized disposable incontinence product, brief/diaper, each
T4534	Youth sized disposable incontinence product, protective underwear/pull-on, each
T4535	Disposable liner/shield/guard/pad/undergarment, for incontinence, each
T4536	Incontinence product, protective underwear/pull-on, reusable, any size, each
T4537	Incontinence product, protective underpad, reusable, bed size, each
T4538	Diaper service, reusable diaper, each diaper
T4539	Incontinence product, diaper/brief, reusable, any size, each
T4540	Incontinence product, protective underpad, reusable, chair size, each
T4541	Incontinence product, disposable underpad, large, each
T4542	Incontinence product, disposable underpad, small size, each
T4543	Adult sized disposable incontinence product, protective brief/diaper, above extra large, each
T4544	Adult sized disposable incontinence product, protective underwear/pull-on, above extra large, each
Other HCPCS codes related to the CPB:
A4216	Sterile water, saline, and/or dextrose, diluent/flush, 10 ml [for as needed/non-routine irrigation] [not for skin or perineum care]
A4217	Sterile water/saline, 500 ml [for as needed/non-routine irrigation] [not for skin or perineum care]
A4320	Irrigation tray with bulb or piston syringe, any purpose [as needed/non-routine basis] [not for skin or perineum care]
A4322	Irrigation syringe, bulb or piston, each [as needed/non-routine basis] [not for skin or perineum care]
A4332	Lubricant, individual sterile packet, each [not medically necessary for CIC]
A4402	Lubricant, per oz. [maximum 8 ounces of non-sterile lubricating gel is per month for CIC]
A4450	Tape, non-waterproof, per 18 square inches [included with male external catheters with adhesive strips or adhesive coating] [maximum 5 yards per month]
A4452	Tape, waterproof, per 18 square inches [included with male external catheters with adhesive strips or adhesive coating] [maximum 5 yards per month]
ICD-10 codes covered if selection criteria are met:
N31.0 - N31.9	Neuromuscular dysfunction of bladder, not elsewhere classified
N32.81	Overactive bladder [impaired detrusor contractility]
N32.89	Other specified disorders of bladder
N39.3 - N39.498	Stress and other specified urinary incontinence [expected to be 3 months duration or more]
R32	Unspecified urinary incontinence [expected to be 3 months duration or more]
R33.0 - R33.9	Retention of urine [expected to be 3 months duration or more]
R39.14	Feeling of incomplete blader emptying
The inFlow Device:
CPT codes covered if selection criteria are met:
0596T	Temporary female intraurethral valve-pump (ie, voiding prosthesis); initial insertion, including urethral measurement
0597T	replacement
HCPCS codes covered if selection criteria are met:
A4341	Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each
A4342	Accessories for patient inserted indwelling intraurethral drainage device with valve, replacement only, each
ICD-10 codes covered if selection criteria are met:
N32.81	Overactive bladder [impaired detrusor contractility]
R33.0 - R33.9	Retention of urine
Ureteral stents:
HCPCS codes covered if selection criteria are met:
C1875	Stent, coated/covered, without delivery system
C2617	Stent, non-coronary, temporary, without delivery system
Other CPT codes related to the CPB:
34701 - 34834	Endovascular Repair of Abdominal Aorta and/or Iliac Arteries [aortoiliac surgery]
45000 - 45999	Colon and Rectum Surgery [rectosigmoid surgery]
50300	Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or bilateral
50320	Donor nephrectomy (including cold preservation); open, from living donor
50323	Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary
50325	Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary
50327	Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each
50328	Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; arterial anastomosis, each
50329	Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; ureteral anastomosis, each
50340	Recipient nephrectomy (separate procedure)
50360	Renal allotransplantation, implantation of graft; without recipient nephrectomy
50365	Renal allotransplantation, implantation of graft; with recipient nephrectomy
50370	Removal of transplanted renal allograft
50380	Renal autotransplantation, reimplantation of kidney
50400	Pyeloplasty (Foley Y-pyeloplasty), plastic operation on renal pelvis, with or without plastic operation on ureter, nephropexy, nephrostomy, pyelostomy, or ureteral splinting; simple
50405	Pyeloplasty (Foley Y-pyeloplasty), plastic operation on renal pelvis, with or without plastic operation on ureter, nephropexy, nephrostomy, pyelostomy, or ureteral splinting; complicated (congenital kidney abnormality, secondary pyeloplasty, solitary kidney, calycoplasty)
50540	Symphysiotomy for horseshoe kidney with or without pyeloplasty and/or other plastic procedure, unilateral or bilateral (1 operation)
50544	Laparoscopy, surgical; pyeloplasty
50547	Laparoscopy, surgical; donor nephrectomy (including cold preservation), from living donor
50575	Renal endoscopy through nephrotomy or pyelotomy, with or without irrigation, instillation, or ureteropyelography, exclusive of radiologic service; with endopyelotomy (includes cystoscopy, ureteroscopy, dilation of ureter and ureteral pelvic junction, incision of ureteral pelvic junction and insertion of endopyelotomy stent)
50590	Lithotripsy, extracorporeal shock wave
50740	Ureteropyelostomy, anastomosis of ureter and renal pelvis
50750	Ureterocalycostomy, anastomosis of ureter to renal calyx
50770	Transureteroureterostomy, anastomosis of ureter to contralateral ureter
50780	Ureteroneocystostomy; anastomosis of single ureter to bladder
50782	Ureteroneocystostomy; anastomosis of duplicated ureter to bladder
50800	Ureteroenterostomy, direct anastomosis of ureter to intestine
52005	Cystourethroscopy, with ureteral catheterization, with or without irrigation, instillation, or ureteropyelography, exclusive of radiologic service
52332	Cystourethroscopy, with insertion of indwelling ureteral stent (eg, Gibbons or double-J type)
52341	Cystourethroscopy; with treatment of ureteral stricture (eg, balloon dilation, laser, electrocautery, and incision)
52344	Cystourethroscopy with ureteroscopy; with treatment of ureteral stricture (eg, balloon dilation, laser, electrocautery, and incision)
52345	Cystourethroscopy with ureteroscopy; with treatment of ureteropelvic junction stricture (eg, balloon dilation, laser, electrocautery, and incision)
52346	Cystourethroscopy with ureteroscopy; with treatment of intra-renal stricture (eg, balloon dilation, laser, electrocautery, and incision)
52351	Cystourethroscopy, with ureteroscopy and/or pyeloscopy; diagnostic
52352	Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with removal or manipulation of calculus (ureteral catheterization is included)
52353	Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral catheterization is included)
52354	Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with biopsy and/or fulguration of ureteral or renal pelvic lesion
52355	Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with resection of ureteral or renal pelvic tumor
52356	Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy including insertion of indwelling ureteral stent (eg, Gibbons or double-J type)
56405 - 58999	Female Genital System Surgery [gynecologic surgery]
ICD-10 codes covered if selection criteria are met:
C64.1 - C64.9	Malignant neoplasm of kidney, except renal pelvis
C65.1 - C65.9	Malignant neoplasm of renal pelvis
C66.1 - C66.9	Malignant neoplasm of ureter
D30.20 - D30.22	Benign neoplasm of ureter
D41.20 - D41.22	Neoplasm of uncertain behavior of ureter
N13.1	Hydronephrosis with ureteral stricture, not elsewhere classified
N13.2	Hydronephrosis with renal and ureteral calculous obstruction
N13.5	Crossing vessel and stricture of ureter without hydronephrosis
N20.0	Calculus of kidney
N20.1	Calculus of ureter
S37.10 - S37.19	Injury of ureter

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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.

Ureteral Stents

An UpToDate review on “Placement and management of indwelling ureteral stents” (Nakada and Patel, 2019) states that “Ureteral stents are indicated for the management of ureteral obstruction, to protect a ureteral anastomosis prophylactically prior to extracorporeal shock wave lithotripsy (ESWL), following complicated ureteroscopy, or prior to surgery to assist with intraoperative identification of the ureter”.

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.

There are no peer-reviewed published literature specific to the PureWick system, or external urinary collection system using a continuous low-pressure pump. Thus, there is no evidence to show the PureWick system to be as an equally effective alternative in managing urinary incontinence.

The revised July 2020 Noridian Medicare Local Coverage Determination (LCD) for urological supplies (L33803) does not include HCPCS code E0740 coverage details.

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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.

Table: Urological Supplies Billing Items

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 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 latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) 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, 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

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References