Urological supplies consist of catheters and urinary collection devices. Urinary catheters and external urinary collection devices are covered to drain or collect urine for a patient who has 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 patient within three months.

For any item to be covered, it must (1) be eligible for a defined Medicare benefit category, (2) be reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member, and (3) meet all other applicable Medicare statutory and regulatory requirements.  For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

The medical necessity for use of a greater quantity of supplies than the amounts specified in the policy must be well documented in the patient’s medical record and must be available upon request.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Indwelling Catheters (A4311-A4316, A4338-A4346):

No more than one catheter per month is covered for routine catheter maintenance.  Non-routine catheter changes are covered when documentation substantiates medical necessity, such as for the following indications:

1. Catheter is accidentally removed (e.g., pulled out by patient)
2. Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter)
3. Catheter is obstructed by encrustation, mucous plug, or blood clot
4. History of recurrent obstruction or urinary tract infection for which it has been established that an acute event is prevented by a scheduled change frequency of more than once per month.

A specialty indwelling catheter (A4340) or an all silicone catheter (A4344, A4312 or A4315) is covered when the criteria for an indwelling catheter (above) are met and there is documentation in the patient's medical record to justify the medical need for that catheter (such as recurrent encrustation, inability to pass a straight catheter, or sensitivity to latex (not all-inclusive).  In addition, the particular catheter must be necessary for the patient.  For example, use of a Coude (curved) tip indwelling catheter (A4340) in female patients is rarely reasonable and necessary.  If documentation is requested and does not substantiate medical necessity, payment for A4340, A4344, A4312, A4315 will be denied as not reasonable and necessary.

A three way indwelling catheter either alone (A4346) or with other components (A4313 or A4316) will be covered only if continuous catheter irrigation is medically necessary. In other situations, A4346, A4313 and A4316 will denied as not medically necessary.

Catheter Insertion Tray (A4310-A4316, A4353, and A4354):

One insertion tray will be covered per episode of indwelling catheter insertion.  More than one tray per episode will be denied as not medically necessary. 

One intermittent catheter with insertion supplies (A4353) will be covered per episode of medically necessary sterile intermittent catheterization.

Catheter insertion trays (A4310-A4316, A4353 and A4354) that contain component parts of the urinary collection system, (e.g., drainage bags and tubing) are inclusive sets and payment for additional component parts will be allowed only per the stated criteria in each section of the policy.

Urinary Drainage Collection System (A4314-A4316, A4354, A4357, A4358, A5102 and A5112):

Payment will be made for routine changes of the urinary drainage collection system.  Additional charges will be allowed for medically necessary non-routine changes when the documentation substantiates the medical necessity, (e.g., obstruction, sludging, clotting of blood or chronic, recurrent urinary tract infection).

Usual Maximum Quantity of Supplies:

Code #/Month
A4314 (1)
A4315 (1)
A4316 (1)
A4354 (1)
A4357 (2)
A4358 (2)
A5112 (1)

Code #/3Month
A5102 (1)

Leg bags are indicated for patients who are ambulatory or are chair or wheelchair bound.  The use of leg bags for bedridden patients would be denied as not medically necessary. 

If there is a catheter change (A4314-A4316, A4354) and an additional drainage bag (A4357) change within a month, the combined utilization for A4314-A4316, A4354 and A4357 should be considered when determining if additional documentation should be submitted with the claim.  For example, if one unit of A4314 and one unit of A4357 are provided, this should be considered as two drainage bags, which is the usual maximum quantity of drainage bags needed for routine changes. 

Payment will be made for either a vinyl leg bag (A4358) or a latex leg bag (A5112).  The use of both is not medically necessary. Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

The medical necessity for 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 established.  Claims for this type of bag will be denied as not medically necessary.

Intermittent Irrigation of Indwelling Catheters:

Supplies for the intermittent irrigation of an indwelling catheter are covered 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 will be denied as not medically necessary.  Routine irrigations are defined as those performed at predetermined intervals.  In individual cases, a copy of the order for irrigation and documentation in the patient’s medical record of the presence of acute catheter obstruction may be requested when irrigation supplies are billed.

Covered supplies for medically necessary non-routine irrigation of a catheter include either an irrigation tray (A4320) or an irrigation syringe (A4322), and sterile water/saline (A4217). 

Continuous Irrigation of Indwelling Catheters:

Supplies for continuous irrigation of a catheter are covered if there is a history of obstruction of the catheter and the patency of the catheter cannot be maintained by intermittent irrigation in conjunction with medically necessary catheter changes.  Continuous irrigation as a primary preventative measure (i.e., no history of obstruction) will be denied as not medically necessary. 

Documentation must substantiate the medical necessity of catheter irrigation and in particular continuous irrigation as opposed to intermittent irrigation.  The records must also indicate the rate of solution administration and the duration of need.  This documentation must be available upon request. 

Covered supplies for medically necessary continuous bladder irrigation include a three-way Foley catheter (A4313, A4316, and A4346), irrigation tubing set (A4355) and sterile water/saline (A4217). More than one irrigation tubing set per day for continuous catheter irrigation will be denied as not medically necessary. 

Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non-covered. The provider cannot bill the member for the denied service. Payment for irrigation solutions such as acetic acid or hydrogen peroxide will be based on the allowance for sterile water/saline (A4217).

Continuous irrigation is a temporary measure.  Continuous irrigation for more than two weeks is rarely medically necessary.  The patient’s medical records should indicate this medical necessity and these medical records must be available upon request.

Intermittent Catheterization:

Intermittent catheterization is covered when basic coverage criteria are met and the patient or caregiver can perform the procedure. 

For each episode of covered sterile catheterization, the following will be covered:

• One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or,
• One sterile intermittent catheter kit (A4353), if additional coverage criteria (see below) are met.

The kit code should be used for billing even if the components are packaged separately rather than together as a kit.  A4353 must not be billed if individual components (i.e., insertion tray, lubricated and catheter) are provided as separate items, rather than in a single sterile package.  When providing a sterile kit, the individual component must not be separately billed.

Intermittent catheterization using a sterile intermittent catheter kit (A4353) is covered when the patient requires catheterization and the patient meets one of the following criteria:

• The patient resides in a nursing facility,
• The patient is immunosuppressed, for example (not all-inclusive): 

-on a regimen of immunosuppressive drugs post-transplant,
-on cancer chemotherapy,
-has AIDS, or
-has a drug-induced state such as chronic oral corticosteroid use

• The patient has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,
• The patient is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only),
• The patient has had distinct, recurrent urinary tract infections, while on a program of sterile intermittent catheterization with A4351/A4352 and sterile lubricant A4332, twice within the 12-months prior to the initiation of sterile intermittent catheterization.

A patient 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 one or more of the following signs, symptoms or laboratory findings:

• Fever (oral temperature greater than 38° C [100.4° F])
• Systemic leukocytosis
• Change in urinary urgency, frequency or incontinence
• Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation)
• Physical signs of prostatitis, epididymitis, orchitis
• Increased muscle spasms
• Pyuria greater than five white blood cells (WBCs) per high powered field

The following table represents the usual maximum number of supplies:

Code #/Month
A4332 (200)
A4351 (200)
A4352 (200)
A4353 (200)

Use of a Coude (curved) tip catheter (A4352) in female patients is rarely medically necessary.  When a Coude tip catheter is used (either male or female patients), there must be documentation in the patient’s medical record of the medical necessity for that catheter.  An example would be the inability to catheterize with a straight tip catheter.  This documentation must be available upon request.  If documentation is requested and does not substantiate medical necessity, claims will be denied as not medically necessary.

External Catheters/Urinary Collection Devices:

Male external catheters (condom-type) or female external urinary collection devices are covered for patients who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

The utilization of male external catheters (A4349) generally should not exceed 35 per month. Greater utilization of these devices must be accompanied by documentation of medical necessity.

Male external catheters (condom-type) or female external urinary collection devices will be denied as not medically necessary when ordered for patients who also use an indwelling catheter. 

Specialty type male external catheters (A4326), such as those that inflate or that include a faceplate or extended wear catheter systems, are covered only when documentation substantiates the medical necessity for such a catheter.  If documentation does not justify the medical need, claims will be denied as not medically necessary. 

For female external urinary collection devices, more than one meatal cup (A4327) per week or more than one pouch (A4328) per day will be denied as not medically necessary. 

Miscellaneous Supplies:

Adhesive strips or tape used with male external catheters are included in the allowance for the code and are not separately payable.

Appliance cleaner (A5131) is covered when used to clean the inside of certain urinary collecting appliances (A5102, A5105, A5112,).  More than one unit of service (16 oz.) per month is rarely medically necessary. 

One external urethral clamp or compression device (A4356) is covered every three months or sooner if the rubber/foam casing deteriorates.

Tape (A4450, A4452) which is used to secure an indwelling catheter to the patient’s body is covered.  More than 10 units (1 unit = 18 sq. in.; 10 units = 180 sq. in. = 5 yds. of 1 inch tape) per month will be denied as not medically necessary.

Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered. More than three per week of A4333 or one per month of A4334 will be denied as not medically necessary. A catheter/tube anchoring device (A5200) is covered and separately payable when it is used to anchor a covered suprapubic tube or nephrostomy tube.

Urethral inserts (A4336) are covered for adult females with stress incontinence when basic coverage criteria are met and the patient 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

The supplier must monitor the amount of supplies and accessories a patient is actually using and assure that the patient has nearly exhausted the supply on hand prior to dispensing any additional items.  Contact with the member or designee regarding refills should take place no sooner than approximately 7 days prior to the delivery/shipping date.  For subsequent deliveries of refills, the supplier should deliver the DMEPOS product no sooner than approximately 5 days prior to the end of usage for the current product.

Reasons for Noncoverage

When syringes, trays, sterile saline, or water are used for routine irrigation, they will be denied as not medically necessary.  Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non-covered. 

Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction (A4321) will be denied as not medically necessary. 

Urinary catheters and external urinary collection devices are covered to drain or collect urine for a patient who has 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 patient within three months.  

If the catheter or the external urinary collection device meets the coverage criteria then the related supplies that are necessary for their effective use are also covered.  Urological supplies that are used for purposes not related to the covered use of catheters or external urinary collection devices (i.e., drainage and/or collection of urine from the bladder) will be denied as non-covered. The provider can bill the member for the non-covered service. Urological supplies billed without a KX modifier will be denied as non-covered.

The patient must have a permanent impairment of urination.  This does not require a determination that there is no possibility that the patient’s condition may improve sometime in the future.  If the medical record, including the judgment of the attending physician, indicates the condition is of long and indefinite duration (ordinarily at least three months), the test of permanence is considered met.  Catheters and related supplies will be denied as non-covered in situations in which it is expected that the condition will be temporary. The provider can bill the member for the non-covered service.

The use of a urological supply for the treatment of chronic urinary tract infection or other bladder condition in the absence of permanent urinary incontinence or retention is non-covered.  Since the patient’s urinary system is functioning, the criteria for coverage under the prosthetic benefit provision are not met. The provider can bill the member for the non-covered service.

When urological supplies are furnished in a physician’s office, they may be billed only if the patient’s condition meets the definition of permanence.  (In this situation, the catheters and related supplies are covered under the prosthetic device benefit).  If the patient’s condition is expected to be temporary, urological supplies may not be billed.  (In this situation they are considered as supplies provided incident to a physician’s service and payment is included in the allowance for the physician services.  When billing for urological supplies furnished in a physician’s office for a permanent impairment, use the place of service code corresponding to the member’s current place of residence; do not use POS 11, office.

Irrigation supplies that are used for care of the skin or perineum of incontinent patients are non-covered. The provider can bill the member for the non-covered service.

Claims for tape (A4450 or A4452) that are billed without an AU modifier or another modifier indicating coverage under a different policy will be denied as non-covered.  The provider can bill the member for the non-covered service.

Other supplies used in the management of incontinence, including but not limited to the following items, will be denied as non-covered because they are not prosthetic devices nor are they required for the effective use of a prosthetic device:

The provider can bill the member for the following non-covered services.

• Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products (A6250)
• Adhesive remover (A4455, A4456) (coverage remains for use with ostomy supplies)
• Disposable underpads, e.g., Chux (A4554)
• Diapers, or incontinent garments, disposable or reusable (A4520)
• Gauze pads (A6216-A6218) and other dressings (coverage remains under other benefits, e.g., surgical dressings)
• Disposable external urethral clamp or compression device, with pad and/or pouch (A4360).

The provider cannot bill the member for the following non-covered services:

• Catheter care kits (A9270)
• Catheter clamp or plug (A9270)
• Drainage bag holder or stand (A9270)
• Urinary suspensory without leg bag (A9270)
• Measuring container (A9270)
• Urinary drainage tray (A9270)
• Other incontinence products not directly related to the use of a covered urinary catheter or external urinary collection device (A9270)

It is expected that the patient's medical records will reflect the need for the care provided.  The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.  This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request.  Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

The order must include the type of supplies ordered and the approximate quantity to be used per unit of time.

KX and GY Modifiers

Suppliers must add a KX modifier to a code only if the order indicates the patient has permanent urinary incontinence or urinary retention, and if the item is a catheter, an external urinary collection device, or a supply used with one of these items. 

If all of the criteria in the policy are not met, the GY modifier must be added to the code. Claims billed without a KX or GY modifier will be rejected as missing information.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Code A5105 should be used when billing for a urinary suspensory with leg bag.

A4326 is a male external catheter with an integrated collection chamber that does not require the use of an additional leg bag.

Irrigation solutions containing antibiotics and chemotherapeutic agents should be coded A9270.  Irrigating solutions, such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction, should be coded A4321.

Adhesive strips or tape used with code A4349 (Male external catheter, with or without adhesive, disposable, each) should not be billed separately.  Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

Adhesive catheter anchoring devices that are used with indwelling urethral catheters are billed using codes A4333 and A4334, respectively.  An anchoring device used with a percutaneous catheter/tube (e.g., suprapubic tube, nephrostomy tube) is billed using code A5200.

Replacement leg straps (A5113, A5114) are used with a urinary leg bag (A4358, A5105 or A5112).  These codes are not used for a leg strap for an indwelling catheter.

When codes A4217, A4450 and A4452 are used with Urological Supplies, they must be billed with the AU modifier.  For this policy, codes A4217, A4450 and A4452 are the only three codes for which the AU modifier may be used.

An external catheter that contains a barrier for attachment should be coded using A4335.

Codes for ostomy barriers (A4369-A4371) should not be used for skin care products used in the management of urinary incontinence.

Extension tubing (A4331) will be covered for use with a latex urinary leg bag (A5112).  It is included in the allowance for codes A4314, A4315, A4316, A4354, A4357, A4358 and A5105 and should not be separately billed with these codes. Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

Payment for items listed in Column II are included in the payment for the Column I code.  In the following table, when providing the items listed in Column II, the Column I code must be used instead of billing separate Column II codes when the items are provided at the same time.

If a code exists that includes multiple products, that code should be used in lieu of the individual codes.  Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.

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For code A4336