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Section: Orthotic & Prosthetic Devices
Number: O-27
Topic: Urological Supplies
Effective Date: July 21, 2008
Issued Date: June 29, 2009

General Policy Guidelines | Procedure Codes | Coding Guidelines | References | Attachments | Procedure Code Attachments | Diagnosis Codes | Glossary

General Policy

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.

Indications and Limitations of Coverage

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.

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.

When a specialty indwelling catheter (A4340) or an all silicone catheter (A4344, A4312 or A4315) is used, there must be documentation in the patient’s medical record of the medical necessity for that catheter rather than a straight Foley type catheter with coating (such as recurrent encrustation, inability to pass a straight catheter or sensitivity to latex).  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 medically necessary.  Documentation of medical necessity may be requested.  If documentation is requested and does not substantiate medical necessity, payment for A4340 will be made based on the least costly medically appropriate alternative (A4338) and payment for A4344, A4312 or A4315 will be based on the least costly medically appropriate alternative (A4338, A4311 or A4314) respectively.

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, payment will be based on the least costly medically appropriate alternative (A4338, A4311, or A4314, respectively).

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 gel matrix or other material which are intended to be disposed of on a daily basis has not been established.  Payment for this type of bag will be based on the allowance and usual frequency of change for the least costly medically appropriate alternative, code A4357.

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. The provider cannot bill the member for the denied service.

Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as noncovered. 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.  When clean, non-sterile catheterization technique is used, replacement of intermittent catheters (A4351-A4352) will be covered on a weekly basis unless there is documentation of the medical necessity for more frequent replacement.  Non-sterile lubricating gel (A4402) would be covered for use with clean, non-sterile catheterization technique.  Eight units of service (8oz.) would be covered per month.  More than eight units per month is not medically necessary.  An individual packet of lubricant (A4332) is not medically necessary for clean, non-sterile intermittent catheterization. The provider cannot bill the member for the denied service.

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 clean 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)

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

  • One catheter (A4351, A4352) and an individual packet of lubricant (A4332) or
  • An intermittent catheter kit (A4353).

The kit code should be used for billing even if the components are packaged separately rather then together as a kit. 

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 rather than a straight tip catheter (A4351).  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, payment will be based on the least costly medically appropriate alternative (A4351).

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.  More than 35 male external catheters is not medically necessary.  The provider cannot bill the member for the denied service. 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.  Payment will be based on the least costly medically appropriate alternative if documentation does not substantiate medical necessity. 

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:

Appliance cleaner (A5131) is covered when used to clean the inside of certain urinary collecting appliances (A5102, 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 unless the claim is accompanied by documentation justifying a larger quantity in the individual case.

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 unless the claim is accompanied by documentation justifying a larger quantity in the individual case. A catheter/tube anchoring device (A5200) is covered and separately payable when it is used to anchor a covered suprapubic tube or nephrostomy tube.  If code A5200 is used to anchor an indwelling urethral catheter, payment will be based on the allowance for the least costly medically appropriate alternative, A4333.

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 noncovered. 

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 noncovered. The provider can bill the member for the denied service. Urological supplies billed without a KX modifier will be denied as noncovered.

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 noncovered in situations in which it is expected that the condition will be temporary. The provider can bill the member for the denied 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 noncovered.  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 denied 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, which are processed by the local carrier).  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.

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

Other supplies used in the management of incontinence, including but not limited to the following items, will be denied as noncovered 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 denied services.

  • Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products (A6250)
  • Adhesive remover (A4455, A4365) (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)

The provider cannot bill the member for the following denied 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)

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.

If a supplier is billing for items, which are noncovered, this must be indicated on the claim.  The recommended way of doing this is to add the GY modifier to the code.

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 the requirements for the KX modifier are not met, the KX modifier must not be used. 

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, the supplier must obtain information supporting the medical necessity for the higher utilization.  This information must be retained in the supplier’s file and be available upon request.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. Effective January 26, 2009, 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.

Procedure Codes

A4217A4310A4311A4312A4313A4314
A4315A4316A4320A4321A4322A4326
A4327A4328A4331A4332A4333A4334
A4335A4338A4340A4344A4346A4349
A4351A4352A4353A4354A4355A4356
A4357A4358A4365A4402A4450A4452
A4455A4520A4554A5102A5105A5112
A5113A5114A5131A5200A9270 

Coding Guidelines

Code A5105 should be used when billing for a urinary suspensory with leg bag.  Urinary suspensory without leg bag should be billed with code A9270.

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 adhesive strip, 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.

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

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.

In the following table, the Column I code includes the items identified by the codes in Column II.  The Column I code must be used instead of multiple Column II codes when the items are provided at the same time.

Column I

Column II

A4310

A4332

A4311

A4310, A4332, A4338

A4312

A4310, A4332, A4344

A4313

A4310, A4332, A4346

A4314

A4310, A4311, A4331, A4332, A4338, A4354, A4357

A4315

A4310, A4312, A4331, A4332, A4344, A4354, A4357

A4316

A4310, A4313, A4331, A4332, A4346, A4354, A4357

A4353

A4310, A4332, A4351, A4352

A4354

A4310, A4332, A4357, A4331

A4357

A4331

A4358

A4331, A5113, A5114

A5112

A5113, A5114

A5105

A4331, A4358, A5112, A5113, A5114

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.

References

www.cms.gov
www.medicare.gov

Attachments

Procedure Code Attachments

Diagnosis Codes

Glossary

TermDescription

External Urinary Collection Devices

External urinary collection devices include male external catheters and female pouches or meatal cups.  It does not include diapers or other types of absorptive pads.

 

Meatal Cup Female External Urinary Collection Device

A meatal cup female external urinary collection device (A4327) 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.


 

Percutaneous Catheter/Tube Anchoring Device

A percutaneous catheter/tube anchoring device (A5200) is a dressing with adhesive that is designed to be applied directly over the cutaneous opening through which the catheter/tube passes.  This dressing has a hole through which the catheter/tube passes and a mechanism for firmly anchoring the catheter/tube to the dressing.

 

 

Pouch Type Female External Collection Device

A pouch type female external collection device (A4328) is a plastic pouch which is attached to a periurethral area with adhesive and which can be connected to a urinary drainage container such as a bag or bottle.

 

Therapeutic Agent for Urinary Irrigation

A therapeutic agent for urinary irrigation (A4321) is defined as a solution containing agents in addition to saline or sterile water (for example acetic acid or hydrogen peroxide) which is used for the treatment or prevention of urinary catheter obstruction.


 

Urinary Catheter Anchoring Device (A4333)

A urinary catheter anchoring device described by code A4333 has an adhesive surface, which attaches to the patient’s skin and a mechanism for releasing and re-anchoring the catheter multiple times without changing the anchoring device.

 

Urinary Catheter Anchoring Device (A4334)

A urinary catheter anchoring device described by code A4334 is a strap, which goes around a patient’s leg and has a mechanism for releasing and re-anchoring the catheter multiple times without changing the anchoring device.


 

Urinary Intermittent Catheter with Insertion Supplies

A urinary intermittent catheter with insertion supplies (A4353) 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.

 






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.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Medicare Advantage plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Medicare Advantage retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Medicare Advantage. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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