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Urological Supplies
MA05.054l
​


Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.​

Indwelling catheters (A4311–A4316, A4338​, A4340, A4344, A4346) are considered medically necessary and, therefore, covered for permanent* urinary incontinence or ​permanent* urinary retention. 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:
  • Catheter is accidentally removed (e.g., pulled out by individual)
  • Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter)
  • Catheter is obstructed by encrustation, mucous plug, or blood clot
  • 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
*Permanent is defined as not expected to be medically or surgically corrected within 3 months. This does not require a determination that there is no possibility that the condition may improve in the future. If the medical record, including the judgement of the treating professional provider, indicates the condition is of long and indefinite duration (ordinarily at least 3 months), the test of permanence is considered met. 

A specialty indwelling catheter (A4340) or an all-silicone catheter (A4344, A4312, or A4315) is considered medically necessary and, therefore, covered when the criteria for an indwelling catheter (listed above) are met, and there is documentation in the individual'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]).

A three-way indwelling catheter, either alone (A4346) or with other components (A4313 or A4316), is considered medically necessary and, therefore, covered only if continuous catheter irrigation is medically necessary. Continuous irrigation is typically a temporary measure that would rarely exceed 2 weeks.

One catheter insertion tray (A4297, A4310–A4316, A4353, and A4354) is considered medically necessary and, therefore, covered per episode of indwelling catheter insertion. More than one tray per episode is considered not medically necessary.

One intermittent catheter with insertion supplies (A4297, A4353) will be covered per episode of medically necessary sterile intermittent catheterization.

A urine drainage collection system (A4314–A4316, A4354, A4357, A4358, A5102, and A5112) is considered medically necessary and, therefore, covered for routine changes of the urinary drainage collection system as noted below. Additional reimbursement may be allowed for medically necessary, non-routine changes when the documentation substantiates the medical necessity for the catheter change (e.g., obstruction, sludging, clotting of blood, or chronic, recurrent urinary tract infection).

Leg bags are considered medically necessary for ​individuals who are ambulatory or are chair or wheelchair bound. The use of leg bags for bedridden individuals is considered not medically necessary and, therefore, not covered.

Coverage will be provided for either a vinyl leg bag (A4358) or a latex leg bag (A5112). The use of both is considered not medically necessary and, therefore, not covered.

Usual Maximum Quantity of Supplies
Code
Number per month
A4314
1
A4315
1
A4316
1
A4354
1
A4357
2
A4358
2
A5112
1
Code
Number per 3 month
A5102
1

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 are considered not medically necessary and, therefore, not covered. Routine irrigations are defined as those performed at predetermined intervals. In individual cases, a copy of the order for irrigation, and documentation in the individual'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). When syringes, trays, sterile saline, or water are used for routine irrigation, they are considered not medically necessary. Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction (A4321), are considered not medically necessary and, therefore, not covered.

CONTINUOUS IRRIGATION OF INDWELLING CATHETERS

Supplies for continuous irrigation of a catheter are considered medically necessary and, therefore, 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 preventive measure (i.e., no history of obstruction) is considered not medically necessary and, therefore, not covered.

Covered supplies for medically necessary continuous bladder irrigation include a 3-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 is considered not medically necessary and, therefore, not covered.

INTERMITTENT CATHETERIZATION

Intermittent catheterization is considered medically necessary and, therefore, covered for urinary incontinence or urinary retention when the individual or caregiver can perform the procedure.

For each episode of covered catheterization, one of the following is covered:
  • One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or
  • One catheter (A4295, A4296); or
  • One sterile intermittent catheter kit (A4297, A4353) if additional coverage criteria (see below) are met
Intermittent catheterization using a sterile intermittent catheter kit (A4297, A4353) is considered medically necessary and, therefore, covered when the individual requires catheterization and meets one of the following criteria (1–4):

1.     The individual resides in a nursing facility.​

2.     The individual is immunosuppressed, as in the following examples (not an all-inclusive list):

        • The individual is on a regimen of immunosuppressive drugs post-transplant.
        • The individual is on cancer chemotherapy.
        • The individual has AIDS.
        • The individual has a drug-induced state, such as chronic oral corticosteroid use.
        • The individual has a spinal cord injury at any level.

3.     The individual has radiologically documented vesicoureteral reflux while on a program of intermittent catheterization.

4.     The individual has had distinct, recurrent urinary tract infections while on a program of sterile intermittent catheterization with either A4295/A4296 with no sterile lubricant (A4332), or ​ A4351/A4352 with sterile lubricant A4332 twice within the 12 months prior to the initiation of sterile intermittent catheter kits.

​
Usual Maximum Quantity of Supplies
Code
Number per Month
​A4295
​200
​A4296
​200
A4297
​200
A4332
200
A4351
200
A4352
200
A4353
200
​Any combination of A4297 and A4353
​200​

EXTERNAL CATHETERS/URINARY COLLECTION DEVICES

Male external catheters (condom-type) or female external urinary collection devices are considered medically necessary and, therefore, covered for individuals 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 are considered not medically necessary and, therefore, not covered when ordered for individuals who also use an indwelling catheter.
​
Specialty-type male external catheters (A4326), such as those that inflate or include a faceplate or extended-wear catheter systems, are considered medically necessary and, therefore, covered only when documentation substantiates the medical necessity for such a catheter.

For female external urinary collection devices, more than one meatal cup (A4327) per week or more than one pouch (A4328) per day is considered not medically necessary and, therefore, not covered.

INFLOW™ INTRAURETHRAL VALVE-PUMP

The inFlow™ device (Intraurethral Valve-Pump and Activator) is considered medically necessary and, therefore, covered for individuals who have permanent urinary retention (PUR) due to impaired detrusor contractility (IDC) when used as an alternative to intermittent catheterization. One inFlow device is covered once every 29 days. More than one inFlow device every 29 days is considered not medically necessary and, therefore, not covered.

Continued coverage 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 professional provider must conduct a clinical re-evaluation and document that the individual continues to use and is benefiting from the inFlow device.

Documentation of use and clinical benefit is demonstrated by:
  • An in-person encounter by the treating professional provider with documentation that urinary symptoms are improved; and
  • The treating professional provider verifies the individual's adherence to use of the inFlow device.
If the above criteria are not met, continued coverage of the inFlow device and related accessories will be considered not medically necessary and, therefore, not covered.

If re-evaluation by the treating professional provider does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from the inFlow device, continued coverage of the inFlow device will commence with the date of that re-evaluation.

PROFESSIONAL INSERTION AND/OR REPLACEMENT OF THE INFLOW INTRAURETHRAL VALVE-PUMP
The initial insertion and/or replacement of the inFlow device performed by the treating professional provider in their office as part of a professional service is considered medically necessary and, therefore, covered for individuals who have PUR due to IDC when used as an alternative to intermittent catheterization. The device and/or accessories used in conjunction with the professional insertion and/or replacement are included in the allowance for the professional service and are not eligible for separate reimbursement.
 ​​​
MISCELLANEOUS SUPPLIES

An 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 3 months, or sooner if the rubber/foam casing deteriorates.

Tape (A4450, A4452) used to secure an indwelling catheter to the individual'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 is considered not medically necessary and, therefore, not covered.

Adhesive catheter-anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered. More than three per week of adhesive catheter-anchoring devices (A4333) or one per month of catheter leg straps (A4334) are considered not medically necessary and, therefore, not covered. A catheter/tube-anchoring device (A5200) is covered when it is used to anchor a covered suprapubic tube or nephrostomy tube. If a catheter/tube-anchoring device is used to anchor an indwelling urethral catheter, it is considered not medically necessary and, therefore, not covered.

Urethral inserts (A4336) are covered for adult females with stress incontinence when basic coverage criteria are met and the individual or caregiver can perform the procedure; however, they are not indicated for women with any of the following:
  • Bladder or other urinary tract infections (UTI)
  • History of urethral stricture, bladder augmentation, pelvic radiation, or other conditions where urethral catheterization is not clinically advisable
  • Immunodeficiency; at significant risk from UTI, interstitial cystitis, or pyelonephritis; or severely compromised urinary mucosa
  • Inability to tolerate antibiotic therapy
  • Anticoagulant therapy
  • Overflow incontinence or neurogenic bladder

External urine management system (for use with suction pump; utilizing disposable wicking material) is covered and contains five components:

  • A urine suction pump
  • A urine collection canister
  • Tubing from collection canister to the suction pump
  • Tubing from collection canister to the external catheter
  • An external urine collection device​
Other supplies, when used in the management of urinary incontinence or urinary retention, including but not limited to the following items, are not covered by the Company because they are items not covered by Medicare. Therefore, they are not eligible for reimbursement consideration. These items are not prosthetic devices, nor are they required for the effective use of a prosthetic device:
  • Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products
  • Catheter care kits
  • Adhesive remover (coverage remains for use with ostomy supplies)
  • Catheter clamp or plug
  • Disposable or reusable underpads
  • Diapers, or incontinent garments, disposable or reusable
  • Drainage bag holder or stand
  • Drainage bags containing absorbent material such as gel matrix or other material
  • Irrigation solutions containing antibiotics and chemotherapeutic agents
  • Urinary suspensory without leg bag
  • Measuring container
  • Urinary drainage tray
  • Gauze pads and other dressings (coverage remains under other benefits, e.g., surgical dressings)
  • Other incontinence products not directly related to the use of a covered urinary catheter or external urinary collection device (e.g., irrigation supplies that are used for the care of the skin or perineum)
  • Disposable external urethral clamp or compression device, with pad and/or pouch
COLUMN I/COLUMN II REIMBURSEMENT EDITS

The reimbursement for the item(s) represented by the code(s) in column II are included in the reimbursement for the item represented by the code in column I.
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
A4354 A4310, A4331, A4332, A4357
A4357 A4331
A4358 A4331, A5113, A5114
A5105 A4331, A4358, A5112, A5113, A5114
A5112 A5113, A5114

FACE-TO-FACE REQUIREMENTS


As a condition for payment, a professional provider must have a face-to-face encounter with the individual for whom the item is ordered that meets all of the following requirements:

  • The treating professional provider must have an in-person encounter with the individual within the 6 months prior to the date of the written order prior to delivery.
  • This encounter must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of durable medical equipment (DME) ordered.

A new face-to-face encounter is required each time a new standard written order for one of the specified items is ordered. A new standard written order is required:

  • For all claims for purchases or initial rentals
  • When there is a change in the standard written order for the accessory, supply, drug, etc.
  • If periodic standard written order renewal is required per medical policy
  • When an item is replaced
  • When there is a change in the supplier ​

​

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports. The initial justification for the item(s) is/are established at the time the item(s) is/are first ordered. Medical records demonstrating that the item(s) is/are medically necessary are prepared just before, or simultaneously with, the initial prescription. Once the initial medical need has been established, unless continued coverage requirements are specified, an ongoing need for the supplies is assumed for an individual with permanent urinary incontinence or retention. ​

 

STANDARD WRITTEN ORDER REQUIREMENTS

Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

 

PROOF OF DELIVERY REQUIREMENTS

Medical record documentation must include a contemporaneously prepared delivery confirmation or member's receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

 

CONSUMABLE SUPPLIES (WHEN APPLICABLE)​

The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 30 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual's medical record. Delivery of the supplies should not be done earlier than approximately 10 days before the individual would exhaust their on-hand supply. The quantity of accessories and supplies for urological use should be based on prospective, not retrospective use. The DME supplier must contact the individual, and document an affirmative response, prior to dispensing the supplies and not automatically ship on a pre-determined basis, even if authorized by the individual. This shall be done to ensure that the refilled item(s) remain(s) needed, existing supplies are expected to end, and to confirm any changes or modifications to the order.​

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.


BILLING REQUIREMENTS

The initial sizing, and insertion of the inFlow device is typically performed by the treating professional provider in their office, as a service incident to the practitioner's office visit. The device and/or accessories used in conjunction with the professional insertion are included in the allowance for the professional service and are not eligible for separate reimbursement; therefore, the Healthcare Common Procedure Coding System HCPCS) code that describes the inFlow device and/or accessories should not be reported in conjunction with a professional service. 


When replacement of the inFlow device is performed by the treating professional provider in their office, as a service incident to the practitioner's office visit, the device and/or accessories used in conjunction with the professional insertion are included in the allowance for the professional service and are not eligible for separate reimbursement; therefore, the HCPCS code that describes the inFlow device and/or accessories should not be reported in conjunction with a professional service. 

The HCPCS code that describe the inFlow device should only be reported when the device would be used in the home setting and replacement is by the individual or a trained caregiver. 


Accessories used with the inFlow device (i.e., activator, charging base) are provided at the time of initial issue by the treating professional provider in their office; therefore, the HCPCS code that describes accessories used with the inFlow device should only be billed as a replacement when being used in the home setting and the individual or trained caregiver is replacing accessories. 

 

When HCPCS codes A4217, A4450, and A4452 are used with urological supplies, they must be billed with the AU modifier (item furnished in conjunction with a urological, ostomy or tracheostomy supply). For this policy, HCPCS codes A4217, A4450, and A4452 are the only codes for which the AU modifier may be used.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's reimbursement methodology may differ from Medicare. 

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, urological supplies are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified as noncovered are not eligible for coverage reimbursement by the Company.

Description

Urological supplies consist of catheters and urinary collection devices. Urinary catheters and external urinary collection devices are used to drain or collect urine for an individual 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 individual within 3 months.

The inFlow™ device (Intraurethral Valve-Pump and Activator) is a urinary catheter intended to be used as an alternative to clean intermittent catheterization (CIC) in individuals with impaired detrusor contractility (IDC). The inFlow device consists of a silicone tube containing a miniature valve and pump, and a separate remote control “activator” wand. The tube is inserted with a disposable introducer and remains inside the urethra for about a month. To empty the bladder, the user sits on the toilet, holds the remote-control wand over the lower pelvic area, and presses a button, which magnetically activates a small valve-pump in the inserted urethral tube. Once the pump is activated, the bladder drains at a normal rate. Once the button is released, a valve closes and urine flow stops. The inFlow device is sized and initially inserted by a treating practitioner; it must be replaced every 29 days. Generally, the user or caregiver can replace the inFlow device because insertion is similar to a urinary catheter. In 2014, the US Food and Drug Administration (FDA) issued approval for the inFlow device via the De Novo pathway.

References

Centers for Medicare & Medicaid Services (CMS). Master list of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) items potentially subject to conditions of payment. 05/13/2024. Available at: Master List of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Items Potentially Subject to Conditions of Payment | CMS. Accessed June 20, 2024.
​
Noridian Healthcare Solutions. Local Coverage Determination (LCD) L33803 Urological supplies. Revised Effective 01/01/2024. Original Effective 10/01/2015. Available at: LCD - Urological Supplies (L33803) (cms.gov). Accessed June 20, 2024. 

Noridian Healthcare Solutions. Local Coverage Article (LCA) A52521 Urological supplies. Revised Effective 04/01/2023. Original Effective 10/01/2015. Available at: Article - Urological Supplies - Policy Article (A52521) (cms.gov)​​​. Accessed June 20, 2024. 

Noridian Healthcare Solutions. PureWick urine collection system – coding and billing instructions – Revised. 03/28/2024. Available at: https://med.noridianmedicare.com/web/jadme/policies/dmd-articles/2024/purewick-urine-collection-system-coding-and-billing-instructions-revised. Accessed June 20, 2024.​

Noridian Healthcare Solutions. Urological supplies. 06/19/2024. Available at: Urological Supplies - JA DME - Noridian (noridianmedicare.com). Accessed June 20, 2024.

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT THE INITIAL INSERTION AND REPLACEMENT OF THE INFLOW DEVICE​​

​0596T
​
0597T ​
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
INCONTINENCE SUPPLY, URETHRAL INSERT, ANY TYPE, EACH (A4336) IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODE

N39.3 Stress incontinence (female) (male)
HCPCS Level II Code Number(s)
MEDICALLY NECESSARY

A4217 Sterile water/saline, 500 ml

A4295 Intermittent urinary catheter: straight tip, hydrophilic coating, each

A4296 Intermittent urinary catheter; coude (curved) tip, hydrophilic coating, each

A4297 Intermittent urinary catheter; hydrophilic coating, with insertion supplies

A4310 Insertion tray without drainage bag and without catheter (accessories only)

A4311 Insertion tray without drainage bag with indwelling catheter, Foley type, 2-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.)

A4312 Insertion tray without drainage bag with indwelling catheter, Foley type, 2-way, all silicone

A4313 Insertion tray without drainage bag with indwelling catheter, Foley type, 3-way, for continuous irrigation

A4314 Insertion tray with drainage bag with indwelling catheter, Foley type, 2-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.)

A4315 Insertion tray with drainage bag with indwelling catheter, Foley type, 2-way, all silicone

A4316 Insertion tray with drainage bag with indwelling catheter, Foley type, 3-way, for continuous irrigation

A4318 Female external urinary collection cup, with or without ring attachment, per day

A4320 Irrigation tray with bulb or piston syringe, any purpose

A4321 Therapeutic agent for urinary catheter irrigation

A4322 Irrigation syringe, bulb or piston, each

A4326 Male external catheter with integral collection chamber, any type, each

A4327 Female external urinary collection device; meatal cup, each

A4328 Female external urinary collection device; pouch, each

A4331 Extension drainage tubing, any type, any length, with connector/adaptor, for use with urinary leg bag or urostomy pouch, each

A4332 Lubricant, individual sterile packet, each

A4333 Urinary catheter anchoring device, adhesive skin attachment, each

A4334 Urinary catheter anchoring device, leg strap, each

A4335 Incontinence supply; miscellaneous

A4336 Incontinence supply, urethral insert, any type, each

A4338 Indwelling catheter; Foley type, 2-way latex with coating (Teflon, silicone, silicone elastomer, or hydrophilic, etc.), each

A4340 Indwelling catheter; specialty type, (eg; Coude, mushroom, wing, etc.), each

A4344 Indwelling catheter, foley type, 2-way, all silicone or polyurethane​, each

A4346 Indwelling catheter; Foley type, 3 way for continuous irrigation, each

A4349 Male external catheter, with or without adhesive, disposable, each

A4351 Intermittent urinary catheter; straight tip, with or without coating (Teflon, silicone, or silicone elastomer etc.), each

A4352 Intermittent urinary catheter; Coude (curved) tip, with or without coating (Teflon, silicone, or silicone elastomeric etc.), each

A4353 Intermittent urinary catheter, with insertion supplies

A4354 Insertion tray with drainage bag but without catheter

A4355 Irrigation tubing set for continuous bladder irrigation through a 3-way indwelling Foley catheter, each

A4356 External urethral clamp or compression device (not to be used for catheter clamp), each

A4357 Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each

A4358 Urinary drainage bag, leg or abdomen, vinyl, with or without tube, with straps, each

A4402 Lubricant, per oz

A4450 Tape, nonwaterproof, per 18 square in

A4452 Tape, waterproof, per 18 sq in

A5102 Bedside drainage bottle with or without tubing, rigid or expandable, each

A5105 Urinary suspensory with leg bag, with or without tube, each

A5112 Urinary drainage bag, leg or abdomen, latex, with or without tube, with straps, each

A5113 Leg strap; latex, replacement only, per set

A5114 Leg strap; foam or fabric, replacement only, per set

A5131 Appliance cleaner, incontinence and ostomy appliances, per 16 oz.

A5200 Percutaneous catheter/tube anchoring device, adhesive skin attachment

A6590 External urinary catheters; disposable, with wicking material, for use with suction pump, per month

A7001 Canister, nondisposable, used with suction pump, each

A7002 Tubing, used with suction pump, each
​​
E2001​​ Suction pump, home model, portable or stationary, electric, any type, for use with external urine and/or fecal​ management system


THE FOLLOWING CODE IS USED TO REPRESENT THE INFLOW DEVICE

A4341 Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each


THE FOLLOWING CODE IS USED TO REPRESENT ACCESSORIES USED WITH THE INFLOW DEVICE (i.e., activator, charging base)

A4342 Accessories for patient inserted indwelling intraurethral drainage device with valve, replacement only, each​


NOT COVERED

A4360 Disposable external urethral clamp or compression device, with pad and/or pouch, each

A4553 Non-disposable underpads, all sizes

A4554 Disposable underpads, all sizes

A4520 Incontinence garment, any type, (e.g., brief, diaper), each


THE FOLLOWING CODES ARE NOT COVERED WHEN USED TO REPRESENT THE MANAGEMENT OF URINARY INCONTINENCE OR URINARY RETENTION

A4455 Adhesive remover or solvent (for tape, cement or other adhesive), per oz

A4456 Adhesive remover, wipes, any type, each

A6216 Gauze, nonimpregnated, nonsterile, pad size 16 sq in or less, without adhesive border, each dressing

A6217 Gauze, nonimpregnated, nonsterile, pad size more than 16 sq in but less than or equal to 48 sq in, without adhesive border, each dressing

A6218 Gauze, nonimpregnated, nonsterile, pad size more than 48 sq in, without adhesive border, each dressing

A6250 Skin sealants, protectants, moisturizers, ointments, any type, any size


THE FOLLOWING CODE IS USED TO REPRESENT IRRIGATION SOLUTIONS CONTAINING ANTIBIOTICS AND CHEMOTHERAPEUTIC AGENTS

A4335 Incontinence supply; miscellaneous


THE FOLLOWING CODE IS USED TO REPRESENT DRAINAGE BAGS CONTAINING ABSORBENT MATERIAL SUCH AS GEL MATRIX OR OTHER MATERIAL

A4335 Incontinence supply; miscellaneous​

Revenue Code Number(s)
N/A

Modifiers​​

AU Item furnished in conjunction with a urological, ostomy, or tracheostomy supply​

Coding and Billing Requirements

Policy History

Revisions From MA05.054l:
​04/01/2026
​Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time.

This policy has been identified for a HCPCS code update, effective 04/01/2026.

The following HCPCS code has been added to the medically necessary section of this policy:

  • ​​A4318 Female external urinary collection cup, with or without ring attachment, per day​
Revisions From MA05.054k:
​01/01/2026
​​This version of the policy will be issued on 04/06/2026 with a retroactively effective date of 01/01/2026.


The following condition was added to the medically necessary list of immunosuppressed conditions that intermittent catheterization is considered medically necessary for:

  • Individuals with spinal cord injury

The following condition was deleted from the medically necessary conditions that intermittent catheterization is considered medically necessary:

The individual is a spinal cord–injured female with neurogenic bladder who is pregnant (for duration of pregnancy only).​​

The following HCPS codes have been added to the medically necessary section of this policy:
  • A4295 Intermittent urinary catheter; straight tip, hydrophilic coating, each
  • A4296 Intermittent urinary catheter; coude (curved) tip, hydrophilic coating, each
  • A4297 Intermittent urinary catheter; hydrophilic coating, with insertion supplies

The following HCPS codes have been revised in the medically necessary section of this policy:

  • A4351 Intermittent urinary catheter; straight tip, with or without coating (teflon, silicone, or silicone elastomer, etc.), each
  • ​A4352 Intermittent urinary catheter; coude (curved) tip, with or without coating (teflon, silicone, or silicone elastomeric, etc.), each

​Face-to-face requirements were deleted for the following HCPCS codes:
  • A4342 Accessories for patient inserted indwelling intraurethral drainage device with valve, replacement only, each
  • A4352 Intermittent urinary catheter; coude (curved) tip, with or without coating (teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each
  • A4353 Intermittent urinary catheter, with insertion supplies​

Revisions From MA05.054j:
​04/02/2025
​This policy has been reissued in accordance with the Company's annual review process.
​08/12​/2024
​This version of the policy will become effective 08/12/2024. ​


The following policy criteria have been revised:
  • Permanent urinary incontinence and permanent urinary retention (along with the Noridian definition of permanent) in order to be eligible for indwelling catheters in accordance with LCA 52521
  • Consumable Supplies in accordance with Local Coverage Determination (LCD 33803):
    • When the individual should be contacted by the DME supplier
    • When the supplies can be delivered
    • What the quantity of supplies should be based on:
      • ​​Documentation of contact with the individual 

Face-to-face requirements were added for the following HCPCS codes:

  • ​A4342 Accessories for patient inserted indwelling intraurethral drainage device with valve, replacement only, each
  • ​A4352 Intermittent urinary catheter; coude (curved) tip, with or without coating (teflon, silicone, silicone elastomeric, or hydrophilic, etc.), each​
  • A4353 Intermittent urinary catheter, with insertion supplies​

Medical Coding

The following HCPCS codes were ​added as covered to the policy:

  • A6590 External urinary catheters; disposable, with wicking material, for use with suction pump, per month
  • A7001 Canister, nondisposable, used with suction pump, each
  • A7002 Tubing, used with suction pump, each
  • E2001​​ Suction pump, home model, portable or stationary, electric, any type, for use with external urine and/or fecal​ management system


Revisions From MA05.054i:
​01/01/2024
​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
11/15/2023
​This version of the policy will become effective 11/15/2023. ​

The intent of this policy has not changed, however, billing requirements have been incorporated to clarify reimbursement for the ​inFlow™ Intraurethral Valve-Pump system and accessories. 

​In addition, the following CPT codes have been added to this policy:

0596T
​0597T

The following HCPCS codes have been added to this policy:

  • ​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​


Revisions From MA05.054h:
10/01/2023

​This policy has been identified for a HCPCS code update effective 10/01/2023.

The following code narrative has been revised:


​FROM: A4344 Indwelling catheter, Foley type, 2-way, all silicone, each​


TO: A4344 Indwelling catheter, foley type, two-way, all silicone or polyurethane, each​

Revisions From MA05.054g:
02/08/2023This policy has been reissued in accordance with the Company's annual review process.
​05/18/2022

​The policy has been reviewed and reissued to communicate the Company's continuing position on Urological Supplies​.
​04/01/2021
​This policy has been identified for a HCPCS code update effective 04/01/2021.

The following HCPCS codes have been deleted from this policy:

  • ​​K1010 Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each​

  • ​K1011 Activation device for intraurethral drainage device with valve, replacement only, each
  • K1012 Charger and base station for intraurethral activation device, replacement only
The following HCPCS code is used to represent the INFLOW™​ Device (Intraurethral Valve-Pump and Activator)

  • A4335 Incontinence supply; miscellaneous

Revisions From ​MA05.054f:
02/24/2021
​This policy has been reissued in accordance with the Company's annual review process.
01/04/2021This version of the policy will become effective 01/04/2021. 

The intent of this policy has not changed.  Billing requirements have been incorporated to clarify reimbursement for the the ​inFlow™ Intraurethral Valve-Pump system. 

In addition, the following HCPCS codes have been added to the policy for the ​inFlow™ Intraurethral Valve-Pump system:

K1010 Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each

K1011 Activation device for intraurethral drainage device with valve, replacement only, each

K1012 Charger and base station for intraurethral activation device, replacement only​

Revisions From MA05.054e:
07/26/2020This version of the policy will become effective 07/26/2020. In accordance with Noridian Healthcare Solutions, the Company’s coverage position has changed from Not Medically Necessary to Medically Necessary for the inFlow™ Intraurethral Valve-Pump (A4335) and/or any of the components (catheter, activator) in individuals with permanent urinary retention (PUR) due to impaired detrusor contractility (IDC) when used as an alternative to intermittent catheterization.

The following HCPCS code has been changed from Not Covered to Medically Necessary when used to represent the inFlow™ Intraurethral Valve-Pump and/or any components of the inFlow™ Intraurethral Valve-Pump system (catheter, activator):
  • A4335 Incontinence supply; miscellaneous

Revisions From MA05.054d:
02/26/2020This policy has been reissued in accordance with the Company's annual review process.
03/27/2019The policy has been reviewed and reissued to communicate the Company's continuing position on Urological Supplies.
04/25//2018The policy has been reviewed and reissued to communicate the Company's continuing position on Urological Supplies.
08/25/2017This version of the policy will become effective 08/25/2017.
The intent of this policy remains unchanged, but the policy has been updated to further clarify current benefits.

The following ICD-10 CM code has been added to this policy:
N39.3 Stress incontinence (female) (male)

Revisions From MA05.054c:
01/01/2017This policy has been identified for a HCPCS code update effective 01/01/2017.

The following code was added:
A4553 Non-disposable underpads, all sizes

Revisions From MA05.054b:
10/14/2016Revised policy MA05.054b was issued as a result of the Company's annual review.

HCPCS code A6250 was added to the non-covered section of the coding table.

Revisions From MA05.054a:
6/8/2016This policy has been reviewed and reissued to communicate the Company's continuing position for urological supplies.
10/28/2015This policy has been reviewed and reissued to communicate the Company's continuing position for urological supplies.
07/22/2015This policy has been identified for an ad hoc HCPCS code update.

HCPCS code A9270 was replaced with A4335

Revisions From MA05.054:
01/01/2015This is a new policy.

4/1/2026
4/7/2026
MA05.054
Medical Policy Bulletin
Medicare Advantage
No
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.