Medicare Urological Supplies Coverage


INDWELLING CATHETERS (A4311, A4312, A4313, A4314, A4315, A4316, A4338, A4340, A4344, and 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 beneficiary)
  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 beneficiary'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 beneficiary. For example, use of a Coude (curved) tip indwelling catheter (A4340) in a female beneficiary is rarely reasonable and necessary. If documentation is requested and does not substantiate medical necessity payment for A4340, A4344, A4312, or 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 reasonable and necessary. (Refer to the section "Continuous Irrigation of Indwelling Catheters" for indications for continuous catheter irrigations.) In other situations, A4346, A4313 and A4316 will be denied as not reasonable and necessary.

 

CATHETER INSERTION TRAY (A4310, A4311, A4312, A4313, A4314, A4315, 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 reasonable and necessary.

One intermittent catheter with insertion supplies (A4353) will be covered per episode of reasonable and necessary sterile intermittent catheterization (see below).

 

URINARY DRAINAGE COLLECTION SYSTEM (A4314, A4315, A4316, A4354, A4357, A4358, A5102, and A5112)

 

Payment will be made for routine changes of the urinary drainage collection system as noted below. Additional charges will be allowed for reasonable and 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

Number per month

A4314

1

A4315

1

A4316

1

A4354

1

A4357

2

A4358

2

A5112

1

 

Code

Number per 3 month

A5102

1

 

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

If there is a catheter change (A4314, A4315, A4316, A4354) and an additional drainage bag (A4357) change within a month, the combined utilization for A4314, A4315, A4316, A4354, and A4357 should be considered when determining if additional documentation should be submitted with the claim. For example, if 1 unit of A4314 and 1 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 reasonable and necessary.

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 reasonable and 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 reasonable and 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 beneficiary's medical record of the presence of acute catheter obstruction may be requested when irrigation supplies are billed.

Covered supplies for reasonable and 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 will be denied as not reasonable and 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 reasonable and necessary.

 

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 reasonable and necessary catheter changes. Continuous irrigation as a primary preventative measure (i.e., no history of obstruction) will be denied as not reasonable and 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 reasonable and 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 will be denied as not reasonable and necessary.

Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non-covered. Payment for irrigating 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 2 weeks is rarely reasonable and necessary. The beneficiary'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 beneficiary or caregiver can perform the procedure.

For each episode of covered catheterization, Medicare will cover:

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

Intermittent catheterization using a sterile intermittent catheter kit (A4353) is covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1-5):

  1. The beneficiary resides in a nursing facility,
  2. The beneficiary is immunosuppressed, for example (not all-inclusive):
  • on a regimen of immunosuppressive drugs post-transplant,
  • on cancer chemotherapy,
  • has AIDS,
  • has a drug-induced state such as chronic oral corticosteroid use.
  • The beneficiary has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,
  • The beneficiary is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only),
  • The beneficiary 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-month prior to the initiation of sterile intermittent catheter kits.

    • A beneficiary 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 38º C [100.4º 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 5 white blood cells [WBCs] per high-powered field)

    Usual Maximum Quantity of Supplies:

    Code 

    Number per Month

    A4332

    200

    A4351

    200

    A4352

    200

    A4353

    200

     

    Refer to Coding Guidelines section of the related Policy Article for contents of the kit (A4353). A4353 should not be used for billing if the components are packaged separately rather than together as a kit. Separately provided components do not provide the equivalent degree of sterility achieved with an A4353. If separate components are provided instead of a kit (A4353) they will be denied as not reasonable and necessary.

    Use of a Coude (curved) tip catheter (A4352) in female beneficiaries is rarely reasonable and necessary. When a Coude tip catheter is used (either male or female beneficiaries), there must be documentation in the beneficiary'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 reasonable and necessary.

     

    EXTERNAL CATHETERS/URINARY COLLECTION DEVICES

     

    Male external catheters (condom-type) or female external urinary collection devices are covered for beneficiaries 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 reasonable and necessary when ordered for beneficiaries 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 reasonable and 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 reasonable and necessary.

     

    INITIAL COVERAGE FOR THE INFLOW DEVICE

     

    The inFlow device is considered to be reasonable and necessary as an alternative to intermittent catheterization for beneficiaries with Permanent Urinary Retention (PUR) due to Impaired Detrusor Contractility (IDC).

    One (1) inFlow device may be covered no more than once every 29 days. Claims for the inFlow device billed more than once every 29 days will be denied as not reasonable and necessary.

     

    CONTINUED COVERAGE FOR THE INFLOW DEVICE BEYOND THE FIRST THREE MONTHS OF THERAPY

    Continued coverage of the inFlow device beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary continues to use and is benefiting from the inFlow device.

    Documentation of use and clinical benefit is demonstrated by:

    1. An in-person encounter by the treating practitioner with documentation that urinary symptoms are improved; and,
    2. The treating practitioner verifies the beneficiary’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 denied as not reasonable and necessary.

    If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from the inFlow device as defined in criteria 1 and 2 above, continued coverage of the inFlow device will commence with the date of that re-evaluation.

     

    If there is discontinuation of usage of the inFlow device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.

     

    MISCELLANEOUS SUPPLIES

     

    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 reasonable and 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) which is used to secure an indwelling catheter to the beneficiary'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 reasonable and necessary.

    Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered. More than 3 per week of A4333 or 1 per month of A4334 will be denied as not reasonable and 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. If code A5200 is used to anchor an indwelling urethral catheter, the claim will be denied as not reasonable and necessary.

    Urethral inserts (A4336) are covered for adult females with stress incontinence (refer to the ICD-10 Codes section in the LCD-related Policy Article for applicable diagnoses) when basic coverage criteria are met and the beneficiary 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 pyelonephritis, or who have severely compromised urinary mucosa
    • Unable to tolerate antibiotic therapy
    • On anticoagulants
    • With overflow incontinence or neurogenic bladder

    HCPCS CODES

    Group 1 Codes

    Code

    Description

    A4217

    STERILE WATER/SALINE, 500 ML

    A4310

    INSERTION TRAY WITHOUT DRAINAGE BAG AND WITHOUT CATHETER (ACCESSORIES ONLY)

    A4311

    INSERTION TRAY WITHOUT DRAINAGE BAG WITH INDWELLING CATHETER, FOLEY TYPE, TWO-WAY LATEX WITH COATING (TEFLON, SILICONE, SILICONE ELASTOMER OR HYDROPHILIC, ETC.)

    A4312

    INSERTION TRAY WITHOUT DRAINAGE BAG WITH INDWELLING CATHETER, FOLEY TYPE, TWO-WAY, ALL SILICONE

    A4313

    INSERTION TRAY WITHOUT DRAINAGE BAG WITH INDWELLING CATHETER, FOLEY TYPE, THREE-WAY, FOR CONTINUOUS IRRIGATION

    A4314

    INSERTION TRAY WITH DRAINAGE BAG WITH INDWELLING CATHETER, FOLEY TYPE, TWO-WAY LATEX WITH COATING (TEFLON, SILICONE, SILICONE ELASTOMER OR HYDROPHILIC, ETC.)

    A4315

    INSERTION TRAY WITH DRAINAGE BAG WITH INDWELLING CATHETER, FOLEY TYPE, TWO-WAY, ALL SILICONE

    A4316

    INSERTION TRAY WITH DRAINAGE BAG WITH INDWELLING CATHETER, FOLEY TYPE, THREE-WAY, FOR CONTINUOUS IRRIGATION

    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, TWO-WAY LATEX WITH COATING (TEFLON, SILICONE, SILICONE ELASTOMER, OR HYDROPHILIC, ETC.), EACH

    A4340

    INDWELLING CATHETER; SPECIALTY TYPE, (E.G., COUDE, MUSHROOM, WING, ETC.), EACH

    A4344

    INDWELLING CATHETER, FOLEY TYPE, TWO-WAY, ALL SILICONE, EACH

    A4346

    INDWELLING CATHETER; FOLEY TYPE, THREE 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, SILICONE ELASTOMER, OR HYDROPHILIC, ETC.), 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

    A4354

    INSERTION TRAY WITH DRAINAGE BAG BUT WITHOUT CATHETER

    A4355

    IRRIGATION TUBING SET FOR CONTINUOUS BLADDER IRRIGATION THROUGH A THREE-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

    A4360

    DISPOSABLE EXTERNAL URETHRAL CLAMP OR COMPRESSION DEVICE, WITH PAD AND/OR POUCH, EACH

    A4402

    LUBRICANT, PER OUNCE

    A4450

    TAPE, NON-WATERPROOF, PER 18 SQUARE INCHES

    A4452

    TAPE, WATERPROOF, PER 18 SQUARE INCHES

    A4455

    ADHESIVE REMOVER OR SOLVENT (FOR TAPE, CEMENT OR OTHER ADHESIVE), PER OUNCE

    A4456

    ADHESIVE REMOVER, WIPES, ANY TYPE, EACH

    A4520

    INCONTINENCE GARMENT, ANY TYPE, (E.G., BRIEF, DIAPER), EACH

    A4553

    NON-DISPOSABLE UNDERPADS, ALL SIZES

    A4554

    DISPOSABLE UNDERPADS, ALL SIZES

    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

    A9270

    NON-COVERED ITEM OR SERVICE


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