LCD/NCD Portal

L11566 UROLOGICAL SUPPLIES

 

08/05/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

• 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.

o If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

 

 

GENERAL

• The statutory coverage criteria for coverage of urological supplies are specified in the related Policy Article.

• 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:

o Catheter is accidentally removed (e.g., pulled out by patient)

o Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter)

o Catheter is obstructed by encrustation, mucous plug, or blood clot

o 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)).

o In addition, the particular catheter must be necessary for the patient.

o For example, use of a Coude (curved) tip indwelling catheter (A4340) in female patients is rarely reasonable and necessary.

o 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.

o (Refer to the section "Continuous Irrigation of Indwelling Catheters" for indications for continuous catheter irrigations.)

o In other situations, A4346, A4313 and A4316 will be denied as not reasonable and 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 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-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

o Obstruction.

o Sludging.

o Clotting of blood.

o 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 months

A5102        1

 

• Leg bags are indicated for patients who are ambulatory or are chair or wheelchair bound.

o The use of leg bags for bedridden patients would be denied as not reasonable and 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.

o 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.

o Claims for this type of bag will be denies 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.

o Routine intermittent irrigations of a catheter will be denied as not reasonable and necessary. Routine irrigations are defined as those performed at predetermined intervals.

o 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 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).

o When syringes, trays, sterile saline, or water are used for routine irrigation, they will be denied as not reasonable and necessary.

o Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as noncovered.

o 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.

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

o Documentation must substantiate the medical necessity of catheter irrigation and in particular continuous irrigation as opposed to intermittent irrigation.

o The records must also indicate the rate of solution administration and the duration of need.

o 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).

o 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 noncovered.

o 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.

o 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 catheterization, Medicare will cover:

o One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or

o 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 patient requires catheterization and the patient meets one of the following criteria (1-5):

o The patient resides in a nursing facility

o The patient 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

o The patient has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,

o The patient is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only),

o 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-month prior to the initiation of sterile intermittent catheter kits

• A patient would be considered to have a urinary tract infection if they have

o a urine culture with greater than 10,000 colony forming units of a urinary pathogen

o AND

o 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

o Sweating

o Bradycardia

o 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).

o A4353 should not be used for billing if the components are packaged separately rather than together as a kit.

o Separately provided components do not provide the equivalent degree of sterility achieved with an A4353.

o 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 patients is rarely reasonable and necessary.

o 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.

o An example would be the inability to catheterize with a straight tip catheter.

o This documentation must be available upon request.

o 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 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.

o 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 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.

o 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 metal cup (A4327) per week or more than one pouch (A4328) per day will be denied as not reasonable and necessary.

 

 

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 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 reasonable and necessary.

• Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered.

o More than 3 per week of A4333 or 1 per month of A4334 will be denied as not reasonable and necessary.

o A catheter/tube anchoring device (A5200) is covered and separately payable when it is used to anchor a covered suprapubic tube or nephrostomy tube.

o 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 (ICD-9 625.6) when basic coverage criteria are met and the patient or caregiver can perform the procedure.

o 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

 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. CMS’ Program Integrity Manual (Internet-Only Manual, CMS Pub. 100-8, Chapter 4, section 4.26.1) requires, “Contact with the beneficiary 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.”

 

 

Coding Information

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

 

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

 

 

HCPCS MODIFIERS:

 

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

 

EY - No physician or other licensed health care provider order for this item or service

 

GY – Item or service statutorily excluded or does not meet the definition of any Medical benefit

 

KX - Requirements specified in the medical policy have been met

 

 

HCPCS CODES:

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, EG; 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

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

 

ICD-9 Codes that Support Medical Necessity

 

 

The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on Indications and Limitation of Coverage and/or Medical Necessity for other coverage criteria and payment information.

 

 

For HCPCS code A4336:

625.6 STRESS INCONTINENCE FEMALE

 

Diagnoses that Support Medical Necessity

Refer to previous section.

 

ICD-9 Codes that DO NOT Support Medical Necessity

For the specific HCPCS codes indicated above, all ICD-9 codes that are not specified in the preceding section.

 

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

 

Diagnoses that DO NOT Support Medical Necessity

For the specific HCPCS codes indicated above, all diagnoses codes that are not specified in the preceding section.

 

 

General Information

Documentations Requirements

• Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider."

o It is expected that the patient's medical records will reflect the need for the care provided.

o 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.

o 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.

o 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 HCPCS 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 the criteria in the related Policy Article are not met, the GY modifier must be added to the code.

• Claims lines billed without a KX or GY modifier will be rejected as missing information.

• Refer to the Supplier Manual for more information on documentation requirements.

 

 

Sources of Information and Basis for Decision

 

A25620 - Urological Supplies - Policy Article - Effective February 2011

 

CMS Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 230.17

 

 

Local Coverage Determination (LCD) for Urological Supplies (L11566)