LCD L33803: Urological Supplies

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

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

• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

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 beneficiary's medical record and must be available upon request.

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:

• Catheter is accidentally removed (e.g., pulled out by beneficiary)

• 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

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. 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 (A4297, 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 (A4297, 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

A4315

A4316

A4354

A4357

A4358

A5112

Code

Number per 3 month

A5102

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:

• 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 covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1-4):

• The beneficiary resides in a nursing facility,

• 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,

• has a diagnosis of spinal cord injury at any level. (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article).

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

• The beneficiary 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.

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

A4295

200

A4296

200

A4297

200

A4332

200

A4351

200

A4352

200

A4353

200

Any combination of A4297 and A4353

N/A