Aetna considers urinary catheters and external urinary collection devices medically necessary prosthetics for members who have 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 person within 3 months.

Note: The general term "external urinary collection devices" used in this policy includes male external catheters and female pouches or meatal cups.  This term does not include diapers or other types of absorptive pads.

Indwelling Catheters

Aetna considers 1 catheter per month medically necessary for routine catheter maintenance.  Non-routine catheter changes are considered medically necessary in exceptional circumstances, such as the following:

1. Catheter is accidentally removed (e.g., pulled out by member); or
2. Catheter is obstructed by encrustation, mucous plug, or blood clot; or
3. Catheter malfunctions (e.g., balloon does not stay inflated, hole in catheter); or
4. Member has history of recurrent obstruction or urinary tract infection for which it has been established that an acute event is prevented by a scheduled change at intervals of less than once per month.

Specialty indwelling catheters and all silicone catheters are considered medically necessary where the member is unable to use a straight Foley type catheter with coating (such as recurrent encrustation, inability to pass a straight catheter, or sensitivity to latex).  For example, use of a Coude (curved) tip indwelling catheter in female members is rarely medically necessary.

A 3-way indwelling catheter either alone or with other components is considered medically necessary only if continuous catheter irrigation is medically necessary.

Catheter Insertion Trays

One insertion tray is considered medically necessary per episode of indwelling catheter insertion.  One intermittent catheter with insertion supplies is considered medically necessary per episode of medically necessary sterile intermittent catheterization (see below).  Catheter insertion trays are of no proven benefit for clean, non-sterile intermittent catheterization.

Insertion trays that contain component parts of the urinary collection system, (e.g., drainage bags and tubing) are inclusive sets and additional component parts are considered medically necessary only per the stated criteria in each section of this policy.

Urinary Drainage Collection Systems

The following table indicates the quantity of supplies that are considered medically necessary for routine changes of the urinary drainage collection system.  Additional supplies for non-routine changes are considered medically necessary only under exceptional circumstances (e.g., for obstruction, sludging, clotting of blood, or chronic, recurrent urinary tract infections).

Usual Maximum Medically Necessary Quantity of Supplies:

Leg bags are considered medically necessary for members who are ambulatory or are chair- or wheelchair-bound.  The use of leg bags for bedridden members is not considered medically necessary.

Either a vinyl leg bag or a latex leg bag is considered medically necessary; the use of both is not considered medically necessary.

If there is a catheter change and an additional drainage bag change within a month, the
combined utilization for catheters and drainage bags should be considered when determining if additional documentation should be submitted with the claim. For example, if one insertion tray with drainage bag and indwelling foley-type catheter and one bedside drainage bag are provided, this should be considered as two drainage bags, which is the usual maximum quantity of drainage bags needed for routine changes.

The value drainage bags containing gel matrix or other material, which are intended to be disposed of on a daily basis, has not been proven.

Intermittent Irrigation of Indwelling Catheter

Supplies for the intermittent irrigation of an indwelling catheter are considered medically necessary 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 (i.e., catheterizations performed at pre-determined intervals) are of no proven value.

Medically necessary supplies for medically necessary non-routine irrigation of a catheter include either an irrigation tray or an irrigation syringe, and sterile saline or sterile water. When syringes, trays, sterile saline, or water are used for routine irrigation, they will be considered not medically necessary.

Therapeutic agent for urinary irrigation is defined as a solution containing agents in addition to saline or sterile water (e.g., acetic acid or hydrogen peroxide), which is used for the treatment or prevention of urinary catheter obstruction.  Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction, are of no proven value.  Irrigation solutions containing antibiotics and chemotherapeutic agents are considered experimental and investigational because their value is unproven.

Note: Irrigation supplies that are used for care of the skin or perineum of incontinent members are not covered.

Continuous Irrigation of Indwelling Catheter

Supplies for continuous irrigation of a catheter are considered medically necessary if there is a history of obstruction of the catheter and the patency of the catheter can not be maintained by intermittent irrigation and catheter changes.  Continuous irrigation has not been proven to be of benefit as a primary preventative measure (i.e., no history of obstruction).

Medically necessary supplies for medically necessary continuous bladder irrigation include a 3-way Foley catheter, irrigation tubing set, and sterile saline or sterile water.  More than 1 irrigation tubing set per day for continuous catheter irrigation is not considered medically necessary.

Irrigation solutions containing antibiotics and chemotherapeutic agents are considered experimental and investigational because their value is unproven.    Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction, are of no proven value. Sterile water or sterile saline are considered medically necessary for use as irrigation solutions.

Continuous irrigation is a temporary measure; continuous irrigation for more than 2 weeks is rarely considered medically necessary.

Intermittent Catheterization

Intermittent catheterization is considered medically necessary when basic medical necessity criteria are met and the member or caregiver can perform the procedure.

Intermittent catheterization using sterile technique is considered medically necessary when the member requires catheterization and the member meets any of the following criteria:

1. The member resides in a nursing facility; or
2. The member is immunosuppressed, for example (not all inclusive):
   
   
   1. Has AIDS,
   2. Has a drug-induced state such as chronic oral corticosteroid use,
   3. On a regimen of immunosuppressive drugs post-transplant,
   4. On cancer chemotherapy; or
       
3. The member has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or
4. The member is a spinal cord-injured female with neurogenic bladder who is pregnant (for duration of pregnancy only); or
5. The member has had distinct, recurrent urinary tract infections, while on a program of clean intermittent catheterization with sterile lubricant, twice within the 12-month period prior to the initiation of sterile intermittent catheterization.

A member 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 any of the following signs, symptoms or laboratory findings:

• Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation)
• Change in urinary urgency, frequency, or incontinence
• Fever (oral temperature over 38º C [100.4º F])
• Increased muscle spasms
• Physical signs of prostatitis, epididymitis, orchitis
• Pyuria (greater than 5 white blood cells (WBCs) per high-powered field)
• Systemic leukocytosis

Intermittent catheterization using sterile technique is of no proven benefit for other indications.  Requests for sterile intermittent catheterization for members who fail to meet the above criteria are subject to medical review.

The following table lists usual medically necessary quantity of supplies for intermittent catheterization:

For each episode of medically necessary sterile catheterization, Aetna considers medically necessary either (a) 1 catheter plus an individual packet of lubricant or (b) an intermittent catheter kit.  A urinary intermittent catheter with insertion supplies is a kit, which includes a catheter, lubricant, gloves, antiseptic solution, applicators, drape, and a tray or bag in a sterile package intended for single use.

Use of a Coude (curved) tip catheter in female members is rarely medically necessary.  A Coude tip catheter is considered medically necessary for either male or female members only when a straight tip catheter can not be used.  An example would be the inability to catheterize with a straight tip catheter.

External Catheters/Urinary Collection Devices

Male external catheters (condom-type) or female external urinary collection devices are considered medically necessary for members who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

Generally, no more than 35 male external catheters are considered medically necessary per month.

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

Male external catheters (condom-type) or female external urinary collection devices are not considered medically necessary when ordered for members who also use an indwelling catheter.

Specialty-type male external catheters such as those that inflate or that include a faceplate are considered medically necessary where the clinical situation justifies their need.

A meatal cup female external urinary collection device is a plastic cup, which is held in place around the female urethra by suction or pressure and is connected to a urinary drainage container such as a bag or bottle.  A pouch type female external collection device is a plastic pouch which is attached to the peri-urethral area with adhesive and which can be connected to a urinary drainage container such as a bag or bottle.  For female external urinary collection devices, more than 1 meatal cup per week or more than 1 pouch per day are not considered medically necessary.

Miscellaneous Supplies

Appliance cleaner is considered medically necessary when used to clean the inside of certain urinary collecting appliances.  More than 16 oz. per month is rarely considered medically necessary.

One external urethral clamp or compression device is considered medically necessary every 3 months or sooner if the rubber/foam casing deteriorates.

Tape that is used to secure an indwelling catheter to the member’s body is considered medically necessary.  More than 5 yards of 1-inch tape per month is usually not considered medically necessary.

A urinary catheter anchoring device with an adhesive skin attachment has an adhesive surface, which attaches to the member's skin and a mechanism for releasing and re-anchoring the catheter multiple times without changing the device.  A urinary catheter anchoring device with a leg strap has a strap, which goes around a member's leg and has a mechanism for releasing and re-anchoring the catheter multiple times without changing the device.  Adhesive catheter anchoring devices and catheter leg straps for indwelling urethral catheters are considered medically necessary.  More than 3 per week of adhesive catheter anchoring devices or 1 catheter leg strap per month is usually not considered medically necessary.  A percutaneous catheter/tube anchoring device is considered medically necessary when it is used to anchor a covered suprapubic tube or nephrostomy tube.

Urethral inserts are considered medically necessary for adult women with stress incontinence when basic medical necessity criteria are met and the member 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 pyleonephritis, or who have severely compromised urinary mucosa
• Unable to tolerate antibiotic therapy
• On anticoagulants
• With overflow incontinence or neurogenic bladder.

Extension tubing is considered medically necessary for use with a latex urinary leg bag.  Note: Extension tubing is included in the allowance for insertion trays with drainage bags, bedside drainage bags, vinyl urinary drainage bags, and urinary suspensories with leg bags, and should not be separately billed with these items.

Notes on Non-covered Supplies

The following supplies used in the management of incontinence are not covered, other than for home care suppliers who bill for the supplies as part of the home health care visit, because they are not prosthetic devices and are not required for the effective use of a prosthetic device:

1. Adhesive remover (Note: these are considered medically necessary for ostomy supplies)
2. Catheter care kits
3. Catheter clamp or plug
4. Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products
5. Diapers, drip collectors, or incontinent garments, disposable or reusable
6. Disposable underpads (e.g., Chux)
7. Drainage bag holder or stand
8. Gauze pads and other dressings (may be covered under other benefits, e.g., surgical dressings)
9. Measuring container
10. Urinary drainage tray
11. Urinary suspensory without leg bag
12. Other incontinence products not directly related to the use of medically necessary urinary catheter or external urinary collection device.

Note: The following items are not covered other than for home care suppliers because they are not medical supplies and/or they could be used by the member or the member's family for purposes other than to replace the urine collection and retention function of the bladder:

1. Rubber bands
2. Rubber gloves
3. Scissors
4. Sheets.

Note: These lists are not all-inclusive.

Urinary drainage systems are used to replace the urine collection, urine retention function and bladder emptying function in individuals with permanent urinary incontinence, urinary obstruction or neurogenic bladder dysfunction resulting from disease, accidental injury, or surgery.

External systems are worn by incontinent male patients in situations where injury to the urethra prohibits use of an indwelling catheter.  The external system consists of a latex sheath fitted over the penis and connects directly or with a drainage tube to a urine collection bag strapped to the patient's leg.

Internal systems consist of an indwelling urethral catheter attached to a bag for collection and retention of urine.  This system requires flushing or irrigation of the catheter.

Intermittent systems are used for intermittent catheterization of patients who require regularly performed, periodic bladder catheterizations as an alternative to indwelling catheters.  An example of one type of intermittent system is a catheter enclosed in a plastic bag permitting lubrication and insertion without touching.  The urine is collected in a calibrated lower chamber eliminating the need for a sterile field and gloves.  Intermittent systems are identical for male and female patients.  When the bladder is emptied, the catheter is withdrawn and the kit is discarded after emptying the urine into a urinal or toilet.

Sterile catheterization technique involves the use of a new, sterile packaged catheter and sterile lubricant for each catheterization.  It may also involve use of sterile gloves and drape and use of an antiseptic solution to cleanse the peri-urethral area.  Clean, non-sterile intermittent catheterization technique involves the use of soap and water for cleansing of the periurethral area, a reusable catheter that is cleansed between episodes, and non-sterile lubricant.