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.

Urinary catheters and external urinary collection devices may be considered medically necessary to drain or collect urine for an individual who meets ANY ONE of the following indications:

·         Permanent urinary incontinence; or

·         Permanent urinary retention (defined as retention that is not expected to be medically or surgically corrected in that individual within three (3) months).

The medical necessity for use of a greater quantity of supplies than the amounts specified in this policy must be well documented in the individual’s medical record and must be available upon request.

Indwelling Catheters

No more than one catheter per month may be considered medically necessary for routine catheter maintenance. Quantities in excess will be considered not medically necessary. 

Non-routine catheter changes may be considered medically necessary in exceptional circumstances:

·         Catheter is accidentally removed (e.g., pulled out by individual); or

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

·         Catheter is obstructed by encrustation, mucous plug, or blood clot; or

·         History of recurrent obstruction or urinary tract infection (UTI) for which it has been established that an acute event is prevented by a scheduled change frequency of more than once per month.

Any other indication not listed above will be denied as not medically necessary.

Specialty Indwelling Catheter
A specialty indwelling catheter or an all silicone catheter may be considered medically necessary when the criteria for an indwelling catheter (above) are met and there is documentation in the individual’s medical record to justify the medical need for that catheter. If documentation is requested and does not substantiate medical necessity, specialty indwelling catheters will be considered not medically necessary.

Three Way Indwelling Catheter and Continuous Irrigation of Indwelling Catheter
A three way indwelling catheter either alone or with other components may be considered medically necessary only if continuous catheter irrigation is medically necessary. In other situations, a three way indwelling catheter will be considered not medically necessary. 

Supplies for continuous irrigation of a catheter may be considered medically necessary if there is a history of obstruction of the catheter and the patency of the catheter cannot be maintained by intermittent irrigation and catheter changes. 

Supplies for medically necessary continuous bladder irrigation include a 3-way Foley catheter, irrigation tubing set, and sterile saline or sterile water.

More than one set of irrigation tubing per day, for continuous catheter irrigation, will be considered not medically necessary.

Therapeutic irrigation solutions containing antibiotics and chemotherapeutic agents are considered experimental/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 and are considered experimental/investigational.

Sterile water or sterile saline may be considered medically necessary for use as irrigation solutions.

Continuous irrigation is a temporary measure; continuous irrigation for more than two (2) weeks is rarely considered medically necessary and will be considered not medically necessary when there is no supporting medical documentation

Any other indication not listed above will be denied as not medically necessary.

Urinary Drainage Collection System
See Table A, entitled “Usual Maximum Medically Necessary Quantity of Supplies”, for the quantity of supplies that may be considered medically necessary for routine changes of the urinary drainage collection system. Quantities in excess will be considered not medically necessary.

Additional supplies for non-routine changes may be considered medically necessary only under exceptional circumstances (e.g., for obstruction, sludging, clotting of blood, or chronic, recurrent UTIs). Quantities in excess of those listed on Table A will be considered not medically necessary.

Leg bags may be considered medically necessary for individuals who are ambulatory or are chair- or wheelchair-bound.  The use of leg bags for bedridden individuals will be considered not medically necessary.

More than two drainage bags per month for routine changes will be considered not medically necessary. Quantities in excess will be considered not medically necessary.

Drainage bags containing gel matrix or other material, which are intended to be disposed of on a daily basis, has not been proven, and will be denied as non-covered.

Intermittent Irrigation of Indwelling Catheter
Supplies for the intermittent irrigation of an indwelling catheter may be 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 are of no proven value. 

Medically necessary supplies for medically necessary non-routine irrigation of a catheter include an irrigation tray and 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. 

Irrigation supplies that are used for care of the skin or perineum of incontinent individuals are considered not medically necessary. 

Any other indication not listed above will be denied as not medically necessary.

Catheter Insertion Trays
One insertion tray may be considered medically necessary per episode of indwelling catheter insertion. Quantities in excess will be considered not medically necessary.

One intermittent catheter with insertion supplies may be considered medically necessary per episode of medically necessary sterile intermittent catheterization. Quantities in excess will be considered not medically necessary. 

Catheter insertion trays are of no proven benefit for clean, non-sterile intermittent catheterization and will be considered not medically necessary.

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

Intermittent Catheterization

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

Intermittent catheterization using sterile technique may be considered medically necessary when the individual requires catheterization and the individual meets ANY ONE of the following criteria:

• The individual resides in a nursing facility; or
• The individual is immunosuppressed, for example (not all inclusive):
  • Has AIDS; or
  • Has a drug-induced state such as chronic oral corticosteroid use; or
  • On a regimen of immunosuppressive drugs post-transplant; or
  • On cancer chemotherapy; or  
• The individual has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or
• The individual is a spinal cord-injured female with neurogenic bladder who is pregnant (for duration of pregnancy only); or
• The individual has had distinct, recurrent UTI’s, 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 individual would be considered to have a UTI if they have a urine culture with greater than 10,000 colony forming units of a urinary pathogen and concurrent presence of ANY ONE of the following signs, symptoms or laboratory findings:

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

Intermittent catheterization using sterile technique is of no proven benefit for any other indication not listed above and will be considered experimental/investigational.

See Table B, entitled “Supplies for Intermittent Catheterization”, for the quantity of supplies that may be considered medically necessary for intermittent catheterization. Quantities in excess, of those listed on Table B, will be considered not medically necessary.

Any other indication not listed above will be denied as not medically necessary

External Catheters/Urinary Collection Devices
Male external catheters (condom-type) or female external urinary collection devices may be considered medically necessary for individuals who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

No more than 35 male external catheters may be considered medically necessary per month. Quantities in excess of 35 per month will be considered not medically necessary.

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 will be denied as non-covered when ordered for individuals who also use an indwelling catheter.

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

For female external urinary collection devices,more than  one (1) meatal cup per week or more than one (1) pouch per day will be considered not medically necessary.

Any other indication not listed above will be denied as not medically necessary.

Miscellaneous Supplies

One external urethral clamp or compression device may be considered medically necessary every three (3) months or sooner if the rubber/foam casing deteriorates.

Tape that is used to secure an indwelling catheter to the individual’s body may be considered medically necessary. 

More than five (5) yards of one (1)-inch tape per month will be considered not medically necessary.

Adhesive catheter anchoring devices and catheter leg straps for indwelling urethral catheters may be considered medically necessary. 

More than three (3) per week of adhesive catheter anchoring devices or one (1) catheter leg strap per month will be considered not medically necessary.
 
A percutaneous catheter/tube anchoring device may be considered medically necessary when it is used to anchor a covered suprapubic tube or nephrostomy tube.

Urethral inserts may be considered medically necessary for adult women with stress incontinence when basic medical necessity criteria are met and the individual or caregiver can perform the procedure. They are not indicated for women with ANY ONE of the following indications and will be considered not medically necessary:

• With bladder or other UTI; or With a history of urethral stricture, bladder augmentation, pelvic radiation or other conditions where urethral catheterization is not clinically advisable; or 
• Who are immunocompromised, at significant risk from UTI, interstitial cystitis, or pyelonephritis, or who have severely compromised urinary mucosa; or 
• Unable to tolerate antibiotic therapy; or 
• On anticoagulants; or 
• With overflow incontinence or neurogenic bladder.

Extension tubing may be considered medically necessary for use with a latex urinary leg bag. Extension tubing is included in the allowance for insertion trays with drainage bag, bedside drainage bags, vinyl urinary drainage bags and urinary suspensories with leg bags.

Non-covered Supplies

Prosthetic devices dispensed to a patient prior to performance of the procedure that will necessitate use of the device will be denied as non-covered for the treatment of the patient's condition. 

ANY ONE of the following supplies used in the management of incontinence are non-covered, because they are not prosthetic devices and are not required for the effective use of a prosthetic device:

• Adhesive remover (Note: these may be considered medically necessary for ostomy supplies); or 
• Catheter care kits; or
• Catheter clamp or plug; or
• Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products; or 
• Diapers, drip collectors, or incontinent garments, disposable or reusable; or
• Disposable underpads (e.g., Chux); or
• Drainage bag holder or stand; or
• Gauze pads and other dressings (may be covered under other benefits, e.g., surgical dressings); or
• Gloves (Note: these may be considered medically necessary for end-stage renal disease (ESRD. Refer to medical policy E-2); or
• Measuring container; or
• Urinary drainage tray; or
• Urinary suspensory without leg bag; or
• Other incontinence products not directly related to the use of medically necessary urinary catheter or external urinary collection device.

An Orthotic or Prosthetic Device is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.