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:

  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.
  3. The beneficiary has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,
  4. The beneficiary is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only),
  5. 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 (A4341) 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

  
GENERAL

  
A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.  
  
REFILL REQUIREMENTS  
  
For DMEPOS items and supplies provided on a recurring basis, billing must be
based on prospective, not retrospective use. For DMEPOS products that are
supplied as refills to the original order, suppliers must contact the
beneficiary, and document an affirmative response, prior to dispensing the
refill and not automatically ship on a pre-determined basis, even if
authorized by the beneficiary. This shall be done to ensure that the refilled
item remains reasonable and necessary, existing supplies are expected to end,
and to confirm any changes or modifications to the order. Contact with the
beneficiary or designee regarding refills must take place no sooner than 30
calendar days prior to the expected end of the current supply. For delivery of
refills, the supplier must deliver the DMEPOS product no sooner than 10
calendar days prior to the expected end of the current supply. This is
regardless of which delivery method is utilized.  
  
For all DMEPOS items that are provided on a recurring basis, suppliers are
required to have contact with the beneficiary or caregiver/designee and
document an affirmative response, prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request and an affirmative
response from a beneficiary. Items delivered without a valid, documented
refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's
expected utilization. Suppliers must stay attuned to changed or atypical
utilization patterns on the part of their clients. Suppliers must verify with
the treating practitioner that any changed or atypical utilization is
warranted.

Regardless of utilization, a supplier must not dispense more than a three (3)
- month quantity at a time.