Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Urological Supplies
Policy #:MA05.054d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.


Refer to the following News Article: Waiver of certain requirements during COVID-19 outbreak related to Durable Medical Equipment (DME), prosthetics, orthotics, and supplies for Medicare Advantage members (updated June 30, 2020)

Indwelling catheters (A4311--A4316, A4338--A4346) are considered medically necessary and, therefore, covered for urinary incontinence or urinary retention. 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 patient)
  • 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 considered medically necessary and, therefore, covered 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 (such as recurrent encrustation, inability to pass a straight catheter, or sensitivity to latex (not all-inclusive).

A three-way indwelling catheter, either alone (A4346) or with other components (A4313 or A4316), is considered medically necessary and, therefore, covered only if continuous catheter irrigation is medically necessary. Continuous irrigation is typically a temporary measure that would rarely exceed two weeks.

One catheter insertion tray (A4310--A4316, A4353, and A4354) is considered medically necessary and, therefore, covered per episode of indwelling catheter insertion. More than one tray per episode is considered not medically necessary.

One intermittent catheter with insertion supplies (A4353) will be covered per episode of medically necessary sterile intermittent catheterization.

A urine drainage collection system (A4314--A4316, A4354, A4357, A4358, A5102, and A5112) is considered medically necessary and, therefore, covered for routine changes of the urinary drainage collection system as noted below. Additional reimbursement may be allowed for medically necessary, non-routine changes when the documentation substantiates the medical necessity for the catheter change (e.g., obstruction, sludging, clotting of blood, or chronic, recurrent urinary tract infection).

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 considered not medically necessary and, therefore, not covered.

Coverage will be provided for either a vinyl leg bag (A4358) or a latex leg bag (A5112). The use of both is considered not medically necessary and, therefore, not covered.

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

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 are considered not medically necessary and, therefore, not covered. Routine irrigations are defined as those performed at predetermined intervals. In individual cases, a copy of the order for irrigation, and documentation in the individual's medical record of the presence of acute catheter obstruction, may be requested when irrigation supplies are billed.

Covered supplies for medically 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 are considered not medically necessary. Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction (A4321), are considered not medically necessary and, therefore, not covered.

CONTINUOUS IRRIGATION OF INDWELLING CATHETERS

Supplies for continuous irrigation of a catheter are considered medically necessary and, therefore, 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 medically necessary catheter changes. Continuous irrigation as a primary preventive measure (i.e., no history of obstruction) is considered not medically necessary and, therefore, not covered.

Covered supplies for medically 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 is considered not medically necessary and, therefore, not covered.

INTERMITTENT CATHETERIZATION

Intermittent catheterization is considered medically necessary and, therefore, covered for urinary incontinence or urinary retention when the individual or caregiver can perform the procedure.

For each episode of covered catheterization, either of the following is covered:
  • One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or
  • One sterile intermittent catheter kit (A4353) if additional coverage criteria (see below) are met

Intermittent catheterization using a sterile intermittent catheter kit (A4353) is considered medically necessary and, therefore, covered when the individual requires catheterization and meets one of the following criteria (1-5):
    1. The individual resides in a nursing facility.
    2. The individual is immunosuppressed, as in the following examples (not an all-inclusive list):
      • The individual is on a regimen of immunosuppressive drugs post-transplant.
      • The individual is on cancer chemotherapy.
      • The individual has AIDS.
      • The individual has a drug-induced state, such as chronic oral corticosteroid use.
    3. The individual has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization.
    4. The individual is a spinal cord--injured female with neurogenic bladder who is pregnant (for duration of pregnancy only).
    5. The individual 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 months prior to the initiation of sterile intermittent catheter kits.

Usual Maximum Quantity of Supplies
Code
Number per Month
A4332
200
A4351
200
A4352
200
A4353
200

EXTERNAL CATHETERS/URINARY COLLECTION DEVICES

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

Specialty-type male external catheters (A4326), such as those that inflate or include a faceplate or extended-wear catheter systems, are considered medically necessary and, therefore, covered only when documentation substantiates the medical necessity for such a catheter.

For female external urinary collection devices, more than one meatal cup (A4327) per week or more than one pouch (A4328) per day is considered not medically necessary and, therefore, not covered.

MISCELLANEOUS SUPPLIES

An appliance cleaner (A5131) is covered when used to clean the inside of certain urinary collecting appliances (A5102, A5105, A5112). More than 1 unit of service (16 oz.) per month is rarely medically 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) 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 is considered not medically necessary and, therefore, not covered.

Adhesive catheter-anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered. More than 3 per week of adhesive catheter-anchoring devices (A4333) or 1 per month of catheter leg straps (A4334) are considered not medically necessary and, therefore, not covered. A catheter/tube-anchoring device (A5200) is covered when it is used to anchor a covered suprapubic tube or nephrostomy tube. If a catheter/tube-anchoring device is used to anchor an indwelling urethral catheter, it is considered not medically necessary and, therefore, not covered.

Urethral inserts (A4336) are covered for adult females with stress incontinence when basic coverage criteria are met and the individual or caregiver can perform the procedure; however, they are not indicated for women with any of the following:
  • Bladder or other urinary tract infections (UTI)
  • History of urethral stricture, bladder augmentation, pelvic radiation, or other conditions where urethral
    catheterization is not clinically advisable
  • Immunodeficiency; at significant risk from UTI, interstitial cystitis, or pyelonephritis; or severely compromised urinary mucosa
  • Inability to tolerate antibiotic therapy
  • Anticoagulant therapy
  • Overflow incontinence or neurogenic bladder

The inFlow™ Intraurethral Valve-Pump (A4335) or any of the components (catheter, battery, wand) for initial issue or replacement is considered not medically necessary and, therefore, not covered.

Other supplies, when used in the management of urinary incontinence or urinary retention, including but not limited to the following items, are not covered by the Company because they are items not covered by Medicare. Therefore, they are not eligible for reimbursement consideration. These items are not prosthetic devices, nor are they required for the effective use of a prosthetic device:
  • Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products
  • Catheter care kits
  • Adhesive remover (coverage remains for use with ostomy supplies)
  • Catheter clamp or plug
  • Disposable or reusable underpads
  • Diapers, or incontinent garments, disposable or reusable
  • Drainage bag holder or stand
  • Drainage bags containing absorbent material such as gel matrix or other material
  • Irrigation solutions containing antibiotics and chemotherapeutic agents
  • Urinary suspensory without leg bag
  • Measuring container
  • Urinary drainage tray
  • Gauze pads and other dressings (coverage remains under other benefits, e.g., surgical dressings)
  • Other incontinence products not directly related to the use of a covered urinary catheter or external urinary collection device (e.g., irrigation supplies that are used for the care of the skin or perineum)
  • Disposable external urethral clamp or compression device, with pad and/or pouch

COLUMN I/COLUMN II REIMBURSEMENT EDITS

The reimbursement for the item(s) represented by the code(s) in column II are included in the reimbursement for the item represented by the code in column I.
Column I
Column II
A4310 A4332
A4311 A4310, A4332, A4338
A4312 A4310, A4332, A4344
A4313 A4310, A4332, A4346
A4314 A4310, A4311, A4331, A4332, A4338, A4354, A4357
A4315 A4310, A4312, A4331, A4332, A4344, A4354, A4357
A4316 A4310, A4313, A4331, A4332, A4346, A4354, A4357
A4354 A4310, A4331, A4332, A4357
A4357 A4331
A4358 A4331, A5113, A5114
A5105 A4331, A4358, A5112, A5113, A5114
A5112 A5113, A5114

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's reimbursement methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, urological supplies are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified as noncovered are not eligible for coverage reimbursement by the Company.

Description

Urological supplies consist of catheters and urinary collection devices. Urinary catheters and external urinary collection devices are used to drain or collect urine for an individual who has 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 individual within three months.
References

Noridian Healthcare Solutions. Local Coverage Determination (LCD). L33803 Urological Supplies. Policy Article A52521 Effective 01/01/2017 Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Urological+Supplies+LCD/3aeb7caa-2773-4c83-acdc-758d245fd643 Accessed February 11, 2019.

Noridian Healthcare Solutions. Local Coverage Determination (LCD). L33803 Urological Supplies. Policy Article A52521 Effective 01/01/2017 Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Urological+Supplies+LCD/3aeb7caa-2773-4c83-acdc-758d245fd643. Accessed February 11, 2019.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

INCONTINENCE SUPPLY, URETHRAL INSERT, ANY TYPE, EACH (A4336) IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODE

N39.3 Stress incontinence (female) (male)



HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

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, 2-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.)

A4312 Insertion tray without drainage bag with indwelling catheter, Foley type, 2-way, all silicone

A4313 Insertion tray without drainage bag with indwelling catheter, Foley type, 3-way, for continuous irrigation

A4314 Insertion tray with drainage bag with indwelling catheter, Foley type, 2-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.)

A4315 Insertion tray with drainage bag with indwelling catheter, Foley type, 2-way, all silicone

A4316 Insertion tray with drainage bag with indwelling catheter, Foley type, 3-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, 2-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, 2-way, all silicone, each

A4346 Indwelling catheter; Foley type, 3 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 3-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

A4402 Lubricant, per oz

A4450 Tape, nonwaterproof, per 18 square in

A4452 Tape, waterproof, per 18 sq in

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


NOT COVERED

A4360 Disposable external urethral clamp or compression device, with pad and/or pouch, each

A4553 Non-disposable underpads, all sizes

A4554 Disposable underpads, all sizes

A4520 Incontinence garment, any type, (e.g., brief, diaper), each


THE FOLLOWING CODES ARE NOT COVERED WHEN USED TO REPRESENT THE MANAGEMENT OF URINARY INCONTINENCE OR URINARY RETENTION

A4455 Adhesive remover or solvent (for tape, cement or other adhesive), per oz

A4456 Adhesive remover, wipes, any type, each

A6216 Gauze, nonimpregnated, nonsterile, pad size 16 sq in or less, without adhesive border, each dressing

A6217 Gauze, nonimpregnated, nonsterile, pad size more than 16 sq in but less than or equal to 48 sq in, without adhesive border, each dressing

A6218 Gauze, nonimpregnated, nonsterile, pad size more than 48 sq in, without adhesive border, each dressing

A6250 Skin sealants, protectants, moisturizers, ointments, any type, any size

THE FOLLOWING CODE IS USED TO REPRESENT IRRIGATION SOLUTIONS CONTAINING ANTIBIOTICS AND CHEMOTHERAPEUTIC AGENTS

A4335 Incontinence supply; miscellaneous

THE FOLLOWING CODE IS USED TO REPRESENT INFLOW™ INTRAURETHRAL VALVE-PUMP SYSTEM

A4335 Incontinence supply; miscellaneous

THE FOLLOWING CODE IS USED TO REPRESENT ANY COMPONENTS OF THE INFLOW™ INTRAURETHRAL VALVE-PUMP SYSTEM (CATHETER, BATTERY, WAND) FOR INITIAL USE OR REPLACEMENT

A4335 Incontinence supply; miscellaneous

THE FOLLOWING CODE IS USED TO REPRESENT DRAINAGE BAGS CONTAINING ABSORBENT MATERIAL SUCH AS GEL MATRIX OR OTHER MATERIAL

A4335 Incontinence supply; miscellaneous


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA05.054d
02/26/2020This policy has been reissued in accordance with the Company's annual review process.
03/27/2019The policy has been reviewed and reissued to communicate the Company's continuing position on Urological Supplies.
04/25//2018The policy has been reviewed and reissued to communicate the Company's continuing position on Urological Supplies.
08/25/2017This version of the policy will become effective 08/25/2017.
The intent of this policy remains unchanged, but the policy has been updated to further clarify current benefits.

The following ICD-10 CM code has been added to this policy:
N39.3 Stress incontinence (female) (male)

MA05.054c
01/01/2017This policy has been identified for a HCPCS code update effective 01/01/2017.

The following code was added:
A4553 Non-disposable underpads, all sizes

MA05.054b
10/14/2016Revised policy MA05.054b was issued as a result of the Company's annual review.

HCPCS code A6250 was added to the non-covered section of the coding table.

MA05.054a
6/8/2016This policy has been reviewed and reissued to communicate the Company's continuing position for urological supplies.
10/28/2015This policy has been reviewed and reissued to communicate the Company's continuing position for urological supplies.
07/22/2015This policy has been identified for an ad hoc HCPCS code update.

HCPCS code A9270 was replaced with A4335

MA05.054
01/01/2015This is a new policy.






Version Effective Date: 08/25/2017
Version Issued Date: 08/25/2017
Version Reissued Date: 02/28/2020