Urological Supplies
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Coverage and medical necessity criteria for urinary catheters, external urinary collection devices, related supplies, and selected devices (e.g., inFlow) for Aetna members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
General medical necessity
Covered when ALL of the following are met
Permanent urinary retention = not expected to be corrected within 3 months
Indwelling catheter coverage
Indwelling catheter routine and non-routine supply coverage
Irrigation
Irrigation supplies
Medically necessary supplies include an irrigation tray or syringe and sterile saline or sterile water; routine use is not covered
Medically necessary supplies include a 3-way Foley, irrigation tubing set, and sterile saline/water; more than one irrigation tubing set per day is not medically necessary
Intermittent catheterization
Intermittent catheterization (CIC)
UTI defined by urine culture >10,000 CFU plus listed signs/symptoms
An intermittent catheter kit should be used when packaged as a kit; separately provided components do not provide equivalent sterility
External urinary collection devices
External catheters and female external devices
Adhesive strips/tape used with male external catheters are included in the allowance
inFlow device coverage
inFlow device
Device sizing and initial insertion performed by a physician; device replaced every 29 days
If re-evaluation occurs after day 91 and shows benefit, coverage resumes from date of re-evaluation
Miscellaneous supplies
Miscellaneous supplies
A catheter/tube anchoring device is considered medically necessary to anchor a covered suprapubic or nephrostomy tube but not to anchor an indwelling urethral catheter
Covered with criteria
Covered when selection criteria are met for devices and supplies
Supported by background evidence and device description; continued coverage requires re-evaluation as specified
Claims must meet policy selection criteria and appropriate ICD-10 coding
The policy lists specific supplies that are not covered when billed separately (except when billed by home health suppliers as part of a home health visit). Examples include: adhesive remover (except when used for ostomy supplies), catheter care kits, catheter clamp or plug, creams/salves/lotions/skin barriers, diapers or disposable underpads, drainage bag holders/stands, gauze pads and other dressings (may be covered under other benefits), measuring containers, urinary drainage trays, urinary suspensory without leg bag, and other incontinence products not directly related to a prosthetic catheter or external urinary collection device.
Irrigation solutions intended for use in the urinary tract are addressed separately. The policy permits supplies for intermittent irrigation when needed for acute catheter obstruction, and allows continuous irrigation only when patency cannot be maintained otherwise and typically for no more than 2 weeks. Solutions that contain therapeutic agents such as antibiotics or chemotherapeutic agents, or certain agents (e.g., acetic acid, hydrogen peroxide), are listed as items of concern and may be considered not covered or experimental for some indications.
Irrigation solutions that contain antibiotics and chemotherapeutic agents are specifically identified as non-covered under HCPCS code A9270.
The policy notes the code A5200 for a percutaneous catheter/tube anchoring device described as an adhesive skin attachment with a quantity limit of maximum 3 per week. The code descriptor indicates that this adhesive skin attachment is not medically necessary to anchor an indwelling urethral catheter, although anchoring devices may be appropriate for suprapubic or nephrostomy tubes per other guidance.
Within the excerpted appendix and ancillary material there are no additional explicit exclusions beyond those listed in the policy’s exclusions section.
Routine irrigation of indwelling catheters is not considered medically necessary; irrigation supplies are permitted only for acute obstruction or when clinically indicated. Additionally, leg bags are considered medically necessary for ambulatory or chair/wheelchair-bound members but the use of leg bags for bedridden members is not medically necessary. The policy also specifies that vinyl and latex leg bags should not be used concurrently.
The PureWick female urine collection system is stated as unproven and not medically necessary for management of urinary incontinence.
The HCPCS code A5200 is described as a percutaneous catheter/tube anchoring device, adhesive skin attachment, with a stated limit of maximum 3 per week. The code descriptor includes the notation that it is not medically necessary to anchor an indwelling catheter.
The provided excerpt does not include additional explicit statements labeled 'not medically necessary' beyond those already cited in the exclusions and code descriptors.
Codes, Quantity Limits, and Frequency Guidance
| A4310 | Insertion tray without drainage bag and without catheter (accessories only) [maximum 1 per month for indwelling, not medically necessary for CIC] [includes A4332] |
| A4311 | Insertion tray without drainage bag with indwelling catheter, Foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4332, A4338] |
| A4312 | Insertion tray without drainage bag with indwelling catheter, Foley type, two-way, all silicone [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4332, A4344] |
| A4313 | Insertion tray without drainage bag with indwelling catheter, Foley type, three-way, for continuous irrigation [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4332, A4346] |
| A4314 | Insertion tray with drainage bag with indwelling catheter, Foley type, two-way latex with coating (Teflon, silicone, silicone elastomer or hydrophilic, etc.) [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4311, A4331, A4332, A4338, A4354, A4357] |
| A4315 | Insertion tray with drainage bag with indwelling catheter, Foley type, two-way, all silicone [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4312, A4331, A4332, A4344, A4354, A4357] |
| A4316 | Insertion tray with drainage bag with indwelling catheter, Foley type, three-way, for continuous irrigation [maximum 1 per month, not medically necessary for CIC] [includes A4310, A4313, A4331, A4332, A4346, A4354, A4357] |
| A4326 | Male external catheter with integral collection chamber, any type, each [alternative to indwelling only - for members with permanent incontinence] |
| A4327 | Female external urinary collection device; metal cup, each [alternative to indwelling only - for members with permanent incontinence] [maximum 1 cup per week] |
| A4328 | Female external urinary collection device; pouch, each [alternative to indwelling only - for members with permanent incontinence] [maximum 1 pouch per day] |
| A4245 | Alcohol wipes, per box |
| A4247 | Betadine or iodine swabs/wipes, per box |
| A4321 | Therapeutic agent for urinary catheter irrigation |
| A4335 | Incontinence supply; miscellaneous |
| A4455 | Adhesive remover or solvent, per oz |
| A4520 | Incontinence garment, any type, each |
| A4554 | Disposable underpads, all sizes |
| A4649 | Surgical supply; miscellaneous |
| A4927 | Gloves, non-sterile, per 100 |
| A4930 | Gloves, sterile, per pair |
| 34701-34834 | Endovascular Repair of Abdominal Aorta and/or Iliac Arteries |
| 45000-45999 | Colon and Rectum Surgery |
| 50300-50380 | Donor nephrectomy and renal transplant procedures |
| 50540-50547 | Pyeloplasty and related renal surgeries |
| 50575 | Renal endoscopy through nephrotomy or pyelotomy |
| 50590 | Extracorporeal shock wave lithotripsy (ESWL) |
| 50740-50782 | Ureteral/renal reconstructive procedures |
| 52005 | Cystourethroscopy, with ureteral catheterization |
| 52332-52356 | Cystourethroscopy with various ureteroscopy/pyeloscopy treatments |
| 56405-58999 | Female Genital System Surgery |
| N31.0-N31.9 | Neuromuscular dysfunction of bladder |
| N32.81 | Overactive bladder [impaired detrusor contractility] |
| N32.89 | Other specified disorders of bladder |
| N39.3-N39.498 | Stress and other specified urinary incontinence |
| R32 | Unspecified urinary incontinence |
| R33.0-R33.9 | Retention of urine |
| R39.14 | Feeling of incomplete bladder emptying |
| C64.1-C66.9 | Malignant neoplasm of kidney/renal pelvis/ureter (selected ranges) |
| D30.20-D41.22 | Benign/neoplasm of ureter and uncertain behavior codes |
| N13.1-N13.5 | Hydronephrosis and ureteral stricture/obstruction codes |
| No codes listed |
Provider Requirements, Authorization, and Documentation
HCPCS codes covered only if policy criteria and utilization limits met
HCPCS and other supply codes in this policy are covered only when the selection and medical necessity criteria in the policy are met; utilization limits and frequency thresholds noted in the code descriptions apply (for example, one indwelling catheter per month for routine maintenance and specified monthly limits for external catheters and supplies).
- One indwelling catheter per month is medically necessary for routine maintenance (see code descriptions and policy criteria).
- Utilization limits for specific HCPCS codes (e.g., male external catheters, insertion trays, irrigation tubing) are listed in the code table and apply when selection criteria are met.
Device-specific codes require meeting selection criteria (prior auth may apply)
Certain device-specific CPT/HCPCS codes (for example, inFlow CPT 0596T/0597T and HCPCS A4341/A4342, and ureteral stent codes C1875/C2617) are covered only when the policy's selection/medical necessity criteria are met; prior authorization may be required per payer procedures.
No general prior authorization rule stated for listed urological supplies
The policy excerpt does not specify a blanket prior authorization requirement for the listed urological supply HCPCS codes; check payer-specific prior authorization procedures for potential requirements.
- No explicit prior authorization rule is stated for general urological supplies within these chunks; device-specific codes (see inFlow, stents) are noted separately.
Use external catheters as alternative to indwelling — do not use together
Male external catheters and female external urinary collection devices are considered medically necessary as alternatives to indwelling catheters for members with permanent urinary incontinence; they are not medically necessary when the member also uses an indwelling catheter.
- Male external catheters: generally limited to 35 per month when used as an alternative to indwelling catheters.
- Female devices: limits include no more than 1 meatal cup per week or 1 pouch per day; specialty types may be allowed when clinically justified.
- External devices must not be billed/used concurrently with an indwelling catheter.
inFlow considered alternative to CIC for women with impaired detrusor contractility
The inFlow device is presented as a covered alternative to intermittent catheterization for women with permanent urinary retention due to impaired detrusor contractility when selection criteria are met.
- inFlow is a sterile, single-use intra-urethral valve-pump replaced every 29 days; initial insertion is physician-sized/inserted.
- Clinical trial data (Chen et al.) support inFlow as an alternative to CIC for appropriately selected women.
No step therapy requirements described
The policy does not describe step therapy requirements for inFlow or other urological supplies in the cited excerpts.
- Therapeutic pathway notes describe inFlow as an alternative to CIC, but no formal step therapy/required trial sequence is mandated in these chunks.
inFlow continued-coverage requires in-person re-evaluation (day 31–91)
For continued inFlow coverage beyond the initial 3 months, the treating practitioner must perform and document an in-person re-evaluation between day 31 and day 91 after initiation showing symptom improvement and verified adherence to use.
- Re-evaluation must be an in-person encounter documenting that urinary symptoms are improved and the practitioner verifies adherence to use.
- If re-evaluation occurs after day 91 and shows benefit, coverage resumes from the date of that re-evaluation.
- If required documentation is not present, continued coverage is considered not medically necessary.
Sterile CIC requests lacking required clinical criteria may be medically reviewed/denied
Requests for sterile intermittent catheterization that do not meet the policy's specified clinical criteria (e.g., nursing facility residence, immunosuppressed status, documented VUR on CIC, pregnant spinal cord–injured female, or recurrent UTIs while on clean CIC) are subject to medical review and may be denied.
- Sterile CIC is limited to members meeting at least one listed condition; the policy defines UTI for these criteria (culture >10,000 CFU plus signs/symptoms).
- Requests failing to meet criteria are subject to medical review and potential denial.
Include listed ICD-10 diagnosis codes that meet selection criteria on claims
Use ICD-10 diagnosis codes listed in the policy (for example, N31.x, N32.81, N39.3–N39.498, R32, R33.x, R39.14) on claims when selection criteria are met to support medical necessity for urological supplies.
- Codes such as N32.81 (overactive bladder with impaired detrusor contractility) and R33.x (retention of urine) are specifically associated with inFlow and other device coverage when criteria are met.
- Ensure the diagnosis code on the claim aligns with the policy's selection criteria for the requested supply or device.
No other explicit documentation requirements provided in these excerpts
No additional explicit documentation requirements beyond the inFlow re-evaluation and sterile CIC criteria are provided in these excerpts; the policy history and references are listed but do not add other documentation rules.
- Providers should follow the inFlow re-evaluation and sterile CIC documentation standards noted elsewhere in the policy; no other specific documentation requirements are stated in these chunks.
Irrigation solutions with antibiotics/chemotherapeutic agents (A9270) are non‑covered
Irrigation solutions that contain antibiotics or chemotherapeutic agents (HCPCS A9270) are listed as non-covered and may trigger claim denial if billed.
- HCPCS A9270 is identified as a non-covered item for irrigation solutions containing antibiotics/chemotherapeutic agents.
- Claims for these solutions should not be submitted as covered supplies under this policy.
Lack of required in-person re-evaluation documentation for inFlow risks denial of continued coverage
Continued coverage of the inFlow device beyond the initial 3 months will be considered not medically necessary if the required in-person re-evaluation documentation (symptom improvement and verified adherence) is not present.
- Supplier must stop billing if inFlow usage discontinues; absence of required re-evaluation documentation is a basis for denial of continued supplies.
- If re-evaluation after day 91 documents benefit, coverage resumes from the date of that evaluation.
Document member meets listed clinical criteria to support sterile CIC
Sterile intermittent catheterization documentation must demonstrate the member meets one of the specific clinical indications listed in the policy (e.g., resides in a nursing facility, is immunosuppressed, has radiologically documented vesico-ureteral reflux on CIC, is a pregnant spinal cord–injured female, or has recurrent UTIs on clean CIC).
- For UTI-based criteria, documentation should support culture >10,000 CFU and concurrent listed signs/symptoms.
- For each episode of medically necessary sterile catheterization, document either catheter plus individual lubricant packet or an intermittent catheter kit.
Claims may be denied if coverage rules, code limits, or documentation requirements are not met
Claims for urological supplies are subject to the policy's coverage rules and code-specific frequency/quantity limits; however, this excerpt does not list additional specific denial triggers beyond those already noted (e.g., non-covered items like A9270 or missing required documentation).
- Verify the requested HCPCS/CPT code aligns with the member’s clinical indication and policy selection criteria before billing.
- Adhere to code frequency limits (e.g., insertion trays, catheter monthly allowances, male external catheter monthly maximum) to reduce claim denials.
Background and Context
Urinary catheters and external urinary collection devices are prosthetic supplies used to manage permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined in the policy as retention not expected to be corrected medically or surgically within 3 months. The policy distinguishes indwelling, intermittent (clean and sterile), and external devices, and sets quantity and duration expectations (for example, routine indwelling catheter allowance and limits for continuous irrigation).
Definitions and Terms
Policy Dates, References, and Revision History
Policy metadata in the header shows the policy effective date as 08/21/2001, the last review date as 02/19/2024, and the next scheduled review date as 06/13/2024.
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