CurrentBlue Cross Blue Shield - MassachusettsPolicy 370

Urological Supplies

Defines medical necessity, quantity limits, and coverage rules for indwelling and intermittent catheters, irrigation supplies, drainage systems, external collection devices, the inFlow device, and miscellaneous urological accessories for Commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyUrological Supplies

Policy CodePolicy 370

Change TypeAdded (10/2021)Clarified coding (4/2026, 1/2026, 4/2023)

Effective DateOct 1, 2021

Next Review Date

Key ActionDocument medical necessity for non-routine changes, specialty devices, greater-than-usual quantities, and continuous irrigation; make records available upon request.

SourceLink

POLICY UPDATE CHANGES

New medical policy describing medically necessary and not medically necessary urological supplies created 10/2021 (effective 10/1/2021).

Clarified coding information in 4/2026, 1/2026, and 4/2023.

370Policy Number

200Intermittent catheter/lubricant max per month

35Male external catheters usual max/month

29inFlow replacement interval (days)

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2 weeksContinuous irrigation typical max duration

Coverage Summary

This policy (Policy Number 370, effective 10/01/2021) defines medical necessity, quantity limits, and coverage rules for urological supplies including indwelling and intermittent catheters, irrigation supplies (intermittent and continuous), urinary drainage systems, external collection devices, the inFlow device, and miscellaneous accessories. It specifies specific HCPCS codes that are covered when medical necessity criteria are met and identifies items or solutions that are non-covered or not medically necessary. The policy includes quantity and frequency thresholds (for example: no more than one indwelling catheter per month for routine maintenance; intermittent catheter/lubricant usual maximums up to 200 per month; male external catheters usually not to exceed 35 per month; inFlow device replacement interval no more than once every 29 days; and limits for irrigation tubing sets, tapes, appliance cleaner, and other accessories). The coverage stance is mixed: many items are covered when the stated clinical and documentation criteria are met, while specified supplies and solutions (e.g., antibiotic/chemotherapeutic irrigation solutions, certain irrigants) are explicitly denied as not medically necessary or non-covered. Providers must document medical necessity for non-routine changes, specialty devices, and higher-than-usual quantities, and follow inpatient precertification rules when applicable.

Key Limits & Thresholds

inFlow replacement intervalNo more than once every 29 days

inFlow re-evaluation windowRe-evaluate no sooner than day 31 and no later than day 91 after initiating therapy

Male external catheter maxGenerally should not exceed 35 per month

Intermittent catheter / lubricant maxUsual maximum 200 per month

Insertion tray per episodeOne insertion tray per episode

Irrigation tubing set (continuous) daily maxNo more than one irrigation tubing set per day

Continuous irrigation durationContinuous irrigation > 2 weeks is rarely reasonable and necessary

Tape limitMore than 10 units per month will be denied (10 units = 180 sq in)

Appliance cleaner limitMore than one 16 oz unit per month is rarely reasonable and necessary

External urethral clamp frequencyOne external urethral clamp every 3 months (or sooner if deteriorates)

Medical-Necessity Criteria

Not Medically Necessary / Non‑Covered

Not Medically Necessary / Non-covered Items and Conditions

All of the following items or uses are specified as NOT MEDICALLY NECESSARY or non-covered in the policy:

ALL of the following

Irrigation solutions with antibiotics/chemotherapeutic agents: Irrigation solutions containing antibiotics/chemotherapeutic agents (represented by A9270) are non-covered and will be denied.
Acetic acid/hydrogen peroxide irrigation solutions: Irrigating solutions such as acetic acid or hydrogen peroxide (A4321) used for treatment/prevention of urinary obstruction will be denied as NOT MEDICALLY NECESSARY.
Routine intermittent irrigations performed at predetermined intervals are denied as NOT MEDICALLY NECESSARY.

Coding

Covered HCPCS Codes (subject to medical necessity criteria)HCPCSCovered

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, two-way latex with coating.
A4312	Insertion tray without drainage bag with indwelling catheter, foley type, two-way, all silicone.
A4313	Insertion tray without drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation.
A4314	Insertion tray with drainage bag with indwelling catheter, foley type, two-way latex with coating.
A4315	Insertion tray with drainage bag with indwelling catheter, foley type, two-way, all silicone.
A4316	Insertion tray with drainage bag with indwelling catheter, foley type, three-way, for continuous irrigation.
A4318	Female external urinary collection cup, with or without ring attachment, per day.
A4320	Irrigation tray with bulb or piston syringe, any purpose.

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Provider Actions & Billing Rules

Prior Authorization

Inpatient precertification required

Precertification/preauthorization is required for all products described in this policy when the procedure is performed inpatient. For outpatient settings: Commercial Managed Care (HMO and POS) and Commercial PPO/Indemnity do not require prior authorization per policy.

Documentation Required

Document medical necessity for non-routine changes and specialty devices

Document medical necessity for non-routine catheter changes and for specialty or all-silicone catheters and Coude-tip use in females. Documentation must be available upon request and should explain the clinical indication (e.g., accidental removal, malfunction, obstruction from encrustation/mucous plug/blood clot, history of recurrent obstruction or UTI warranting > once/month changes). When billing for greater-than-usual quantities or for continuous irrigation, include supporting medical record documentation.

Non-routine changes: document accidental removal, malfunction, obstruction (encrustation, mucous plug, blood clot), or history of recurrent obstruction/UTI requiring scheduled changes > once/month.

Background & Evidence

Background: The policy defines clinical terms including Impaired Detrusor Contractility (IDC) (a contraction of reduced strength and/or duration resulting in prolonged or incomplete bladder emptying) and links IDC to Permanent Urinary Retention (PUR) in the policy context. The inFlow device (intraurethral valve-pump and activator) received FDA De Novo authorization in 2014 and is described as a silicone intraurethral tube with a miniature valve-pump activated by a remote wand, designed to remain in place about one month and be replaced every 29 days. Clinical evidence includes a pivotal multicenter trial (single-arm crossover) and other studies showing that, in an evaluable subset of women with IDC, post-void residuals (PVR) were comparable to clean intermittent catheterization and quality-of-life scores improved, with decreased monthly UTI rates among completers. The policy concludes that the inFlow device (HCPCS A4335) is an alternative to intermittent catheterization for a subset of beneficiaries with PUR due to IDC. See the policy definitions section for key terms (e.g., IDC, routine vs non-routine irrigation, PUR).

Definitions

Impaired Detrusor Contractility (IDC)Contraction of reduced strength and/or duration causing prolonged bladder emptying or failure to achieve complete emptying; may be called atonic bladder or detrusor underactivity.

Permanent Urinary Retention (PUR)Long-standing inability to empty the bladder requiring chronic management; policy links PUR due to IDC as indication for inFlow device.

Routine irrigation

Medicare Determinations

Name	Number	Type	Effective
Urological Supplies	L33803	LCD
Urological Supplies - Policy Article	A52521	Local Coverage Article
inFlow device (HCPCS A4335)	A4335	HCPCS / Device	Replaces every 29 days; continued coverage re-eval between day 31-91

Revision History

10/2021added

New medical policy describing medically necessary and not medically necessary urological supplies created (effective 10/1/2021).

4/2023clarified

Clarified coding information: DME MACs revised to remove HCPCS code spans and list codes individually; no changes to reasonable and necessary requirements.

1/2026clarified

Clarified coding information: DME MACs revised to remove HCPCS code spans and list codes individually; no changes to reasonable and necessary requirements.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyUrological Supplies

Policy CodePolicy 370

Change TypeAdded (10/2021)Clarified coding (4/2026, 1/2026, 4/2023)

Effective DateOct 1, 2021

Next Review Date

Key ActionDocument medical necessity for non-routine changes, specialty devices, greater-than-usual quantities, and continuous irrigation; make records available upon request.

SourceLink

On This Page

Prophylactic continuous irrigation: Continuous irrigation used as a primary preventative measure without a history of obstruction will be denied as NOT MEDICALLY NECESSARY.

Drainage bags with absorbent material: Drainage bags containing absorbent material (gel matrix, daily disposable) are NOT MEDICALLY NECESSARY and will be denied.

External device with indwelling catheter: External catheters or female external collection devices are NOT MEDICALLY NECESSARY when ordered for members who also use an indwelling catheter.

More than one tray per episode: More than one insertion tray per episode will be denied as NOT MEDICALLY NECESSARY.

More than one irrigation tubing set per day for continuous irrigation will be denied as NOT MEDICALLY NECESSARY.

Irrigation solutions billed as A4321/A9270: Irrigation solutions billed as therapeutic agents (A4321) or represented by A9270 are denied per above.

inFlow billed more frequently than 29 days: Claims for the inFlow device (A4335) billed more than once every 29 days will be denied as NOT MEDICALLY NECESSARY.>29 days interval required

Non-covered / Not Medically Necessary HCPCSHCPCSNot Covered

A9270	Non-covered item or service (used to represent irrigation solutions containing antibiotics/chemotherapeutic agents)
A4321	Therapeutic irrigating solutions such as acetic acid/hydrogen peroxide - denied as NOT MEDICALLY NECESSARY

Specialty/all-silicone catheters (A4340, A4344, A4312, A4315): document justification (recurrent encrustation, inability to pass straight catheter, latex sensitivity).

Coude-tip (curved) indwelling catheter use in females (A4340) is rarely reasonable; must justify in record.

Document and justify greater-than-usual quantities of supplies.

For continuous irrigation, document necessity and have records available upon request (see continuous irrigation documentation requirements).

Billing Rule

inFlow device frequency billing

Bill no more than one inFlow device (A4335) every 29 days. Claims billed more frequently will be denied as not medically necessary.

Documentation Required

inFlow device continued coverage re-evaluation

For continued coverage beyond the first three months, the treating practitioner must perform an in-person clinical re-evaluation no sooner than day 31 and no later than day 91 after initiating therapy. The record must document that urinary symptoms are improved and verify the member's adherence to use of the inFlow device. If re-evaluation is not completed within this window or documentation does not demonstrate benefit and adherence, continued coverage will be denied. If re-evaluation occurs after day 91 and demonstrates benefit, coverage may commence from that re-evaluation date.

In-person encounter between day 31 and day 91 documenting symptom improvement.
Treating practitioner verification of adherence to device use.

Billing Rule

Insertion tray per episode

One insertion tray is considered medically necessary per episode of indwelling catheter insertion. More than one insertion tray per episode will be denied as not medically necessary.

Affected codes: A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4353, A4354

Billing Rule

Sterile kit billing

Do not bill A4353 (sterile intermittent catheter kit) when the components are packaged and provided separately. Separately provided components do not provide the equivalent sterility and will be denied as not medically necessary.

Denial Risk

Denial for routine irrigation and prophylactic continuous irrigation

Claims for routine/intermittent scheduled irrigations and continuous irrigation without a documented history of catheter obstruction will be denied as not medically necessary. Codes specifically noted include A4320, A4322, and A4355.

Codes mentioned: A4320, A4322, A4355
Routine intermittent irrigations (performed at predetermined intervals) are denied.
Continuous irrigation as a prophylactic measure without history of obstruction is denied.

Documentation Required

Continuous irrigation documentation requirements

For continuous irrigation, document the medical necessity versus intermittent irrigation, and ensure records indicate the rate of solution administration and duration of need; these records must be available upon request. Applicable codes include A4355, A4313, A4316, and A4346.

Codes mentioned: A4355, A4313, A4316, A4346
Documentation must indicate rate of solution administration and duration of need.
Records must be available upon request.

Irrigations performed at predetermined intervals — considered not medically necessary.

Acute catheter obstructionObstruction requiring as‑needed (non‑routine) intermittent irrigation (e.g., encrustation, mucous plug, clot).

Clinical Evidence Summary

Pivotal trial participantsPivotal multicenter trial enrolled 273 participants; 77 completed; 115 were evaluable for the primary endpoint.

PVR comparability98% of evaluable subjects had comparable post-void residual (PVR) values for inFlow device and CIC.

Quality of life (QOL) changeAmong those with available data, mean QOL scores increased by 25 points (p<0.0001).

UTI ratesAmong completers, monthly UTI rate decreased with continued inFlow device use; authors found inFlow equivalent or superior to CIC for UTI rate.

4/2026clarifiedLatest

Clarified coding information: DME MACs revised to remove HCPCS code spans and list codes individually; no changes to reasonable and necessary requirements.