CurrentBlue Cross Blue Shield - MassachusettsPolicy 370

Medical Policy Urological Supplies

Medical policy governing coverage and medical necessity criteria for urological supplies (indwelling and intermittent catheters, drainage systems, irrigation supplies, external collection devices, inFlow device, and related accessories) for Commercial members of Blue Cross Blue Shield - Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMedical Policy Urological Supplies

Policy CodePolicy 370

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization for inpatient services and document medical necessity in the member's medical record.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

200max units/month (certain intermittent supplies)

2drainage bags/month

29 daysinFlow replacement interval

2 weekscontinuous irrigation limit

Coverage and Medical Necessity Criteria

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Indwelling Catheter Medical Necessity

Covered when ALL of the following are met

Indwelling catheter basic necessity: Indwelling catheter must meet medical necessity and be documented in the member's medical record

General requirement

Non-routine catheter change indications: Catheter accidentally removed; catheter obstructed by encrustation, mucous plug, or blood clot; malfunction (balloon not inflated; hole in catheter); history of recurrent obstruction or UTI requiring scheduled changes > once/month

Any one qualifies as non-routine change

Coude tip restriction in females: Use of Coude (curved) tip indwelling catheter in female members is rarely reasonable and necessary unless documentation substantiates medical necessity

Lack of documentation leads to denial for codes A4340/A4344/A4312/A4315

Continuous Irrigation Criteria

Covered when ALL of the following are met

Continuous irrigation necessity: History of catheter obstruction and patency cannot be maintained by intermittent irrigation plus catheter changes

Documentation must include rate and duration; continuous irrigation is temporary and rarely reasonable beyond 2 weeks

Covered supplies for continuous irrigation: Three-way catheter (A4313/A4316/A4346), irrigation tubing set (A4355), and sterile water/saline (A4217)

More than one irrigation tubing set per day will be denied

Intermittent Irrigation Criteria

Covered when ALL of the following are met

Intermittent irrigation necessity: Used on an as-needed (non-routine) basis for acute catheter obstruction

Routine (predetermined interval) irrigations and antibiotic/chemotherapeutic irrigation solutions (A9270) are denied

Intermittent Catheterization Criteria

Intermittent catheterization considered MEDICALLY NECESSARY when basic coverage criteria are met and the member or caregiver can perform the procedure

Per-episode coverage: For each episode of medically necessary catheterization, coverage includes one sterile intermittent catheter kit (A4353) when additional criteria are met, or one catheter (A4351 or A4352) plus individual packet of lubricant (A4332)

Indications for sterile intermittent catheter kit (A4353): Member is immunosuppressed (examples: resides in nursing facility; on immunosuppressive drugs post-transplant; has AIDS; on cancer chemotherapy; chronic oral corticosteroid use); spinal cord injured pregnant female (duration of pregnancy only); radiologically documented vesico-ureteral reflux on program of intermittent catheterization; distinct recurrent UTIs while on sterile intermittent catheter program (two within prior 12 months)

Any one satisfies requirement

UTI definition for recurrence: Urine culture >10,000 CFU of urinary pathogen AND concurrent presence of ONE OR MORE signs/symptoms (systemic leukocytosis; fever >100.4°F; change in urgency/frequency/incontinence; physical signs of prostatitis/epididymitis/orchitis; new/increased autonomic dysreflexia; increased muscle spasms; pyuria >5 WBC/hpf)

Defines recurrent UTI

Kit billing requirement: A4353 should be used only when components are packaged together as a kit; separately billed components will be denied as NOT MEDICALLY NECESSARY

External Catheters/Collection Devices

Covered when ALL of the following are met

External catheter necessity: Male external catheters or female external collection devices are medically necessary for members with permanent urinary incontinence when used as an alternative to an indwelling catheter and with documentation of medical necessity

Devices ordered for members who also use an indwelling catheter will be denied

Specialty external catheters: Specialty male external catheters (A4326) are medically necessary only when documentation substantiates need; otherwise denied

One pouch (A4328) per day will be denied

inFlow Device Coverage

Covered when ALL of the following are met

Initial inFlow coverage: inFlow device is medically necessary as an alternative to intermittent catheterization for members with permanent urinary retention due to impaired detrusor contractility; one device permitted no more than once every 29 days

Claims billed more frequently than once every 29 days will be denied

Continued inFlow coverage: Continued coverage beyond the first three months requires an in-person re-evaluation between day 31 and 91 documenting adherence and clinical benefit; if re-evaluation after day 91 demonstrates benefit, coverage commences from the re-evaluation date

Supplier must stop billing if member discontinues use

Miscellaneous Supplies Criteria

Covered when ALL of the following are met

Appliance cleaner (A5131) is medically necessary for cleaning certain urinary collecting appliances; more than one 16 oz unit per month is rarely reasonable and necessary

External urethral clamp: One external urethral clamp or compression device (A4356) is medically necessary every 3 months or sooner if casing deteriorates

Tape limits: Tape (A4450/A4452) used to secure an indwelling catheter is medically necessary; more than 10 units per month will be denied

Adhesive anchoring and leg straps: Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) are medically necessary; more than 3 per week of A4333 or more than 3 per month of A4334 will be denied

Coverage for inFlow device (summary criteria)

Covered when ALL of the following are met

Primary criteria

Clinical evidence support: Pivotal trial and other studies demonstrate comparable post-void residuals to CIC and quality-of-life improvements; device FDA-cleared
Pivotal trial: 98% comparable PVR; QOL improvement reported

Irrigation solutions that contain antibiotics or chemotherapeutic agents (HCPCS A9270) are not covered. Irrigating solutions such as acetic acid or hydrogen peroxide (HCPCS A4321) used for treatment or prevention of urinary obstruction are considered not medically necessary and will be denied. Sterile water/saline (HCPCS A4217) is the allowable irrigant when intermittent or continuous irrigation is medically necessary, and records supporting clinical need may be requested.

Disposal‑type daily absorbent drainage bags and similar disposables are not established as medically necessary for bedridden members; leg bags are indicated only for ambulatory or chair/wheelchair‑bound members and the use of leg bags for bedridden members will be denied.

Published evidence for the intraurethral valve‑pump (inFlow) device shows improvements in quality of life and comparable post‑void residuals versus clean intermittent catheterization in selected women, but there were high discontinuation rates largely attributed to patient discomfort. The device does not treat the underlying detrusor underactivity; it functions as an alternative means to empty the bladder.

Because tolerability is a common issue and the device does not correct detrusor contractility, candidacy should be limited to members who meet the policy clinical criteria and demonstrate ability or willingness to use the device; documentation of clinical benefit and adherence is required for continued coverage.

Routine (predetermined interval) intermittent irrigation of indwelling catheters is denied as not medically necessary. Intermittent irrigation supplies (e.g., irrigation tray A4320, irrigation syringe A4322, and sterile water/saline A4217) are covered only when used on an as‑needed basis for acute catheter obstruction and when documentation of the obstruction is available on request.

Continuous bladder irrigation is a temporary, clinically justified intervention when catheter patency cannot be maintained by intermittent irrigation and catheter changes; documentation must include rate and duration of administration. Continuous irrigation beyond 2 weeks is rarely reasonable and more than one irrigation tubing set per day will be denied.

Irrigation solutions with antibiotics or chemotherapeutic agents (A9270) are non‑covered, and routine supplies or solutions used for prevention (including acetic acid or hydrogen peroxide A4321) are considered not medically necessary. Use of routine irrigation supplies without acute obstruction documentation will be denied.

HCPCS code A9270 is listed in this policy as a non‑covered item or service and will not be reimbursed when billed.

HCPCS and Billing Codes

Included HCPCS CodesHCPCS

A4310	Catheter insertion tray
A4311	Catheter insertion tray (listed in policy)
A4312	Catheter insertion tray (listed in policy)
A4313	Three-way catheter listed in policy
A4314	Insertion tray with drainage bag with indwelling catheter; Foley type, two-way
A4315	Insertion tray with drainage bag with indwelling catheter, Foley type, two-way, all silicone
A4316	Insertion tray with drainage with indwelling catheter, Foley type, three-way
A4320	Irrigation tray
A4321	Irrigation solution such as acetic acid or hydrogen peroxide
A4322	Irrigation syringe

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HCPCS Codes listedHCPCS

A4217	Sterile water/saline, 500 ml
A4310	Insertion tray without drainage bag and without catheter (accessories only)
A4311	Insertion tray without drainage with indwelling catheter, foley type, two-way latex with coating
A4312	Insertion tray without drainage with indwelling catheter, foley type, two-way, all silicone
A4313	Insertion tray without drainage with indwelling catheter, foley type, three-way, for continuous irrigation
A4314	Insertion tray with drainage bag with indwelling catheter, foley type, two-way latex
A4315	Insertion tray with drainage with indwelling catheter, foley type, with bag
A4316	Insertion tray with drainage bag with indwelling catheter, three-way, for continuous irrigation
A4320	Irrigation tray with bulb or piston syringe, any purpose
A4322	Irrigation syringe, bulb or piston, each

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Device coding highlighted in conclusionHCPCSCovered

A4335

inFlow device (identified as intraurethral valve‑pump)

Intermittent catheter / lubricant monthly limit

LimitA4332/A4351/A4352/A4353 — 200 units per month

Applies toLubricant packets and intermittent urinary catheters (straight and coude tip) and intermittent catheter kits (A4353)

Billing noteA4353 (kit) should be billed only when components are packaged together; separate component billing will be denied

Drainage bag usual maximum

Usual maximumA4357/A4358/A5112 — 2 bedside/leg drainage bags per month

Codes includedA4357 (bedside drainage bag), A4358 (vinyl leg bag), A5112 (latex leg bag)

Clinical useLeg bags intended for ambulatory, chair, or wheelchair-bound members; use for bedridden members denied

inFlow device replacement interval

Replacement intervalinFlow device — replace every 29 days (claims billed more frequently will be denied)

Device descriptionSilicone intraurethral tube with miniature valve and pump activated by a remote-control wand; inserted similar to a urinary catheter

Regulatory statusFDA cleared via De Novo pathway

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Precertification/preauthorization is REQUIRED for services described in this policy when the procedure is performed inpatient. Outpatient prior authorization requirements vary by product and product line — for Commercial Managed Care (HMO and POS) and Commercial PPO/Indemnity, outpatient prior authorization is not required per this policy; verify member contract benefits and product-specific rules before billing.

Inpatient procedures described in this policy: precertification/preauthorization is REQUIRED.
Outpatient: Commercial Managed Care (HMO and POS) = prior authorization not required; Commercial PPO and Indemnity = prior authorization not required.
Always check the member's contract benefits for coverage and prior authorization requirements.

Documentation Required

Medical Record Documentation Required

Providers must document medical necessity in the member's medical record and have records available upon request. Documentation must demonstrate the need for the specific device or supply, frequency of use, and any clinical indications supporting selection of a particular catheter type.

Medical records must support non-routine catheter changes, indications such as accidental removal, obstruction (encrustation, mucous plug, blood clot), malfunction (balloon failure, hole), or recurrent obstruction/UTI requiring scheduled changes.
Use of specialized catheters (e.g., Coude tip in females) requires explicit documentation of medical necessity; absence of documentation may result in denial.
Records for continuous irrigation must indicate rate of solution administration, duration needed, and justification why intermittent irrigation is insufficient.

Denial Risk

Leg Bag Restrictions

Leg bags (A4358 vinyl and A5112 latex) are intended for ambulatory or chair/wheelchair-bound members. Use of leg bags for bedridden members is NOT MEDICALLY NECESSARY. Do not bill both vinyl and latex leg bags together for the same member.

Leg bags indicated for ambulatory or chair/wheelchair-bound members only.
Use of leg bags for bedridden members will be denied as NOT MEDICALLY NECESSARY.
Do not bill A4358 and A5112 together for the same period of service.

Billing Rule

Intermittent Catheter Kit Billing

Intermittent catheter kit (A4353) should be billed only when the kit components are provided as a packaged kit. If components are supplied separately rather than as a packaged kit, do not bill A4353 — separately provided components will be denied as NOT MEDICALLY NECESSARY.

A4353 represents an intermittent urinary catheter with insertion supplies as a packaged kit.
Separate billing of kit components in lieu of a packaged A4353 kit will be denied.

Documentation Required

Continuous Irrigation Documentation & Limits

Continuous irrigation is considered medically necessary only when there is a history of catheter obstruction and patency cannot be maintained with intermittent irrigation and reasonable catheter changes. Continuous irrigation is temporary and generally reasonable for no more than 2 weeks; documentation must justify the need and include rate and duration of solution administration. More than one irrigation tubing set per day will be denied.

Covered supplies for continuous irrigation include 3-way catheter codes (A4313, A4316, A4346), irrigation tubing set (A4355), and sterile water/saline (A4217).
Irrigation solutions containing antibiotics/chemotherapeutics (A9270) are denied as NOT MEDICALLY NECESSARY.
Continuous irrigation beyond 2 weeks is rarely reasonable and will require supporting documentation; >1 tubing set per day will be denied.

Documentation Required

Coding and Documentation

Report services using the most up-to-date industry-standard CPT, HCPCS, revenue, and diagnosis codes, including appropriate modifiers. Inclusion of a code in policy does not guarantee coverage — the medical necessity criteria in this policy must be met for coverage.

Providers should report services with current procedure, revenue, and diagnosis codes and include modifiers where applicable.
Inclusion or exclusion of a code in the policy is informational only; verify coverage against the member's contract and apply the policy medical necessity criteria.
The listed codes require that the policy's medical necessity criteria be met for Commercial Members.

Note

inFlow Device Coverage and Re-evaluation Steps

The inFlow device (HCPCS A4335) is covered as an alternative to intermittent catheterization for members with Permanent Urinary Retention (PUR) due to Impaired Detrusor Contractility (IDC). Initial coverage allows one inFlow device no more than once every 29 days. Continued coverage beyond the first three months requires an in-person re-evaluation between day 31 and day 91 with documentation of adherence and clinical benefit; if criteria are not met, coverage will be denied.

Initial: One inFlow device (A4335) may be provided no more than once every 29 days — claims more frequent than every 29 days will be denied as NOT MEDICALLY NECESSARY.
Continued coverage: No sooner than day 31 and no later than day 91 after initiation, treating practitioner must perform an in-person clinical re-evaluation documenting continued use and clinical benefit (improved urinary symptoms) and verify adherence.
If re-evaluation occurs after day 91 but documents benefit, continued coverage may commence from the re-evaluation date.
If member discontinues use, supplier must stop billing for the device and accessories.

Step Therapy

Step therapy: none specified in this policy. The inFlow device is identified as an alternative to clean intermittent catheterization for a subset of beneficiaries with PUR due to IDC, but no formal step therapy sequence or prior trial requirements are detailed here — verify product-level or contract-specific step therapy rules if applicable.

No step therapy requirements are specified in this policy.
Treating practitioners should document why the inFlow device is appropriate as an alternative to CIC for the member.

Background and Context

Indwelling and intermittent catheterization, urinary drainage systems, and irrigation are used to manage urinary retention, obstruction, and incontinence. Continuous irrigation is reserved for cases where catheter patency cannot be maintained with intermittent irrigation and catheter changes, and is considered a temporary measure.

Intermittent irrigation supplies and continuous irrigation supplies are allowable only when clinically indicated: intermittent irrigation is permitted for acute catheter obstruction on an as‑needed basis while continuous irrigation requires documentation of obstruction history and justification why intermittent measures are insufficient. Routine, preventive irrigations are not covered.

External collection devices (male external catheters or female pouches) are appropriate alternatives to indwelling catheters for members with permanent urinary incontinence, provided medical necessity is documented. Leg bags are intended for ambulatory or chair/wheelchair‑bound members; use in bedridden members is not medically necessary.

Key Definitions

Routine irrigation

DefinitionRoutine irrigation = irrigations performed at predetermined intervals

Coverage stanceRoutine (predetermined interval) irrigations are denied as NOT MEDICALLY NECESSARY

When allowedIrrigation supplies are medically necessary only when used on an as‑needed (non‑routine) basis for acute catheter obstruction

Continuous irrigation

DefinitionContinuous irrigation = ongoing irrigation via a three‑way catheter when catheter patency cannot be maintained by intermittent irrigation

Temporary useContinuous irrigation is a temporary measure; more than 2 weeks is rarely reasonable and necessary

Covered suppliesThree‑way catheter (A4313/A4316/A4346), irrigation tubing set (A4355), sterile water/saline (A4217); more than one tubing set per day denied

Impaired detrusor contractility (IDC)

Definition (ICS)Impaired detrusor contractility (IDC) = a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or failure to achieve complete bladder emptying within a normal time span

Also known asAtonic bladder or detrusor underactivity

Common causesNeurologic disease or injury (e.g., multiple sclerosis, stroke, spinal cord injury, diabetic neuropathy, Parkinson's disease)

inFlow device (intraurethral valve‑pump)

Device descriptionSilicone intraurethral tube containing a miniature valve and pump activated by a remote-control wand to induce bladder emptying; inserted similarly to a urinary catheter

Replacement intervalDevice is typically replaced every 29 days

Insertion and useSized and initially inserted by a treating practitioner; user or caregiver can generally replace the device; empties bladder when remote activator is held over lower pelvis

Policy Revision History

4/2023technical_correction

Clarified coding information related to HCPCS code spans in Coverage Indications, Limitations, and/or Medical Necessity section.

10/2021policy_publicationLatest

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

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMedical Policy Urological Supplies

Policy CodePolicy 370

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization for inpatient services and document medical necessity in the member's medical record.

SourceLink

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