Obtain and document a complete Standard Written Order (SWO) before billing

A completed Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted; if the supplier bills without first receiving a completed SWO the claim will be denied as not medically necessary. The SWO must include member ID, order date, item description (HCPCS code or brand/model), separately listed options/accessories/supplies with HCPCS codes and quantities, treating practitioner name, NPI and signature.

• SWO elements required: member name/ID; order date; description (HCPCS code, narrative, or brand/model); each concurrently ordered option/accessory/supply listed separately with HCPCS code and quantity; treating practitioner name and NPI; practitioner signature.
• A new prescription from the treating practitioner is required each time a new device or repair is requisitioned.

Document selection criteria for specific supplies/devices (prior review likely)

Certain specialized supplies and devices are covered only when documented selection criteria are met and therefore are likely subject to prior review; examples include three‑way Foley catheters for continuous irrigation (A4346), irrigation tubing sets (A4355), ureteral stents (C1875, C2617) and the inFlow device (CPT 0596T/0597T and HCPCS A4341/A4342).

• A4346 (three‑way Foley for continuous irrigation) — coverage only when continuous irrigation is medically necessary.
• A4355 (irrigation tubing set) — see quantity limits and clinical criteria.
• Ureteral stent codes C1875 and C2617 — covered only if selection criteria are met.
• inFlow device codes 0596T/0597T and A4341/A4342 — covered only when selection criteria documented.

Prior authorization/document clinical criteria for select device/procedure codes

Certain procedure and device codes are listed as covered only if selection criteria are met and therefore require documentation of clinical selection criteria and may require prior authorization (examples include CPT 0596T/0597T and HCPCS A4341/A4342 for the inFlow device, and ureteral stent codes C1875/C2617).

• 0596T / 0597T — inFlow initial insertion and replacement: document indication (e.g., impaired detrusor contractility, retention) and selection criteria.
• A4341 / A4342 — inFlow related HCPCS: replacement/accessories require documented selection criteria.
• C1875 / C2617 — ureteral stents require documented clinical indication per policy.

Check appendix items — prior‑auth requirements not specified in excerpt

The policy appendix lists numerous urological supply items (insertion trays, drainage bags, extension tubing, leg straps, lubricants, indwelling catheters, etc.); the excerpt does not specify explicit prior authorization requirements for each listed Appendix item, so verify payor-specific prior‑auth rules as needed.

• Appendix includes insertion trays with/without drainage bag, bedside drainage bags, extension tubing, lubricant packets, leg straps and related items.
• Explicit prior authorization requirements for these appendix items are not stated in the provided excerpt.

Perform and document in‑person re‑evaluation for inFlow between day 31–91

For continued coverage of the inFlow device beyond the first 3 months, the treating practitioner must perform and document a clinical re‑evaluation between day 31 and day 91 after initiating therapy showing (1) an in‑person encounter documenting improved urinary symptoms and (2) verification of member adherence to device use; if these are not met continued use is not medically necessary.

• Re‑evaluation window: no sooner than day 31 and no later than day 91 after initiation.
• Documentation must show in‑person encounter with symptom improvement and practitioner verification of adherence.
• If re‑evaluation occurs after day 91 but documents benefit, coverage resumes from the date of that re‑evaluation.

Document use of external collection devices as alternatives to indwelling catheters

Consider documented alternatives to indwelling catheters for members with permanent incontinence; external collection devices (HCPCS A4326, A4327, A4328, A4349) are indicated as alternatives and should be selected and documented when clinically appropriate.

• A4326, A4327, A4328, A4349 — external collection devices as alternatives to indwelling catheters for permanent incontinence.
• Document rationale for choosing an external device instead of an indwelling catheter and adhere to quantity limits (e.g., A4349 maximum 35 per month).

Document prior therapies and rationale when sequencing to inFlow

When ordering the inFlow device, document prior therapies and rationale (for example prior trial of CIC and its tolerability) because clinical trial evidence compares inFlow to clean intermittent catheterization; the medical record should show prior therapy and reasons for choosing inFlow.

• Document prior management such as CIC and trial tolerability (e.g., 1‑week tolerability trial described in studies).
• Record clinical rationale for device selection and any contraindications to alternative therapies.

No additional step‑therapy requirements specified in excerpt

No step therapy or formal sequencing rules are specified in the provided excerpt; do not assume additional step‑therapy requirements beyond those explicitly stated for specific devices (e.g., inFlow re‑evaluation).

• The excerpt explicitly states no step therapy requirements or sequencing rules are specified.
• Follow device‑specific documentation/re‑evaluation requirements where present.

Maintain complete medical record and SWO content to support coverage

Medical records must contain sufficient information demonstrating that all applicable coverage criteria are met; supplier‑prepared statements or attestations alone are insufficient. Ensure the record includes clinical indications, prior therapy, device sizing/insertion notes (when applicable), and a new practitioner prescription for each new device or repair.

• Supplier or financially interested records are not sufficient by themselves to support medical necessity.
• Forms or supplier statements must be corroborated by information in the member’s medical record.
• A new prescription is required each time a new device or repair is requisitioned.

Document qualifying ICD‑10 diagnosis and support for billed codes

Document the specific ICD‑10 diagnosis(es) that qualify for coverage (examples include N31.x neuromuscular dysfunction of bladder, N32.81 impaired detrusor contractility, R33.x retention, and incontinence codes expected to be of 3 months’ duration); the medical record must support the billed ICD‑10 and HCPCS/CPT codes.

• Record one of the policy‑listed diagnoses when billing related supply/device codes (e.g., N32.81, R33.0‑R33.9, N31.0‑N31.9, R32).
• Document expected duration (e.g., incontinence/retention diagnoses expected to be ≥3 months) where applicable.

Support billed codes with medical record documentation

Ensure the medical record supports the clinical rationale for each billed HCPCS/CPT code (selection criteria, indication, and quantity limits); supplier statements alone are insufficient and coverage depends on documentation corroborating the order and clinical need.

• Corroborate supplier orders with clinical notes showing indication, prior therapies, and expected duration.
• Include device sizing/insertion details for physician‑performed procedures (e.g., inFlow initial insertion).

Providers must follow plan provisions and verify benefits

Providers are responsible for the medical advice and treatment they provide and must follow plan benefits and program provisions referenced by Aetna; the Clinical Policy Bulletin is a summary and does not replace plan provisions.

• The bulletin is a partial description of benefits and is not a contract or guarantee of coverage.
• Providers should verify plan‑specific provisions when ordering supplies/devices.

Failure to provide SWO before billing will result in denial

If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not medically necessary.

• Suppliers expected to stop billing if device use is discontinued.
• Ensure SWO transmitted to supplier before claim submission to avoid denial.

Billing not‑covered HCPCS codes for excluded indications may be denied

HCPCS codes listed as not covered for indications in this bulletin (examples include A4245, A4247, A4318, A4321, A4335 and others) may trigger denials when billed for excluded indications; verify that the indication billed is permitted under policy.

• Review the policy’s not‑covered/exclusion lists before billing these HCPCS codes.
• Document clinical justification if an otherwise listed code is being requested for a covered indication.

Certain supply codes (eg, A4332) are non‑covered for specific indications

Use of certain supply codes is specifically noted as not medically necessary for particular indications (for example A4332: lubricant individual sterile packet is 'not medically necessary for CIC'); billing these supplies for excluded indications may result in denial.

• A4332 — not medically necessary for clean intermittent catheterization (CIC).
• Ensure lubricant and supply quantities conform to policy limits (e.g., A4402 non‑sterile gel max 8 oz/month for CIC).

No additional explicit denial triggers stated in excerpt — corroborate documentation

This excerpt does not present explicit administrative denial triggers beyond the SWO and not‑covered lists; the Clinical Policy Bulletin is informational and does not guarantee coverage decisions — always corroborate documentation against policy criteria.

• Administrative statements emphasize the bulletin is not exhaustive and may be updated.
• Absence of an explicit denial trigger in the excerpt does not replace case‑level documentation requirements.