CurrentPremera BluecrossPolicy 7.01.175

Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia

Defines coverage stance and coding for temporarily implanted nitinol devices (e.g., iTind) to treat lower urinary tract symptoms from benign prostatic hyperplasia for Premera Blue Cross; intended for provider use.

Policy Summary

PayerPremera Bluecross

PolicyTemporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia

Policy CodePolicy 7.01.175

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateMar 1, 2026

Key ActionVerify appropriate CPT code and member benefit/prior authorization before submitting claims; CPT 53865 and 53866 are listed but requests for these codes are likely to be denied as investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalCoverage stance for iTind

53865, 53866Procedure codes listed

FDA de novo 2019Regulatory status

5-7 daysTypical implant duration

Clinical/MedicalPolicy type

Coverage Determination

Investigational / Not Covered with Criteria

Covered when ALL of the following are met:

Investigational designation: The use of a temporarily implanted nitinol device (e.g., iTind) for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia is considered investigational.

Policy states investigational — not covered as medically necessary.

Investigational / Not established

Policy history states investigational determination

Investigational stance: The use of a temporarily implanted nitinol device (e.g., iTind) is considered investigational as a treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

From policy history entry creating the policy on 03/01/23.

The use of a temporarily implanted nitinol device (e.g., iTind) for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia is designated investigational and is therefore excluded from coverage.

Policy Summary

PayerPremera Bluecross

PolicyTemporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia

Policy CodePolicy 7.01.175

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateMar 1, 2026

SourceLink

On This Page

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Procedure and Billing Codes

Procedure CPT codes listedCPT

53865	Cystourethroscopy with insertion of temporary device for ischemic remodeling (i.e., pressure necrosis) of bladder neck and prostate
53866	Catheterization with removal of temporary device for ischemic remodeling (i.e., pressure necrosis) of bladder neck and prostate

Policy-referenced CPT/HCPCS codes (history notes additions/removals)mixed

53865	CPT code added (document history)
53866	CPT code added (document history)
53899	Unlisted CPT code referenced (added previously/removed later as noted)
55899	Unlisted CPT code referenced (history shows addition and later removal)
58399	Previously listed unlisted CPT code (removed)
C9769	HCPCS code removed (termed Jan 1, 2025)

inv-09: Device dwell time — typical implant duration

Typical implant durationTypically removed after 5–7 days

Purpose of dwell timeAllows ischemic remodeling and tissue reshaping via circumferential force from nitinol struts

Removal methodRetrieved using distal nylon retrieval wire via snare into cytoscope sheath or open-ended silicone catheter (20–22 Fr)

Provider Requirements and Billing Guidance

Denial Risk

Investigational — Denial Risk

The use of a temporarily implanted nitinol device (e.g., iTind) is considered investigational for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia and may be denied as not medically necessary.

Investigational — denial risk: claims for temporarily implanted nitinol devices (e.g., iTind) are subject to noncoverage/denial due to the investigational policy status.

Documentation Required

Coding Documentation

Include the appropriate CPT codes on clinical documentation and claims: record insertion (CPT 53865) and removal (CPT 53866) when applicable.

CPT 53865 — Cystourethroscopy with insertion of temporary device for ischemic remodeling of bladder neck and prostate.
CPT 53866 — Catheterization with removal of temporary device for ischemic remodeling of bladder neck and prostate.
Note: CPT descriptions copyrighted by AMA.

Prior Authorization

Benefit Verification

Verify member benefits and plan coverage prior to scheduling. Coverage is subject to the limits and conditions of the member benefit plan and this medical policy does not apply to Medicare Advantage.

Check member benefit booklet or contact member services for applicable coverage, limits, and exclusions.
Confirm whether the service is covered under the member's plan; investigational designation may lead to denial even if billed with the listed CPT codes.

Step Therapy

Medical Therapy Prior to Procedural Options

Medical therapy is generally recommended as first-line treatment for BPH. Ensure conservative/medical management has been considered or attempted before procedural options.

First-line therapies include: α-adrenergic blockers (e.g., tamsulosin, doxazosin), 5α-reductase inhibitors (e.g., finasteride, dutasteride), or combination therapy.
Other options include antimuscarinics and phosphodiesterase-5 inhibitors as clinically indicated.
Document prior medical management (agents tried, duration, response) in the medical record prior to procedural consideration.

Prior Authorization

Verify CPT Codes & Authorization

Prior authorization: verify any prior authorization requirements with the payer for the planned procedure codes; authorization rules may change over time.

If prior authorization is required, ensure the authorization corresponds to the correct CPT code (53865 for insertion, 53866 for removal).
Verify that any authorization dates and code sets reflect the most recent plan and policy updates.

Terms and Device Information

inv-19: iTind / temporarily implanted nitinol device — device description and placement

Device typeTulip-shaped temporarily implanted nitinol implant with three double-intertwined struts

Placement locationTemporarily implanted into the obstructed prostatic urethra using a rigid cystoscope

Mechanism of actionExpands to exert circumferential force causing ischemic necrosis of mucosa, urethral expansion and longitudinal channels for improved urine outflow

Retrieval featureDistal nylon wire facilitates device retrieval by snare into a cytoscope sheath or open-ended silicone catheter (20–22 Fr)

inv-20: AUASI / IPSS — symptom score definition and ranges

InstrumentAmerican Urological Association Symptom Index (AUASI) / International Prostate Symptom Score (IPSS)

Questionnaire lengthSelf-administered 7-item questionnaire (AUASI) with an additional quality-of-life 'Bother' question included in IPSS

Score range and categoriesTotal score 0–35: mild ≤7; moderate 8–19; severe 20–35

UseEvaluates severity of BPH-related urinary symptoms (frequency, nocturia, urgency, hesitancy, weak stream)

inv-21: iTind System — FDA de novo classification, intended age population (men 50+), product code QKA

FDA classificationGranted de novo 510(k) classification (DEN190020)

Product codeQKA

Intended populationIntended for treatment of symptoms due to urinary outflow obstruction secondary to BPH in men aged 50 and older

OpenPayer

Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia

Coverage Determination

Procedure and Billing Codes

Provider Requirements and Billing Guidance

Clinical Background

Terms and Device Information