CurrentRegence BlueCross BlueShieldPolicy 230

Devices for Treatment of Benign Prostatic Hyperplasia, Urethral Stricture, and Urethral Stenosis

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This policy addresses coverage of temporarily implanted nitinol devices, drug-coated balloon catheter systems, and prostatic urethral scaffolds for benign prostatic hyperplasia, urethral stricture, or urethral stenosis. Drug-coated balloon systems may be medically necessary for selected recurrent anterior bulbar urethral strictures; other reviewed uses and indications outside specified criteria are investigational.

Policy Summary

PayerRegence BlueCross BlueShield

PolicyDevices for Treatment of Benign Prostatic Hyperplasia, Urethral Stricture, and Urethral Stenosis

Policy CodePolicy 230

Change TypeNo material change

Effective DateJanuary 1, 2027

Last ReviewAug 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit history and physical or chart notes, the requested device, stricture size and location, and prior endoscopic treatment documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Medically necessary device indication

3Device categories investigational for all indications

≤3 cmMaximum medically necessary stricture length

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CurrentRegence BlueCross BlueShieldPolicy 230

Devices for Treatment of Benign Prostatic Hyperplasia, Urethral Stricture, and Urethral Stenosis

Customize your policy alerts

Sign up for regence Policy 230 alerts

Get alerted when Policy 230 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerRegence BlueCross BlueShield

PolicyDevices for Treatment of Benign Prostatic Hyperplasia, Urethral Stricture, and Urethral Stenosis

Policy CodePolicy 230

Change TypeNo material change

Effective DateJanuary 1, 2027

Last ReviewAug 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit history and physical or chart notes, the requested device, stricture size and location, and prior endoscopic treatment documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Medically necessary device indication

3Device categories investigational for all indications

≤3 cmMaximum medically necessary stricture length

Required documentation categories

Covered and Investigational Uses

Medically Necessary Drug-Coated Balloon Use

A drug-coated balloon catheter system may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

The stricture is located in the anterior (bulbar) urethra.
The stricture is 3 cm or less in length.≤ 3 cm
The stricture is recurrent and has failed prior endoscopic treatment, such as direct visual internal urethrotomy or dilation.

Investigational Uses

The following uses are investigational:

Any of the following

Use of a drug-coated balloon catheter system when the medically necessary criteria for recurrent anterior (bulbar) urethral stricture are not met.
Use for penile urethral stricture.
First-time treatment of a urethral stricture.
Repeated use of the device.
Use of a temporarily implanted nitinol device, such as iTind, for any indication, including lower urinary tract symptoms due to benign prostatic hyperplasia.
Use of a drug-coated balloon catheter system, such as the Optilume BPH Catheter System, for any indication, including obstructive urinary symptoms associated with benign prostatic hyperplasia.

Optilume BPH Catheter System

Evidence from one randomized controlled trial and one single-arm study suggests that the Optilume BPH Catheter System may improve peak urinary flow rate and symptoms associated with benign prostatic hyperplasia. However, the evidence is limited and does not establish improvement in net health outcome.

Evidence assessment

In the randomized controlled trial, symptom scores did not reach statistical significance.
One study lacked a control group.
Serious adverse events, most commonly hematuria, are a concern.
The treatment may not be generalizable to prostates above 80 g.
Long-term follow-up is needed to determine durability.

Optilume Drug-Coated Urethral Dilation Catheter

Evidence from one randomized controlled trial and two single-arm studies suggests that the Optilume Urethral Drug Coated Balloon may improve outcomes for urethral stricture, but important limitations remain.

Evidence assessment

Studies reported reduced stricture recurrence, increased urinary flow rate, and improved urinary symptom scores.
The randomized controlled trial found significantly greater improvement with the drug-coated balloon than with endoscopic management.
Drug-coated balloon treatment was more durable than endoscopic treatment at one-year follow-up.
Most randomized-trial participants had bulbar urethral strictures, so results may not generalize to all types of urethral strictures.
Hematuria was more common with the drug-coated balloon.

Prostatic Urethral Scaffold Device

Evidence for prostatic urethral scaffold devices is insufficient to establish improvement in net health outcome.

Evidence assessment

Evidence is limited to small, nonrandomized studies focused on safety and feasibility.
The studies do not compare prostatic urethral scaffold devices with other treatments for benign prostatic hyperplasia.

Coverage determination: The evidence is insufficient to determine that the technology improves the net health outcome; use is considered investigational for all indications.

Urethral Drug-Coated Balloon Medical Necessity

For the Optilume Urethral Drug Coated Balloon, available research suggests improved health outcomes for a subset of individuals with urethral stricture. The American Urological Association conditionally recommends drug-coated balloons only in combination with established endoscopic management of urethral strictures.

Medical necessity determination

The device is used for recurrent anterior (bulbar) urethral stricture.
All applicable policy criteria are met, including the required stricture location, length, and prior failed endoscopic treatment.
The drug-coated balloon is used in combination with established endoscopic management.

When the policy criteria are met, the Optilume Urethral Drug Coated Balloon may be considered medically necessary.

When the policy criteria are not met, or for indications other than recurrent anterior (bulbar) urethral stricture, the device is considered investigational, including penile urethral stricture, first-time treatment, and repeated use of the device.

Drug-coated balloon catheter systems (e.g., Optilume Urethral Drug Coated Balloon) are investigational when the covered medically necessary indication and policy criteria are not met, and for all other indications, including but not limited to penile urethral stricture, first-time treatment, and repeated use of the device.

Temporarily implanted nitinol devices (e.g., iTind) are investigational for all indications, including but not limited to treatment of symptoms due to benign prostatic hyperplasia.

Drug-coated balloon catheter systems for benign prostatic hyperplasia (e.g., Optilume BPH) are investigational for all indications, including but not limited to treatment of symptoms due to benign prostatic hyperplasia.

Prostatic urethral scaffold devices (e.g., Zenflow Spring) are investigational for all indications, including but not limited to treatment of symptoms due to benign prostatic hyperplasia.

Coding and Clinical Thresholds

FDA regulatory application and product codesmixed

DEN190020	FDA de novo 510(k) classification for the iTind System
QKA	FDA product code for the iTind System device classification
K210138	Example substantially equivalent device classification associated with the iTind generic device type
P210020	FDA premarket approval application for the Optilume Urethral Drug Coated Balloon
QRH	FDA product code for the Optilume Urethral Drug Coated Balloon
P220029	FDA premarket approval application for the Optilume BPH Catheter System
QXB	FDA product code for the Optilume BPH Catheter System

CPT CodesCPT

0619T	Cystourethroscopy with transurethral anterior prostate commissurotomy and drug delivery, including transrectal ultrasound and fluoroscopy, when performed (Deleted 01/01/2026).
0941T	Cystourethroscopy, flexible; with insertion and expansion of prostatic urethral scaffold using integrated cystoscopic visualization (Deleted 01/01/2026).
0942T	Cystourethroscopy, flexible; with removal and replacement of prostatic urethral scaffold using integrated cystoscopic visualization.
0943T	Cystourethroscopy, flexible; with removal of prostatic urethral scaffold.
52284	Cystourethroscopy, with mechanical urethral dilation and urethral therapeutic drug delivery by drug-coated balloon catheter for urethral stricture or stenosis, male, including fluoroscopy, when performed.
53855	Insertion of a temporary urethral stent, including urethral measurement.
53865	Insertion of temporary device with cystourethroscopy for ischemic remodeling of bladder neck and prostate.

Urethral stricture length

Covered anatomyRecurrent anterior (bulbar) urethral stricture

Maximum length3 cm or less

Prior treatmentPrior endoscopic treatment, such as direct visual internal urethrotomy or dilation, must have failed

Prostate volume for intraprostatic drug-coated balloon

TreatmentIntraprostatic drug-coated balloon for LUTS/BPH

Prostate volume20-80 cc

Additional anatomy

Documentation and Decision Rules

Documentation Required

Submit required clinical documentation

Submit the required clinical information with the request so the policy criteria can be evaluated. Missing information could impact the review and decision outcome.

History and physical or chart notes
The specific device being requested
Documentation of the size and location of the stricture to be treated
Documentation of prior endoscopic treatment

Denial Risk

Confirm urethral balloon criteria before requesting coverage

Coverage is denied as investigational when a drug-coated balloon catheter system is used for a urethral stricture that does not meet the medically necessary criteria.

Clinical Background

Benign prostatic hyperplasia may cause lower urinary tract symptoms including frequency, nocturia, urgency, hesitancy, and a weak urinary stream. Complications can include urinary retention and urinary infection.

Terms and Measures

Urethral stricture

DefinitionChronic fibrosis and narrowing of the urethral lumen

Common causesAcute injury, inflammatory conditions, urethral instrumentation, surgery, or prostate cancer treatment

Anatomic terminologyThe preferred term for abnormal narrowing of the anterior urethra

Urethral stenosis

DefinitionNarrowing of the posterior urethra

Anatomic locationPosterior urethra

Related terminologyAnterior urethral narrowing is referred to as stricture; posterior narrowing is referred to as stenosis

Policy Summary

PayerRegence BlueCross BlueShield

PolicyDevices for Treatment of Benign Prostatic Hyperplasia, Urethral Stricture, and Urethral Stenosis

Policy CodePolicy 230

Change TypeNo material change

Effective DateJanuary 1, 2027

Last ReviewAug 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit history and physical or chart notes, the requested device, stricture size and location, and prior endoscopic treatment documentation.

SourceLink

On This Page

Use of a prostatic urethral scaffold, such as the Zenflow Spring System, for any indication, including symptoms due to benign prostatic hyperplasia.

No studies directly compared the Optilume BPH Catheter System with established treatments.

There is a lack of data on paclitaxel in tissues at long-term follow-up.

Coverage determination: There is not yet enough evidence that the Optilume BPH Catheter System improves the net health outcome; use is considered investigational for all indications.

The treatment has not been compared with urethroplasty, which is most successful for treating recurrent strictures.

Additional long-term data on paclitaxel in tissues are needed to assess device safety.

Coverage determination: There is not yet enough evidence that the technology improves the net health outcome generally; coverage may be considered only for the policy-defined medically necessary indication.

The guideline also specifies a prostatic urethral length of 32-55 mm and no obstructing median lobe

Prostatic urethral length for intraprostatic drug-coated balloon

TreatmentIntraprostatic drug-coated balloon for LUTS/BPH

Prostatic urethral length32-55 mm

Additional anatomyThe guideline also specifies a prostate volume of 20-80 cc and no obstructing median lobe

Prostate volume for temporary implanted prostatic device

DeviceTemporary implanted prostatic device (TIPD)

Prostate volume25-75 g

Additional anatomyThe guideline specifies no obstructing median lobe

Recurrent bulbar urethral stricture length for drug-coated balloon combination therapy

TreatmentUrethral dilation or direct visual internal urethrotomy combined with a drug-coated balloon

Stricture typeRecurrent bulbar urethral stricture

Maximum lengthLess than 3 cm

Penile urethral stricture
First-time treatment
Repeated use of the device

Denial Risk

iTind is investigational

Use of a temporarily implanted nitinol device such as iTind is investigational for all indications, including treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

Do not assume coverage for iTind based on the indication of lower urinary tract symptoms due to benign prostatic hyperplasia.

Denial Risk

Optilume BPH system is investigational

Use of an Optilume BPH Catheter System is investigational for all indications, including treatment of obstructive urinary symptoms associated with benign prostatic hyperplasia.

Coverage is not established for obstructive urinary symptoms associated with benign prostatic hyperplasia.

Denial Risk

Prostatic scaffold use is investigational

Use of a prostatic urethral scaffold such as the Zenflow Spring System is investigational for all indications, including treatment of symptoms due to benign prostatic hyperplasia.

Coverage is not established for symptoms due to benign prostatic hyperplasia.

Denial Risk

Avoid urethral balloon use outside the covered indication

Drug-coated balloon catheter systems for urethral stricture are investigational when policy criteria are not met or when used for indications other than recurrent anterior bulbar urethral stricture.

Penile urethral stricture
First-time treatment
Repeated use of the device

Denial Risk

Temporary implanted nitinol devices are investigational

Temporarily implanted nitinol devices such as iTind are considered investigational for all indications, including treatment of symptoms due to benign prostatic hyperplasia.

The policy does not establish coverage for any indication.

Denial Risk

Optilume BPH catheter system is investigational for all indications

Drug-coated balloon catheter systems for benign prostatic hyperplasia, such as Optilume BPH, are considered investigational for all indications, including treatment of symptoms due to benign prostatic hyperplasia.

The investigational status applies to all indications.

Denial Risk

Prostatic urethral scaffolds are investigational

Prostatic urethral scaffold devices such as Zenflow Spring are considered investigational for all indications, including treatment of urinary obstruction and symptoms due to benign prostatic hyperplasia.

The investigational status applies to treatment of urinary obstruction from benign prostatic hyperplasia.
No clinical guidelines based on research recommend these devices to treat benign prostatic hyperplasia.

Temporarily implanted nitinol device

DeviceA temporarily implanted nitinol device placed in the obstructed prostatic urethra

Intended functionFacilitates tissue reshaping and improves urine outflow

Typical durationTypically removed after five to seven days

Drug-coated balloon catheter system

DeviceA balloon catheter system used for obstructive urinary tract symptoms associated with benign prostatic hyperplasia or urethral stricture

Dilation functionDilates the urethra or prostate lobes by mechanical balloon expansion

Drug deliveryDelivers paclitaxel to help prevent future obstructive urinary symptoms or stricture recurrence

Prostatic urethral scaffold

DeviceA nitinol urethral spring designed to maintain patency within the prostate

Intended functionMaintains urethral patency to treat urinary obstruction

ImplantationPlaced using minimally invasive surgery and designed to remain permanently implanted

AUASI / IPSS

MeasurePatient-administered seven-item measure of lower urinary tract symptom severity

Scoring range0 to 35; the IPSS also includes a separate quality-of-life question scored from 0 to 6

Symptom categoriesMild: 0-7; moderate: 8-19; severe: 20-35

SHIM

MeasurePatient-administered five-item measure of erectile function

Scoring range1 to 25

InterpretationSevere erectile dysfunction: 1-7; moderate: 8-11; mild to moderate: 12-16; mild: 17-21; fewest symptoms: 22-25

BII

MeasurePatient-administered four-item measure assessing the effect of urinary symptoms on health

Assessment focusImpact of urinary symptoms on health

Clinically meaningful changeA minimum change of 0.4 points

Anatomical success

ROBUST III definitionAnatomical success was a urethral diameter of at least 14 French

Assessment methodDetermined by urethral cystoscopy or calibration

Assessment time pointMeasured at six months

Optilume DCB

DeviceA drug-coated balloon catheter

Clinical useUsed to treat recurrent anterior urethral strictures

ROBUST III populationAdults with anterior urethral strictures no more than 3 cm long and at least two prior endoscopic treatments

Prostatic urethral scaffold

DeviceA nitinol spring or scaffold placed through a minimally invasive procedure

Intended functionMaintains urethral patency within the prostate

Intended permanenceDesigned to be permanent

LUTS/BPH

AbbreviationLUTS/BPH

MeaningLower urinary tract symptoms

AttributionSymptoms attributed to benign prostatic hyperplasia

TIPD

AbbreviationTIPD

DefinitionTemporary implanted prostatic device

Guideline contextThe guideline lists TIPDs as a surgical treatment option for selected patients with LUTS/BPH; the cited criteria include prostate volume of 25-75 g and no obstructing median lobe