CurrentBlue Cross Blue Shield - MassachusettsPolicy 744

Transurethral Needle Ablation (TUNA) and other surgical/thermal treatments for benign prostatic hyperplasia (BPH)

This policy governs coverage and prior authorization requirements for Transurethral Needle Ablation (TUNA) and other surgical/thermal treatments for benign prostatic hyperplasia (BPH) for Blue Cross Blue Shield - Massachusetts commercial and Medicare members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyTransurethral Needle Ablation (TUNA) and other surgical/thermal treatments for BPH

Policy CodePolicy 744

Change TypeNo material changes noted in this revision

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization when the procedure is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not medically necessaryTUNA coverage stance

Prior authPrecert required (inpatient)

IPSS ≥12IPSS threshold

<80 mLProstate volume limit

N40.1ICD-10 code

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Through 10/2025Policy history

Coverage Criteria for BPH Procedures

Transurethral Needle Ablation (TUNA)

Policy statement

TUNA coverage: Transurethral Needle Ablation (TUNA) is considered NOT MEDICALLY NECESSARY for any indication.

Prostatic Urethral Lift (PUL)

Prostatic urethral lift — MEDICALLY NECESSARY when ALL criteria are met

Prostatic urethral lift criteria: Persistent or progressive lower urinary tract symptoms despite medical therapy (alpha-1 adrenergic antagonists, 5-alpha reductase inhibitors, or combination) maximally titrated for no less than 6 months OR unable to tolerate medical therapy; AND prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND prostate gland volume < 80 mL; AND no urinary retention related to causes other than BPH, no active urinary tract infection, and no prostatitis within the past year; AND no known allergy to nickel, titanium, or stainless steel; AND appropriate testing to exclude diagnosis of prostate cancer.6 months trial

Use in other situations, including repeat procedures, is considered investigational.

Rezum (Transurethral Water Vapor Thermal Therapy)

Transurethral Water Vapor Thermal Therapy (Rezum) — MEDICALLY NECESSARY when ALL criteria are met

Rezum criteria: Persistent or progressive lower urinary tract symptoms despite medical therapy (alpha-1 adrenergic antagonists, 5-alpha reductase inhibitors, or combination) maximally titrated for no less than 6 months OR patient is not a suitable candidate for anesthesia or unable to tolerate medical therapy; AND age >= 50; AND IPSS score >= 12; AND no active urinary tract infection or prostatitis within the past year; AND prostate gland volume < 80 mL; AND if urinary retention is present, candidate only if cannot tolerate anesthesia or is a suboptimal anesthesia candidate; AND appropriate testing to exclude diagnosis of prostate cancer.IPSS >=12; age >=50; prostate volume <80 mL

Aquablation (Waterjet Tissue Ablation)

Waterjet Tissue Ablation (Aquablation) — MEDICALLY NECESSARY when ALL criteria are met

Aquablation criteria: Persistent or progressive lower urinary tract symptoms despite medical therapy (alpha-1 adrenergic antagonists, 5-alpha reductase inhibitors, or combination) maximally titrated for no less than 6 months OR patient is not a suitable candidate for anesthesia or unable to tolerate medical therapy; AND age >= 45; AND IPSS score >= 12; AND no active urinary tract infection or prostatitis within the past year; AND prostate gland volume as stated in policy (policy text lists inconsistent thresholds including 230 and 150 cc); AND no diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture; AND no known allergy to nickel, titanium or stainless steel; AND appropriate testing to exclude diagnosis of prostate cancer.IPSS >=12; age >=45; prostate volume threshold in text

See LCD L38367 for Medicare members.

Laser/TUIP/TUMT criteria

Laser-based procedures, TUIP, and TUMT — MEDICALLY NECESSARY when ALL criteria are met

Laser-based procedures criteria: Persistent or progressive lower urinary tract symptoms despite medical therapy (alpha-1 adrenergic antagonists, 5-alpha reductase inhibitors, or combination) maximally titrated for no less than 6 months OR patient is not a suitable candidate for anesthesia or unable to tolerate medical therapy; AND age >= 40 for laser procedures; AND IPSS score >= 12; AND no active urinary tract infection or prostatitis within the past year; AND appropriate testing to exclude diagnosis of prostate cancer.IPSS >=12; age >=40

Procedures include PVP, HoLAP, HoLEP.

TUIP criteria: Persistent or progressive lower urinary tract symptoms despite medical therapy maximally titrated for no less than 6 months OR patient not suitable for anesthesia; AND IPSS score >= 12; AND prostate size < 30 cc; AND prostate anatomy demonstrates normal bladder neck without an obstructive median lobe; AND no active urinary tract infection or prostatitis within past year; AND appropriate testing to exclude diagnosis of prostate cancer.IPSS >=12; prostate size <30 cc

TUNA — Evidence summary and coverage conclusion

Coverage stance for TUNA and investigational procedures

TUNA coverage conclusion: TUNA has been evaluated in multiple randomized controlled trials but demonstrates variable retreatment rates, high rates of adverse events, and is no longer recommended as a standard of care or alternative to TURP by the American Urological Association; overall evidence is insufficient to determine effects on health outcomes.

Listed as insufficient/investigational in policy text

Other minimally invasive/surgical BPH treatments

Comparative evidence summaries for other minimally invasive procedures

Other MIST evidence: PUL, Rezum, Aquablation, laser therapies, TUIP, and TUMT have varying levels of evidence: PUL, Rezum, Aquablation, and several laser procedures have sufficient evidence demonstrating improvement in health outcomes; other treatments (cryosurgical ablation, prostatic arterial embolization, temporarily implanted nitinol devices such as iTind) are considered investigational or have insufficient evidence.

Extracts reflect varied evidence strength

Not medically necessary / Insufficient evidence summary for TUNA

Coverage stance and summary for TUNA

Coverage determination for TUNA: Evidence from multiple randomized controlled trials shows some symptom reduction but high adverse event and retreatment rates; the American Urological Association no longer recommends TUNA as a standard of care or alternative to TURP; therefore evidence is insufficient to determine effects on net health outcomes and TUNA is not considered medically necessary.

Do not consider TUNA as standard of care; coverage decisions should reflect insufficient evidence and high retreatment/adverse event rates.

Cryosurgical ablation, prostatic arterial embolization (PAE), and the use of a temporarily implanted nitinol device (eg, iTind) are considered investigational for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). These procedures lack sufficient randomized controlled trial data and long‑term evidence demonstrating consistent improvements in health outcomes compared with established therapies, and therefore are not covered as standard treatments for BPH.

Cryosurgical ablation for BPH is considered investigational because the published evidence is limited to small case series and lacks randomized, controlled trials and long‑term safety and efficacy data. Available reports do show symptom reduction in some patients, but the absence of comparative and long‑term outcomes prevents concluding a net benefit on health outcomes.

Transurethral needle ablation (TUNA) is not recommended as a standard of care or as an alternative to transurethral resection of the prostate (TURP) according to American Urological Association guidance. Although TUNA has been evaluated in multiple randomized controlled trials, guideline statements no longer endorse it as a routine option for BPH management.

Transurethral Needle Ablation (TUNA) is considered NOT MEDICALLY NECESSARY for any indication. Claims for TUNA should be reviewed in the context of this coverage determination; documentation supporting medical necessity will not change the policy stance that TUNA is not a covered, medically necessary treatment.

The evidence base for TUNA is insufficient to determine its effects on net health outcomes. Although some randomized trials reported symptom improvement, studies show substantial variability in retreatment rates, postoperative complications, and primary outcomes; consequently TUNA is no longer recommended as standard therapy and its clinical benefit remains unproven.

Use of TUNA is considered investigational/insufficient because trials demonstrate variable retreatment rates and inconsistent postoperative complication rates and outcomes. These limitations in the evidence prevent reliable conclusions about long‑term safety and effectiveness.

Coding: CPT, HCPCS, and ICD-10

Covered/Referenced CPT CodesCPT

0421T	Transurethral waterjet ablation of prostate, including control of post-operative bleeding; including ultrasound guidance, complete
52441	Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant
52442	Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant
52450	Transurethral incision of prostate
52630	Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete
52647	Laser coagulation of prostate, including control of postoperative bleeding, complete
52648	Laser vaporization of prostate, including control of postoperative bleeding, complete
52649	Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete
53850	Transurethral destruction of prostate tissue; by microwave thermotherapy
53854	Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy

IPSS score threshold referenced across multiple procedures

ThresholdIPSS (AUASI) score >= 12 is required for many minimally invasive prostate procedures (Rezum, Aquablation, laser-based procedures, TUIP, TUMT)

Source examplesRezum criteria lists 'IPSS score >=12' (Rezum); Aquablation and laser procedures and TUIP/TUMT list IPSS >=12 in their criteria

PurposeUsed to document moderate-to-severe LUTS and meet medical necessity criteria prior to procedural interventions

Prostate gland volume limits (< 80 mL for several procedures)

ThresholdProstate gland volume < 80 mL is required for several procedures (PUL, Rezum; also referenced for other procedures)

Procedures citing this limit

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Inpatient prior authorization — Precertification required when services are performed inpatient

Precertification/preauthorization is required when procedures described in this policy are performed in the inpatient setting.

Precertification required for inpatient procedures.

Billing Rule

Investigational CPT codes — Certain CPT codes considered investigational and may require prior authorization or be non-covered

Certain CPT and HCPCS codes referenced in this policy are considered investigational or not medically necessary and may be subject to prior authorization review or denial. Report all services using current procedure, revenue, and diagnosis codes, including applicable modifiers. Document the use of any investigational CPT codes and include clinical justification in the medical record.

Background and Scope

This policy addresses multiple surgical and minimally invasive procedures for moderate‑to‑severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It compares established options (for example, prostatic urethral lift, water vapor thermal therapy, waterjet ablation, and various laser procedures) and discusses prerequisites common to many interventions—such as a trial of maximally tolerated medical therapy, use of validated symptom scores (eg, AUASI/IPSS), prostate volume considerations, and exclusion of active infection or prostate cancer—while identifying treatments that remain investigational or not medically necessary.

Definitions and Abbreviations

ICD-10 diagnosis code — N40.1 = Benign prostatic hyperplasia with lower urinary tract symptoms

ICD-10-CM codeN40.1 = Benign prostatic hyperplasia with lower urinary tract symptoms

Usage noteUse N40.1 when documenting BPH with LUTS for procedures referenced in this policy

Documentation guidanceInclude appropriate diagnosis coding with procedure claims; inclusion/exclusion of a code does not guarantee coverage

AUASI / IPSS — validated questionnaires; scores 0-35

DefinitionAUASI / IPSS are validated questionnaires assessing urinary symptom severity; total scores range 0–35

Severity categoriesScores: mild (<7), moderate (8–19), severe (20–35)

Policy Revision History

10/2025annual_reviewLatest

Annual policy review; Prostatic Urethral Lift literature reviewed through July 15, 2025; policy statements unchanged; coding information clarified.

8/2025update

Policy updated with literature review through April 29, 2025; references added; policy statements unchanged.

5/2025clarification

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyTransurethral Needle Ablation (TUNA) and other surgical/thermal treatments for BPH

Policy CodePolicy 744

Change TypeNo material changes noted in this revision

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization when the procedure is performed inpatient.

SourceLink

On This Page

TUMT criteria: Persistent or progressive lower urinary tract symptoms despite medical therapy maximally titrated for no less than 6 months OR unable to tolerate medical therapy; AND IPSS score >= 12; AND no active urinary tract infection or prostatitis within the past year; AND individual is not a suitable candidate for anesthesia; AND appropriate testing to exclude diagnosis of prostate cancer; AND individual is not a suitable candidate for any of the procedures listed above.IPSS >=12

Prostatic urethral lift (PUL) and Rezum explicitly state prostate gland volume <80 mL as a criterion

Clinical rationaleVolume limit used to define appropriate anatomy for specific minimally invasive interventions

Prostate gland volume note for Aquablation (policy text inconsistent; >= 150 cc mentioned)

Inconsistent policy languageAquablation section lists prostate gland volume as '230 150cc' indicating inconsistent thresholds (both 230 cc and 150 cc mentioned in text)

ImplicationPolicy text contains conflicting numeric prostate volume values for Aquablation; refer to note and external LCD L38367 for Medicare members

Action for reviewers/providersClarify prostate volume eligibility for Aquablation prior to authorization due to inconsistent wording in policy text

Investigational CPT codes (examples): 0714T, 0867T, 53852, 53865, 53866, 55873; see policy code list for full details.
Use ICD-10-CM N40.1 for BPH with lower urinary tract symptoms.
Providers must report services using current procedure, revenue, and diagnosis codes and applicable modifiers.

Denial Risk

Investigational procedure denial risk — TUNA considered investigational/insufficient; claims may be denied

Transurethral needle ablation (TUNA) is considered NOT MEDICALLY NECESSARY for any indication. Procedures lacking sufficient clinical evidence or that are not consistent with standard of care may be denied. When an investigational or non-standard procedure is requested, include detailed clinical rationale and supporting evidence; absence of sufficient justification may result in claim denial.

TUNA is NOT MEDICALLY NECESSARY for any indication — claims may be denied.
Include clinical trial evidence, comparative data, and explanation for selecting investigational procedures when submitting requests.

Step Therapy

Medical therapy trial requirement (alternatives) — many procedures require persistent/progressive LUTS despite maximally titrated medical therapy

Many minimally invasive and surgical procedures for BPH require a documented trial of medical therapy prior to consideration of procedural intervention. Document attempts at and responses to maximally titrated medical therapy (alpha-1 adrenergic antagonists, 5-alpha reductase inhibitors, or combination therapy) for a period of no less than 6 months, unless the patient is unable to tolerate medical therapy or is not a suitable candidate for anesthesia.

Document trial of maximally titrated medical therapy for >= 6 months OR document intolerance/unsuitability for medical therapy or anesthesia.
Record specific medications, dosing, duration, and reason for discontinuation or intolerance.

Documentation Required

Clinical evidence and justification — include clinical trial evidence and reason for selecting TUNA given high adverse event/retreatment rates

When requesting prior authorization or submitting claims, include the following clinical evidence and documentation: problem list and relevant history; IPSS/AUASI score and baseline symptom severity; results of prostate evaluation (size/volume, anatomy regarding median lobe); prior medical therapies and response; urine culture/assessment to exclude active UTI or prostatitis; documentation excluding prostate cancer as appropriate; and rationale for selecting the proposed procedure over established alternatives. For investigational or high-retreatment-risk procedures (eg, TUNA), include supporting literature and justification for choice of treatment.

Include IPSS or AUASI score and quality-of-life measure.
Document prostate volume and anatomy (eg, presence/absence of obstructive median lobe).
Document prior therapies, duration (>=6 months), and intolerance if applicable.
Include diagnostic testing to exclude prostate cancer and evidence excluding active UTI or recent prostatitis.

Role in policyIPSS/AUASI score is used to determine eligibility for several procedures (thresholds commonly >=12)

TUNA definition — insertion of interstitial radiofrequency needles into prostate to ablate lateral lobes

Procedure descriptionTUNA involves insertion of interstitial radiofrequency needles into the urethra and delivery of radiofrequency ablation to the lateral lobes of the prostate

Treatment goalAblation of prostatic lateral lobes to reduce LUTS symptoms

Clinical noteTUNA has been associated with variable retreatment rates and long-term side effects; its use has declined with newer therapies

TUNA definition (alternate phrasing)

Alternate phrasingTransurethral needle ablation (TUNA): a minimally invasive thermal ablation procedure using needles to ablate prostatic tissue via the urethra

Evidence summaryEvaluated in multiple RCTs; shows some symptom reduction but high adverse events and retreatment rates; not recommended as standard of care by AUA

Coverage stanceTUNA is considered NOT MEDICALLY NECESSARY/insufficient due to variable outcomes and safety concerns

Clarified coding information.

2025-01-17clarification

Clarified coding information.

1/2025clarification

Clarified coding information.

11/2024annual_review

Annual policy review; no changes to policy statements; description, summary and references reviewed.

7/2024clarification

Clarified coding information.

2/2024update

Removed LCD L37808 information for Transurethral Water Vapor Thermal Therapy following LCD L37808 retirement effective 2/15/2024.

10/2023annual_review

Annual policy review; Prostatic Urethral Lift criteria clarified and description and references updated.

5/2023update

Investigational statement on temporary implantable nitinol device (iTind) added; coding information clarified effective 5/1/2023.

1/2023update

Added LCD information for Transurethral Water Vapor Thermal Therapy and Waterjet Tissue Ablation.

10/2022annual_review

Annual policy review; description and summary updated; policy statements unchanged.

6/14/2021references_added

New references added.

4/1/2021coverage_change

New medically necessary indications added and title changed from Prostatic Urethral Lift to Minimally Invasive and Surgical Treatment Options for Benign Prostatic Hyperplasia (BPH), effective 4/1/2021.

1/2021annual_review

Annual policy review; repeat procedures added to the investigational policy statement effective 1/1/2021.

1/2020annual_review

Annual policy review; medically necessary statement updated to remove prior PSA threshold language.