CurrentKaiser PermanentePolicy N/A

Kaiser Foundation Health Plan of Washington - Rezum System for the Treatment of LUTS due to BPH

Clinical review criteria for Kaiser Foundation Health Plan of Washington governing medical necessity, coverage, and non-coverage determinations for Rezum (water vapor therapy), Prostatic Urethral Lift (UroLift), Transurethral Waterjet Ablation (Aquablation), Prostate Artery Embolization (PAE), and related procedures for treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Distinguishes Medicare and non-Medicare policy positions and lists applicable CPT/HCPCS/ICD-10 codes and documentation requirements.

Policy Summary

PayerKaiser Permanente

PolicyKaiser Foundation Health Plan of Washington - Rezum System for the Treatment of LUTS due to BPH

Policy CodePolicy N/A

Change TypeMultiple coding, criteria and evidence updates

Effective DateMar 1, 2021

Next Review DateAug 21, 2025

Key ActionWhen requesting UroLift or Rezum for non-Medicare members, submit the last 6 months of clinical notes from the requesting provider and/or specialist to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

05/04/2021 MPC approved medical necessity criteria for Rezum with effective date 03/01/2021 (60-day notice).

05/05/2020 Added diagnosis codes N35.010-N35.92, N40.0-N40.3 and C61 for PAE; added CPT code 53854 and removed 53899 (Rezum).

02/07/2023 Added 0421T code with Medicare coverage LCD and Hayes report.

05/02/2023 Added MTAC review for Transurethral Waterjet Ablation; MPC endorsed MTAC decision and continued non-coverage.

06/03/2025 MPC approved to maintain policy of non-coverage and added April 2025 MTAC review.

08/21/2025 Added 'MNR no longer required for TURP, TULIP & HOLEP' in revision history.

2Procedures covered with criteria

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3Not medically necessary (non‑Medicare)

1Medicare conditional/IDE/LCD

Coverage Summary

This policy provides clinical review criteria for minimally invasive and interventional treatments for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), including the Rezum water vapor thermal therapy, Prostatic Urethral Lift (UroLift), Transurethral Waterjet Ablation (Aquablation), and Prostate Artery Embolization (PAE). The coverage stance is mixed: Rezum and UroLift are considered covered when specified criteria are met, while Aquablation and PAE are considered not medically necessary for non-Medicare members (with certain Medicare exceptions).

The policy distinguishes Medicare and non-Medicare positions and lists applicable CPT/HCPCS/ICD-10 codes and documentation requirements. Effective date: 2021-03-01. Last review: 2025-06-03.

Policy thresholds and dates

Rezum prostate volume>= 30 cm3 and < 80 cm3

Rezum age requirement>= 50 years

PUL (UroLift) age requirement>= 50 years

Prior medical therapy duration>= 6 months (at least one drug trial from stated classes)

Policy effective date2021-03-01

Last review date2025-06-03

Next review date2025-08-21

Medical-Necessity Criteria (Non-Medicare)

Prostatic Urethral Lift (PUL / UroLift) - Non-Medicare Members

Covered when ALL of the following criteria are met:

ALL of the following

Age 50 years or above
Prostate volume <= 80 cc on ultrasound imaging≤ 80 cc
policy text says 'prostate volume 80 cC' — interpreted as ≤ 80 cc
Anatomic finding: No obstructive median lobe of the prostate identified on cystoscopy
Prior medical therapy:

Not Medically Necessary / Insufficient Evidence (Non-Medicare)

Transurethral Waterjet Ablation (Aquablation) - Non-Medicare Members

Coverage position:

Coverage position: Insufficient evidence — considered Not Medically Necessary for non-Medicare members

There is insufficient published evidence to show Aquablation is as safe and effective as standard therapies; non-coverage maintained

Coding note: CPT 0421T and HCPCS C2596 referenced for Aquablation; verify authorization requirements by plan type

Medicare LCD L38707 applies (see Medicare section)

Prostate Artery Embolization (PAE) for BPH - Non-Medicare Members

Coverage position:

Medicare Members — Policy Positions & Exceptions

Medicare Members - General statements

NCD/LCD variability: CMS/MAC guidance varies: NCD Therapeutic Embolization (20.283) referenced

Local and national determinations differ by jurisdiction

LCD for Aquablation: Local Coverage Determination (LCD) exists for Transurethral Waterjet Ablation (L38707)

Medicare LCD may allow coverage when its criteria are met

Retired UroLift article: UroLift Local Coverage Article A54044 retired; retired LCD cannot be cited on appeal and decisions should be based on medical judgment or applicable criteria

Retired LCA still used for initial decision but not in appeals

Coding

Transurethral Waterjet Ablation (Aquablation) CPTCPT

0421T

Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete

Aquablation HCPCS / DeviceHCPCS

C2596

Probe, image-guided robotic waterjet ablation

UroLift CPTCPTCovered

52441	Cystourethroscopy with insertion of permanent adjustable transprostatic implant; single implant
52442	Cystourethroscopy with insertion of permanent adjustable transprostatic implant; each additional implant (list separately)

UroLift HCPCSHCPCSCovered

C9739	Cystourethroscopy with insertion of transprostatic implant; one to three implants
C9740	C9739 - continued in document but description truncated

Rezum CPTCPTCovered

53854

Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy

Prostate Artery Embolization (PAE) CPTCPTExperimental

37242	Vascular embolization or occlusion; arterial, other than hemorrhage or tumor
37243	Vascular embolization or occlusion; for tumors, organ ischemia, or infarction

PAE ICD-10 Diagnosis codes referencedICD-10

D29.1	Benign neoplasm of prostate
N35.010	Urethral obstruction by prostate, initial
N35.016	Urethral obstruction by prostate, other
N35.1	Urethral stricture (range N35.1 - N35.919 appears in document)
N40.0	Enlarged prostate - range N40.0-N40.3 presented
N42.30	Unspecified dysplasia of prostate
N42.31	Prostatic intraepithelial neoplasia
N42.32	Atypical small acinar proliferation of prostate
N42.39	Other dysplasia of prostate
C61	Malignant neoplasm of prostate

Billing Rule

Code reporting guidance

Use the listed CPT/HCPCS/ICD-10 codes as applicable when reporting these procedures; verify that codes are current and check for deletions or inactive codes prior to billing.

0421T
C2596
52441
52442
C9739
53854
37242
37243
ICD-10 codes: N35.010-N35.92, N40.0-N40.3, C61 (as applicable)

Provider Actions & Documentation Requirements

Prior Authorization

Preauthorization / medical necessity review

Use the Pre-authorization Code Check to verify whether authorization is required for a specific code and submit requests for medical necessity review per the criteria in this policy.

Documentation Required

Supporting documentation for non-Medicare requests

For non‑Medicare requests for UroLift or Rezum, submit clinical documentation to support medical necessity.

Last 6 months of clinical notes from requesting provider
Specialist notes (if applicable)

Documentation Required

Medicare IDE trial exception for PAE

Background & Evidence Summary

Benign prostatic hyperplasia (BPH) commonly affects men over age 50 and causes lower urinary tract symptoms (LUTS) — frequency, urgency, nocturia, weak stream, and incomplete emptying — that reduce quality of life. Management ranges from lifestyle modification, watchful waiting, and medical therapy (alpha-blockers, 5‑alpha‑reductase inhibitors, antimuscarinics, PDE5 inhibitors) to surgical options (TURP, simple prostatectomy) for patients with moderate-to-severe or complicated disease.

Minimally invasive therapies have been developed to provide symptom relief with less morbidity and shorter recovery than conventional surgery; the ideal therapy is durable, office- or outpatient-performable, preserves sexual function, and has low complication rates.

The Rezum System is a transurethral convective water vapor (steam) thermal therapy that uses radiofrequency energy to generate water vapor which is injected into transition-zone prostate tissue. Each 9‑second vapor injection delivers stored thermal energy that condenses and raises target tissue temperature to approximately 70°C, producing cell death; treatments are performed under cystoscopic guidance with multiple overlapping injections tailored to prostate anatomy. Reported procedure-related effects include transient dysuria, hematuria, urinary frequency/urgency, hematospermia, and possible need for secondary surgery.

Assessment	Conclusion
Rezum	Low-quality evidence; insufficient to meet MTAC/INTC criteria (insufficient quantity and quality)
UroLift (PUL)	Moderate evidence supports use; meets MTAC criteria (effective and durable with moderate quality evidence)
Aquablation (Transurethral Waterjet Ablation)	Insufficient/low-quality evidence overall; does not meet MTAC criteria for non-Medicare coverage (not medically necessary for non-Medicare)
Prostate Artery Embolization (PAE)	Insufficient evidence; does not meet MTAC criteria; may have higher retreatment rates vs TURP (considered not medically necessary for non-Medicare)

Definitions

LUTSLower urinary tract symptoms

BPHBenign prostatic hyperplasia

MTAC/INTCInternal technology assessment/review committees referenced in document

IDEInvestigational Device Exemption (CMS-approved clinical trial exception for Medicare coverage)

Revision History

12/03/2019policy_action

MPC approved non-coverage policy for Prostate Artery Embolization (PAE) for benign prostatic hyperplasia (BPH).

05/05/2020coding_update

Added diagnosis codes N35.010-N35.92, N40.0-N40.3 and C61 for PAE; added CPT code 53854 and removed 53899 (Rezum).

05/04/2021policy_change

MPC approved medical necessity criteria for Rezum with effective date 03/01/2021 (60-day notice).

Policy Summary

PayerKaiser Permanente

PolicyKaiser Foundation Health Plan of Washington - Rezum System for the Treatment of LUTS due to BPH

Policy CodePolicy N/A

Change TypeMultiple coding, criteria and evidence updates

Effective DateMar 1, 2021

Next Review DateAug 21, 2025

Key ActionWhen requesting UroLift or Rezum for non-Medicare members, submit the last 6 months of clinical notes from the requesting provider and/or specialist to support medical necessity.

SourceLink

On This Page

Failure, contraindication or intolerance to at least six months of conventional medical therapy for BPH (e.g., at least one drug trial from one of the following categories: alpha blocker; PDE5 inhibitor; finasteride/dutasteride)

If requesting this service, submit last 6 months of clinical notes to support medical necessity

Procedure codes: UroLift CPT/HCPCS codes (e.g., 52441, 52442, C9739) apply when covered per criteria

Rezum System (Water vapor thermal therapy) - Non-Medicare Members

Covered when ALL of the following criteria are met:

ALL of the following

Age 50 years or above
Prostate volume: Estimated prostate volume ≥ 30 cm3 and < 80 cm3>= 30 cm3 and < 80 cm3
Prior medical therapy: Failure, contraindication or intolerance to at least six months of conventional medical therapy for BPH (e.g., at least one drug trial from one of the following categories: alpha blocker, PDE5 inhibitor, finasteride/dutasteride)>= 6 months
If requesting this service, submit last 6 months of clinical notes to support medical necessity

Procedure description: Rezum (water vapor thermal therapy) device and procedural details as convection radiofrequency thermal therapy

Manufacturer device description and mechanism: water vapor injected under cystoscopic guidance

Insufficient evidence — considered Not Medically Necessary for non-Medicare members

PAE does not meet MTAC criteria; evidence insufficient to show safety/effectiveness vs standard therapies

Medicare IDE exception: PAE may be covered for Medicare members when performed as part of an approved Investigational Device Exemption (IDE) trial; document IDE enrollment/approval

Coding/diagnosis: PAE CPT codes (e.g., 37242, 37243) and referenced ICD-10 diagnosis codes (e.g., N40.0-N40.3, N35.x, C61) apply as applicable

Prostate Artery Embolization is considered experimental/investigational for Medicare and not recommended outside clinical trials; covered when part of an approved IDE trial

Document IDE enrollment/approval for Medicare coverage

Medicare conditional coverage: Medicare may consider procedures medically necessary when criteria in applicable Medicare policy statements are met

Use Medicare-specific NCD/LCD/LCA guidance where applicable

Procedure-specific codes: Medicare section references procedure codes (e.g., 0421T for Aquablation; 52441/52442/C9739 for UroLift; 53854 for Rezum; 37242/37243 for PAE)

Codes listed may not be all-inclusive; verify deletions or inactive codes prior to billing

Medicare-specific guidance referenced in the policy includes the National Coverage Determination (NCD) Therapeutic Embolization (20.283) and a Local Coverage Determination (LCD) for Transurethral Waterjet Ablation (L38707). The UroLift Local Coverage Article A54044 is noted as retired, and the retired article cannot be cited on appeal; Medicare reviewers may rely on clinical judgment or other guidance for coverage decisions.

For PAE, Medicare policy treats the procedure as investigational outside of clinical trials, but it may be covered when performed as part of a CMS-approved Investigational Device Exemption (IDE) trial. For Rezum, in the absence of active NCD/LCD guidance, Kaiser Permanente applies its own non-Medicare clinical review criteria to determine medical necessity.

For Medicare members requesting PAE as part of an IDE study, document the member's IDE enrollment and CMS/IDE approval to support coverage under the investigational device exemption exception.

02/07/2023coding_and_coverage_note

Added CPT code 0421T for Transurethral Waterjet Ablation (Aquablation) with Medicare coverage LCD (L38707) and referenced Hayes report.

05/02/2023evidence_review

Added MTAC evidence review for Transurethral Waterjet Ablation (Aquablation); MPC endorsed MTAC decision and continued non-coverage for non-Medicare members.

06/03/2025policy_reviewLatest

MPC approved to maintain policy of non-coverage and added April 2025 MTAC review.

08/21/2025metadata_note

Document metadata updated: 'MNR no longer required for TURP, TULIP & HOLEP' (future-dated revision history entry).