Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A58227 (Billing and Coding: Transurethral Waterjet Ablation of the Prostate) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A58227: Billing and Coding: Transurethral Waterjet Ablation of the Prostate (Billing and Coding, effective 2026-03-05)
- Covered ICD-10-CM codes
- 1
- 1 group
- Non-covered ICD-10-CM codes
- 1
- Procedure codes listed
- 2
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| N40.1 | — |
Procedure codes: 52597, C2596 (Probe, Image-Guided, Robotic, Waterjet Ablation).
Coverage indications, limitations and medical necessity
Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.
History/Background and/or General Information
Benign prostatic hyperplasia (BPH) is a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is most common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men greater than 50 years old suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur due to prostate enlargement and compression of the urethra leading to bothersome lower urinary tract symptoms (LUTS), including voiding symptoms such as hesitancy, weak stream, straining, prolonged voiding, and storage symptoms (frequency, urgency, and nocturia). LUTS/BPH can have a significant impact on the quality of life and can cause serious complications such as infections, bleeding, calculus formation, urinary retention, and decline of renal function when untreated. 1 First line treatment generally consists of treatment with medications such as alpha blockers, PDE5 Inhibitors, or finasteride/dutasteride. If treatment with medications is not successful, surgical options may then be considered. Transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) are the standard surgical treatments for LUTS/BPH and are highly effective and provide improved outcomes in urinary functions. However, neither TURP nor OSP are without considerable perioperative complication and morbidity. 2 Transurethral waterjet ablation is a surgical-based therapy that combines image guidance and robotics to remove prostatic tissue. 3 The system works by pumping high pressure saline (500 to 8000 pounds per square inch [PSI]) through a probe nozzle to cut and dissect tissue at predetermined system parameters. 3
Covered Indications
Treatment for LUTS/BPH will be considered reasonable and necessary when performed using an FDA approved/cleared device ONCE in patients with the following:
• Indications including ALL of the following:
• Prostate volume of 30-150 mL. 4,5
• Persistent moderate to severe symptoms despite maximal medical management including ALL of the following:
• International Prostate Symptom Score (IPSS) ≥12.
• Maximum urinary flow rate (Qmax) of ≤15 mL/s. 4,5
• Failure, contraindication, or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)
Limitations
The following are considered not reasonable and necessary:
• Body mass index 6 ≥ 42kg/m. 2
• Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines 7 ) or a prostate specific antigen (PSA) >10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months. 8
• Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum. 6
• Active urinary tract infection or systemic infection. 9
• Treatment for chronic prostatitis. 6
• Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture. 6
• Damaged external urinary sphincter. 6
• Known allergy to device materials. 9
• Inability to safely stop anticoagulants or antiplatelet agents preoperatively. 9
CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in an LCD states services will be considered reasonable and necessary only if performed by appropriately trained providers.
Patient safety and quality of care mandate that healthcare professionals who perform transurethral waterjet ablation of the prostate are appropriately trained and credentialed by a formal residency/fellowship program. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.
All aspects of care must be within the provider’s medical licensure and scope of practice.
Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.
Summary of evidence (opening)
This evidence review focuses on transurethral waterjet ablation of the prostate, also known as Aquablation, and whether the evidence supporting this procedure provides certainty that it will result in improved health outcomes for the Medicare population. This review examines whether prostate volume size, PSA score, specific imaging for prostate volume measurement, maximum urinary flow rate (Qmax), and the presence of bladder calculus should limit who receives the transurethral waterjet procedure. In general, health outcomes of interest include patient mortality, morbidity, quality of life, and function.
For patients with BPH, transurethral waterjet ablation of the prostate endeavors to improve patient outcomes through an image-guided, robotics-assisted surgical procedure that minimizes adverse effects. Noridian sought patient-centered outcomes as the underlying justification for undergoing the transurethral waterjet ablation procedure. Therefore, a search for peer-reviewed literature was performed in PubMed to identify key clinical circumstances representing covered indications and limitations for performing the procedure. These included prostate volume size, known or suspected prostate cancer (e.g., PSA >10 ng/mL), specific imaging for prostate volume measurement, maximum urinary flow rate, and the presence of bladder calculus. Several searches were performed on PubMed, Google Scholar, and Google. Keywords and Boolean operators used in conjunction for the search were as follows: aquabeam*[tw] OR aqua beam*[tw] OR aquablation*[tw] OR waterablat*[tw] OR water ablat*[tw], waterjet[tw] OR water jet* AND ablat* AND procept OR prostat*, Transurethral waterjet ablat* OR aquablation AND prostat*, Transrectal ultrasound AND prostate AND MRI AND prostate volume. Beyond industry sponsored studies, only a few peer-reviewed papers have been published addressing the performance of transurethral waterjet ablation of the prostate and/or Aquablation. Search limitations included studies that were only adult-focused (≥19 years of age), human subject, and English language. The search identified 65 studies which were chosen for in-depth review following the title and abstract appraisal. Of the 65 studies, 35 were included for analysis and 30 were excluded for lack of relevancy. Additionally, 2 FDA 510(k) Premarket Notification Database letters were submitted with the reconsideration request and were reviewed.
Pivotal Studies
Initial clinical experience for transurethral waterjet ablation of the prostate was reported in 2016. 10 After FDA clearance in 2017, this technology was further studied with the publication of the WATER trial, a PHASE III multicenter, international, double-blinded, randomized, non-inferiority study with 181 subjects compared Aquablation (N=116) to TURP (N=65). 11,12 Men 45 to 80-years-old with prostate size 30-80 cc (by TRUS), moderate-to-severe LUTS (International Prostate Symptom Score [IPSS] ≥ 12), and maximum urinary flow rate (Qmax) P P =.13). The primary safety endpoint was the proportion of subjects with adverse events, defined as Clavien-Dindo grade 2 or higher or any grade 1 with persistent disability. The 3 month primary safety endpoint rate was lower in the Aquablation group than in the TURP group (26% vs. 42%; P =.015). At two years, IPSS score improvement was sustained ( Δ IPSS = 14.7 in Aquablation and 14.9 in TURP [ P =.83; 95% CI for difference -2.1 to 2.6]), and Qmax improvement was large in both groups (11.2 and 8.6 cc/s for Aquablation and TURP, respectively [ P =.19; 95% CI for difference -1.3 to 6.4]). 13 These results demonstrated that Aquablation was as effective, if not more effective, as to the standard TURP procedure. The two-year reduction in post-void residual volume (PVR) was 57 cc and 70 cc for Aquablation and TURP, respectively ( P =.39). PSA decreased significantly in both groups by 1 point ( P P =.42) in the Aquablation and TURP groups, respectively. Among the subset of sexually active men without the condition at baseline, anejaculation was less common after Aquablation (10% vs. 36%; P =.0003). When post-Aquablation cautery was avoided rates of anejaculation were lower (7% vs. 16%; P =.18), and this resulted in reduced grade 1 persistent events identified in the Aquablation group. The authors believe that Aquablation avoids damage to tissues involved in ejaculation through precise, image-based targeting, and robotic execution. The limitations of the study include the risk of performance bias, as surgeons were not blinded, and unknown generalizability to a more heterogeneous US population as it is a single-center study of males ages 50-80 years in New Zealand. The three-year results were essentially unchanged. 4
The contractor cites 72 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2020-12-27
- Current revision effective
- 2026-03-05
- MCD version
- 14
Other related documents: A60347 (Response to Comments), A60348 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Noridian Healthcare Solutions, LLC hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L38705 cover?
Benign prostatic hyperplasia (BPH) is a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is most common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men greater than 50 years old suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur due to prostate enlargement and compression… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L38705 apply to?
Noridian Healthcare Solutions, LLC applies it to Medicare claims in AK, AS, AZ, CA, CNMI, GU, HI, ID, MT, ND, NF, NV, OR, SD, SF, UT, WA, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L38705?
The companion billing and coding article A58227 lists 1 ICD-10-CM codes in 1 group that support medical necessity and 1 that do not; the first 1 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L38705?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.