Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hyperplasia

POLICY NUMBER

A.2.01.49

DESCRIPTION

Transurethral water vapor thermal therapy and transurethral waterjet ablation (aquablation) have been investigated as minimally invasive alternatives to transurethral resection of the prostate, considered the traditional standard treatment for benign prostatic hyperplasia. Transurethral water vapor thermal therapy uses radiofrequency-generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective versus conductive heat transfer to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.

Benign prostatic hyperplasia (BPH) is a common condition in older men, affecting to some degree 40% of men in their 50s, 70% of those between ages 60 and 69, and almost 80% of those ages 70 and older. Benign prostatic hyperplasia is a histologic diagnosis defined as an increase in the total number of stromal and glandular epithelial cells within the transition zone of the prostate gland. In some men, BPH results in prostate enlargement which can, in turn, lead to benign prostate obstruction and bladder outlet obstruction, which are often associated with lower urinary tract symptoms including urinary frequency, urgency, irregular flow, weak stream, straining, and waking up at night to urinate. Lower urinary tract symptoms are the most commonly presenting urological complaint and can have a significant impact on quality of life.

Benign prostatic hyperplasia does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on quality of life along with the potential side effects of treatment. Options for medical treatment include alpha-1-adrenergic antagonists, 5-alpha-reductase inhibitors, and phosphodiesterase-5 inhibitors. Medications may be used as monotherapy or in combination.

Patients with persistent symptoms despite medical treatment may be considered for surgical treatment. The traditional standard treatment for BPH is transurethral resection of the prostate (TURP). Transurethral resection of the prostate is generally considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have also been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate. The prostatic urethral lift procedure involves the insertion of one or more permanent implants into the prostate, which retracts prostatic tissue and maintains an expanded urethral lumen.

Transurethral water vapor thermal therapy and Aquablation have been investigated as minimally invasive alternatives to transurethral resection of the prostate. Transurethral water vapor thermal therapy uses radiofrequency-generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective vs conductive heat transfer to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.

In September 2016, the Rezum™ System (NxThera, Inc, acquired by Boston Scientific in 2018) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K150786). The FDA determined that this device was substantially equivalent to existing devices (Medtronic Prostiva devices). Rezum is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia. It is indicated for men at least 50 years of age with a prostate volume between 30cm³ and 80cm³. The Rezum System is also indicated for the treatment of prostate with hyperplasia of the central zone and/or a median lobe.

In April 2017, the Aquabeam^® System (Procept Robotics Corporation) was cleared for marketing by the FDA through the 513(f)(2) (de novo) classification process (DEN170024). The device is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia, based on WATER trial.

POLICY

Transurethral water vapor thermal therapy is considered investigational as a treatment of benign prostatic hyperplasia.

Transurethral waterjet ablation (Aquablation) is considered investigational as a treatment of benign prostatic hyperplasia.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/21/2019: Approved by Medical Policy Advisory Committee.

12/20/2019: Code Reference section updated to add new CPT code 0582T effective 01/01/2020.

07/13/2020: Policy description updated. Policy statement unchanged.

06/13/2022: Policy title changed from "Transurethral Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia" to "Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hyperplasia." Policy description updated regarding aquablation and devices. Policy section updated to add that transurethral waterjet ablation (aquablation) is considered investigational as a treatment of benign prostatic hyperplasia. Code Reference section updated to add CPT code 0421T and HCPCS code C2596.

07/24/2023: Policy description updated regarding devices. Policy statements unchanged.

07/10/2024: Policy reviewed; no changes.

08/18/2025: Policy description updated. Policy statements unchanged.

01/01/2026: Code Reference section updated to add new CPT code 52597.

SOURCE(S)

Blue Cross Blue Shield Association policy #2.01.49

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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