Latest Review Date: February 2024

Category: Surgery                                                                  

POLICY:

Effective for Dates of Service on and after October 03, 2022:

1. Water vapor energy ablation (Rezum) or waterjet tissue ablation (Aquabeam) for the treatment of benign prostatic hyperplasia (bph) may be considered medically necessary and appropriate when all of the following criteria are met:

• Moderate to severe lower urinary tract symptoms [e.g., International Prostate Symptom Score (IPSS) score ≥13]; AND
• Failure or inability to tolerate medical therapy (a1-adrenergic antagonists maximally titrated, 5a-reductase inhibitors, or combination medication therapy maximally titrated) over an adequate trial period; AND
• Prostate volume ≤80cm³; AND
• Appropriate testing to exclude diagnosis of prostate cancer has been completed; AND
• No contraindications to the procedure, including urinary retention, urinary tract infection, or recent prostatitis within the past year.

2. Water vapor energy ablation (Rezum) or waterjet tissue ablation (AquaBeam) is considered investigational for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

DESCRIPTION OF PROCEDURE OR SERVICE:

Benign prostatic hyperplasia (BPH) is a common condition in older men that can lead to increased urinary frequency, an urgency to urinate, a hesitancy to urinate, nocturia, and a weak stream when urinating. BPH prevalence increases with age and is present in more than 80% of individuals ages 70 to 79. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection.

Medical and surgical interventions are available for the treatment of BPH, including a-adrenergic blockers, 5a-reductase inhibitors, combination a-adrenergic blockers and 5a-reductase inhibitors, anti-muscarinic agents, and phosphodiesterase-5 inhibitors. Patients who do not have sufficient response to medical therapy, or who are experiencing significant side effects with medical therapy, may be referred for surgical or ablative therapies. Historically, transurethral resection of the prostate has generally been considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate.

The Rezum System is a minimally invasive, transurethral treatment the uses convective radiofrequency water vapor energy to ablate the hyperplastic tissue. The system consists of a radiofrequency power generator and disposable delivery device. The shaft of the delivery system contains a needle which injects steam into the diseased prostate area, which immediately condenses to water, thereby dispersing thermal energy and destroying the surrounding cells.

The Rezum System received FDA 510(k) designation in August 2015. It is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH and is indicated for men ≥50 years of age with a prostate volume ≥30cm³ and ≤80cm³. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The AquaBeam Robotic System is an image-guided, heat-free robotic therapy also designed to treat lower urinary tract symptoms (LUTS) due to BPH. The device is able to image the treatment area and operates by using a pressurized jet of fluid delivered to the prostatic urethra.

AquaBeam received FDA 510(k) clearance in March 2021 for the same indication as the de novo approval that served as the predicate device. AquaBeam is intended for the resection and removal of prostate tissue in males suffering from LUTS due to BPH.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

HCPCS Codes:

POLICY HISTORY:

Reviewed and posted August 16, 2022.

August 2022: New policy created. Effective for Dates of Service on and after October 03, 2022. Available for comment August 16, 2022 through October 2, 2022.

March 2023: Update to Current Coding section to remove CPT code 53899. No change to policy intent.

February 2024: Annual review completed. No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent, therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.