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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.
I. 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:
II. Water vapor energy ablation (Rezum) or waterjet tissue ablation (AquaBeam) is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
0421T 53854 53899 C2596
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Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
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Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
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Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.
