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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. 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 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 (K150786) 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.
I. Water vapor energy ablation (Rezum) 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) is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies.
Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. 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.
For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and /or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.