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Benign prostatic hyperplasia (BPH) is a common condition in older patients 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 α-adrenergic blockers, 5α-reductase inhibitors, combination α-adrenergic blockers and 5α-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 prostatic urethral lift (PUL) procedure involves the insertion of one or more permanent implants into the prostate, which retracts prostatic tissue. The implant device is designed to retract the prostate to allow expansion of the prostatic urethra. The implants are retained in the prostate to maintain an expanded urethral lumen.
The NeoTract UroLift System was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process in December 2013. The device has two main components: the delivery device and the implant. Each delivery device comes preloaded with a UroLift implant. In March 2016, FDA determined that the UL500 was substantially equivalent to existing devices (UL400) for the treatment of symptoms of urinary flow obstruction secondary to benign prostatic hyperplasia in individuals age 50 years and older.
I. Use of prostatic urethral lift in patients with moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
II. Use of prostatic urethral lift in other situations is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
No additional statements.
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.