Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requests authorization and coverage for the UroLift procedure. According to the enrollees medical record, the enrollee is diagnosed with benign prostatic hyperplasia (BPH) with severe obstructive symptoms.  He was told 20 years ago that he has a congenital deformity of the median lobe.  He has urinary frequency, nocturia, and incontinence.  He received treatment from multiple urologists and tried four medications (Proscar, Avodart, Flomax, and Cardura).  He had not pursued surgery before because he was concerned for retrograde ejaculation; however, his symptoms have worsened.  The enrollee states that because of his age and history of sleep apnea, he cannot tolerate the general anesthesia required for a transurethral resection of the prostate (TURP) procedure.  His treating physician recommends the UroLift procedure and asserts that it is associated with significant and rapid symptom improvement and avoidance of complications associated with other procedures, so it was the best treatment option for this enrollee.  According to the medical literature, the urolift received approval in 2013 as a de novo device indicated for treatment of bothersome benign prostatic hypertrophy symptoms in men older than 50 years. Originally, the procedure was only indicated for treatment of small to average sized prostate with lateral lobe obstruction.  Several studies since then have reported on treatment durability results with functional improvements in voiding sustained up to 4-5 years.  In 2018, UroLift was approved for treatment of symptomatic benign prostatic hypertrophy (BPH) in men as young as 45-years-old, and approved it for treatment of voiding symptoms secondary to an obstructive median lobe of the prostate.  A 2018 American Urological Association (AUA) Guideline on the Surgical Management of lower urinary tract symptoms secondary to BPH indicates clinicians should consider prostatic urethral lift as an option for lower urinary tract symptoms attributed to BPH provided prostate volume is less than 80 grams and verified absence of obstructive middle lobe. Prostatic Urethral Lift may be offered to eligible patients concerned with erectile and ejaculatory function for the treatment of lower urinary tract symptoms attributed to BPH or in a patient who has lower urinary tract symptoms secondary to BPH, has failed medical therapy and is concerned about loss of ejaculation secondary to the BPH surgical procedure.  UroLift does not require general/spinal anesthesia and has been approved for treatment of lower urinary tract symptoms attributable to BPH in certain patient groups.   Data supports sustained improvement in voiding symptoms up to 4-5 years after the procedure. Final Result: Two of the three reviewers determined that the requested services are likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in Urology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.