Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Benign Prostatic Hypertrophy (BPH)

Treatment: medical procedure (37242 x 2, 37243 x 2, 37244 x 2), prostate embolization

The insurer denied coverage for medical procedure (37242 x 2, 37243 x 2, 37244 x 2), prostate embolization.  The denial is upheld.

This is a patient with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms. The International Prostate Symptom Score (IPSS) is 29. The prostate size is 36 grams by ultrasound. He also has hematuria, urinary urgency, frequency, and nocturia. The patient has been on alpha blocking medication, which helps minimally. The request is for coverage of Prostatic Artery Embolization (PAE).

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes.

Prostatic arterial embolization (PAE) is considered an unproven technique to treat symptomatic BPH. Very limited studies have demonstrated possible short-term safety and efficacy. The most recent American Urologic Association (AUA) guidelines do not recommend this procedure outside of a clinical trial setting due to the heterogeneity in the available literature and safety concerns regarding radiation exposure, postembolization syndrome, vascular access, technical feasibility, and higher clinical failure rate compared with more traditional methods.

"While there is still a lack of long-term data, efficacy and safety data have been published for the short to mid-term. As with any minimally invasive technique, relief of bladder outlet obstruction is less pronounced after PAE compared to more invasive resective techniques. This is likely to be associated with higher re-intervention rates during the longer term." (Abt et al., 2021).      

Prostatic arterial embolization (PAE) has de novo FDA (food and drug administration) classification for the treatment of BPH and lower urinary tract symptoms. The safety and/or effectiveness in the treatment of urinary outlet obstruction due to BPH has not been fully established by review of the available published peer-reviewed.     

The patient is not a good candidate for prostate embolization. It is not the best available treatment for this patient at this time.

"Prostatic artery embolization (PAE) is an emerging, novel interventional technique in the management of patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BPH is a common clinical condition in middle-aged and elderly men resulting in LUTS, including nocturia, urinary frequency, urgency, decreased urinary flow rates, hesitancy, and incomplete bladder emptying. Traditionally, LUTS have been managed by medical or surgical therapies. Since the initial incidental discovery that selective PAE performed for uncontrolled bleeding secondary to BPH resulted in improved LUTS, the technique has continually evolved with a growing body of evidence supporting its safety and efficacy. However, despite the available data, PAE has yet to be established as a standard-of-care treatment option for patients with LUTS/BPH. In this article, the authors review the history and current state of PAE, including published data from case reports, animal studies, retrospective/prospective cohort studies, and prospective randomized controlled trials." (Yu et al., 2016).     

In summary, the denial of medical procedure (37242 x 2, 37243 x 2, 37244 x 2), prostate embolization and coverage for the treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.