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 overturned.

This patient has outlet obstruction due to benign prostatic hyperplasia (BPH). The patient has been using an alpha blocker for treatment, which has mildly helped. Due to comorbidities of high blood pressure, and coronary artery disease, the treating provider feels the patient is not a candidate for Transurethral resection of the prostate (TURP). His physician has requested prostatic artery embolization (PAE), which has been previously refused as investigational.

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcomes.

"All patients considered for surgical management of BPO [benign prostatic obstruction] could concurrently be considered for PAE. However, current evidence suggests there are clearly patients particularly suited for PAE and therefore efforts should be made to identify those patients. Patients with a prostate volume greater than 80 cm3 or deemed unsuitable for transurethral resection of prostate (TURP)23 are in fact those most likely to benefit from the procedure.  8,24 However, a smaller study has found no such correlation between size and outcome.17 Furthermore, patients with prominent median lobes who are excluded from other minimal access procedures such as UroLift may benefit from PAE.25 Despite this, some urologists have found that although there is reduction in volume of the median lobe, a ball-valve effect of the lobe can cause continued symptoms. This can be managed by limited resection. Patients keen to maintain their sexual function or preserve fertility may be particularly interested in PAE due to its advantages in minimizing this risk typically associated with other BPO surgeries.16 Additionally, it may be the preferred option for those unsuitable for a general or spinal anaesthetic. However, typical contraindications would include patients with poor renal function, those with severe atherosclerosis of the prostatic arteries or additional issues requiring surgery (such as bladder calculi or chronic retention). These factors would preclude PAE in favour of surgical therapies (Table 1). Malignancy needs excluding if possible prior to embolization, although with close follow up (including multiparametric magnetic resonance imaging) areas of concern are occasionally picked up and can be managed as appropriate." (Maclean et al., 2017).      

PAE has been FDA (food and drug administration) approved since 2017 and is an approved radiologic society procedure. It is covered by Medicare.     

The described symptoms of LUTS (lower urinary tract symptoms) are described as indications for the requested procedure. 

It is appropriate for the symptoms and diagnosis described, as are several alternative procedures that have been FDA approved for the same diagnosis. Additionally, the patient is not considered a good candidate for TURP.     

The risks do not appear to be increased over other standard treatments for prostatic hyperplasia.

"BPH is a major health problem worldwide that has a major impact on men's quality of life. PAE has emerged as a minimally invasive and highly effective treatment option for selected men with BPH and moderate to severe symptoms. An adequate pre- and post-procedure evaluation, as well as PAE technique standardization, is of key importance to achieve a successful treatment." (Dias et al., 2021).     

The requested service is likely to be comparably beneficial as any of the other alternative procedures for benign prostatic hyperplasia.

"Lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) are a very common problem in men ranging from mild urinary symptoms to recurrent urinary tract infections or renal failure. Numerous treatment options are available ranging from conservative medical therapies to more invasive surgical options. Prostate artery embolization (PAE) has emerged as a novel treatment option for this common problem with clinical efficacy comparable to the current surgical gold standard, transurethral resection of the prostate (TURP). PAE offers fewer complications and side effects without a need for general anesthesia or hospitalization." (Naidu et al., 2021). 

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