Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1:  This patient is a 53-year-old female who presented in December 2004 with a one-year history of urinary urgency and frequency every one-half hour during the day (about 50 ml each time) and hourly at night. On examination she was overweight. Urinalysis was normal. Cystoscopy under local anesthesia was normal with bladder capacity noted to be 400 ml and residual urine volume only 5 ml. CT scan of the abdomen and pelvis in January 2005 revealed a gallstone and ovarian cysts.In January 2005 it was reported that treatment with anti-spasmodic medications Levbid and Ditropan, had not helped. Urodynamics testing was performed in March 2005. First sensation of bladder filling was noted at 400 ml, first urge to void occurred at 425 ml, and at 500 ml she voided, with appropriate bladder contractions. Urethral pressures were reportedly high and the bladder neck did not relax. In the uroflow study the patient voided 113 ml over 70 seconds, with peak flow of 5 ml per second, and residual was 70 ml. She was treated with a striated muscle relaxant, Flexeril.Urology consultation at UCSF Medical Center was performed in June 2005. The patient still had frequency and nocturia, but no urgency or incontinence. The Flexeril had not helped. She was on treatment for hypertension, hypothyroidism, and diabetes mellitus. The provider recommended treatment with the Stoller Afferent Nerve Stimulation System (SANS). The patient received multiple SANS treatments over the next several weeks. These treatments involve peripheral electrical stimulation of the posterior tibial nerve. As of June 2006, the patient reported she still had daytime frequency every thirty minutes and hourly nocturia despite fluid restriction.The patient has requested coverage for additional SANS treatments. The Health Plan has denied this request on the basis that there is insufficient evidence the requested therapy is effective.The patient has an overactive bladder of undetermined etiology. She had cystoscopy, which was normal, showing good bladder capacity and good bladder emptying. She underwent urodynamic studies, which showed apparent decreased bladder sensation, high urethral pressures, and poor urinary flow with questionable bladder emptying. She had a short course of treatment with two anti-spasmodic medications, which did not help. She also had a course of treatment with Flexeril, which also failed to relieve her symptoms.Instead of having further treatment with medications for her overactive bladder, she then underwent SANS treatment, which is an acupuncture-like treatment involving electrical stimulation of peripheral nerves. The submitted clinical evidence does not demonstrate the patients condition improved with the prior SANS treatments she received.The long-term effectiveness of SANS therapy in treating overactive bladder has not been demonstrated in peer-reviewed literature. This type of treatment is not widely used, and its equivalency or superiority to other treatments, including appropriate medications, has not been demonstrated. The patient is likely to receive greater benefit from standard of care therapies.Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 2:  The patient is a 53-year-old female who has been experiencing urinary frequency for over a year. There is no evidence of pelvic pain or gross hematuria. Urodynamic profile demonstrated initial uroflow curve with a voiding volume of 113 mL, a peak flow rate of 5 mL per second and a voiding time of 70 seconds. The patient has failed treatment with Ditroplan and Detrol. She began receiving Stoller Afferent Nerve Stimulation (SANS) therapy with initial benefit reported. She has now requested authorization for additional SANS treatments. The Health Plan has denied the patients request on the basis that SANS therapy is considered experimental/investigational.Although SANS therapy has been approved by the Food and Drug Administration it remains investigational at this time. There is insufficient evidence in peer-reviewed scientific literature demonstrating its efficacy and clinical utility. Adequate data supporting the therapy is lacking. Thus, it cannot be said that the requested therapy is likely to be superior in efficacy to standard of care therapies. For these reasons, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 3:  The patient is a 53-year-old woman who has significant urgency and frequency of urination. She has not benefited from standard therapy for uninhibited bladder in the form of bladder anticholinergics. Her workup, however, has demonstrated a normal or delayed first sensation, 500 cc bladder capacities and no evidence of unstable bladder contractions. The patient has received Stoller Afferent Nerve Stimulation (SANS) therapy in the past and has requested authorization for additional SANS treatments. The Health Plan has denied her request citing a lack of proven efficacy.SANS therapy or neuromodulation therapy has not been proven to be effective for the treatment of bladder frequency and is considered experimental/investigational. No standard evaluation or standards for application of the multiple techniques have been established. There is insufficient data demonstrating SANS therapy is likely to result in improved clinical outcomes. Furthermore, it does not appear the patient has exhausted standard treatment modalities in this case. Accordingly, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.