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

Physician 1: The patient is a 61-year-old male who in 1999 was diagnosed with prostate cancer with a Gleason score total of 7. He underwent radical retropubic prostatectomy with bilateral pelvic lymphadenectomy. Surgical margins were positive for cancer, and there was invasion of both seminal vesicles with a positive pelvic lymph node on the right side. He then underwent external beam radiation therapy for the prostate cancer. In July 2005, he was hospitalized because of abdominal pains and in July 2005 underwent laparotomy and sigmoid colon resection for poorly differentiated prostate adenocarcinoma invading the sigmoid colon. The patient also had mild left hydronephrosis and mild renal insufficiency, with BUN of 28 and creatinine of 2.0. In September 2005, a CT scan of the abdomen revealed bilateral mild hydronephrosis.The submitted records indicate that in early September 2005 hematuria became a problem, increasing from mild to severe and leading to clot retention mid-September 2005. The patient apparently bled enough to require a two-unit blood transfusion.Treatment with catheter irritations and Amicar apparently failed. In September 2005 the patient underwent cystoscopy under anesthesia for removal of clots, bladder fulguration, and bladder trigone biopsy. The latter revealed poorly differentiated prostate adenocarcinoma. Other diagnoses were clot retention, urinary infection, and hemorrhagic cystitis due to radiation (radiation cystitis). The urethral catheter was apparently removed, as the records indicate the patient passed a clot in September 2005 and an in-dwelling urethral catheter was placed in September 2005 for clot retention.Bleeding diminished after that and the episode was apparently not as severe as the last one. A treatment note from October 2005 indicated the plan was to remove the catheter in one week. The patients provider has requested authorization to treat the patient with hyperbaric oxygen because of potential recurrence and difficulty in managing that problem. The Health Plan has denied this request indicating that hyperbaric oxygen therapy is considered investigational in this setting.Per the patients urologist, both the cancer and the radiation cystitis are the source of the bleeding. Given these clinical findings, treatment with hyperbaric oxygen should be deferred at this time.Based on the information provided, 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. However, if the bladder hemorrhage is uncontrollable by other non-surgical means and documented to be coming from radiation cystitis and not from recurrent prostate cancer, then the patients request for hyperbaric oxygen should be reconsidered.Physician 2: The patient is a 61-year-old male with recurrent prostate cancer and persistent gross hematuria secondary to radiation cystitis. His provider has recommended the patient undergo treatment with hyperbaric oxygen therapy. The Health Plan has denied this request on the basis that the proposed therapy is experimental for treatment of the patients condition.Clearly this case involves a very difficult clinical situation. Most symptoms of radiation cystitis including hematuria can be treated with conventional methods. In some instances, refractory gross hematuria requires drastic therapeutic options. Hyperbaric oxygen therapy may be beneficial in this situation. There is evidence to suggest that hyperbaric oxygen therapy helps prevent long-term hematuria as it promotes rapid healing of the bladder. Given the scientific evidence currently available and the absence of other therapeutic options in this case, the use of hyperbaric oxygen is medically appropriate and should be authorized. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3: The patient is a 61-year-old male who was diagnosed with prostate cancer in 1999 and treated with a radical prostatectomy. The procedure did not appear to be curative so it was followed with adjuvant radiation therapy, which has resulted in severe radiation cystitis. Radiation cystitis is a complication of radiation to the prostate bed and bladder base. This patient has received maximum medical therapy in the form of hormonal ablation (Lupron) so there is no additional cancer treatment available to him. The symptoms of radiation cystitis have included bleeding unresponsive to conservative catheters and irrigation, and the bleeding episodes have been repetitive. They have required restriction of activity, hospitalization, and transfusion. The patient, on the recommendation of his urologist, has requested authorization for hyperbaric oxygen treatment in an attempt to heal the bladder and stop the bleeding. The Health Plan has denied coverage for the requested therapy on the basis it is considered investigational.The patient has severe radiation cystitis that is causing bladder bleeding. Radiation cystitis is a very debilitating condition, which occurs in about 5% of patients who have undergone pelvic irradiation for prostate cancer. Conservative therapies in the form of catheters, irrigation, formalin instillation or alum installation are often ineffective or only temporarily helpful.  Radiation cystitis is thought to be caused by endarteritis, tissue hypoxia and fibrosis. The submitted review article adequately summarizes the literature on the use of hyperbaric oxygen to treat intractable radiation cystitis and reports 73% resolution in 190 patients treated. The patients life expectancy is significantly compromised by the extent of his prostate cancer and the alternative to hyperbaric oxygen therapy is total cystectomy with urinary diversion, which is not reasonable given the extent of his medical problems. The requested therapy is a medically accepted treatment for radiation cystitis and is appropriate in this clinical setting. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.