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

Physician 1: The patient is a 62-year-old male diagnosed with prostate adenocarcinoma. In September 2004, the patient has a Gleason score of 3+3 (total 6) on 8 of 12 biopsy cores obtained with a PSA of 7.0. After obtaining opinions regarding possible different treatment modalities including surgical radical prostatectomy, external beam radiation, and brachytherapy, the patient decided to proceed with cryoablation of the prostate. The procedure was performed on 1/17/05 after a few months of prior hormone deprivation therapy. The Health Plan has denied reimbursement for the procedure at issue on the basis cryoablation of the prostate is considered investigational.Relevant medical literature reveals increasing support for cryoablation. As indicated in the Horger and Clark article referenced above, morbidity associated with cryoablation, with the exception of erectile dysfunction, has improved to a level comparable to other therapeutic options. The authors concluded, while long-term data and randomized prospective trials comparing cryoablation with other forms of treatment for prostate cancer are still lacking, the advances of recent years have improved the efficacy and safety of cryosurgery. Thus, improved techniques and experience with cryosurgery of prostate cancer have led to decreased morbidity from the procedure itself. However, at this time there is insufficient evidence in peer-reviewed medical literature to demonstrate that cryoablation for prostate adenocarcinoma is comparable in terms of survival to other modes of treatment.Based upon the information set forth above, I have determined that the procedure at issue was 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.Physician 2: The patient is a 62-year-old male with a Gleason score of 6 (8/12 cores) and negative metastatic workup. He is requesting reimbursement for cryoablation of the prostate. The Health Plan has denied this request indicating the long-term efficacy of cryoablation for treatment of prostate cancer has not been proven.There is no evidence establishing the long-term effectiveness of cryoablation in the treatment of prostate cancer. Additionally, cryoablation has not been shown to be more effective than traditional or robotic surgery. There are other well-established and effective modalities for treatment of the patients prostate cancer. As such, I have determined that the procedure at issue was not likely to be more beneficial for treatment of the patients condition than any available standard therapy. The Health Plans denial should be upheld.Phycisian 3: The patient is a 62-year-old male who was diagnosed with localized Gleason 6 adenocarcinoma of the prostate and a PSA of 7.0. The patient indicates he wished to avoid the risks of radical surgery and the side effects of radiation therapy, which are the two most commonly, applied therapies with prospects of curing the disease. He preferred definitive therapy for his cancer with cryoablation of the prostate with curative intent. He initially pursued the option of cryoablation at the recommendation of his urologist who concurred with the patient that this was a reasonable treatment given the patients age as well as the stage, and grade of his prostate cancer, and the patients lifestyle and personal preference. He has requested reimbursement for cryoablation, which has already been performed.Cryoablation is one of a number of definitive therapies for prostate cancer with curative potential. It is not more commonly applied because its availability is relatively scarce due to the lack of trained physicians in the technique. Review of the medical literature reveals the technique has improved significantly in the last several years. Cryoablation for prostate cancer has been approved by the Centers for Medicaid and Medicare as primary therapy for prostate cancer since 1999. The body of literature regarding cryoablation is substantial and adequate to support its use in this clinical setting. Based upon the information set forth above, I have determined that the procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.