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

Physician 1:  The patient is a 61-year-old male diagnosed with a low-grade adenocarcinoma of the prostate in July 1998. At that time, he elected to undergo watchful waiting. More recently, his PSA rose to 7.4 in June 2005. Repeat biopsy revealed a Gleason score of 3+2=5/10, three of eleven core biopsies were positive. Physical examination was consistent with a clinical stage T2a.  According to the radiation oncologist consult note, options regarding definitive treatment were discussed and the patient appears to favor treatment with prostate brachytherapy.  The records are unclear as to why the patient did not undergo a brachytherapy implant, but rather, received IMRT fractionated radiotherapy to the prostate. He was treated with the IMRT technique to the prostate with 6 MV photons, utilizing IGRT techniques to deliver a tumor dose of 7560 cGy. As part of the IGRT treatment, small non-radioactive gold seeds were placed within the prostate. Prior to each radiation treatment, an image was acquired on the treatment machine localizing the seed and positioning the patient so that the treatment fields remained the same on a daily basis.  The Health Plan has denied reimbursement for the implantation of the gold marker seeds indicating the procedure remains investigational.The gold seeds implanted were not radioactive; rather, they were implanted so as to direct daily treatment. These gold seeds would be termed implanted fiducial markers and are justified when patients are treated with image-guided radiation therapy. According to NCCN guidelines for prostate cancer, this patient would be considered a low recurrence risk. Based on his clinical stage T2a, Gleason score of 5, and PSA less than 10, recommendations for initial therapy for patients in low recurrence risk would include expectant management, radiation therapy or radical prostatectomy. Furthermore, the principles of radiation therapy indicate that either 3D conformal or IMRT technique should be employed.  The guidelines state that if target margins are reduced such as for doses above 75Gy, extra attention to daily prostate localization with techniques such as ultrasound, implanted fiducials or an endorectal balloon is indicated. In the case of this patient, the dose was delivered above 75Gy and thus, implanted fiducials were placed. The procedure at issue was medically reasonable and appropriate and within the standard of care.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.Physician 2:  The patient is a 61-year-old male had a PSA of 7.59 in December 2004. A repeat PSA performed in June 2006 was 7.4. In August 2005 the patient underwent ultrasound-guided biopsy of the prostate. Results showed a Gleason score of 3+2=5 and 3 of 11 biopsies were positive. DRE revealed the right lobe to be larger than the left. The patient was staged by the radiation oncologist as T2aNoMo. The patient was offered conventional radiation, brachytherapy and IMRT. At the time of the consultation he was in favor of prostate brachytherapy, however, he was subsequently treated with IMRT. The patient received IMRT between May 2006 and July 2006 with 6 MV and image-guided radiation therapy (IGRT). The tumor dose was 7560 cGy in 42 fractions in 59 days. Gold seeds were implanted prior to the procedure to help visualize the prostate. The Health Plan has denied coverage for the use of the gold marker seeds on the basis that the procedure is considered experimental/investigational.The use of gold seed markers in this clinical setting is standard of care and within current NCCN guidelines. IMRT is a very precise form of external beam irradiation with tight margins. The difficulty with this therapy is reproduction and maintaining the target in focus. The treating radiation oncologist recommended using gold marker seeds to facilitate his capturing and focusing on the prostate. This is a sound approach that improves the conformality of the beam radiotherapy. As such, 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.Physician 3:  The patient is a 61-year-old man with prostate cancer dating to 1998. He was treated with IMRT using gold seed implantation for verifying the position of the prostate during highly conformal radiation treatment. The Health Plan considers the use of gold seed implants investigational and therefore, has denied coverage for the procedure.This patient received IMRT treatment for localized prostate cancer. Prior to this therapy the patient underwent gold seed implantation to verify the location of the prostate before the start of treatment. This is a practical means of prostate localization during highly precise high dose IMRT treatment. Gold seed implantation is a safe and appropriate technique to verify and correct the position of the prostate during IMRT. Many radiation oncologists have adopted this technique as the standard of care. Therefore, 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.