Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  This patient is a 59-year-old female who was diagnosed with breast cancer in February 2006. She had a 1.4cm cancer with negative lymph nodes. She underwent radiation therapy with the Mammosite brachytherapy technique soon after the lumpectomy was performed and has submitted a request for reimbursement to the Health Plan. The Health Plan denied her request citing the investigational nature of the therapy.The Mammosite technique is one of a variety of newer approaches to the treatment of the residual breast cancer following lumpectomy. The conventional treatment is whole-breast radiation, which entails daily treatment for six to seven weeks. The Mammosite technique involves the insertion of a balloon into the biopsy cavity and then loading the areas with radiation needles over a five day period. This technique delivers a high dose of radiation in a short period of time, but only to a smaller localized area of the breast. Inasmuch as the vast majority of breast cancer recurrences are very close to the site of the original cancer, it is believed that treatment of the whole breast is not required. Mammosite brachytherapy has been available for several years and is offered as a treatment alternative at many cancer centers and clinical trials are on-going. Data thus far appears to show that the Mammosite technique is as effective as whole breast radiation. Although additional data is needed, Mammosite brachytherapy offers a reasonable and perhaps less toxic option for post-lumpectomy breast radiation. Therefore, I have determined that the therapy 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 59-year-old woman diagnosed with breast cancer in February 2006. She underwent a lumpectomy in March 2006 and pathology showed a 1.4cm cancer, ER/PR negative and HER-2/neu positive. She was treated with Mammosite brachytherapy after her lumpectomy with plans for on-going chemotherapy. The Health Plan denied the patients request for reimbursement for the Mammosite therapy on the basis that it is investigational and has not been shown to be efficacious in the treatment of breast cancer.Mammosite brachytherapy is FDA approved and is widely available at cancer centers throughout the country. The American College of Breast Surgeons (ACBS) has determined that partial breast irradiation is an accepted technique for early breast cancer with negative nodes and has established guidelines for its application. These guidelines are fully applicable to the patient in this instance and Mammosite therapy is equally as effective as whole breast irradiation, yet it is less toxic, less time-consuming, and less costly. All things considered, Mammosite therapy offers a clear advantage over conventional treatment alternatives.  Based upon the information set forth above, I have determined that the therapy 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 59-year-old female who was found to have left breast cancer in February 2006. She underwent lumpectomy and lymph node sampling in early March 2006. The tumor was a 1.4cm invasive ductal carcinoma, SBR 8/9, ER and PR negative and  HER-2/neu positive. In March 2006 she underwent Mammosite catheter placement and received high dose rate radiation twice per day in March 2006 for which she is now seeking reimbursement. The Health Plan deemed the Mammosite brachytherapy experimental/investigational in this clinical setting and the patients request for reimbursement was denied.Mammosite HDR radiation was given an FDA approval in May 2002 and the American Brachytherapy Society (ABS) has determined that partial breast irradiation is an accepted technique for early breast cancer with negative nodes. However, Mammosite HDR radiation is not yet the standard of care for the management of breast cancer. While Mammosite therapy may be more practical than standard therapy in some situations, it has not been found to be superior to conventional treatment. As such, Mammosite therapy remains investigational and based on available data it 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.