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

Physician #1:  The patient is a 54-year-old male who presented with rectal bleeding in May 2004.  He was found to have a 5.0cm circumferential rectal cancer. The CT scan showed a 3.5cm lesion in the liver which was positive on PET scan leading to a diagnosis of stage IV adenocarcinoma of the rectum. He was treated with chemotherapy (FOLFOX plus Avastin) and had a resection of his rectal carcinoma.  There was a second operation with resection of his liver metastases and a second round of chemotherapy (FOLFOX) and radiation. A CT scan in July 2005 showed a mass in the right lung.  A repeat CT scan and a PET scan showed three nodules in the right lung and one nodule in the left lung.  In October 2005 the patient underwent right lower lobectomy and resection of the right middle lobe nodule. The pathology report showed metastatic adenocarcinoma in each specimen.  In November 2005 the patient had left lower lobe segmentectomy and a biopsy of the left lower lobe. The pathology report was negative for metastatic carcinoma.  A CT scan from January 2005 showed a 1.5cm x 1.1cm nodule in the right lung base and a 1.4cm x.7cm and a 1.2cm nodule in the left lung.  The February 2006 PET scan was positive in the right hilum, and the other areas were negative.  The patient appears to be living well and is asymptomatic from his disease.  The patients clinician has requested authorization for radiofrequency ablation of the lung nodules. The Health Plan has denied the request citing the investigational nature of radiofrequency ablation in this clinical context.Based on the surgical and medical literature, radiofrequency ablation of lung nodules is indicated for: 1)Primary lung nodule less than 4.0cm, and no evidence of metastases in a patient that refuses surgery or is a poor surgical risk.2)Lung nodules less than 4.0cm that are metastatic from a primary tumor that is under control and the patient refuses surgical resection or is a poor surgical risk.3)Symptomatic lung nodule less than 4.0cm that have failed palliative treatment with chemotherapy or radiation or both.The patient is a 54-year-old male with Stage IV adenocarcinoma of the rectum who has been treated with multiple doses of chemotherapy, radiation therapy, two abdominal surgeries and two chest surgeries over the past 22 months.  He had recurrent lung nodules two and four months after curative surgical resection of his lung lesions. This primary adenocarcinoma of the rectum is not controlled, and radiofrequency ablation of the lung nodules would be palliative in an asymptomatic patient and is therefore not indicated.  After thorough consideration of the clinical presentation, I have determined that the requested procedure 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.Physician #2:  The patient is a 54-year-old man who was diagnosed with stage IV rectal cancer in May 2004. He was known to have liver metastases at the time of presentation. His was initially treated with neoadjuvant chemotherapy with FOLFOX, followed by resection of the tumor. The patient next underwent additional pelvic irradiation followed by chemotherapy with FOLFOX and Avastin. In early 2005, he was noted to have several pulmonary nodules. These remained stable over 2005 and he was subsequently evaluated for surgical resection in late 2005. A total of three pulmonary nodules were identified and the right middle and lower lobes were resected in October 2005 and the left superior segment of the left lower lobe in November 2005.  The final pathology documented metastatic tumor in the two specimens from the right lung, but no tumor in the left lung.The follow up CT scan of January 2006 demonstrated multiple bilateral lung nodules, including a 1.5cm right lower nodule, a 1.4cm left lower nodule (previously seen at 5mm) and another 1.2cm left lower lobe nodule. A PET scan in February 2006 demonstrated uptake only in the right hilum, possibly representing postoperative changes or recurrent/residual disease. Radiofrequency ablation of the bilateral pulmonary nodules was recommended by the treating thoracic surgeon who feels that the tumor is very aggressive based on the short length of time before discovery of new metastases, and advocates for an urgent intervention.  The Health Plan denied the providers request for authorization because radiofrequency ablation is experimental/ investigational in this clinical setting.The treating surgeon is correct in that rapid recurrence of tumor following surgical resection represents aggressive disease, but this also portends a lack of meaningful life prolongation by continued surgical or ablative therapies. There is limited data on resection of pulmonary metastases from rectal cancer, though most would agree that bilateral disease in multiple lobes is not best treated with surgery. Furthermore, there is no data on the long-term disease control of pulmonary metastases using radiofrequency ablation. Secondly, additional chemotherapy would be the standard of care in this situation. The requested procedure is not likely to be more beneficial for treatment of the patients medical condition. The Health Plans denial should be upheld.Physician #3:  This case pertains to a 54-year-old male with a diagnosis of rectal carcinoma with metastases to the liver and lung. He had previously undergone pulmonary metastectomies in the form of right lower lobectomy and left lower lobe superior segmentectomy, according to the thoracic surgical oncology note dated March 2006. Surveillance CT scans revealed spiculated, calcified pulmonary nodules in the right lung base and left lower lobe, approximately 1cm in diameter. One of these nodes however, has recently enlarged from 5mm to 1.4cm. Considering the extent of pulmonary resection the patient had already undergone, it was determined that further resection would not be appropriate and the consulting surgeon recommended percutaneous radiofrequency ablation of the lesions. The Health Plan concluded that radiofrequency ablation was an experimental procedure in this clinical situation, and denied the requested authorization.The most recent National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines addressing local and regional recurrence in non-small cell lung cancer recommend consultation and discussion with a multidisciplinary team and treatment with external beam radiation therapy.  Conversely, current NCCN guidelines do not include radiofrequency ablation in the standard of care. Based upon the available data, there is insufficient evidence radiofrequency ablation is likely to be of clinical benefit in this case. Therefore, I have determined that the requested procedure is not more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.