Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a young woman with breast cancer with a very high risk of relapse based on persistently positive lymph nodes after induction chemotherapy. She has had PET imaging as follow-up in 2002 and 2003. The patient wishes to undergo further PET imaging. She has no localizing symptoms or findings. Based upon the records provided, other imaging has not been performed recently. The Health Plan has denied coverage for the requested PET scan on the basis it is considered investigational in this clinical setting. PET scanning is not indicated as a screen for recurrent cancer in this setting. It is only questionably more sensitive and specific than other modalities. In addition, treatment would not be based on a PET scan alone (other imaging and biopsies would be needed). There is no evidence that a PET detected early relapse would lead to treatment that would improve survival or quality of life.  Therefore, I have determined that the requested PET scan is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 2: The patient is a 37-year-old female who was diagnosed with left breast cancer in November 2001. The patient was given preoperative chemotherapy and underwent a left mastectomy and node dissection in February 2002. Pathology results indicate 7 of 22 axillary nodes were positive. In December 2002, the patient underwent a prophylactic right mastectomy. PET scans were performed on 11/25/02 and 5/27/03, which were negative. The patients clinician has ordered a follow-up PET scan for increasing fatigue and restaging. The Health Plan has denied authorization and coverage for the requested PET scan on the basis that PET scanning is considered investigational for patients such as this patient. Over the last decade there have been many studies showing the efficacy of PET scan for staging breast cancer. In October 2002, the Centers for Medicare and Medicaid Services (CMS) approved PET scans for breast cancer for staging and restaging of local and regional recurrence or distant metastases. PET scan has been shown to be more sensitive and specific than CT scans for detection of mediastinal and internal mammary lymph node metastases. In addition, PET scan has been shown to be more sensitive, specific, and accurate than conventional imaging for detecting local recurrences or distant metastases. Furthermore, PET scan has been shown to have a significant impact on the care of breast cancer patients, influencing both clinical stage and management. A recent article by Van der Hoeven, et al. states the addition of FDG PET to the standard workup of patients with locally advanced breast cancer may lead to the detection of unexpected distant metastases. Another article by Eubank, et al. indicates the sensitivity and specificity of PET for recurrent/metastatic breast cancer is high, 94% and 91% with the results of the PET scan altering the therapeutic plan in 32% of patients. In the case of this patient she also has had prior PET scans, which can be used for comparison adding more value to the follow-up exam. Based upon the information set forth above, I have determined that the requested PET scan is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned. Physician 3: The patient is a 37-year-old woman who was diagnosed with multicentric breast cancer in November 2001. She had three distinct masses in her breast (the largest of which was 4cm), all of which were confirmed to be poorly differentiated breast cancer. Her exam revealed minimally mobile adenopathy of her axilla. Based on the information provided, it is assumed the patient had no metastatic disease and therefore, had a locally advanced breast cancer. She received neoadjuvant chemotherapy and then underwent a modified radical mastectomy in February 2002. Her pathology demonstrated only residual DCIS in the breast, though 7 metastatic nodes in her axilla. It is unclear whether she received any additional chemotherapy or radiation therapy. Since that time the patient has been followed with annual PET scans for routine surveillance. PET scans were performed in 2002 and 2003. Request has been made for another PET scan as part of annual surveillance. Minimal symptoms of fatigue have been noted, but without any apparent localized symptoms indicating a recurrence. No additional information is provided about other routine imaging studies performed for surveillance (e.g., CT scans, bone scans. etc.). The Health Plan has denied coverage for the requested PET scan on the basis it is considered investigational for evaluation of patients such as this patient.At issue is whether a PET scan is useful for routine surveillance of breast cancer patients following treatment without any clinical or radiologic suspicion for recurrence. The patients symptoms of fatigue are insufficient to justify a clinical concern for recurrence. In addition, standard imaging studies of CT scan and bone scan have not been performed to identify any potential area of radiologic abnormality concerning for recurrence. There is no data on the utility of PET scan for routine surveillance of any cancer that yields significant improved clinical outcomes of prolonged survival.The article by Moon, et al., which was referred to by the patients provider, involved a series of 57 patients in whom a PET scan was performed and then correlated with diagnostic testing, and clinical follow-up of additional imaging. These patients were referred specifically for clinical or radiologic concern for recurrence, and the PET scan was not performed as part of a routine surveillance. Furthermore, while the Centers for Medicare and Medicaid Services (CMS) approved PET scans for breast cancer for staging and restaging of local and regional recurrence or distant metastases, the criteria are very specific and based on data that supports the utility of this imaging modality in cancer patients. This patient is not within the group of patients for which PET scan has been demonstrated to be useful. Based upon the information set forth above, I have determined that the requested PET scan is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.