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

Physician 1:  The patient is a 59-year-old male with chronic foot pain related to peripheral neuropathy. Medical management apparently failed, and the patient was referred to a physical therapist who utilized Anodyne therapy treatments. The patient reports significant improvement in his painful symptoms and has requested reimbursement for a home Anodyne therapy unit he purchased. The Health Plan denied his request citing the experimental nature of the device.The Anodyne therapy unit has been FDA approved since 1994. It is in use by over half of a million patients and many podiatrists have come to appreciate the benefits of this therapeutic device. The patient had previously tried many other treatments modalities, and none had provided measurable relief. He indicates that the Anodyne therapy unit was extremely beneficial during his course of physical therapy and he is likely to derive similar benefit from a home unit. Therefore, I have determined that the device 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 male with peripheral neuropathy. He reports poor soft-touch sensation to monofilament testing. The patient has persistent foot pain and failed treatment with anticonvulsant, antidepressant, and narcotic medications. Between May 2006 and June 2006 the patient was treated by a physical therapist that performed Anodyne therapy (monochromatic infrared therapy) on his feet to improve sensation. The patient noted dramatic improvement and purchased an Anodyne unit for home. The Health Plan considers this to be an experimental device, and denied his request for reimbursement. Monochromatic infrared therapy has been utilized for many years for the treatment of peripheral neuropathy. Unfortunately, there have not been any large, double-blind, placebo-controlled studies supporting the efficacy of this intervention. A review of the literature reveals only small studies and case reports. Generally speaking, although there have been some reports of positive results, the long-term use of this device has not been critically analyzed and its safety and efficacy in the treatment of chronic peripheral neuropathic pain has not been established. At this time, Anodyne therapy is not a generally accepted medical modality for the management of peripheral neuropathy and the benefits of a home unit are questionable. Given the lack of proven efficacy associated with the Anodyne therapy unit, I have determined that the device 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 3:  The patient is a 59-year-old male with a diagnosis of peripheral neuropathy and chronic foot pain. Previous attempts to alleviate his symptoms have proven to be unsuccessful. The patient reported 90% improvement in his foot pain when the Anodyne therapy unit was utilized during physical therapy. He acquired an Anodyne unit for home, and now requests reimbursement from the Health Plan. The Health Plan has determined that the efficacy of the device remains unproven for the treatment peripheral neuropathy and has therefore denied coverage.There is no submitted or available scientific data supporting the use of the Anodyne therapy unit for the treatment of peripheral neuropathy. The efficacy of Anodyne therapy has not been established through well designed studies. Anodyne therapy is not a standard or accepted therapy for treating neuropathy in the literature or in general practice within the podiatric community. Therefore, I have determined that the device 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.