Stem Cell Transplant denials: what the review data shows

Where the denial was overturned

Physician 1: The patient is a 44-year-old male originally diagnosed with Stage IVB Hodgkin’s Disease in 1975 treated with C-MOP chemotherapy and a single fraction of thoracic radiation. He next presented in June 2004 with an abnormal chest X-ray showing a spiculated 1.4cm nodule in the right upper lobe. Ultimately he underwent resection of an invasive non-small cell lung cancer and per the record, he had a 1.7cm lung tumor resected with pleural invasion but no nodal involvement He received no adjuvant therapy for what appears to have been a Stage I lung cancer. Within the same timeframe he was noted to have a progressive thrombocytopenia and was subsequently diagnosed with myelodysplastic syndrome (MDS).

A 55-year-old female enrollee has requested authorization and coverage for a phase II multi-center study of high dose cyclophosphamide and antithymocyte globulin followed by autologous hematopoietic cell transplantation for treatment of the enrollee’s diffuse systemic sclerosis with severe lung involvement. Findings: Three physician reviewers found that the patient has Raynaud’s syndrome, and was diagnosed with systemic sclerosis (SSc). She underwent an extensive evaluation including serologic testing, imaging and biopsy. She was treated initially with methotrexate and corticosteroids after developing aching joints and weight loss, as well as proximal weakness in her arms and legs. Pulmonary function testing revealed a significant decrease in forced vital capacities compared to studies done previously.

Where the denial was upheld

Physician 1The patient is a 45-year-old man who was diagnosed with Crohn’s disease in 1988. In addition to bowel manifestations, the patient has experienced pyoderma gangrenosum. He has undergone treatment with Rowasa enemas, sulfasalazine, 6-MP, and Remicade. A diverting ileostomy was performed because of colitis from the rectum to the hepatic flexure with a rectal stricture and anal fistula. The patient has requested authorization for treatment under a protocol for stem cell transplantation after immune ablation. The Health Plan has denied authorization for the requested procedure on the basis that it is considered experimental.The requested procedure is unproven and is being conducted under institutional IRB approval. The technique is a radical departure from standard treatments, and involves a substantial risk of morbidity and mortality.

Physician 1The patient is a 55-year-old man with a history of renal cell carcinoma who underwent nephrectomy in March 2002. Prior to that time he had been diagnosed with acute myelogenous leukemia (AML), which went into remission in 2001 with chemotherapy. He has not had a relapse of his acute leukemia. In May 2003, the patient was found to have multiple lung metastases from his renal cell carcinoma. As of June 2004 these appeared to have increased in size.The patient has a fully HLA-matched sibling who has already donated allogeneic stem cells. It has been proposed that the patient be treated with non-myeloablative allogeneic stem cell transplant. The goals of this therapy would be to control his metastatic renal cell carcinoma, and presumably to provide further treatment of his AML.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Stem Cell Transplantwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.