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

Physician 1:  The patient is a 61-year-old female who has had multiple hospitalizations and surgeries for small bowel obstruction due to adhesions following abdominal hysterectomy at age 30. Other medical problems include a history of breast cancer for which she had a surgical lumpectomy and radiation therapy in 2002 and is still taking oral medications, gastroesophageal reflux disease and depression. While hospitalized in February 2006 for a small bowel obstruction, the patient was found to have a 2cm by 1cm solid exophytic right lower pole renal mass.  An urologist consulted with her regarding the lesion, and after considering the alternatives recommended surgical treatment with laparoscopic cryoablation. This procedure was felt to be less invasive, but as effective as other available surgical options. In March 2006 the patient underwent laparoscopic cryoablation of a 3cm renal mass with two freezing cycles done under ultrasound guidance. A retroperitoneal approach was utilized due to her history of intra-abdominal adhesions. The operative report noted that a biopsy was done, but the pathology report was not submitted with the records. The available records indicate the patient had a satisfactory post-operative course and has done well. The patients request for reimbursement was denied by the Health Plan based upon their determination that cryoablation is an experimental/investigational procedure.This patients renal tumor was an incidental finding, but is presumed to represent a renal neoplasm. The exact pathological nature of the mass would usually not be determined until definitive surgical treatment of some sort was undertaken. In the past, the preferred treatment had been surgical removal through an incision, with either a radical or partial nephrectomy performed. Small, peripherally located neoplasms such as this one, could be removed through a nephron-sparing technique which involved excising the mass along with a small adjacent rim of normal kidney. More recently, urologists have been able to do this surgery laparoscopically, which avoids a large abdominal or flank incision and is better tolerated by the patient. Cryoablation is an alternative treatment generally utilized for smaller (3cm or less in diameter) tumors that are located on the periphery of the kidney. The tumor can be removed using energy ablation (cryoablation or radiofrequency ablation).  This technique destroys that part of the kidney containing the tumor, but does not involve cutting the tumor out of the kidney.  Cryoablation is usually well tolerated by the patient, and as with a partial nephrectomy, preserves the rest of the kidney. The results for selected patients have been comparable to more invasive, open surgeries. Although the cryoablation procedure is not clinically superior to partial nephrectomy, per se, the outcomes are at least comparable and the less invasive nature of the surgery provides added benefit. Cryoablation is currently an accepted form of management and is not experimental nor investigational.Based upon the information set forth above, I have determined that the procedure 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:  This patient is a 61-year-old female who was incidentally found to have a 2cm asymptomatic right renal mass during a hospitalization for a partial bowel obstruction. A repeat, contrast-enhanced CT scan confirmed the mass and raised the possibility of a neoplastic process. The patient was seen and evaluated by an urologist who presented a variety of options, including conservative observation and resection. The possible surgical alternatives included laparoscopic approaches, open approaches, partial nephrectomy and total nephrectomy. Cryoablation was also discussed and the patient selected this option and proceeded with the surgery on 3/01/06. A request for authorization of laparoscopic renal cryoablation was submitted to the Health Plan, but was denied due to the experimental nature of the procedure.Limited data is available on the efficacy of cryoablation for the treatment of renal tumors. Most reports are case-series with only short term follow-up. Advocacy for laparoscopic cryoablation was apparently based upon lower complication rates, shorter hospital stays and faster recovery. However, there is no substantiating data based upon direct comparison between cryoablation and other treatment modalities, particularly partial nephrectomy. The recent review article by Cambio and Evans suggests that cryoablation remains in the arena of clinical trials and efficacy has not yet been clearly established. Therefore, I have determined that the procedure 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 61-year-old female noted to have a small renal mass on a CT done to evaluate an unrelated problem with bowel obstruction. The mass was described as 1cm by 2cm in size and did enhance with contrast. This lesion was not biopsied as it was so small in size that the procedure would be difficult to do with confidence, safety and accuracy. Neoplasm was certainly a possibility, however renal masses are not considered to have metastatic potential until they are at least 3cm to 4cm in size. The usual approach to these small incidental findings is observation with serial CT scans to document growth; a clear sign of malignancy. Other treatment options would be partial nephrectomy, or less likely, total nephrectomy. Both could also be accomplished with the laparoscopic approach. The patient underwent laparoscopy with cryoablation of the renal lesion in March 2006 and was later readmitted for an episode of pain and possible hematoma. The patient has recovered from the procedure and is now requesting reimbursement. The health plan has classified this approach as experimental/investigational and denied the patients request.It should also be noted that this was not an emergent condition and there would have been no loss of health or cure opportunity by waiting to see if indeed this mass would grow. There is no documentation that this was a cancer for the reasons noted above. Research is on-going as to the indications and outcomes associated with cryoablation and as such, I have determined that the procedure 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.