Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 52-year-old man who had a cardiac transplant in February 2004. He requires chronic immunosuppressive therapy to prevent rejection. A consultative report in February 2005, indicates the patient was enrolled in the IMAGE protocol comparing the efficacy and safety of molecular gene profiling (AlloMap testing) for the detection of acute rejection in heart transplant patients, compared with the conventional method of endomyocardial biopsy. The Health Plan has denied coverage for AlloMap testing on the basis it is considered experimental.AlloMap testing is a procedure in an early investigational phase. To date, there is no published literature demonstrating the efficacy of AlloMap testing for patients such as this patient. Thus, the testing at issue has not been established to be more effective than any available standard diagnostic modalities. Therefore, I have determined that the testing at issue was 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 52-year-old male post cardiac transplant in February 2004. The member was enrolled in a protocol comparing AlloMap molecular expression testing to the conventional method of endomyocardial biopsy. The Health Plan has denied coverage for the testing at issue on the basis it is considered experimental. At issue is whether AlloMap testing was likely to be more beneficial for evaluation of the patients condition than other available standard modalities.AlloMap molecular expression testing is a novel method for detection of acute rejection in heart transplant recipients that relies on the activity of genes involved in the immune system to assess the potential of rejection. Though AlloMap testing is intriguing and may ultimately obviate the need for many invasive biopsies, to date there are no peer-reviewed trials comparing this test to conventional endomyocardial biopsy. Moreover, there is no data comparing outcomes using the two techniques. As such, there is insufficient evidence AlloMap testing is superior to traditional modalities. Therefore, I have determined the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapies. The Health Plans denial should be upheld.Physician 3:The patient is a 52-year-old male with a history of dilated cardiomyopathy who underwent orthotopic heart transplant in February 2004. He was seen for a nine-month follow-up and surveillance endomyocardial biopsy post transplant in November 2004. The patient was seen again in February 2005 for his one-year follow-up post transplant, at which time AlloMap testing was performed.During the February 2005 visit the treating cardiologist stated the patient had a complicated perioperative course. He was bridged to transplant with a Jarvik left ventricular assist device. He experienced two strokes postoperatively, sternal wound infection, and chronic aspiration secondary to left vocal cord paralysis.The Health Plan has denied reimbursement for AlloMap testing indicating the efficacy of the testing at issue has not been established in peer-reviewed literature. At issue is whether the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Endomyocardial biopsy (EMB) has been the standard of care for monitoring cardiac allograft rejection. Several non-invasive methods have been evaluated including Echo, MRI, nuclear scanning, and other modalities without success.Other efforts regarding non-invasive rejection monitoring have focused on leukocyte gene expression profiling in peripheral blood mononuclear cells, as it is widely accepted that allograft rejection is immune mediated primarily affecting cytotoxic T cells, and other immune cells. AlloMap tests evaluate activity by quantifying expression of gene products. This allows monitoring of changes in disease states and responses to therapy. This technology provides for higher sensitivity and better reproductivity. The test includes 11 informative genes that reliably distinguish between rejection and quiescence. AlloMap testing translates complex molecular data into an objective clinically actionable score. Test results range for 0 to 40, with higher values associated with greater risk of rejection. It is indicated for use in distinguishing rejection from quiescence in clinically stable cardiac transplant outpatients who are more than 15 years of age and more than 6 months post transplant.Most transplant patients in the US undergo multiple biopsies during their first year post transplant with the number decreasing to approximately 1-4 in subsequent years. The biopsy procedure is invasive and unpleasant for the patient and associated with complications with morbidity rates in the range of .5 to 1.5%. Complications could be cumulative with successive biopsies. Furthermore, biopsy procedures detect rejection only after cellular infiltration or graft damage has already occurred, and are subject to sampling error as well as variably of interpretation among pathologists reading the same slide. AlloMap testing detects rejection before they become apparent in tissue specimens. Therefore, immunosuppressive therapy can be initiated earlier.Although EMB is commonly used for distinguishing rejection from quiescence, it is not a perfect standard for rejection. Inter-reader variably and reduced sensitivity of biopsy due to focal sampling error are just some of the weaknesses of EMB.Therefore, based upon the information set forth above, I have determined the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.