Excellus – Medical Policy Updates
October 13, 2020New Policy
Gene Expression Profiling for Cutaneous Melanoma is a new policy that addresses three types of tests that can be used to determine risk of malignancy and risk of recurrence of cutaneous melanoma. Standard of care for skin lesions suspicious for melanoma include visual assessment, surgical biopsy and histopathology. To improve diagnostic accuracy and to reduce the number of surgical biopsies and side effects, non-invasive gene expression signatures have been developed. The DermTech pigmented lesion assay (PLA) consists of an adhesive patch that is placed over skin samples of lesions at least 5 mm in diameter. The lesion is marked and the patch removed. This is repeated four times with a new patch. The expression of six genes is measured and a PLA score that ranges from 0 to 100 is reported, with higher scores indicating higher suspicion of malignant disease. The myPath® melanoma test is performed on five standard tissue sections from an existing formalinfixed, paraffin-embedded biopsy specimen and measures the expression of 23 genes. The test report includes an algorithmic myPath® score ranging from -16.7 to 11.1 which indicates the sample is “benign,” “indeterminate,” or “malignant.” The DecisionDx-Melanoma test measures expression of 31 genes and is performed on standard tissue sections from an existing formalin-fixed, paraffin-embedded biopsy or wide local excision specimen. The test report provides a class result which stratifies tumors as low-risk (class 1) or highrisk (class 2) and a probability score which ranges from zero to one which appears to be the risk of recurrence within five years. Due to the lack of literature to support how these tests change management and improve outcomes, the tests are considered investigational at this time.
Current Policies Recently Updated with Changes
(#2.01.10) Allergy Testing is divided into vivo and in vitro testing. In vivo tests include skin testing and in vitro tests include various techniques to test the blood for the presence of specific IgE antibodies to a particular antigen. Intracutaneous/intradermal tests (serial end point testing) are considered medically appropriate. Serial endpoint testing (SET), or intradermal dilutional testing (IDT) is a form of intradermal skin testing that uses increasing doses of antigen to determine the concentration at which the reaction changes from negative to positive (the “endpoint”). These tests have been used for diagnosing allergic disorders and to guide the initiation of immunotherapy by using the endpoint dilution as the starting antigen dose. The policy includes an extensive list of tests that are considered medically appropriate in the diagnosis of the allergic patient. The following allergy tests have not been medically proven to be effective and are considered investigational: ▪ Leukocyte histamine release test (LHR); ▪ Ophthalmic mucous membrane test; ▪ Direct nasal mucous membrane test; and ▪ Cytotoxicity, Provocative testing (e.g. Rinkel test), Rebuck skin window test. With this year’s update, the peanut allergen specific IgE and quantitative assessment was added to the policy and considered investigational.
(#2.01.51) The Colorectal Cancer Screening policy addresses several different modalities for colorectal cancer screening as well as the intervals for repeat testing. These modalities include colonoscopy, fecal occult blood test (e.g., guaiac-based (gFOBT) or immunochemical (FIT)), flexible sigmoidoscopy, virtual colonoscopy (CT colonography), and DNA analysis of stool samples using the Cologuard® multitargeted stool DNA test. The policy follows USPSTF criteria for screening intervals for each modality and are further outlined in the medical policy. An investigational statement for blood serum testing for colorectal cancer screening was added to the policy with this year’s update