Notification of Policy Revisions Effective July 24, 2024 (Posted May 15, 2024)

Reviewed by Avalon 1st Quarter 2024 CAB. Description, Policy Guidelines and References updated. Related Policies added to the Description section. Removed code 0386U from Billing/Coding section. Changes to When Covered section: new criteria 1 now reads “For individuals who have been newly diagnosed with cancer of the esophagus or esophagogastric junction (EGJ), reimbursement is allowed for mismatch repair (MMR) analysis by immunohistochemistry (IHC).” Former criteria 1 and 2 combined into new criteria 2 and now reads “For individuals who have been diagnosed with locally advanced, recurrent, or metastatic cancer of the esophagus or EGJ and for whom PD-1 inhibitor treatment is being considered, reimbursement is allowed for tumor analysis of PD-L1 expression by IHC.” Former criteria 2 is now criteria 3: “For individuals who have been diagnosed with inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the esophagus or EGJ and for whom trastuzumab or an approved biologic or biosimilar drug to trastuzumab is being considered for first-line therapy, reimbursement is allowed for HER2 overexpression testing by IHC, fluorescence in situ hybridization (FISH), or other in situ hybridization (ISH).” Former criteria 3 is now criteria 4: “For individuals diagnosed with unresectable locally advanced, recurrent, or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or EGJ and for whom one of the following drugs is being considered as a second-line therapy, the corresponding gene testing is considered medically necessary: a. Larotrectinib or entrectinib: NTRK gene fusion. b. Selpercatinib: RET gene fusion. c. Dabrafenib or trametinib: BRAF V600E mutation.” Changes to the When Not Covered section: Combined former criteria 1 and 2 into new criteria 1: “The use of genetic testing, (e.g., molecular panel tests, gene expression profiling) to diagnose or monitor an individual with eosinophilic esophagitis (EoE) or to assess the risk of an individual developing EoE is considered not medically necessary.” New criteria 2: “Reimbursement is not allowed for wide area transepithelial sampling (WATS) for the diagnosis and evaluation of Barrett’s esophagus, low-grade esophageal dysplasia, or high-grade esophageal dysplasia.” Criteria 3 updated: “Reimbursement is not allowed for assessing for risk of Barrett’s esophagus and/or esophageal, including esophagogastric junction, cancer using a molecular classifier (e.g., BarreGEN test).” Criteria 4 updated: “Epigenetic analysis for the likelihood for Barrett’s esophagus, esophageal, or esophagogastric junction cancer (e.g., methylation analysis, EsoGuard) is considered not medically necessary.” Medical Director review 4/2024. Notification given 5/15/24 for effective date 7/24/24.