Originally Posted by
850man
CMS LCA59417 dated 2 June 2023 states “At this time, the Contractor does not have an LCD with a positive coverage statement for any of the Pacific Edge Diagnostics tests which include the Cxbladder Detect (CPT code 0012M) and Cxbladder Monitor (CPT code 0013M). These CPT codes are only located in the article Billing and Coding: Molecular Pathology and Genetic Testing A58917 which includes the statement “This instruction focuses on coding and billing for molecular pathology diagnostics and genetic testing. Nothing stated in this instruction implies or infers coverage.”
PEB made an announcement on 3 July 2020 - “PACIFIC EDGE NOTIFIED OF POSITIVE LCD DECISION IN USA. Transformational reimbursement milestone for Pacific Edge with notification of LCD coverage for CMS patients in the USA. The LCD coverage facilitates reimbursement for CMS patients using Cxbladder Detect and Cxbladder Monitor. New Zealand bladder cancer diagnostics provider, Pacific Edge Limited (NZX:PEB), has been notified by Novitas that the LCD: Biomarkers for Oncology (L35396) provides coverage for Cxbladder, CPT codes 0012M (Cxbladder Detect) and 0013M (Cxbladder Monitor), for tests performed on or after July 1, 2020 that are medically necessary.
On 2/6/2023 CMS advises that there has never been any coverage for CXB yet PEB advised the market on 3/7/2020 that there was. Misleading??