Medicare Coverage Tightens on Molecular and Transplant Diagnostics

Medicare contractor Palmetto GBA proposed local coverage determinations (LCDs) that impose stricter requirements on molecular diagnostics for ductal carcinoma in situ (DCIS) and transplant surveillance tests. The contractor declined coverage for Exact Sciences’ Oncotype DX DCIS Score and PreludeDx’s DCISion RT tests due to limited evidentiary support. Similarly, a proposed LCD would limit the number of transplant surveillance tests covered annually, affecting offerings by CareDx such as AlloSure and AlloMap, and introducing more stringent analytical validity standards. These changes could markedly reduce market opportunities for diagnostic firms by restricting testing frequency and demanding higher evidence levels, reflecting a cautious Medicare stance on molecular diagnostics utility.