NEW YORK (GenomeWeb) – Immucor announced Monday that it has received final local coverage determinations for its PreciseType HEA test from Medicare Administrative Contractors (MACs) participating in Palmetto's Molecular Diagnostic Services (MolDX) program.
Noridian Healthcare Solutions, a MAC which covers Medicare Part B in 14 states north and west of Colorado in jurisdictions E and F, finalized an LCD for the test on Friday, Immucor said. This follows a precedent set by other MACs in the MolDX program — Palmetto GBA, which issued an LCD for PreciseType in June 2015, and CGH Administrators, which issued its LCD in October 2015.
PreciseType is a US Food and Drug Administration-approved molecular diagnostic that evaluates blood compatibility between donors and patients to help prevent mismatches that can cause potentially life-threatening reactions, the firm added. Â
"The PreciseType HEA test is the only molecular immunohematology test to have successfully completed the MolDX technical assessment, a process that involves demonstrating the test's analytical and clinical validity to subject-matter experts, among other requirements," Joel de Jesus, Immucor's senior director of government affairs and payer relations, said in a statement.