On June 11, the Centers for Medicare & Medicaid Services (CMS) released a proposed Local Coverage Determination (LCD) for Molecular Diagnostic Services Program (MolDX): Pharmacogenomics Testing. The scope of this LCD includes testing to determine how genes affect the body’s response to certain medicines, known as pharmacogenetic, or pharmacogenomic testing. This LCD addresses single gene, multi-gene panels, and combinatorial tests aimed at determining an individual’s drug response.
If the proposed LCD becomes effective, molecular/genetic laboratories will need to ensure billing is done correctly or it could negatively affect reimbursement.
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