A new perspective just out in Genetics in Medicine describes the improvements in the US payer landscape for pharmacogenomics test reimbursement from this past summer and their implications for the field moving forward.
The Medicare Administrative Contractors (MACs) participating in the Molecular Diagnostic Services (MolDx) program released their final local coverage determinations (LCDs) pharmacogenomic testing in July/August.
PharmGKB and CPIC view these as significant advances because of the large number of US Medicare patients impacted. Further, the LCDs state PGx testing as reasonable and necessary when medications have a clinically actionable gene(s)-drug interaction as defined by CPIC guidelines (category A and B) or the FDA (PGx information required for safe drug administration). Coverage for panel testing was also supported if more than one gene on the panel is considered reasonable and necessary for the safe use of a medication or if multiple drugs are being considered that have different relevant gene associations.
The authors’ analysis lists >50 gene/drug pairs that are covered by the LCD and provides a map (below) of MAC regions impacted. They make a strong argument that harmonization of coverage is needed and that standardization, improved clarity in the regulatory landscape, practitioner education, and research to measure downstream clinical outcomes are needed more than ever to fully capture the value of pharmacogenomic testing.
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