Policy & Legislation
News on government policy and legislation impacting the life science and diagnostics markets.
AMP Petitions Congress to Revisit CLIA Update, Eyes Legal Action Against New Proposed FDA LDT Rule
While AMP asked members to register their opposition officially, one official said "there probably will be a lawsuit."
Laws passed in 14 states appear to require commercial payors to cover biomarker tests broadly that meet certain evidentiary criteria, but payors may have a different interpretation.
European Commission Orders Illumina to Divest Grail
Illumina will be able to choose the method of divestment, but may need to provide Grail with more than $1 billion in cash to fund operations for several years.
California Governor Signs Bill That Specifies PGx Testing is Covered Under Medi-Cal
AB 425 makes pharmacogenetic testing a covered benefit under the state healthcare coverage program for low-income residents starting July 1, 2024.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.