Source: Lab Advocate
Throughout 2022, AACC educated lawmakers about the harmful impact the Verifying Leading-edge IVCT Development (VALID) Act would have on the ability of laboratories to conduct timely innovative testing for their patient populations. If enacted, the legislation would have extended Food and Drug Administration (FDA) regulatory oversight over laboratory developed tests (LDTs) on top of the existing regulatory framework overseen by the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA).
VALID was a major priority for now-retired Senator Richard Burr (R-NC) and the legislation had significant momentum earlier in the year. Backers of the bill sought to include it in the then-pending FDA user-fee agreement which is negotiated every five years and considered “must-pass” legislation. When that effort was defeated, VALID’s supporters sought to include it in the year-end fiscal year 2023 spending package. AACC, and its members, along with the efforts of its partner organizations, succeeded in keeping the measure out of the final bill.
Supporters of VALID will need to reintroduce the bill in the new Congress. AACC will continue to meet with lawmakers and their staff to educate them about the harmful impact the bill, in its current form, would have on patient access to care.