Advocacy - Lab Advocate
AACC’s efforts to prevent the passage of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would significantly alter the regulation of laboratory developed tests (LDTs), has been in high gear for months. Throughout the spring, AACC members have been meeting virtually with the offices of legislators on the Senate Health, Labor Education, Pensions (HELP) Committee, and the House Energy & Commerce Committee, the two panels with authority over the issue.
On June 14th, the Senate HELP committee voted to send the bill to the full Senate. During the session, Sen. Tommy Tuberville, R-Ala., proposed an amendment to the FDA user fee package that would have exempted academic medical centers (AMCs) from VALID, arguing that the LDT provisions would create “significant hurdles” for AMCs to provide patient care. The committee voted, at the request of the Chair, to table the amendment on a vote 12-10 vote.
It is anticipated that the Senate will enter negotiations with the House, in advance of a formal vote, to expedite final passage of the user fee package. The FDA has stated that if a final bill is not reached by August, when the current agreement expires, it may have to start laying off employees. AACC and others have suggested that removing VALID from the agreement would permit Congress to meet the August deadline and give legislators more time to address widespread concerns with VALID.
The outcome of this policy debate is likely to be determined within the next few weeks. Stay tuned for future updates.