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- Bipartisan, Bicameral LDT Oversight Legislation Is Reintroduced in Congress
On June 24, Sens. Richard Burr (R-NC) and Michael Bennet (D-CO), and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) introduced the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, which would provide regulatory oversight of laboratory-developed tests if enacted into law. The CAP had engaged with the VALID Act’s sponsors and other stakeholders to suggest improvements to the bill over the last year. The CAP remains engaged, will review the latest version of the bill, and provide its feedback to the sponsors of the VALID Act.
“As the leader in laboratory quality and improvement programs, the CAP is committed to excellence in the practice of pathology and ensuring patient access to high-quality tests. The CAP appreciates the efforts of Sens. Burr and Bennet, and Reps. DeGette and Bucshon to solicit broad input from multiple stakeholders to produce the bipartisan, bicameral VALID Act,” said CAP President Patrick Godbey, MD, FCAP, following the reintroduction of the legislation. “This bill continues to move in the right direction and provides the most viable legislative pathway to reaching a consensus on the oversight of laboratory-developed tests. A legislative approach to oversight of LDTs must leverage existing processes to maintain safe and reliable testing for patients today without stifling innovation of future tests.”
The bill's legislative sponsors said VALID Act would establish a new, risk-based framework for the review and approval of LDTs that would accelerate innovation and improve the quality of testing. The legislation seeks to clarify the regulatory authority between the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), and limit duplication between the two agencies, the lawmakers said.
“In the operating room, time is a precious commodity – even the smallest delay can be the difference between life or death for a patient,” said Rep. Bucshon, who is a cardiothoracic surgeon. “Recent advancements in diagnostic testing technology have transformed the speed and accuracy in which doctors receive this life-changing information, giving patients and doctors what they need most: more time. The VALID Act makes sure that a safe, accurate, and risk-based framework is in place to allow leading edge development and innovation to thrive in our hospitals and laboratories, while assuring doctors and patients that their test results are analytically and clinically valid.”