AMP commends US Congress on VALID Act decision

The VALID Act proposed dramatic oversight modifications that would have been disruptive to clinical testing laboratories and harmful to patients throughout the US.

“AMP members have worked tirelessly to lead advocacy efforts to inform policymakers on how to best modernise the current regulatory framework for laboratory testing services,” said Mary Steele Williams, Executive Director, Association for Molecular Pathology. “We are grateful for champions in Congress such as US Senator Rand Paul (Republican, Kentucky), who shared our concerns about the significant flaws in the VALID Act. We look forward to continuing to work with Congress and other stakeholders in 2023 to help ensure widespread patient access to high-quality, essential medical procedures.”

Senator Paul commented: “For decades we have allowed clinical labs in our nation’s academic medical centres the freedom to innovate under the Clinical Laboratory Improvement Amendments (CLIA). The VALID Act would have upended that system and replicated the testing nightmare of the early days of the COVID pandemic, putting all lab-developed tests under the FDA’s control. I have been fighting to stop the VALID Act for years, so I am pleased to say that despite a major push all year by powerful special interests, the VALID Act was kept out of the 2022 year-end legislation.”

AMP has also thanked Congress for including the following provisions and protections for clinical laboratory professionals in the Consolidated Appropriations Act:

• One-year delay to the implementation of the clinical-laboratory fee-schedule provisions within the Protecting Access to Medicare Act
• Two-year extension to existing telehealth waivers without any restrictions for laboratory test ordering
• Additional infectious disease reporting infrastructure and support for efforts that will enable early detection of emerging variants of concern from the PREVENT Pandemics Act.