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- CAP Identifies Provisions it Supports and Wants Changed in Senate LDT Proposal
On May 17, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released the latest version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act as part of the next user fee authorization bill for the Food and Drug Administration (FDA). The latest version of VALID Act represented a positive step in the right direction on the oversight of laboratory-developed tests (LDTs) and captured several of the CAP’s long-held policy positions.
On May 26, CAP President Emily Volk, MD, FCAP provided CAP members with an update on the VALID Act. Read this message to members. The VALID Act would establish an oversight framework for laboratory-developed tests if enacted into law. Since 2009, the CAP has advocated that LDT legislation ensures quality laboratory testing for patients, allows for innovation in laboratory testing, and prevents undue administrative or regulatory burdens on laboratories.
After an initial review of the legislation, the CAP detailed in a letter to the HELP Committee the provisions it supports in the bill. The CAP will continue to engage with the members of Congress through the legislative process to advocate for patient protections, continued access to diagnostic testing, and reducing burdens on laboratories.
In a letter to the HELP Committee, the CAP outlined several aspects of the VALID Act bipartisan, bicameral legislation that the CAP supports while also identifying areas in the bill for improvement. On May 27, the HELP Committee introduced the bill after receiving comments. Additional information about this issue, including frequently asked questions, is available on the CAP’s website.