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- CAP Engages with Lawmakers on VALID Act as Compromise on Exemption for AMCs is Considered
The CAP has stayed engaged with members of Congress as they consider changes to the VALID Act. The Senate Health, Education, Labor, and Pensions (HELP) Committee released a modified draft of the legislation that included an exemption for laboratories operating at an academic medical center (AMC).
As communicated throughout 2022, the CAP supports moving forward with VALID as the best legislative alternative to regulating LDTs. With the Food and Drug Administration’s (FDA’s) intent to regulate laboratory-developed tests with or without legislation, the CAP has successfully advocated to add to the VALID Act guardrails around the FDA that lessen the burden on pathologists and laboratories. The CAP has worked to protect these guardrails as Congress considers final action on the bill.
The CAP does not support including an exemption in the bill for Academic Medical Centers because the CAP has consistently lobbied for an oversight framework that is based on risk of a test to the patient, not where the test is performed. However, the CAP has advocated to congressional leaders that if an exemption for AMCs is included in the final package, the exemption should be extended to other laboratories that could meet the criteria required to be granted an exemption. The CAP will continue to monitor developments on VALID and any potential exemptions for AMCs.
Read the CAP’s latest letter to Congress on the VALID Act.