CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The FDA could choose not to appeal the LDT ruling to […]
In the Past, Labs Used Courts to Thwart Feds
Back in 2008, clinical labs squared off with CMS and the agency eventually backed off
- By Robert Michel
- > From the Volume XXXII, No. 6 - April 21, 2025 Issue
- Tags: Centers for Medicare and Medicaid Services, CMS, FDA, Food and Drug Administration, Judge Sean Jordan, LabCorp, laboratory-developed test, ldt, Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project, Medicare Part B, PAMA, people, Protecting Access to Medicare Act, Quest Diagnostics
