Stakeholders Again Seek Consensus On LDTs As Congress Weighs Options

With the expected release of final FDA guidance on regulation of laboratory developed tests growing closer and the prospect of legislation dimming, stakeholders are making what some view as a last ditch attempt to reach consensus on where to draw the line between FDA and CMS oversight of LDTs. While the House continues trying to obtain stakeholder agreement on LDT legislation, and has asked for feedback on revisions to the previous draft bill by Feb. 5, the Senate appears to...