Molecular Pathology Association Floats Risk-Based CLIA Modernization Plan

The Association for Molecular Pathology is circulating a proposal among the Senate health committee and the general public that puts the onus on CMS, with input from subject matter experts, to modernize the Clinical Laboratory Improvement Amendments by setting minimum clinical and analytical validation standards for laboratory developed tests. The plan would subject most of the tests to CMS oversight--except in situations where test makers prefer to keep information on complex, algorithm-based tests private, in which case FDA would step...