CMS has published its application for new “U” codes for advanced diagnostic laboratory tests (ADLTs) and FDA-cleared or approved clinical diagnostic laboratory tests (CDLTs). These new “U” codes are intended to describe a single test. Reviews of submitted applications are to occur on a quarterly basis.

Stakeholders continue to have questions and concerns about the purpose of the “U” codes and the potential burden if required to create a new code for every FDA-approved or cleared test from manufacturers.

Application for Level II HCPCS Code for ADLTs and FDA Cleared Approved Tests under the Medicare CLFS