Laboratory Question for the Week of August 8, 2016

Laboratory Compliance Question of the Week

Question:

I have heard that CMS created an advanced lab test for the new payment system. Can you provide a definition of this?

Answer:

As required by law, the Centers for Medicare & Medicaid Services (CMS) created new advanced diagnostic laboratory tests (ADLTs), which are tests covered under Medicare Part B. They are offered and furnished only by a single laboratory—that is, they are not sold for use by a lab other than the original developing laboratory (or a successor owner). These tests, which must be cleared or approved by the U.S. Food & Drug Administration (FDA), also must:

• Be an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result.
• Produce a result that predicts the probability that a specific individual patient will develop a certain condition or respond to a particular therapy
• Provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.

Disclaimer: Every reasonable effort was made to ensure the accuracy of this information at the time it was published. However, due to the nature of industry changes over time we cannot guarantee its validity after the year it was published.