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.