The test is defined by its approval route and its method
What the document says“``(A) is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act;”
Section 6221 adds a new subsection (nnn) to section 1861 of the Social Security Act. The term means a test for the concurrent detection of multiple cancer types across multiple organ sites, furnished on or after January 1, 2029, that has passed one of three named routes under the Federal Food, Drug, and Cosmetic Act, is a genomic sequencing blood test analyzing cell-free nucleic acids or a comparable test on other biological material as the Secretary determines, and that the Secretary finds reasonable and necessary and appropriate for people in part A or part B.
What the document actually says“``(A) is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act;”
The test must have passed one of three checks by the drug and device agency. Each check is named by its part of the law.
The test looks for many kinds of cancer at once. It works from a blood sample. Coverage starts January 1, 2029.
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