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The applicant and commenter asserted that the aprevo Cervical ACDF System does not conform to CMS guidance related to the category codes, and therefore, they believe that C1831 is specific to the original (lumbar-specific) aprevo and does not apply to the aprevo Cervical ACDF System

Thats why the FDAs own technical staff has recommended against expanded access, and the public health group Partnership for Safe Medicines calls them "popular, unproven, dangerous. As Peter Kolchinsky, managing partner of biotech investor RA Capital Management, puts it: Is the FDA going to stand on science or is it going to permit all kinds of snake oil to be readily available? The FDA meeting will last two days