After consideration of the comments received, and for the reasons previously discussed, we are finalizing our proposed market-based data collection requirement as proposed
In addition, manufacturers need to undergo regular audits by regulatory authorities to ensure that their production facilities and quality management systems comply with GMP requirements
Specifically, we proposed updating the regulations at 419.46(e)(1), 419.95(g)(1), and 416.310(d)(1) to state that CMS may grant an ECE with respect to reporting requirements in the event of an extraordinary circumstancedefined as an event beyond the control of a hospital, REH, or ASC (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing)that affected the ability of the hospital, REH, or ASC to comply with one or more applicable ( reporting requirements with respect to a calendar year
Coders must also avoid D64.9, which reflects anemia of chronic disease, not iron deficiency
Already using B12