AABB, America’s Blood Centers and the American Red Cross, which collectively represent the nation’s blood collection establishments, transfusion services, and transfusion medicine professionals, are submitting these comments on the interim final rule with comment period, CMS3401-IFC: Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments of 1988 (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency.
We are collectively concerned about CMS’ interpretation that the reporting requirements apply to blood centers’ antibody testing on donations from healthy individuals during the manufacture of convalescent plasma.