Statement attributable to:
Carmen L. Wiley, PhD
President, American Association for Clinical Chemistry
“AACC greatly values the work that the U.S. House of Representatives has done to support American families in the midst of the coronavirus outbreak and is supportive of the goals of H.R. 6201, the Families First Coronavirus Response Act. However, we are concerned that the language as currently drafted does not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA). We ask Congress to correct this oversight, which seems counter to the FDA guidance that permits CMS-certified clinical laboratories to begin testing patients prior to submitting an EUA request. AACC is concerned that this provision may result in some patients getting billed for a COVID-19 test -- which we believe to be antithetical to the intent of the legislation and which may deter laboratories from performing the tests. AACC thanks Congress for the work that it is doing to control the outbreak and looks forward to working with legislators to correct this oversight and ensure that all Americans have insurance coverage for COVID-19 testing.”
Since the beginning of the COVID-19 outbreak, AACC has been providing laboratory professionals with the latest guidelines from CDC and FDA to help them to create and validate accurate, reliable tests for COVID-19. AACC additionally developed a COVID-19 online resource center and continues to publish research on innovative tests for this virus in its journals.
AACC also created a free YouTube tutorial on COVID-19 as well as a free Learning Lab mini-course that highlights origins of the disease, how it is transmitted, and its symptoms, diagnosis, and prevention.
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.