Sens. Lamar Alexander (R-Tenn.) and Roy Blunt (R-Mo.) penned an April 8 letter to Alex Azar, Secretary of Health and Human Services, urging Azar to make explicit that antibody tests for the SARS-CoV-2 virus will be conducted free of charge to American citizens. The senators noted that two pieces of legislation, including the so-called CARES Act, made provisions for no-cost testing for both current and future diagnostics, adding that it was “the express intent of Congress” that future testing to determine immunity from the virus is covered, “at least for the short term.”
Three Senate Democrats urged officials with the Department of Health and Human Services to provide “additional regulatory flexibility to hospitals and private laboratories” to allow those labs to scale up testing for the COVID-19 pandemic. Sens. Ed Markey (Mass.), Richard Durbin (Ill.) and Tammy Duckworth (Ill.) said the Centers for Medicare and Medicaid Services could also provide additional guidance regarding tests for home use, adding that CLIA-certified labs may not be fully aware of whether a test authorized under the FDA’s emergency use authorization can be treated as a waived test. CMS might further consider loosening its restrictions on the training of personnel who would conduct clinical lab testing.
The European Union’s medical device coordination group said in an April 6 advisory that clinical evaluation of medical devices may not be needed to comply with the Medical Device Regulations (MDRs) under several circumstances. In some instances, this includes devices that are the subject of a CE mark renewal, and when modifications to an existing CE-marked device to not adversely affect the benefit-risk ratio of the device. Notified bodies will have to verify that the modifications do not detract from that benefit-risk ratio.