By WK Editorial Staff
To assist stakeholders with the COVID-19 outbreak, Health Law Daily is compiling coverage and resources in this recurring tracker.
Emergency authorization revoked. The FDA has revoked the emergency use authorizations (EUA) for manufacturers with tests for COVID-19 antibodies. The revocations were made due to EUA criteria for issuance no longer being met and other circumstances, according to the FDA. The FDA said that the revocations were appropriate to protect public health or safety. The FDA concluded that it was not reasonable to believe that the product may be effective in detecting IgM antibodies to SARS-CoV-2 or that the known or potential risks outweigh the benefits. The second revocation issued by the FDA was to manufacturers and other stakeholders for certain in vitro diagnostic SARS-CoV-2 antibody tests and did not name specific manufacturers (see FDA revokes emergency use authorizations for manufacturers of COVID-19 antibody tests, October, 5, 2020).
Loan repayments. CMS amended terms for payments issued under the Accelerated and Advance Payment (AAP) Program as required by recent action by President Trump and Congress. The Medicare loan program allows CMS to make advance payments to providers and are typically used in emergency situations. Under the Continuing Appropriations Act 2021 and Other Extensions Act, repayment will now begin one year from the issuance date of each provider or supplier’s accelerated or advance payment. CMS issued $106 billion in payments to providers and suppliers in order to alleviate the financial burden healthcare providers faced while experiencing cash flow issues in the early stages of combating COVID-19.
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