The U.S. House passed H.R. 1868 late April 13, extending the pandemic-related moratorium on the automatic 2% Medicare sequester through the end of the year. The previous moratorium expired March 31. The bill, which needs the president’s signature to become law, doesn’t address the potential of a 4% sequester that could be triggered next year by the federal spending in the $1.9 trillion stimulus package passed last month. The 2% Medicare sequester has been in place since 2012 to offset other government spending. As part of the CARES Act, the first COVID-19 stimulus package that was passed last May, Congress put the sequester on hold until Jan. 1 because of the pandemic and then extended it for three more months. The second stimulus package failed to include the moratorium, so the stand-alone bill was needed.
FDA provides guidance on remote evaluations
The U.S. FDA released guidance April 14 describing the various interactive and virtual tools the agency is using to conduct remote evaluations, during the COVID-19 pandemic, of biopharma manufacturing plants and facilities covered under its bioresearch monitoring program. Those tools include record requests in advance of, or in lieu of, a drug facility inspection; information from trusted regulatory partners; and remote interactive evaluations, such as live-streaming video of operations, teleconferences and screen sharing. The FDA said it will consider remote interactive evaluations for pre-approval and pre-license, post-approval, surveillance, for-cause and bioresearch monitoring inspections, “recognizing that there will be instances where only an inspection will be appropriate.” The FDA will make decisions to offer a remote evaluation based on a facility’s risk and compliance history. While facilities can decline the FDA's request for a remote evaluation, that decision may delay the agency's ability to make a regulatory decision.