Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS announced additional funding to support the 2021 Special Enrollment Period (SEP) for Marketplace health coverage. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On March 4, 2021, the Food and Drug Agency (FDA) issued guidance entitled,
COVID-19 Container Closure System and Component Changes. FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new