K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On May 5, 2023, the World Health Organization declared an end to the global health emergency caused by the SARS-CoV-2 virus, known as COVID-19. While the emergency has, in many ways, waned, the virus and the need for COVID-19...more
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
With multiple states rolling out phased access to COVID-19 vaccines, many employers are considering whether they want to require employees to be vaccinated, how to encourage employee vaccinations, and the implications of...more
In Washington: The House passed a one-week funding extension (HR 8900) to give lawmakers more time to finalize a fiscal 2021 spending package and coronavirus relief. The vote was 343-67. The measure (HR 8900) now goes to...more
In Washington: The Center for Disease Control and Prevention (CDC) is finalizing new guidelines to shorten its recommended coronavirus quarantine period from 14 days to between 7 and 10 days. The agency hopes more people...more
In Washington: President Donald Trump and first lady Melania Trump have tested positive for the coronavirus, the White House physician announced late Thursday. The President tweeted at 12:54 a.m. Friday: “Tonight, @FLOTUS...more
In Washington - President Trump announced a plan Monday to deploy 150 million rapid tests to states and vulnerable communities. This comes one month after the administration initially announced the purchase. During a Rose...more
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
Why It Matters - This decision casts doubt on the ability of nursing homes to rely on the PREP Act to shield them from liability against state-law claims or, at the very least, to remove such claims to federal court....more
In Washington - The divide between Democrats and Republicans continues as talks today have still resulted in no deal on a new coronavirus stimulus package. House Speaker Nancy Pelosi (D-CA), Senate Minority Leader Chuck...more
[co-author: Daniel Weinstein] In response to widespread cash flow issues resulting from the COVID-19 public health emergency, Congress enacted two key pieces of legislation: the CARES Act and the Paycheck Protection...more
Hospitals will have a limited waiver of HIPAA sanctions and penalties during the COVID-19 outbreak as a result of a bulletin issued on March 16, 2020 by the U.S. Department of Health and Human Services....more
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more