K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more
The COVID-19 pandemic brought multiple temporary changes for ERISA-governed group health and welfare plans. Certain coverage mandates apply for only the duration of the COVID-19 public health emergency (the Public Health...more
The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more
On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more
In a recent letter to state governors, Acting Secretary of Health and Human Services Norris Cochran signaled the US Department of Health and Human Services’ (HHS’s) commitment to “predictability and stability” in the ongoing...more
On January 7, 2021, Secretary Azar of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, until April 21, 2021. Without this extension, the declaration would have...more
On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more
On September 4, 2020, to prevent the further spread of COVID-19, the Centers for Disease Control and Prevention (“CDC”) issued an Order under Section 361 of the Public Health Service Act to temporarily halt residential...more
On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more
Extraordinary times call for extraordinary measures – this is the approach the Centers for Medicare and Medicaid Services (“CMS”) has taken with respect to the federal Physician Self-Referral Law (the “Stark Law”) by issuing...more