On April 19, 2022, a federal district court in Florida determined the federal mask mandate from the Biden Administration was unlawful and therefore void. The mandate required patrons to wear a mask on public transportation, like airplanes, trains, and buses.
Enforcement
Lundbeck v Sandoz – High Court decision
1. Introduction
The High Court has delivered the latest instalment in Lundbeck and Sandoz’s lengthy saga concerning escitalopram. The particular circumstances giving rise to this dispute are unique, however, the High Court’s approach to interpreting a patent licence granted by…
Australia – TGA updates the Therapeutic Goods Advertising Code
The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure…
US 5th Cir. grants a nationwide stay of OSHA’s vaccine-or-test mandate
On November 6, 2021, the Fifth Circuit Court of Appeals granted a nationwide stay of the Occupational Health and Safety Administration (OSHA)‘s Emergency Temporary Standard (ETS) vaccine-or-test mandate that was issued on November 5, 2021. The court granted the…
OSHA Updates Its COVID Interim Enforcement Response Plan
Based on an evaluation of current inspection and illness data, federal OSHA has revised its March 21, 2021 National Emphasis Program (NEP), adjusting the targeted industries to those most at risk for COVID-19 exposure. The revised NEP still…
ACA Survives “[T]hird Installment in [U.S. Supreme Court’s] epic Affordable Care Act [T]rilogy”
On Thursday, June 17, 2021, in a 7-2 opinion, the U.S. Supreme Court upheld the Affordable Care Act (“ACA”) in the case California v. Texas. The Court held that Texas, the other plaintiff states, and the two individual…
Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules
In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on…
CMS Withdraws Proposed Medicaid Fiscal Accountability Rule
On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda.
The MFAR, which was proposed in…
COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting
On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical…
COVID-19 Update: CMS Announces Resumption of Survey Activities
On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. …