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During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the  Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.…

Continue Reading The Legal Battle Over Mifepristone

Health-law-columns

As explained in greater detail by our colleague Stuart M. Gerson, the Supreme Court of the United States handed down two major, and quickly decided, rulings on January 13, 2022. After hearing oral arguments only six days earlier, the Court issued two unsigned decisions per curiam. A 5-4 decision in Biden v. Missouri dissolved a preliminary injunction against enforcement of an interim final rule (“Rule”) promulgated by the Centers for Medicare & Medicaid Services (CMS), requiring recipients of federal Medicare and Medicaid funding to ensure that their employees are vaccinated against COVID-19.
Continue Reading Supreme Court Blocks OSHA Vax-or-Test ETS for Large Employers, Allows CMS Health Care Vax Rule

Health-law-columns

On the evening of Wednesday, December 22, 2021, the Supreme Court of the United States announced that it will hold a special session on January 7, 2022, to hear oral argument in cases concerning whether two Biden administration vaccine mandates should be stayed. One is an interim final rule promulgated by the Centers for Medicare and Medicaid Services (“CMS”); the other is an Emergency Temporary Standard (“ETS”) issued by the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”). The CMS interim final rule, presently stayed in 24 states, would require COVID-19 vaccination for staff employed at Medicare and Medicaid certified providers and suppliers. The OSHA ETS, which requires businesses with 100 or more employees to ensure that workers are vaccinated against the coronavirus or otherwise to undergo weekly COVID-19 testing, was allowed to take effect when a divided panel of the United States Court of Appeals for the Sixth Circuit, to which the consolidated challenges had been assigned by the Judicial Panel on Multidistrict Litigation issued a ruling, on December 17, 2021, lifting a stay that had been previously entered by the Fifth Circuit. Multiple private sector litigants and states immediately challenged the decision.
Continue Reading Rare Hearing by the Supreme Court as to Stays in Vaccine Mandate Cases

This Employment Law This Week® Monthly Rundown discusses the most important developments for employers in August 2019.

This episode includes:

  • Increased Employee Protections for Cannabis Users
  • First Opinion Letters Released Under New Wage and Hour Leadership
  • New Jersey and Illinois Enact Salary History Inquiry Bans
  • Deadline for New York State Anti-Harassment Training Approaches
  • Tip

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On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following:…

aca and microscope

Since the inauguration of President Trump, the Affordable Care Act (ACA) has taken quite a few significant jabs and blows. When Congress failed to repeal the ACA, Congress instead eliminated the individual mandate penalty through the GOP tax bill. The individual mandate penalty was one of the main pillars of the ACA because it effectively…

Executive Order Delay Trumps Administration Policy Development

President Trump’s first hundred days did not produce the event that most people in the cybersecurity community expected – a Presidential Executive Order supplanting or supplementing the Obama administration’s cyber policy – but that doesn’t mean that this period has been uneventful, particularly for those in the health…

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If enacted, both would create significant new obligations for agencies such as CMS and the FDA, expand the scope of judicial review of rules, and would increase the potential for political influence over the…

Stuart Gerson
Stuart Gerson

Today, the U.S. Supreme Court decided (6-2, with Kennedy writing for the majority and  Ginsburg and Sotomayor dissenting) the case of Gobeille v. Liberty Mutual Insurance Co.  The matter before the Court involved Vermont law requiring certain entities, including health insurers, to report payments relating to health care claims …

Supreme CourtWith the untimely passing of Supreme Court Justice Antonin Scalia, perhaps the best known and most controversial Justice on the Court, commentators, including this one, have been called upon to assess his legacy – both immediate and long term – in various areas of the law.

Justice Scalia was not known primarily as an antitrust…