The U.S. Department of Health and Human Services (HHS) has announced a new general policy on what factors the agency will take into...
Reed Smith LLP
On May 12, 2025, the Trump Administration released Executive Order 14297, entitled “Delivering Most-Favored-Nation Drug Pricing to...
In February 1971, at the tail end of Richard Nixon’s first term, his Secretary of Health, Education and Welfare, Elliot Richardson,...
The Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”)...
As Reed Smith has previously covered, an issue before the Supreme Court that could be decided this week could bring a seismic shift in...
On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as...
The Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (collectively, “the departments”)...
Building on prior requests for information and an increased focus on Medicare Advantage oversight, the Centers for Medicare and Medicaid...
On January 17, 2024, the Supreme Court of the United States heard oral argument in two cases—Relentless v. Dep’t of Commerce, and Loper...
Recent efforts by the federal government to develop a strategy for guiding (and regulating) the use of artificial intelligence (AI) have...
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.” This webinar comes...
The Drug Enforcement Administration (DEA) has published a new final rule regarding reporting of theft or significant loss of controlled...
Health care and health care-adjacent organizations are seeing a steep increase in risk arising from the frequently utilized third-party...
The three agencies that oversee the independent dispute resolution (IDR) process established by the No Surprises Act have notified...
For the second time in 12 months, a federal district court has set aside provisions of the No Surprises Act’s Independent Dispute...
Health care and life science companies operating globally should be aware of the increased regulatory scrutiny in the U.S., the UK and...