K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On July 24, 2025, the Trump Administration turned to the U.S. Supreme Court to block U.S. District Judge Young’s preliminary injunction prohibiting the National Institutes of Health (NIH) from cutting hundreds of grant...more
On February 24, 2020, the Ninth Circuit, sitting en banc, upheld the Trump administration’s regulation that prohibits grantees under Title X of the Public Health Service Act from referring patients for, or otherwise...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
Timely Topics - By Shannon B. Hartsfield - The U.S. Department of Health and Human Services (HHS) announced on Jan. 18, 2018, the creation of a new division within its Office for Civil Rights (OCR). OCR is described as...more
On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more