Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more
On Friday, November 3, 2023, the U.S. District Court for the District of South Carolina issued a long-awaited decision in Genesis Health Care, Inc. v. Becerra—a case dating back to 2017 contesting HRSA’s definition of...more
The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more