K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more
On February 23, 2024, CMS published a final rule updating the regulatory requirements of the Medicaid disproportionate share hospital (DSH) program in response to the Consolidated Appropriations Act (CAA) of 2021. The final...more
On January 28th, President Biden issued an “Executive Order on Strengthening Medicaid and the Affordable Care Act.” The E.O. states that the Biden Administration will promote policies that “protect and strengthen Medicaid and...more
The Centers for Medicare and Medicaid Services (CMS) just released its 2021 Final Rule (Physician Fee Schedule), with telehealth policy changes and a list of new services covered under Medicare. Actions taken by CMS during...more
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
On June 23, the U.S. District Court for the District of Columbia dismissed a challenge to a federal rule requiring hospitals to disclose prices they privately negotiated with insurers....more
On September 17, 2019, the US District Court for the District of Columbia ruled in American Hospital Association, et al. v. Alex Azar, II, et al that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory...more
This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would...more
On December 27, 2018, the U.S. District Court for the District of Columbia issued a permanent injunction to the Department of Health and Human Services (HHS) to stop a major reduction in Medicare reimbursement to hospitals...more
On Saturday, December 31, 2016, a federal judge in Texas entered a nationwide preliminary injunction barring the enforcement of antidiscrimination protections pertaining to transgender and abortion health services and...more