On September 25, 2025, the Department of Justice announced a new office within the Civil Division—the Enforcement & Affirmative Litigation Branch—“dedicated to safeguarding public health and safety through proactive enforcement and high-impact affirmative litigation.” The creation of this new office restructures and consolidates affirmative litigation into a specialized branch to “hold powerful actors accountable, protect public health and safety, and enforce critical national policies.”
On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...
Blog Editors
Recent Updates
- Brand Licensing in Health Care: An Overview for Hospitals
- FDA Proposal Would Extend Food Traceability Rule’s Compliance Deadline to July 2028
- NYDFS Cybersecurity Crackdown: New Requirements Now in Force, and "Covered Entities" Include HMOs, CCRCs—Are You Compliant?
- The Case for Regular Legal Maintenance: A Litigation Readiness Mindset for Modern Health Care Organizations
- The Rising Threats of Multi-Modal and Agentic AI in Cyber Attacks