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 ...
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Recent Updates
- DOJ’s Second National Health Care Fraud Takedown of the Second Trump Administration Heavily Targets Medicaid Fraud
- FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements
- OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing
- IL HB 5000 Set to Expand Notice Requirements for Health Care Transactions in Illinois
- Will FDA Withdraw Its Wound Care Device Rule? Stakeholders Sure Hope So…