This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare Advantage (MA) audits. We discuss several enforcement actions focusing on allegations under the Anti-Kickback Statute (AKS), the Stark Law, the False Claims Act (FCA), and other fraud and abuse laws, including allegations related to the submission of fraudulent claims to Medicare for reimbursement of over-the-counter COVID-19 test kits and billing federal healthcare programs for medically unnecessary services. This issue also discusses developments related to the One Big Beautiful Bill Act, the Make America Healthy Again Commission, and a jointly issued request for information on how to improve prescription drug price transparency.

Read below an overview of this month’s regulatory and enforcement activity roundup. For a deeper dive, subscribe to the newsletter to get our detailed analysis of all updates.

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Notable Enforcement Resolutions and Activities

A pharmaceutical company agreed to pay $50 million to settle a class action lawsuit accusing the company of scheming with another drug manufacturer to delay the release of a generic version of a narcolepsy drug, causing health plans to pay higher prices, in violation of US antitrust law.

A pharmaceutical company agreed to pay $3.6 million to...

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