Insights on Enforcement Resolutions, Health Care Fraud, CMS Regulatory Updates and More
TL/DR –
The DOJ announced the results of its 2025 National Health Care Fraud Takedown, which resulted in criminal charges against 324 defendants for fraudulent claims to Medicare and other healthcare benefit programs. The HHS and DOJ have established the False Claims Act Working Group to take a more active role in evaluating and potentially intervening in qui tam actions under the FCA. Finally, the medical device company Janssen Products LP challenged the constitutionality of the FCA’s qui tam provisions after receiving a monetary judgment for submitting false claims, marking a rare move in the healthcare industry.
Notable Enforcement Resolutions and Activities
On June 30, 2025, the Department of Justice (DOJ) revealed the results of its 2025 National Health Care Fraud Takedown. The operation, conducted in partnership with 12 state attorneys general, led to criminal charges against 324 defendants across 50 federal districts.
The DOJ and the Department of Health and Human Services (HHS) also announced the formation of the False Claims Act Working Group on July 2, 2025. This initiative aims to intensify the government’s scrutiny of qui tam actions under the False Claims Act.
CMS Regulatory Updates
The Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the CY 2026 Physician Fee Schedule. Among the key proposals are changes to physician rate setting, a new mandatory payment model for heart failure and lower back pain, and telehealth updates.
CMS also proposed updates for remote monitoring services and sought comments on how to price software as a service (SaaS) under the PFS. Meanwhile, the CY 2026 OPPS and ASC Payment System proposed rule, which aims to update payment rates and regulations for outpatients and ASCs, was released by CMS.
OIG Updates
The Office of Inspector General (OIG) issued a favorable advisory opinion regarding a pharmaceutical manufacturer’s proposal to provide assistance for certain travel, lodging, and associated expenses for qualifying patients. However, the OIG gave a negative advisory opinion for a medical device company’s proposal to pay to access an electronic billing system operated by a third-party vendor.
Other Notable Developments
The California attorney general proposed a $1.55 million settlement with Healthline Media LLC for alleged violations of the California Consumer Privacy Act (CCPA). The case centers on the use of cookies disclosing sensitive health information.
CMS expanded its site-neutral payment policy for drug administration services in the CY 2026 OPPS proposed rule. CMS proposed reducing hospital payments for drug administration services furnished at all off-campus hospital outpatient departments.
On July 4, 2025, the One Big Beautiful Bill Act (H.R. 1) was signed by the president, permanently reinstating the telehealth safe harbor for high-deductible health plans (HDHPs) starting in 2025.
The White House released “Winning the Race: America’s AI Action Plan” on July 23, 2025. The document sets out nonbinding policy goals for federal regulation and support of artificial intelligence (AI).
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