The 2025 National Health Care Fraud Takedown, announced in June, was the largest in history, with 325 defendants charged (including 96 providers) in 50 federal districts. In all, the charged schemes involved more than $14 billion in intended loss, and more than $245 million in cash, luxury vehicles, cryptocurrency and other assets were seized. These

OMIG publishes audit protocols to “assist the Medicaid provider community in developing programs to evaluate compliance with Medicaid requirements under federal and state statutory and regulatory law.”[1]  Such protocols are “applied to a specific provider type or category of service in the course of an audit and involve OMIG’s application of articulated Medicaid agency policy

New York’s Consumer Directed Personal Assistance Program (CDPAP) has long been the subject of enforcement at the New York State Attorney General’s Office (AG).  Many of those enforcement actions involve caregivers who billed Medicaid for CDPAP services never provided but sometimes also implicate agencies that are responsible for processing caregiver payments and protecting against fraud.

The federal government has demonstrated that it is more than willing to use the United States criminal code to prosecute home care agencies that pay unlawful financial inducements to generate referrals in violation of the Anti-Kickback Statute (AKS).

In a superseding indictment unsealed in March 2025, the United States Attorney’s Office for the Eastern District

The U.S. Food and Drug Administration (FDA) announced the availability of the Final Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug and Cosmetic Act (Edition 5). This final guidance is replacing all previously issued draft and final guidances by FDA concerning allergen labeling.

Jeff Kaiser’s article, “COVID-19 Pandemic Fraud Enforcement Efforts Overview,” was published on the Lexis Nexis legal research tool, Practical Guidance.

In the article, Jeff offers a comprehensive overview of enforcement efforts related to COVID-19 pandemic fraud.

John Queenan, Mary Aperance and Jeff Ehrhardt wrote, “Quality of Care Considerations in OIG’s nursing Facility Compliance Guidance,” for the spring 2025 issue of USLAW Magazine.

The article details the Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (ICPG) and how the guidance may be used as a basis for investigations and enforcement actions.

To read

Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex processes involved in making a dietary supplement can occur because human beings are not perfect. These events can range from

Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale?

If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and Drug Administration (FDA) expanded authority to regulate dietary supplements?

“Gas station heroin” is a

Marc Ullman recently authored “The Problem Isn’t DSHEA — It’s FDA Siloing” in Natural Products Insider.

In the article, Marc explains the dangers of the silo effect and how it limits interactions between members of different branches of the FDA. This results in reduced productivity and the issuing of only single-center warning letters on noncompliant