Compliance, Investigations & White Collar
August 8, 2025 | Geoffrey R. Kaiser | |
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
Read MoreJuly 2, 2025 | Steven Shapiro |
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.
Read MoreMay 23, 2025 | Geoffrey R. Kaiser | |
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.
Read MoreMarch 25, 2025 | John F. Queenan | Mary Aperance | Jeffrey Ehrhardt | |
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
Read MoreNovember 19, 2024 | Stella Lellos | Lindsay M. Brocki | |
WHAT: A filing with FinCEN disclosing information about certain entities and owners.
WHO: Nonexempt entities formed or registered to do business by filing a document with the state and the beneficial owners of such entities.
WHEN: Companies formed prior to January 1, 2024, must file by January 1, 2025.
WHERE: FinCEN’s Beneficial Owner e-filing system here.
Read MoreOctober 29, 2024 | Jeffrey Ehrhardt | |
On October 9, 2024, the United States Attorney’s office in the Eastern District of New York unsealed an indictment alleging that eight defendants defrauded Medicaid of approximately $68 million.[1] The alleged scheme involved two adult day care programs and a home care financial intermediary, all owned and controlled by the same individuals, as well as
Read MoreAugust 20, 2024 | Marc S. Ullman |
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
Read MoreJuly 30, 2024 | Jeffrey P. Rust | | |
On April 23, 2024, the Federal Trade Commission finalized its rule enforcing a noncompete ban for a vast majority of workers. The noncompete ban is set to take effect on September 4, 2024. With limited exceptions, the rule invalidates existing noncompete clauses and bans new noncompete clauses.
On the same day, Ryan, LLC filed suit
Read MoreJuly 9, 2024 | Benjamin P. Malerba | Jeffrey Ehrhardt | |
On June 24, 2024, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a final rule that establishes disincentives for certain health care providers that have committed information blocking, or any activity that is likely to hamper access, exchange, or use of electronic protected health information (PHI). This rule applies
Read MoreJuly 1, 2024 | Steven Shapiro |
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
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