The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 16, 2026. The DOJ announced a record level of recoveries from FCA resolutions in Fiscal Year (FY) 2025 (ending Sept. 30, 2025), which exceeded $6.8 billion. These statistics reflect the highest single-year dollar amount recovery on-record since the DOJ began reporting such statistics in 1987.
The Zafirov Appellate Argument — Panel Steers Parties to Address Whistleblower Control
Posted in Fraud & Abuse & False Claims ActThe much-anticipated appellate showdown regarding the constitutionality of the whistleblower (or qui tam) provision of the federal False Claims Act (FCA) took place before a three-judge panel of the Eleventh Circuit Court of Appeals (Judge Elizabeth L. Branch, Judge Robert J. Luck, and Senior District Court Judge Federico A. Moreno, sitting by designation). The panel heard oral argument on December 13, 2025, in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to hold that the FCA’s qui tam provision is unconstitutional. The key point for all who listened was control.
New Year, New AI Rules: Healthcare AI Laws Now in Effect
Posted in Government Affairs, Licensure & Regulatory, HIPAA, Privacy, and Data Security, TechnologyAs healthcare organizations ring in 2026, they will also be ringing in a new era of AI regulation. With Congress yet to pass comprehensive AI legislation and federal regulatory guidance in flux, states have stepped in to fill the void. The new year will see several new laws imposing disclosure, transparency, and data protection requirements on those developing, deploying, or using AI in healthcare settings. This post highlights the key laws healthcare organizations should have on their radar.
From Biologics to Bandages, Skin Substitutes Are No Longer the Biologics You Think They Are…
Posted in Fraud & Abuse & False Claims Act, Medicare & MedicaidHHS Announces Increased Efforts to Curb Information Blocking Practices
Posted in Digital Health, Electronic Health Records & Medical Records, Government Affairs, Licensure & Regulatory, HIPAA, Privacy, and Data SecurityIn a September 3 Press Release, the U.S. Department of Health and Human Services (HHS) announced that it is increasing efforts to curb information blocking. This was quickly followed by a September 4 Enforcement Alert issued jointly by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) and the HHS Office of Inspector General (OIG). Both developments come against the backdrop of CMS’s newly announced voluntary interoperability framework initiative, launched earlier this year, which seeks to accelerate open, standards-based health data exchange for a patient-centered digital health ecosystem. These developments signal HHS’s focus on empowering patients and healthcare providers with what HHS is calling “friction-free information.”
AHCA Proposes New Rule Requiring Providers to Implement Data Breach Continuity Plans
Posted in Government Affairs, Licensure & Regulatory, Health Care Providers, Healthcare Law, HIPAA, Privacy, and Data SecurityThe Florida Agency for Health Care Administration (AHCA or the Agency) recently issued a new proposed rule that would require all “providers” licensed by AHCA to have a “continuity plan” for data and information technology disruptions. The proposed rule would also mandate the reporting of certain information to AHCA upon the occurrence of an “information technology incident.”
FBI Warning: Criminals Posing as Health Insurers and Fraud Investigators Are Targeting Providers and Patients
Posted in Health Care Providers, Health Insurers & Managed Care OrganizationsThe FBI issued a warning on June 27, 2025, that criminals impersonating healthcare insurers and fraud investigators are sending text messages and emails to healthcare providers and patients to trick them into providing protected health information (PHI), medical records, personal financial information, or providing reimbursement for alleged overpayments under false pretenses. The FBI warns that these messages are disguised as authentic communications from known authorities. This fraudulent criminal practice is otherwise known as “phishing.”
Federal Court Vacates 2024 HIPAA Privacy Rule Modifications That Supported Reproductive Healthcare Privacy: What Regulated Entities Need to Know
Posted in HIPAA, Privacy, and Data SecurityOn June 18, 2025, the U.S. District Court for the Northern District of Texas issued an order in Purl v. United States Department of Health and Human Services, No. 2:24-CV-228-Z (N.D. Tex. 2025) (the June 18 Order) that vacated recent modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule intended to strengthen reproductive healthcare privacy. In light of this decision, Covered Entities and their Business Associates (Regulated Entities) should consider unwinding any measures they have taken to comply with those HIPAA Privacy Rule modifications. We dive into the details below.
New Florida Law Requires Licensed Health Care Facilities, Providers, and Practitioners to Promptly Refund Patient Overpayments
Posted in Health Care ProvidersDon’t sit on those patient credits. Effective January 1, 2026, a new Florida law (CS/CS/SB 1808) requires licensed health care facilities, providers, and practitioners (each, a “Licensed Provider”) to refund any overpayment made by a patient no later than 30 days after the Licensed Provider determines that the patient made an overpayment.
Florida Chooses to Exclude Health Care Practitioners from New Noncompete Law
Posted in Healthcare LawThe Florida Legislature recently passed a bill, called the CHOICE Act, that augments Florida’s laws governing restrictive covenants to make it significantly easier for employers to enforce two new types of noncompete agreements: (1) “covered garden leave agreements” and (2) “covered noncompete agreements.” However, these new types of agreements and the employer-friendly mechanisms available to enforce them will not apply to licensed health care practitioners.
