A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure adherence to federal regulations governing medical necessity, lab requisition practices, and the Anti-Kickback Statute (AKS).
On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of enforcement of the September 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule. In the letter, ERIC urged the Departments to exercise their authority under 5 U.S.C. § 705 to postpone the effective date of the Final Rule while litigation challenging its validity is ongoing. This request marks a significant development in the legal landscape surrounding mental health parity laws and could have far-reaching implications for employers, health plans, and other stakeholders in the health insurance industry.
On January 17, 2025, the ERISA Industry Committee (ERIC) filed a lawsuit in the U.S. District Court for the District of Columbia, claiming that the 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule oversteps legal bounds, breaches the Administrative Procedure Act (APA), improperly delegates the Departments of Labor, Health and Human Services and Treasury’s (Departments) executive power to private entities, and violates the Due Process Clause. ERIC argues that under the Mental Health Parity Act of 1996, the plan was not obligated to assess any disparate impact that a term, applicable to both medical/surgical (M/S) and mental health and substance use disorder (MH/SUD) benefits, might have had on access to MH/SUD benefits. The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) similarly maintained the disparate treatment standard of liability, rather than the disparate impact standard. Moreover, the Departments acknowledged in the 2013 regulations that “disparate results alone” did not constitute a parity violation.
On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), issued proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule (the Proposed Rule) to strengthen the cybersecurity protections that HIPAA-regulated entities are required to maintain for electronic protected health information (ePHI).
On January 8, 2025, a federal grand jury in Virginia returned an indictment against a hospital. This rare criminal event in healthcare alleges that Chesapeake Regional Medical Center conspired to defraud the United States and committed healthcare fraud. Hospitals are almost never criminally charged, as federal investigations into hospitals are nearly always civil proceedings under the False Claims Act. This post explains how this hospital’s alleged actions rose to the level that merited criminal indictment.
On November 15, 2024, the California Board of Pharmacy issued a public notice of its intent to modify Cal. Code Regs. tit. 16 § 1708.2, which governs the discontinuation of pharmacy businesses in California. The regulation currently states:
“Any permit holder shall contact the board prior to transferring or selling any dangerous drugs, devices or
Keypoint: With the increased frequency and severity of cyberattacks against healthcare systems, state and federal agencies strive to improve cybersecurity controls with varied success.
In November 2023, New York Governor Kathy Hochul announced proposed regulations that would be the first state regulations for hospitals in New York. The governor described the proposed regulation as a “nation-leading blueprint” that would complement the federal Health Insurance Portability and Accountability Act (HIPAA) Security Rule enforced by the U.S. Department of Health and Human Services (HHS).
On September 9, 2024, the U.S. Department of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued a Final Rule clarifying and adding additional requirements on health plans to provide equitable access to health insurance coverage for treatment of mental health and substance use disorders (SUDs), as required by the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and implementing regulations at 45 C.F.R. Part 146 and 147 (the 2024 Final Rule).
MHPAEA is a federal law that prevents group health plans and health insurance issuers (collectively, Health Plans) that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than it does for a medical condition or surgical procedure. This means that Health Plans cannot impose additional financial requirements or apply non-quantitative treatment limitations (NQTLs) to these benefits more stringently than those applied to medical/surgical benefits.
On August 26, 2024, the United States Attorney’s Office for the District of Montana filed a False Claims Act (FCA) complaint against a Montana oncologist, alleging that the oncologist’s busy schedule led to excessive claims that violated the FCA. The complaint is unusual in that its chief theory is the amount of time the oncologist spent with patients, relative to what the Justice Department claims is the standard practice of other oncologists. In that respect, the complaint is a warning sign to busy physicians across the country.
This blog post begins by explaining how this Montana oncologist found himself on the Justice Department’s radar—a self-disclosure by the health system that previously employed the oncologist—before discussing what the Justice Department is alleging against the oncologist, as well as what other physicians should learn from this lawsuit.
Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a sale, these discussions become more complex when practicing physicians are the business’s revenue generators. These conversations must be handled carefully to comply with the spirit and letter of healthcare’s strict fraud and abuse laws. To ensure these discussions are both productive and compliant, it’s essential to navigate these complex regulations effectively.