In what will create a glimmer of hope for beleaguered Medicare Advantage Organizations (MAOs) who are facing looming waves of Risk Adjustment Data Validation (RADV) audits, on September 25, 2025, a Northern District (ND) of Texas District Court invalidated the Centers for Medicare & Medicaid Services’ (CMS) 2023 RADV Final Rule, finding that the agency violated the notice-and-comment requirements of the Administrative Procedure Act (APA). This ruling comes amidst a recently announced aggres...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
As EBG previously reported, on March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), announced that the U.S. Food and Drug Administration (the “FDA”) is exploring rulemaking to eliminate the pathway allowing entities to self-affirm that food ingredients are Generally Recognized as Safe (“GRAS”). Earlier this month, on September 4, 2025, the Trump administration’s Spring 2025 Unified Regulatory Agenda (“Agenda”) was pub...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
Many U.S. companies are responding to tariff pressures by rethinking supply lines. In a September 14, 2025, Wall Street Journal article, a major U.S. consumer goods manufacturer accused its competitors of dodging increased tariff costs by under-reporting the value of the goods imported into the United States. Such allegations are likely to incur scrutiny from the Department of Justice’s (DOJ’s) cross-agency Trade Fraud Task Force, which is aimed at investigating such allegations and prose...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On September 12, 2025, the United States Court of Appeals for the Fifth Circuit, in AbbVie v. Fitch, Case No. 24-60375, (5th Cir. 2025), affirmed a federal District Court’s denial of a preliminary injunction sought by the pharmaceutical manufacturer AbbVie.| www.healthlawadvisor.com
By the third quarter of 2025, the Department of Justice (DOJ) has made plain that it will continue using the False Claims Act (FCA) to advance administration priorities. While the focus on diversity, equity, and inclusion (DEI)—addressed in our August 8 post—continues to make headlines, DOJ is not taking its eye off cybersecurity. Two settlements announced in late July, totaling approximately $11.5 million, reinforce that noncompliance with cybersecurity obligations can trigger FCA exposure.| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
The DOJ has made clear that it will use “every available tool” to pursue both companies and individuals in connection with potential trade violations, meaning effective compliance programs and self-disclosure mechanisms will play a critical role in mitigating risk.| www.healthlawadvisor.com
California’s Assembly Bill 489 (“AB 489”) signals more than just a tweak to existing healthcare law—it’s a glimpse into how the next generation of regulation may shape the future of AI development and deployment in healthcare.| www.healthlawadvisor.com
On July 17, 2025, the U.S. Court of Appeals for the Fourth Circuit held that a federal district court was “within bounds to order a do-over” in the case of Ron Elfenbein, a Maryland doctor who was found guilty of COVID-19-related health care fraud in 2023 in connection with upcoding and false documentation. Elfenbein was acquitted by the district court four months after his trial. The Fourth Circuit affirmed a contingent order of the U.S. District Court for the District of Maryland granti...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 17, 2025, Oregon Governor Tina Kotek signed SB 537, which adds to Oregon’s growing set of workplace violence prevention laws relating to health care. The bill passed the state Senate with an 18-11 vote on June 23, and the House, 37-12, on June 26, during the final days of the legislative session. The new provisions add detailed requirements for health care work sites.| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
On July 29, 2025, Attorney General Pam Bondi issued a memorandum to all federal agencies providing guidance addressing “unlawful discrimination” on the basis of race, color, national origin, sex, religion, or other protected characteristics (the "July 29 Guidance"). According to the memorandum, the July 29 Guidance is intended to clarify “the application of federal antidiscrimination laws to programs or initiatives that may involve discriminatory practices, including those labeled [DEI]...| Health Law Advisor - Laws and Regulations Affecting Health Care and Life Scie...
Last month, Judge Matthew Kaszmaryk of the U.S. District Court, Northern District of Texas, in Purl v. United States Department of Health and Human Services, No. 2:24-cv-00228-Z (N.D. Tex Jun. 18, 2025) struck down nearly all of the 2024 Reproductive Health Amendment to the HIPAA Privacy Rule.| www.healthlawadvisor.com
Delivers cutting-edge commentary on important legal issues affecting health care and life sciences institutions.| www.healthlawadvisor.com
On June 16, 2023, Nevada enacted Senate Bill 370 (“SB 370”), which imposes broad restrictions on the collection, use, and sale of consumer health data. This law is set to go into effect on March 31, 2024.| www.healthlawadvisor.com
