Insights on Health Care
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The Medicaid Drug Rebate Program (MDRP) Summit 2025 will be held in Chicago, IL, from September 15-17, 2025. This hybrid event is hosted by Informa Connect and will feature topics such as 340B, drug pricing policy, and the Inflation Reduction Act (IRA), designed to aid attendees in mastering complex regulatory guidelines.
Headlines that Matter for Companies and Executives in Regulated Industries
A North Carolina federal court’s recent order granting remand in the case Nash Hospitals, Inc. v. UnitedHealthcare of North Carolina, Inc., et al., No. 5:25-CV-28-FL underscores the limits of federal question jurisdiction in disputes arising from health care provider-payer agreements, particularly where the claims are grounded in state law and do not necessarily require resolution of a substantial federal issue.
ArentFox Schiff is pleased to announce that 132 attorneys have been recognized by The Best Lawyers in America 2026, with two attorneys highlighted as “Lawyers of the Year” and 66 attorneys listed as “Ones to Watch.”
On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs).
Headlines that Matter for Companies and Executives in Regulated Industries
Health Care Industry Group Co-Leader Annie Chang Lee was quoted on how hospitals and health care workers are vulnerable to potential raids by US Immigration and Customs Enforcement (ICE) following changes to federal policy regarding enforcement in sensitive locations.
Headlines that Matter for Companies and Executives in Regulated Industries
Food, Drug, Medical Device & Cosmetic Counsel Abha Kundi will deliver the opening presentation of the Healthcare Distribution Alliance’s (HDA) 2025 Traceability Seminar on August 5, 2025.
Headlines that Matter for Companies and Executives in Regulated Industries
On July 31, 2025, ArentFox Schiff hosted the HGPII Annual Best Practices Forum, one of the group purchasing sector’s premier training and leadership development conferences.
Immigration enforcement actions are no longer a theoretical concern for health care facilities — they are happening now.
Partner Emily Cowley Leongini was quoted on Sarepta Therapeutics’ decision to pause sales of its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) following a request from the US Food and Drug Administration (FDA).
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These rules are the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule.
Headlines that Matter for Companies and Executives in Regulated Industries
As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.
The government has announced a renewed and expanded focus on False Claims Act enforcement, doubling down on traditional healthcare priorities like kickbacks and drug pricing while signaling increased scrutiny of electronic health records manipulation, a shift that could expose data vendors and other nontraditional healthcare entities to scrutiny from the US Department of Justice and the US Department of Health and Human Services.
On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device company would pay licensing fees to a third-party vendor for access to an electronic billing portal used by some of the medical device company’s provider customers.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of Electronic Health Records (EHR) manipulation.
On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”
ArentFox Schiff is pleased to announce that 21 practices and 84 attorneys have been recognized by The Legal 500 United States 2025 guide, including three Tier 1 rankings for (1) Chicago Elite – Corporate and M&A Leading Law Firms, (2) Intellectual Property – Patents: Prosecution (Including Re–Examination and Post–Grant Proceedings), and (3) Finance – Restructuring (Including Bankruptcy): Municipal.
The District of Columbia is set to implement sweeping changes to its DC Health Care Alliance, a program that has provided vital health coverage to low-income residents who do not qualify for Medicaid or Medicare, including many non-citizens, since its inception in 2001.
District of Columbia Mayor Muriel Bowser’s FY 2026 Budget introduces a new Basic Health Program (BHP) that will fundamentally reshape health coverage options for thousands of District residents beginning next calendar year.