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
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.
On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations (MSOs).
Headlines that Matter for Companies and Executives in Regulated Industries
Congress enacted the No Surprises Act (NSA) to protect patients from unexpected medical bills. A central pillar of the NSA is its independent dispute resolution (IDR) process, under which payers and providers can submit disputed claims to binding arbitration.
As of mid-2025, private equity (PE) investors remain intensely interested in health care services and technology companies despite higher borrowing costs, heightened regulatory scrutiny, and an increasingly complex state review landscape.
Headlines that Matter for Companies and Executives in Regulated Industries
Welcome to the Summer 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
Join AFS Health Care Partner Annie Lee for an insightful Strafford Webinar on June 18, 2025, from 1:00pm-2:30pm EDT.
A recent decision from the US District Court for the Eastern District of New York has significant implications for providers navigating the No Surprises Act (NSA) independent dispute resolution (IDR) process.
Gayland Hethcoat was quoted on a federal judge’s order to remove the confidentiality designation from hundreds of hours of recordings of presentations and panel discussions that were produced in discovery by the World Professional Association for Transgender Health (WPATH), which is often cited by expert witnesses in cases regarding gender-affirming care.