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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.
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.
Partner Kevin Matz will present on the recent federal tax law changes at an upcoming ACTEC ALI-CLE webinar.
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.
ArentFox Schiff is pleased to announce the firm has been recognized among “The BTI Client Service 30,” the top 30 law firms featured in BTI Consulting Group’s 2025 BTI Client Service A-Team report for delivering top-tier levels of client service.
Headlines that Matter for Companies and Executives in Regulated Industries
The US Patent and Trademark Office (USPTO) has announced that, effective September 1, all PTAB hearings will be conducted in person at USPTO offices, marking a departure from the virtual and hybrid formats adopted in recent years.
ArentFox Schiff is pleased to announce that the firm’s Private Clients, Trusts & Estates group and 11 partners have been recognized by the Chambers High Net Worth (HNW) 2025 guide, which ranks the top attorneys and law firms for excellence in private wealth law.
On July 18, President Trump signed the GENIUS Act into law, marking a significant development in the regulation of digital assets and stablecoins in the United States.
Last month, we provided an overview of the Patent Trial and Appeal Board’s (PTAB) application of the “settled expectations” doctrine, articulated in recent PTAB director-level decisions. Interim Director Coke Morgan Stewart has favored discretionary denial of inter partes review (IPR) petitions for older patents.
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.
Food, Drug, Medical Device & Cosmetic Partner Emily Cowley Leongini will give a presentation titled “Inspections: What to Do if the Government Shows Up at Your Door” at the American Conference Institute’s Food Law and Regulation Boot Camp on July 23.
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 15, the Office of the US Trade Representative (USTR) announced the initiation of a Section 301 investigation into Brazil’s trade practices to determine whether certain acts, policies, and practices of the Brazilian government are unreasonable or discriminatory and burden or restrict US commerce.
A typical tactic employed by retailers is to reduce the price of an item that has remained in a consumer’s shopping cart. This practice may now become illegal if those retailers fail to state, “THIS PRICE WAS SET BY AN ALGORITHM USING YOUR PERSONAL DATA.”
The US Supreme Court’s recent decision in CASA v. Trump, 606 US ___ (June 27, 2025), sharply limited the ability of individual plaintiffs to obtain nationwide injunctions.
Investigations Practice Group Leader D. Jacques Smith and Health Care Industry Co-Leader Nadia Patel were quoted on the recent increase in health care enforcement actions under the False Claims Act (FCA), as it remains a top priority for the US Department of Justice (DOJ).
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.
The US Patent and Trademark Office (USPTO) has announced the upcoming launch of an artificial intelligence (AI)-powered image-based prior-art search tool for design patents, scheduled to go live on October 1, 2025 (fiscal year 2026). Examiner training for the new tool is set to begin this month, with a public notice anticipated in the near future.
The qualified small business stock (QSBS) rules can be a powerful tax planning tool, and, following the recent enactment of a signature tax law, they have become even more potent.
The One Big Beautiful Bill Act introduces substantial changes to federal tax law, including select provisions affecting tax-exempt organizations and charitable contribution deductions for individual and corporate taxpayers.
On July 4, President Donald Trump signed into law P.L. 119-21, the “One Big Beautiful Bill Act” (OBBBA), enacting significant changes to the US tax system.
Headlines that Matter for Companies and Executives in Regulated Industries
In September 2024, the US Securities and Exchange Commission (SEC) adopted rule changes to its Electronic Data Gathering, Analysis, and Retrieval (EDGAR) file access and account management system (EDGAR Next), which went into effect on March 24. EDGAR Next is designed to improve the security and manageability of electronic filings.