Insights on Pharmaceuticals & Medical Devices

Last month, a federal court in Maine halted the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program in its tracks — a mere four days before it was to go into effect.

For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.

Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care.

On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System (HOPPS).

After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the submission of reasonable assumptions related to their average sales price (ASP) calculations. CMS also mandates that manufacturers submit Bona Fide Service Fee (BFSF) certification or warranty letters for new or renewal contracts dated January 1, 2026, or later that contain BFSFs with quarterly ASP.

On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026.

The US Food and Drug Administration (FDA) regulates the products hospitals and health systems use, make, or study. As health system innovations increasingly leap quickly across service lines, regulatory obligations can shift in real time.

Last week’s jury convictions of Safe Chain Solutions’ co-owners in United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.) coupled with US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enforcement make one conclusion unavoidable: The DSCSA is both a regulatory mandate and a criminal risk boundary.

Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, to unpack the recent acceleration of mergers and acquisitions across the life sciences sector.

Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.

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 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.

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 69 attorneys were recognized as leaders in their field and 23 practices spanning the firm’s litigation, regulatory, and transactional capabilities were ranked in the 2025 edition of Chambers USA: America’s Leading Lawyers for Business.

Health Care Partner Stephanie Trunk will participate in the External Counsel Fireside Chat at Informa Connect’s Pricing & Contracting USA 2025 conference in Philadelphia, Pennsylvania, on May 21.

There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota.

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, as they explore the major shifts occurring in the pharmaceutical industry under the Trump Administration.

ArentFox Schiff professionals will discuss recent matters that directly impact the life sciences industry and its trajectory.

With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.