Insights on Pharmaceuticals & Medical Devices
141 total results. Page 1 of 6.
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 CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.
Health Care Practice Leader Douglas Grimm will co-lead a CLE webinar on the new 340B Administrative Dispute Resolution (ADR) Final Rule process for the American Health Law Association’s (AHLA) Education Center on November 7, 2024.
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies.
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules.
ArentFox Schiff is pleased to announce that 70 attorneys were recognized as leaders in their field and 23 practices spanning the firm’s litigation, regulatory, and transactional capabilities were ranked among the best in the country in the 2024 edition of Chambers USA: America’s Leading Lawyers for Business.
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR) process under a Final Rule published on April 19, by the US Department of Health and Human Services’ Health Resources and Services Administration (HRSA).
On April 25, the US Court of Appeals for the Third Circuit issued its precedential opinion in Mallinckrodt v. Sanofi-Aventis, Case No. 23-1111.
Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program.
As we predicted at the end of the 117th Congress, 2023 was a year of progress for advocates of Pharmacy Benefit Manager (PBM) reform.
Health Care Partner Stephanie Trunk will host a webinar titled “Medicaid AMP Cap Removal, Practical Implications & Solutions” on November 14, 2023.
Health Care Partner Stephanie Trunk will present at BuyandBill.com’s webinar on office-administered drug coding and reimbursement on Tuesday, August 8, 2023.
ArentFox Schiff is pleased to announce that 70 attorneys were recognized as leaders in their field and 24 practices spanning the firm’s litigation, regulatory, and transactional capabilities were ranked in the 2023 edition of Chambers USA.
Health Care Partner Stephanie Trunk will present at the Healthcare Distribution Alliance’s (HDA) 2023 Distribution Management Conference on March 13.
Health Care Partner Stephanie Trunk will teach a Lawline course titled “An Overview of Reimbursement and Coverage Basics for Medical Devices” on December 20.
The Centers for Medicare & Medicaid Services (CMS) has issued its annual final rules related to both the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for calendar year 2023 (the HOPPS Final Rule) and the Physician Fee Schedule Final Rule (the PFS Final Rule)
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on July 26, 2022.
The life sciences and pharmaceutical industry is investigating potential applications in the Metaverse to reduce costs, increase efficiency, and develop novel functionalities.
The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in the Federal Register on July 29, 2022.
Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions.
ArentFox Schiff Intellectual Property Partner Alex Spiegler will present at the International Bar Association (IBA) 8th Annual World Life Sciences Conference.
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the Requestor’s provision of free genetic testing and counseling.