Hogan Lovells – Global Life Sciences and Health Care

On March 12, 2025, the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation announced that it intends to end early four payment models to achieve $750 million in savings: the Primary Care First and Making Care Primary Models; the mandatory ESRD Treatment Choices Model; and the Maryland Total Cost of Care Model. CMMI also announced that it would not move forward with two previously-announced models, the Medicare $2 Drug List and the Accelerating Clinical Evidence Models. Read more here: https://lnkd.in/d-QiYT9p Authors: James Huang, Joseph Liss, and Caroline Farrington #Medicare #Medicade #PrimaryCareFirst

Join Partner Brian Carey on 26 March as he speaks at the Myriad Genetics webinar on the impact of the recent biomarker legislation. Find out more and register your interest here: https://lnkd.in/eqhE8Gf8 #BiomarkerLegislation #Medicaid

The European Commission has revised the Urban Wastewater Treatment Directive, which is instrumental in mitigating urban wastewater pollution across EU. This revision, prompted by emerging environmental challenges, particularly addresses micropollutants, marking a significant regulatory shift for industries such as pharmaceuticals and cosmetics. The updated Directive introduces Extended Producer Responsibility obligations for pharmaceutical and cosmetic companies, compelling them to cover the costs associated with micropollutant removal. Read more here: https://lnkd.in/eHGpXxy4 Authors: Fabien Roy and Anastasia Vernikou #Pharmaceutical #EULaw #EPR

Strategic innovators in rare disease research and treatment are planning ahead for new False Claims Act (FCA) scrutiny. In a Westlaw Today featured article, Eliza Andonova, Ron Wisor, Michael Dohmann, and Laura Hunter explain the factors at play – including FCA background, recent cases, government-sanctioned sponsored testing programs, and a look ahead for manufacturers. Read the full article here: https://lnkd.in/ehwy3xn2 Discover more FCA analysis in the False Claims Act Guide: 2024 and the road ahead: https://lnkd.in/gXuUHHJV #FCA #LifeSciences #HealthCare #RareDisease #ClinicalResearch?

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the manufacturing and distribution of medical devices, it supports state boards of pharmacy by creating model standards, credentialing programs, and regulatory resources that assist in the creation and enforcement of state licensing requirements. This article explores the NABP’s impact on licensing and compliance for prescription medical device manufacturers and distributors, highlighting its role in enforcing safety and quality standards. We also list strategies for working with the NABP and navigating state-based licensing requirements. Read more here: https://lnkd.in/eKcYNhDN Authors: Jodi Scott, Wil Henderson, Greg Kass, Lauren Massie, and Hannah Wailes #NABP #MedicalDevices #Pharma

Take a listen to our latest episode of the The Influencers, featuring Marisa Krummrich, Investment Manager at b2venture, as she unpacks the fast-evolving world of AI, biotech, and venture capital with Hogan Lovells host Leopold von Gerlach, including her groundbreaking tech biomarket map that charts AI’s transformative role in drug discovery and development, as well as insights on what makes a biotech startup truly investable: https://shorturl.at/tuz6e

On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain binding rules and regulations. Specifically, the Policy Statement rescinds a waiver dating back to the early 1970s that required rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” to undergo the Administrative Procedure Act’s (“APA’s”) notice-and-comment rulemaking requirements. Read more here: https://lnkd.in/egT52NKF Authors: Beth Halpern, Kenneth Choe, James Huang, Lynn Mehler, Stephanie Agu, Joy Sturm, William Ferreira, Joe Liss, Viraj Paul, and Randy Prebula #HHS #APA #CMS

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can vary significantly. Unlike the standardized federal approach, state regulations can differ greatly, making compliance a challenging task for companies operating in multiple jurisdictions. Read more here: https://lnkd.in/ei5iE9ax Authors: Jodi Scott, William Henderson, Greg Kass, Lauren Massie, and Hannah Wailes #MedicalDevice #StateLicensing #FDA

On 4 July, 2024 the German Parliament passed the Medical Research Act (“Medizinforschungsgesetz”) as part of a larger national strategy to incentivize pharmaceutical and medical device research and production in Germany. Read more here: https://lnkd.in/e9hgEDHg Authors: Arne Thiermann, Dr. Tina Welter-Birk and Dr. Benjamin Goehl #MedicalResearchAct #Pharma #MedicalDevices #LifeSciences

Join Partner Kristin Zielinski Duggan at Essentials of Working with FDA for Patient Organizations as she speaks on the “Postmarket Issues: Postmarketing trials, pharmacovigilance, and more” panel on March 4th. This panel will cover post-market issues such as postmarketing clinical trials, including confirmatory clinical trials, pharmacovigilance, FDA’s Adverse Event Reporting System (FAERS), and more! Last call to register:?https://lnkd.in/es3AM4SK #FDLI #ClinicalTrials #FDA