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The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.

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The Future of the 340B Program: 2023 Key Decisions

By Anil Shankar Stephanie J. Schwartz Adria Warren

This article discusses the critical decisions that are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care providers, referred to as “covered entities.” The resolution of these issues will have an enormous financial impact on the health care industry, including pharmaceutical manufacturers, 340B hospitals, and federal grantees.

Articles

COVID-19 Related Medical Devices: FDA Finalizes Transition Plan Guidance

By Monica R. Chmielewski Nathan A. Beaver

This blog explores the U.S. Food & Drug Administration (FDA) two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19 Public Health Emergency (PHE), and (ii) that were issued emergency use authorizations (EUAs). These guidance documents finalize the corresponding draft guidance documents that were issued on December 23, 2021.

Articles

FDA Publishes Framework for Digital Health Technologies in Clinical Trials

By Alexandra B. Maulden Kyle Y. Faget

This blog focuses on U.S. Food and Drug Administration (FDA) published framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of technologies, including software applications that run on a phone, wearables, and environmental sensors, among others. As DHT becomes more sophisticated, the technologies have the potential to play an even larger role in health care, including clinical research.

Articles

The Tax Man Cometh: Tax Perils in Physician Recapitalization Transactions

By Roger D. Strode Steven M. Gerenraich Timothy L. Voigtman

This blog explores physician recapitalization transactions and how complex they are and their myriad issues. At Foley, in our representation of both investors in, and sellers of, physician practices, we note how often tax issues become gating items that drive the structural aspects of the transaction.

Articles

Collusion & Competition: What Antitrust Means for AI in Health Care

By Benjamin R. Dryden Kate E. Gehl

This blog post focuses on health care companies who are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply antitrust law to the modern, data-driven economy. Amid these myriad changes in technology and the law, the time is ripe to consider what the growth of AI in health care means for antitrust compliance.

Articles

What FQHCs Need to Know About Telehealth After the PHE

By Samantha Robbins Jamali Adam J. Hepworth

This blog focuses on the Biden Administration’s announcement on its intention to end the COVID-19 public health emergency (PHE) on May 11, 2023. For Federally Qualified Health Centers (FQHCs), flexibilities offered under the PHE expanded opportunities to be paid for telehealth services, particularly for Medicare patients. Any FQHC relying on PHE flexibilities should begin preparing for the end of the PHE to ensure its service offerings are in compliance with post-pandemic requirements.

Articles

NLRB General Counsel Says Noncompete Agreements Violate Federal Labor Law

By Jennifer G. Betts, Tobias E. Schlueter, Thomas M. Stanek, Christine Bestor Townsend, Zachary V. Zagger (Ogletree Deakins)

This article discusses the National Labor Relations Board (NLRB) General Counsel's memorandum explaining that noncompete agreements in employment contracts and severance agreements violate the National Labor Relations Act (NLRA) except in limited circumstances.

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