Health and Human Services

Recent efforts by the federal government to develop a strategy for guiding (and regulating) the use of artificial intelligence (AI) have targeted multiple industry sectors, with healthcare at the forefront. For example, under the President’s recent executive order, in 2024 the Department of Health and Human Services is required to educate itself, publish guidance, and

On June 11, 2021, the Department of Health and Human Services (“HHS”) announced that it had released revised reporting requirements for those providers and suppliers that have received Provider Relief Fund payments during the COVID-19 pandemic. Readers may recall that HHS previously issued notices on post-payment reporting requirements starting in July 2020, and that previous

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B