Insights

Washington – July 22, 2022:  Crowell & Moring is advising Amazon on health care and related matters in its acquisition of One Medical for approximately $3.9 billion. Completion of the transaction is subject to customary closing conditions and regulatory approvals.

Washington – June 26, 2019: Crowell & Moring has launched a biweekly health care podcast series entitled Payers, Providers, and Patients – Oh My! The podcast covers legal and regulatory issues that affect in-house counsel, executives, and investors at health care companies.

As the primary civil enforcement statute for investigating and remedying fraud in connection with United States government programs, the False Claims Act (FCA) has resulted in more than $75 billion in recoveries of government funds since 1986. The FCA imposes liability on any person or entity that knowingly submits false claims or certifications to the government or improperly retains money owed to the U.S. government.

2023 brought many important False Claims Act developments for companies with business involving government funds.  While overall recoveries remained down compared to pre-2022 levels, the total number of settlements and judgments exceeded any prior year.  Those settlements and judgments also highlight areas of particular focus for the Government, including cybersecurity compliance, pandemic fraud, and small business fraud, among others.  Of particular note, 2023 saw the U.S. Supreme Court issue decisions concerning the Government’s authority to dismiss qui tam actions and the critical element of scienter/knowledge that will have wide-reaching impact.  The courts of appeals also issued significant decisions on damages, materiality, and more.  Crowell attorneys discuss these highlights and others in a "Feature Comment" published in The Government Contractor.

On July 25, 2023, the U.S. Departments of Labor, Treasury, and Health and Human Services (the “Tri-Agencies”) released long awaited proposed regulations (the “Proposed Rule”) and a Technical Release, which together propose new requirements for comparative analyses of nonquantitative treatment limitations (“NQTL”) under the Mental Health Parity and Addiction Equity Act of 2008 (“MHPAEA”).  On the same day, the Tri-Agencies released their annual report to Congress on implementation of MHPAEA, as required under the Consolidated Appropriations Act, 2021 (“CAA 2021”). 

The federal government awards billions of dollars in grants annually to fund public service, support non-profits, drive research initiatives and fund programs for colleges and universities.  With the Infrastructure Investment and Jobs Act (the “Act”), the Federal Government is poised to launch $1.2 trillion into the economy, providing funding to commercial entities through federal grants over the next 5 years, which will impact the infrastructure of this country for the next generation.  Like government contracts, federal grants have their own myriad of regulatory requirements that each grant recipient must meet and which are flowed down to subrecipients and subcontractors.  

Like all other aspects of life, the COVID-19 global pandemic had a dramatic effect on False Claims Act (FCA) enforcement in 2020. Please join members of Crowell & Moring’s Government Contracts and Healthcare Groups as they explore the most significant FCA developments across industries in this two-part webinar series.

In this episode, hosts Payal Nanavati and Megan Beaver talk to Jodi Daniel and Lidia Niecko-Najjum about how HIPAA and existing data privacy protections are shaping health care organizations’ use of artificial intelligence. Jodi and Lidia discuss the various regulations at play and also provide practical takeaways.

In this episode, hosts Payal Nanavati and Savanna Williams talk to Paul Pollock and Wayne Pryor about how private equity (PE) got its start in the health care industry, current trends in PE regulation, and where listeners can expect to see PE to continue investing in the industry. 

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions’ white paper on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity.