- Posts by Eleanor T. ChungAssociate
Eleanor Chung is a litigator, strategic advisor, and creative problem-solver for health care and life sciences companies.
Hospital systems, hospital staffing companies, and providers turn to Eleanor to handle their ...
On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also available.
This EO is a significant milestone as companies and other organizations globally grapple with the trustworthy use and creation of AI. Previous Biden-Harris Administration action on AI have been guidance of principles (e.g., the AI Bill of Rights) or have been targeted guidance on a particular aspect of AI such as the Executive Order Addressing Racial ...
Throughout the course of the pandemic, the Health Resources and Services Administration (HRSA) distributed $178 billion in Provider Relief Funds (PRF) to hospitals and health care providers. The Public Health Emergency has ended, and HRSA is now turning an eye to how the money was spent, and whether it was spent properly.
PRF funds were distributed with nearly no-strings-attached; hospitals and providers had to simply agree to a few terms and conditions. Yet a number of facilities and providers have received one of two types of letters from HRSA: (1) a Final Repayment Notice stating the money must be returned, or (2) a letter stating that HRSA will be conducting an audit.
On March 22, 2023, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) updated its Frequently Asked Questions (“FAQs”), drafting 13 FAQs aimed at easing the transition from COVID-era flexibilities to the end of the Public Health Emergency (“PHE”) on May 11, 2023. These FAQs arrive on the tail of OIG’s March 10, 2023 COVID-19 Public Health Emergency policy statement, which announced that the expiration of the PHE in May also marks the end of flexibilities extended during the crisis. The updated FAQs offer a glimpse into how OIG investigations and enforcement might play out after the end of the PHE. These FAQs address subjects including “General Questions Regarding Certain Fraud and Abuse Authorities,” the “Application of Certain Fraud and Abuse Authorities to Certain Types of Arrangements,” and “Compliance Considerations.”
The vast majority of the principles articulated in the updated FAQs will undoubtedly be familiar to many. Generally speaking, the updated FAQs restate or clarify longstanding OIG policy. The updated FAQs are more than reiteration, however; they offer condensed policy and explanation in a single location, and demonstrate that for the most part, investigations and enforcement may return to the pre-PHE status quo.
On April 20, 2022, the Department of Justice (DOJ) announced a nationwide coordinated enforcement action targeting COVID-19-related fraud involving charges against 21 individuals across nine federal districts, and over $149 million in alleged false claims submitted to federal programs.
This marks the first significant DOJ enforcement action since Attorney General Merrick Garland named Associate Deputy Attorney General Kevin Chambers as the Director for COVID-19 Fraud Enforcement on March 10, an appointment President Biden previewed in his State of the Union address on March 1.
- DOJ’s FY 2023 Statistics: Highest Number of Settlements, Judgments, and Civil Investigative Demands in History and a Continued Health Care Focus
- FDA Releases Updated Directory on Select Dietary Supplement Ingredients
- In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute
- NJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders
- Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities