The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more
7/9/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing...more
A recent settlement agreement presents another example of how educational institutions can find themselves facing potential liability under the False Claims Act (FCA). The settlement illustrates how FCA liability remains a...more
The US Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer...more
As the COVID-19 Public Health Emergency comes to an end on May 11, various regulatory flexibilities simultaneously expire, including certain waivers issued by the Centers for Medicare & Medicaid Services, among other...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
In a proposed rule issued on December 27, 2022 to make technical changes to the Medicare Advantage Program, the Centers for Medicare and Medicaid Services (CMS) buried in the regulatory arcana a material legal change to the...more
In United States ex rel. Cairns v. DS Medical LLC, the US Court of Appeals for the Eighth Circuit set a higher bar for proving causation in False Claims Act cases where plaintiffs seek to establish liability under the 2010...more
Biogen Inc., a global biotechnology company, denies that it violated the federal Anti-Kickback Statute and False Claims Act by paying healthcare professionals for fraudulent speaking engagements in order to incentivize them...more
Last month we had an incredibly insightful Fast Break analyzing a significant HIPAA enforcement victory for The University of Texas MD Anderson Cancer Center (MD Anderson) in the US Court of Appeals for the Fifth Circuit. ...more
The US Court of Appeals for the Fifth Circuit issued its ruling in the landmark HIPAA case between The University of Texas MD Anderson Cancer Center (MD Anderson) and the US Department of Health and Human Services (HHS). The...more
With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) recently updated its FAQs providing some additional...more
Medicare (and in the future Medicaid) providers that receive grant money under the CARES Act Relief Fund must pay close attention to the terms and conditions of the assistance and rigorously document how the funds are used to...more
In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources. ...more
Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid...more
The US government continues its focus on healthcare fraud through criminal actions. It has demonstrated its willingness to pursue physicians and investors alike and to take creative approaches in order to secure convictions....more