Health Care Counsel Blog
801 total results. Page 2 of 33.
Jeffrey E. Rummel
The event will be held on November 17, 2023, to explore the intersection of broadband connectivity and maternal health.
Stephanie Trunk, Wayne H. Matelski, Kevin R. Pinkney, Brian P. Waldman
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the horizon for pharmaceutical manufacturers operating in the US market:
D. Jacques Smith, Randall A. Brater, Michael F. Dearington, Nadia Patel, Morgan R. Pankow, Mattie Bowden
Headlines that Matter for Companies and Executives in Regulated Industries
Jeffrey E. Rummel
The Federal Communications Commission (FCC) has launched a comprehensive inquiry designed to explore ways the Commission’s Mapping Broadband Health in America platform could be expanded and enhanced to help better leverage digital health tools to improve maternal care.
Jack R. Bierig, Shoshana Golden, Wayne H. Matelski
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs).
Caroline Turner English, Alison Lima Andersen, D. Austin Rettew, David S. Greenberg, Jack R. Bierig, Aphrodite Kokolis
On September 21, 2023, the US Departments of Treasury (DOT), Labor (DOL), and Health and Human Services (HHS) (the Departments) issued new rulemaking governing the administrative fee required to access the arbitration process established under the No Surprises Act (the Act). Under the proposed rule, the new fee would be set at $150.
Douglas A. Grimm, Moyosore O. Koya
On September 12, 2023, the Senate Judiciary Subcommittee on Privacy, Technology, and the Law convened a hearing to discuss potential legislation focused on AI models, the third in a series of hearings by the subcommittee analyzing issues in AI oversight. A key discussion topic was the Bipartisan Framework for US AI Act introduced by Senators Richard Blumenthal and Josh Hawley.
D. Jacques Smith, Randall A. Brater, Michael F. Dearington, Nadia Patel, Mattie Bowden, Heather M. Zimmer
Headlines that Matter for Companies and Executives in Regulated Industries
Caroline Turner English, Alison Lima Andersen, Jack R. Bierig, David S. Greenberg, Aphrodite Kokolis, D. Austin Rettew
On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act).
D. Jacques Smith, Randall A. Brater, Michael F. Dearington, Nadia Patel, Shoshana Golden, Rebecca W. Foreman
Headlines that Matter for Companies and Executives in Regulated Industries
Caroline Turner English, Alison Lima Andersen, Jack R. Bierig, Pascal Naples, D. Austin Rettew
Last week, the US Court of Appeals for the Ninth Circuit, in its third opinion in the case, reversed a lower court’s decision allowing patients challenging United Behavioral Health’s (UBH) internal mental health coverage guidelines to seek reprocessing of their benefits claims.
Debra Albin-Riley, Fernanda Sanchez Jara
California health care employers that apply mandatory vaccination policies objectively can take great comfort in a recent California Court of Appeal decision.
Caroline Turner English, Pascal Naples, D. Austin Rettew
On July 25, 2023, the US Departments of Labor (DOL), Treasury (USDT), and Health and Human Services (HHS) (the Departments) released a much-anticipated interim final rule to ensure that group health plans comply with the Mental Health Parity and Addiction Equity Act (MHPAEA).
Douglas A. Grimm, Gayland O. Hethcoat II
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online provider marketplace.
Thomas E. Jeffry, Jr., Gayland O. Hethcoat II
A final rule published on July 3, 2023, empowers the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) to impose civil monetary penalties (CMP) of up to $1 million for unlawful acts of information blocking.
Stephanie Trunk
It is the annual summer pastime for the pharmaceutical community. Time to review the Centers for Medicare & Medicaid Services (CMS) release of the 2024 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules.
D. Jacques Smith, Randall A. Brater, Michael F. Dearington, Nadia Patel, Mattie Bowden, Heather M. Zimmer
Headlines that Matter for Companies and Executives in Regulated Industries
Anne M. Murphy, Jill A. Steinberg, Gayland O. Hethcoat II
In this installment of our post-Dobbs risk assessment series for hospitals and academic medical centers, we consider the ongoing impact of Dobbs v. Jackson Women’s Health Organization on delivery of clinical services beyond abortion.
Dan Jasnow, Jo-Ann Marchica, Mindy Pittell Hurwitz, Stephen Blake
For better or worse, generative artificial intelligence (AI) is already transforming the way we live and work. Within two months of its initial release to the public, ChatGPT reached 100 million monthly active users, making it at the time the fastest-growing consumer application in history.
D. Jacques Smith, Randall A. Brater, Nadia Patel, Mattie Bowden, Michael F. Dearington, D. Austin Rettew
Headlines that Matter for Companies and Executives in Regulated Industries
Douglas A. Grimm
No personal services are more important than health care. The use of artificial intelligence (AI), involving machines to perform tasks normally requiring human intelligence, is leading to an expansion of the term “personal.”
Gayland O. Hethcoat II, Mariam Al-Koshnaw Creedon
As more states adopt consumer data privacy laws, Nevada and Washington stand out for their recent passage of legislation aimed specifically at protecting “consumer health data.”
Cissy Jackson, Daniel Sjostedt*
In November of 2022, we predicted a fertile post-election congressional landscape for Pharmacy Benefit Manager (PBM) practice reform.
D. Jacques Smith, Randall A. Brater, Morgan R. Pankow
On June 16, 2023, in United States, ex rel. Polansky v. Executive Health Resources, Inc., the US Supreme Court addressed the government’s authority to dismiss a qui tam False Claims Act (FCA) suit over a relator’s objection when the government initially declines to intervene in the litigation.
Annie Chang Lee, Gayland O. Hethcoat II, M.H. Joshua Chiu
The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians programs to improve mental health and resiliency.