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In the past year, healthcare systems and providers across the country have filed a series of antitrust lawsuits against MultiPlan Inc. and major US health insurers, alleging a hub-and-spoke conspiracy to fix and reduce...more
The following is a review of notable cases and regulatory developments for nonprofit organizations at the federal and state levels during the last two years....more
Federal Circuit Allows Teva Patents to Remain in Orange Book. - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more
In July 2024, Pennsylvania enacted two significant pieces of legislation relating to telemedicine and physician noncompetition agreements that will have a meaningful impact within the healthcare delivery system with the...more
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines....more
Last week, a federal judge in North Carolina declined to preliminarily enjoin Novant Health, Inc.’s (“Novant”) acquisition of two hospitals from Community Health Systems, Inc. (“CHS”). The FTC filed suit in federal court and...more
The American reverence for entrepreneurial spirit and free enterprise is reflected in the profound influence of capitalism on our healthcare system. In contrast to many other advanced industrialized countries with state-run...more
With the end of the first quarter of 2024, we highlight five developments, changes, or challenges that health systems, hospitals, nursing homes, clinics, physician practices, health insurers, and other health care providers,...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
The House of Representatives aims to keep the U.S. at the leading edge of AI policy and innovation with a bipartisan task force while the FTC considers expanding a rule to crack down on AI impersonation. Meanwhile, a recent...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more
This WSJ story highlights the challenges faced by patients as they navigate the “convoluted” ways in which drug prices are set between manufacturers and the pharmacy benefit managers (PBMs) who negotiate on behalf of health...more
Artificial intelligence that can create new texts, images, and other content (or“generative AI”) is revolutionizing every industry, and healthcare is no exception. Doctors are experimenting with using generative AI to improve...more
FTC, DoJ propose changes to HSR Act for more effective, efficient merger reviews - The FTC, along with the Assistant Attorney General of the Antitrust Division, proposed changes to the premerger notification form and...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •AG James Sues Cryptocurrency Platform KuCoin, Alleging...more
Hosted by ACI, 14th Annual Advanced Forum on Managed Care Disputes and Litigation returns for another exciting year with curated programming that will help you make sense of these developments, and their profound impact on...more
Earlier this year, Assistant Attorney General Jonathan Kanter, who leads the Department of Justice’s (DOJ) Antitrust Division, announced that the Antitrust Division would eschew settlements in merger challenges in...more
Background- Many states have enacted Certificate of Public Advantage (“COPA”) laws which seek to permit hospital mergers that might otherwise have been challenged by the Federal Trade Commission (“FTC”) and found to violate...more
The Health Insurance Portability and Accountability Act of 1996 may be the most well-known privacy law in the United States, but it is also one of the most misunderstood....more
Introduction - On August 10, the Sixth Circuit issued its opinion in St. Luke's Hospital et al. v. ProMedica Health System, Inc., reversing an unusual preliminary injunction under Section 2 of the Sherman Act that ordered...more
On July 9, 2021, President Biden issued an “Executive Order on Promoting Competition in the American Economy,” (the “Order”) which aims to drive down prices for consumers, increase wages for workers, and promote innovation...more
President Biden issued Executive Order 14036 on July 9, 2021, calling for a “whole-of-government approach” to promote competition across many industries, including healthcare. The order establishes a White House Competition...more
On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”) intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order, among other things, encourages the...more