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United States
Manatt, Phelps & Phillips LLP
The Affordable Care Act (ACA) Marketplaces have nearly tripled their enrollment in their first decade of operation, from eight million people in 2014 to 21.4 million in 2024.
Jackson Lewis
On April 22, 2024, the federal Department of Health and Human Services' Office for Civil Rights (OCR) announced a final rule enhancing privacy protections relating to reproductive health care.
Manatt, Phelps & Phillips LLP
Half of Medicare beneficiaries are enrolled in Medicare Advantage (MA) plans. This extensive growth, which represents a doubling of MA enrollment since 2010...
Barnes & Thornburg
On April 8, the U.S. Department of Health and Human Services' Office of Inspector General (HHS-OIG) released Advisory Opinion No. 24-02, a favorable opinion regarding patient assistance programs (PAPs)...
Vorys Sater Seymour & Pease
On Friday, April 19, 2024, Pennsylvania's Office of Development Programs (ODP) provided public notice of the new fee schedule rates for services provided...
Nixon Gwilt
No centralized framework for the regulation of artificial intelligence in the United States currently exists. That said, the flurry of regulatory policymaking and legislation...
Mintz
Madison said, "Looking at the historical context of why pregnant women are excluded from these studies is important,"
referencing a period when the use of thalidomide by pregnant people to treat nausea...
Mintz
These sweeping final rules finalized many changes that were introduced in the Proposed 2025 Rules and other changes that were proposed in the Proposed 2024 Rules.
Goodwin Procter LLP
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson's STELERA® (ustekinumab).
Goodwin Procter LLP
As we previously reported, the U.S. Department of Justice ("DOJ") filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts...
Goodwin Procter LLP
As we previously reported, trial in Regeneron Pharmaceutical, Inc.'s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, "the Biocon Defendants")...
Foley & Lardner
In its November 2023 Proposed Rule and in its recently issued Final Rule that was published in the Federal Register on April 23, 2024, the Centers for Medicare & Medicaid Services (CMS)...
Goodwin Procter LLP
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.
Crowell & Moring LLP
The Federal Trade Commission (FTC) recently entered into a settlement with Monument, Inc., an alcohol addiction treatment service, ...
Exponent
On March 15, the Food and Drug Administration issued new draft guidance that impacts premarket submissions for all medical devices that produce temperature changes in patient tissues...
Mintz
The government's continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 ...
Holland & Knight
In this episode of "Counsel That Cares," healthcare attorney Jesse Neil examines the unique challenges and strategic options facing public hospitals...
Perkins Coie LLP
The Washington State Supreme Court significantly expanded the scope of potential hospital tort liability for the allegedly negligent actions of nonemployee, independently contracted emergency room service physicians...
Exponent
On Nov. 17, the Food and Drug Administration released the final guidance for assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions.
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts.
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