Articles and Blogs

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Traditionally, the FDA exercised enforcement discretion over LDTs, meaning that the FDA has not…Read More

On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued the 2024 Medicare Physician Fee Schedule Final Rule (“Final Rule”) for calendar year (“CY”) 2024. Among other changes, the Final Rule refines and builds on changes finalized in the CY 2023 Physician Fee Schedule Final Rule to the Medicare Shared Savings Program…Read More

On November 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) posted a pre-publication copy of the Calendar Year (“CY”) 2024 Home Health Prospective Payment System Rate Update Final Rule (“2024 Final Rule”), which has since been filed in the Federal Register. The 2024 Final Rule was the subject of a significant amount of…Read More

On October 30, 2023, President Biden issued an Executive Order on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). The Executive Order outlines several steps that the Biden Administration will take with respect to the regulation of artificial intelligence (“AI”) technologies and tools across various industry sectors and previews…Read More

On October 27, 2023, the National Labor Relations Board (“NLRB” or the “Board”) issued its final rule revising the standard for determining whether two employers are considered joint employers under the National Labor Relations Act (“NLRA”) (“Final Rule”). The Final Rule goes into effect on February 26, 2024. It will apply to cases filed after…Read More

The United States District Court for the Eastern District of Wisconsin recently issued a decision involving protections for employees whose jobs involve the investigation of fraud. The case, brought under the anti-retaliation provision of the False Claims Act (“FCA”), is available here. Since 2009, the FCA’s anti-retaliation provision,(codified at 31 U.S.C. § 3730(h)(1)), has provided that…Read More

On November 17, 2023, CMS published its final rule requiring Medicare and Medicaid nursing facilities to provide more detailed ownership and managerial information. The final rule includes new definitions of “private equity company” and “real estate investment trust” for Medicare enrollment purposes. HCA plans to invest $5.3B in already-approved projects in 2024, including freestanding EDs…Read More

On November 3, 2023, the Departments of Health and Human Services, Labor, and the Treasury (collectively, “the Departments”) released a proposed rule that would implement significant administrative and technical changes to the No Surprises Act’s (“NSA”) Independent Dispute Resolution (“IDR”) process (the “Proposed Rule”). These changes aim to create a more efficient IDR process by…Read More