In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring laboratory‑developed test services (“LDTs”) within the scope of the agency’s medical device regulatory framework. The case
Healthcare
DOH Issues Guidance on New York’s Material Health Care Transaction Law
Nearly two years ago, and as previously discussed in a Proskauer alert, New York enacted Public Health Law Article 45-A (the “Material Transactions Law”), which requires reporting of certain material health care transactions. Last month, the New York State (“NYS”) Department of Health (“DOH”) published long-awaited guidance concerning the…
HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking
On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for regulations on public property, loans, grants, benefits, or contracts. Under the new framework, HHS and its…
First Circuit Clarifies FCA Liability Standard for AKS Violations, Deepening Circuit Split
The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”) violations. The First Circuit held that an AKS violation must be the “but-for” cause of a claim for it…
Spurred on by the Steward Health Care Bankruptcy, Massachusetts Adopts Bill Regulating Private Equity and REITs in Health Care, Continuing a National Trend
By David Manko, Jason S. Madden & Jonian Rafti on
On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill 5159 (the “Bill”). The Bill grants the state new regulatory powers to oversee and review health care transactions involving private equity firms, real estate investment trusts (“REITs”), and management services organizations (“MSOs…
No Surprises Here! Fifth Circuit Upholds QPA Calculations and Disclosure Requirements, but Sides with Providers on Payment Deadlines
By Vinay Kohli & D. Austin Rettew on
The Fifth Circuit Court of Appeals has handed down a significant decision in response to a challenge from health care providers to the implementing regulations of the No Surprises Act (“NSA”). The Court upheld the Departments of Treasury, Labor, and Health and Human Services’ (the “Departments”) approach to certain key…
California Governor Vetoes Transaction Review Law, But Bill’s Rapid Advancement Underscores a Shifting Regulatory Landscape
By David Manko, Vinay Kohli & Jonian Rafti on
This article was initially published as a Bulletin for the AHLA’s Physician Organizations Practice Group.
California Assembly Bill 3129[1] (“AB3129”), which targeted for regulatory review a variety of health care transactions involving “private equity groups” and “hedge funds,” was vetoed by Governor Gavin Newsom on September 28, 2024.[2]…
Relator, No More? Florida Federal Court Declares Qui Tam Provisions of False Claims Act Unconstitutional, with Potentially Broad Implications for Government Fraud Litigation
By Vinay Kohli, G. Patrick Regan & D. Austin Rettew on
On September 30, 2024, the U.S. District Court for the Middle District of Florida issued an order dismissing a qui tam case under the False Claims Act (“FCA”) and holding the relator provisions of the FCA to be unconstitutional.[1] In reaching this conclusion, the Court reasoned that the…
Post‑Chevron Spotlight: Disproportionate Share Hospital Payments Restored as Texas Hospitals Prevail in Challenge to HHS Exclusion Rule
By Vinay Kohli & D. Austin Rettew on
In a victory for Texas health care providers, in Baylor All Saints Medical Center dba Baylor Scott & White All Saints Medical Center‑Fort Worth et al. v. Xavier Becerra, case number 4:24‑cv‑00432, the United States District Court for the Northern District of Texas (“District Court”) has vacated a regulation…
No Surprises Here! Fifth Circuit Upholds Health Care Provider Challenge to No Surprises Act Regulations
By D. Austin Rettew & Vinay Kohli on
In a recent win for health care providers, the United States Court of Appeals for the Fifth Circuit has affirmed a lower court’s decision to vacate key portions of regulations issued by the U.S. Departments of Treasury, Labor, and Health and Human Services (collectively, the “Departments”) under the No Surprises…