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
DEI and Government Contractors: A High-Stakes Shift
By Guy Brenner & Olympia Karageorgiou on
[This post has been re-published from Proskauer’s “Government Contractor Compliance & Regulatory Update” blog: DEI and Government Contractors: A High-Stakes Shift | Government Contractor Compliance & Regulatory Update.]
While much of the focus on President Trump’s recent Executive Order on Ending Illegal Discrimination and Restoring Merit-Based Opportunity (the “EO”)…
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…
CMS Publishes Final Rule, Effective January 1, 2025, Addressing the Requirements for Reporting and Returning Overpayments
By Matthew J. Westbrook, Vinay Kohli & David Manko on
The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge” standard. The previous “reasonable diligence” standard, which, as it related to Part C, had been…
This New Year, California Imposes Guardrails on the Use of AI by Payors for Utilization Management Determinations
By Whitney Phelps, Jonian Rafti & Michael Menconi on
SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management.[1] As discussed in a prior Proskauer alert, the Bill represents one of the latest attempts by the…
OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers
On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and referrals between Medicare Advantage (“MA”) health plans, health care professionals, and third-party marketers (e.g., agents and…
Arrangements Involving Intraoperative Neuromonitoring Continue to be Scrutinized under the Federal Anti-Kickback Statute
This week, the U.S. Attorney’s Office for the District of Colorado (“USAO”) announced that it entered into a series of interrelated settlement agreements with companies that provide intraoperative neuromonitoring (“IONM”) services, the companies’ founder, a neurosurgeon, and a businessman affiliated with the companies. IONM services involve the use of electrodes…
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]…
Fault Lines Expected to Deepen: Major False Claims Act Circuit Split
By Matthew J. Westbrook & Vinay Kohli on
The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The First Circuit will decide whether the FCA “result[s] from” a kickback if that claim would not…