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
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…
Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’ (“District Court”) declaring unlawful and vacating a portion of an HHS-OCR Bulletin…
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…
AB 3129 Passes California Legislature, Targeting Private Equity Health Care Transactions and Granting AG Consent Right
By David Manko, Vinay Kohli, Jonian Rafti & Michael Menconi on
On August 31, 2024, the California State Assembly and State Senate passed Assembly Bill 3129 (“AB 3129”). If signed by Governor Newsom, AB 3129 would establish a comprehensive transaction review law that (i) targets private equity firms and hedge funds, and (ii) grants the Attorney General explicit consent rights over…
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…
No Surprises Here! CMS Audit Uncovers Non-Compliance by Aetna in Calculation and Disclosure Requirements Under the No Surprises Act
By D. Austin Rettew & Vinay Kohli on
In a recent audit, the Centers for Medicare & Medicaid Services (“CMS”) uncovered non-compliance by Aetna Health Inc. of Texas (“Aetna”) in calculating key payment information for air ambulance services under the No Surprises Act (“NSA”). These audit results highlight the ongoing challenges faced by providers and payors in…
CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments
By Matthew J. Westbrook & Whitney Phelps on
In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. § 401.305(a) regarding the standard for an “identified overpayment” under Medicare Parts A–D…
OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28, 2024, OIG published a report (“OIG Report”) summarizing its finding that, of the NIH‑funded clinical trials randomly selected by OIG for review, a majority failed to meet NIH’s requirements for inclusion of diverse trial participants.
No Surprises Here! Divergent Court Rulings Spotlight Ongoing Challenges in No Surprises Act Implementation; Tee Up Split in Authority on Award Enforcement Mechanisms
By D. Austin Rettew & Vinay Kohli on
Two District Courts have reached opposite conclusions on the enforceability of arbitration awards under the No Surprises Act (“NSA”). The two decisions, while far from the final word on the subject, highlight the most recent challenge relating to the implementation of the NSA.
Enacted by Congress in 2020, the NSA…