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…
New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive Health Care Information
By Whitney Phelps & Michael Menconi on
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). The Final Rule, which goes into effect on June 25, 2024, promulgates…
Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA Violation Predicated on an AKS Violation
By Matthew J. Westbrook & Vinay Kohli on
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute (“AKS”) is a predicate violation for the false claim. The spotlight is now on…
As Scrutiny Escalates, DOJ Announces the Formation of the Health Care Monopolies and Collusion Task Force
The U.S. Department of Justice (“DOJ”) recently announced the creation of the Health Care Monopolies and Collusion Task Force (the “HCMC Task Force”) aimed at resolving antitrust issues in the health care industry. Specifically, the HCMC Task Force will focus on investigating issues related to the quality of patient care…