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
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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…
CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments
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…
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…
California Considers New Restrictions as Health Care Notice Requirements Go Live for Transactions Closing on or After April 1
In August 2023, we published a blog post about the California Office of Health Care Access and Information’s (“OHCA”) proposed cost and market impact review (“CMIR”) regulations under the California Health Care Quality and Affordability Act (“Proposed Regulations”). The final CMIR regulations implementing the notice requirements for large health care transactions in California (“Final Regulations”) were approved on December 18, 2023. As enacted, all health care entities that meet certain threshold requirements and are a party to a “material change transaction” expected to close on or after April 1, 2024, must provide at least 90 days’ advance notice to OHCA. OHCA began accepting notices as of January 1.
Continuing the trend towards greater scrutiny of health care transactions, on February 16, the California Assembly introduced a new bill, AB-3129, which would subject private equity groups and hedge funds to a 90-day notice and consent requirement for change of control transactions or acquisitions of health care facilities or provider groups that are expected to close on or after January 1, 2025. While the Final Regulations are intended to promote competition in the health care sector, the stated purpose of AB‑3129 is to improve the quality and lower the cost of health care.
This blog discusses the scope of the Final Regulations and what to look out for as AB-3129 makes its way through the California legislative process.
FTC Announces 2024 Thresholds Under HSR Act and Clayton Act
The Federal Trade Commission has announced revisions to HSR Act and Clayton Act Section 8 thresholds, which are indexed annually in alignment with prior year economic activity. The article identifies the adjustments that are likely to be the most relevant to our clients and reiterates several important practice tips.
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Recent Supreme Court Case Affirms Government’s Power to Dismiss Qui Tam Suits
On June 16, 2023, the Supreme Court (the “Court”) in United States ex rel. Polansky v. Executive Health Resources affirmed the federal government’s power to dismiss a False Claims Act (“FCA”) action brought under the qui tam provisions whenever it chooses to intervene. Polansky is the second FCA case this summer in which the Court has ruled in favor of the federal government—i.e., the Department of Justice, acting through the Attorney General (“DOJ”). Writing for an 8-1 majority, Justice Kagan explained that DOJ receives considerable deference, even over the objection of the individual who raised the action (i.e., the relator or whistleblower), to dismiss cases that are inconsistent with DOJ’s interests.
The Supreme Court’s Ruling Narrows Available FCA Scienter Defenses
In a unanimous opinion, the United States Supreme Court (“Court”) recently held that the False Claims Act’s (“FCA”) scienter requirement refers to a defendant’s knowledge and subjective beliefs, rather than what a hypothetical reasonable person could have known or believed. As supported by the text of the FCA itself and by its common‑law roots, the Court explained that the “focus is what a defendant thought when submitting a claim—not what a defendant may have thought after submitting it.” Consequently, the Court vacated the holding of the Seventh Circuit and remanded the matter for further proceedings consistent with the Court’s opinion. Because the Seventh Circuit had affirmed a Federal district court’s grant of the defendants’ motions for summary judgment, the Court’s opinion effectively revives the FCA claim against the defendants.
President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector
On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”. Asserting that a “fair, open, and competitive marketplace…