News & Analysis as of

False Claims Act (FCA) Patient Protection and Affordable Care Act (PPACA)

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Akerman LLP - Health Law Rx

Blizzard of Executive Orders Signals Trump Administration’s Healthcare Priorities

As harsh winter weather swept the nation’s capital, President Donald Trump commenced his second term by signing a blizzard of Executive Orders (EOs) that span many hot-button issues. Several of the EOs signal President...more

Goodwin

Health Headlines: January 2025

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Welcome to the second issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. In this issue, we cover expected changes under the new Trump administration, the Food and Drug Administration’s...more

Kaufman & Canoles

Medicare’s 60-Day Rule

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The Centers for Medicare & Medicaid Services (CMS) finalized significant updates to the Medicare 60-Day Rule, which governs how providers and organizations must handle overpayments. Taking effect January 1, 2025, these...more

Goodwin

Watch the Clock! CMS Makes Important Changes to Medicare Overpayment Rules

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The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...more

Robinson+Cole Health Law Diagnosis

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related Overpayments

As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the...more

Proskauer - Health Care Law Brief

Fault Lines Expected to Deepen: Major False Claims Act Circuit Split

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...more

Epstein Becker & Green

Affordable Care Act Overpayments in the CY 2025 Medicare Physician Fee Schedule Proposed Rule: Implications for False Claims

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Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more

Stevens & Lee

Welcome to the Post-Chevron World: HHS on the Defensive

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The Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo (and its companion case, Relentless v. Department of Commerce), in which it overruled the Chevron doctrine, has received a great deal of attention...more

Foley & Lardner LLP

Medicare Overpayments: CMS Proposes Regulation Establishing Six Month Suspended Deadline for 60-Day Refund Rule

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The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more

Quarles & Brady LLP

Is Your Employee or Contractor Excluded?

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Employers must check its employees, contractors and vendors to see if an individual or organization is excluded from participating in federal and/or state programs. While there are a variety of exclusion programs at the...more

Stevens & Lee

Two Recent Federal Court Cases Tackle Three Critical Components of the Anti-Kickback Statute

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Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute (“AKS”), namely: •the requirement that a violation of the AKS must...more

Baker Donelson

Private Equity in the Crosshairs: Administration Continues to Raise Questions Over Role of Private Equity in Long Term Care

Baker Donelson on

Over the past year, the Biden administration has expressed serious doubts about the developing role of private equity investment in the long term care industry. In a Fact Sheet released in late February 2022, the White House...more

Cozen O'Connor

Online Pharmacy Start-up Settles with AG Bonta for $15 Million over Alleged Medi-Cal Fraud

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California AG Rob Bonta settled with Hey Favor, Inc. and affiliated and predecessor entities that previously conducted business as “The Pill Club” for allegedly violating the California False Claims Act by knowingly...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Foley & Lardner LLP

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

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On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more

Benesch

Dialysis & Nephrology Digest - December 2022

Benesch on

Benesch: AKS claims against Azura dropped; FCA allegations to continue with DOJ intervention - The DOJ filed an Amended Intervenor Complaint in Aug. alleging between 2012 and 2018, Fresenius Medical Care’s business unit,...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2022

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The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

Mintz - Health Care Viewpoints

Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations

In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth...more

Sheppard Mullin Richter & Hampton LLP

Eighth Circuit: In False Claims Act Cases Based On Kickback Violations, the Kickback Violation Must Be the “But For” Cause of the...

The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of...more

McGuireWoods LLP

District Court finds that AKS Violations are Per Se Material

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Last month, the Central District of California granted the government’s affirmative motion for partial summary judgment in U.S. v. Reliance Medical Sys., 2022 WL 524062 (C.D. Cal. Feb. 2, 2022). The Reliance Medical case...more

ArentFox Schiff

Investigations Newsletter: New DC Circuit Ruling Impacts Medicare Advantage Plans and FCA Enforcement

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In a unanimous opinion, the DC Circuit reversed a successful challenge brought by UnitedHealth (United) and other Medicare Advantage insurers to vacate a Medicare Advantage Overpayment Rule. The Overpayment Rule requires that...more

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