News & Analysis as of

Anti-Kickback Statute Patient Protection and Affordable Care Act (PPACA)

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
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

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

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

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

Goodwin

Additional Disclosure Required: CMS Implements Substantial Changes to Reporting Skilled Nursing Facility Ownership Information

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On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that will require skilled nursing facilities (SNFs) to disclose an expanded array of ownership, managerial, and control information...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

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

Akin Gump Strauss Hauer & Feld LLP

Updates in Co-Pay Assistance and Accumulators Legal Developments

Key Points - Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs. The Second Circuit has upheld HHS’ prohibition of co-pay...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

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

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On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Nelson Mullins Riley & Scarborough LLP

New Opportunities in Value-Based Care Part 1: New Opportunities for Provider Collaboration

This is the first in a five- part series discussing the new Value-Based Regulations adopted last year by the Centers for Medicare & Medicaid Services and the Office of Inspector General. At the end of 2020 the Centers for...more

Seyfarth Shaw LLP

Xavier Becerra, Biden’s HHS Appointee, Anticipated to Support ACA, Access to Care, and Reproductive Rights

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Xavier Becerra was recently named by President Elect Joe Biden as his appointee to be Secretary of the Department of Health and Human Services. Now that Mr. Biden has been inaugurated, and coupled with the recent change in...more

King & Spalding

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

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On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more

Rivkin Radler LLP

Medtronic Settles Kickback And Open Payments Violations For $9.2M

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The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

King & Spalding

New Risks, New Rewards, New Exposure

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Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Holland & Knight LLP

Healthcare Law Update: October 2019

Holland & Knight LLP on

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Foley & Lardner LLP

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

McDermott Will & Schulte

Executive Order on Hospital Price Transparency May Prompt Disclosure of Negotiated Prices

President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

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As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

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