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False Claims Act (FCA) Department of Health and Human Services (HHS) Health Care Providers

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...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

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2024

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

WilmerHale

Second Circuit Confirms Willfulness under the Anti-Kickback Statute and False Claims Act Requires Relators to Plead that the...

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The Second Circuit Court of Appeals recently issued a decision with significant implications for healthcare companies and providers facing allegations of violations of the Anti-Kickback Statute (AKS), 42 U.S.C. §...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Jones Day

Second Circuit Reinforces Anti-Kickback Statute's Demanding Willfulness Standard

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The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral for an item or service reimbursable by a...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | February 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more

Harris Beach PLLC

OIG February 2024 Enforcement Actions

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

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Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more

McDermott Will & Emery

DOJ and OIG Actions: 2023 Enforcement Trends Recap

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This report reviews notable areas for government enforcement actions during 2023 that were discussed in our monthly Healthcare Regulatory Check-Up reports. In the past year, we saw the relevant federal government enforcement...more

McDermott Will & Emery

This Week in 340B: February 21 – 26, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Health Care Compliance Association (HCCA)

News Briefs: January 8, 2024

H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more

Harris Beach PLLC

OIG January 2024 Enforcement Summary

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

ArentFox Schiff

Investigations Newsletter: Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations

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Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 19

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The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more

The Volkov Law Group

Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance

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In November 2023, HHS-OIG issued a comprehensive document, the General Compliance Program Guidance ("GCPG"), which outlines important compliance guidance for the healthcare industry. The GCPG provides specific guidance on...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

The Volkov Law Group

HHS-OIG Issues Comprehensive Compliance Guidance that Underscores the Need for a Robust and Independent Compliance Function (Part...

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The health care industry has a rich history of commitment and innovation in developing effective compliance  programs.  Going back to the 1990s, HHS elevated compliance program requirements for healthcare companies. Many of...more

Bass, Berry & Sims PLC

HHS Releases Groundbreaking General Compliance Program Guidance, Setting New Standards for Healthcare Entities

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On November 6, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released the most up-to-date, comprehensive, and practical general compliance guidance in decades. The new...more

Bricker Graydon LLP

A Long-Awaited Change: OIG Updates its Compliance Program Guidances

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From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more

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