News & Analysis as of

Stark Law Department of Justice (DOJ) Centers for Medicare & Medicaid Services (CMS)

Lathrop GPM

Now is Not the Time to Relax: Record Settlements in Stark Law and False Claims Cases

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In early May 2024, the University of Pittsburgh Medical Center (UPMC) agreed to pay $38 million to resolve a False Claims Act case based on alleged Stark Law violations. The size of the settlement in United States ex rel. J....more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | April 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Nelson Mullins Riley & Scarborough LLP

Fair Market Value Defensibility Analysis: Why is It Different from a Fair Market Value Opinion?

Fair market value is a pinnacle issue for compliance under the Stark Law and Anti-Kickback Statute. Compensation arrangements that are required to be representative of fair market value under Stark/AKS include employment,...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

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Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Bass, Berry & Sims PLC

2021 Recap: Hospitals’ Significant False Claims Act Settlements

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Each year, the Department of Justice (DOJ) recovers millions of dollars through False Claims Act (FCA) settlements, and 2021 was no exception. Some of the most sizeable or otherwise noteworthy settlements from 2021 were with...more

Snell & Wilmer

HHS Office of Inspector General Issues Important Update to Self-Disclosure Protocol

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For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

ArentFox Schiff

Investigations Newsletter: HHS Announces Formation of FCA Working Group

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HHS Announces Formation of FCA Working Group - On December 4, 2020, the US Department of Health and Human Services (HHS) announced that it is creating a False Claims Act Working Group to enhance the partnership between...more

Nelson Mullins Riley & Scarborough LLP

Murky Waters – The Stark Controversy in Hospital-Physician Relationships

Since the completion of this article, CMS has announced that its final Stark law rule will be published in the Federal Register on December 2, 2020. I. Introduction - The Stark Law has been litigated for the past two...more

Foley & Lardner LLP

Multiple DOJ Settlements Relating to Electronic Health Records Systems—What Does This Mean for Health Care Entities Today?

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Over the past few years, there have been a number of Department of Justice (DOJ) settlements involving the False Claims Act (FCA) pertaining to electronic health records (EHR). The combined settlements total more than $275...more

Ruder Ware

Changes in Federal Enforcement Cases and the Stark Law May Benefit Health Care Providers

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Some recent changes in federal law and in federal agency interpretation of federal law may both clarify and relieve some regulatory obligations of health care providers. Lessening Dependence on Federal Agency...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Sheppard Mullin Richter & Hampton LLP

Lifting the Limits on Physician-Owned Hospitals: Can Regulators Prevail Where Legislators Have Stalled?

We reported, in early 2017, on what was then the latest legislative effort to repeal the Affordable Care Act’s amendment to the Stark Law’s whole hospital exception, which amendment has effectively prevented new...more

Manatt, Phelps & Phillips, LLP

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

Bradley Arant Boult Cummings LLP

2016 – Health Law Year in Review

We are pleased to present our annual review of developments in the field of health law. The year was marked by key changes in False Claims Act jurisprudence and Medicare payment policy. 2016 also brought with it focused...more

Manatt, Phelps & Phillips, LLP

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

McDermott Will & Emery

OIG Issues New Exclusion and CIA Guidance

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On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Mintz - Health Care Viewpoints

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

McDermott Will & Emery

Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post-Tuomey?

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After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more

Poyner Spruill LLP

Corridors September 2015 - News for North Carolina Hospitals

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This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Baker Donelson

CMS Issues FAQs Regarding Self-Referral Disclosure Protocol

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CMS has released its responses to eight frequently asked questions [PDF] regarding its Self-Referral Disclosure Protocol (SRDP). The questions fall into three categories, listed below, and respond to issues that are often...more

BakerHostetler

A Message From Donna Clark And Darby Allen On The A To Zs Of Stark Law Compliance

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Healthcare providers, particularly physicians and hospitals, regularly engage in business arrangements that may implicate the federal self-referral law, known as the Stark Law. Recent changes to the Stark Law, including...more

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