News & Analysis as of

Anti-Kickback Statute Centers for Medicare & Medicaid Services (CMS) Stark Law

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 | May 2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | November 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more

Holland & Knight LLP

DOJ Scrutinizes Financial Arrangements of Florida Physician Practice

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The U.S. Department of Justice (DOJ) announced in a Nov. 12, 2024, press release that an ophthalmology practice with offices located in West Central Florida (the Provider) entered into an approximately $1.3 million settlement...more

Venable LLP

Event in Review: Major Fraud and Abuse Laws: Anti-Kickback and Self-Referral Prohibitions and False Claims

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Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

McDermott Will & Schulte

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 & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

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

McGuireWoods LLP

Stark Law Regulations Under the Microscope in a Post-Chevron World

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Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Holland & Hart LLP

FMV for Provider Contracts: Regulatory Standards

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As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...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

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

Nelson Mullins Riley & Scarborough LLP

Using A Value-Based Enterprise to Integrate Specialists and Primary Care: Taking Value-Based Care to the Next Level

Meaningful progress has been made in value-based care, but the documented advances in reducing costs and improving patient outcomes have taken place predominately in the primary care sector. Significantly less headway has...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

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Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

Holland & Hart LLP

Patient Inducements: Law and Limits

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Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more

Goodwin

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

Goodwin on

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

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

Health Care Compliance Association (HCCA)

Defensibility of a fair market value analysis

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Maynard Nexsen

The Value Based Enterprise Safe Harbors and Exceptions

Maynard Nexsen on

In recognition that the prior versions of the Stark Law and Anti-Kickback Statute (AKS) rules were not designed for a value-based health care delivery system, the new value-based safe harbors and exceptions (released in late...more

K&L Gates LLP

Health Care Triage: Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?

K&L Gates LLP on

In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers have experienced in navigating the new regulatory flexibilities for...more

Hendershot Cowart P.C.

A Provider’s Guide to OIG's Self-Disclosure Protocol

Hendershot Cowart P.C. on

The OIG offers providers an opportunity to self-report certain violations under its Health Care Fraud Self-Disclosure Protocol. If you uncover a violation of federal healthcare laws or requirements – through your own...more

Morgan Lewis

End of the PHE: Preparing for Return to Normal for Stark Law and Anti-Kickback Statute

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Concurrent with the termination of the COVID-19 Public Health Emergency, various regulatory flexibilities will also come to an end, including the blanket waivers to the Stark Law and related enforcement discretion under the...more

Bodman

One Month Until May 11, 2023 – the Expiration Date for the COVID-19 Public Health Emergency

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The Secretary of the U.S. Department of Health and Human Services (HHS) first declared the existence of a public health emergency (PHE) on January 31, 2020. The PHE allowed HHS to implement a number of regulatory waivers and...more

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