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

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 & Emery

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 & 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

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

Morgan Lewis on

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

Bodman on

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

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

Lathrop GPM

The Public Health Emergency Is Finally (Almost) Over: What Does That Mean for Stark Law and Anti-kickback Statute Compliance?

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The COVID-19 public health emergency (PHE) will expire at the end of the day on May 11, 2023, which is less than three months away. In the early days of the pandemic, the U.S. Department of Health and Human Services (HHS),...more

Fox Rothschild LLP

Five Differences Between the Federal Anti-Kickback Statute and the Federal Stark Law

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Physicians around the country are familiar with the Federal Anti-Kickback Statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) and the Federal Physician Self-Referral Law, commonly referred to as the Stark Law (“Stark”) (42 U.S.C. §...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

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Enforcement Compliance Conference - November 7th - 9th, 8:55 am - 3:30 pm CST

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

Hendershot Cowart P.C.

Investing In or Opening an Ambulatory Surgery Center? Beware of State & Federal Regulations

Hendershot Cowart P.C. on

Investment in ambulatory surgery centers (ASCs) is soaring. Physicians, hospitals, and health systems are attracted by the high margins, significant growth potential, payer influence, and efficient patient care. Beyond...more

Nelson Mullins Riley & Scarborough LLP

Using the New Value-Based Rules to Enhance Your ACO

In November 2020, the Centers for Medicare & Medicaid Services (CMS) finalized value-based exceptions under the Stark law, and the Office of Inspector General (OIG) finalized value-based safe harbors under the Anti-Kickback...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

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