News & Analysis as of November 17, 2024

Anti-Kickback Statute › Safe Harbors

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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 -

OIG’s Perspective on Discount and Refund Programs

Gardner Law on 10/23/2024

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

The Admera Health Settlement Is a Cautionary Tale for Paying Outside Sales Staff on a Commission Basis

Akerman LLP - Health Law Rx on 8/12/2024

The Office of Inspector General recently announced the more than $5.5 million settlement of a qui tam action brought against Admera Health, LLC (Admera). In addition to the fine incurred, the legal fees typically incurred for...more

The Impact of CON Repeal, DHEC Changes, and Ongoing Considerations

Maynard Nexsen on 6/12/2024

South Carolina ASCs Have a Number of Changing Regulatory Requirements Pending – Stakeholders Should Take Notice - In May of 2023, the South Carolina General Assembly unanimously passed S. 164 and the Governor signed the...more

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

WilmerHale on 5/24/2024

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

Ultimate Guide to the Anti-Kickback Statute

Oberheiden P.C. on 5/21/2024

All healthcare providers and other businesses in the healthcare industry need to comply with the Anti-Kickback Statute (AKS). The AKS imposes criminal penalties for knowing and willful violations, and even inadvertent...more

Top Issues in Negotiating Physician Employment Agreements

Dickinson Wright on 12/27/2023

Originally published in Healthcare Michigan, Volume 40, No. 12 - Successful negotiation of physician employment agreements requires a careful balance of the objectives of the prospective employer with those of the...more

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on 11/3/2023

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

OIG Issues Favorable Advisory Opinion Concluding Bonuses to Employed Physicians Are Not Kickbacks

King & Spalding on 10/26/2023

Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...more

OIG Issues Favorable Opinion Concerning Bonus Payments to Employed Physicians

Stevens & Lee on 10/26/2023

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on 10/23/2023

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

DOJ Announces New M&A Safe Harbor Policy to Provide Further Clarity – But is it Enough?

Greenbaum, Rowe, Smith & Davis LLP on 10/18/2023

The U.S. Department of Justice (DOJ) has announced a new M&A Safe Harbor Policy to encourage greater corporate compliance and more robust due diligence by promoting the voluntary disclosure of criminal misconduct uncovered in...more

OIG Says Proposed Surgery Monitoring Arrangement May Violate Kickback Statute

Stevens & Lee on 8/28/2023

On August 18, the Office of Inspector General in the Department of Health and Human Services (“OIG”) issued Advisory Opinion 23-05 in which it concluded that a proposed arrangement involving the formation of a company...more

OIG Issues Unfavorable Advisory Opinion Regarding a Company’s Proposal to Create a Turnkey Physician-Owned Entity to Perform IONM...

King & Spalding on 8/23/2023

On August 18, 2023, OIG posted Advisory Opinion No. 23-05 regarding a proposed arrangement in which the requesting entity (Requestor) proposed to assist physicians who perform surgeries using intraoperative neuromonitoring...more

Defensibility of a fair market value analysis

Health Care Compliance Association (HCCA) on 8/3/2023

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

New Stark Law Exception and Anti-Kickback Statute Safe Harbor Aim to Combat Physician Burnout

Stevens & Lee on 7/26/2023

Health care professionals have faced increasing burnout and mental health issues in the wake of the COVID-19 pandemic. In an effort to address these rising issues, Congress passed the Dr. Lorna Breen Health Care Provider...more

Five years on: EKRA's legacy

BCLP on 7/21/2023

Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to...more

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

K&L Gates LLP on 6/28/2023

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

Physician Wellness Programs: A New Stark Law Exception and AKS Safe Harbor to Combat Burnout

ArentFox Schiff on 6/13/2023

The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians...more

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on 5/26/2023

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more

OIG Issues Guidance for Ambulatory Surgery Center Safe Harbor’s “One-Third” Income Test

King & Spalding on 5/18/2023

In March, OIG published a new frequently asked questions (FAQ) page, General Questions Regarding Certain Fraud and Abuse Authorities. The FAQ page, located here, includes new guidance for ambulatory surgery center (ASC)...more

OIG Permits Health System and Federally Qualified Health Center Look-Alike Collaboration Agreement Restructuring Which Includes...

Hinshaw & Culbertson - Health Care on 1/13/2023

In OIG Advisory Opinion 22-17, the U.S. Department of Health and Human Services (H.H.S.) Office of Inspector General (OIG) analyzed a proposal whereby a regional non-profit health system would forgive debt owed by a federally...more

The Impact of the Decision in U.S. v. Holland on the One Purpose Test

Nelson Mullins Riley & Scarborough LLP on 1/11/2023

The Court’s decision in U.S. v. Holland highlights the apparent contradiction between the judicially created and often relied upon “one purpose test” involving criminal and civil enforcement actions under the Federal...more

Decision in U.S. v. Holland

Nelson Mullins Riley & Scarborough LLP on 12/12/2022

The Court’s decision in U.S. v. Holland highlighted the apparent contradiction between the often relied upon “one purpose test” involving criminal and civil enforcement actions under the Federal Anti-Kickback Statute by...more

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Sheppard Mullin Richter & Hampton LLP on 11/22/2022

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

OIG Declines To Challenge Debt Cancellation and Restructured Financial Arrangements Between Health System and FQHC “Look-Alike”...

ArentFox Schiff on 9/30/2022

In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more

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Anti-Kickback Statute › Safe Harbors

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