News & Analysis as of

Health Care Providers Safe Harbors

Knobbe Martens

Application of Safe Harbor Exceptions to the Anti-kickback Statute

Knobbe Martens on

On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical...more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-03: Navigating Anti-Kickback Rules and Safe Harbors in Telehealth Contractual Arrangements

On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Vorys, Sater, Seymour and Pease LLP

Telehealth Services Safe Harbor for High Deductible Health Plans Expires December 31, 2024

On December 21, 2024, President Biden signed into law the American Relief Act, 2025 (2025 Relief Act), which funds the federal government through March 14, 2025, and provides certain disaster relief provisions and other...more

Burr & Forman

A Reminder for All Health Care Providers When Forming Business Arrangements

Burr & Forman on

According to a federal district judge in Mississippi, a cancer center’s investors bought themselves a lawsuit because of a conscious decision not to structure the ownership arrangement in compliance with a safe harbor. A...more

Akerman LLP - Health Law Rx

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

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

Maynard Nexsen

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

Maynard Nexsen on

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

WilmerHale

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

WilmerHale on

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

Womble Bond Dickinson

DOJ Announces New Task Force on Health Care Monopolies and Collusion

Womble Bond Dickinson on

On May 9, 2024, the Antitrust Division of the Department of Justice (DOJ) announced a new Task Force on Health Care Monopolies and Collusions (HCMC). Comprised of civil and criminal prosecutors, economists, healthcare...more

Oberheiden P.C.

Ultimate Guide to the Anti-Kickback Statute

Oberheiden P.C. on

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

McDermott Will & Schulte

[Event] Value-Based Care Symposium 2024 - May 16th - 17th, Nashville, TN

WHERE VALUE-BASED CARE MEETS THE BUSINESS OF HEALTHCARE - Join hundreds of c-suite leaders, investors, operators and counsel in the healthcare capital of the United States for a deep dive into the key business and policy...more

Bass, Berry & Sims PLC

CMS Proposes New Mandatory Value-Based Payment Initiative: The Transforming Episode Accountability Model

Bass, Berry & Sims PLC on

The Centers for Medicare & Medicaid Services (CMS) recently proposed the Transforming Episode Accountability Model (TEAM) – a new, mandatory, episode-based alternative payment model in the Fiscal Year 2025 Hospital Inpatient...more

Holland & Knight LLP

Substance Use Disorder Confidentiality Regulations Modified to Align with HIPAA

Holland & Knight LLP on

After more than a year since the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued the proposed changes to the...more

Akerman LLP - Health Law Rx

New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program...more

Bradley Arant Boult Cummings LLP

Florida Bill Proposes Safe Harbor Against Breach Suits to Businesses Maintaining Recognized Cybersecurity Programs

A recently introduced bill in the Florida Legislature would provide businesses operating in Florida, including health care providers, with a legal defense to data breach lawsuits if they maintain robust cybersecurity measures...more

Dickinson Wright

Top Issues in Negotiating Physician Employment Agreements

Dickinson Wright on

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

Stevens & Lee

OIG Issues Favorable Opinion Concerning Bonus Payments to Employed Physicians

Stevens & Lee on

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

Stevens & Lee

OIG Says Proposed Surgery Monitoring Arrangement May Violate Kickback Statute

Stevens & Lee on

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

McDermott Will & Schulte

New MHPAEA Guidance Regarding NQTLs: Network Access and Composition

Recently proposed regulations attempt to ensure that health plans allow access to mental health or substance use disorder (MH/SUD) benefits as easily as medical or surgical (M/S) benefits. The proposed regulations, issued by...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

Stevens & Lee

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

Stevens & Lee on

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

BCLP

Five years on: EKRA's legacy

BCLP on

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

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

Womble Bond Dickinson

Current Trends and Real-World Best Practices in Healthcare Fraud Compliance

Womble Bond Dickinson on

Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more

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