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Health Care Providers Physicians Safe Harbors

Knobbe Martens

Application of Safe Harbor Exceptions to the Anti-kickback Statute

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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

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

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

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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

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

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

Sheppard Mullin Richter & Hampton LLP

California District Court Finds that EKRA Applies to Compensation Methodologies for Labs’ Employed Marketers Who Market to...

Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here...more

Tarter Krinsky & Drogin LLP

The Anti-Kickback Statute and its Implications on Medical Practices

The Anti-Kickback Statute (AKS) protects healthcare beneficiaries from the influence of money in their medical decision-making. Overall, the AKS criminalizes renumeration “intended to induce patient referrals or influence the...more

Proskauer - Health Care Law Brief

OIG Publishes Favorable Advisory Opinion Related to the Employment Safe Harbor

In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in...more

Steptoe & Johnson PLLC

What to Expect, Part III: Modified AKS Safe Harbor for Personal Services & Management Contracts

Steptoe & Johnson PLLC on

The Office of Inspector General’s (“OIG”) new Anti-Kickback Statute (“AKS”) regulations modify the safe harbor for personal services and management contracts (42 CFR § 1001.952(d)) in a manner that allows providers...more

Rivkin Radler LLP

OIG Issues Favorable Advisory Opinion On Hospital/Physician Joint Venture ASC

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In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that certain investments by a health system, manager and physicians in an ambulatory surgery center...more

Miles & Stockbridge P.C.

The Stark Law and Anti-Kickback Statute Final Rules: Value-Based Arrangements

The Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) jointly published final rules that expand upon and modify regulatory safe harbors and exceptions to the Anti-Kickback Statute and...more

Epstein Becker & Green

Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care

The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing...more

K&L Gates LLP

Value-Based Safe Harbors and Exceptions to the Anti-Kickback Statute and Stark Law

K&L Gates LLP on

On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse...more

K&L Gates LLP

White Paper: Value-Based Safe Harbors and Exceptions to the Anti-Kickback Statute and Stark Law

K&L Gates LLP on

On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse...more

PilieroMazza PLLC

Healthcare Blog Series: CMS and HHS-OIG Issue Final Rules Updating the Anti-Kickback Statute and Stark Law

PilieroMazza PLLC on

On November 20, 2020, over one year after releasing proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law), the Department of Health and Human Services’ Office of the Inspector...more

McGuireWoods LLP

Fraud and Abuse Rules Part III: New Value-Based Arrangement Protections

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the...more

Health Care Compliance Association (HCCA)

[Webinar] What Compliance Professionals Need to Know About the New Stark and Anti-Kickback Regulations - January 29th, 12:00 pm -...

Learning Objectives: - Explain changes to existing concepts including fair market value, commercial reasonableness, and volume or value - Examine the new definitions, exceptions, and safe harbors and their impact on...more

McGuireWoods LLP

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Verrill

The Regulatory Sprint is Over – What’s at the Finish Line Under the New Stark and AKS Final Rules?

Verrill on

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare &...more

Harris Beach Murtha PLLC

Breaking Down the New Stark Law and Anti-Kickback Statute Final Rules

Harris Beach Murtha PLLC on

In late November, the Centers for Medicare and Medicaid Services and the Office of the Inspector General released their final rules revising the Physician Self-Referral Law (the “Stark Law”) and the Anti-Kickback Statute. The...more

Bass, Berry & Sims PLC

CMS and the OIG Issue Final Rules Modernizing and Clarifying the Federal Stark and Anti-Kickback Laws

Bass, Berry & Sims PLC on

In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more

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