False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
2022 Resolutions: What Healthcare Practices Need To Tackle In the New Year
Goran Musinovic on Healthcare Real Estate Compliance
Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Anti Kickback and Stark Law Enforcement and Compliance Issues
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
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
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
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
As previous False Claims Act (FCA) Fundamentals posts have discussed, the FCA, 31 U.S.C. § 3729, et seq., can be triggered by submitting claims tied to violations of certain federal statutes. This post will explain the basics...more
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
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
On November 20, 2020, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules modifying regulations for the Physician...more
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
This is the fifth in a five-part series discussing the new Value-Based Regulations adopted last year by the Centers for Medicare & Medicaid Services and the Office of Inspector General. The Stark Full Financial Risk...more
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
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
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
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
A January 20, 2021 memo issued by the Biden Administration may freeze the implementation of the Stark Law and Anti-kickback Statute (“AKS”) final rules that went into effect on January 19, 2021. According to the U.S....more
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more
The Situation: The Office of Inspector General ("OIG") recently modified the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand protections to...more
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
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
The Situation: The adoption of new technologies has been a hallmark of the health care industry in the twenty-first century. While these technologies have helped to improve both industry efficiency and patient outcomes, the...more
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
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value...more
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