News & Analysis as of November 15, 2024

Cybersecurity

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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 -

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

Jones Day on 4/8/2024

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part I

Jones Day on 4/1/2024

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on 3/25/2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

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

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

[Event] 2023 Board & Audit Committee Compliance Conference - October 23rd - 24th, Fort Lauderdale, FL

Health Care Compliance Association (HCCA) on 6/30/2023

Discover today's best practices for your role in healthcare compliance oversight - The Office of Inspector General of Health and Human Services expects healthcare board members, board audit/compliance committee members,...more

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

Health Care Compliance Association (HCCA) on 9/1/2022

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

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

ArentFox Schiff on 3/3/2021

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

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity...

Mintz - Health Care Viewpoints on 2/8/2021

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

Changes to Stark and Anti-Kickback Regulations Address Technology Advances, Tighten Rules for EHR Contributions, and Promote...

ArentFox Schiff on 2/1/2021

Fraud and abuse regulations have been adapted to meet today’s technology for electronic data, promoting cooperation among health care providers for the exchange of health information and the protection of such information...more

White Paper: OIG Finalizes New and Revises Existing AKS Safe Harbors and Creates New CMP Law Exception

K&L Gates LLP on 1/22/2021

On 2 December 2020, the Office of Inspector General (OIG) in the U.S. Department of Health & Human Services (HHS) issued a long-awaited final rule (the Final Rule or Rule). The Final Rule adds multiple new safe harbors,...more

OIG and CMS Modify AKS Safe Harbor and Stark Law Exception for EHR Donations

Jones Day on 1/21/2021

The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more

New Stark Law and Anti-Kickback Statute Protections for Cybersecurity Technology

Jones Day on 1/19/2021

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

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

McGuireWoods LLP on 1/13/2021

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

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

Verrill on 1/8/2021

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

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on 12/23/2020

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

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

Harris Beach PLLC on 12/23/2020

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

[Webinar] Unpacking the Anti-Kickback and Stark Reforms: Promoting Value-Based Care and Easing Regulatory Compliance - January...

Manatt, Phelps & Phillips, LLP on 12/22/2020

A New Manatt Webinar Guides You Through New Reforms Promoting Value-Based Care and Easing Regulatory Compliance—the Most Significant Changes to the Federal Fraud and Abuse Landscape in the Last Decade. On November 20,...more

HHS Issues Final Cybersecurity Safe Harbor and Exception

Faegre Drinker Biddle & Reath LLP on 12/16/2020

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each released a final rule (the Final Rules). The Final...more

Final Rules Modernize Stark Law and Anti-Kickback Statute (AKS) Regulations

Womble Bond Dickinson on 12/11/2020

In November 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) each issued long-awaited final rules that modernize and change the Stark...more

New Sprint Regulations Encourage Investment in EHR and Cybersecurity Technology

Davis Wright Tremaine LLP on 12/4/2020

On December 2, 2020, under the Trump Administration's "Regulatory Sprint to Coordinated Care" initiative, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final...more

HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations, Part 2: Beneficiary...

Mintz - Health Care Viewpoints on 12/2/2020

While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more

Major Changes Finalized to Stark Rules, Anti-Kickback Statute Safe Harbors and the Beneficiary Inducements CMP

King & Spalding on 12/1/2020

CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more

Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the...

Sheppard Mullin Richter & Hampton LLP on 11/30/2020

On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more

HHS Issues Final Rules Implementing Stark Law and Anti-Kickback Statute Reforms

King & Spalding on 11/30/2020

On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more

HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations

Mintz - Health Care Viewpoints on 11/24/2020

On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark...more

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Anti-Kickback Statute › Office of the Inspector General › Cybersecurity

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