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Department of Health and Human Services (HHS) Cybersecurity Anti-Kickback Statute

Jones Day

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

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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

Jones Day

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

Jones Day on

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

Jones Day

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

Jones Day on

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

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 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

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Health Care Compliance Association (HCCA)

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

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

Health Care Compliance Association (HCCA)

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

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

Goodwin

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

Goodwin on

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

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - April 2023

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

ArentFox Schiff

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

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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

Mintz - Health Care Viewpoints

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

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

K&L Gates LLP

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

K&L Gates LLP on

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

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

McDermott Will & Emery

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

McDermott Will & Emery on

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

Manatt, Phelps & Phillips, LLP

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

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

BakerHostetler

The HHS Regulatory Sprint Removes Some Stark and AKS Hurdles for Donating Healthcare Technology

BakerHostetler on

This is the second in a series of client alerts on the collaborative effort between the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS), which...more

Faegre Drinker Biddle & Reath LLP

HHS Issues Final Cybersecurity Safe Harbor and Exception

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

Manatt, Phelps & Phillips, LLP

New HHS Regulations Create Opportunities for Digital Health Partnerships

On November 20, 2020, the Department of Health and Human Services (HHS) finalized a set of sweeping changes to the regulatory framework that governs fraud and abuse in the Medicare and Medicaid programs. Among other changes,...more

Mintz - Health Care Viewpoints

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

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

King & Spalding

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

King & Spalding on

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

Mintz - Health Care Viewpoints

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

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

Holland & Hart - Health Law Blog

Final Rules for Stark and Anti-Kickback Reforms Issued by CMS and OIG

On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician...more

Robinson+Cole Health Law Diagnosis

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the...more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

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