News & Analysis as of

Anti-Kickback Statute Centers for Medicare & Medicaid Services (CMS) Fraud and Abuse

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... more +
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 -
Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Holland & Hart LLP

Patient Inducements: Law and Limits

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Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

King & Spalding

OIG Issues Advisory Opinion for Alzheimer’s Study to Subsidize PET Imaging Coinsurance Costs

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On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study...more

McDermott Will & Emery

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

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Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

McGuireWoods LLP

Fraud and Abuse Rules Part V: Easing Stark Law Compliance

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As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more

Troutman Pepper

Anti-Kickback Statute Enforcement Year in Review and Outlook for 2021

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I. Introduction - While 2020 was a year like no other in many ways, the challenges posed by the global COVID-19 pandemic do not appear to have stalled the Department of Justice’s (DOJ) health care fraud enforcement...more

ArentFox Schiff

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

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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

McGuireWoods LLP

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

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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

ArentFox Schiff

Searching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute Protection

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Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more

McGuireWoods LLP

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

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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

McGuireWoods LLP

Stark Law and Anti-Kickback Statute Reform: Six Key Insights for Private Equity Healthcare Affiliations

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Two new healthcare fraud and abuse final rules, effective Jan. 19, 2021, may increase flexibility for private equity firms exploring opportunities in the healthcare space as well as private equity-backed healthcare platforms...more

Faegre Drinker Biddle & Reath LLP

New Stark Exceptions Mark Shift to Value-Based Care

On November 20, 2020, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations” (Final Rule)....more

Hogan Lovells

HHS Regulatory Sprint takes final shape: Part 1: Substantial Stark Law regulatory revisions adopted

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Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) adopted additional revisions to the Stark Law regulations (the final...more

Seyfarth Shaw LLP

HHS OIG and CMS Release Historic, Sweeping Reforms to Stark Law and Anti-Kickback Statute Regulations

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As mentioned in our earlier report, on November 20, 2020, The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) published two long-awaited final...more

Bricker Graydon LLP

[Webinar] Stark Law and Anti-Kickback Statute Final Rules – Exploring the major changes to fraud and abuse laws - December 14th,...

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On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services Office of Inspector General issued highly anticipated final rules to reform fraud and abuse law for the...more

Morgan Lewis - Health Law Scan

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

Polsinelli

HHS and CMS Finalize Historic Changes to Medicare Fraud and Abuse Laws

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On November 20, 2020, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), and the Centers for Medicare and Medicaid Services (CMS) finalized three rules making historic changes to three of...more

Bricker Graydon LLP

[Webinar] Stark Law and Anti-Kickback Statute Final Rules – Exploring the major changes to fraud and abuse laws - December 7th,...

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On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services Office of Inspector General issued highly anticipated final rules to reform fraud and abuse law for the...more

Troutman Pepper

Fraud Emerges as Telemedicine Surges: Compliance Guidance for Telemedicine Providers

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Telemedicine providers – whether they are established or new to the space – should examine the type of conduct DOJ has recently focused on and adapt their compliance systems accordingly. Providers should also consider the...more

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