News & Analysis as of August 14, 2025

Health Care Providers

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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 -

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on 6/25/2025

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Schulte on 4/28/2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Stark Law Changes for Group Practices

Shumaker, Loop & Kendrick, LLP on 9/9/2021

On December 2, 2020, the Center for Medicare and Medicaid Services (CMS) issued final regulations revising and clarifying regulations, which govern physician referrals for designated health services, commonly known as the...more

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

Steptoe & Johnson PLLC on 5/24/2021

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

Stark Law Updates Aimed at Advancing the Transition to Value-Based Care: CMS Issues a Final Rule Creating New Exceptions for...

Epstein Becker & Green on 12/21/2020

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published in the Federal Register companion final...more

OIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework

Epstein Becker & Green on 12/4/2020

On December 2, 2020, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register long-awaited, companion...more

CMS and OIG Release Stark and AKS Final Rules to Support Reforms for Coordinated, Value-Based Care

Butler Snow LLP on 12/1/2020

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”) released their highly-anticipated final rules to modernize and...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

Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint

BakerHostetler on 11/27/2020

With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback...more

Healthcare Blog Series: “Safe Harbor” Exceptions, Common Infractions, and Legislative Updates to the Anti-Kickback Statute and...

PilieroMazza PLLC on 11/12/2020

This is the second installment in a blog series examining the regulatory environment and key concerns for persons or businesses operating in the healthcare industry. The first installment of this series introduced the...more

[Virtual Event] 2020 Virtual Regional Healthcare Compliance Conference - Nashville, TN - November 13th, 8:10 am - 5:00 pm CST

Health Care Compliance Association (HCCA) on 10/28/2020

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

CMS Announces One-Year Delay in Finalizing Highly Anticipated Stark Law Reform

Mintz - Health Care Viewpoints on 8/28/2020

On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark...more

CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

Mintz - Health Care Viewpoints on 6/26/2020

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more

Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules

Health Care Compliance Association (HCCA) on 5/28/2020

As healthcare moves increasingly from fee-for-service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to...more

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

Seyfarth Shaw LLP on 4/7/2020

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

Newly Proposed AKS and Stark Law Protections For Value-Based Care Models

Jones Day on 3/12/2020

The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more

Proposed Revisions to Stark Law and AKS Protections for Electronic Health Records Donations

Jones Day on 2/27/2020

The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more

Changes coming to the Stark Law and Anti-Kickback Statute regulations

Bricker Graydon LLP on 2/10/2020

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

[Webinar] 2019 Q4 Healthcare Enforcement Roundup - February 5th, 2:30 pm ET

McDermott Will & Schulte on 1/28/2020

The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more

OIG Proposes Modifications to Personal Services Safe Harbor Under the AKS

Jones Day on 1/23/2020

The Situation: The Office of Inspector General ("OIG") proposes modifications to the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand shelter to...more

Triage in 2020: Health Care Topics to Watch in the New Year

K&L Gates LLP on 1/23/2020

In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more

Newly Proposed Protections for Cybersecurity Technology Under the AKS and Stark Law

Jones Day on 1/16/2020

The Situation: Despite the ongoing evolution of cybersecurity technology and services, patients' health information and other confidential data remain vulnerable to cyberattacks because such technology and services are often...more

The Race to Modernize Stark and the AKS: Unpacking the Value-based Proposals in HHS Regulatory Sprint Rulemaking

BakerHostetler on 12/18/2019

The U.S. Department of Health & Human Services (HHS) made great strides in its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark), Anti-Kickback Statute (AKS) and...more

A Giant Leap Forward in Value-Based Innovation or an Avalanche of New Administrative Requirements? An Analysis of the Value-Based...

K&L Gates LLP on 12/12/2019

As part of the Department of Health and Human Services’ (“HHS”) “Regulatory Sprint to Coordinated Care,” the following two proposed rules were issued on October 17, 2019, that, if finalized, will markedly change the...more

Special Report - Untangling VBEs, ACOs and CINs - What to Know about CMS and OIG's Proposed Regulations - December 2019

McDermott Will & Schulte on 12/10/2019

The Centers for Medicare & Medicaid Services and the Office of Inspector General recently released notices of proposed rulemaking relating to the Stark Law and the Anti-Kickback Statute. We break down the new proposed...more

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