News & Analysis as of

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

Morgan Lewis - Health Law Scan

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Husch Blackwell LLP on

In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

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

Foley & Lardner LLP

Unpacking the Federal Anti-Kickback Statute’s Application to Payments to Medicare Advantage Agents and Brokers

Foley & Lardner LLP on

On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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

A&O Shearman

First Circuit Ruling Requiring “But-For” Causation In FCA Kickback Claims Deepens Circuit Split

A&O Shearman on

In an opinion that may complicate the U.S. Department of Justice’s (“DOJ”) efforts to enforce the False Claims Act (“FCA”), the U.S. Court of Appeals for the First Circuit held in a unanimous opinion on February 18, 2025 that...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Foley Hoag LLP

False Claim Act Liability Under Anti-Kickback Statute Requires But-For Causation: First Circuit Narrows Liability in Growing...

Foley Hoag LLP on

On February 18, 2025, the First Circuit Court of Appeals issued its decision in U.S. v. Regeneron Pharmaceuticals, ruling that the Anti-Kickback Statute (“AKS”) requires the government to prove that an AKS violation was the...more

Arnall Golden Gregory LLP

Lowering the Bar: Second Circuit Finds “At-Least-One-Purpose” Sufficient for Proving Anti-Kickback Statute Violation

On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Travel-Related Subsidies

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

Hinshaw & Culbertson - Health Care

Healthcare Providers, Agents, and Brokers: Please Stop, Look, and Listen Before Entering Into Suspect Medicare Advantage Plan...

The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) issues Special Fraud Alerts regarding healthcare fraud and abuse patterns or practices it has recently identified and intends to...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | November 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more

Akerman LLP - Health Law Rx

Don’t Be Suspicious, Don’t Be Suspicious: New OIG Special Fraud Alert Warns About Suspect Payments in Medicare Advantage Marketing...

The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage...more

Fox Rothschild LLP

OIG Publishes Special Fraud Alert on Medicare Advantage Marketing Arrangements

Fox Rothschild LLP on

On December 11, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Special Fraud Alert warning against suspect payment arrangements involving the Medicare Advantage (“MA”) program...more

Proskauer - Health Care Law Brief

OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more

Health Care Compliance Association (HCCA)

[Event] 2025 Board & Compliance Committee Conference - February 24th - 25th, Phoenix, AZ

The Board & Compliance Committee Conference is designed specifically to educate board members on best practices and recommendations for establishing and maintaining an effective compliance program. The OIG-HHS will discuss...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | October 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

Venable LLP

Event in Review: Major Fraud and Abuse Laws: Anti-Kickback and Self-Referral Prohibitions and False Claims

Venable LLP on

Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

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