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Anti-Kickback Statute › Manufacturers

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 -
Morgan Lewis - Health Law Scan

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

Morgan Lewis - Health Law Scan on

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

Baker Donelson

OIG Advisory Opinion 25-08: Unfavorable DME – Vendor Payment Arrangement

Baker Donelson on

On July 1, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 25-08, an unfavorable opinion discussing a proposed arrangement in which a medical device company...more

Hogan Lovells

OIG issues two unfavorable decisions, cautions against some customer service fees paid by manufacturers

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued two unfavorable decisions in Advisory Opinions (AOs) 25-04 and 25-08 (the “Opinions”), finding that some service fees paid by...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

Foley & Lardner LLP on

In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Skadden, Arps, Slate, Meagher & Flom LLP on

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

Bass, Berry & Sims PLC

OIG Declines to Approve Medical Device Company's Proposal to Subsidize Screening Costs

Bass, Berry & Sims PLC on

On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical device company (Requestor) to pay the...more

Epstein Becker & Green

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

Epstein Becker & Green on

On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....more

Mintz - Health Care Viewpoints

OIG Favorable Advisory Opinion on Physician Practice’s Arrangement with Telehealth Platform and Recent Corporate Practice of...

Mintz - Health Care Viewpoints on

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more

Goodwin

New Dental Industry Compliance Standards Take Shape: Dental Trade Alliance (DTA) Releases Revised Code of Ethics

Goodwin on

On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers – issued a revised and restated U.S. Code of Ethics...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

Dentons on

In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

Rivkin Radler LLP

Seventh Circuit Rejects Extension of AKS to Marketing Companies Without Evidence of Intent to Induce Referrals

Rivkin Radler LLP on

The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more

King & Spalding

Seventh Circuit Reverses AKS Conviction Involving Payments to Marketers and DME Manufacturer

King & Spalding on

On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more

Foley & Lardner LLP

Health Care Marketing: The Seventh Circuit Addresses “Referrals” Under The Anti-Kickback Statute

Foley & Lardner LLP on

Health care organizations working with marketers, independent sales representatives, advertising, and other consulting support to promote sales of products or services received welcomed news that their arrangements may be...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Travel-Related Subsidies

Arnall Golden Gregory LLP on

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

Morrison & Foerster LLP on

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

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

Arnall Golden Gregory LLP on

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Cozen O'Connor

The State AG Report – 10.10.2024

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •GOP AGs Urge Congress to Tune In and Support AM Radio in...more

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

Arnall Golden Gregory LLP on

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Foley & Lardner LLP

New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers

Foley & Lardner LLP on

The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more

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