News & Analysis as of August 11, 2025

Medical Devices

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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 -

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

Epstein Becker & Green on 8/5/2025

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

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

Morgan Lewis - Health Law Scan on 8/1/2025

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

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

McDermott Will & Schulte on 7/28/2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

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

Venable LLP on 7/15/2025

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

Office of Inspector General Highlights Flat Fee Structures Not Immune From Anti-Kickback Statute

Holland & Knight LLP on 7/9/2025

The U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-08 (Opinion) on July 7, 2025, highlighting the limitations of the often-leveraged Personal Services and...more

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

Epstein Becker & Green on 6/24/2025

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

2025 Top-of-Mind Issues for Life Sciences Companies

Sheppard Mullin Richter & Hampton LLP on 1/31/2025

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

OIG December Enforcement Summary

Harris Beach Murtha PLLC on 1/12/2024

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

Bass, Berry & Sims PLC on 11/13/2023

On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

Nelson Mullins Riley & Scarborough LLP on 11/7/2023

On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more

OIG Determines That Providing Free Hearing Aids to Bimodal-Hearing Candidates Implicates the Anti-Kickback Statute and Beneficiary...

Arnall Golden Gregory LLP on 11/3/2023

On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

McDermott Will & Schulte on 9/26/2023

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

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

Goodwin on 5/26/2023

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

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

McDermott Will & Schulte on 3/30/2023

After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

Dorsey & Whitney LLP on 10/20/2022

The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

Mintz - Health Care Viewpoints on 10/11/2022

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more

Buyers Take Note: OIG Opinion Provides Insights on Physician-Owned Entities & Their Technologies

Paul Hastings LLP on 8/30/2022

PART I- On April 20, 2022, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued Advisory Opinion, No. 22-07 (“Opinion 22-07”), an informative opinion regarding arrangements...more

OIG Permits Arrangement Involving Physician-Owned Medical Device Company

Rivkin Radler LLP on 6/3/2022

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device...more

Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory...

ArentFox Schiff on 5/23/2022

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more

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Anti-Kickback Statute › Department of Health and Human Services (HHS) › Medical Devices

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

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

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

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

Office of Inspector General Highlights Flat Fee Structures Not Immune From Anti-Kickback Statute

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

2025 Top-of-Mind Issues for Life Sciences Companies

OIG December Enforcement Summary

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

OIG Determines That Providing Free Hearing Aids to Bimodal-Hearing Candidates Implicates the Anti-Kickback Statute and Beneficiary...

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

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

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

Buyers Take Note: OIG Opinion Provides Insights on Physician-Owned Entities & Their Technologies

OIG Permits Arrangement Involving Physician-Owned Medical Device Company

Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory...

OIG Anti-Kickback Opinion Examines Physician Ownership of Medical Device Manufacturer and Referrals

OIG OKs Physician Ownership of Medical Device Company

OIG Approves Physician-Owned Medical Device Company

AdvaMed Updates Code of Ethics on Interactions with HCPs: What’s the Impact on MedTech?

Latest Open Payments Data Released Under Heightened Government Scrutiny

Pharmaceutical and Medical Device Manufacturers Be Advised: Sunshine Act / Open Payments Enforcement is on the Rise

Anti-Kickback Statute › Department of Health and Human Services (HHS) › Medical Devices

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