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Office of the Inspector General Anti-Kickback Statute Medical Devices

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

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Harris Beach PLLC

OIG December Enforcement Summary

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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

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding the Subsidization of Certain Medicare Cost-Sharing Obligations in the Context of a...

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On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...more

Bass, Berry & Sims PLC

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

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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

Nelson Mullins Riley & Scarborough LLP

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

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

Arnall Golden Gregory LLP

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

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

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Harris Beach PLLC

Cochlear Implant Manufacturer Proposes to Provide Free Compatible Hearing Aids

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This opinion addresses a proposed arrangement (“Proposed Arrangement”) by the manufacturer of cochlear implants (“Requestor”), where the Requestor would provide certain patients who receive one of their implants with a free...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

McDermott Will & Emery on

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

McDermott Will & Emery

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

McDermott Will & Emery on

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more

Dorsey & Whitney LLP

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

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​​​​​​​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

Paul Hastings LLP

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

Paul Hastings LLP on

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

McDermott Will & Emery

The Tale of Two CE Programs: OIG Compares Healthcare Provider and Third-Party Continuing Education in Recent Advisory Opinion

The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more

Sheppard Mullin Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving...more

Rivkin Radler LLP

OIG Permits Arrangement Involving Physician-Owned Medical Device Company

Rivkin Radler LLP on

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

ArentFox Schiff

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

ArentFox Schiff on

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

Stevens & Lee

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

Stevens & Lee on

The Office of Inspector General (“OIG”) in the Department of Health and Human Services has longstanding concerns regarding physician-owned entities that derive revenue from selling items ordered by their physician owners for...more

Holland & Knight LLP

OIG OKs Physician Ownership of Medical Device Company

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion on April 20, 2022, regarding physician ownership in a medical device company. The Advisory Opinion is significant...more

McGuireWoods LLP

OIG Approves Physician-Owned Medical Device Company With Several Safeguards

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On April 20, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-07) regarding physician ownership of a medical device company that manufactures...more

King & Spalding

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

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On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more

Mintz - Health Care Viewpoints

OIG Approves Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned Device Companies

After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more

McDermott Will & Emery

AdvaMed Updates Code to Provide Guidance on Innovative Arrangements, Medical Technology, Interactions with HCPs

The Advanced Medical Technology Association (AdvaMed) announced its revised Code of Ethics on Interactions with Health Care Professionals (2022 Code) on March 18, 2022. Notable updates to the 2022 Code provide guidance on...more

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