News & Analysis as of September 21, 2024

Fraud

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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 -

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

McDermott Will & Emery on 3/9/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

McDermott Will & Emery on 2/8/2023

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

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

Sheppard Mullin Richter & Hampton LLP on 6/28/2022

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

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

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

King & Spalding on 5/4/2022

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

Investigations Newsletter: DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller

ArentFox Schiff on 11/15/2021

DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more

OIG Issues Warning About Speaker Programs Sponsored by Drug and Device Companies

King & Spalding on 12/1/2020

On November 16, 2020, OIG issued a significant Special Fraud Alert that warns about certain “inherent” fraud and abuse risks raised by speaker programs sponsored by pharmaceutical and medical device companies. OIG expressed...more

HHS OIG Highlights "Inherent Fraud and Abuse Risks" of Company-Sponsored Speaker Programs in Rare Special Fraud Alert

K&L Gates LLP on 11/30/2020

Lavish “speaker programs” sponsored by pharmaceutical and medical-device companies may soon be a thing of the past—and not just because of the COVID-19 pandemic. In a 16 November 2020 Special Fraud Alert (Alert) issued by the...more

Special Fraud Alert: Speaker Programs – If It's Too Good to Be True, It Probably Is

Bass, Berry & Sims PLC on 11/25/2020

On November 16, the Department of Health and Human Services Office of Inspector General (OIG) took a shot across the bow of the healthcare industry when it published a Special Fraud Alert highlighting some of the fraud and...more

Are Pharma Speaker Programs Facing an Existential Crisis?

King & Spalding on 11/25/2020

Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more

OIG Issues Special Fraud Alert On Speaker Programs

Fox Rothschild LLP on 11/23/2020

Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...more

OIG Issues Special Fraud Alert On Speaker Programs

Rivkin Radler LLP on 11/23/2020

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose...more

OIG Takes Aim at Speaker Programs in Special Fraud Alert

Bradley Arant Boult Cummings LLP on 11/20/2020

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more

OIG Issues Fraud Alert: Should Pharma and Device Companies Cease Speaker Programs?

ArentFox Schiff on 11/18/2020

The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 1/24/2020

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Investigations Newsletter: Podiatrist Sentenced to Prison for Fraudulent Billing Scheme

ArentFox Schiff on 7/29/2019

Podiatrist Sentenced to Prison for Fraudulent Billing Scheme - On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

Bass, Berry & Sims PLC on 5/16/2017

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

OIG Special Fraud Alert Labels Physician-Owned Distributorships (PODs) as “Inherently Suspect”

Davis Wright Tremaine LLP on 4/22/2013

The U.S. Department of Health & Human Services, Office of Inspector General (the “OIG”) issued a Special Fraud Alert (“Alert”) on March 26, underscoring its heightened focus on fraud and abuse risks posed by physician-owned...more

OIG Special Fraud Alert on Physician-Owned Distributorships

Bradley Arant Boult Cummings LLP on 4/16/2013

On March 26, 2013, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled “Physician-Owned Entities.” The Alert is consistent with an ongoing theme of concern...more

OIG Issues Special Fraud Alert on Business Arrangements with Physician-Owned Entities

Proskauer Rose LLP on 4/15/2013

On March 26, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert (Fraud Alert) reiterating its long-standing concern that the opportunity for a referring physician to earn a profit by investing in a venture...more

OIG Issues Special Fraud Alert for Physician-Owned Entities

BakerHostetler on 4/5/2013

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued a Special Fraud Alert expressing concern that physician-owned entities "that derive revenue from selling, or arranging for the...more

OIG Calls PODs "Inherently Suspect"

Baker Donelson on 3/29/2013

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

Hospitals and Doctors Beware: OIG Issues Special Fraud Alert on Physician-Owned Entities

Morgan Lewis on 3/28/2013

Alert notes attributes and practices that produce substantial fraud and abuse risk. On March 26, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its "Special Fraud...more

OIG Places Fraud and Abuse Spotlight on Physician-Owned Entities

Saul Ewing Arnstein & Lehr LLP on 3/28/2013

Physician-owned distributorships continue to attract federal scrutiny. A new OIG Alert highlights health care transactions that make these distributorships vulnerable to enforcement activity. ...more

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Anti-Kickback Statute › Medical Devices › Fraud

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