News & Analysis as of

Fraud Office of the Inspector General Medical Devices

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

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

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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

King & Spalding

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

King & Spalding on

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

Bass, Berry & Sims PLC

OIG Approves Arrangement Involving Physician-Owned Device Manufacturer— Distinguishes Prior Special Fraud Alert on Physician-Owned...

Bass, Berry & Sims PLC on

On April 25, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-07, approving an arrangement whereby physicians hold ownership interests in a medical...more

Bass, Berry & Sims PLC

Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements

Bass, Berry & Sims PLC on

Improper billing for electro-acupuncture using a “P-Stim” device (or peri-auricular stimulation device) has been the subject of two False Claims Act (FCA) settlements already in 2021, following a trend of such enforcement...more

King & Spalding

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

King & Spalding on

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

K&L Gates LLP

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

K&L Gates LLP on

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

Bass, Berry & Sims PLC

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

Bass, Berry & Sims PLC on

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

King & Spalding

Are Pharma Speaker Programs Facing an Existential Crisis?

King & Spalding on

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

Fox Rothschild LLP

OIG Issues Special Fraud Alert On Speaker Programs

Fox Rothschild LLP on

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

Rivkin Radler LLP

OIG Issues Special Fraud Alert On Speaker Programs

Rivkin Radler LLP on

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

Bradley Arant Boult Cummings LLP

OIG Takes Aim at Speaker Programs in Special Fraud Alert

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

BakerHostetler

FDA and Pharmacy Weekly Digest - November 2020 #1

BakerHostetler on

Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more

ArentFox Schiff

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

ArentFox Schiff on

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

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 28, Number 37. News Briefs - October 2019 #2

California physician Donald Woo Lee was found guilty Oct. 17 for his role in providing medically unnecessary procedures to Medicare beneficiaries, upcoding, and repackaging single-use catheters for re-use, the Department of...more

Polsinelli

Health Reform + Related Health Policy News - October 2013 - Issue 3

Polsinelli on

In This Issue: - Top News ..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law ..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues ..Kaiser Study...more

Akerman LLP - Health Law Rx

PODs Continue To Attract Scrutiny From OIG And Congress

In the wake of a recent U.S. Department of Health and Human Services Office of Inspector General ("OIG") investigation, physicians with ownership interests in medical device distributorships and hospitals should prepare for...more

Davis Wright Tremaine LLP

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

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

Bradley Arant Boult Cummings LLP

OIG Special Fraud Alert on Physician-Owned Distributorships

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

Proskauer Rose LLP

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

Proskauer Rose LLP on

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

Baker Donelson

OIG Calls PODs "Inherently Suspect"

Baker Donelson on

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

Morgan Lewis

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

Morgan Lewis on

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

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