News & Analysis as of

Physicians Anti-Kickback Statute Physician-Owned Distributors

Rivkin Radler LLP

Spinal Device Distributor, Owners and PODs Settle Kickback Claims for $1 Million

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) recently announced that Reliance Medical Systems LLC, a Utah-based distributor of spinal implant devices, two of its individual owners, and two of its physician-owned distributorships...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

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

Holland & Knight LLP on

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

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

Goodwin

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

Foley & Lardner LLP

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Foley & Lardner LLP on

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

Davis Wright Tremaine LLP

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...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

BakerHostetler

OIG Issues Special Fraud Alert for Physician-Owned Entities

BakerHostetler on

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

King & Spalding

OIG Issues Special Fraud Alert on Physician-Owned Distributorships

King & Spalding on

On March 26, 2013, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert warning that OIG will view physician-owned distributorships (PODs) as “inherently suspect” under the Federal anti-kickback statute....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

Saul Ewing Arnstein & Lehr LLP

OIG Places Fraud and Abuse Spotlight on Physician-Owned Entities

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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