News & Analysis as of September 19, 2024

Anti-Kickback Statute › Physician-Owned Distributors

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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... more +

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 -

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

Rivkin Radler LLP on 7/28/2022

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

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

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

Stevens & Lee on 5/16/2022

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

OIG OKs Physician Ownership of Medical Device Company

Holland & Knight LLP on 5/5/2022

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

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

OIG Approves Physician-Owned Medical Device Company

Mintz - Health Care Viewpoints on 4/28/2022

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

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

Manatt, Phelps & Phillips, LLP on 4/28/2022

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

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on 11/5/2021

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

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Foley & Lardner LLP on 5/20/2016

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

Senate Finance Committee Updates Report on Physician-Owned Distributorships

Morgan Lewis on 5/11/2016

The report finds that PODs increase overutilization, lack transparency, and increase the risk of patient harm and warns that hospitals must combat the growing threat of PODs. On May 10, the US Senate Committee on Finance...more

Federal Spotlight Continues to Shine on Physician-Owned Distributorships

Sheppard Mullin Richter & Hampton LLP on 1/5/2016

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business...more

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

Davis Wright Tremaine LLP on 9/26/2014

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

OIG Report Concludes that Physician-owned Distributors Increase Utilization

Baker Donelson on 11/8/2013

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

OIG Comes Down Hard on Physician-Owned Distributorship Arrangements

Morgan Lewis on 10/25/2013

Hospitals and physician-owned entities should consider new report’s cost and utilization concerns. On October 24, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released...more

PODs Beware: OIG Releases Special Fraud Alert

Polsinelli on 5/10/2013

The Office of the Inspector General (OIG) released a Special Fraud Alert on March 26, 2013 warning that physician-owned distributorships (PODs) are "inherently suspect" under the Anti-Kickback Statute (AKS). Generally...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 Issues Special Fraud Alert on Physician-Owned Distributorships

King & Spalding on 4/2/2013

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

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

Trends to Watch in 2013: Physician-Owned Distributors

Snell & Wilmer on 1/2/2013

Physician-owned distributors (PODs) that sell medical devices have seen substantial growth over the last few years as well as increased regulatory scrutiny. We expect both trends to continue in 2013. PODs are arrangements in...more

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