News & Analysis as of

Physician-Owned Distributors Office of the Inspector General

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

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

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

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

Foley & Lardner LLP

The Resurgence of the Ambulatory Surgery Center: Seven Considerations for Ownership

Foley & Lardner LLP on

After a prolonged period of stagnant growth primarily due to a glut of capacity coupled with flat or declining revenue growth, we’re beginning to see a resurgence of Ambulatory Surgery Centers (ASCs). In fact, experts are...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

Sheppard Mullin Richter & Hampton LLP

Federal Spotlight Continues to Shine on Physician-Owned Distributorships

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

Burr & Forman

2013 Healthcare Year In Review

Burr & Forman on

Bob Dylan's quote from 1964 -- "The Times They Are A-Changin" -- could equally apply to the healthcare industry in 2013. This was the year that the Affordable Care Act ("ACA") came into full public view with the start of the...more

Baker Donelson

OIG Report Concludes that Physician-owned Distributors Increase Utilization

Baker Donelson on

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

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

King & Spalding

New OIG Report Examines Cost-Effectiveness of Physician-Owned Spinal Device Distributorships

King & Spalding on

On Thursday, October 24, the HHS Office of Inspector General (OIG) released a report responding to a request from members of the Senate Finance Committee to determine the extent to which physician-owned distributorships...more

Morgan Lewis

OIG Comes Down Hard on Physician-Owned Distributorship Arrangements

Morgan Lewis on

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

King & Spalding

Medical Device Company Files First Amendment Lawsuit Challenging OIG’s Criticism of Physician-Owned Distributors (PODs)

King & Spalding on

On October 8, 2013, Reliance Medical Systems, LLC (“Reliance”) filed a Complaint against the HHS OIG in the United States District Court for the Central District of California. The Complaint alleges that OIG’s assertion in a...more

Polsinelli

PODs Beware: OIG Releases Special Fraud Alert

Polsinelli on

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

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

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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