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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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