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, 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
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
Report on Medicare Compliance 28, no. 41 (November 18, 2019) - - North Carolina physician Damian Brezinski and his medical group, Wilmington Health, agreed to pay $244,000 to settle false claims allegations in connection...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
Generally, when a doctor is convicted for fraud, the misdeeds are limited to a single category of fraud. Maybe the doctor charged for procedures that weren’t performed; maybe there were kickbacks for referrals; or maybe...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
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
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
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
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
In This Issue: Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups Scheduled. ...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