Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more
The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has...more
On December 19, 2022, OIG posted Advisory Opinion 22-20, responding to a request submitted by an acute care hospital (the Hospital) regarding the utilization of its employed nurse practitioners (NPs) to perform services that...more
On February 4, 2022, OIG issued Advisory Opinion No. 22-02 in which it responded to a request for an advisory opinion submitted by a hospital system that operates a children’s hospital (Requestor) regarding a proposed...more
On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
In its last Advisory Opinion of 2019 (19-06), the OIG approved a proposed arrangement involving a retailer rewards program through which out-of-pocket costs on in-store pharmacy purchases would qualify customers for future...more
The Situation: The Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") released an advisory opinion providing new insight into the evaluation of fraud and abuse risks of per-click fee...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
On November 3, 2016, the OIG issued another favorable Advisory Opinion, No. 16–11, regarding an agreement between a Medigap insurer and preferred hospital network. The OIG has issued several opinions regarding similar...more
Recognizing that a narrowly tailored complimentary transportation program may pose minimal risk of fraud and abuse, the OIG posted favorable Advisory Opinion No. 15-13 on October 21, 2015. The Opinion approves an integrated...more