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 clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently posted the final rule establishing civil monetary penalties (CMPs) for information blocking (IB Enforcement Rule). The Rule...more
Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun...more
The Office of Inspector General (OIG) recently unveiled a quicker process to answer the healthcare industry’s most pressing questions on the Anti-Kickback Statute (AKS), allowing healthcare stakeholders to attain more timely...more
The Office of the National Coordinator for Health Information Technology (ONC) published noteworthy information blocking claim submission trends to date in its recent Information Blocking Claims: By the Numbers post on the...more
On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”). Prior...more
On November 6, 2021, the Fifth Circuit Court of Appeals temporarily blocked enforcement of the OSHA vaccination-or-testing rule. Citing “grave statutory and constitutional issues” with the rule, a three-judge panel issued the...more