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
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more
On August 4, 2020, the Office of Inspector General for the United States Department of Health and Human Services (OIG) released an FAQ regarding whether a clinical laboratory may provide free antibody testing to federal...more
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more