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
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...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
On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...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
On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach...more
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...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 December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...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 May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...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
At the annual meeting of the American Health Lawyers Association (AHLA) held this week in Washington D.C., the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new legal team...more