Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more
On April 11, 2022, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion No. 22-06 (AO 22-06), which approved a biopharmaceutical company’s proposed arrangement to...more
On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and...more
In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were...more
On November 20, 2020, in addition to new Stark Law regulations intended to accommodate value-based financial arrangements with physicians, the Centers for Medicare and Medicaid Services (CMS) issued final regulations that...more
As part of its Regulatory Sprint to Coordinated Care, on November 20, 2020, the Department of Health and Human Services (HHS) published two final rules which make significant and sweeping changes to regulations relating to...more
On November 16, 2020, the Department of Health and Human Services, Office of Inspector General (OIG) published a Special Fraud Alert for Speaker Programs. The Special Fraud Alert "highlights some of the inherent fraud and...more
On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more
The Department of Justice (DOJ) has begun to file health care fraud and kickback cases arising from the novel coronavirus crisis. For example, on March 30, 2020, the U.S. Attorney’s Office for the District of New Jersey...more