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
HHS has recently issued a great number of clarifications to multiple aspects of its Provider Relief Fund programs authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act....more
On April 27, 2020, the Health Resources and Services Administration (HRSA), a component of the U.S. Department of Health and Human Services (HHS), announced guidance for health care providers regarding HRSA COVID-19 Claims...more
The Coronavirus Aid, Relief and Economic Security (CARES) Act makes $100 billion in funds available to hospitals and other health care providers for health care-related expenses or lost revenues attributable to COVID-19. The...more
The Department of Health and Human Services (HHS) is in the process of completing a $50 billion general distribution (General Distribution) from the $100 billion available to health care providers through the Public Health...more
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a brief explanatory guidance document related to the scope and application of its previous Stark Law blanket waivers to certain financial...more
The U.S. Court of Appeals for the Fifth Circuit affirmed on April 15, 2020 the dismissal of a non-intervened qui tam action in United States ex rel. Porter v. Magnolia Health Plan, because the relator failed to adequately...more
On April 10, 2020, the federal government began distributing $30 billion of the $100 billion in funds that the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) makes available to health care providers through...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
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an unprecedented list of Stark Law blanket waivers under its emergency authority granted in Section 1135 of the Social Security Act (the Act)...more
Following President Trump’s declaration of a national emergency, Secretary of Health and Human Services Alex Azar announced on March 13, 2020 a waiver pursuant to Section 1135 of the Social Security Act of numerous laws and...more