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 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
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 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
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