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Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the Alert, the “speaker programs” are defined as company-sponsored events at which a health care professional makes a speech or presentation to other…

On October 2, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar II, announced the renewal of the public health emergency declaration due to the continued consequences of the COVID-19 pandemic. The 90-day renewal is effective October 23, 2020, and extends until January 20, 2021.

The renewal impacts a number of regulatory flexibilities and…

New guidance issued by the U.S. Department of Justice (DOJ) highlights the importance of updating corporate compliance programs to satisfy regulatory requirements.  The 2020 updates pick up where the 2019 guidance left off in addressing the evaluation metrics for compliance.  The key takeaway for 2020 is that companies are encouraged to update and improve compliance…

On October 24, 2018, Congress enacted a new anti-kickback law that applies to many commercial health insurance plans, as well as Medicare and Medicaid.  The law, known as the “Eliminating Kickbacks in Recovery Act of 2018” (the “Law”), was passed as part of the SUPPORT for Patients and Communities Act, which generally targets the national…

The Office of Inspector General (“OIG”) of the Department of Health and Human Services, generally, would have concerns about a potential or existing referral source receiving free goods or services, since these free goods and services could be used to provide unlawful payments for the referral of Federal health care program business.  However, under Advisory …

In a recent Advisory Opinion (No. 16-02), the OIG concluded that it would not seek sanctions against a state-run hospital (the “Hospital”) under the federal anti-kickback statute or the civil monetary penalty law for two arrangements under which the Hospital provides transportation aid and short-term lodging to pregnant women covered by federal health care programs.  …

The Office of Inspector General (OIG) of the Department of Health and Human Services posted an Advisory Opinion today addressing a hospital system’s proposal to lease administrative employees and to provide operational and management services to a related psychiatric hospital for an amount equal to the hospital system’s fully loaded costs (i.e., salary plus benefits…