In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more
4/7/2023
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare ,
OIG ,
Regulatory Standards ,
Remuneration
In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in...more
11/30/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Physicians ,
Safe Harbors ,
Self-Referral ,
Stark Law
The U.S. Department of Justice (the “DOJ”) recently settled whistleblower False Claims Act (“FCA”) allegations against The University of Miami (“UMiami”) for $22 million, which resolves claims from three separate lawsuits...more
A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the...more
The Department of Health and Human Services (“HHS”), in collaboration with the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”), has issued two final rules clarifying certain...more
On October 9, 2019, the Department of Health and Human Services ("HHS") issued proposed changes to the regulations implementing the Physician Self-Referral Law (the "Stark Law"), the Anti-Kickback Statute (the "AKS"), and the...more
10/15/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
EHR ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
OIG ,
Proposed Amendments ,
Stark Law ,
Value-Based Care
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more
12/16/2016
/ Ambulance Providers ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
FQHC ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Low-Income Issues ,
Medicaid ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part B ,
OIG ,
Pharmacies ,
Remuneration ,
Rural Areas ,
Safe Harbors ,
TRICARE ,
Veterans Administration
On March 26, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert (Fraud Alert) reiterating its long-standing concern that the opportunity for a referring physician to earn a profit by investing in a venture...more