The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective

The U.S. Department of Justice announced on November 20 that Doctor’s Choice Home Care, Inc. agreed to pay $3,856,000 to resolve allegations that the agency paid illegal kickbacks to physicians for referring patients. The agency will pay an additional $675,000 to resolve separate allegations that its employees pressured clinical personnel to increase the number of

On November 20, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) announced the issuance of long-awaited final rules to modernize the Stark Law and federal Anti-Kickback Statute (AKS). Proposed changes, intended to promote value-based arrangements for providers and coordinated care for patients,

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose inherent fraud and abuse risks. OIG is “skeptical about the educational value of such programs” and cautioned that remuneration to referring practitioners

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying kickbacks to a South Dakota neurosurgeon to use Medtronic’s medical devices. Medtronic will pay an additional $1.11 million for

An article in the November issue of Healthcare Risk Management, “$50 Million Stark Settlement Shows Risk of Violation, Whistleblowers,” discussed Wheeling Hospital’s $50 million settlement with the U.S. Department of Justice (DOJ) that resolved a whistleblower complaint filed in 2017 by a former executive of the hospital. Rivkin Radler’s Jeff Kaiser was quoted in the

On October 2, the U.S. Department of Justice (DOJ) announced that Phamatech, Inc. and its CEO have agreed to pay $3,043,484 to settle alleged False Claims Act (FCA) allegations. San Diego-based Phamatech, a medical technology company that manufactures diagnostic devices and provides laboratory testing, allegedly submitted false claims to Medicare for drug-testing services.

In addition

In the words of the American Association of Naturopathic Physicians: “Since March, the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) have been aggressive in policing online language about COVID—and with good reason! Fraudulent products and false claims abound.” In one such instance, discussed here, the U.S. Department of Justice charged a physician with

On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug Letairis. In addition to the False Claims Act

In United States ex rel. Cimznhca, LLC v. UCB, Inc., the 7th Circuit Court of Appeals weighed in on a Circuit Court of Appeals dispute over the correct standard to apply to the government’s decision to dismiss a qui tam lawsuit under the False Claims Act (FCA). The authority of the government to dismiss an action,