In a matter of first impression, the Ninth Circuit Court of Appeals interpreted the scope of the 2018 Eliminating Kickbacks in Recovery Act (EKRA) in the context of a lab operator who allegedly paid marketers to induce...more
On April 9, 2025, OIG posted Advisory Opinion No. 25-02, a favorable advisory opinion allowing a community health center operating under Section 330 of the Public Health Service Act (the Requestor) to ask individuals, to whom...more
In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more
Under the Federal Ethics in Patient Referrals Act (more commonly known as “Stark”), if a physician has a financial relationship with an entity, the physician may not refer patients to the entity for medical services payable...more
The U.S. Department of Justice (DOJ) announced that Flower Mound Hospital Partners LLC, a partially physician-owned hospital in Flower Mound, Texas, agreed to pay $18.2 million to settle its alleged violations of the False...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
Most health care providers have at least a basic understanding of the Anti-Kickback Statute. This federal law prohibits providers from offering, paying, soliciting, or accepting any form of “remuneration” for patient...more
Nonprofit Hospital System and Physician Practice Reach $10 Million Settlement for False Claims Act Allegations - Centra Health Inc., a nonprofit hospital system, and Blue Ridge Ear, Nose, Throat and Plastic Surgery, Inc.,...more
Boston Heart Diagnostics, a Massachusetts company, agree to pay $26.7 million to settle a False Claims Act case involving allegations of paying illegal kickbacks to physicians....more
On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited...more
As part of the long-awaited proposed changes “to modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) released on October 9, 2019, the Centers for Medicare and Medicaid...more
• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more
Despite the controversial impact of the Supreme Court’s Escobar decision, the Justice Department’s False Claims Act prosecutions and settlements are continuing at a consistent rate – heading towards another multi-billion...more
CMS is seeking input on ways to reduce the regulatory burdens of the physician self-referral law (commonly known as the Stark Law), particularly as it relates to the ongoing effort to transition from a fee-for-service to a...more
The Department of Justice (DOJ) reports that, in fiscal year 2016 ending September 30, it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims. More than half of this...more
The Physician Self-Referral Law, also known as the Stark law, prohibits a physician from referring federal health care program patients for “designated health services” to an entity in which the physician (or an immediate...more
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...more
On June 9, 2015, the Department of Health and Human Services, Office of Inspector General issued a new Fraud Alert entitled "Physician Compensation Arrangements May Result in Significant Liability" (Alert) in the wake of 12...more
Hailed as “another achievement” for the government’s Health Care Fraud Prevention and Enforcement Action Team (referred to as “HEAT”), the U.S. Department of Justice has announced that a Florida skilled nursing company and...more
It appears that the Office of Inspector General (“OIG”) now has physicians squarely in the crosshairs of one of its most powerful enforcement tools: the Anti-Kickback Statute (“AKS”). The AKS is a criminal statute with...more
Emphasizing its continued focus on physician compensation arrangements, the OIG issued a Fraud Alert on June 9, 2015, warning that physicians risk significant penalties if medical directorships and other compensation...more