The Audit Process - While Medicaid audits are meant to ensure integrity and efficiency of the Medicaid Program, they can often be incredibly cumbersome and challenging for medical providers to navigate. During an audit,...more
On December 14, the U.S. Attorney’s Office for the Southern District of New York and other agencies announced the indictment of Niranjan Mittal, a Brooklyn cardiologist, on multiple fraud charges. Mittal allegedly fabricated...more
On September 18th, the U.S. Attorney’s Office for the Southern District of New York (includes Manhattan and the Bronx) announced a settlement with a cardiologist, Klaus Peter Rentrop (“Rentrop”), and his medical practice...more
New Florida legislation, Senate Bill 768 (2023), amending the Patient Self-Referral Act of 1992 (the Act), also known as the Florida "mini-Stark law," has been signed by Gov. Ron DeSantis and is set to take effect on July 1,...more
Background - In January 2023, the American Academy of Pediatrics (AAP) released new clinical practice guidelines on the evaluation and treatment of children with obesity. The new guidance, AAP’s first such update in 15...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
The Visiting Nurse Service of New York (VNSNY) has agreed to pay $57 million to settle a whistleblower lawsuit that alleged it billed the Medicare and Medicaid programs for hundreds of millions of dollars in home care visits...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 United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more
On December 1, 2016, the United States Attorney’s Office for the Northern District of Texas announced the indictment of 21 executives, physicians, surgeons, and others affiliated with Forest Park Medical Center (FPMC) in...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
The law firm of Baker, Donelson, Bearman, Caldwell & Berkowitz, P.C., sincerely appreciates the opportunity to comment upon the proposed clarifications and changes to the Stark regulations issued by the Centers and Medicare...more
The Centers for Medicare & Medicaid Services (CMS) recently proposed regulatory changes to the Stark Law that may ease certain compliance challenges. The Physician Self-Referral Law, located at 42 U.S.C. § 1395nn, and its...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