The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more
Last week, the U.S. Supreme Court denied the request of qui tam relators that it review the Sixth Circuit’s recent decision in United States of America ex rel. Martin v. Hathaway, No. 22-1463 (6th Cir.). In so doing, the...more
On March 28, 2023, the U.S. Court of Appeals for the Sixth Circuit issued a decision in U.S. ex rel. Martin v. Hathaway limiting the scope of liability under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) in...more
This week, the Sixth Circuit closed two paths the government and relators have tried to take to expand liability for medical providers under the Anti-Kickback Statute (AKS) and False Claims Act (FCA): the meaning of...more
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently posted Advisory Opinion 22-20, approving an acute care hospital’s arrangement under which its employed nurse practitioners...more
Hospitals and Other Providers Should Make Sure Any Items or Services of Value That They Provide to Their Referring Physicians To Alleviate Burnout Comply With the Stark Law - Amidst the ongoing labor market shortages and...more
Report on Medicare Compliance 30, no. 4 (February 1, 2021) - Saint Peter’s University Hospital and New Brunswick Cardiac Cath Lab LLC in New Jersey have agreed to pay $3.04 million to settle a civil monetary penalty case...more
As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is...more
CMS made impactful changes to the Federal physician self-referral law’s (i.e., Stark Law’s) regulations in its Final Rule that were effective January 19, 2021 (with the exception of the changes to 42 C.F.R. § 411.352(i) that...more
The Situation: On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the long-awaited final rule to modernize and clarify the Stark Law. As part of this final rule, CMS reviewed stakeholder...more
A recent Eleventh Circuit opinion clarified the mens rea burden the Government must prove to establish criminal intent to violate the Federal Anti-Kickback Statute (“AKS”) for a recipient or payee of a kickback or bribe under...more
The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) has issued a Policy Statement declaring that it will not impose administrative sanctions under the Federal Anti-Kickback Statute for certain...more
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or market value...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
Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited...more
On December 17, 2018, the Department of Justice (DOJ) moved to dismiss 11 False Claims Act (FCA) cases brought by whistleblowers against pharmaceutical manufacturers and their commercial outsourcing vendors, alleging that...more
A recent piece of federal legislation intended to address the opioid crisis across the United States may have some unintended consequences. In attempting to prohibit “patient brokering” in the narrow context of addiction...more
On October 24, 2018, President Trump signed into law comprehensive opioid legislation known as the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the...more
On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more
There are many health care financial arrangements where one entity has a financial obligation to another, with whom it either does business directly, or to which it makes referrals, and that obligation is either past due or...more
The Ethics in Patient Referrals Act (“Stark”) prevents hospitals from paying employed or contracted physicians in the same way that physicians are or were paid by independent physician groups. Specifically, physician groups...more
The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a...more
A clinical laboratory has received a green light from CMS to offer pop-up notifications alerting physicians of various potential issues (Laboratory Alerts) through its web-based portal for ordering and reporting results of...more