The Eliminating Kickbacks in Recovery Act (EKRA), 18 U.S.C. § 220, is a criminal statute that prohibits knowingly and willfully soliciting or receiving remuneration for referring patients to recovery homes, clinical treatment...more
The U.S. Attorney’s Office for the District of New Jersey recently announced a $750,000 settlement with Sentynl Therapeutics Inc., a California-based specialty pharmaceutical company. The settlement resolves allegations that...more
On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 23-12, approving a physician-owned hospital’s offer to redeem over a two-year period the...more
This opinion addresses a proposed arrangement (“Proposed Arrangement”) by the manufacturer of cochlear implants (“Requestor”), where the Requestor would provide certain patients who receive one of their implants with a free...more
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
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...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
Does your practice pay to advertise in online directories? Or do you contract with a website to allow patients to book appointments or look for services? If the answer to these questions is “yes,” you may be interested in a...more
On the heels of the Sixth Circuit’s recent decision in Martin v. Hathaway, previously discussed on Health Law Observer, a critical issue in that case, i.e., the meaning of the term “remuneration” for purposes of the federal...more
The federal health care Anti-Kickback Statute (Federal AKS) targets bribery and corruption in the health care industry. There are two core provisions of the Federal AKS: one targeting the bribe recipient and one targeting the...more
The decision should prove helpful for those in the health care and life sciences industries whose daily operations require compliance with the federal Anti-Kickback Statute ("AKS")....more
In a prior blog post, we discussed U.S. ex. rel. Shannon Martin, M.D. v. Darren Hathaway, M.D. et al, a Sixth Circuit case involving the questions (1) whether a hospital’s decision not to hire an ophthalmologist (Dr. Martin)...more
In this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth...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
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion (AO) 23-03, analyzing a proposed arrangement in which a company that manufactures an at-home colon cancer...more
Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute (“AKS”), namely: •the requirement that a violation of the AKS must...more
On March 28, 2023, the U.S. Court of Appeals for the Sixth Circuit affirmed the dismissal of a qui tam action brought under the False Claims Act based on an illegal kickback under the Anti-Kickback Statute. This decision not...more
On March 29, 2023, OIG posted Advisory Opinion No. 23-03 regarding a laboratory’s proposed arrangement to provide a prepaid card of up to $75 to encourage individuals to return the sample collection kit associated with the...more
On March 28, 2023, the Sixth Circuit issued an important False Claims Act (“FCA”) decision in U.S. ex rel. Shannon Martin, et al. v. Darren Hathaway, et al., No. 22-1463, which (1) adopted a “but-for” causation standard for...more
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
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more
In Short - The Situation: The Anti-Kickback Statute ("AKS") prohibits a defendant from willfully paying or receiving "remuneration" in exchange for referrals—and, in addition, also specifies that any claims "resulting...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 Sixth Circuit expanded the existing circuit split regarding when a kickback causes a federal health care claim to be false or fraudulent under the False Claims Act (FCA) and set out a new analysis for what constitutes...more
The Anti-Kickback Statute (AKS) is a criminal statute that, in broad strokes, bars the payment or receipt of “remuneration” in exchange for referrals. It has become one of the most lucrative theories of civil liability under...more