Health Law Advisor

In the latest in a series of recent cases involving the “but-for” causation standard for Anti-Kickback Statute (“AKS”) claims, Judge Waverly D. Crenshaw in the U.S. District Court for the Middle District of Tennessee has dismissed United States, et al., ex rel. Nolan, et al. v. HCA Healthcare, Inc., 2025 WL 2713747 (M.D. Tenn. Sept. 22, 2025) pursuant to Rules 12(b)(6) and 9(b).

Judge Crenshaw weighed in Nolan whether the relators, co-owners of Pathologists Laboratory P.C. (“PLPC”), had plausibly alleged that: 1) defendant HCA Healthcare Inc. (“HCA”) solicited or received “remuneration” for purposes of an AKS violation; and 2) PLPC or the second lab submitted claims “resulting from” an illegal kickback for purposes of a False Claims Act (FCA). He ultimately determined that the relators had not, in fact, plausibly alleged that HCA either solicited or received “remuneration” for purposes of the AKS.

In the absence of a comprehensive federal data privacy law, state legislators continue to add to the often-contradictory array of laws aimed at protecting the security and privacy of their residents’ data. Very recently, Washington State’s My Health My Data Act was signed into law by Governor Jay Inslee in late April, Florida lawmakers passed Senate Bill 262 in early May, and the Tennessee Information Protection Act was signed into law earlier this month as well. While preparing this update, Montana’s enacted its Consumer Data Privacy Act on May 19^th, which we will address in subsequent guidance due to its recency. These newly enacted state laws build upon the growing patchwork of laws enacted in California, Connecticut, Colorado, Virginia, and Utah, all of which we previously discussed here and here. Yet, among these state laws there is significant variety, including inconsistencies as to whether the laws allow for private rights of action, and whether the laws provide affirmative defenses and other incentives based on compliance with relevant best practices.

On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to the basic nutrition and hygiene ...