Health Law Advisor

On January 6, 2025, the U.S. District Court for the District of Massachusetts granted a defendant laboratory’s motion for summary judgment in a False Claims Act (FCA)/Anti-Kickback Statute (AKS) case brought by a physician objecting to the lab’s testing practices and its use of independent contractors paid on commission. Judge Patti B. Saris held that plaintiffs in FCA cases must establish that “but for” the payment of illegal remuneration in violation of the AKS, the claim would not have been submitted. Applying the “but-for” standard, Judge Saris dismissed OMNI Healthcare Inc. v. MD Spine Solutions LLC, et al. because the record did not support that the independent contractor status of some of the lab’s sales representatives or their conduct unduly influenced any provider’s decision to purchase the product.

Adoption of “But-For” Causation in FCA Cases

There is a circuit split regarding whether FCA plaintiffs must prove that “but for” the AKS violation, a claim would not have been submitted. Requiring “but-for” causation poses a significantly greater burden for plaintiffs seeking to advance FCA claims because they must show the kickback actually affected what good, item, or service was provided.

In the U.S. Courts of Appeals for the Sixth and Eighth Circuits, the heightened “but-for” causation must be established. The Third Circuit has adopted a less rigorous standard, requiring only a showing that at least one of the claims sought reimbursement for medical care that was provided in violation of the AKS. Plaintiffs in circuits with no clear precedent often argue for the application of the more plaintiff-friendly standards of the Third Circuit and use that ambiguity as leverage in negotiating settlement agreements.

Medical providers are often asked, or feel obligated, to disclose confidential information about patients.  This blog post discusses when disclosures of confidential medical information involve law enforcement, but the general principles discussed herein are instructive in any scenario.  To protect patient confidentiality and avoid costly civil liability arising from improper disclosures, it is imperative that providers ask questions to assess the urgency of any request and to understand for what purpose the information is sought by authorities.  Knowing what questions to ask at the outset prepares providers to make informed decisions about disclosing confidential information in a manner that balances the obligation to maintain patient confidentiality and trust with legitimate law enforcement requests for information aimed at protecting the public.

On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space or referring specimens to such laboratories should know that what happened in this case is ...

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 ...

On January 16, 2018, the Department of Health and Human Services Office of Inspector General (OIG) published its most recent update to the agency’s “Work Plan.”  Of note to Durable Medical Equipment (DME) manufacturers, suppliers and prescribers, OIG signaled increased interest in the investigation of three specific off-the-shelf orthotic devices identified by the HCPCS codes:

• L0648—back bracing
• L0650—back bracing
• L1833—knee bracing

According to OIG, the government paid out $349 million for these braces in 2016, representing a 97% increase from just 2014.  OIG ...

At this point, it's not really ground-breaking news that America has a problem with opioid drugs. By way of anecdote, when I became a federal prosecutor in 2011, the last heroin case that had been prosecuted in the Nashville U.S. Attorney's office was in the early-1990s; although, to be fair, there were then lots of what we called "pill" cases involving opioids. When I left the office in 2017, at least half of the office's major investigations were directly related to opioids--some pills, but mostly outright heroin or fentanyl/carfentanyl . In Nashville, Tennessee, OxyContin (which ...