“Incident to” billing is widely practiced, and its regulations are generally well-known. But one Arizona physician recently found himself pleading guilty in federal court on April 3, 2024, to a criminal healthcare fraud charge over improperly billing Medicare and private payors for healthcare services that failed to abide by the rules over “incident to” billing. This blog post explores how this lack of compliance resulted in such a serious criminal consequence.Continue Reading Arizona Physician Pleads Guilty to Healthcare Fraud over Improper “Incident To” Billings

Most experienced False Claims Act (FCA) practitioners are all too familiar with the statutory provision requiring defendants to pay whistleblowers’ attorneys’ fees at the end of FCA cases. What is less commonly known is the provision that grants defendants their attorneys’ fees in certain circumstances.

One whistleblower learned about that provision the hard way, when on March 14, 2024, a Mississippi federal judge ordered that he pay over $1 million to cover the defendants’ attorneys’ fees, following grant of summary judgment to defendants in what the judge labeled a “frivolous” qui tam. This blog post looks at the case that led to such a large attorneys’ fees award and considers the types of cases in which these efforts are wise.Continue Reading Federal Judge Orders Whistleblower Who Filed a “Frivolous” Qui Tam to Pay Over $1 Million for Defendants’ Attorneys’ Fees

In the United States, mental health (“MH”) and substance use disorder (“SUD”) (collectively “MH/SUD”) have continued to represent areas of intense concern. During the COVID-19 pandemic, the MH struggles of essential workers and health care professionals were pushed to the forefront. However, issues related to MH/SUD have continued to escalate.Continue Reading Mental Health Parity and Addiction Equity Act: Comprehensive Final Rule Expected in 2024

For years, law enforcement has bypassed traditional means of securing evidence by informal requests for documents from witnesses of crimes. At some point, that practice bled over into informal requests for healthcare providers’ documents, including documents reflecting protected health information (PHI). Healthcare providers, for the most part, have complied with these informal requests because, as the logic goes, law enforcement couldn’t possibly prosecute me for complying with law enforcement, right? Isn’t that entrapment?

This cooperative, well-intentioned practice by healthcare providers now appears to be drawing scrutiny from Congress. On December 12, 2023, members of Congress sent a letter to Health & Human Services Secretary Xavier Becerra announcing the results of a Congressional inquiry into the practice of pharmacies handing over patient information without legal process. In the face of that new scrutiny, which is sure to extend beyond pharmacies to all healthcare providers, what are healthcare providers to do when asked for PHI through informal means?Continue Reading Should Healthcare Providers Give Law Enforcement Protected Health Information When Informally Requested? Congress Says No.

The Rise of Ketamine Clinics and Ketamine-Assisted Therapy

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the utilization of pharmaceutical drugs for, among other factors, unapproved indications. An approved indication occurs when the Food and Drug Administration (FDA) formally approves a given drug for a named medical condition.Continue Reading Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

On November 6, 2023, the Office of Inspector General (“OIG”) issued its long-awaited General Compliance Program Guidance (“Guidance”) “to help advance the industry’s voluntary compliance efforts in preventing fraud, waste, and abuse in the health care system.” Although the Guidance is nonbinding, it reflects the OIG’s expectation that compliance programs become increasingly sophisticated in their approach to identifying and managing compliance risks as healthcare delivery and payment models continue to evolve.Continue Reading Not Worth the [Compliance] Risk! OIG’s New Integrated Approach

Large managed care plans have been squarely in DOJ’s crosshairs for years, but a late July 2023 Justice Department settlement agreement with one regional healthcare provider’s Medicare Advantage Plan offers a glimpse into an issue health systems and providers with their own managed care plans need to track.

This post examines the recent DOJ settlement, analyzes the trend towards enforcement of provider-owned managed care plans, and offers a prediction on what might be coming on the enforcement side.Continue Reading DOJ Continues Enforcement Efforts Against Provider-Owned Managed Care Plans

On February 27, 2023, a jury in Minnesota federal court rendered a verdict in favor of the United States and against a surgical product distributor following a False Claims Act jury trial that lasted six weeks.[1] The jury identified $43 million in Medicare payments flowing from 64,575 kickback-procured claims.Continue Reading Trial Lost, $400+ Million Liability Looming: Quick Takeaways From a Recent False Claims Act Jury Trial

OSHA is currently considering a possible “Prevention of Workplace Violence in Healthcare and Social Assistance” rule. If passed, the Rule would apply to employers whose employees face an increased risk of workplace violence from their patients, clients, residents and/or facility visitors. Such employees include those who work in hospitals, ambulatory medical care or substance abuse

On July 26, 2022, Judge Jeremy Kernodle of the Eastern District of Texas affirmed that certain parts of the Interim Final Rule Part II implementing the No Surprises Act (the Act) were invalid. This ruling is nearly identical to Judge Kernodle’s February decision in Texas Medical Association & Corley v. US Dept. of Health and Human Services. This decision vacated a portion of the Interim Final Rule that required arbitrators to give more weight to the out-of-network rate, including what is called the Qualified Payment Amount (QPA), over other permissible factors. The rule’s requirement ultimately contradicted the Act’s direction that arbitrators consider various factors, and not weight any one more heavily than another.
Continue Reading Eastern District of Texas Invalidates Parts of Implementing the No Surprises Act