On September 9, 2024, the U.S. Department of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued a Final Rule clarifying and adding additional requirements on health plans to provide equitable access to health insurance coverage for treatment of mental health and substance use disorders (SUDs), as required by the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and implementing regulations at 45 C.F.R. Part 146 and 147 (the 2024 Final Rule).

MHPAEA is a federal law that prevents group health plans and health insurance issuers (collectively, Health Plans) that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than it does for a medical condition or surgical procedure. This means that Health Plans cannot impose additional financial requirements or apply non-quantitative treatment limitations (NQTLs) to these benefits more stringently than those applied to medical/surgical benefits.

As previously reported in this post, criminal trials premised on upcoding evaluation and management (E/M) service codes are extremely rare. The Justice Department took that rare step in Maryland in connection with a practice in which Dr. Ron Elfenbein, a physician, billed Medicare and private payors a Level 4 E/M for patients receiving COVID-19 tests. That billing practice, which at times took place at drive-through COVID testing centers, resulted in Dr. Elfenbein’s indictment and conviction by a jury in Maryland federal court.

But on December 21, 2023, the federal judge who presided over that trial granted Dr. Elfenbein’s motion for judgment of acquittal, vacating the conviction. These motions are commonly made but seldom granted. Why was this particular motion for acquittal granted? And what can the healthcare community learn from this case? Read on for details.

Plaintiffs often disclose medical experts to opine not only as to the diagnosis or prognosis of an injury or medical condition, but also as to whether the defendant’s actions caused plaintiff’s alleged injury/condition. In the usual course of treatment, physicians often focus simply on the diagnosis a patient’s injury/condition, rather than on what caused it. Thus, when medical records contain statements regarding causation, those statements typically derive solely from a patient’s own subjective statements. It is therefore important to distinguish between a patient’s subjective causation statements and objective medical evidence.

Evaluation and management (E/M) services have been called “the core” of healthcare billing.[1] E/M is a catch-all claim, allowing medical professionals to bill for diagnosing or treating nearly any illness or injury. E/M is also divided into fairly subjective levels depending on complexity, and the differences between levels is often merely a difference of opinion. While the DOJ has brought cases based on disputes over E/M services before, those cases are typically civil and part of a more complex upcoding or unbundling scheme.[2] This is because nearly everything involving some effort expended by a physician could arguably justify that physician believing the E/M service was proper, and therefore criminal cases requiring scienter evidence that proves the case beyond a reasonable doubt are incredibly rare.

Yet one of those rare cases went to trial this month.

Distances in rural health care can be hard to fathom. A 2018 study found it took rural Americans, on average, 17 minutes to get to a hospital, but only 10 minutes in an urban center.[i] The distance between rural hospitals can be vastly further – in 2019, a National Institutes of Health study noted that hospitals in one rural state were generally at least 50 miles apart.[ii] These areas have been described (without meaning to be pejorative) as “health deserts.”[iii] Small populations, and a growing shortage of physicians in rural areas,[iv] often lead to hospitals in these areas having only one or two physicians in a particular specialty. Advanced health practitioners (AHP’s) with specialty training, such as psychiatric nurse practitioners or certified nurse midwives, can be an excellent way to preserve access to specialty care, particularly when lack of physician coverage would otherwise mean the hospital must divert or transfer emergency patients.

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.

On June 14, 2023, a federal jury found that a Georgia physician knowingly violated the False Claims Act following a two-week trial on allegations that he made false claims to the Medicare Program. Now, despite just $1.1 million in improper payments stemming from false claims, a federal court is likely to impose a judgment that exceeds $27 million after adding statutory per-claim penalties and trebling the amount determined by the jury to be false.

Recently, CMS changed its process for approving provider transactions structured as equity transfers – which in Medicare’s eyes is generally classified as a change of information (“CHOI”).  Previously, the process for approving such a transaction was for the provider to submit the applicable 855 Enrollment Application as CHOI to the provider’s assigned Medicare Administrative Contractor (“MAC”) and the MAC would then approve the CHOI.  With this prior process, a provider only needed MAC approval for CHOIs. The CMS Regional Office only reviewed initial enrollments and changes of ownership (“CHOWs”).