Academic Medical Centers

The regulatory landscape for substance use disorder (SUD) treatment records is changing—and the impact will extend far beyond traditional addiction treatment programs. With treatment options for SUD limited, some providers are exploring ketamine as a potential therapy due to its effects on glutamatergic neurotransmission.[i] Additionally, psychedelic-assisted therapies involving certain Schedule I substances – such as psilocybin, ibogaine, and MDMA – are currently being studied by researchers as potential treatments for SUDs.[ii] While these investigational therapies are not yet available in clinical practice and the new federal privacy rules do not apply to research records, providers should be aware of the evolving treatment landscape as these therapies move closer to potential approval and clinical use.

On March 7, 2025, the U.S. Department of Health and Human Services (HHS) announced that its Office for Civil Rights (OCR) had initiated four investigations into unnamed medical schools and hospitals over allegations that the schools and hospitals “discriminate on the basis of race, color, national origin, or sex” by continuing to implement “DEI” programs.

This blog post explains what HHS OCR is investigating, what laws are at issue, and what those operating medical schools and hospitals with DEI programs should consider, given this and other federal attention to DEI.

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.

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.

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.

Cosmetic surgeries are on the rise. One study of cosmetic surgery data found that body procedures like tummy tucks, buttock augmentation, and liposuction increased by 63 percent from 2020 to 2021.[1] Facelifts were up 54 percent.[2] And breast procedures were up 48 percent.[3] According to that study, Americans spent over $14.6 billion on aesthetic procedures in 2021 with surgical revenues increasing by 63 percent.[4]

Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.”[1] The article is the latest in a sequence of alarms that some clinical researchers might not be as squeaky clean as we would hope them to be. Senior DOJ officials have in turn emphasized in public remarks that investigating clinical research shortcomings is now a Justice Department priority, with the whistleblower bar following suit.

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.

A medical school applicant recently filed suit, alleging that several Texas medical schools improperly rejected him by basing their admissions decisions on race and gender. The complaint asserts that these schools (along with “nearly every school and university in the United States”) participate in the practice known as affirmative action, giving preference to women and non-Asian minorities rather than candidates with more impressive academic accomplishments.

Elevating Health Equity

The American Health Law Association released its Special Edition of its Journal of Health and Life Sciences Law on Emerging Issues in Health Equity in the United State: Legal, Legislative, and Policy Perspectives. The association strives to advance public discourse on these issues for the benefit of AHLA members, the public, academia, and decision makers in both the legislative and executive branches of government.