The plan of a healthcare consulting firm (the “Firm”) to give gift cards to physicians in exchange for referrals to new customers does not violate the Federal Anti-Kickback Statute (the “AKS”), according to an Advisory Opinion from the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”). The Firm provides practice optimization services including data analytics services, electronic health record consulting services, compliance monitoring, and assistance with Merit-Based Incentive Payment System (“MIPS”) performance measures and submissions. Importantly, the Firm does not provide any services, nor does it invest in or own any other entity that provides services, that would be paid for, in whole or in part, directly or indirectly, by a Federal health care program.

Under the proposed plan, the Firm would give current customers $25 gift cards in exchange for recommending its consulting services to other physicians. If the recommendation were successful, the recommender would receive an additional $50 gift card.

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.

Physician Practice Program with Weaver

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.

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?

On November 28, 2023, the California Office of Health Care Affordability (“OHCA”) submitted proposed emergency regulations (the “Regulations”) on the reporting of certain transactions involving health care entities for review by the California Office of Administrative Law, the final step in the regulation process. The final Regulations, reflecting changes in response to public comments and those proposed by the Office of Administrative Law, were released on December 18, 2023, and will apply as of January 1, 2024, to covered transactions with a proposed closing date on or after April 1, 2024. Earlier articles covered the draft regulations and revised regulations, which parallels similar reporting regulations in nine other states, including Massachusetts, Washington, and Oregon. New York is proposing similar regulations for adoption in 2024.

This article will comment on the most recent changes to the Regulations and certain practical issues that must be considered in future transactions that will be subject to the reporting regime and cost and market impact reviews (“CMIR”).

On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of 3,4-Methylenedioxymethamphetamine (“MDMA”) for the treatment of post-traumatic stress disorder (“PTSD”).

Wyoming physicians are sometimes confronted with the awkward and difficult choice of whether to bring a colleague’s potentially unprofessional, unethical, or harmful conduct to light by making a report to a hospital’s peer review committee, or even the Wyoming Board of Medicine in some circumstances. However, physicians are often unsure whether such a report is justified, and whether it is ethically or legally required. Whether a report is justified or ethically required in any particular situation is beyond the scope of this article–however, we can shed light on whether it is required by Wyoming law.

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.

Provider Relief Fund Update

In the ever-evolving landscape of COVID-19 regulations, Texas has taken a unique stance with Senate Bill 7, which was signed into law by Texas Governor Greg Abbott on November 10, 2023. This legislation specifically addresses COVID-19 vaccination mandates in the private sector, introducing a series of measures aimed at protecting employees’ rights while balancing public health concerns.

When the same health plan administrator both administers a benefit plan and pays the benefits due under the plan, it is considered by courts to have a structural conflict of interest.  That conflict of interest is not problematic on its own – it is perfectly legal, and it is not a breach of fiduciary duty.  However, when a plan member files a lawsuit challenging the administrator’s denial of the member’s benefits, a court can consider the conflict of interest as a factor in whether the administrator’s denial was arbitrary and capricious.

Over the last several years, courts have provided administrators and their attorneys with guidance on how to limit the impact of this common structural conflict of interest.  When defending against denial of benefits claims under ERISA, 29 U.S.C. § 1132(a)(1)(B), defendant plan administrators should be aware of whether the conflict of interest exists and address it proactively to avoid negative inferences.