Artificial intelligence is burgeoning thrughout society with special meaning in healthcare. In “Does ChatGPT Dream of Electric Sheep? Legal Implications of Artificial Intelligence in Health Care” Dan Shay explains the terminology of AI, which has a lingo of its own, and then discusses how it actually works, including its very real limitations. There are many misconceptions abounding here. AI is NOT fancy Google. He addresses current applications of AI in health care and speculates on future uses. He then examines state and federal regulatory controls, presents some of the very small amount of caselaw on point, and considers HIPAA and fraud and abuse implications from using AI.This is a must read for people who have wondered what is realistic about AI in health care and how it can create legal liabilities.

Alice takes on an in depth untangling of confounding issues under the Stark statute in The Stark Statute: Parsed, Probed and Panned -- from whether it even works, to such basics as the definitions of referral, a consultation, and a group practice, none of which is actually straightforward. She moves on to the quagmires of supervision where the law sweeps into its ambit the issues of personal supervision, direct supervision and incident to—used without reference to their long-standing presence in Medicare prior to Stark.  Shifting to pure financial issues, she  addresses the distinctions between fair market value vs. commercially reasonable vs. the fair market value exception. Additional nuance arises with respect to the differences among indirect compensation arrangements vs. under arrangements vs. stand in the shoes concepts, as well as shared facilities by contrast with timeshare arrangements.  She also considers permitted directed referrals vs value-based arrangements. She ends with a consideration of the dilemma created by how the drafters addressed Medicaid. She chose these specific issues, which are hardly all that can be said about this travesty of a statute, because the law is both vague and ambiguous on these points.

The OIG has published Model Compliance Guidance over the years and in some cases has updated them. This is not the case for the guidances both to small physician practices or billing agents. Those have not been updated it more than twenty years. The risk areas they identify are not complete given the inexorable enforcement by the OIG in the years since. In late 2023, the OIG published an entirely new document, General Compliance Program Guidance, which is not limited to any specific sector of the health care industry. It is actually a useful document to provide guidance to physician groups and billing companies to update existing compliance programs. Maintaining a compliance program is still voluntary for these sectors, but to not have one in this day and age is just foolhardy. A good plan and program are dynamic and change over time. We recommend (1) reviewing this OIG document which does not have to be read in detail to draw value from it; and (2) revisiting the vitality of your compliance program.

For many years we have advised our clients, do not pay sales commission to independent contractor sales reps. We have frequently been met with, “but everyone does that.” In 2024, the OIG entered into a settlement of multiple thousands of dollars with a company in multiple thousands of dollars for precisely that activity. The government claimed the practice violated the civil money penalties law. There are other ways that independent contractor reps can be compensated, but commission payments from federal doollars is not one of them. This prohibition does not pertain to bona fide employees.

Against the backdrop of its typically restrictive views of rewarding the referral of federal business, in an Advisory Opinion in 2023 the OGI approved a program where a physician consulting company would pay a $25 gift card to its physician customers for each potential additional physician customer the physician group referred, and further payment of $50 for each referred customer who signed with them. The consulting company advised on a range of issues some of which might increase a physician’s incentive payments under MIPS. Nonetheless the OIG took the position that these were not payments to refer federal business, they were not paid out of federal business payments and that the whole arrangement was outside the scope of their jurisdiction. We have many clients who seek to find ways to reward referrals to them. This Opinion offers some guidance on the restrictions that must be in place for such a program be compliant.

The FTC’s attempt to ban post-termination non-competes for physicians has been struck down. Still, states have proceeded with their own rules. In Pennsylvania, health care practitioner non-competes of more than a year are banned, effective Jan 1, 2025. The law is not generally retrospective, but there are conditions associated with it. It applies to physicians, CRNAs, NPs and physician assistants.

In “Ongoing Best Practices for HIPAA,” Dan discusses the importance of ongoing HIPAA compliance efforts, such as staff training to be aware of PHI in context, and having policies and procedures in place to address how to mitigate HIPAA violations when they happen. This advice is all premised on the assumption that, at some point, something will go awry with HIPAA compliance. Nobody bats 1.000, but when things inevitably go wrong, effective preparations can help minimize the negative impact of the violation, and potentially avoid fines.