The project included various prompts and refinements on my part, and time reviewing and confirming or adjusting inferred or borderline findings manually. The proposal, for those who don’t know, aims to create new device classifications covering hundreds of currently marketed antimicrobial wound dressings—devices that primarily incorporate ingredients like hypochlorous acid or silver, have been staples of wound care for decades, and have excellent safety and efficacy profiles. 

Six months after implementation—with the U.S. Senate now passing the BIOSECURE Act restricting certain biotech business with China—compliance remains the key for affected stakeholders, including those exchanging personal health data. As we reported in July, the 2025 Final Rule implemented the prior administration’s Executive Order 14117 of February 28, 2024, by prohibiting and restricting “bulk” data transactions with countries that could threaten U.S. national security through the use of Americans’ sensitive personal data.

While the 2025 Final Rule remains largely untested, federal agencies and stakeholders alike have taken action to test the bounds of the Rule and, in some instances, expand applicability beyond 28 CFR Part 202. Below is a brief refresher of the key elements of the Rule and some recent developments.

• prohibits a private equity group or hedge fund that is involved—including as an investor or owner—with a physician or dental practice doing business in the state, from interfering with the professional judgment of physicians and dentists in making health care decisions;
• prohibits these entities from exercising power over specified actions, including hiring practices and coding and billing procedures for patient services, and
• prohibits contracts between a private equity group or hedge fund or an entity controlled by a private equity group or a hedge fund and a physician or dental practice, if the contract would allow the conduct described above or impose a noncompete or nondisparagement clause.

The law will take effect on January 1, 2026. The state attorney general is empowered to enforce the new law through injunctive relief and other equitable remedies. It is the latest in a national trend among states to strengthen corporate practice of medicine (CPOM) doctrines by limiting the influence of non-licensed entities in clinical decision-making. The bill, introduced by California State Senator Christopher Cabaldon, passed the state legislature in September with bipartisan support.

Judge Crenshaw weighed in Nolan whether the relators, co-owners of Pathologists Laboratory P.C. (“PLPC”), had plausibly alleged that: 1) defendant HCA Healthcare Inc. (“HCA”) solicited or received “remuneration” for purposes of an AKS violation; and 2) PLPC or the second lab submitted claims “resulting from” an illegal kickback for purposes of a False Claims Act (FCA). He ultimately determined that the relators had not, in fact, plausibly alleged that HCA either solicited or received “remuneration” for purposes of the AKS.

Regulatory agencies such as HHS and its components, including the Centers for Medicare and Medicaid Services (“CMS”), the Food and Drug Administration (“FDA”), and the National Institutes of Health (“NIH”) must follow rulemaking procedures set out in the Administrative Procedure Act (“APA”) when they formulate and publish regulations that are intended to implement a statute and have the force of law. Those procedures include offering the public an opportunity to be notified of proposed regulations and to submit comments to the agency. The APA also contains several exceptions to the notice and comment requirement, including one for matters relating to “public property, loans, grants, benefits, or contracts.” Nevertheless, HHS and several other federal departments adopted policies that voluntarily waived these exceptions.

This amendment, however, did not end the debate over the relationship between the AKS and the FCA. Over the last several years, multiple courts have been called upon to interpret what it means for a claim to “result from” a violation of the AKS. Courts across the country are split on the correct standard. On February 18, 2025, the U.S. Court of Appeals for the First Circuit joined the Sixth and Eight Circuits in adopting a stricter “but-for” standard of causation—while the Third Circuit has previously declared that the government must merely prove a causal connection between an illegal kickback and a claim being submitted for reimbursement.

Executive orders are not mentioned in the Constitution, but they have been around since the time of George Washington. Executive orders are signed, written, and published orders from the President of the United States that manage and direct the Executive Branch and are binding on Executive Branch agencies.  Executive orders can be used to implement or clarify existing federal law or policies and can direct and manage the way federal agencies interact with private entities.   However, executive orders are not a substitute for either statutes or regulations.

The current procedure for implementing executive orders was set out in a 1962 executive order that requires that all such orders must be published in the Federal Register, the same publication where executive agencies publish proposed and final rules. Once published, any executive order can be revoked or modified simply by issuing a new executive order.  In addition, Congress can ratify an existing executive order in cases where the authority may be ambiguous.

As awareness grows, so too does legal scrutiny and the push for new regulations and enforcement. In these seemingly critical times, what should health care employers be thinking about and incorporating into their comprehensive strategies to prevent and address workplace violence?

On this episode, Epstein Becker Green attorneys Sharon Peters, Eric Neiman, and Avery Schumacher dissect the legal landscape surrounding health care workplace violence, examining the steps being taken at various levels of government and what they mean for health care providers and institutions. Join us as we explore the legal frameworks, emerging policies, and broader compliance implications for health care employers.

“Health Care Services” include: (1) adult cardiac catheterization; (2) adult open heart surgery; (3) pediatric cardiac catheterization; (4) pediatric cardiovascular surgery; (5) pediatric intensive care; (6) a linear accelerator, cobalt radiation, or gamma knife service; (7) solid organ transplant services, and (8) blood and bone marrow transplant service. The revised Health Care Services rules make changes to nearly every regulation in Chapter 3701-84, many of a substantial nature. 

Of particular interest to Ohio hospitals, changes to the adult cardiac catheterization services requirements include:

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?