Health Law Advisor

On October 14, 2026, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., published a notice (the “Publication”) in the Federal Register formalizing the delegation to the administrator of the Centers for Medicare & Medicaid Services (CMS) of the power to exclude individuals and entities, including providers, from participation in federally funded health care programs—effective immediately.

The Publication follows the Secretary’s July 21, 2026, announcement that he would be giving CMS permissive exclusion authority under section 1128(b) of the Social Security Act—which was, until now, within the exclusive domain of the HHS Office of Inspector General (HHS-OIG) (see Epstein Becker Green’s previous blog post here). The July announcement was made during an HHS press conference covered by C-SPAN.

Although the Publication purports to “reduc[e] redundancy” by “align[ing] investigative and enforcement responsibilities within a single operating division,” it does not clarify the extent and scope of the delegated authority, how it could be exercised jointly with HHS-OIG, and what impact it has on False Claims Act (FCA) cases.

In September 2025, the U.S. Attorneys’ Office for the Eastern District of Pennsylvania (EDPA) announced that it would be implementing a White-Collar Justice Program to strengthen its white- collar enforcement framework. Among other things, the program will “empower Assistant United States Attorneys to aggressively pursue complex investigations and significant new matters on their own initiative.”

This announcement demonstrates another step in federal districts ramping up their white-collar enforcement efforts while encouraging robust procedures for compliance and self-disclosure. This is a trend several years in the making: in September 2022, then-Deputy Attorney General Lisa Monaco directed U.S. attorneys and others within the DOJ to review their policies on corporate voluntary self-disclosure, and to draft and share a formal written policy to incentivize such self-disclosure, if one was lacking.

Background

On December 10, 2024, the Supreme Court of Ohio issued its decision in Stull v. Summa, a medical negligence case in which the defendants argued that Ohio’s statutory peer-review privilege protected from discovery the file the hospital maintained on a resident physician, which included, among other things, quality reviews and assessments of the resident’s clinical competency and professional conduct. The Supreme Court of Ohio decided one issue: Does the peer-review privilege in R.C. 2305.252 apply to a health care entity’s files about resident physicians?

This case arose from the medical treatment of head injuries that the patient sustained during a car crash. The patient and his guardians filed a medical negligence lawsuit against the hospital and its employed health care professionals, including a resident physician who participated in the patient’s care. The plaintiffs alleged that the resident improperly intubated the patient, causing the patient to sustain a brain injury.

In September of this year, New York City Councilwoman Julie Menin announced her plan to introduce a series of bills that would create further price transparency requirements for hospitals, with noncompliance resulting in high financial penalties.

The bill package would create an office of hospital accountability that would inform the public as to how much hospitals are charging for various services via a price transparency information portal, where hospitals would be required to provide certain key pricing information to the public. Currently, such pricing data is not typically available for public access, and patients typically have little knowledge regarding how much they will be charged for services.

Building on attempts in recent years to strengthen the Department of Justice’s (DOJ’s) white collar criminal enforcement, on September 15, 2022, Deputy Attorney General Lisa Monaco announced revisions to DOJ’s corporate criminal enforcement policies. The new policies, and those that are in development, further attempt to put pressure on companies to implement effective compliance policies and to self-report if there are problems. Notably, the new DOJ policies set forth changes to existing DOJ policies through a “combination of carrots and sticks – with a mix of incentives and deterrence,” with the goal of “giving general counsels and chief compliance officers the tools they need to make a business case for responsible corporate behavior” through seven key areas: