Regulatory Enforcement + Compliance

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A coalition of hospital associations and individual safety‑net providers recently filed suit in the U.S. District Court for the District of Maine challenging the Health Resources and Services Administration’s (HRSA) newly announced 340B Rebate Model Pilot Program, alleging violations of the Administrative Procedure Act (APA). As framed in the complaint, the program would replace the 30‑year‑old practice of offering 340B discounts at the point of sale with a post‑dispense rebate for a set of high‑volume drugs, compelling covered entities to pay wholesale acquisition cost (WAC) upfront and then pursue reimbursement from manufacturers. The plaintiffs contend the shift will impose hundreds of millions of dollars in administrative and cash‑flow costs on safety‑net hospitals, jeopardize care in rural and underserved communities, and reflect a sudden, unexplained reversal of HRSA’s longstanding position that upfront discounts are the most effective and efficient way to administer the program.

On November 25, the House Financial Services Committee majority staff published Operation Chokepoint 2.0: Biden’s Debanking of Digital Assets, a detailed account of how, in the Committee’s view, federal prudential regulators between 2021 and early 2025 discouraged banks from serving lawful digital asset businesses through informal guidance, supervisory posture, and enforcement.

As reported by Bloomberg, the Democratic Attorneys General Association (DAGA) has hired Rohit Chopra, former Director of the Consumer Financial Protection Bureau (CFPB or Bureau), to lead a new Consumer Protection and Affordability Working Group within DAGA’s policy arm. The move was announced as a coordinated, state-led response to rising living costs and widespread fraud, with a policy agenda that spans financial services, technology, and health care.

Private equity’s footprint in health care has expanded rapidly over the past decade, and in response states have begun to retool long‑standing doctrines and create new guardrails that target ownership, control, and transparency. The result is an emerging patchwork of laws and review processes that remake the corporate practice of medicine landscape, constrain common “friendly PC” structures, and require far more visibility into transactions involving private equity, hedge funds, real estate investment trusts (REITs), and management services organizations (MSOs).

On November 24, the Ninth Circuit issued an unpublished memorandum disposition in Dedicato Treatment Center, Inc. v. Aetna Life Insurance Co., affirming dismissal of an out-of-network provider’s state-law claims as preempted by ERISA’s remedial scheme. The panel’s brief decision underscores that the Court’s 2024 decision in Bristol Holdings (discussed here) applies broadly to state-law causes of action arising from pre-service verification-of-benefits and authorization communications, even where a provider also pleads an alternative ERISA benefits claim pursuant to an assignment of benefits from the member. Although not precedential under Ninth Circuit Rule 36-3, the disposition is a clear, persuasive affirmation of Bristol’s reach.

On November 24, the plaintiffs in National Treasury Employees Union (NTEU) v. Consumer Financial Protection Bureau (CFPB or Bureau) filed a motion to clarify the existing injunction, asking the court to confirm that the CFPB may not justify noncompliance by declining to request funds from the Federal Reserve Board (Fed) and that “combined earnings” under 12 U.S.C. § 5497(a)(1) refers to the Federal Reserve System’s total earnings, not a net figure reduced by interest expense. In response, Judge Amy Berman Jackson issued a minute order directing the parties to file submissions by November 26 identifying which provisions of the preliminary injunction they believe remain in force and addressing the court’s authority to enforce those provisions in light of the D.C. Circuit’s August 15 opinion and the pending petition for rehearing en banc.

On November 21, the Consumer Financial Protection Bureau (CFPB or Bureau) notified staff that it will restart supervision and require examiners, beginning with the 2026 examination cycle, to open each review by reading to the supervised entity a Humility in Supervisions Pledge. The pledge signals a notable shift in tone and execution that is in line with the CFPB’s Memorandum on Supervision and Enforcement Priorities from April 2025. Specifically, examinations will now have tighter alignment to the CFPB’s statutory authority, narrower and more clearly scoped exams (with a focus on “identified priority markets”), greater transparency and predictability, and an express preference to remediate issues in Supervision rather than escalate to Enforcement. It also formalizes a renewed focus on tangible consumer harm, especially to service members, their families, and veterans, and aims to minimize duplicative oversight where states or other regulators are already active.

As reported by Law360 on November 20, the Consumer Financial Protection Bureau (CFPB or Bureau) will hand off its remaining enforcement lawsuits and other active litigation to the U.S. Department of Justice (DOJ) as the Bureau prepares for a potential funding lapse. CFPB staff were informed that DOJ will begin assuming matters from the CFPB’s enforcement and legal divisions in the coming weeks, with transfer logistics to be worked out. It remains unclear whether all pending cases will survive the transition or whether case schedules and continuity will be affected.

Yesterday, President Trump nominated Stuart Levenbach, an energy official at the Office of Management and Budget (OMB), to serve a five-year term as permanent director of the Consumer Financial Protection Bureau (CFPB or Bureau). Levenbach’s experience is in natural resources and energy policy rather than financial regulation, and he would inherit an agency facing profound uncertainty after months of leadership turmoil, enforcement retrenchment, and dwindling finances.

The Consumer Financial Protection Bureau (CFPB or Bureau) has issued a new proposed rule that would substantially revise the 2023 small business lending data collection and reporting rule under the Equal Credit Opportunity Act (ECOA) and Regulation B, which implements Section 1071 of the Dodd-Frank Act. The proposal re-centers Section 1071 on “core” providers, products, and data, with a single compliance date and material carve-outs to reduce complexity and improve data quality. The proposal is open for comment for 30 days after publication in the Federal Register. However, just this week the CFPB filed a notice with the D.C. Circuit attaching a Department of Justice (DOJ) Office of Legal Counsel (OLC) opinion which concluded that the Bureau will only be legally funded through December 31, potentially affecting rulemaking and operations timelines.