U.S. Department of Health and Human Services

Subscribe to U.S. Department of Health and Human Services via RSS

On June 24, 2026, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) seeking public input on whether OIG should add or modify its regulatory safe harbors for the Federal anti-kickback statute (“AKS”) or statutory exceptions to the Beneficiary Inducements Civil Monetary Penalties Law (“Beneficiary Inducements CMP”) for remuneration provided to individuals in connection with clinical trial participation.

The RFI sits within HHS’s broader clinical trial reform initiative. Dubbed “Operation Trailblazer”, HHS’s initiative seeks to strengthen U.S. leadership in early clinical research and development. To accomplish that goal, HHS created a Roadmap, which identifies the ways to modernize regulatory processes, encourage more efficient trial practices, better leverage existing data and technologies, and improve patient access and engagement in clinical trials. To increase clinical trial participation, HHS proposes expanding decentralized and hybrid trial models, embedding research in community-based settings, using telehealth, remote monitoring, AI-enabled tools, and real-world data. The roadmap also identifies patient financial burdens—including co-payment obligations for standard-of-care services delivered during a trial, tax issues, possible Medicaid eligibility impacts, and geography—as structural barriers to clinical trial access and retention.

On Thursday, May 28, 2026, after years of delay, the Departments of Labor, the Treasury, and Health and Human Services through the Centers for Medicare & Medicaid Services issued a final rule for the No Surprises Act (“NSA”), implementing major reforms intended to improve the functioning of the NSA’s independent…

2026 has opened with unmistakable signals that False Claims Act (“FCA”) enforcement in the health care sector is accelerating. On January 16, 2026, the Department of Justice (“DOJ”) announced a record-breaking $6.8 billion in FCA settlements and judgments for fiscal year (“FY”) 2025—the largest annual total in the statute’s history…

In a recently issued opinion, the Fifth Circuit has added yet another chapter to the growing debate over whether providers may seek judicial enforcement of Independent Dispute Resolution (“IDR”) awards issued under the No Surprises Act (“NSA”).  In a much-anticipated decision, the Fifth Circuit has held that the NSA does…

On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans.

For newly initiated audits of MA plans, CMS will audit all eligible MA contracts for each payment year. Additionally, for audits already initiated…

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for regulations on public property, loans, grants, benefits, or contracts.  Under the new framework, HHS and its…

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). The Final Rule, which goes into effect on June 25, 2024, promulgates…

The U.S. Department of Health and Human Services (“HHS”) has expanded upon its recent Healthcare Sector Cybersecurity Concept Paper (which we covered in a prior blog post), issuing cybersecurity performance goals (“CPGs”) for the healthcare and public health (“HPH”) sector. These CPGs aim to help healthcare organizations protect against…

The Department of Health and Human Services (“HHS”) has issued a formal request for information from the public about how regulated entities are implementing industry recognized security practices. The request for information represents a chance for the private sector to contribute to HHS regulation. Interested parties have until June 6,…

Given the current political dynamic within Congress, the chances of the Biden Administration enacting significant, substantive health care legislation appear slim in the short-term. Thus, the Biden Administration has sought alternative routes to advance its policy priorities, mainly through budget reconciliation (see here for a comprehensive explainer from the Congressional Research Service) and agency regulation. For example, we have previously written here and here about the “No Surprises Act”, enacted through the legislative short-cut of budget reconciliation as part of the 2021 Consolidated Appropriations Act, and the Biden Administration’s new regulations implementing consumer protections against surprise medical bills. In this mold, President Biden’s July 9 Executive Order on Promoting Competition in the American Economy (the “Order”) appears to lay out an aspirational, yet somewhat more practical agenda to implementing reforms in the health care sector, as compared to relying on new legislation coming through Congress.

The Order tasks federal agencies across the “whole-of-government” to “protect competition in the American economy” by acting on 72 regulatory initiatives, to be coordinated by a newly established “White House Competition Council” with representatives from key federal agencies. While the “whole-of-government” is involved and the entirety of the U.S. economy is targeted, there is a distinct focus among these initiatives on “improving health care” by addressing “overconcentration, monopolization, and unfair competition” in the sector. The Order specifically cites four areas in the health care sector ripe for renewed enforcement and regulatory attention with the goal of lowering prices, promoting competition, and benefiting consumers.

Our Editorial Team

View entire team
The Proskauer Blog Network
View All Proskauer Blogs