In our Q1 2026 update, we reported on the Trump Administration’s new fraud-enforcement initiatives — the creation of the FCA Working Group, the National Fraud Enforcement Division, and the White House Task Force on fraud reduction — and the record-setting $6.8 billion in False Claims Act (“FCA”) recoveries for
U.S. Department of Health and Human Services
OIG Seeks Comment on Clinical Trial Participant Remuneration Under the AKS and Beneficiary Inducements CMP
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.
No Surprises Here! Government Issues Final Rule in NSA, Streamlining IDR Process and Lowering Dispute Costs
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…
False Claims Act Roundup Series: Q1 2026 – Increased Government Enforcement Efforts and Circuit Court Developments
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…
No Surprises Here! Fifth Circuit Holds NSA Provides No Private Right of Action to Enforce IDR Awards, Deepening Judicial Divide on Award Enforcement Mechanisms
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…
CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts
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…
HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking
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…
New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive Health Care Information
By Whitney Phelps & Michael Menconi on
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…
Cybersecurity a Top Priority – HHS Publishes New Cybersecurity Performance Goals
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…
Department of Health and Human Services Issues Request for Information on Cybersecurity Standards
By Ryan P. Blaney & Vincent J. Tennant on
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,…