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On Monday, June 22, 2026, the U.S. Department of Health and Human Services (“HHS”) announced Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clinical research leadership and engagement in the United States. The initiative emphasizes the growth of early-stage clinical research overseas, with HHS acknowledging the threat to “America’s position as a global leader.” See Operation TrialBlazer, HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development, Executive Summary p. 2-3.

HHS indicated that Operation TrialBlazer…
Continue Reading HHS’s Operation TrialBlazer

Following a series of hospital sale-leaseback transactions that preceded bankruptcy filings in 2024 and 2025, lawmakers at both the federal and state levels have taken notice. In response, legislators have introduced measures aimed at regulating, or increasing oversight of, certain health care real estate transactions.

These efforts seek to protect community hospitals from transactions that may weaken their finances, shift disproportionate value to private-sector investors or jeopardize access to essential services by saddling providers with long-term lease obligations.

As…
Continue Reading Weekly Hospital Real Estate Briefing: A Flurry of Legislation Restricting Hospital Real Estate Transactions – What You Need to Know

The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) has issued a meaningful Request for Information (“RFI”) seeking stakeholder input on potential new or modified Anti-Kickback Statute (“AKS”) regulatory safe harbors and Beneficiary Inducements Civil Monetary Penalty (“CMP”) exceptions for remuneration to clinical trial participants. The RFI was published as part of HHS’s Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clinical research leadership and engagement in the United States, including a push…
Continue Reading OIG Issues RFI on Anti-Kickback Statute Safe Harbors for Clinical Trial Participant Remuneration – Comments Due August 24, 2026

We have all been waiting, with something close to bated breath, for a fix to the looming closure of the THC “loophole” in November. Today, we at least have a small glimmer of potential hope worth watching.

Rep. Beth Van Duyne of Texas has circulated a draft bill called the Hemp-Derived Beverage Regulatory Clarity Act. You can read the draft bill here.

At a high level, the bill would put hemp beverages under the authority of the Alcohol…
Continue Reading Hemp Beverage Update and Potential TTB Oversight

As Eliminating Kickbacks in Recovery Act (“EKRA”) enforcement continues to expand, the United States District Court for the Southern District of California in United States v. Simons  offers an early look at how courts may handle the evidentiary and testimonial issues likely to arise in future prosecutions. On May 1, 2026, the Court issued an Order on the parties’ motions in limine (the “Order”) providing practical guidance on the admissibility of charged terminology, the permissible scope of fact and…
Continue Reading United States v. Simons: Key Evidentiary Guidance in an Emerging Area of EKRA Enforcement

Workers at the construction site
Architects and investors meeting at the construction site, on top of the residential building under construction.

Wisconsin’s recently enacted 2025 Act 173, commonly referred to as the “Truth in Planning” law, introduces important changes to the relationship between comprehensive planning and zoning for municipalities. Act 173 represents a meaningful shift in Wisconsin land use law and reflects broader policy objectives related to housing availability and affordability. By requiring municipalities to plan for residential development in a more detailed and transparent manner, the legislature intended the updated statutes to reduce uncertainty and facilitate the construction of…
Continue Reading Truth in Planning Law Changes Planning and Zoning for Municipalities

Wisconsin joins the growing list of states granting Advanced Practice Registered Nurses (“APRNs”) full practice authority. Passed in early August 2025, the APRN Modernization Act (the “Act”) will take effect on September 1, 2026, and the license of qualified advanced practice nurses will no longer require that they practice in a collaborative arrangement with a physician or dentist. However, questions still remain regarding how this new law will interact with certain government and commercial payor requirements.

Historically, Wisconsin provided…
Continue Reading REMINDER: Wisconsin’s APRN Modernization Act Becomes Effective September 1

On April 30, 2026, the U.S. Department of Justice (“DOJ”) announced the creation of the West Coast Health Care Fraud Strike Force to target health care fraud in Silicon Valley. Specifically, the strike force unites the District of Arizona, District of Nevada and Northern District of California Health Care Fraud Divisions.
Background
The Health Care Strike Force program is a traditional DOJ enforcement model that adds resources from other federal Districts to supplement the enforcement target. The Health Care…
Continue Reading DOJ Announces New Strike Force Targeting Health Care Fraud on West Coast

On May 22, 2026, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule regarding both Medicaid State directed payments (“SDPs”) and Medicaid fee-for-service reimbursement. The proposed rule is based on two distinct but reinforcing authorities: (i) section 71116 of H.R. 1 (a/k/a the “One Big Beautiful Bill Act”); and (ii) the Presidential Memorandum titled “Eliminating Waste, Fraud, and Abuse in Medicaid” (effective June 6, 2025).

The proposed rule would implement section 71116 by revising the SDP…
Continue Reading New CMS Proposed Rule Would Impose a Payment Limit on Additional State Directed Payments and Establish a Payment Limit for ‘Targeted’ Medicaid Fee-for-Service Payments

FMLA family medical leave act symbol. Concept words FMLA family medical leave act on wooden blocks on beautiful wooden background. Medical FMLA family medical leave act concept.
FMLA family medical leave act symbol. Concept words FMLA family medical leave act on wooden blocks on beautiful wooden background. Medical FMLA family medical leave act concept.

When a key employee takes FMLA leave under the federal Family and Medical Leave Act (FMLA), staying in touch may feel necessary to keep business operations running. But what many employers underestimate is that liability under the FMLA extends well beyond denying leave for an unlawful reason. It can arise from everyday decisions about communication, workload, and expectations during that leave.

Courts across the country continue to see a steady stream of litigation from employees who claim their employers

…
Continue Reading OOTO but Not Out of the Woods: Legal Risks for Employers During and After FMLA Leave

In April, the Centers for Medicare & Medicaid Services (“CMS”) released the FY 2027 Inpatient Prospective Payment System (“IPPS”) Proposed Rule (“Proposed Rule”) to update IPPS payment rates and uncompensated care payments, refine CMS’s definition of new GME residency programs, request input on new quality measures, expand the joint replacement payment model, CJR-X, on a nationwide basis and introduce quality measures into the Transforming Episode Accountability Model (“TEAM”) program.
Increase to Payment Rates Under the IPPS
Following a rebasing…
Continue Reading CMS Publishes FY 2027 IPPS Proposed Rule

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Health care enforcement is entering a data-driven era in which artificial intelligence (“AI”) and large-scale analytics increasingly shape how fraud is identified and pursued, as reflected in the U.S. Department of Justice’s (“DOJ”) launch of the Fraud Oversight through Careful Use of Statistics (“FOCUS”) initiative.
Overview of the FOCUS Initiative
On April 7, 2026, DOJ launched the FOCUS initiative, a first-of-its-kind program formalizing the Civil Division’s engagement with data miners who file qui tam complaints under the False…
Continue Reading DOJ’s Data-Driven FCA Enforcement Initiative Raises Stakes for Health Care Providers

On May 1, 2026, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-09 (“AO 26-09”), which opines on a pediatric dental and orthodontic service provider’s (“Requestor’s”) proposal to offer free orthodontic treatment for one patient per year at each of Requestor’s three practice locations (the “Proposed Arrangement”).
How the Proposed Arrangement Would Work
Requestor’s treating providers could nominate existing patients to receive the free service (the patients may not nominate themselves). Each…
Continue Reading Straight Talk on Free Orthodontic Treatment: Key Takeaways from OIG Advisory Opinion 26-09

On April 14, 2026, the Centers for Medicare & Medicaid Services (“CMS”) published the Fiscal Year (“FY”) 2027 Inpatient Prospective Payment System (“IPPS”) Proposed Rule (the “Proposed Rule”), which can be found here. Among other things, the Proposed Rule would make updates to Graduate Medical Education (“GME”) policies for teaching hospitals under the Medicare program. These updates include (i) modifications to the criteria by which a program is deemed a “new program” for Medicare funding purposes; (ii) clarification…
Continue Reading CMS Proposes Changes to Graduate Medical Education in 2027 IPPS Proposed Rule

CMS is imposing a six-month nationwide moratorium on new Medicare enrollment for hospices and home health agencies in a sweeping effort to combat fraud.

Effective immediately, CMS will not process new Medicare enrollment applications or certain changes in majority ownership for hospices and home health agencies across the country for the next six months. This action is designed to prevent fraudulent providers from entering the Medicare program and to disrupt schemes that exploit vulnerable beneficiaries and taxpayer funds. Existing…
Continue Reading Moratorium on New Medicare Enrollment

UPDATE: Shortly after this alert was published, the Supreme Court granted an administrative stay of the Fifth Circuit’s order. This means that, while the Supreme Court reviews Danco’s and GenBioPro’s emergency requests that the Fifth Circuit’s stay be vacated, mifepristone is available under the 2023 REMS, which permits dispensing of mifepristone directly to patients by certain pharmacies, including by certain mail-order pharmacies. We will continue to follow this litigation and will provide further updates as they are available.
Continue Reading Fifth Circuit Court of Appeals Panel Grants Stay in Case Challenging FDA Regulation of Mifepristone