In my November 2025 blog post, I discussed the uncertainty surrounding the DEA’s then-pending telemedicine rule and its implications for ketamine clinics. At that time, the future of pandemic-era telehealth prescribing flexibilities was unclear, and clinics across the country were bracing for the possibility of a significant regulatory shift at the end of 2025.
The Wyoming Supreme Court began the year 2026 with a landmark decision in State v. Johnson, 2026 WY 1, delivering a ruling with implications that extend far beyond its immediate outcome. While headlines will focus on the Court’s decision to strike down Wyoming’s comprehensive abortion restrictions—the Life is a Human Right Act (“Life Act”)[1] and the Medication Ban[2]—as unconstitutional, the true significance lies elsewhere. The Court held that Wyoming’s constitutional amendment guaranteeing adults the right to make their own healthcare decisions is a fundamental right protected by the highest level of judicial scrutiny.
This holding may ultimately have more far-reaching consequences, setting the stage for future challenges to a wide range of healthcare regulations across Wyoming.
CMS has extended its Provisional Period of Enhanced Oversight (PPEO) and its Expanded Prepayment Review (EPR) enforcement efforts to Georgia and Ohio. The enhanced enforcement efforts can lead to the revocation of a hospice’s Medicare billing privileges, termination of Medicare/Medicaid enrollment, and/or the prepayment review of 100% of a hospice’s claims.
The regulatory landscape for substance use disorder (SUD) treatment records is changing—and the impact will extend far beyond traditional addiction treatment programs. With treatment options for SUD limited, some providers are exploring ketamine as a potential therapy due to its effects on glutamatergic neurotransmission.[i] Additionally, psychedelic-assisted therapies involving certain Schedule I substances – such as psilocybin, ibogaine, and MDMA – are currently being studied by researchers as potential treatments for SUDs.[ii] While these investigational therapies are not yet available in clinical practice and the new federal privacy rules do not apply to research records, providers should be aware of the evolving treatment landscape as these therapies move closer to potential approval and clinical use.
This post is the first in our three-part series, Gearing Up for HTLH USA 2025, where our team of attorneys will share insights on intellectual property, equity, and exit strategies and how these issues intersect in the transactional context.
Physicians are driving much of today’s health innovation. From new devices and digital tools to
In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a range of actors including alleged transnational criminal organizations, providers of allegedly fraudulent wound care, alleged prescription opioid traffickers, alleged telemedicine, and genetic testing fraudsters, among others. DOJ also introduced the creation of a Health Care Fraud Data Fusion Center, designed to enhance the detection, investigation, and prosecution of healthcare fraud.
In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review, mandated by the Protecting Access to Medicare Act of 2014 (PAMA), focuses on analyzing the top 25 laboratory tests by Medicare expenditures for the previous calendar year. For clinical laboratories and healthcare providers, this announcement signals the need to pay close attention to billing practices, compliance programs, and potential audit risks.
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at strengthening the government’s civil enforcement of the False Claims Act (FCA) in the healthcare space. While the DOJ and HHS have long worked together to combat fraud, this Working Group marks a formalized, tightly coordinated effort focused on high-impact enforcement areas.
Recently, Attorney General Pam Bondi purportedly issued an internal memorandum in response to Executive Order 14187 (“Protecting Children from Chemical and Surgical Mutilation”) concerning the treatment of transgender minors by medical practitioners, hospitals, clinics, and pharmaceutical companies. The memo set forth guidance for all Department of Justice (DOJ) employees to investigate individuals and entities who provide gender-affirming care to minor patients. To be clear, the memorandum—which has been posted in various locations on the internet and widely reported on by various media outlets but has not been verified as authentic by Husch Blackwell—is an internal policy statement directed to DOJ personnel and is not law. While it purports to issue “guidelines” pursuant to an executive order from the President, that executive order is itself under scrutiny (and has been partially enjoined).
A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure adherence to federal regulations governing medical necessity, lab requisition practices, and the Anti-Kickback Statute (AKS).