What shows up once the story must survive the terms
At the outset of life sciences transactions, there is usually a strong sense of alignment. Founders and investors tend to agree on the importance of discipline, focus, capital efficiency, and long-term value. That was evident throughout JPM Healthcare Week and in conversations around RESI 2026, where many of the same themes surfaced across different rooms and discussions.
A federal judge has issued a preliminary injunction halting the Department of Health and Human Services’ (HHS) 340B Rebate Model Pilot Program, which was scheduled to take effect on January 1, 2026. The December 29, 2025 ruling temporarily prevents implementation of the rebate program that would have fundamentally changed how safety-net hospitals and clinics purchase discounted drugs under the 340B Drug Pricing Program.
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.
The legal and regulatory landscape for ketamine clinics is shifting once again, as the Drug Enforcement Administration (DEA) prepares to release its “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” While the full text of this rule is not yet public, its very existence signals that the DEA may continue the pandemic-era telehealth flexibilities that have proven vital for many clinics and patients. For owners and operators of ketamine clinics, understanding what’s at stake and how to prepare is more important than ever.
California Governor Gavin Newsom has signed a pair of highly anticipated bills that will affect healthcare transactions involving private equity groups and hedge funds, effective January 1, 2026. The new legislation will expand the authority of the California Office of Health Care Affordability (“OHCA”) to review transactions previously excluded from reporting for their impact on healthcare costs and markets and will reinforce prohibitions on lay interference with the delivery of physician and dental services under the California’s corporate practice of medicine laws.
This post is the third 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.
HLTH USA is a whirlwind—partnering, investor meetings, and press all compressed into a few fast-moving days. That intensity can be great, but it can also be risky for protecting and maximizing the value of your intellectual property. In the rush to network, pitch, and show off your innovation, it is easy to jeopardize your patent or trade secret rights by disclosing too much detail in a conversation or showing more than you should at your booth.
As HLTH approaches, it is worth pausing to consider how a thoughtful IP strategy can protect your company’s most valuable assets not only during HLTH itself, but long afterward.
Capturing innovation is just as important as protecting it. A simple invention disclosure form — recording the technical problem, your solution, key data, and alternative embodiments — can become the backbone of a provisional patent filing. Filing quickly, before public disclosures, is critical. But speed shouldn’t come at the expense of substance. A well-prepared provisional application, rich with enabling detail and variations, buys you time to refine claims and sequence international filings. Resist the temptation to file a “skeleton” provisional unless you have no other option.
In medtech and life sciences, it is often valuable to cover not just the device or system, but also methods of use (including physician workflows), manufacturing or assay methods, and the software or algorithms that deliver a concrete technical improvement. Enabling disclosure for a variety of embodiments can make all the difference when it comes to enforcement or licensing down the road.
This post is the second 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.
The healthcare industry is undergoing a rapid transformation, with startups driving innovation in patient care, diagnostics, data management, and telemedicine.
In today’s rapidly evolving healthcare industry, startup companies face significant hurdles in bringing innovative solutions to market. Licensing software and intellectual property provides a practical pathway for startups to overcome high development costs, regulatory complexities, and the need for advanced technology. By understanding various licensing models and the strategic importance of partnerships, healthcare startups can accelerate growth while ensuring compliance and security. This guide aims to empower entrepreneurs with the knowledge needed to make informed decisions about licensing, ultimately supporting innovation and better patient outcomes.