• Maine: Late last month, Judge Lance Walker of the U.S. District Court of Maine paused a controversial 340B drug rebate pilot program that was scheduled to take effect on Jan. 1. Last November, the Health Resources and Services Administration (HRSA) approved a new 340B drug rebate pilot program, which would require providers to pay upfront for drugs before applying for rebates instead of receiving discounts directly. Although the pharmaceutical industry has championed the program, healthcare providers have sharply criticized it. On Dec. 1, the American Hospital Association, the Maine Hospital Association, and four safety-net hospitals filed a lawsuit against HRSA to block the 340B rebate pilot program. In his ruling, Walker said the program would likely violate the Administrative Procedure Act and could potentially harm hospitals. "[HRSA's] roll out has involved a rather threadbare administrative record that likely fails to consider and reasonably explain the impact of a rebate model on 340B hospitals, who rely on upfront price concessions to stretch few resources as far as possible to serve rural and poor communities. The [Administrative Procedure Act] likely requires more from Defendants," Walker wrote. Currently, Walker has issued a preliminary injunction on the program, pending any additional orders. (DeSilva, Modern Healthcare, 12/29/25; Morse, Healthcare Finance, 1/2; Pifer, Healthcare Dive, 1/8)
• Maryland: FDA last week announced it would ease the regulation of digital health products, including wearable devices and AI-driven health tools. According to FDA Commissioner Marty Makary, devices and software that provide general health information instead of clinical-grade measurements will not require FDA review. Makary detailed these changes at the Consumer Electronics Show in Las Vegas and said the agency is planning even more changes in the future, including creating a "new regulatory framework for AI" and reducing the number of guidances related to digital health. "If you're not making medical or clinical claims, you don't need to come through the FDA and we'll get out of the way," Makary said. "This reduces the amount of subjectivity by regulators and guesswork by developers." Although technology companies and digital health startups have praised the decision, consumer and patient advocacy groups caution that reduced oversight could lead to confusion if consumers rely heavily on wellness devices for medical insights. (Lawrence, et al., STAT+ [subscription required], 1/6; Huffman, Consumer Affairs, 1/7; Diaz, Beckers' Health IT, 1/6)
• North Carolina: Cone Health has named Paul Krakovitz its new CEO after a nationwide search, effective March 16. Krakovitz replaces former president and CEO Mary Jo Cagle, who stepped down last May due to a serious family health matter. Bernard Sherry, Cone's interim COO, will continue serving as interim CEO until Krakovitz takes over in March. Most recently, Krakovitz served as the executive-in-residence at Cressey & Company, an investment firm that focuses on healthcare services, providers, facilities, and information technology. Before that, he served as Desert Region president and SVP for Intermountain Health. "With a proud history and a clear vision for the future, Cone Health stands at the intersection of care and community. It's a place where mission and culture come together in meaningful ways. That combination is what attracted me here," Krakovitz said. "I'm honored to lead alongside such dedicated colleagues as we build on this legacy and embrace new opportunities as we continue our transformational journey in value-based care. Together, we will keep this health system vibrant, successful and deeply connected to those who depend on us." (Morse, Healthcare Finance, 12/29/25)

The 340B drug discount program is facing pushback. Find out how provider organizations that depend on 340B savings for financial sustainability can prepare for potential changes to the program.