•  District of Columbia: J&J has filed a lawsuit against HHS and HRSA, asking a federal court to declare the company's proposed 340B rebate model legal and block the government's attempt to prevent the model's implementation. In August, J&J announced that it would change its pricing model for Stelara and Xarelto. Instead of receiving upfront discounts, disproportionate share hospitals would have to pay full price for the drugs and then later apply for a rebate. The plan quickly received criticism from healthcare organizations, such as the  American Hospital Association  and  America's Essential Hospitals, as well as the federal government. In response to the plan, HRSA sent a letter threatening to sanction J&J if it continued with its 340B rebate plan. On Sept. 30, J&J ceased implementation of its rebate plan, but continued to stand by the strategy, saying that it could improve the 340B program. "The Rebate Model that J&J intends to launch represents a limited but significant step toward remedying the dysfunction and abuse that pervades today's 340B program," J&J said in its lawsuit. "Neither the universe of eligible 340B claims nor the amount of the 340B price to [disproportionate share hospitals] would change." (AHA News, 11/13; Pifer, Healthcare Dive, 11/13)
• Georgia: According to a new CDC report, the percentage of Americans without health insurance has remained steady in recent years, but it is unclear whether this will be true going forward. In the report, researchers found that 7.6% of Americans, or 25.3 million people, did not have health insurance at the time of data collection from April to June. Although this was a 0.4 percentage point increase from the same time a year before, it is consistent with the full-year uninsured rate for 2023, which was a historic annual low. "More people have health insurance coverage than ever before — and the peace of mind that comes with it," said HHS Secretary Xavier Becerra. "That is all thanks to the Affordable Care Act's [ACA] expansion of Medicaid and creation of the Marketplace." However, the historic drop in the country's uninsured rate under the Biden administration could rise to 8.9% over the next 10 years as Medicaid redeterminations finish, enhanced ACA subsidies potentially expire, and more immigrants come to the country, according to the Congressional Budget Office. (Berryman, Modern Healthcare, 11/11)
• Maryland: In its 2025 Physician Fee Schedule final rule, CMS relaxed supervision requirements for physician and occupational therapist assistants, a change that could benefit health systems and other providers. When the final rule goes into effect Jan. 1, physical and occupational therapists who employ assistants will need to be immediately reachable by telephone, video, or in person, but are not required to be physically present while care is administered. Previously, supervisors were required to be on-site and assistants had to be directly supervised. This change in regulation could help health systems and other providers better manage patient volume, advance people through stages of care more quickly, and decrease Medicare spending. According to the healthcare consulting firm Dobson & DaVanzo, the change will save $242 million over the next decade. Heather Parsons, VP of federal affairs for the American Occupational Therapy Association, also noted that the change aligns Medicare policy with the broader shift to outpatient care in the healthcare system. (Early, Modern Healthcare, 11/12)

Learn how the 340B drug pricing program helps reduce costs for providers serving low-income populations.