November 13, 2025

The agency is now seeking applications from manufacturers interested in participating in the model, as well as letters of intent from states that may want to opt into the pricing and terms eventually negotiated by the CMS. States will be able to enroll on a rolling basis through Aug. 31.

The waning days of the Biden administration sought to include GLP-1s in Medicare and Medicaid coverage. The Trump administration initially decided not to proceed with these efforts. However, a recent deal aimed at broadening access to these drugs and equalizing U.S. prices with those paid in other nation, circles back to the Biden administration’s efforts. The new monthly price tag on these drugs for Medicare enrollees is $245, down from what used to be in the thousands.

Under CMS’s WISeR model, AI-backed prior authorization is intended to identify unnecessary care and reduce costs for both patients and the federal government. However, Democratic lawmakers warn the approach could instead restrict access, worsen health outcomes for Medicare seniors, and strain providers. Critics have also raised concerns about potential financial incentives to deny care, which could undermine trust in the program.

The FDA’s decision follows a comprehensive review of scientific literature, feedback from an expert panel convened in July, and a public comment period. The original safety warnings stemmed from a landmark study on estrogen plus progestin therapy in postmenopausal women, which found increased risks of breast cancer and heart disease. More recent evidence, however, paints a more nuanced picture — with some studies suggesting potential cardiovascular benefits and reduced fracture risk, prompting the agency to revisit decades-old cautionary labeling.

Washington is moving to restart government operations, but Democrats leave without their key win of securing a long-term extension of enhanced ACA tax credits set to lapse at the end of 2025. Senate Republicans have only agreed to hold a vote before year’s end, offering no assurance the subsidies will continue and resulting in mounting uncertainty heading into the 2026 coverage year.