S.Amdt. 2561

The amendment sets rules for how health plans must cover certain insulin products starting on January 1, 2026. It aims to change and add specific cost rules, coverage standards, and competition measures for insulin and biosimilar products.

The amendment makes the following major changes and additions:

• Sets a maximum cost of $35 per 30-day supply for selected insulin products, with no deductibles applied, for plan years beginning before January 1, 2027.
• Requires that for plan years starting on or after January 1, 2027, the cost for a 30-day supply cannot be more than $35 or 25 percent of the net negotiated price, whichever is less, and keeps the rule that no deductibles apply.
• Bans health plans and pharmacy benefit managers from using prior authorization or other medical management requirements on selected insulin products, unless it is clinically justified for safety reasons or to ensure reasonable quantity limits.
• Requires pharmacy benefit managers, third-party administrators, and health plans to pass 100 percent of insulin rebates, fees, and discounts back to the group health plan.
• Creates a process to speed up the development and review of competitive biosimilar biological products when there is inadequate biosimilar competition.
• Directs the government to complete a study and report to Congress on the causes of delays in getting insulin products to market within one year of enactment.