The Illinois Legislature passed a regulation that changes the way health insurance works compared to Lack of generics and prepares for it come into force on January 1, 2026. The measure signed by the governor JB Pritzkerintroduces a change that directly impacts patients, insurers and health plans.
The text approved by the General Assembly contained a exact definition of “not available”a concept that became the core of the standard.
According to the information contained in the project, this is a medicinal product if listed as “Currently in Stock” or “Discontinued Item”. included in the U.S. Food and Drug Administration shortages database.
The regulations also described in detail what this meant “Generic”by making it clear that this is the case which was approved as part of an application related to a Reference medicineSection 505(j) of the Federal Food, Drug, and Cosmetic Act follows.
This was also determined An “eligible prescription drug” must be a previously approved product under Section 355(c) of the same legal framework and not protected by a patent.
This is what the law states If a generic or a therapeutic equivalent is “not available” Due to supply issues, the dose cannot be adjusted health insurance – including individual plans, group plans and managed care programs – it will be obliged to provide the corresponding branded version.
The insurance coverage provided by health insurance should be maintained until the generic drug or its therapeutic alternative becomes available again be available.
The measure, that The implementation date was originally scheduled for January 1, 2025was changed during the legislative process and the final text provided for this effective immediately only applies to policies “modified, issued, issued or renewed after January 1, 2026.”.
The aim of this change was Give insurers and managed care organizations more time Contracts, internal processes and approval systems need to be readjusted as temporary coverage of branded medicines in times of shortage entails additional costs and procedures.
The debate that led to this regulation arose from a complex national context regarding access to medicines.
The increase in temporary shortages and disruptions forced states to consider what mechanisms they could put in place Reduce impact on patientsas the law explains.
In this sense, Illinois chose to intervene directly in the relationship between insurers, providers and affiliates if a generic is not on the market.
The detailed definition of terms such as “appropriate drugs”, “generics” and “unavailable”, supplemented by the express requirement for all health insurance plans, is part of a Strategy to prevent patients from going without treatment or are forced to pay for branded medications themselves.
In addition, linking the deficiency concept to the FDA database provides an objective and verifiable parameter.
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