The Montana Legislature convened on April 29, 2025, to introduce Senate Bill 535, a significant piece of legislation aimed at regulating experimental treatment centers within the state. The bill seeks to establish a framework for operational standards, oversight mechanisms, and safety protocols for these facilities, addressing growing concerns about the accessibility and safety of experimental medical treatments.

Senate Bill 535 outlines several key provisions. It mandates the creation of written policies and procedures for treatment centers, requires regular facility inspections, and sets forth minimum operational standards. Additionally, the bill emphasizes the importance of data collection and quality assurance systems, including monitoring outcomes and reporting adverse events. To support the administrative costs associated with these regulations, the bill stipulates a $10,000 application fee for new treatment centers and a $5,000 annual renewal fee.

A notable aspect of the bill is its "health freedom and access requirement," which compels licensed experimental treatment centers to allocate 2% of their net annual profits to enhance access to experimental treatments for qualifying Montana residents. This allocation can be fulfilled either by providing free experimental treatments or by contributing to an insurance premium support account. The Department of Health is tasked with developing the necessary policies and procedures to identify qualifying residents and facilitate their access to these treatments.

The introduction of Senate Bill 535 has sparked discussions among lawmakers and stakeholders regarding its implications. Proponents argue that the bill will enhance patient safety and ensure that experimental treatments are accessible to those in need. However, some critics express concerns about the financial burden on treatment centers and the potential impact on their operations.

As the legislative process unfolds, experts suggest that the bill could significantly reshape the landscape of experimental medical treatments in Montana. If passed, it may lead to increased scrutiny of treatment centers while also providing a safety net for residents seeking innovative healthcare solutions. The bill's progress will be closely monitored, as its outcomes could set a precedent for similar legislation in other states.