Senate Bill No. [insert bill number] seeks to establish a comprehensive licensing framework for experimental treatment centers in Montana, ensuring that no center can operate without a proper license issued by the Department of Public Health and Human Services. The bill outlines the application process, which includes a $10,000 fee and an annual renewal fee of $5,000, and mandates the adoption of rules regarding operational standards, facility inspections, and safety protocols. It introduces a new definition for "experimental treatment center" and stipulates that only licensed centers can provide experimental treatment services, while also exempting direct agreements between healthcare providers and patients from certain insurance code provisions.
The bill further amends various sections of the Montana Code Annotated to clarify definitions and requirements related to experimental treatments. Key insertions include a broader definition of "experimental treatment," which now includes investigational drugs or devices that have completed phase 1 clinical trials but are not yet FDA-approved. It emphasizes the need for informed consent, detailing potential outcomes and financial responsibilities, and outlines eligibility criteria for patients seeking these treatments. Additionally, the bill protects healthcare providers from disciplinary actions based solely on their recommendations for experimental treatments and provides immunity from lawsuits for those complying with established protocols. The act is set to take effect upon passage and approval.
Statutes affected: LC Text: 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_1(1): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_1(2): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_1(3): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_1(4): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_1(5): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_1: 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2(1): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2(2): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2(3): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2(4): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2(5): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2(6): 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110
SB0535_2: 33-1-102, 37-3-103, 50-5-101, 50-12-102, 50-12-103, 50-12-104, 50-12-105, 50-12-106, 50-12-107, 50-12-108, 50-12-109, 50-12-110