SB 535: Revise laws related to experimental treatments - Montana

SB0535_X(3).pdf → SB0535_X(4).pdf · 3 edits

MINOR

The bill was amended to remove references to several specific sections of the state code (37-3-103 and 50-12-110) from the list of sections being modified, likely to correct a clerical error or narrow the scope of amendments. Additionally, the bill added new requirements for the department to establish written policies and procedures alongside operational standards, and introduced a new section regarding an insurance premium support account, which establishes a funding mechanism for experimental treatments without reducing existing state funds.

Scope change

The bill's scope was slightly narrowed by removing specific code section references from the amendment list, and expanded by adding new administrative requirements and a new funding account for experimental treatments.

TECHNICAL

Removed references to sections 37-3-103 and 50-12-110 from the list of code sections being amended.

REQUIREMENT

Added a requirement for the department to create written policies and procedures in addition to operational standards.

FISCAL

Created a new insurance premium support account to fund experimental treatments while ensuring it does not replace existing state funding.

SB0535_3(5).pdf → SB0535_X.pdf · 3 edits

MINOR

This bill was updated from a draft version to an enrolled, final version, incorporating minor formatting corrections and adding a new subsection to an existing insurance code section. The substantive policy content regarding experimental treatment center licensing, fees, and the health freedom and access requirement remains unchanged.

Scope change

The bill's scope and applicability remain the same; no new entities or jurisdictions were added or removed.

TECHNICAL

Corrected formatting inconsistencies, such as removing bracketed placeholders like [SECTION 2] and [SECTION 3] to reflect the final enacted text, and adjusting line breaks for readability.

Updated the bill title and description to reflect the final enrolled version, including the addition of 'AMENDING DEFINITIONS' to the list of actions.

REQUIREMENT

Added a new subsection (3) to Section 33-1-102 of the Montana Code Annotated, clarifying that the insurance code applies to health service corporations as prescribed in 33-30-102.

SB0535_2(11).pdf → SB0535_3.pdf · 5 edits

MODERATE

The bill was renumbered from SB 535.2 to SB 535.3 and significantly expanded its scope by adding a 'Health Freedom and Access Requirement' that mandates experimental treatment centers to donate 2% of their net annual profits to support access for qualifying Montana residents. It also established a new 'Insurance Premium Support Account' to receive these contributions and fund health insurance premiums for low-to-moderate income residents using the federal marketplace.

Scope change

The bill's scope expanded from solely regulating the licensing of experimental treatment centers to include a mandatory funding mechanism where licensed centers must contribute a percentage of their profits to a state account.

REQUIREMENT

Added a new requirement for licensed experimental treatment centers to allocate 2% of their net annual profits to support access to experimental treatments and healthcare for qualifying Montana residents.

FISCAL

Created a new 'Insurance Premium Support Account' in the State Special Revenue Fund to receive contributions from experimental treatment centers.

ELIGIBILITY

Defined 'qualifying Montana residents' as those purchasing health insurance on the federal marketplace with incomes between 139% and 400% of the federal poverty level.

ENFORCEMENT

Added a new section requiring the Department of Public Health and Human Services to develop policies for determining eligibility and processing reimbursement requests for experimental treatments.

TECHNICAL

Updated the bill number from SB 535.2 to SB 535.3 and reorganized the text structure to accommodate the new sections.

SB0535.002.006_combo_final-condensed.pdf → SB0535_2(7).pdf · 5 edits

MODERATE

The bill was significantly restructured to remove the controversial 'Health Freedom and Access Requirement' that previously forced experimental treatment centers to donate 2% of profits. Instead, the new version focuses on establishing a licensing framework with specific application fees and annual renewal fees to fund administrative costs, while adding new safety and data collection standards for oversight.

Scope change

The bill's scope shifted from a hybrid model requiring profit-sharing donations to a standard regulatory licensing model. It also expanded the list of insurance and healthcare entities exempt from the bill's requirements.

REQUIREMENT

Eliminated the mandate requiring experimental treatment centers to allocate 2% of net annual profits to support access to experimental treatments.

Added a new requirement for experimental treatment centers to allocate 2% of net annual profits to support access to experimental treatments.

Expanded the department's rulemaking authority to include facility safety standards and data collection systems for outcome monitoring and adverse event reporting.

FISCAL

Replaced the profit-sharing donation requirement with a specific application fee of $10,000 and an annual renewal fee of $5,000 to cover administrative costs.

SCOPE

Added new exemptions for private air ambulance services, guaranteed asset protection waivers, and expanded existing exemptions for various insurance programs and self-insured plans.

SB0535_2(6).pdf → SB0535.002.006_combo_final-condensed.pdf · 4 edits

MODERATE

This bill amendment adds a 'Health Freedom and Access Requirement' that mandates licensed experimental treatment centers to allocate 2% of their net annual profits to support access to experimental treatments for Montana residents. It also establishes a new 'Insurance Premium Support Account' to fund health insurance premiums for low-to-middle-income residents purchasing coverage on the federal marketplace. The amendment modifies the bill's title to reflect these new obligations and funding mechanisms.

Scope change

The bill's scope expanded from solely regulating the licensing of experimental treatment centers to including mandatory profit-sharing for patient access and the creation of a state fund to subsidize health insurance premiums.

REQUIREMENT

Added a requirement for experimental treatment centers to allocate 2% of net annual profits to support access to experimental treatments for qualifying Montana residents.

FISCAL

Created a new 'Insurance Premium Support Account' in the state treasury to fund health insurance premiums for residents with incomes between 139% and 400% of the federal poverty level.

SCOPE

Updated the bill title to include the new health freedom requirement and the establishment of the insurance premium support account.

ELIGIBILITY

Defined eligibility for the new insurance fund as purchasing health insurance on the federal marketplace with an income between 139% and 400% of the federal poverty level.

SB0535_1(5).pdf → SB0535_2.pdf · 1 edit

MINOR

The bill underwent a technical renumbering and formatting update, changing the bill identifier from 'SB 535.1' to 'SB0535.2'. This adjustment aligns the document with standard legislative numbering conventions. No substantive policy changes, such as new funding, eligibility criteria, or operational requirements, were identified in the provided text.

TECHNICAL

The bill number was updated from 'SB 535.1' to 'SB0535.2' and the header layout was adjusted to remove separator lines.

LC0780.pdf → SB0535_1.pdf · 2 edits

MINOR

The bill text was updated to reflect the official Senate Bill number (SB 535) instead of the committee draft number (LC 0780). A new provision was added to explicitly exempt guaranteed asset protection waivers governed by Title 30 from the bill's requirements.

Scope change

The bill's applicability was narrowed by adding a specific exemption for guaranteed asset protection waivers.

SCOPE

Added an exemption stating that the code does not apply to guaranteed asset protection waivers governed by Title 30.

TECHNICAL

Updated bill headers and page footers to change the identifier from LC 0780 to SB 535.

Revise laws related to experimental treatments

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