The Promising Pathways Act (HB 1381)

The Frame

What this does

The bill impacts how patients with terminal or rare conditions access non-FDA approved therapies and defines the financial liability and insurance obligations for these treatments, potentially changing out-of-pocket costs and access to experimental care for thousands of Florida residents.

Who is mentioned in the record

Potentially affected actors named in the source documents. Mention is not a position.

Patients with terminal or rare diseases

They gain a legal pathway to access experimental treatments and are protected from certain financial liabilities.

Licensed physicians

They are authorized to prescribe experimental treatments and are protected from licensing board actions based on these recommendations.

Health insurers and HMOs

They are encouraged to cover experimental treatments and are prohibited from denying coverage based solely on the experimental status of the treatment.

Experimental treatment manufacturers

They are required to provide temporary price concessions and receive limited liability protections.

What changed

Last recorded activity March 13, 2026.

What's next

Introduced.

Background

The bill was introduced in the 2026 legislative session and underwent committee review before failing to advance. context

Summary

This bill creates a regulated pathway for patients with terminal conditions or rare, life-threatening diseases to access experimental treatments that have passed initial safety trials but lack full FDA approval. It establishes a state-run patient registry, sets reimbursement rules for facilities, and encourages insurance coverage for these treatments.

Key Facts

You don't have to trust us. Each fact below is taken straight from the official document - click any one to see the exact passage, highlighted in the original.

Frequently Asked Questions

Who qualifies as an 'eligible patient'?

A person with a terminal condition (death expected within 1 year) or a life-threatening rare disease (affecting <200,000 people) who has exhausted all FDA-approved treatment options.

Does my insurance have to pay for these treatments?

Insurers are encouraged to provide coverage and are prohibited from denying it solely because the treatment is experimental, but the bill does not mandate that they cover the costs.

What happens if the experimental treatment causes harm?

The bill provides limited liability for manufacturers and providers who act in good faith, meaning patients generally cannot sue for harm unless there is gross negligence or intentional misconduct.

Is participation in this program mandatory for hospitals?

No, participation is entirely voluntary for hospitals and healthcare facilities.

Why It Matters

The bill impacts how patients with terminal or rare conditions access non-FDA approved therapies and defines the financial liability and insurance obligations for these treatments, potentially changing out-of-pocket costs and access to experimental care for thousands of Florida residents.

News Coverage

No news coverage found yet. Articles are indexed twice daily.

Discoveries

Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.

policy shift95% confidence

Conditional Reimbursement Model

The bill shifts from traditional coverage to a model where reimbursement is explicitly linked to participation in a state-run patient registry and evidence development.

Department of Health