No. HB 1381
Filed under Healthcare.
Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases; Authorizes licensed physicians to prescribe & eligible facilities to administer experimental treatments; requires approval of specified platform or master protocol by institutional review board; requires DOH to establish & maintain patient registry; requires DOH to annually publish specified report; encourages health insurers & health maintenance organizations to provide specified insurance coverage for experimental treatments; authorizes licensed physicians & eligible facilities to receive reimbursement for experimental treatments; requires manufacturers of experimental treatments to provide for specified temporary price concession; requires DOH to adopt by rule certain procedures for licensing of experimental treatment centers.
Plain English Summary
AI-GENERATEDDoctors licensed in Florida may now prescribe, and eligible hospitals may administer, treatments that have only cleared phase 1 safety trials and are not yet FDA-approved, to patients with a terminal condition or a rare disease affecting under 200,000 Americans.
Manufacturers must offer a temporary discounted price while a treatment remains unapproved, and the Department of Health sets a capped reimbursement rate for physicians and facilities, tied to registry compliance; the cap disappears once the FDA approves the treatment.
Patients bear the cost of experimental treatment themselves, and their estate is not liable for unpaid bills if they die using it. Manufacturers and providers acting in good faith cannot be sued for resulting harm, except for gross negligence or willful misconduct.
A doctor's license or Medicare certification cannot be pulled solely for recommending an experimental treatment. Insurers are only encouraged, not required, to cover these treatments, and may not refuse coverage solely because a treatment is experimental.
AILets a physician licensed under chapter 458 or 459 prescribe an experimental treatment, meaning a drug, biologic, device, or personalized genomic therapy that has cleared phase 1 trials but is not yet FDA-approved, to an eligible patient.
AIAllows an eligible facility to administer an experimental treatment if it follows a platform or master protocol approved by an institutional review board and meets the patient-registry reporting requirements.
AIRequires a manufacturer of an experimental treatment to provide a temporary price concession, set by the department as a percentage of a recognized pricing benchmark, that expires once the FDA approves the treatment.
AIBlocks a private lawsuit against a manufacturer, or against a person or entity involved in an eligible patient's care, for harm from an experimental treatment, as long as they acted in good faith with reasonable care; gross negligence and willful misconduct remain suable.
AIBars a licensing board from revoking, denying renewal of, or suspending a physician's license, and bars a Medicare-certifying state agency from acting against a physician's certification, based solely on a recommendation to use experimental treatment.
AILimits what physicians and facilities may be reimbursed for an experimental treatment to a discounted rate set by the department as a percentage of a recognized pricing benchmark, adjusted for registry compliance and reviewed every 2 years.
AIBars a health insurer or HMO from denying coverage solely because a treatment is experimental or FDA-unapproved, but the same section makes clear this creates no requirement to cover experimental treatment at all.
AIProhibits a public official, employee, or state agent from denying or attempting to deny a patient's access to experimental treatment, though a physician's standard-of-care counseling or advice does not count as denial.