No. SB 1552
Filed under Healthcare.
Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases; Citing this act as the “Promising Pathways Act"; authorizing licensed physicians to prescribe and eligible facilities to administer experimental treatments, if certain requirements are met; requiring the Department of Health to establish and maintain a patient registry for specified purposes; encouraging health insurers and health maintenance organizations to provide specified insurance coverage for experimental treatments; authorizing licensed physicians and eligible facilities to receive reimbursement for the prescription or administration of experimental treatments if certain requirements are met; requiring manufacturers of experimental treatments to provide for a specified temporary price concession set by the department, etc.
Plain English Summary
AI-GENERATEDLicensed physicians may prescribe FDA-unapproved experimental treatments to patients with a terminal condition or life-threatening rare disease, once they have exhausted approved options and given written informed consent. Eligible hospitals administer the treatment under a state-approved research protocol.
Physicians and facilities can be reimbursed for these treatments, but only at a discounted rate set by the state, and only if the facility feeds data into a new patient registry tracking outcomes. Manufacturers must also offer a temporary discounted price.
Health insurers are encouraged, but not required, to cover experimental treatments, and may not refuse to pay solely because a treatment is unapproved. Patients remain responsible for costs their insurer does not cover.
Physicians cannot be disciplined or lose Medicare certification solely for recommending an experimental treatment. Manufacturers and providers acting in good faith cannot be sued for resulting harm, and a patient's heirs are not liable for unpaid treatment debt.
AIA physician licensed under chapter 458 or 459 may prescribe an experimental drug, biologic, device, or personalized genomic therapy to an eligible patient with a terminal condition or life-threatening rare disease, once FDA-approved options are exhausted and informed consent is given.
AIA facility can be reimbursed only if it actively feeds outcome data into the new state patient registry, and the reimbursement itself may not exceed a state-set discount off a recognized price benchmark, adjusted every two years based on registry compliance.
AIManufacturers of an experimental treatment must offer a temporary price concession set by the department as a percentage of a recognized pricing benchmark, which expires once the FDA approves the treatment for general use.
AIA licensing board may not revoke, suspend, or otherwise act against a physician's medical license, and a Medicare-certification agency may not act against that certification, based solely on the physician recommending an experimental treatment to an eligible patient.
AIManufacturers and anyone involved in a patient's experimental-treatment care cannot be sued over resulting harm if they acted in good faith and used reasonable care, unless the conduct amounts to gross negligence or intentional, willful, or wanton misconduct.
AIOnce an Institutional Review Board approves a platform or master protocol, physicians and eligible facilities may adjust dosing, sequencing, or combinations of authorized experimental treatments within preset limits, without going back to the IRB for each individual adjustment.
AIA patient qualifies as 'eligible' only after considering and exhausting every FDA-approved treatment for their condition, and only after giving written informed consent covering risks, costs, and the effect on hospice eligibility.
AIA health insurer or HMO may not refuse to cover an experimental treatment for the sole reason that it is experimental or not yet FDA-approved, though insurers are only encouraged, not required, to cover these treatments at all.