Andrew Powell
Floridians facing severe illnesses could soon have access to health care treatments produced uniquely for themselves and their conditions.
Doral Republican Sen. Ana Maria Rodriguez filed a bill (SB 680) that would allow eligible patients with life-threatening or severely debilitating illnesses to request and receive individualized treatments from their physicians.
An individualized investigational treatment is defined in the bill as meaning drugs, biological products or devices that are unique and produced exclusively for use by an individual patient based on their own genetic profile. It includes individualized gene therapy antisense oligonucleotides (which targets messenger RNA) and individualized neoantigen vaccines.
To be eligible, a patient would need to meet several requirements, including having a life-threatening or debilitating condition attested to by their physician — based on analysis of the patient’s genomic sequence, human chromosomes, DNA, RNA, genes or gene products, such as enzymes or metabolites.
Patients would further be required to consider all other treatment options currently approved by the Food and Drug Administration.
Written and informed consent for the use of an individualized investigational treatment would be required. That would include an attestation that current treatments would be unlikely to prolong the patient’s life; details on the specific proposed alternative treatment; potential outcomes; and a statement from the patient saying their physician, health plan or third-party administrator are not obligated to pay for any treatment unless required by law or contract.
Hospice eligibility could be withdrawn if the patient begins a curative treatment with the investigational product. However, eligibility for hospice care could be reinstated if the treatment ends and the patient meets requirements.
Patients would further be required to provide a statement acknowledging they are liable for all expenses related to the use of the treatment, which would extend to their estate, unless a contract states otherwise. A patient’s heirs would be protected from liability for debts related to the treatments if the patient dies during the course of their treatment.
Licensing boards and certain state entities who are responsible for Medicare certification, would be prohibited from taking disciplinary action against physicians solely because they recommended the treatments. State officials, employees and agents would be prevented from blocking access.
Health care facilities and manufacturers operating under a Federalwide Assurance for the Protection of Human Subjects under certain U.S. codes, regulations, policies and guidelines would be able to provide the treatments to eligible patients. Health care providers and manufacturers would have limited liability if they comply with the bill’s terms.
The bill further stipulates that it does not expand the coverage an insurer must provide under the Florida Insurance Code.
If passed, the bill would come into effect July 1.
