SB 282

This bill enacts the "Individualized Investigational Treatment Act, which (i) authorizes a manufacturer operating within a public or private entity, or federal or state department or agency, that operates under principles of Federalwide Assurance (FWA) for the Protection of Human Subjects in accordance with federal law (""eligible facility"") to make available drugs, biological products, or devices that are unique to and produced exclusively for use for an individual patient, based on the patient's own genetic profile (""individualized investigative treatment""), and (ii) authorizes an eligible patient to request an individualized investigational treatment, from an eligible facility or such manufacturer. However, this bill does not require a manufacturer to make available an individualized investigational treatment to an eligible patient. This bill also authorizes an eligible fac i lity or manufacturer to either provide an individualized investigational treatment to an eligible patient without receiving compensation, or to require an eligible patient to pay the costs of, or the costs associated with, the manufacture of such treatmen t. As used in this bill, an ""eligible patient"" means an individual who (i) has a life-threatening or severely debilitating illness, attested to by a treating physician; (ii) has, in consultation with a treating physician, considered all other treatment op tions currently approved by the United States food and drug administration; (iii) has received a recommendation from the treating physician for use of an individualized investigational treatment for treatment of such illness; (iv) has given written, infor m ed consent for the use of the investigational drug, biological product, or device; and (v) has documentation from the patient's physician that the patient meets all of these requirements. This bill clarifies that ""written, informed consent"" must be signe d by the patient, the patient's parent if the patient is a minor, the patient's legal guardian, or the patient's attorney-in-fact; attested to by the patient's physician and a witness; and include, at a minimum, all of the following:  An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers.  An attestation that the patient concurs with the patient's physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life.  Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use.  A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition.  A release of liability relative to the treating physician, licensed healthcare providers, hospital, and manufacturer.  A statement that the patient's health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the individualized investigational treatment, unless they are specifically required to do so by law or contract.  A statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational treatment and that care may be reinstated if such treatment ends and the patient meets hospice eligibility requirements.  A statement that the patient understands that the patient is liable for all expenses consequent to the use of the individualized investigational treatment and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer states otherwise. EXTENT OF COVERAGE AND SERVICES This bill clarifies that it does not expand the coverage required of an insur er under the insurance laws of this state, nor does it affect any mandatory healthcare coverage for participation in clinical trials under such laws. However, a health plan, third-party administrator, or governmental agency may provide coverage for the c o st of an individualized investigational treatment, or the cost of services related to the use of an individualized investigational treatment. Likewise, this bill does not require any governmental agency to pay costs associated with the use, care, or trea t ment of a patient with an individualized investigational treatment, nor does this bill require a hospital or facility licensed by the department of health, or any physician or healthcare provider to provide any items or services unless a request by an eli g ible patient is approved by the hospital, facility, physician, or healthcare provider. OUTSTANDING DEBT UPON DEATH This bill provides that if a patient dies while being treated by an individualized investigational treatment, the patient's heirs are not liable for any outstanding debt related to the treatment or lack of insurance due to the treatment. ACTIONS AGAINST LICENSE AND CERTFICATION PROHIBITED This bill prohibits a licensing board or disciplinary subcommittee from revoking, failing to renew, s uspending, or taking any action against a healthcare provider's license, based solely on the provider's recommendations to an eligible patient regarding access to or treatment with an individualized investigational treatment. Additionally, an entity resp o nsible for medicare certification must not take action against a provider's medicare certification based solely on the provider's recommendation that a patient have access to an individualized investigational treatment. ACTIONS BY THE STATE PROHIBITED T his bill prohibits an official, employee, or agent of this state from blocking or attempting to block an eligible patient's access to an individualized investigational treatment. However, the rendering of counseling, advice, or a recommendation consisten t with medical standards of care from a licensed healthcare provider is not a violation of such prohibition. PRIVATE CAUSE OF ACTION PROHIBITED This bill does not create a private cause of action against a manufacturer of an individualized investigationa l treatment or against any other person or entity involved in the care of an eligible patient using the individualized investigational treatment for any harm done to the eligible patient resulting from the individualized investigational treatment, if the m anufacturer or other person or entity is complying in good faith with this bill and has exercised reasonable care. ON MARCH 6, 2025, THE SENATE ADOPTED AMENDMENT #1 AND PASSED SENATE BILL 282, AS AMENDED. AMENDMENT #1 revises the exemption provision of the bill that provides that the bill does not require a hospital or facility licensed in this state, or any physician or healthcare provider, to provide any items or services unless a request by an eligible patient is approved by the hospital, facility, p hysician, or healthcare provider to, instead, require the approval to be approved by the hospital, facility, physician, and healthcare provider ."