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As Introduced
136th
General Assembly
Regular
Session
S. B. No. 170
2025-2026
Senators Huffman, Roegner
A
BILL
To
enact sections 4729.891, 4731.971, 4731.972, 4731.973, 4731.975,
4731.976, 4731.977, 4731.978, 4731.979, and 4731.9710 of the Revised
Code
regarding
individualized investigational treatments for life-threatening or
severely debilitating illnesses.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section
1.
That
sections 4729.891, 4731.971, 4731.972, 4731.973, 4731.975, 4731.976,
4731.977, 4731.978, 4731.979, and 4731.9710 of the Revised Code be
enacted to read as follows:
Sec.
4729.891.
(A)
As used in this section:
(1)
"Eligible facility" means an institution that is operating
under a federalwide assurance for the protection of human subjects
under 42 U.S.C. 289(a) and 45 C.F.R. Part 46 and is subject to the
federalwide assurance laws, regulations, policies, and guidelines.
(2)
"Eligible patient" and "individualized investigational
treatment" have the same meanings as in section 4731.971 of the
Revised Code.
(B)
A manufacturer operating within an eligible facility and pursuant to
all applicable federalwide assurance laws and regulations may make
available an individualized investigational treatment, and an
eligible patient may request an individualized investigational drug,
biological product, or device from an eligible facility or
manufacturer operating within an eligible facility. Nothing in this
section requires a manufacturer to make available an individualized
investigational treatment to an eligible patient.
(C)
An eligible facility or a manufacturer operating within an eligible
facility may do both of the following:
(1)
Provide an individualized investigational treatment to an eligible
patient without receiving compensation;
(2)
Require an eligible patient to pay the costs of, or associated with,
the manufacture of the investigational drug, biological product, or
device.
Sec.
4731.971.
As
used in sections 4731.971 to 4731.9710 of the Revised Code:
(A)
"Eligible patient" means an individual who meets all of the
requirements of section 4731.972 of the Revised Code.
(B)
"Health benefit plan" and "health plan issuer"
have the same meanings as in section 3922.01 of the Revised Code.
(C)
"Individualized investigational treatment" means a drug,
biological product, or device that is unique to and produced
exclusively for use by an individual patient, based on the patient's
own genetic profile, including individualized gene therapy antisense
oligonucleotides and individualized neoantigen vaccines.
(D)
"Life-threatening or severely debilitating illness" means
diseases or conditions that meet one or more of the following:
(1)
The likelihood of death is high unless the course of the disease is
interrupted.
(2)
The outcome is potentially fatal and the end point of clinical trial
analysis is survival.
(3)
Cause major irreversible morbidity.
Sec.
4731.972.
An
individual is an eligible patient for purposes of sections 4731.971
to 4731.9710 and section 4729.891 of the Revised Code if the
individual meets all of the following:
(A)
The individual has a life-threatening or severely debilitating
illness, as attested to by the individual's treating physician.
(B)
The individual has considered all treatment options for the illness
that are approved by the United States food and drug administration.
(C)
The individual has received a recommendation from the individual's
treating physician for an individualized investigational treatment,
based on an analysis of the individual's genomic sequence; human
chromosomes; deoxyribonucleic acid; ribonucleic acid; genes; gene
products, such as enzymes and other types of proteins; or
metabolites.
(D)
Written, informed consent has been executed in accordance with
section 4731.973 of the Revised Code for the use of the
individualized investigational treatment.
(E)
The individual has documentation from the individual's treating
physician that the individual meets the requirements of divisions (A)
to (D) of this section.
Sec.
4731.973.
(A)
A treating physician may treat an eligible patient with an
individualized investigational treatment after securing the patient's
written, informed consent in a signed document that includes all of
the provisions described in division (B) of this section. The
document shall be signed by the patient's treating physician and one
of the following, in the presence of a witness who must also sign the
document:
(1)
The patient;
(2)
If the patient is a minor, the patient's parent, legal custodian, or
guardian;
(3)
If the patient has designated an individual as the patient's attorney
in fact under a durable power of attorney for health care in
accordance with section 1337.12 of the Revised Code, by the attorney
in fact;
(4)
If an individual has been appointed by a court to act as the
patient's guardian, by the guardian.
(B)
Written, informed consent shall include all of the following:
(1)
An explanation of the currently approved products and treatments for
the life-threatening or severely debilitating illness from which the
patient suffers;
(2)
Clear identification of the specific proposed individualized
investigational treatment that the patient is seeking to use;
(3)
A description, based on the treating physician's knowledge of the
proposed treatment in conjunction with an awareness of the patient's
condition, of the potentially best and worst outcomes of using the
individualized investigational treatment and a realistic description
of the most likely outcome, including the possibility that new,
unanticipated, different, or worse symptoms might result and that
death could be hastened by the proposed treatment;
(4)
A statement that the patient's health plan issuer and provider are
not obligated to pay for any care or treatment directly related to
the use of the individualized investigational treatment, unless the
entity is specifically required to do so by law or contract;
(5)
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 hospice care may be
reinstated if this treatment ends and the patient meets hospice
eligibility requirements;
(6)
A statement that the patient understands that the patient is liable
for all expenses directly related 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 of the drug, biological product, or device states
otherwise.
(7)
An attestation that the patient has a life-threatening or severely
debilitating illness and the physician believes that all approved and
conventionally recognized products and treatments are unlikely to
prolong the patient's life.
(8)
An attestation that the patient, or the patient's representative,
agrees with the physician's attestation under division (B)(7) of this
section.
Sec.
4731.975.
(A)
A health benefit plan or governmental agency may provide coverage for
the cost of an individualized investigational treatment or the cost
of services related to the use of an individualized investigational
treatment.
(B)
Nothing in section 4729.891 or sections 4731.971 to 4731.9710 of the
Revised Code shall not be construed to do any of the following:
(1)
Expand the coverage required under a health benefit plan;
(2)
Require any governmental agency to pay costs associated with the use
by an eligible patient of an individualized investigational drug,
biological product, or device, including any related care or
treatment of that patient;
(3)
Require a hospital or facility to provide new or additional services,
unless approved by the hospital or facility;
(4)
Authorize a health benefit plan or governmental agency to exclude
coverage for a covered person receiving an individual investigational
treatment for health services that are not related to an individual
investigational treatment and that are otherwise covered by the
health benefit plan or governmental agency;
(5)
Negate, abrogate, or in any way affect any mandatory coverage for
participation in clinical trials required in sections 1739.05,
1751.01, and 3923.80 of the Revised Code.
Sec.
4731.976.
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 coverage due to
the treatment.
Sec.
4731.977.
(A)
The state medical board shall not limit, revoke, or suspend; refuse
to grant, renew, or reinstate; or take any other action against a
physician's license or certificate to practice based solely on the
physician's recommendations to an eligible patient regarding an
individualized investigational treatment.
(B)
To the extent permitted under federal law, an entity responsible for
medicare certification shall not take action against a physician's
medicare certification based solely on the physician's recommendation
that an eligible patient have access to an individualized
investigational treatment.
Sec.
4731.978.
(A)
An official, employee, or agent of this state shall not prevent or
attempt to prevent access by an eligible patient or eligible
patient's treating physician to an individualized investigational
treatment that is being provided or is to be provided in accordance
with sections 4731.971 to 4731.977 and section 4729.891 of the
Revised Code.
(B)
Counseling, advice, or a recommendation consistent with medical
standards of care from a treating physician shall not be considered a
violation of this section.
Sec.
4731.979.
Nothing
in sections 4731.971 to 4731.978 and section 4729.891 of the Revised
Code shall be construed to create a private cause of action against a
manufacturer of an individualized investigational treatment or
against any other person or entity involved in the care of an
eligible patient using the individualized investigational treatment
for any harm to the patient resulting from the individualized
investigational treatment, if the manufacturer or other person or
entity has complied in good faith with sections 4731.971 to 4731.978
and section 4729.891 of the Revised Code and has exercised reasonable
care.
Sec.
4731.9710.
A
patient who is an eligible patient under section 4731.97 and sections
4731.971 to 4731.979 of the Revised Code may elect to receive
treatment in accordance with either or both section 4731.97 and
sections 4731.971 to 4731.979 of the Revised Code.