SENATE BILL No. 250
AN ACT concerning health and healthcare; relating to treatments for life-threatening
illnesses; enacting the right to try for individualized treatments act to permit certain
manufacturers to make individualized investigative treatments available to eligible
requesting patients.
Be it enacted by the Legislature of the State of Kansas:
Section 1. (a) As used in this act, unless the context otherwise
requires:
(1) "Biospecimen" means biological materials obtained from
living or deceased human subjects.
(2) "Eligible patient" means an individual who has:
(A) A life-threatening or severely debilitating illness, attested to
by the patient's treating physician;
(B) considered all other treatment options currently approved by
the United States food and drug administration;
(C) received a recommendation from the patient's physician for an
individualized investigational treatment, based on analysis of the
patient's genomic sequence, human chromosomes, deoxyribonucleic
acid, ribonucleic acid, genes, gene products, such as enzymes and other
types of proteins, or metabolites;
(D) given written, informed consent for the use of the
investigational drug, biological product or device; and
(E) documentation from the patient's physician that such patient
meets the requirements of this act.
(3) "Individualized investigational treatment" means drugs,
biological products or devices that are unique to and produced
exclusively for use on an individual patient, based on the patient's own
genetic profile. "Individualized investigational treatment" includes, but
is not limited to, individualized gene therapy antisense oligonucleotides
(ASO) and individualized neoantigen vaccines.
(4) "Life-threatening or severely debilitating illness" means the
same as currently defined in 21 C.F.R. § 312.81.
(5) "Physician" means an individual licensed by the state board of
healing arts to practice medicine and surgery.
(6) "Written, informed consent" means a written document that is
signed by the patient, a parent if the patient is a minor, the legal
guardian or authorized representative as defined in K.S.A. 65-6836,
and amendments thereto, and attested to by the patient's physician and a
witness who is unaffiliated with such patient's physician or the
physician's place of business and that includes all of the following:
(A) An explanation of the currently approved products and
treatments for the disease or condition from which the patient suffers;
(B) clear identification of the specific proposed individualized
investigational drug, biological product or device that the patient is
seeking to use;
(C) a description of the potentially best and worst outcomes of
using the individualized investigational drug, biological product or
device and a realistic description of the most likely outcome. The
description shall include the possibility that new, unanticipated,
different or worse symptoms might result and that death could be
hastened by the proposed treatment. Such description shall be based on
the physician's knowledge of the proposed treatment in conjunction
with an awareness of the patient's condition;
(D) a statement that the patient's health plan or third party
administrator and provider are not obligated to pay for any care or
treatments as a result of the use of the individualized investigational
drug, biological product or device, unless such provider is specifically
required to do so by law or contract;
(E) a statement that the patient's eligibility for hospice care may
be withdrawn if the patient begins curative treatment with the SENATE BILL No. 250—page 2
individualized investigational drug, biological product or device and
that such care may be reinstated if such treatment ends and the patient
meets hospice eligibility requirements; and
(F) a statement that the patient understands that such patient is
liable for all expenses related to the use of the individualized
investigational drug, biological product or device 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) "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 the "eligible facility" is
subject to the federalwide assurance laws, regulations, policies and
guidelines including renewals or updates.
(b) (1) If a patient's biospecimen is used or requested for use by an
eligible facility for a purpose other than the individualized investigative
treatment of such patient, the patient or the patient's estate shall be
notified of the intended use and asked to consent to such intended use
of such biospecimen.
(2) Prior to a profit being realized on any product developed from
a patient's biospecimen, an eligible facility shall disclose to the patient
or the patient's estate each potential commercial application. The
patient or the patient's estate must consent to each commercial
application of the patient's biospecimen, which shall include a profit-
sharing agreement or other contractual obligations benefiting the
patient or such patient's estate for the commercial application of such
patient's biospecimen.
(c) (1) A manufacturer operating within an eligible facility,
pursuant to all applicable federalwide assurance laws and regulations,
may make available an individualized investigative 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 under this act. This act does not
require that a manufacturer make available an individualized
investigational drug, biological product or device to an eligible patient.
(2) An eligible facility or manufacturer operating within an
eligible facility may:
(A) Provide an individualized investigational drug, biological
product or device to an eligible patient without receiving compensation;
or
(B) require an eligible patient to pay the costs of, or the costs
associated with, the manufacture of the investigational drug, biological
product or device.
(d) This act shall not expand the coverage required of an insurer
under the insurance code of the state of Kansas.
(e) A health plan, third party administrator or governmental
agency may provide coverage for the cost of an individualized
investigational drug, biological product or device or the cost of services
related to the use of an individualized investigational drug, biological
product or device under this act, except that, this act shall not require:
(1) Any governmental agency to pay costs associated with the use,
care or treatment of a patient with an individualized investigational
drug, biological product or device; or
(2) a hospital or facility licensed under article 4 of chapter 65 of
the Kansas Statutes Annotated, and amendments thereto, to provide
new or additional services unless approved by the hospital or facility.
(f) If a patient dies while being treated by an individualized
investigational drug, biological product or device, the patient's heirs
shall not be liable for any outstanding debt related to the treatment or SENATE BILL No. 250—page 3
lack of insurance due to the treatment, except that, a patient's estate
may be held liable for any outstanding debt related to the treatment or
lack of insurance due to such treatment.
(g) (1) A licensing board shall not revoke, fail to renew, suspend
or take any discplinary action against a healthcare provider's license
issued under chapter 65 of the Kansas Statutes Annotated, and
amendments thereto, based solely on the healthcare provider's
recommendations to an eligible patient regarding access to or treatment
with an individualized investigational drug, biological product or
device.
(2) Counseling, advice or a recommendation consistent with
medical standards of care from a licensed healthcare provider shall not
be a violation of this act.
(h) An entity responsible for medicare certification shall not take
action against a healthcare provider's medicare certification based
solely on the healthcare provider's recommendation that a patient have
access to an individualized investigational drug, biological product or
device.
(i) An official, employee, or agent of this state shall not block or
attempt to block an eligible patient's access to an individualized
investigational drug, biological product or device.
(j) This act shall not create a private cause of action against a
manufacturer of an individualized investigational drug, biological
product or device or against any other person or entity involved in the
care of an eligible patient using the individualized investigational drug,
biological product or device for any harm done to the eligible patient
resulting from the individualized investigational drug, biological
product or device if the manufacturer or other person or entity is
complying in good faith with the terms of this act and has exercised
reasonable care.
(k) This act shall not affect any mandatory healthcare coverage for
participation in clinical trials under the insurance code of the state of
Kansas.
(l) This section shall be known and may be cited as the right to try
for individualized treatments act. SENATE BILL No. 250—page 4
Sec. 2. This act shall take effect and be in force from and after its
publication in the statute book.
I hereby certify that the above BILL originated in the
SENATE, and passed that body
__________________________
SENATE adopted
Conference Committee Report ________________
_________________________
President of the Senate.
_________________________
Secretary of the Senate.
Passed the HOUSE
as amended _________________________
HOUSE adopted
Conference Committee Report ________________
_________________________
Speaker of the House.
_________________________
Chief Clerk of the House.
APPROVED _____________________________
_________________________
Governor.