AN ACT relating to the use of experimental treatments for life-threatening or severely debilitating illness.

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AN ACT relating to the use of experimental treatments for life -threatening or 1
severely debilitating illness. 2
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 3
SECTION 1. A NEW SECTION OF KRS CHAPTER 217 IS CREATED TO 4
READ AS FOLLOWS: 5
(1) As used in this section: 6
(a) "Eligible facility" means an institution operating under Federalwide 7
Assurance for the Protection of Human Subjects in accordance with 45 8
C.F.R. pt. 46 and 42 U.S.C. sec. 289(a); 9
(b) "Eligible patient" means an individual who has: 10
1. A life -threatening or severely debilitating illness as attested by the 11
patient's treating physician; 12
2. In consultation with the patient's treating physician, considered all 13
other treatment options currently approved by the United States Food 14
and Drug Administration; 15
3. Received a recommendation from the patient's treating physician for 16
the use of an individualized investigational drug, biological product, 17
or device for treatment of the life -threatening or severely debilitating 18
illness; 19
4. a. Provided writt en informed consent to the use of the 20
individualized investigational drug, biological product, or device 21
for treatment of the life -threatening or severely debilitating 22
illness; or 23
b. If the individual is a minor or is otherwise incapable of providing 24
informed consent, the parent or legal guardian has given 25
informed consent in writing to the use of the individualized 26
investigational drug, biological product, or device; and 27
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5. Documentation from the patient's treating physician that the 1
individual meets all t he criteria for an eligible patient, including an 2
attestation from the treating physician that the treating physician was 3
consulted in the creation of the written, informed consent required 4
under this section; 5
(c) "Individualized investigational drug, biological product, or device" means a 6
drug, biological product, or device that is unique and produced exclusively 7
for use for an individual patient, based on the patient's own genetic profile, 8
including individualized gene therapy antisense oligonucleotides a nd 9
individualized neoantigen vaccines; 10
(d) "Institution" has the same meaning as in 45 C.F.R. sec. 46.102(f); 11
(e) "Life-threatening or severely debilitating illness" has the same meaning as 12
"life-threating" and "severely debilitating" in 21 C.F.R. sec. 312.81; and 13
(f) "Written, informed consent" means a written document that: 14
1. Is signed by: 15
a. An eligible patient; 16
b. If the patient is a minor, by a parent or legal guardian; or 17
c. If the patient is incapacitated, by a designated health care agent 18
pursuant to a health care power of attorney; and 19
2. Includes the following: 20
a. An explanation of the currently approved products and 21
treatments for the eligible patient's life -threatening or severely 22
debilitating illness; 23
b. An attestation that the eligible patient concurs with the treating 24
physician in believing that all currently approved treatments are 25
unlikely to prolong the eligible patient's life; 26
c. Clear identification of the specific individualized investigational 27
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drug, biological product, or device propose d for treatment of the 1
eligible patient's terminal illness; 2
d. A description of the potentially best and worst outcomes resulting 3
from use of the individualized investigational drug, biological 4
product, or device to treat the eligible patient's life -threatening 5
or severely debilitating illness, along with a realistic description 6
of the most likely outcome. The description shall be based on the 7
treating physician's knowledge of the proposed treatment in 8
conjunction with an awareness of the eligible patient's life-9
threatening or severely debilitating illness and shall include a 10
statement acknowledging that new, unanticipated, different, or 11
worse symptoms might result from, and that death could be 12
hastened by, the proposed treatment; 13
e. A statement that eligibi lity for hospice care may be withdrawn if 14
the eligible patient begins treatment of the life -threatening or 15
severely debilitating illness with an individualized investigational 16
drug, biological product, or device and that hospice care may be 17
reinstated if s uch treatment ends and the eligible patient meets 18
hospice eligibility requirements; 19
f. A statement that the eligible patient's health benefit plan or 20
third-party administrator and provider are not obligated to pay 21
for any care or treatments consequent to the use of the 22
individualized investigational drug, biological product, or device, 23
unless specifically required to do so by law or contract; 24
g. A statement that the eligible patient understands that he or she is 25
liable for all expenses consequent to the use of the individualized 26
investigational drug, biological product, or device and that this 27
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liability extends to the eligible patient's estate, unless a contract 1
between the patient and the manufacturer of the drug, biological 2
product, or device states otherwise; and 3
h. A statement that the eligible patient or, for an eligible patient 4
who is a minor or lacks capacity to provide informed consent, 5
that the parent or legal guardian consents to the use of the 6
individualized investigational drug, biological produ ct, or device 7
for treatment of the life -threatening or severely debilitating 8
illness. 9
(2) (a) A manufacturer operating within an eligible facility in accordance with all 10
applicable federal laws may make available to an eligible patient, and an 11
eligible pat ient may request, the manufacturer's individualized 12
investigational drug, biological product, or device from an eligible facility 13
or manufacturer operating within an eligible facility. 14
(b) A manufacturer of an individualized investigational drug, biologica l 15
product, or device may: 16
1. Provide the individualized investigational drug, biological product, or 17
device to an eligible patient without receiving compensation; or 18
2. Require the eligible patient to pay the costs of, or the costs associated 19
with, the manufacture of the individualize d investigational drug, 20
biological product, or device. 21
(c) Nothing in this subsection shall be construed to require a manufacturer of 22
an individualized investigational drug, biological product, or device to make 23
the individualized investigational drug, bio logical product, or device 24
available to an eligible patient. 25
(3) If an eligible patient dies while being treated with an individualized 26
investigational drug, biological product, or device, the eligible patient's heirs 27
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shall not be liable for any outstanding debt related to the treatment, including any 1
costs attributed to lack of insurance coverage for the treatment. 2
(4) (a) A licensing board shall not revoke, fail to renew, suspend, or take any other 3
disciplinary action against a health care provider licens ed in Kentucky 4
based solely on the health care provider's recommendations to an eligible 5
patient regarding access to or treatment with an individualized 6
investigational drug, biological product, or device. 7
(b) The Cabinet for Health and Family Services sh all not take action against a 8
health care provider's Medicare or Medicaid certification based solely on 9
the health care provider's recommendation that a patient have access to an 10
individualized investigational drug, biological product, or device. 11
(5) (a) An official, employee, or agent of the Commonwealth of Kentucky shall not 12
block or attempt to block an eligible patient's access to an individualized 13
investigational drug, biological product, or device. 14
(b) Counseling, advice, or a recommendation consistent with medical standards 15
of care from a licensed health care provider or denial of coverage by the 16
Kentucky Medicaid program shall not constitute a violation of this 17
subsection. 18
(6) A private right of action may not be brought against a manufacturer of an 19
individualized investigational drug, biological product, or device, or against any 20
other person or entity involved in the care of an eligible patient using an 21
individualized investigational drug, biological product, or device, for any harm 22
caused to the eli gible patient resulting from use of the individualized 23
investigational drug, biological product, or device as long as the manufacturer or 24
other person or entity has made a good -faith effort to comply with the provisions 25
of this section and has exercised re asonable care in actions undertaken in 26
accordance with this section. 27
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(7) This section shall be not construed to: 1
(a) Expand the coverage required to be offered or provided by a health 2
insurance policy, plan, certificate, or contract; 3
(b) Affect any requir ement for a health insurance policy, plan, certificate, or 4
contract to provide coverage for routine patient costs for patients involved in 5
approved cancer clinical trials; 6
(c) Require an insurer, third -party administrator, or governmental agency to 7
pay cos ts associated with the treatment of an eligible patient with an 8
individualized investigational drug, biological product, or device; or 9
(d) Require a hospital or health facility to provide new or additional services. 10