Official Summary Text
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
.
Current Bill Text
Read the full stored bill text
SENATE BILL 282
By Watson
HOUSE BILL 192
By Terry
HB0192
001074
- 1 -
AN ACT to amend Tennessee Code Annotated, Title 53
and Title 63, relative to medical treatment.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, is amended by adding
the following as a new part:
63-6-1301.
This part is known and may be cited as the "Individualized Investigational
Treatment Act."
63-6-1302.
As used in this part:
(1) "Eligible facility" means an institution operating under principles of
Federalwide Assurance (FWA) for the Protection of Human Subjects in
accordance with 45 C.F.R. § 46 and 42 U.S.C. § 289(a);
(2) "Eligible patient" means an individual who meets all of the following
criteria:
(A) Has a life-threatening or severely debilitating illness, attested
to by a treating physician;
(B) Has, in consultation with a treating physician, considered all
other treatment options currently approved by the United States food and
drug administration;
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(C) Has received a recommendation from the treating physician
for use of an individualized investigational treatment for treatment of the
life-threatening or severely debilitating illness;
(D) Has given written, informed consent for the use of the
investigational drug, biological product, or device; and
(E) Has documentation from the patient's physician that the
patient meets the requirements of this subdivision (2);
(3) "Individualized investigational treatment":
(A) Means 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; and
(B) Includes individualized gene therapy antisense
oligonucleotides and individualized neoantigen vaccines;
(4) "Institution" has the same meaning as defined in 45 C.F.R. §
46.102(f);
(5) "Life-threatening or severely debilitating illness" has the same
meaning as those terms are defined in 21 C.F.R. § 312.81; and
(6) "Written, informed consent" means a written document that is signed
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 designated by the patient under title 34,
chapter 6, part 2, and attested to by the patient's physician and a witness, and
that, at a minimum, 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;
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(B) 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;
(C) Clear identification of the specific proposed individualized
investigational treatment that the patient is seeking to use;
(D) A description of the potentially best and worst outcomes of
using the individualized investigational treatment and a realistic
description of the most likely outcome. The description must include the
possibility that new, unanticipated, different, or worse symptoms might
result and that death could be hastened by the proposed treatment. The
description must be based on the physician's knowledge of the proposed
treatment in conjunction with an awareness of the patient's condition;
(E) A release of liability relative to the treating physician, licensed
healthcare providers, hospital, and manufacturer of the individualized
investigational treatment;
(F) 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;
(G) 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; and
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(H) 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 of the
individualized investigational treatment states otherwise.
63-6-1303.
(a) A manufacturer operating within an eligible facility and pursuant to all
applicable FWA laws and regulations may make available an individualized investigative
treatment and an eligible patient may request an individualized investigational treatment
from an eligible facility or manufacturer operating within an eligible facility under this part.
This part does not require that a manufacturer make available an individualized
investigational treatment to an eligible patient.
(b) An eligible facility or manufacturer operating within an eligible facility may do
all of the following:
(1) Provide an individualized investigational treatment to an eligible
patient without receiving compensation; and
(2) Require an eligible patient to pay the costs of, or the costs associated
with, the manufacture of the individualized investigational treatment.
63-6-1304.
(a) This part does not expand the coverage required of an insurer under title 56,
chapter 7.
(b) A health plan, third-party administrator, or governmental agency may, but is
not required to, provide coverage for the cost of an individualized investigational
treatment, or the cost of services related to the use of an individualized investigational
treatment under this part.
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(c) This part does not require any governmental agency to pay costs associated
with the use, care, or treatment of a patient with an individualized investigational
treatment.
(d) This part does not require any hospital or facility licensed under title 68,
chapter 11, 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, physician, or
healthcare provider.
63-6-1305.
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.
63-6-1306.
A licensing board or disciplinary subcommittee shall not revoke, fail to renew,
suspend, or take any action against a healthcare provider's license issued under this
title, based solely on the healthcare provider's recommendations to an eligible patient
regarding access to or treatment with an individualized investigational treatment. 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
treatment.
63-6-1307.
An official, employee, or agent of this state shall not block or attempt to block an
eligible patient's access to an individualized investigational treatment. The rendering of
counseling, advice, or a recommendation consistent with medical standards of care from
a licensed healthcare provider is not a violation of this section.
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63-6-1308.
(a) This part does not 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 done to the eligible patient resulting from the individualized investigational
treatment, if the manufacturer or other person or entity is complying in good faith with the
terms of this part and has exercised reasonable care.
(b) This part does not affect any mandatory healthcare coverage for participation
in clinical trials under § 56-7-2365.
SECTION 2. If any provision of this act or its application to any person or circumstance
is held invalid, then the invalidity does not affect other provisions or applications of the act that
can be given effect without the invalid provision or application, and to that end, the provisions of
this act are severable.
SECTION 3. This act takes effect July 1, 2025, the public welfare requiring it.