Health Care

Plain English Breakdown

Checked against official source text during the last sync.

Act for Investigational Stem Cell Treatment Access

This bill allows patients with severe chronic diseases or terminal illnesses to use investigational stem cell treatments under certain conditions and requires informed consent.

What This Bill Does

• Allows patients with specific serious health issues to access investigational stem cell treatments if their doctor recommends it after considering other treatment options.
• Requires patients to sign a written agreement (informed consent) before getting the treatment, unless they are minors or unable to give consent due to mental incapacity.
• Prevents medical boards from punishing doctors who recommend these treatments as long as the care meets standard requirements and follows this law.
• Stops government entities from interfering with patients' access to approved investigational stem cell treatments.
• Requires the health commissioner to create rules that list which diseases qualify for this treatment.

Who It Names or Affects

• Patients with severe chronic diseases or terminal illnesses
• Doctors who recommend and provide investigational stem cell treatments
• Government agencies involved in regulating medical practices

Terms To Know

Investigational Stem Cell Treatment

A type of treatment using adult stem cells that is being tested in clinical trials but has not yet been approved for general use by the FDA.

Informed Consent

A written agreement signed by a patient before receiving medical treatment, stating they understand the risks and benefits involved.

Limits and Unknowns

• The bill does not change insurance coverage rules for clinical trial participants.
• It does not affect laws about handling fetal tissue or organs.

Official Summary Text

PATIENT ELIGIBILITY

This bill authorizes a
patient
to
access and use an investigational stem cell treatment
, which is
under investi
gation in a clinical trial to human participants
and h
as not yet been approved for general use by the United States food and drug administration
(FDA)
;
if
all of the following criteria is met:



The patient has a severe chronic disease or terminal illness
that is
listed in the rules adopted
by the commissioner of health ("commissioner")
and attested to by the patient's treating physician
.



The patient's treating physician
(i) i
n consultation with the patient, has considered all other treatment options currently approved by the
FDA
and determined that those treatment options are unavailable or unlikely to alleviate the significant impairment or severe pain associated with the severe chronic disease or terminal illness; and
(ii) h
as recommended or prescribed in writing that the patient use a specific class of investigational stem cell treatment.

INFORMED CONSENT

Before receiving an investigational stem cell treatment,
this bill requires
an eligible patient
to
sign a written informed consent.

If the patient i
s a minor or lacks the mental capacity to provide informed consent, then a parent, guardian, or conservator may provide informed consent on the patient's behalf.
This bill authorizes t
he commissioner
to
develop and make available to physicians a form for
such
informed consent.

EFFECT ON OTHER LAW

This bill clarifies that it does not (i)
affect the
insurance
coverage of enrollees in clinical trials
or (ii)
affect or authorize a person to violate any law regulating the possession, use, or transfer of feta
l tissue, fetal stem cells, adult stem cells, or human organs.

PROHIBITED ACTIONS

This bill prohibits the
board of medical examiners and the board of osteopathic examination
from
revok
ing
, fail
ing
to renew, suspend
ing
, or tak
ing
action against a physician's license based solely on the physician's recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment if the care provided or recommendations made to the patient meet the standard

of care and the requirements of this
bill
.

This bill also prohibits a
governmental entity or an officer, employee, or agent of a governmental entity
from
interfer
ing
with an eligible patient's access to
,
or use of
,
an investigational stem cell treatment authorized under this
bill
.

RULEMAKING

This bill requires the commissioner to
promulgate rules to effectuate this
bill
.
Such
rules must include designating the medical conditions that constitute a severe chronic
disease or terminal illness for purposes of this
bill
.

Current Bill Text

SENATE BILL 152
By Pody

HOUSE BILL 413
By Lynn

HB0413
000703
- 1 -

AN ACT to amend Tennessee Code Annotated, Title 53;
Title 63 and Title 68, relative to stem cell
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:
63-6-901. Part definitions.
As used in this part:
(1) "Commissioner" means the commissioner of health;
(2) "Governmental entity" means this state or an agency or political
subdivision of this state;
(3) "Investigational stem cell treatment" means an adult stem cell
treatment that:
(A) Is under investigation in a clinical trial and being administered
to human participants in that trial; and
(B) Has not yet been approved for general use by the United
States food and drug administration;
(4) "Severe chronic disease" means a condition, injury, or illness that:
(A) May be treated;
(B) Is never cured or eliminated; and
(C) Entails significant functional impairment or severe pain; and

- 2 - 000703

(5) "Terminal illness" means an advanced stage of a disease with an
unfavorable prognosis that, without life-sustaining procedures, will soon result in
death or a state of permanent unconsciousness from which recovery is unlikely.
63-6-902. Patient eligibility.
A patient may access and use an investigational stem cell treatment under this
part if:
(1) The patient has a severe chronic disease or terminal illness listed in
the rules adopted under § 63-6-907 and attested to by the patient's treating
physician; and
(2) The patient's treating physician:
(A) In consultation with the patient, has considered all other
treatment options currently approved by the United States food and drug
administration and determined that those treatment options are
unavailable or unlikely to alleviate the significant impairment or severe
pain associated with the severe chronic disease or terminal illness; and
(B) Has recommended or prescribed in writing that the patient
use a specific class of investigational stem cell treatment.
63-6-903. Informed consent.
(a) Before receiving an investigational stem cell treatment, an eligible patient
must sign a written informed consent.
(b) If the patient is a minor or lacks the mental capacity to provide informed
consent, then a parent, guardian, or conservator may provide informed consent on the
patient's behalf.
(c) The commissioner may develop and make available to physicians a form for
the informed consent under this section.

- 3 - 000703

63-6-904. Effect on other law.
(a) This part does not affect the coverage of enrollees in clinical trials under §
56-7-2365.
(b) This part does not affect or authorize a person to violate any law regulating
the possession, use, or transfer of fetal tissue, fetal stem cells, adult stem cells, or
human organs, including § 39-15-208.
63-6-905. Action against physician license prohibited.
Notwithstanding another law, the board of medical examiners and the board of
osteopathic examination shall not revoke, fail to renew, suspend, or take any action
against a physician's license based solely on the physician's recommendations to an
eligible patient regarding access to or use of an investigational stem cell treatment if the
care provided or recommendations made to the patient meet the standard of care and
the requirements of this part.
63-6-906. Governmental interference prohibited.
A governmental entity or an officer, employee, or agent of a governmental entity
shall not interfere with an eligible patient's access to or use of an investigational stem
cell treatment authorized under this part.
63-6-907. Rules.
The commissioner shall promulgate rules to effectuate this part. The rules must
include designating the medical conditions that constitute a severe chronic disease or
terminal illness for purposes of this part. Rules must be promulgated in accordance with
the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
SECTION 2. The headings to sections in this act are for reference purposes only and do
not constitute a part of the law enacted by this act. However, the Tennessee Code Commission
is requested to include the headings in any compilation or publication containing this act.

- 4 - 000703

SECTION 3. This act takes effect upon becoming a law, the public welfare requiring it.