Bill Text: TX HB810 | 2017-2018 | 85th Legislature | Enrolled

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Bill Title: Relating to the provision of certain investigational stem cell treatments to patients with certain severe chronic diseases or terminal illnesses and regulating the possession, use, and transfer of adult stem cells; creating a criminal offense.

Spectrum: Moderate Partisan Bill (Republican 18-5)

Status: (Passed) 2017-06-12 - Effective on 9/1/17 [HB810 Detail]

Download: Texas-2017-HB810-Enrolled.html

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H.B. No. 810

AN ACT
relating to the provision of certain investigational stem cell
treatments to patients with certain severe chronic diseases or
terminal illnesses and regulating the possession, use, and transfer
of adult stem cells; creating a criminal offense.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. This Act shall be known as Charlie's Law.
SECTION 2. Chapter 1003, Health and Safety Code, is amended
by designating Sections 1003.001, 1003.002, and 1003.003 as
Subchapter A and adding a subchapter heading to read as follows:
SUBCHAPTER A. GENERAL PROVISIONS
SECTION 3. Chapter 1003, Health and Safety Code, is amended
by adding Subchapter B to read as follows:
SUBCHAPTER B. PROVISION OF INVESTIGATIONAL STEM CELL TREATMENTS TO
PATIENTS WITH CERTAIN SEVERE CHRONIC DISEASES OR TERMINAL ILLNESSES
Sec. 1003.051. DEFINITIONS. In this subchapter:
(1) "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.
(2) "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.
(3) "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.
Sec. 1003.052. RULES. The executive commissioner shall
adopt rules designating the medical conditions that constitute a
severe chronic disease or terminal illness for purposes of this
subchapter.
Sec. 1003.053. PATIENT ELIGIBILITY. A patient is eligible
to access and use an investigational stem cell treatment under this
subchapter if:
(1) the patient has a severe chronic disease or
terminal illness listed in the rules adopted under Section 1003.052
and attested to by the patient's treating physician; and
(2) the patient's 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.
Sec. 1003.054. 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, a parent, guardian, or conservator may
provide informed consent on the patient's behalf.
(c) The executive commissioner by rule may adopt a form for
the informed consent under this section.
Sec. 1003.055. TREATMENT REQUIREMENTS; TEXAS MEDICAL BOARD
RULES. (a) Treatment provided under this subchapter must be:
(1) administered directly by a physician certified
under Subsection (c);
(2) overseen by an institutional review board
described by Subsection (d); and
(3) provided at:
(A) a hospital licensed under Chapter 241;
(B) an ambulatory surgical center licensed under
Chapter 243; or
(C) a medical school, as defined by Section
61.501, Education Code.
(b) A physician administering an investigational stem cell
treatment under this subchapter shall comply with all applicable
Texas Medical Board rules.
(c) An institutional review board described by Subsection
(d) may certify a physician to provide an investigational stem cell
treatment under this subchapter.
(d) An institutional review board that oversees
investigational stem cell treatments administered under this
subchapter must be affiliated with:
(1) a medical school, as defined by Section 61.501,
Education Code; or
(2) a hospital licensed under Chapter 241 that has at
least 150 beds.
(e) The Texas Medical Board may adopt rules regarding
institutional review boards as necessary to implement this section.
Sec. 1003.056. EFFECT ON OTHER LAW. (a) This subchapter
does not affect the coverage of enrollees in clinical trials under
Chapter 1379, Insurance Code.
(b) This subchapter 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 Sections 48.02 and 48.03, Penal Code.
Sec. 1003.057. ACTION AGAINST PHYSICIAN'S LICENSE
PROHIBITED. Notwithstanding any other law, the Texas Medical Board
may not revoke, fail to renew, suspend, or take any action against
a physician's license under Subchapter B, Chapter 164, Occupations
Code, based solely on the physician's recommendations to an
eligible patient regarding access to or use of an investigational
stem cell treatment, provided that the care provided or
recommendations made to the patient meet the standard of care and
the requirements of this subchapter.
Sec. 1003.058. GOVERNMENTAL INTERFERENCE PROHIBITED. (a)
In this section, "governmental entity" means this state or an
agency or political subdivision of this state.
(b) A governmental entity or an officer, employee, or agent
of a governmental entity may not interfere with an eligible
patient's access to or use of a stem cell treatment authorized under
this subchapter.
Sec. 1003.059. INSTITUTIONAL REVIEW BOARD DOCUMENTATION;
REPORT. (a) An institutional review board overseeing an
investigational stem cell treatment under this subchapter shall
keep a record on each person to whom a physician administers the
treatment and document in the record the provision of each
treatment and the effects of the treatment on the person throughout
the period the treatment is administered to the person.
(b) Each institutional review board overseeing an
investigational stem cell treatment under this subchapter shall
submit an annual report to the Texas Medical Board on the review
board's findings based on records kept under Subsection (a). The
report may not include any patient identifying information and must
be made available to the public in both written and electronic form.
SECTION 4. Chapter 48, Penal Code, is amended by adding
Section 48.03 to read as follows:
Sec. 48.03. PROHIBITION ON PURCHASE AND SALE OF ADULT STEM
CELLS FOR CERTAIN INVESTIGATIONAL TREATMENTS. (a) In this
section:
(1) "Adult stem cell" means an undifferentiated cell
that is:
(A) found in differentiated tissue; and
(B) able to renew itself and differentiate to
yield all or nearly all of the specialized cell types of the tissue
from which the cell originated.
(2) "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.
(b) A person commits an offense if the person knowingly
offers to buy, offers to sell, acquires, receives, sells, or
otherwise transfers any adult stem cells for valuable consideration
for use in an investigational stem cell treatment.
(c) It is an exception to the application of this section
that the valuable consideration is:
(1) a fee paid to a physician or to other medical
personnel for services rendered in the usual course of medical
practice or a fee paid for hospital or other clinical services;
(2) reimbursement of legal or medical expenses
incurred for the benefit of the ultimate receiver of the
investigational stem cell treatment; or
(3) reimbursement of expenses of travel, housing, and
lost wages incurred by the donor of adult stem cells in connection
with the donation of the adult stem cells.
(d) It is an exception to the application of this section
that the actor engaged in conduct authorized under Chapter 162,
Health and Safety Code.
(e) A violation of this section is a Class A misdemeanor.
SECTION 5. As soon as practicable after the effective date
of this Act, the executive commissioner of the Health and Human
Services Commission shall adopt rules necessary to implement
Subchapter B, Chapter 1003, Health and Safety Code, as added by this
Act.
SECTION 6. This Act takes effect September 1, 2017.
______________________________ ______________________________
President of the Senate Speaker of the House
I certify that H.B. No. 810 was passed by the House on May 12,
2017, by the following vote: Yeas 141, Nays 0, 1 present, not
voting; that the House refused to concur in Senate amendments to
H.B. No. 810 on May 26, 2017, and requested the appointment of a
conference committee to consider the differences between the two
houses; and that the House adopted the conference committee report
on H.B. No. 810 on May 28, 2017, by the following vote: Yeas 145,
Nays 0, 1 present, not voting.
______________________________
Chief Clerk of the House
I certify that H.B. No. 810 was passed by the Senate, with
amendments, on May 24, 2017, by the following vote: Yeas 31, Nays
0; at the request of the House, the Senate appointed a conference
committee to consider the differences between the two houses; and
that the Senate adopted the conference committee report on H.B. No.
810 on May 28, 2017, by the following vote: Yeas 30, Nays 0.
______________________________
Secretary of the Senate
APPROVED: __________________
Date
__________________
Governor