Model Policy:

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 XXXX:

SECTION 1.  This Act shall be known as XXXX Law.

SECTION 2.  Chapter XXX, Health and Safety Code, is amended by designating Sections xxx.xxx, xxx.xxx, and xxx.xxx as Subchapter A and adding a subchapter heading to read as follows:

SUBCHAPTER A.  GENERAL PROVISIONS

SECTION 3.  Chapter XXX, 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. xxx.xxx.  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 a disease that, without life-sustaining procedures, will result in death in the near future and is not considered by a treating physician to be reversible even with administration of current federal Food and Drug Administration approved and available treatments.

Sec. xxx.xxx  RULES.  The Health and Human Services executive commissioner shall adopt rules designating the medical conditions that constitute, but is not limited to, certain severe chronic disease or terminal illness for purposes of this subchapter.

Sec. xxx.xxx  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. xxx.xxx.  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 Health and Human Services executive commissioner by rule may adopt a form for the informed consent under this section.

Sec. xxx.xxx.  TREATMENT REQUIREMENTS; XXX MEDICAL BOARD RULES.  (a)  Treatment provided under this subchapter must be:

(1)  administered directly by a physician certified under Subsection (c);and

(2)  overseen by an institutional review board described by Subsection (d); and

(3) provided at:

(A) a hospital licensed under Chapter xxx;

(B) an ambulatory surgical center licensed under Chapter xxx; or

 (C) a medical school, as defined by Section xxx, Education Code.

(b)  A physician administering an investigational stem cell treatment under this subchapter shall comply with all applicable XXX 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)  The XXX Medical Board may adopt rules regarding institutional review boards as necessary to implement this section.

Sec. xxx.xxx.  EFFECT ON OTHER LAW.  (a)  This subchapter does not affect the coverage of enrollees in clinical trials under Chapter xxx, xxx 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 xx.xx and xx.xx, Penal Code.

Sec. xxx.xxx.  ACTION AGAINST PHYSICIAN’S LICENSE PROHIBITED.  Notwithstanding any other law, the XXX Medical Board may not revoke, fail  to renew, suspend, or take any action against a physician’s license under Subchapter B, Chapter XXX, 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. xxx.xxx.  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. xxx.xxx.  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 XXX 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 XX, Penal Code, is amended by adding Section xx.xx to read as follows:

Sec. xx.xx.  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 xxx, Health and Safety Code, relating to blood banks and the donation of blood.

(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 xxx, Health and Safety Code, as added by this Act.

SECTION 6.  This Act takes effect immediately.