84R494 JSC-D
By: Canales H.B. No. 438
A BILL TO BE ENTITLED
AN ACT
relating to authorizing patients with certain terminal conditions
to access certain investigational drugs, biological products, and
devices that are in clinical trials.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. (a) This Act shall be known as the "Right To Try
Act."
(b) The legislature finds that:
(1) the process of approval for investigational drugs,
biological products, and devices in the United States protects
future patients from premature, ineffective, and unsafe
medications and treatments over the long run, but the process often
takes many years;
(2) patients with a terminal condition do not have the
luxury of waiting until an investigational drug, biological
product, or device receives final approval from the United States
Food and Drug Administration;
(3) patients with a terminal condition have a
fundamental right to attempt to pursue the preservation of their
own lives by accessing available investigational drugs, biological
products, and devices;
(4) the use of available investigational drugs,
biological products, and devices is a decision that should be made
by the patient with a terminal condition in consultation with the
patient's physician and the patient's health care team, if
applicable; and
(5) the decision to use an investigational drug,
biological product, or device should be made with full awareness of
the potential risks, benefits, and consequences to the patient with
a terminal condition and the patient's family.
(c) It is the intent of the legislature to allow for
patients with a terminal condition to use potentially life-saving
investigational drugs, biological products, and devices.
SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
amended by adding Chapter 489 to read as follows:
CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
WITH TERMINAL CONDITIONS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 489.001. DEFINITIONS. In this chapter:
(1) "Investigational drug, biological product, or
device" means a drug, biological product, or device that has
successfully completed phase one of a clinical trial but has not yet
been approved for general use by the United States Food and Drug
Administration and remains under investigation in a United States
Food and Drug Administration approved clinical trial.
(2) "Terminal condition" means an incurable condition
caused by injury, disease, or illness that, without life-sustaining
procedures, will soon result in death or a state of permanent
unconsciousness from which recovery is unlikely.
SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL CONDITIONS
Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible
to access and use an investigational drug, biological product, or
device under this chapter if:
(1) the patient has a terminal condition, attested to
by the patient's treating physician;
(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 unlikely to prolong the patient's life;
and
(B) has recommended in writing that the patient
use a specific investigational drug, biological product, or device;
and
(3) the patient:
(A) is unable to participate in a clinical trial
of the recommended investigational drug, biological product, or
device within 100 miles of the patient's home address; or
(B) has not been accepted to the clinical trial
before the eighth calendar day after the patient completed the
application process for the trial.
Sec. 489.052. INFORMED CONSENT. (a) Before receiving an
investigational drug, biological product, or device, an eligible
patient must sign a written informed consent described by this
section that is attested to by the patient's physician and a
witness.
(b) The informed consent must:
(1) explain the currently approved products and
treatments for the disease or condition from which the patient
suffers;
(2) attest to the fact 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;
(3) identify the specific proposed investigational
drug, biological product, or device that the patient is seeking to
use;
(4) describe the potentially best and worst outcomes
of using the investigational drug, biological product, or device
with a realistic description of the most likely outcome, including
the possibility that new, unanticipated, different, or worse
symptoms might result, and that death could be hastened by the
proposed treatment, based on the physician's knowledge of the
proposed treatment in conjunction with an awareness of the
patient's condition;
(5) state that the patient's health benefit plan is not
obligated to pay for any care or treatments resulting from the use
of the investigational drug, biological product, or device;
(6) state that the patient's eligibility for hospice
care may be withdrawn if the patient begins curative treatment and
that care may be reinstated if the curative treatment ends and the
patient meets hospice eligibility requirements;
(7) state that in-home health care may be denied if
treatment begins; and
(8) state that the patient understands that the
patient is liable for all expenses resulting from the use of the
investigational drug, biological product, or device, and that this
liability extends to the patient's estate, unless a contract
between the patient and the manufacturer of the drug, biological
product, or device provides otherwise.
(c) The executive commissioner of the Health and Human
Services Commission by rule may adopt a form for the informed
consent under this section.
Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG,
BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer
of an investigational drug, biological product, or device may make
available the manufacturer's investigational drug, biological
product, or device to eligible patients in accordance with this
chapter if the patient provides to the manufacturer the informed
consent required under Section 489.052.
(b) This chapter does not require that a manufacturer make
available an investigational drug, biological product, or device to
an eligible patient.
(c) A manufacturer may:
(1) provide an investigational drug, biological
product, or device to an eligible patient without receiving
compensation; or
(2) require an eligible patient to pay the costs of, or
the costs associated with, the manufacture of the investigational
drug, biological product, or device.
Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does
not create a private cause of action against a manufacturer of an
investigational drug, biological product, or device or against any
other person or entity involved in the care of an eligible patient
using the investigational drug, biological product, or device for
any harm done to the eligible patient resulting from the
investigational drug, biological product, or device.
Sec. 489.055. STATE MAY NOT INTERFERE WITH ACCESS TO
INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. (a) An
official, employee, or agent of this state may not block or attempt
to block an eligible patient's access to an investigational drug,
biological product, or device under this section.
(b) Counseling, advice, or a recommendation consistent with
medical standards of care from a licensed health care provider is
not a violation of this section.
SUBCHAPTER C. HEALTH INSURANCE
Sec. 489.101. APPLICABILITY OF SUBCHAPTER. (a) This
subchapter applies only to a health benefit plan that provides
benefits for medical or surgical expenses incurred as a result of a
health condition, accident, or sickness, including an individual,
group, blanket, or franchise insurance policy or insurance
agreement, a group hospital service contract, or a small or large
employer group contract or similar coverage document that is
offered by:
(1) an insurance company;
(2) a group hospital service corporation operating
under Chapter 842, Insurance Code;
(3) a fraternal benefit society operating under
Chapter 885, Insurance Code;
(4) a stipulated premium company operating under
Chapter 884, Insurance Code;
(5) a reciprocal exchange operating under Chapter 942,
Insurance Code;
(6) a health maintenance organization operating under
Chapter 843, Insurance Code;
(7) a multiple employer welfare arrangement that holds
a certificate of authority under Chapter 846, Insurance Code; or
(8) an approved nonprofit health corporation that
holds a certificate of authority under Chapter 844, Insurance Code.
(b) This subchapter applies to group health coverage made
available by a school district in accordance with Section 22.004,
Education Code.
(c) Notwithstanding Section 172.014, Local Government Code,
or any other law, this subchapter applies to health and accident
coverage provided by a risk pool created under Chapter 172, Local
Government Code.
(d) Notwithstanding any provision in Chapter 1551, 1575,
1579, or 1601, Insurance Code, or any other law, this subchapter
applies to:
(1) a basic coverage plan under Chapter 1551,
Insurance Code;
(2) a basic plan under Chapter 1575, Insurance Code;
(3) a primary care coverage plan under Chapter 1579,
Insurance Code; and
(4) basic coverage under Chapter 1601, Insurance Code.
(e) Notwithstanding any other law, this subchapter applies
to coverage under:
(1) the child health plan program under Chapter 62 or
the health benefits plan for children under Chapter 63; and
(2) the medical assistance program under Chapter 32,
Human Resources Code.
Sec. 489.102. HEALTH BENEFIT PLANS. (a) A health benefit
plan may, but is not required to, provide coverage for the cost of
an investigational drug, biological product, or device.
(b) Except as otherwise provided by this section, a health
benefit plan may deny coverage to an eligible patient from the date
the eligible patient begins use of the investigational drug,
biological product, or device until the 181st day after the date the
patient ceases using the investigational drug, biological product,
or device.
(c) A health benefit plan issuer may not deny covered
benefits under Subsection (b) for a condition that existed before
the date the eligible patient begins use of the investigational
drug, biological product, or device, regardless of whether the
issuer was providing benefits for the condition before that date.
Sec. 489.103. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
TRIAL ENROLLEES. This chapter does not affect the coverage of
enrollees in clinical trials under Chapter 1379, Insurance Code.
SUBCHAPTER D. PHYSICIANS
Sec. 489.151. 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 issued under Subchapter B, Chapter 164,
Occupations Code, based solely on the physician's recommendations
to an eligible patient regarding access to or treatment with an
investigational drug, biological product, or device.
SECTION 3. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2015.