Bill Text: TX HB438 | 2015-2016 | 84th Legislature | Introduced
Bill Title: Relating to authorizing patients with certain terminal conditions to access certain investigational drugs, biological products, and devices that are in clinical trials.
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2015-02-19 - Referred to Public Health [HB438 Detail]
Download: Texas-2015-HB438-Introduced.html
84R494 JSC-D | ||
By: Canales | H.B. No. 438 |
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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. |