Texas 2019 - 86th Regular

Texas House Bill HB3147 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	H.B. No. 3147
	1	+	By: Parker, et al. (Senate Sponsor - Creighton) H.B. No. 3147
	2	+	(In the Senate - Received from the House May 13, 2019;
	3	+	May 14, 2019, read first time and referred to Committee on Health &
	4	+	Human Services; May 20, 2019, reported favorably by the following
	5	+	vote: Yeas 9, Nays 0; May 20, 2019, sent to printer.)
	6	+	Click here to see the committee vote
2	7
3	8
	9	+	A BILL TO BE ENTITLED
4	10		AN ACT
5	11		relating to a cancer clinical trial participation program.
6	12		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
7	13		SECTION 1. The legislature finds that:
8	14		(1) the ability to translate medical findings from
9	15		research to practice relies largely on robust subject participation
10	16		and a diverse subject participation pool in clinical trials;
11	17		(2) diverse subject participation in cancer clinical
12	18		trials depends significantly on whether an individual is able to
13	19		afford ancillary costs, including transportation and lodging,
14	20		during the course of participation in a cancer clinical trial;
15	21		(3) a national study conducted in 2015 found that
16	22		individuals from households with an annual income of less than
17	23		$50,000 were 30 percent less likely to participate in cancer
18	24		clinical trials;
19	25		(4) direct and indirect costs, including
20	26		transportation, lodging, and child-care expenses, prevent eligible
21	27		individuals from participating in cancer clinical trials according
22	28		to the National Cancer Institute;
23	29		(5) the disparities in subject participation in cancer
24	30		clinical trials threaten the basic ethical underpinning of clinical
25	31		research, which requires the benefits of the research to be made
26	32		available equitably among all eligible individuals;
27	33		(6) while the United States Food and Drug
28	34		Administration recently confirmed to Congress and provided
29	35		guidance on its Internet website that reimbursement of direct
30	36		subject-incurred expenses is not an inducement, many
31	37		organizations, research sponsors, philanthropic individuals,
32	38		charitable organizations, governmental entities, and other persons
33	39		still operate under the misconception that such reimbursement is an
34	40		inducement;
35	41		(7) it is the intent of the legislature to enact
36	42		legislation to further define and establish a clear difference
37	43		between items considered to be an inducement for a subject to
38	44		participate in a cancer clinical trial and the reimbursement of
39	45		expenses for participating in a cancer clinical trial; and
40	46		(8) further clarification of the United States Food
41	47		and Drug Administration's confirmation and guidance is appropriate
42	48		and important to improve subject participation in cancer clinical
43	49		trials, which is the primary intent of this legislation.
44	50		SECTION 2. Subtitle B, Title 2, Health and Safety Code, is
45	51		amended by adding Chapter 50 to read as follows:
46	52		CHAPTER 50. CANCER CLINICAL TRIAL PARTICIPATION PROGRAM
47	53		Sec. 50.0001. DEFINITIONS. In this chapter:
48	54		(1) "Cancer clinical trial" means a research study
49	55		that subjects an individual to a new cancer treatment, including a
50	56		medication, chemotherapy, adult stem cell therapy, or other
51	57		treatment.
52	58		(2) "Inducement" means the payment of money, including
53	59		a lump-sum or salary payment, to an individual for the individual's
54	60		participation in a cancer clinical trial.
55	61		(3) "Program" means the cancer clinical trial
56	62		participation program established under this chapter.
57	63		(4) "Subject" means an individual who participates in
58	64		the program.
59	65		Sec. 50.0002. ESTABLISHMENT. An independent, third-party
60	66		organization may develop and implement the cancer clinical trial
61	67		participation program to provide reimbursement to subjects for
62	68		ancillary costs associated with participation in a cancer clinical
63	69		trial, including costs for:
64	70		(1) travel;
65	71		(2) lodging;
66	72		(3) parking and tolls; and
67	73		(4) other costs considered appropriate by the
68	74		organization.
69	75		Sec. 50.0003. REQUIREMENTS; NOTICE. (a) The program:
70	76		(1) must collaborate with physicians and health care
71	77		providers to notify a prospective subject about the program when:
72	78		(A) the prospective subject provides informed
73	79		consent for a cancer clinical trial; or
74	80		(B) funding is available to provide the program
75	81		for the cancer clinical trial in which the prospective subject
76	82		participates;
77	83		(2) must reimburse subjects based on financial need,
78	84		which may include reimbursement to subjects whose income is at or
79	85		below 700 percent of the federal poverty level;
80	86		(3) must provide reimbursement for ancillary costs,
81	87		including costs described by Section 50.0002, to eliminate the
82	88		financial barriers to enrollment in a clinical trial;
83	89		(4) may provide reimbursement for reasonable
84	90		ancillary costs, including costs described by Section 50.0002, to
85	91		one family member, friend, or other person who attends a cancer
86	92		clinical trial to support a subject; and
87	93		(5) must comply with applicable federal and state
88	94		laws.
89	95		(b) The independent, third-party organization
90	96		administering the program shall provide written notice to
91	97		prospective subjects of the requirements described by Subsection
92	98		(a).
93	99		Sec. 50.0004. REIMBURSEMENT REQUIREMENTS; NOTICE. (a) A
94	100		reimbursement under the program must:
95	101		(1) be reviewed and approved by the institutional
96	102		review board associated with the cancer clinical trial for which
97	103		the reimbursement is provided; and
98	104		(2) comply with applicable federal and state laws.
99	105		(b) The independent, third-party organization operating the
100	106		program is not required to obtain approval from an institutional
101	107		review board on the financial eligibility of a subject who is
102	108		medically eligible for the program.
103	109		(c) The independent, third-party organization operating the
104	110		program shall provide written notice to a subject on:
105	111		(1) the nature and availability of the ancillary
106	112		financial support under the program; and
107	113		(2) the program's general guidelines on financial
108	114		eligibility.
109	115		Sec. 50.0005. REIMBURSEMENT STATUS AS INDUCEMENT.
110	116		Reimbursement to a subject of ancillary costs under the program:
111	117		(1) does not constitute an inducement to participate
112	118		in a cancer clinical trial;
113	119		(2) is not considered coercion or the exertion of
114	120		undue influence to participate in a cancer clinical trial; and
115	121		(3) is meant to accomplish parity in access to cancer
116	122		clinical trials and remove barriers to participation in cancer
117	123		clinical trials for financially burdened subjects.
118	124		Sec. 50.0006. FUNDING. The independent, third-party
119	125		organization that administers the program may accept gifts, grants,
120	126		and donations from any public or private source to implement this
121	127		chapter.
122	128		Sec. 50.0007. COLLABORATION. The independent, third-party
123	129		organization that administers the program may collaborate with the
124	130		Cancer Prevention and Research Institute of Texas established under
125	131		Chapter 102 to provide reimbursement under the program.
126	132		SECTION 3. Section 102.203(b), Health and Safety Code, is
127	133		amended to read as follows:
128	134		(b) Except as otherwise provided by this section, money
129	135		awarded under this subchapter may be used for authorized expenses,
130	136		including honoraria, salaries and benefits, travel, conference
131	137		fees and expenses, consumable supplies, other operating expenses,
132	138		contracted research and development, capital equipment, [and]
133	139		construction or renovation of state or private facilities, and
134	140		reimbursement for costs of participation incurred by cancer
135	141		clinical trial participants, including transportation, lodging,
136	142		and any costs reimbursed under the cancer clinical trial
137	143		participation program established under Chapter 50.
138	144		SECTION 4. This Act takes effect September 1, 2019.
139		-	______________________________ ______________________________
140		-	President of the Senate Speaker of the House
141		-	I certify that H.B. No. 3147 was passed by the House on May
142		-	10, 2019, by the following vote: Yeas 128, Nays 3, 1 present, not
143		-	voting.
144		-	______________________________
145		-	Chief Clerk of the House
146		-	I certify that H.B. No. 3147 was passed by the Senate on May
147		-	22, 2019, by the following vote: Yeas 31, Nays 0.
148		-	______________________________
149		-	Secretary of the Senate
150		-	APPROVED: _____________________
151		-	Date
152		-	_____________________
153		-	Governor
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