Texas 2009 - 81st Regular

Texas Senate Bill SB296 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	81R1959 JSC-D
2	2	By: West S.B. No. 296
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the disclosure of certain payments or other transfers
8	8	of value by manufacturers of prescription drugs, medical devices,
9	9	and medical supplies; providing a penalty.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Subtitle H, Title 2, Health and Safety Code, is
12	12	amended by adding Chapter 174 to read as follows:
13	13	CHAPTER 174. REPORTING REQUIREMENTS FOR MANUFACTURERS OF
14	14	PRESCRIPTION DRUGS, MEDICAL DEVICES, AND MEDICAL SUPPLIES
15	15	SUBCHAPTER A. GENERAL PROVISIONS
16	16	Sec. 174.001. APPLICABILITY. This chapter applies to a
17	17	manufacturer that exceeds $1 million in annual gross revenue and
18	18	produces, prepares, compounds, converts, or processes a
19	19	prescription drug, medical device, or medical supply for which
20	20	payment is available through the medical assistance program under
21	21	Chapter 32, Human Resources Code, or under Title XVIII, XIX, or XXI
22	22	of the Social Security Act (42 U.S.C. Sections 1395 et seq., 1396 et
23	23	seq., and 1397aa et seq.).
24	24	Sec. 174.002. RULES. The attorney general shall adopt
25	25	rules necessary to implement this chapter.
26	26	[Sections 174.003-174.050 reserved for expansion]
27	27	SUBCHAPTER B. REPORTING REQUIREMENTS
28	28	Sec. 174.051. QUARTERLY REPORT. (a) A manufacturer doing
29	29	business in this state shall submit a report for each fiscal quarter
30	30	to the attorney general that discloses any payment or other
31	31	transfer of value provided directly, indirectly, or through an
32	32	agent, subsidiary, or other third party to:
33	33	(1) a physician;
34	34	(2) an entity that a physician is employed by, has
35	35	tenure with, or has a significant ownership interest in; or
36	36	(3) an organization involved in health care financing,
37	37	organization, or delivery and in which a physician is a voluntary
38	38	paying member or through which a physician receives professional
39	39	certification.
40	40	(b) For each payment or other transfer of value reported,
41	41	the quarterly report shall list:
42	42	(1) the name of the physician and, if applicable:
43	43	(A) the entity required to be listed by
44	44	Subsection (a)(2); or
45	45	(B) the organization required to be listed by
46	46	Subsection (a)(3);
47	47	(2) the address of the physician's office or primary
48	48	address of the entity required to be listed by Subsection (a)(2) or
49	49	the organization required to be listed by Subsection (a)(3);
50	50	(3) the facility with which the physician is
51	51	affiliated, if any;
52	52	(4) the value of the payment or other transfer of
53	53	value;
54	54	(5) the date on which the payment or other transfer of
55	55	value was provided;
56	56	(6) a description of the nature of the payment or other
57	57	transfer of value; and
58	58	(7) the purpose of the payment or other transfer of
59	59	value.
60	60	(c) The following payments or other transfers of value are
61	61	exempt from the quarterly reporting requirement:
62	62	(1) free samples of prescription drugs intended for
63	63	distribution to patients;
64	64	(2) a transfer of anything of value to a physician who
65	65	is a patient and not acting in the physician's professional
66	66	capacity;
67	67	(3) a gift, payment, fee, subsidy, or other economic
68	68	benefit valued at less than $25; and
69	69	(4) compensation paid by a manufacturer to a physician
70	70	who is directly employed by and works solely for the manufacturer.
71	71	(d) A manufacturer shall submit each quarterly report
72	72	electronically in the manner prescribed by the attorney general not
73	73	later than the 30th day after the date the state fiscal year quarter
74	74	ends.
75	75	Sec. 174.052. ANNUAL SUMMARY REPORT. (a) Not later than
76	76	October 15 of each year, each manufacturer that is required to
77	77	submit quarterly reports under Section 174.051 shall submit an
78	78	annual summary report to the attorney general that:
79	79	(1) summarizes each submission of information under
80	80	Section 174.051 made by the manufacturer during the previous fiscal
81	81	year; and
82	82	(2) includes the aggregate amount of all transfers of
83	83	anything of value less than $25 for the previous fiscal year.
84	84	(b) The manufacturer shall submit the annual summary report
85	85	electronically in the manner prescribed by the attorney general.
86	86	(c) The attorney general may assess a fee for filing the
87	87	annual summary report in an amount sufficient to recover the cost of
88	88	administering this chapter.
89	89	Sec. 174.053. PUBLICATION OF REPORTS. (a) The attorney
90	90	general shall review and make available to the public information
91	91	reported under Sections 174.051 and 174.052.
92	92	(b) The attorney general shall publish the quarterly and
93	93	annual summary reports on the attorney general's website and shall
94	94	make printed copies of the reports available on request.
95	95	Sec. 174.054. REPORT TO THE LEGISLATURE. Not later than
96	96	December 1 of each year, the attorney general shall submit a report
97	97	to the legislature that includes:
98	98	(1) information collected under Sections 174.051 and
99	99	174.052 for the preceding fiscal year; and
100	100	(2) a description of any action taken to enforce this
101	101	chapter during the preceding fiscal year.
102	102	Sec. 174.055. CIVIL PENALTY. (a) A manufacturer that fails
103	103	to report a payment or other transfer of value is liable to the
104	104	state for a civil penalty of not less than $500 but not more than
105	105	$2,500 for each violation, not to exceed $50,000 in one fiscal year.
106	106	(b) A manufacturer that fails to file a quarterly or annual
107	107	summary report required under this subchapter is liable to the
108	108	state for a civil penalty of not less than $5,000 but not more than
109	109	$25,000, not to exceed $250,000 in one fiscal year.
110	110	(c) Each failure to report a payment or other transfer of
111	111	value or failure to file a quarterly or annual summary report
112	112	constitutes a separate violation.
113	113	(d) The attorney general may sue to collect a penalty under
114	114	this section.
115	115	SECTION 2. (a) The attorney general shall require the first
116	116	quarterly report under Section 174.051, Health and Safety Code, as
117	117	added by this Act, to be submitted not later than December 30, 2009.
118	118	(b) The attorney general shall require the first annual
119	119	summary report under Section 174.052, Health and Safety Code, as
120	120	added by this Act, to be submitted not later than October 15, 2010.
121	121	(c) The attorney general shall submit the first report to
122	122	the legislature required by Section 174.054, Health and Safety
123	123	Code, as added by this Act, not later than December 1, 2010.
124	124	(d) As soon as practicable after the effective date of this
125	125	Act, the attorney general shall adopt rules required by Section
126	126	174.002, as added by this Act.
127	127	SECTION 3. This Act takes effect immediately if it receives
128	128	a vote of two-thirds of all the members elected to each house, as
129	129	provided by Section 39, Article III, Texas Constitution. If this
130	130	Act does not receive the vote necessary for immediate effect, this
131	131	Act takes effect September 1, 2009.