Texas 2023 - 88th Regular

Texas House Bill HB25 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New	Differences
1	1	H.B. No. 25
2	2
3	3
4	4	AN ACT
5	5	relating to wholesale importation of prescription drugs in this
6	6	state; authorizing a fee.
7	7	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
8	8	SECTION 1. This Act may be cited as the Wholesale
9	9	Prescription Drug Importation Act.
10	10	SECTION 2. Subtitle A, Title 6, Health and Safety Code, is
11	11	amended by adding Chapter 444 to read as follows:
12	12	CHAPTER 444. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM
13	13	Sec. 444.001. DEFINITIONS. In this chapter:
14	14	(1) "Canadian supplier" means a manufacturer,
15	15	wholesale distributor, or pharmacy that is appropriately licensed
16	16	or permitted under Canadian federal or provincial laws and rules to
17	17	manufacture, distribute, or dispense prescription drugs.
18	18	(2) "Commission" means the Health and Human Services
19	19	Commission.
20	20	(3) "Prescription drug wholesaler" means a person
21	21	licensed as a wholesale distributor under Subchapter N, Chapter
22	22	431, that contracts with this state to import prescription drugs
23	23	under the program.
24	24	(4) "Program" means the wholesale prescription drug
25	25	importation program established under this chapter.
26	26	Sec. 444.002. ESTABLISHMENT OF WHOLESALE PRESCRIPTION DRUG
27	27	IMPORTATION PROGRAM. (a) The commission shall establish the
28	28	wholesale prescription drug importation program to provide lower
29	29	cost prescription drugs available outside of the United States to
30	30	consumers in this state at the lower cost.
31	31	(b) The commission shall implement the program by:
32	32	(1) contracting with one or more prescription drug
33	33	wholesalers and Canadian suppliers to import prescription drugs and
34	34	provide prescription drug cost savings to consumers in this state;
35	35	(2) developing a registration process for health
36	36	benefit plan issuers, health care providers, and pharmacies to
37	37	obtain and dispense prescription drugs imported under the program;
38	38	(3) developing a list of prescription drugs, including
39	39	the prices of those drugs, that meet the requirements of Section
40	40	444.003 and publishing the list on the commission's Internet
41	41	website;
42	42	(4) establishing an outreach and marketing plan to
43	43	generate program awareness;
44	44	(5) establishing and administering a telephone call
45	45	center or electronic portal to provide information about the
46	46	program;
47	47	(6) ensuring the program and the prescription drug
48	48	wholesalers that contract with this state under Subdivision (1)
49	49	comply with the tracking, tracing, verification, and
50	50	identification requirements of 21 U.S.C. Section 360eee-1;
51	51	(7) prohibiting the distribution, dispensing, or sale
52	52	of prescription drugs imported under this chapter outside the
53	53	boundaries of this state; and
54	54	(8) performing any other duties the executive
55	55	commissioner determines necessary to implement the program.
56	56	(c) The commission shall ensure that the program meets the
57	57	requirements of 21 U.S.C. Section 384.
58	58	(d) In developing the program, the commission may consult
59	59	with interested parties.
60	60	Sec. 444.003. ELIGIBLE PRESCRIPTION DRUGS. A prescription
61	61	drug may be imported into this state under the program only if the
62	62	drug:
63	63	(1) meets the United States Food and Drug
64	64	Administration's standards related to prescription drug safety,
65	65	effectiveness, misbranding, and adulteration;
66	66	(2) does not violate any federal patent laws through
67	67	its importation;
68	68	(3) is expected to generate cost savings for
69	69	consumers; and
70	70	(4) is not:
71	71	(A) listed as a controlled substance under state
72	72	or federal law;
73	73	(B) a biological product;
74	74	(C) an infused drug;
75	75	(D) an intravenously injected drug;
76	76	(E) a drug that is inhaled during surgery; or
77	77	(F) a parenteral drug.
78	78	Sec. 444.004. ANTICOMPETITIVE BEHAVIOR MONITORING. The
79	79	commission, in consultation with the attorney general, shall
80	80	identify and monitor any potential anticompetitive activities in
81	81	industries affected by the program.
82	82	Sec. 444.005. PROGRAM FUNDING. In addition to money
83	83	appropriated by the legislature, the commission may impose a fee on
84	84	each prescription drug sold under the program or establish another
85	85	funding method to administer the program.
86	86	Sec. 444.006. AUDIT PROCEDURES. The executive commissioner
87	87	by rule shall develop procedures to effectively audit a
88	88	prescription drug wholesaler participating in the program.
89	89	Sec. 444.007. ANNUAL REPORTING. Not later than December 1
90	90	of each year, the commission shall submit a report to the governor
91	91	and the legislature regarding the operation of the program during
92	92	the preceding state fiscal year, including:
93	93	(1) which prescription drugs and Canadian suppliers
94	94	are included in the program;
95	95	(2) the number of health benefit plan issuers, health
96	96	care providers, and pharmacies participating in the program;
97	97	(3) the number of prescriptions dispensed through the
98	98	program;
99	99	(4) the estimated cost savings to consumers, health
100	100	plans, employers, and this state since the establishment of the
101	101	program and during the preceding state fiscal year;
102	102	(5) information regarding the implementation of the
103	103	audit procedures under Section 444.006; and
104	104	(6) any other information:
105	105	(A) the governor or the legislature requests; or
106	106	(B) the commission considers necessary.
107	107	SECTION 3. As soon as practicable after the effective date
108	108	of this Act, the executive commissioner of the Health and Human
109	109	Services Commission shall adopt any rules necessary to implement
110	110	Chapter 444, Health and Safety Code, as added by this Act.
111	111	SECTION 4. If before implementing any provision of this Act
112	112	a state agency determines that a waiver or authorization from a
113	113	federal agency is necessary for implementation of that provision,
114	114	the agency affected by the provision shall request the waiver or
115	115	authorization and may delay implementing that provision until the
116	116	waiver or authorization is granted.
117	117	SECTION 5. This Act takes effect September 1, 2023.
118	118	______________________________ ______________________________
119	119	President of the Senate Speaker of the House
120	120	I certify that H.B. No. 25 was passed by the House on April
121	121	12, 2023, by the following vote: Yeas 144, Nays 1, 2 present, not
122	122	voting.
123	123	______________________________
124	124	Chief Clerk of the House
125	125	I certify that H.B. No. 25 was passed by the Senate on May 22,
126	126	2023, by the following vote: Yeas 31, Nays 0.
127	127	______________________________
128	128	Secretary of the Senate
129	129	APPROVED: _____________________
130	130	Date
131	131	_____________________
132	132	Governor