Texas 2019 - 86th Regular

Texas House Bill HB2536 Compare Versions

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Version 2 (New)

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1		-	H.B. No. 2536
	1	+	By: Oliverson, Blanco (Senate Sponsor - Hancock) H.B. No. 2536
	2	+	(In the Senate - Received from the House May 13, 2019;
	3	+	May 14, 2019, read first time and referred to Committee on Business &
	4	+	Commerce; May 20, 2019, reported favorably by the following vote:
	5	+	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 transparency related to drug costs.
6	12		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
7	13		SECTION 1. Subtitle A, Title 6, Health and Safety Code, is
8	14		amended by adding Chapter 441 to read as follows:
9	15		CHAPTER 441. DRUG COST TRANSPARENCY
10	16		SUBCHAPTER A. GENERAL PROVISIONS
11	17		Sec. 441.0001. DEFINITIONS. In this chapter:
12	18		(1) "Animal health product" means a medical product
13	19		approved and licensed for use in animal or veterinary medicine,
14	20		including a pharmaceutical, a biologic, an insecticide, and a
15	21		parasiticide.
16	22		(2) "Pharmaceutical drug manufacturer" means a person
17	23		engaged in the business of producing, preparing, propagating,
18	24		compounding, converting, processing, packaging, labeling, or
19	25		distributing a drug. The term does not include a wholesale
20	26		distributor or retailer of prescription drugs or a pharmacist
21	27		licensed under Subtitle J, Title 3, Occupations Code.
22	28		(3) "Prescription drug" and "drug" have the meanings
23	29		assigned by Section 551.003, Occupations Code, except that the term
24	30		"prescription drug" does not include a device or an animal health
25	31		product.
26	32		(4) "Wholesale acquisition cost" means, with respect
27	33		to a drug, the pharmaceutical drug manufacturer's list price for
28	34		the drug charged to wholesalers or direct purchasers in the United
29	35		States, as reported in wholesale price guides or other publications
30	36		of drug pricing data. The cost does not include any rebates, prompt
31	37		pay or other discounts, or other reductions in price.
32	38		Sec. 441.0002. DISCLOSURE OF DRUG PRICING INFORMATION. (a)
33	39		Not later than the 15th day of each calendar year, a pharmaceutical
34	40		drug manufacturer shall submit a report to the executive
35	41		commissioner stating the current wholesale acquisition cost
36	42		information for the United States Food and Drug
37	43		Administration-approved drugs sold in or into this state by that
38	44		manufacturer.
39	45		(b) The executive commissioner shall develop an Internet
40	46		website to provide to the general public drug price information
41	47		submitted under Subsection (a). The Internet website shall be made
42	48		available on the Health and Human Services Commission's Internet
43	49		website with a dedicated link that is prominently displayed on the
44	50		home page or by a separate easily identifiable Internet address.
45	51		(c) This subsection applies only to a drug with a wholesale
46	52		acquisition cost of at least $100 for a 30-day supply before the
47	53		effective date of an increase described by this subsection. Not
48	54		later than the 30th day after the effective date of an increase of
49		-	40 percent or more over the preceding ~~three~~ calendar years or 15
50		-	percent or more in the preceding ~~calendar year~~ in the wholesale
	55	+	40 percent or more over the preceding five calendar years or 10
	56	+	percent or more in the preceding 12 months in the wholesale
51	57		acquisition cost of a drug to which this subsection applies, a
52	58		pharmaceutical drug manufacturer shall submit a report to the
53	59		executive commissioner. The report must include the following
54	60		information:
55	61		(1) the name of the drug;
56	62		(2) whether the drug is a brand name or generic;
57	63		(3) the effective date of the change in wholesale
58	64		acquisition cost;
59	65		(4) aggregate, company-level research and development
60	66		costs for the most recent year for which final audit data is
61	67		available;
62	68		(5) the name of each of the manufacturer's
63	69		prescription drugs approved by the United States Food and Drug
64		-	Administration in the previous ~~three~~ calendar years;
	70	+	Administration in the previous five calendar years;
65	71		(6) the name of each of the manufacturer's
66	72		prescription drugs that lost patent exclusivity in the United
67		-	States in the previous three calendar years; and
68		-	(7) a statement regarding the factor or factors that
69		-	caused the increase in the wholesale acquisition cost and an
70		-	explanation of the role of each factor's impact on the cost.
	73	+	States in the previous five calendar years;
	74	+	(7) all factors that caused the increase in the
	75	+	wholesale acquisition cost;
	76	+	(8) the percentage of the total increase in the
	77	+	wholesale acquisition cost that is attributable to each factor
	78	+	listed in Subdivision (7); and
	79	+	(9) an explanation of the role of each factor listed in
	80	+	Subdivision (7) in contributing to the increase in the wholesale
	81	+	acquisition cost.
71	82		(d) The quality and types of information and data that a
72	83		pharmaceutical drug manufacturer submits to the executive
73	84		commissioner under Subsection (c) must be consistent with the
74	85		quality and types of information and data that the manufacturer
75	86		includes in the manufacturer's annual consolidated report on
76	87		Securities and Exchange Commission Form 10-K or any other public
77	88		disclosure.
78	89		(e) Not later than the 60th day after receipt of the report
79	90		submitted under Subsection (c), the executive commissioner shall
80	91		publish the report on the Health and Human Services Commission's
81	92		Internet website described by Subsection (b).
82	93		(f) The executive commissioner may adopt rules to implement
83	94		this section.
84	95		SECTION 2. Chapter 1369, Insurance Code, is amended by
85	96		adding Subchapter K to read as follows:
86	97		SUBCHAPTER K. PRESCRIPTION DRUG COST TRANSPARENCY
87	98		Sec. 1369.501. DEFINITIONS. In this subchapter:
88	99		(1) "Animal health product" means a medical product
89	100		approved and licensed for use in animal or veterinary medicine,
90	101		including a pharmaceutical, a biologic, an insecticide, and a
91	102		parasiticide.
92	103		(2) "Health benefit plan" means an individual,
93	104		blanket, or group plan, policy, or contract for health care
94	105		services issued or delivered by a health benefit plan issuer in this
95	106		state.
96	107		(3) "Health benefit plan issuer" means an insurance
97	108		company, a health maintenance organization, or a hospital and
98	109		medical service corporation.
99	110		(4) "Pharmaceutical drug manufacturer" means a person
100	111		engaged in the business of producing, preparing, propagating,
101	112		compounding, converting, processing, packaging, labeling, or
102	113		distributing a prescription drug. The term does not include a
103	114		wholesale distributor or retailer of prescription drugs or a
104	115		pharmacist licensed under Subtitle J, Title 3, Occupations Code.
105	116		(5) "Pharmacy benefit manager" has the meaning
106	117		assigned by Section 4151.151.
107	118		(6) "Prescription drug" has the meaning assigned by
108	119		Section 551.003, Occupations Code, except that the term
109	120		"prescription drug" does not include a device or an animal health
110	121		product.
111	122		(7) "Rebate" means a discount or concession that
112	123		affects the price of a prescription drug to a pharmacy benefit
113	124		manager or health benefit plan issuer for a prescription drug
114	125		manufactured by the pharmaceutical drug manufacturer.
115	126		(8) "Specialty drug" means a prescription drug covered
116	127		under Medicare Part D that exceeds the specialty tier cost
117	128		threshold established by the Centers for Medicare and Medicaid
118	129		Services.
119	130		(9) "Utilization management" means a set of formal
120	131		techniques designed to monitor the use of, or evaluate the medical
121	132		necessity, appropriateness, efficacy, or efficiency of, health
122	133		care services, procedures, or settings.
123	134		Sec. 1369.502. PHARMACY BENEFIT MANAGER INFORMATION. (a)
124	135		Not later than February 1 of each year, each pharmacy benefit
125	136		manager shall file a report with the commissioner. The report must
126	137		state for the immediately preceding calendar year:
127	138		(1) the aggregated rebates, fees, price protection
128	139		payments, and any other payments collected from pharmaceutical drug
129	140		manufacturers; and
130	141		(2) the aggregated dollar amount of rebates, fees,
131	142		price protection payments, and any other payments collected from
132	143		pharmaceutical drug manufacturers that were:
133	144		(A) passed to:
134	145		(i) health benefit plan issuers; or
135	146		(ii) enrollees at the point of sale of a
136	147		prescription drug; or
137	148		(B) retained as revenue by the pharmacy benefit
138	149		manager.
139		-	(a-1) Notwithstanding Subsection (a), the report due not
140		-	later than February 1, 2020, under that subsection must state the
141		-	required information for the immediately preceding three calendar
142		-	years in addition to stating the required information for the
143		-	preceding calendar year. This subsection expires September 1,
144		-	2021.
145	150		(b) A report submitted by a pharmacy benefit manager may not
146	151		disclose the identity of a specific health benefit plan or
147	152		enrollee, the price charged for a specific prescription drug or
148	153		class of prescription drugs, or the amount of any rebate or fee
149	154		provided for a specific prescription drug or class of prescription
150	155		drugs.
151		-	(c) Not later than May 1 of each year, the commissioner
152		-	shall publish the aggregated data from all reports for that year
153		-	required by this section in an appropriate location on the
154		-	department's Internet website. The combined aggregated data from
155		-	the reports must be published in a manner that does not disclose or
156		-	tend to disclose proprietary or confidential information of any
157		-	pharmacy benefit manager.
	156	+	(c) Not later than the 60th day after receipt, the
	157	+	commissioner shall publish the report in an appropriate location on
	158	+	the department's Internet website.
158	159		Sec. 1369.503. HEALTH BENEFIT PLAN ISSUER INFORMATION. (a)
159	160		Not later than February 1 of each year, each health benefit plan
160	161		issuer shall submit to the commissioner a report that states for the
161	162		immediately preceding calendar year:
162	163		(1) the names of the 25 most frequently prescribed
163	164		prescription drugs across all plans;
164	165		(2) the percent increase in annual net spending for
165	166		prescription drugs across all plans;
166	167		(3) the percent increase in premiums that were
167	168		attributable to prescription drugs across all plans;
168	169		(4) the percentage of specialty drugs with utilization
169	170		management requirements across all plans; and
170	171		(5) the premium reductions that were attributable to
171	172		specialty drug utilization management.
172	173		(b) A report submitted by a health benefit plan issuer may
173	174		not disclose the identity of a specific health benefit plan or the
174	175		price charged for a specific prescription drug or class of
175	176		prescription drugs.
176		-	(c) Not later than May 1 of each year, the commissioner
177		-	shall publish the aggregated data from all reports for that year
178		-	required by this section in an appropriate location on the
179		-	department's Internet website. The combined aggregated data from
180		-	the reports must be published in a manner that does not disclose or
181		-	tend to disclose proprietary or confidential information of any
182		-	health benefit plan issuer.
	177	+	(c) Not later than the 60th day after receipt, the
	178	+	commissioner shall publish the report in an appropriate location on
	179	+	the department's Internet website.
183	180		Sec. 1369.504. RULES. The commissioner may adopt rules to
184	181		implement this subchapter.
185	182		SECTION 3. Notwithstanding Chapter 441, Health and Safety
186	183		Code, as added by this Act, and Subchapter K, Chapter 1369,
187	184		Insurance Code, as added by this Act, a pharmaceutical drug
188	185		manufacturer, pharmacy benefit manager, or health benefit plan
189	186		issuer is not required to submit a summary report as required by
190	187		Chapter 441, Health and Safety Code, as added by this Act, or
191	188		Subchapter K, Chapter 1369, Insurance Code, as added by this Act, as
192	189		applicable, before January 1, 2020.
193	190		SECTION 4. This Act takes effect September 1, 2019.
194		-	______________________________ ______________________________
195		-	President of the Senate Speaker of the House
196		-	I certify that H.B. No. 2536 was passed by the House on May
197		-	10, 2019, by the following vote: Yeas 134, Nays 0, 1 present, not
198		-	voting; and that the House concurred in Senate amendments to H.B.
199		-	No. 2536 on May 24, 2019, by the following vote: Yeas 142, Nays 0,
200		-	2 present, not voting.
201		-	______________________________
202		-	Chief Clerk of the House
203		-	I certify that H.B. No. 2536 was passed by the Senate, with
204		-	amendments, on May 22, 2019, by the following vote: Yeas 27, Nays
205		-	4.
206		-	______________________________
207		-	Secretary of the Senate
208		-	APPROVED: __________________
209		-	Date
210		-	__________________
211		-	Governor
	191	+	* * * * *