Wisconsin 2023-2024 Regular Session

Wisconsin Assembly Bill AB1134 Compare Versions

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

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3	3	2023 - 2024 LEGISLATURE
4	4	2023 ASSEMBLY BILL 1134
5	5	March 6, 2024 - Introduced by Representatives CONLEY, SUBECK, RATCLIFF, JOERS,
6	6	CLANCY, JACOBSON, SHANKLAND, EMERSON, SINICKI, MOORE OMOKUNDE, HONG,
7	7	J. ANDERSON, BARE, MADISON, OHNSTAD, VINING and CONSIDINE, cosponsored by
8	8	Senators AGARD, PFAFF, ROYS, SPREITZER and CARPENTER. Referred to
9	9	Committee on Health, Aging and Long-Term Care.
10	10	*AUTHORS SUBJECT TO CHANGE*
11	11	AN ACT to create 146.901 of the statutes; relating to: prescription drug cost
12	12	reporting by manufacturers and providing a penalty.
13	13	Analysis by the Legislative Reference Bureau
14	14	This bill requires certain cost reporting by manufacturers of brand-name and
15	15	generic drugs. The bill requires a manufacturer to notify the Department of Health
16	16	Services and the Office of the Commissioner of Insurance if it is 1) increasing the
17	17	wholesale acquisition cost of a brand-name drug on the market in Wisconsin by more
18	18	than 25 percent over a 24-month period; 2) intending to introduce in Wisconsin a
19	19	brand-name drug that has an annual wholesale acquisition cost of $30,000 or more;
20	20	3) increasing the wholesale acquisition cost of a generic drug on the market in
21	21	Wisconsin by more than 25 percent or by more than $300 during any 12-month
22	22	period; or 4) intending to introduce in Wisconsin a generic drug that has an annual
23	23	wholesale acquisition cost of $3,000 or more. The manufacturer must provide the
24	24	notice at least 30 days before the planned date of the increase or introduction and
25	25	must provide a justification including a description described in the bill. A
26	26	manufacturer is also required to annually report to DHS and OCI the value of price
27	27	concessions provided to each pharmacy benefit manager for each drug sold in
28	28	Wisconsin for which a notice was required. The bill also requires each manufacturer
29	29	of a brand-name or generic drug sold in Wisconsin to submit to DHS and OCI a report
30	30	containing a description of each manufacturer-sponsored assistance program in
31	31	effect during the previous year that includes the criteria for participation, the
32	32	program terms, and the number of prescriptions and the total market value of
33	33	assistance provided to residents of Wisconsin under the program. The manufacturer
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37	37	ASSEMBLY BILL 1134
38	38	must certify the information provided in a notice or report required under the bill
39	39	under penalty of perjury, and failure to provide the notice or report is subject to a
40	40	forfeiture determined by DHS but not to exceed $10,000 per day past due.
41	41	The bill requires DHS to publish the pricing justification information reported
42	42	by manufacturers on its website. DHS must also analyze the information and
43	43	publish a report on its website describing trends in drug pricing.
44	44	The people of the state of Wisconsin, represented in senate and assembly, do
45	45	enact as follows:
46	46	SECTION 1. 146.901 of the statutes is created to read:
47	47	146.901 Prescription drug cost reporting by manufacturers. (1)
48	48	DEFINITIONS. In this section:
49	49	(a) “Brand-name drug” means a prescription drug approved under 21 USC 355
50	50	(b) or 42 USC 262.
51	51	(b) “Generic drug” means a prescription drug approved under 21 USC 355 (j).
52	52	(c) “Manufacturer” has the meaning given in s. 450.01 (12). “Manufacturer”
53	53	does not include an entity that is engaged only in the dispensing, as defined in s.
54	54	450.01 (7), of a brand-name drug or a generic drug.
55	55	(d) “Manufacturer-sponsored assistance program” means a program offered by
56	56	a manufacturer or an intermediary under contract with a manufacturer through
57	57	which a brand-name drug or a generic drug is provided to a patient at no charge or
58	58	at a discount.
59	59	(e) “Office” means the office of the commissioner of insurance.
60	60	(f) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
61	61	(g) “Wholesale acquisition cost” means the most recently reported
62	62	manufacturer list or catalog price for a brand-name drug or a generic drug available
63	63	to wholesalers or direct purchasers in the United States, before application of
64	64	discounts, rebates, or reductions in price.
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86	86	SECTION 1
87	87	ASSEMBLY BILL 1134
88	88	(2) PRICE INCREASE OR INTRODUCTION NOTICE; JUSTIFICATION REPORT. (a) A
89	89	manufacturer shall notify the department and the office if it is increasing the
90	90	wholesale acquisition cost of a brand-name drug on the market in this state by more
91	91	than 25 percent over a 24-month period or if it intends to introduce to market in this
92	92	state a brand-name drug that has an annual wholesale acquisition cost of $30,000
93	93	or more.
94	94	(b) A manufacturer shall notify the department and the office if it is increasing
95	95	the wholesale acquisition cost of a generic drug on the market in this state by more
96	96	than 25 percent or by more than $300 during any 12-month period or if it intends
97	97	to introduce to market in this state a generic drug that has an annual wholesale
98	98	acquisition cost of $3,000 or more.
99	99	(c) The manufacturer shall provide the notice under par. (a) or (b) in writing
100	100	at least 30 days before the planned effective date of the cost increase or drug
101	101	introduction and shall provide a justification that includes all documents and
102	102	research related to the manufacturer's selection of the price increase or introduction
103	103	price and includes a description of all of the following:
104	104	1. The estimated cost-effectiveness of the drug.
105	105	2. The price and effectiveness of similar drugs available in this state and the
106	106	anticipated sales performance of the drug as compared to similar drugs.
107	107	3. The impact of negotiated or mandated discounts to pharmacy benefit
108	108	managers, insurers, and other payers of health care costs on the pricing
109	109	determination for the drug.
110	110	(d) By March 1 annually, each manufacturer shall report to the department and
111	111	the office the value of price concessions, expressed as a percentage of the wholesale
112	112	acquisition cost, provided to each pharmacy benefit manager for each drug sold by
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139	139	SECTION 1 ASSEMBLY BILL 1134
140	140	the manufacturer in this state for which a notice is required under par. (a) or (b) in
141	141	the previous calendar year.
142	142	(3) MANUFACTURER-SPONSORED ASSISTANCE PROGRAMS. By March 1 annually,
143	143	each manufacturer of a brand-name drug or generic drug sold in this state shall
144	144	submit to the department and the office a report containing a description of each
145	145	manufacturer-sponsored assistance program in effect during the previous calendar
146	146	year that includes all of the following:
147	147	(a) The criteria for participation in the manufacturer-sponsored assistance
148	148	program and the manufacturer-sponsored assistance program terms.
149	149	(b) The number of prescriptions provided to residents of this state under the
150	150	manufacturer-sponsored assistance program.
151	151	(c) The total market value of assistance provided to residents of this state under
152	152	the manufacturer-sponsored assistance program.
153	153	(4) PENALTY. The manufacturer shall certify the information reported under
154	154	sub. (2) or (3) as accurate under penalty of perjury. A manufacturer that fails to
155	155	provide the notice or report under sub. (2) or (3) is subject to a forfeiture as
156	156	determined by the department but not to exceed $10,000 for each day the notice or
157	157	report is past due.
158	158	(5) POSTING OF REPORT; HEARING. (a) The department shall publish on its website
159	159	the justification documentation provided under sub. (2) (c).
160	160	(b) The department shall analyze the information submitted under subs. (2)
161	161	and (3) and publish a report on its website describing trends in drug pricing. The
162	162	department shall conduct at least one public hearing annually on the findings of the
163	163	report.
164	164	(END)
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