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2023 - 2024 LEGISLATURE
2023 ASSEMBLY BILL 1134
March 6, 2024 - Introduced by Representatives CONLEY, SUBECK, RATCLIFF, JOERS,
CLANCY, JACOBSON, SHANKLAND, EMERSON, SINICKI, MOORE OMOKUNDE, HONG,
J. ANDERSON, BARE, MADISON, OHNSTAD, VINING and CONSIDINE, cosponsored by
Senators AGARD, PFAFF, ROYS, SPREITZER and CARPENTER. Referred to
Committee on Health, Aging and Long-Term Care.
***AUTHORS SUBJECT TO CHANGE***
AN ACT to create 146.901 of the statutes; relating to: prescription drug cost
reporting by manufacturers and providing a penalty.
Analysis by the Legislative Reference Bureau
This bill requires certain cost reporting by manufacturers of brand-name and
generic drugs. The bill requires a manufacturer to notify the Department of Health
Services and the Office of the Commissioner of Insurance if it is 1) increasing the
wholesale acquisition cost of a brand-name drug on the market in Wisconsin by more
than 25 percent over a 24-month period; 2) intending to introduce in Wisconsin a
brand-name drug that has an annual wholesale acquisition cost of $30,000 or more;
3) increasing the wholesale acquisition cost of a generic drug on the market in
Wisconsin by more than 25 percent or by more than $300 during any 12-month
period; or 4) intending to introduce in Wisconsin a generic drug that has an annual
wholesale acquisition cost of $3,000 or more. The manufacturer must provide the
notice at least 30 days before the planned date of the increase or introduction and
must provide a justification including a description described in the bill. A
manufacturer is also required to annually report to DHS and OCI the value of price
concessions provided to each pharmacy benefit manager for each drug sold in
Wisconsin for which a notice was required. The bill also requires each manufacturer
of a brand-name or generic drug sold in Wisconsin to submit to DHS and OCI a report
containing a description of each manufacturer-sponsored assistance program in
effect during the previous year that includes the criteria for participation, the
program terms, and the number of prescriptions and the total market value of
assistance provided to residents of Wisconsin under the program. The manufacturer
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ASSEMBLY BILL 1134
must certify the information provided in a notice or report required under the bill
under penalty of perjury, and failure to provide the notice or report is subject to a
forfeiture determined by DHS but not to exceed $10,000 per day past due.
The bill requires DHS to publish the pricing justification information reported
by manufacturers on its website. DHS must also analyze the information and
publish a report on its website describing trends in drug pricing.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SECTION 1. 146.901 of the statutes is created to read:
146.901 Prescription drug cost reporting by manufacturers. (1)
DEFINITIONS. In this section:
(a) “Brand-name drug” means a prescription drug approved under 21 USC 355
(b) or 42 USC 262.
(b) “Generic drug” means a prescription drug approved under 21 USC 355 (j).
(c) “Manufacturer” has the meaning given in s. 450.01 (12). “Manufacturer”
does not include an entity that is engaged only in the dispensing, as defined in s.
450.01 (7), of a brand-name drug or a generic drug.
(d) “Manufacturer-sponsored assistance program” means a program offered by
a manufacturer or an intermediary under contract with a manufacturer through
which a brand-name drug or a generic drug is provided to a patient at no charge or
at a discount.
(e) “Office” means the office of the commissioner of insurance.
(f) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
(g) “Wholesale acquisition cost” means the most recently reported
manufacturer list or catalog price for a brand-name drug or a generic drug available
to wholesalers or direct purchasers in the United States, before application of
discounts, rebates, or reductions in price.
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SECTION 1
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(2) PRICE INCREASE OR INTRODUCTION NOTICE; JUSTIFICATION REPORT. (a) A
manufacturer shall notify the department and the office if it is increasing the
wholesale acquisition cost of a brand-name drug on the market in this state by more
than 25 percent over a 24-month period or if it intends to introduce to market in this
state a brand-name drug that has an annual wholesale acquisition cost of $30,000
or more.
(b) A manufacturer shall notify the department and the office if it is increasing
the wholesale acquisition cost of a generic drug on the market in this state by more
than 25 percent or by more than $300 during any 12-month period or if it intends
to introduce to market in this state a generic drug that has an annual wholesale
acquisition cost of $3,000 or more.
(c) The manufacturer shall provide the notice under par. (a) or (b) in writing
at least 30 days before the planned effective date of the cost increase or drug
introduction and shall provide a justification that includes all documents and
research related to the manufacturer's selection of the price increase or introduction
price and includes a description of all of the following:
1. The estimated cost-effectiveness of the drug.
2. The price and effectiveness of similar drugs available in this state and the
anticipated sales performance of the drug as compared to similar drugs.
3. The impact of negotiated or mandated discounts to pharmacy benefit
managers, insurers, and other payers of health care costs on the pricing
determination for the drug.
(d) By March 1 annually, each manufacturer shall report to the department and
the office the value of price concessions, expressed as a percentage of the wholesale
acquisition cost, provided to each pharmacy benefit manager for each drug sold by
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SECTION 1 ASSEMBLY BILL 1134
the manufacturer in this state for which a notice is required under par. (a) or (b) in
the previous calendar year.
(3) MANUFACTURER-SPONSORED ASSISTANCE PROGRAMS. By March 1 annually,
each manufacturer of a brand-name drug or generic drug sold in this state shall
submit to the department and the office a report containing a description of each
manufacturer-sponsored assistance program in effect during the previous calendar
year that includes all of the following:
(a) The criteria for participation in the manufacturer-sponsored assistance
program and the manufacturer-sponsored assistance program terms.
(b) The number of prescriptions provided to residents of this state under the
manufacturer-sponsored assistance program.
(c) The total market value of assistance provided to residents of this state under
the manufacturer-sponsored assistance program.
(4) PENALTY. The manufacturer shall certify the information reported under
sub. (2) or (3) as accurate under penalty of perjury. A manufacturer that fails to
provide the notice or report under sub. (2) or (3) is subject to a forfeiture as
determined by the department but not to exceed $10,000 for each day the notice or
report is past due.
(5) POSTING OF REPORT; HEARING. (a) The department shall publish on its website
the justification documentation provided under sub. (2) (c).
(b) The department shall analyze the information submitted under subs. (2)
and (3) and publish a report on its website describing trends in drug pricing. The
department shall conduct at least one public hearing annually on the findings of the
report.
(END)
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