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(a) “Brand-name drug” means a prescription drug approved under
21 USC 355 20(b) or
42 USC 262.
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(b) “Generic drug” means a prescription drug approved under
21 USC 355 (j).
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(c) “Manufacturer” has the meaning given in s. 450.01 (12). “Manufacturer”
23does not include an entity that is engaged only in the dispensing, as defined in s.
24450.01 (7), of a brand-name drug or generic drug.
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1(d) “Manufacturer-sponsored assistance program” means a program offered by
2a manufacturer or an intermediary under contract with a manufacturer through
3which a brand-name drug or generic drug is provided to a patient at no charge or at
4a discount.
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(e) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
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(f) “Pharmacy services administrative organization” means an entity that
7provides contracting and other administrative services to a pharmacy to assist the
8pharmacy in interactions with a 3rd-party payer, pharmacy benefit manager,
9wholesale drug distributor, or other entity.
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(g) “Wholesale acquisition cost” means the most recently reported
11manufacturer list or catalog price for a brand-name drug or generic drug available
12to wholesalers or direct purchasers in the United States, before application of
13discounts, rebates, or reductions in price.
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14(2) Price increase or introduction notice; justification report. (a) A
15manufacturer shall notify the commissioner if it is increasing the wholesale
16acquisition cost of a brand-name drug on the market in this state by more than 10
17percent or by more than $10,000 during any 12-month period or if it intends to
18introduce to market in this state a brand-name drug that has an annual wholesale
19acquisition cost of $30,000 or more.
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(b) A manufacturer shall notify the commissioner if it is increasing the
21wholesale acquisition cost of a generic drug by more than 25 percent or by more than
22$300 during any 12-month period or if it intends to introduce to market a generic
23drug that has an annual wholesale acquisition cost of $3,000 or more.
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(c) The manufacturer shall provide the notice under par. (a) or (b) in writing
25at least 30 days before the planned effective date of the cost increase or drug
1introduction with a justification that includes all documents and research related to
2the manufacturer's selection of the cost increase or introduction price and a
3description of life cycle management, market competition and context, and
4estimated value or cost-effectiveness of the product.
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5(3) Net prices paid by pharmacy benefit managers. By March 1 annually, the
6manufacturer shall report to the commissioner the value of price concessions,
7expressed as a percentage of the wholesale acquisition cost, provided to each
8pharmacy benefit manager for each drug sold in this state.
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9(4) Rebates and price concessions. By March 1 annually, each pharmacy
10benefit manager shall report to the commissioner the amount received from
11manufacturers as drug rebates and the value of price concessions, expressed as a
12percentage of the wholesale acquisition cost, provided by manufacturers for each
13drug.
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14(5) Manufacturer-sponsored assistance programs. By March 1 annually,
15each manufacturer shall provide the commissioner with a description of each
16manufacturer-sponsored patient assistance program in effect during the previous
17year that includes all of the following:
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(a) The terms of the programs.
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(b) The number of prescriptions provided to state residents under the program.
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(c) The total market value of assistance provided to residents of this state under
21the program.
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22(6) Pharmacy services administrative organizations. By March 1 annually,
23each pharmacy services administrative organization shall report to the
24commissioner all of the following information:
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1(a) The negotiated reimbursement rate of the 25 prescription drugs with the
2highest reimbursement rates during the previous year.
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(b) The 25 prescription drugs with the highest year-to-year change in
4reimbursement rate for the previous year.
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(c) The schedule of fees charged by the organization to pharmacies.
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6(7) Certification and penalties for noncompliance. Each manufacturer and
7pharmacy services administrative organization that is required to report under this
8section shall certify each report as accurate under the penalty of perjury. A
9manufacturer or pharmacy services administrative organization that fails to submit
10a report required under this section is subject to a forfeiture of no more than $10,000
11each day the report is overdue.
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12(8) Hearing and public reporting. (a) The commissioner shall publicly post
13manufacturer price justification documents. The commissioner shall keep any trade
14secret or proprietary information confidential.
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(b) The commissioner shall analyze data collected under this section and
16publish annually a report on emerging trends in prescription prices and price
17increases and shall annually conduct a public hearing based on the analysis under
18this paragraph. The report under this paragraph shall include analysis of
19manufacturer prices and price increases and analysis of how pharmacy benefit
20manager discounts and net costs compare to retail prices paid by patients.
AB68,2968
21Section
2968. 632.868 of the statutes is created to read:
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22632.868 Insulin safety net programs. (1) Definitions. In this section:
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(a) “Manufacturer" means a person engaged in the manufacturing of insulin
24that is self-administered on an outpatient basis.
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(b) “Navigator" has the meaning given in s. 628.90 (3).
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1(c) “Patient assistance program” means a program established by a
2manufacturer under sub. (3) (a).
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(d) “Pharmacy" means an entity licensed under s. 450.06 or 450.065.