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9Section 2094k. 632.865 (3) of the statutes is created to read:
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632.865
(3) Registration required. (a) No person may perform any activities
11of a pharmacy benefit manager in this state without first registering with the
12commissioner under this subsection.
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(b) The commissioner shall establish a registration procedure for pharmacy
14benefit managers. The commissioner may promulgate any rules necessary to
15implement the registration procedure under this paragraph.
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16Section 2095k. 632.866 of the statutes is created to read:
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17632.866 Prescription drug cost reporting. (1) Definitions. In this section:
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(a) “Brand-name drug” means a prescription drug approved under
21 USC 355 19(b) or
42 USC 262.
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(b) “Covered hospital” means an entity described in
42 USC 256b (a) (4) (L) to
21(N) that participates in the federal drug-pricing program under
42 USC 256b.
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(c) “Disability insurance policy” has the meaning given in s. 632.895 (1) (a).
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(d) “Generic drug” means a prescription drug approved under
21 USC 355 (j).
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1(e) “Manufacturer” has the meaning given in s. 450.01 (12). “Manufacturer”
2does not include an entity that is engaged only in the dispensing, as defined in s.
3450.01 (7), of a brand-name drug or a generic drug.
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(f) “Manufacturer-sponsored assistance program” means a program offered by
5a manufacturer or an intermediary under contract with a manufacturer through
6which a brand-name drug or a generic drug is provided to a patient at no charge or
7at a discount.
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(g) “Margin” means, for a covered hospital, the difference between the net cost
9of a brand-name drug or generic drug covered under the federal drug-pricing
10program under
42 USC 256b and the net payment by the covered hospital for that
11brand-name drug or generic drug.
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(h) “Net payment” means the amount paid for a brand-name drug or generic
13drug after all discounts and rebates have been applied.
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(i) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
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(j) “Wholesale acquisition cost” means the most recently reported
16manufacturer list or catalog price for a brand-name drug or a generic drug available
17to wholesalers or direct purchasers in the United States, before application of
18discounts, rebates, or reductions in price.
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19(2) Price increase or introduction notice; justification report. (a) A
20manufacturer shall notify the commissioner if it is increasing the wholesale
21acquisition cost of a brand-name drug on the market in this state by more than 10
22percent or by more than $10,000 during any 12-month period or if it intends to
23introduce to market in this state a brand-name drug that has an annual wholesale
24acquisition cost of $30,000 or more.
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1(b) A manufacturer shall notify the commissioner if it is increasing the
2wholesale acquisition cost of a generic drug by more than 25 percent or by more than
3$300 during any 12-month period or if it intends to introduce to market a generic
4drug 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
6at least 30 days before the planned effective date of the cost increase or drug
7introduction with a justification that includes all documents and research related to
8the manufacturer's selection of the cost increase or introduction price and a
9description of life cycle management, market competition and context, and
10estimated value or cost-effectiveness of the product.
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11(3) Net prices paid by pharmacy benefit managers. By March 1 annually, the
12manufacturer shall report to the commissioner the value of price concessions,
13expressed as a percentage of the wholesale acquisition cost, provided to each
14pharmacy benefit manager for each drug sold in this state.
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15(4) Rebates and price concessions. By March 1 annually, each pharmacy
16benefit manager shall report to the commissioner the amount received from
17manufacturers as drug rebates and the value of price concessions, expressed as a
18percentage of the wholesale acquisition cost, provided by manufacturers for each
19drug.
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20(5) Hospital margin spending. By March 1 annually, each covered hospital
21operating in this state shall report to the commissioner the per unit margin for each
22drug covered under the federal drug pricing program under
42 USC 256b dispensed
23in the previous year multiplied by the number of units dispensed at that margin and
24how the margin revenue was used.
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1(6) Manufacturer-sponsored assistance programs. By March 1 annually,
2each manufacturer shall provide the commissioner with a description of each
3manufacturer-sponsored patient assistance program in effect during the previous
4year 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
8the program.
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9(7) Certification and penalties for noncompliance. Each manufacturer and
10covered hospital that is required to report under this section shall certify each report
11as accurate under the penalty of perjury. A manufacturer or covered hospital that
12fails to submit a report required under this section is subject to a forfeiture of no more
13than $10,000 each day the report is overdue.
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14(8) Hearing and public reporting. (a) The commissioner shall publicly post
15manufacturer price justification documents and covered hospital documentation of
16how each hospital spends the margin revenue. The commissioner shall keep any
17trade secret or proprietary information confidential.
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(b) The commissioner shall analyze data collected under this section and
19publish annually a report on emerging trends in prescription prices and price
20increases, and shall annually conduct a public hearing based on the analysis under
21this paragraph. The report under this paragraph shall include analysis of
22manufacturer prices and price increases, analysis of hospital-specific margins and
23how that revenue is spent or allocated on a hospital-specific basis, and analysis of
24how pharmacy benefit manager discounts and net costs compare to retail prices paid
25by patients.
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1(9) Allowing cost disclosure to insured. The commissioner shall ensure that
2every disability insurance policy that covers prescription drugs or biological products
3does not restrict a pharmacy or pharmacist that dispenses a prescription drug or
4biological product from informing and does not penalize a pharmacy or pharmacist
5for informing an insured under a policy of a difference between the negotiated price
6of, or copayment or coinsurance for, the drug or biological product under the policy
7and the price the insured would pay for the drug or biological product if the insured
8obtained the drug or biological product without using any health insurance coverage.