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3. The pharmacy may submit a reorder to the manufacturer if the individual's
11eligibility statement described in par. (c) 3. has not expired. The reorder shall be
12treated as an order for purposes of subd. 2.
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4. Notwithstanding subds. 2. and 3., a manufacturer may send the insulin
14directly to the individual if the manufacturer provides a mail-order service option,
15in which case the pharmacy may not collect a copayment from the individual.
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16(4) Exceptions. (a) This section does not apply to a manufacturer who shows
17to the commissioner's satisfaction that the manufacturer's annual gross revenue
18from insulin sales in this state does not exceed $2,000,000.
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(b) A manufacturer may not be required to make an insulin product available
20under sub. (2) or (3) if the wholesale acquisition cost of the insulin product does not
21exceed $8, as adjusted annually based on the U.S. consumer price index for all urban
22consumers, U.S. city average, per milliliter or the applicable national council for
23prescription drug programs' plan billing unit.
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1(5) Confidentiality. All medical information solicited or obtained by any
2person under this section shall be subject to the applicable provisions of state law
3relating to confidentiality of medical information, including s. 610.70.
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4(6) Reimbursement prohibition. No person, including a manufacturer,
5pharmacy, pharmacist, or 3rd-party administrator, as part of participating in an
6urgent need safety net program or patient assistance program may request or seek,
7or cause another person to request or seek, any reimbursement or other
8compensation for which payment may be made in whole or in part under a federal
9health care program, as defined in
42 USC 1320a-7b (f).
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10(7) Reports. (a) Annually, no later than March 1, each manufacturer shall
11report to the commissioner all of the following information for the previous calendar
12year:
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1. The number of individuals who received insulin under the manufacturer's
14urgent need safety net program.
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2. The number of individuals who sought assistance under the manufacturer's
16patient assistance program and the number of individuals who were determined to
17be ineligible under sub. (3) (c) 4.
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3. The wholesale acquisition cost of the insulin provided by the manufacturer
19through the urgent need safety net program and patient assistance program.
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(b) Annually, no later than April 1, the commissioner shall submit to the
21governor and the chief clerk of each house of the legislature, for distribution to the
22legislature under s. 13.172 (2), a report on the urgent need safety net programs and
23patient assistance programs that includes all of the following:
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1. The information provided to the commissioner under par. (a).
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12. The penalties assessed under sub. (9) during the previous calendar year,
2including the name of the manufacturer and amount of the penalty.
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3(8) Additional responsibilities of commissioner. (a)
Application form. The
4commissioner shall make the application form described in sub. (2) (c) 1. a. available
5on the office's Internet site and shall make the form available to pharmacies and
6health care providers who prescribe or dispense insulin, hospital emergency
7departments, urgent care clinics, and community health clinics.
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(b)
Public outreach. 1. The commissioner shall conduct public outreach to
9create awareness of the urgent need safety net programs and patient assistance
10programs.
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2. The commissioner shall develop and make available on the office's Internet
12site an information sheet that contains all of the following information:
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a. A description of how to access insulin through an urgent need safety net
14program.
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b. A description of how to access insulin through a patient assistance program.
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c. Information on how to contact a navigator for assistance in accessing insulin
17through an urgent need safety net program or patient assistance program.
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d. Information on how to contact the commissioner if a manufacturer
19determines that an individual is not eligible for a patient assistance program.
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e. A notification that an individual may contact the commissioner for more
21information or assistance in accessing ongoing affordable insulin options.
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(c)
Navigators. The commissioner shall develop a training program to provide
23navigators with information and the resources necessary to assist individuals in
24accessing appropriate long-term insulin options. The commissioner shall compile
25a list of navigators who have completed the training program and are available to
1assist individuals in accessing affordable insulin coverage options. The list shall be
2made available on the office's Internet site and to pharmacies and health care
3practitioners who dispense and prescribe insulin.
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(d)
Satisfaction surveys. 1. The commissioner shall develop and conduct a
5satisfaction survey of individuals who have accessed insulin through urgent need
6safety net programs and patient assistance programs. The survey shall ask whether
7the individual is still in need of a long-term solution for affordable insulin and shall
8include questions about the individual's satisfaction with all of the following, if
9applicable:
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a. Accessibility to urgent-need insulin.
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b. Adequacy of the information sheet and list of navigators received from the
12pharmacy.
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c. Helpfulness of a navigator.
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d. Ease of access in applying for a patient assistance program and receiving
15insulin from the pharmacy under the program.
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2. The commissioner shall develop and conduct a satisfaction survey of
17pharmacies that have dispensed insulin through urgent need safety net programs
18and patient assistance programs. The survey shall include questions about the
19pharmacy's satisfaction with all of the following, if applicable:
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a. Timeliness of reimbursement from manufacturers for insulin dispensed by
21the pharmacy under urgent need safety net programs.
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b. Ease in submitting insulin orders to manufacturers.
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c. Timeliness of receiving insulin orders from manufacturers.
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3. The commissioner may contract with a nonprofit entity to develop and
25conduct the surveys under subds. 1. and 2. and to evaluate the survey results.
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14. No later than July 1, 2024, the commissioner shall submit to the governor
2and the chief clerk of each house of the legislature, for distribution to the legislature
3under s. 13.172 (2), a report on the results of the surveys under subds. 1. and 2.
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4(9) Penalty. A manufacturer that fails to comply with this section may be
5assessed a penalty of up to $200,000 per month of noncompliance, with the maximum
6penalty increasing to $400,000 per month if the manufacturer continues to be in
7noncompliance after 6 months and increasing to $600,000 per month if the
8manufacturer continues to be in noncompliance after one year.