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2021 - 2022 LEGISLATURE
September 10, 2021 - Introduced by Representatives Subeck, Anderson,
Cabral-Guevara, Cabrera, Conley, Considine, Emerson, Hebl, Hesselbein,
Hong, B. Meyers, Milroy, L. Myers, Neubauer, Pope, S. Rodriguez,
Shankland, Shelton, Sinicki, Snodgrass, Spreitzer, Stubbs, Vining and
Vruwink, cosponsored by Senators Erpenbach, Johnson, Agard,
Bewley,
Carpenter, Larson, Pfaff, Ringhand, Roys and Wirch. Referred to
Committee on Health.
AB557,1,2
1An Act to create 632.868 of the statutes;
relating to: insulin safety net
2programs and providing a penalty.
Analysis by the Legislative Reference Bureau
This bill requires insulin manufacturers to establish a program under which
qualifying Wisconsin residents who are in urgent need of insulin and are uninsured
or have limited insurance coverage can be dispensed insulin at a pharmacy. Under
the program, if a qualifying individual in urgent need of insulin provides a pharmacy
with a form attesting that the individual meets the program's eligibility
requirements, specified proof of residency, and a valid insulin prescription, the
pharmacy must dispense a 30-day supply of insulin to the individual and may charge
the individual a copayment of no more than $35. The pharmacy may submit an
electronic payment claim for the insulin's acquisition cost to the manufacturer or
agree to receive a replacement of the same insulin in the amount dispensed.
The bill also requires that insulin manufacturers establish a patient assistance
program to make insulin available to any qualifying Wisconsin resident who is
uninsured or has limited insurance coverage and whose income does not exceed 400
percent of the federal poverty guidelines. Under the bill, an individual must apply
to participate in a manufacturer's program. If the manufacturer determines that the
individual meets the program's eligibility requirements, the manufacturer issues
the individual a statement of eligibility, which is valid for 12 months and may be
renewed. Under the bill, if an individual with a statement of eligibility and valid
insulin prescription requests insulin from a pharmacy, the pharmacy must submit
an order to the manufacturer, who must then provide a 90-day supply of insulin at
no charge to the individual or pharmacy. The pharmacy may charge the individual
a copayment of no more than $50. Under the bill, a manufacturer is not required to
issue a statement of eligibility if the individual has prescription drug coverage
through an individual or group health plan and the manufacturer determines that
the individual's insulin needs are better addressed through the manufacturer's
copayment assistance program. In such case, the manufacturer must provide the
individual with the necessary drug coupons, and the individual may not be required
to pay more than a $50 copayment for a 90-day supply of insulin.
Under the bill, if the manufacturer determines that an individual is not eligible
for the patient assistance program, the individual may file an appeal with the Office
of the Commissioner of Insurance. The bill directs OCI to establish procedures for
deciding appeals. Under the bill, OCI must issue a decision within 10 days, and that
decision is final.
The bill requires that insulin manufacturers annually report to OCI
information about the number of patients served and amount of insulin dispensed
under the programs and that OCI annually report to the legislature on the programs.
The bill also directs OCI to conduct public outreach and develop an information sheet
about the programs, conduct satisfaction surveys of individuals and pharmacies who
participate in the programs, and report to the legislature on the surveys by July 1,
2024. Additionally, the bill requires that OCI develop a training program for health
care navigators to assist individuals in accessing appropriate long-term insulin
options and maintain a list of trained navigators.
The bill provides that a manufacturer that fails to comply with the bill's
provisions may be assessed a penalty of up to $200,000 per month of noncompliance,
which increases to $400,000 if the manufacturer continues to be in noncompliance
after six months and to $600,000 if the manufacturer continues to be in
noncompliance after one year. The bill's requirements do not apply to manufacturers
with annual insulin sales revenue in Wisconsin of no more than $2,000,000 or to
insulin that costs less than a specified dollar amount.
For further information see the state fiscal estimate, which will be printed as
an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB557,1
1Section
1. 632.868 of the statutes is created to read:
AB557,2,2
2632.868 Insulin safety net programs. (1) Definitions. In this section:
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(a) “Manufacturer" means a person engaged in the manufacturing of insulin
4that 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.
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(e) “Urgent need of insulin" means having less than a 7-day supply of insulin
5readily available for use and needing insulin in order to avoid the likelihood of
6suffering a significant health consequence.
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(f) “Urgent need safety net program” means a program established by a
8manufacturer under sub. (2) (a).
AB557,3,12
9(2) Urgent need safety net program. (a)
Establishment of program. No later
10than July 1, 2022, each manufacturer shall establish an urgent need safety net
11program to make insulin available in accordance with this subsection to individuals
12who meet the eligibility requirements under par. (b).
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(b)
Eligible individual. An individual shall be eligible to receive insulin under
14an urgent need safety net program if all of the following conditions are met:
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1. The individual is in urgent need of insulin.
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2. The individual is a resident of this state.
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3. The individual is not receiving public assistance under ch. 49.
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4. The individual is not enrolled in prescription drug coverage through an
19individual or group health plan that limits the total cost sharing amount, including
20copayments, deductibles, and coinsurance, that an enrollee is required to pay for a
2130-day supply of insulin to no more than $75, regardless of the type or amount of
22insulin prescribed.
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5. The individual has not received insulin under an urgent need safety net
24program within the previous 12 months, except as allowed under par. (d).
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1(c)
Provision of insulin under an urgent need safety net program. 1. In order
2to receive insulin under an urgent need safety net program, an individual who meets
3the eligibility requirements under par. (b) shall provide a pharmacy with all of the
4following:
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a. A completed application, on a form prescribed by the commissioner that shall
6include an attestation by the individual, or the individual's parent or legal guardian
7if the individual is under the age of 18, that the individual meets all of the eligibility
8requirements under par. (b).
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b. A valid insulin prescription.
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c. A valid Wisconsin driver's license or state identification card. If the
11individual is under the age of 18, the individual's parent or legal guardian shall meet
12this requirement.
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2. Upon receipt of the information described in subd. 1. a. to c., the pharmacist
14shall dispense a 30-day supply of the prescribed insulin to the individual. The
15pharmacy shall also provide the individual with the information sheet described in
16sub. (8) (b) 2. and the list of navigators described in sub. (8) (c). The pharmacy may
17collect a copayment, not to exceed $35, from the individual to cover the pharmacy's
18costs of processing and dispensing the insulin. The pharmacy shall notify the health
19care practitioner who issued the prescription no later than 72 hours after the insulin
20is dispensed.
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3. A pharmacy that dispenses insulin under subd. 2. may submit to the
22manufacturer, or the manufacturer's vendor, a claim for payment that is in
23accordance with the national council for prescription drug programs' standards for
24electronic claims processing, except that no claim may be submitted if the
25manufacturer agrees to send the pharmacy a replacement of the same insulin in the
1amount dispensed. If the pharmacy submits an electronic claim, the manufacturer
2or vendor shall reimburse the pharmacy in an amount that covers the pharmacy's
3acquisition cost.
AB557,5,54
4. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the
5application form described in subd. 1. a.
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(d)
Eligibility of certain individuals. An individual who has applied for public
7assistance under ch. 49 but for whom a determination of eligibility has not been made
8or whose coverage has not become effective or an individual who has an appeal
9pending under sub. (3) c. 4. may access insulin under this subsection if the individual
10is in urgent need of insulin. To access a 30-day supply of insulin, the individual shall
11attest to the pharmacy that the individual is described in this paragraph and comply
12with par. (c) 1.
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13(3) Patient assistance program. (a)
Establishment of program. No later than
14July 1, 2022, each manufacturer shall establish a patient assistance program to
15make insulin available in accordance with this subsection to individuals who meet
16the eligibility requirements under par. (b). Under the program, the manufacturer
17shall do all of the following:
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1. Provide the commissioner with information regarding the program,
19including contact information for individuals to call for assistance in accessing the
20program.
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2. Provide a hotline for individuals to call or access between 8 a.m. and 10 p.m.
22on weekdays and between 10 a.m. and 6 p.m. on Saturdays.
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3. List the eligibility requirements under par. (b) on the manufacturer's
24Internet site.
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14. Maintain the privacy of all information received from an individual applying
2for or participating in the program and not sell, share, or disseminate the
3information unless required under this section or authorized, in writing, by the
4individual.
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(b)
Eligible individual. An individual shall be eligible to receive insulin under
6a patient assistance program if all of the following conditions are met:
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1. The individual is a resident of this state.
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2. The individual, or the individual's parent or legal guardian if the individual
9is under the age of 18, has a valid Wisconsin driver's license or state identification
10card.
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3. The individual has a valid insulin prescription.
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4. The family income of the individual does not exceed 400 percent of the
13poverty line as defined and revised annually under
42 USC 9902 (2) for a family the
14size of the individual's family,
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5. The individual is not receiving public assistance under ch. 49.
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6. The individual is not eligible to receive health care through a federally
17funded program or receive prescription drug benefits through the U.S. department
18of veterans affairs, except that this subdivision does not apply to an individual who
19is enrolled in a policy under Part D of Medicare under
42 USC 1395w-101 et seq. if
20the individual has spent at least $1,000 on prescription drugs in the current calendar
21year.
AB557,7,222
7. The individual is not enrolled in prescription drug coverage through an
23individual or group health plan that limits the total cost sharing amount, including
24copayments, deductibles, and coinsurance, that an enrollee is required to pay for a
130-day supply of insulin to no more than $75, regardless of the type or amount of
2insulin needed.
AB557,7,113
(c)
Application for patient assistance program. 1. An individual may apply to
4participate in a patient assistance program by filing an application with the
5manufacturer who established the program, the individual's health care practitioner
6if the practitioner participates in the program, or a navigator included on the list
7under sub. (8) (c).
A health care practitioner or navigator shall immediately submit
8the application to the manufacturer. Upon receipt of an application, the
9manufacturer shall determine the individual's eligibility under par. (b) and, except
10as provided in subd. 2., notify the individual of the determination no later than 10
11days after receipt of the application.
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2. If necessary to determine the individual's eligibility under par. (b), the
13manufacturer may request additional information from an individual who has filed
14an application under subd. 1. no later than 5 days after receipt of the application.
15Upon receipt of the additional information, the manufacturer shall determine the
16individual's eligibility under par. (b) and notify the individual of the determination
17no later than 3 days after receipt of the requested information.
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3. Except as provided in subd. 5., if the manufacturer determines under subd.
191. or 2. that the individual is eligible for the patient assistance program, the
20manufacturer shall provide the individual with a statement of eligibility. The
21statement of eligibility shall be valid for 12 months and may be renewed upon a
22determination by the manufacturer that the individual continues to meet the
23eligibility requirements of par. (b).
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4. If the manufacturer determines under subd. 1. or 2. that the individual is not
25eligible for the patient assistance program, the manufacturer shall provide the
1reason for the determination in the notification under subd. 1. or 2. The individual
2may appeal the determination by filing an appeal with the commissioner that shall
3include all of the information provided to the manufacturer under subds. 1. and 2.
4The commissioner shall establish procedures for deciding appeals under this
5subdivision. The commissioner shall issue a decision no later than 10 days after the
6appeal is filed, and the commissioner's decision shall be final. If the commissioner
7determines that the individual meets the eligibility requirements under par. (b), the
8manufacturer shall provide the individual with the statement of eligibility described
9in subd. 3.
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5. In the case of an individual who has prescription drug coverage through an
11individual or group health plan,
if the manufacturer determines under subd. 1. or 2.
12that the individual is eligible for the patient assistance program but also determines
13that the individual's insulin needs are better addressed through the use of the
14manufacturer's copayment assistance program rather than the patient assistance
15program, the manufacturer shall inform the individual of the determination and
16provide the individual with the necessary coupons to submit to a pharmacy. The
17individual may not be required to pay more than the copayment amount specified in
18par. (d) 2.
AB557,8,2519
(d)
Provision of insulin under a patient assistance program. 1. Upon receipt
20from an individual of the eligibility statement described in par. (c) 3. and a valid
21insulin prescription, a pharmacy shall submit an order containing the name of the
22insulin and daily dosage amount to the manufacturer. The pharmacy shall include
23with the order the pharmacy's name, shipping address, office telephone number, fax
24number, electronic mail address, and contact name, as well as any days or times
25when deliveries are not accepted by the pharmacy.
AB557,9,9
12. Upon receipt of an order meeting the requirements under subd. 1., the
2manufacturer shall send the pharmacy a 90-day supply of insulin, or lesser amount
3if requested in the order, at no charge to the individual or pharmacy. The pharmacy
4shall dispense the insulin to the individual associated with the order. The insulin
5shall be dispensed at no charge to the individual, except that the pharmacy may
6collect a copayment from the individual to cover the pharmacy's costs for processing
7and dispensing in an amount not to exceed $50 for each 90-day supply of insulin.
8The pharmacy may not seek reimbursement from the manufacturer or a 3rd-party
9payer.
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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: