SB553: Bill Text

SB553,7,11 (c) Application for patient assistance program. 1. An individual may apply to participate in a patient assistance program by filing an application with the manufacturer who established the program, the individual's health care practitioner if the practitioner participates in the program, or a navigator included on the list under sub. (8) (c). A health care practitioner or navigator shall immediately submit the application to the manufacturer. Upon receipt of an application, the manufacturer shall determine the individual's eligibility under par. (b) and, except as provided in subd. 2., notify the individual of the determination no later than 10 days after receipt of the application.

SB553,7,17 2. If necessary to determine the individual's eligibility under par. (b), the manufacturer may request additional information from an individual who has filed an application under subd. 1. no later than 5 days after receipt of the application. Upon receipt of the additional information, the manufacturer shall determine the individual's eligibility under par. (b) and notify the individual of the determination no later than 3 days after receipt of the requested information.

SB553,7,23 3. Except as provided in subd. 5., if the manufacturer determines under subd. 1. or 2. that the individual is eligible for the patient assistance program, the manufacturer shall provide the individual with a statement of eligibility. The statement of eligibility shall be valid for 12 months and may be renewed upon a determination by the manufacturer that the individual continues to meet the eligibility requirements of par. (b).

SB553,8,9 4. If the manufacturer determines under subd. 1. or 2. that the individual is not eligible for the patient assistance program, the manufacturer shall provide the reason for the determination in the notification under subd. 1. or 2. The individual may appeal the determination by filing an appeal with the commissioner that shall include all of the information provided to the manufacturer under subds. 1. and 2. The commissioner shall establish procedures for deciding appeals under this subdivision. The commissioner shall issue a decision no later than 10 days after the appeal is filed, and the commissioner's decision shall be final. If the commissioner determines that the individual meets the eligibility requirements under par. (b), the manufacturer shall provide the individual with the statement of eligibility described in subd. 3.

SB553,8,18 5. In the case of an individual who has prescription drug coverage through an individual or group health plan, if the manufacturer determines under subd. 1. or 2. that the individual is eligible for the patient assistance program but also determines that the individual's insulin needs are better addressed through the use of the manufacturer's copayment assistance program rather than the patient assistance program, the manufacturer shall inform the individual of the determination and provide the individual with the necessary coupons to submit to a pharmacy. The individual may not be required to pay more than the copayment amount specified in par. (d) 2.

SB553,8,25 (d) Provision of insulin under a patient assistance program. 1. Upon receipt from an individual of the eligibility statement described in par. (c) 3. and a valid insulin prescription, a pharmacy shall submit an order containing the name of the insulin and daily dosage amount to the manufacturer. The pharmacy shall include with the order the pharmacy's name, shipping address, office telephone number, fax number, electronic mail address, and contact name, as well as any days or times when deliveries are not accepted by the pharmacy.

SB553,9,9 2. Upon receipt of an order meeting the requirements under subd. 1., the manufacturer shall send the pharmacy a 90-day supply of insulin, or lesser amount if requested in the order, at no charge to the individual or pharmacy. The pharmacy shall dispense the insulin to the individual associated with the order. The insulin shall be dispensed at no charge to the individual, except that the pharmacy may collect a copayment from the individual to cover the pharmacy's costs for processing and dispensing in an amount not to exceed $50 for each 90-day supply of insulin. The pharmacy may not seek reimbursement from the manufacturer or a 3rd-party payer.

SB553,9,12 3. The pharmacy may submit a reorder to the manufacturer if the individual's eligibility statement described in par. (c) 3. has not expired. The reorder shall be treated as an order for purposes of subd. 2.

SB553,9,15 4. Notwithstanding subds. 2. and 3., a manufacturer may send the insulin directly to the individual if the manufacturer provides a mail-order service option, in which case the pharmacy may not collect a copayment from the individual.

SB553,9,18 (4) Exceptions. (a) This section does not apply to a manufacturer who shows to the commissioner's satisfaction that the manufacturer's annual gross revenue from insulin sales in this state does not exceed $2,000,000.

SB553,9,23 (b) A manufacturer may not be required to make an insulin product available under sub. (2) or (3) if the wholesale acquisition cost of the insulin product does not exceed $8, as adjusted annually based on the U.S. consumer price index for all urban consumers, U.S. city average, per milliliter or the applicable national council for prescription drug programs' plan billing unit.

SB553,10,3 (5) Confidentiality. All medical information solicited or obtained by any person under this section shall be subject to the applicable provisions of state law relating to confidentiality of medical information, including s. 610.70.

SB553,10,9 (6) Reimbursement prohibition. No person, including a manufacturer, pharmacy, pharmacist, or 3rd-party administrator, as part of participating in an urgent need safety net program or patient assistance program may request or seek, or cause another person to request or seek, any reimbursement or other compensation for which payment may be made in whole or in part under a federal health care program, as defined in 42 USC 1320a-7b (f).

SB553,10,12 (7) Reports. (a) Annually, no later than March 1, each manufacturer shall report to the commissioner all of the following information for the previous calendar year:

SB553,10,14 1. The number of individuals who received insulin under the manufacturer's urgent need safety net program.

SB553,10,17 2. The number of individuals who sought assistance under the manufacturer's patient assistance program and the number of individuals who were determined to be ineligible under sub. (3) (c) 4.

SB553,10,19 3. The wholesale acquisition cost of the insulin provided by the manufacturer through the urgent need safety net program and patient assistance program.

SB553,10,23 (b) Annually, no later than April 1, the commissioner shall submit to the governor and the chief clerk of each house of the legislature, for distribution to the legislature under s. 13.172 (2), a report on the urgent need safety net programs and patient assistance programs that includes all of the following:

SB553,10,24 1. The information provided to the commissioner under par. (a).

SB553,11,2 2. The penalties assessed under sub. (9) during the previous calendar year, including the name of the manufacturer and amount of the penalty.

SB553,11,7 (8) Additional responsibilities of commissioner. (a) Application form. The commissioner shall make the application form described in sub. (2) (c) 1. a. available on the office's Internet site and shall make the form available to pharmacies and health care providers who prescribe or dispense insulin, hospital emergency departments, urgent care clinics, and community health clinics.

SB553,11,10 (b) Public outreach. 1. The commissioner shall conduct public outreach to create awareness of the urgent need safety net programs and patient assistance programs.

SB553,11,12 2. The commissioner shall develop and make available on the office's Internet site an information sheet that contains all of the following information:

SB553,11,14 a. A description of how to access insulin through an urgent need safety net program.

SB553,11,15 b. A description of how to access insulin through a patient assistance program.

SB553,11,17 c. Information on how to contact a navigator for assistance in accessing insulin through an urgent need safety net program or patient assistance program.

SB553,11,19 d. Information on how to contact the commissioner if a manufacturer determines that an individual is not eligible for a patient assistance program.

SB553,11,21 e. A notification that an individual may contact the commissioner for more information or assistance in accessing ongoing affordable insulin options.

SB553,12,3 (c) Navigators. The commissioner shall develop a training program to provide navigators with information and the resources necessary to assist individuals in accessing appropriate long-term insulin options. The commissioner shall compile a list of navigators who have completed the training program and are available to assist individuals in accessing affordable insulin coverage options. The list shall be made available on the office's Internet site and to pharmacies and health care practitioners who dispense and prescribe insulin.

SB553,12,9 (d) Satisfaction surveys. 1. The commissioner shall develop and conduct a satisfaction survey of individuals who have accessed insulin through urgent need safety net programs and patient assistance programs. The survey shall ask whether the individual is still in need of a long-term solution for affordable insulin and shall include questions about the individual's satisfaction with all of the following, if applicable:

SB553,12,10 a. Accessibility to urgent-need insulin.

SB553,12,12 b. Adequacy of the information sheet and list of navigators received from the pharmacy.

SB553,12,13 c. Helpfulness of a navigator.

SB553,12,15 d. Ease of access in applying for a patient assistance program and receiving insulin from the pharmacy under the program.

SB553,12,19 2. The commissioner shall develop and conduct a satisfaction survey of pharmacies that have dispensed insulin through urgent need safety net programs and patient assistance programs. The survey shall include questions about the pharmacy's satisfaction with all of the following, if applicable:

SB553,12,21 a. Timeliness of reimbursement from manufacturers for insulin dispensed by the pharmacy under urgent need safety net programs.

SB553,12,22 b. Ease in submitting insulin orders to manufacturers.

SB553,12,23 c. Timeliness of receiving insulin orders from manufacturers.

SB553,12,25 3. The commissioner may contract with a nonprofit entity to develop and conduct the surveys under subds. 1. and 2. and to evaluate the survey results.

SB553,13,3 4. No later than July 1, 2024, the commissioner shall submit to the governor and the chief clerk of each house of the legislature, for distribution to the legislature under s. 13.172 (2), a report on the results of the surveys under subds. 1. and 2.

SB553,13,8 (9) Penalty. A manufacturer that fails to comply with this section may be assessed a penalty of up to $200,000 per month of noncompliance, with the maximum penalty increasing to $400,000 per month if the manufacturer continues to be in noncompliance after 6 months and increasing to $600,000 per month if the manufacturer continues to be in noncompliance after one year.

SB553,13,9 (End)