AB50-ASA2-AA11,16,1715(i) The relative financial impacts to health, medical, or social services costs 16that can be quantified and compared to baseline effects of existing therapeutic 17alternatives to the prescription drug product. AB50-ASA2-AA11,16,1918(j) The average patient copay or other cost sharing for the prescription drug 19product in this state. AB50-ASA2-AA11,16,2020(k) Any information a manufacturer chooses to provide. AB50-ASA2-AA11,16,2121(L) Any other factors as determined by the board by rule. AB50-ASA2-AA11,17,222(4) Upper payment limit. (a) If the board determines under sub. (3) that use 23of a prescription drug product has led or will lead to an affordability challenge, the
1board shall establish an upper payment limit for the prescription drug product after 2considering all of the following: AB50-ASA2-AA11,17,331. The cost of administering the drug. AB50-ASA2-AA11,17,442. The cost of delivering the drug to consumers. AB50-ASA2-AA11,17,553. Other relevant administrative costs related to the drug. AB50-ASA2-AA11,17,116(b) For a prescription drug product identified in sub. (1) (b) or (d) 2., the board 7shall solicit information from the manufacturer regarding the price increase. To 8the extent that the price increase is not a result of the need for increased 9manufacturing capacity or other effort to improve patient access during a public 10health emergency, the board shall establish an upper payment limit under par. (a) 11that is equal to the cost to consumers prior to the price increase. AB50-ASA2-AA11,17,1512(c) 1. The upper payment limit established under this subsection shall apply 13to all purchases and payor reimbursements of the prescription drug product 14dispensed or administered to individuals in this state in person, by mail, or by other 15means. AB50-ASA2-AA11,18,3162. Notwithstanding subd. 1., while state-sponsored and state-regulated 17health plans and health programs shall limit drug reimbursements and drug 18payment to no more than the upper payment limit established under this 19subsection, a plan subject to the Employee Retirement Income Security Act of 1974 20or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse 21more than the upper payment limit. A provider who dispenses and administers a 22prescription drug product in this state to an individual in this state may not bill a 23payor more than the upper payment limit to the patient regardless of whether a
1plan subject to the Employee Retirement Income Security Act of 1974 or Part D of 2Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above 3the upper payment limit. AB50-ASA2-AA11,18,54(5) Public inspection. Information submitted to the board under this 5section shall be open to public inspection only as provided under ss. 19.31 to 19.39. AB50-ASA2-AA11,18,96(6) No prohibition on marketing. Nothing in this section may be construed 7to prevent a manufacturer from marketing a prescription drug product approved by 8the federal food and drug administration while the prescription drug product is 9under review by the board. AB50-ASA2-AA11,18,1410(7) Appeals. A person aggrieved by a decision of the board may request an 11appeal of the decision no later than 30 days after the board makes the 12determination. The board shall hear the appeal and make a final decision no later 13than 60 days after the appeal is requested. A person aggrieved by a final decision of 14the board may petition for judicial review in a court of competent jurisdiction. AB50-ASA2-AA11,18,1816609.83 Coverage of drugs and devices. Limited service health 17organizations, preferred provider plans, and defined network plans are subject to 18ss. 632.853, 632.861, and 632.895 (6) (b), (16t), and (16v). AB50-ASA2-AA11,18,2020632.868 Insulin safety net programs. (1) Definitions. In this section: AB50-ASA2-AA11,18,2221(a) “Manufacturer” means a person engaged in the manufacturing of insulin 22that is self-administered on an outpatient basis. AB50-ASA2-AA11,18,2323(b) “Navigator” has the meaning given in s. 628.90 (3). AB50-ASA2-AA11,19,2
1(c) “Patient assistance program” means a program established by a 2manufacturer under sub. (3) (a). AB50-ASA2-AA11,19,33(d) “Pharmacy” means an entity licensed under s. 450.06 or 450.065. AB50-ASA2-AA11,19,64(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. AB50-ASA2-AA11,19,87(f) “Urgent need safety net program” means a program established by a 8manufacturer under sub. (2) (a). AB50-ASA2-AA11,19,129(2) Urgent need safety net program. (a) Establishment of program. No 10later than July 1, 2026, 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). AB50-ASA2-AA11,19,1413(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: AB50-ASA2-AA11,19,15151. The individual is in urgent need of insulin. AB50-ASA2-AA11,19,16162. The individual is a resident of this state. AB50-ASA2-AA11,19,17173. The individual is not receiving public assistance under ch. 49. AB50-ASA2-AA11,19,22184. 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. AB50-ASA2-AA11,20,2
15. The individual has not received insulin under an urgent need safety net 2program within the previous 12 months, except as allowed under par. (d). AB50-ASA2-AA11,20,63(c) Provision of insulin under an urgent need safety net program. 1. In order 4to receive insulin under an urgent need safety net program, an individual who 5meets the eligibility requirements under par. (b) shall provide a pharmacy with all 6of the following: AB50-ASA2-AA11,20,107a. A completed application, on a form prescribed by the commissioner that 8shall include an attestation by the individual, or the individual’s parent or legal 9guardian if the individual is under the age of 18, that the individual meets all of the 10eligibility requirements under par. (b). AB50-ASA2-AA11,20,1111b. A valid insulin prescription. AB50-ASA2-AA11,20,1412c. A valid Wisconsin driver’s license or state identification card. If the 13individual is under the age of 18, the individual’s parent or legal guardian shall 14meet this requirement. AB50-ASA2-AA11,20,22152. Upon receipt of the information described in subd. 1. a. to c., the pharmacist 16shall dispense a 30-day supply of the prescribed insulin to the individual. The 17pharmacy shall also provide the individual with the information sheet described in 18sub. (8) (b) 2. and the list of navigators described in sub. (8) (c). The pharmacy may 19collect a copayment, not to exceed $35, from the individual to cover the pharmacy’s 20costs of processing and dispensing the insulin. The pharmacy shall notify the 21health care practitioner who issued the prescription no later than 72 hours after the 22insulin is dispensed. AB50-ASA2-AA11,21,7233. A pharmacy that dispenses insulin under subd. 2. may submit to the
1manufacturer, or the manufacturer’s vendor, a claim for payment that is in 2accordance with the national council for prescription drug programs’ standards for 3electronic claims processing, except that no claim may be submitted if the 4manufacturer agrees to send the pharmacy a replacement of the same insulin in 5the amount dispensed. If the pharmacy submits an electronic claim, the 6manufacturer or vendor shall reimburse the pharmacy in an amount that covers 7the pharmacy’s acquisition cost. AB50-ASA2-AA11,21,984. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the 9application form described in subd. 1. a. AB50-ASA2-AA11,21,1610(d) Eligibility of certain individuals. An individual who has applied for public 11assistance under ch. 49 but for whom a determination of eligibility has not been 12made or whose coverage has not become effective or an individual who has an 13appeal pending under sub. (3) (c) 4. may access insulin under this subsection if the 14individual is in urgent need of insulin. To access a 30-day supply of insulin, the 15individual shall attest to the pharmacy that the individual is described in this 16paragraph and comply with par. (c) 1. AB50-ASA2-AA11,21,2117(3) Patient assistance program. (a) Establishment of program. No later 18than July 1, 2026, each manufacturer shall establish a patient assistance program 19to make insulin available in accordance with this subsection to individuals who 20meet the eligibility requirements under par. (b). Under the patient assistance 21program, the manufacturer shall do all of the following: AB50-ASA2-AA11,22,2221. Provide the commissioner with information regarding the patient
1assistance program, including contact information for individuals to call for 2assistance in accessing the patient assistance program. AB50-ASA2-AA11,22,432. Provide a hotline for individuals to call or access between 8 a.m. and 10 p.m. 4on weekdays and between 10 a.m. and 6 p.m. on Saturdays. AB50-ASA2-AA11,22,653. List the eligibility requirements under par. (b) on the manufacturer’s 6website. AB50-ASA2-AA11,22,1074. Maintain the privacy of all information received from an individual 8applying for or participating in the patient assistance program and not sell, share, 9or disseminate the information unless required under this section or authorized, in 10writing, by the individual. AB50-ASA2-AA11,22,1211(b) Eligible individual. An individual shall be eligible to receive insulin under 12a patient assistance program if all of the following conditions are met: AB50-ASA2-AA11,22,13131. The individual is a resident of this state. AB50-ASA2-AA11,22,16142. The individual, or the individual’s parent or legal guardian if the individual 15is under the age of 18, has a valid Wisconsin driver’s license or state identification 16card. AB50-ASA2-AA11,22,17173. The individual has a valid insulin prescription. AB50-ASA2-AA11,22,20184. The family income of the individual does not exceed 400 percent of the 19poverty line as defined and revised annually under 42 USC 9902 (2) for a family the 20size of the individual’s family. AB50-ASA2-AA11,22,21215. The individual is not receiving public assistance under ch. 49. AB50-ASA2-AA11,23,4226. The individual is not eligible to receive health care through a federally 23funded program or receive prescription drug benefits through the U.S. department
1of veterans affairs, except that this subdivision does not apply to an individual who 2is enrolled in a policy under Part D of Medicare under 42 USC 1395w-101 et seq. if 3the individual has spent at least $1,000 on prescription drugs in the current 4calendar year. AB50-ASA2-AA11,23,957. The individual is not enrolled in prescription drug coverage through an 6individual or group health plan that limits the total cost sharing amount, including 7copayments, deductibles, and coinsurance, that an enrollee is required to pay for a 830-day supply of insulin to no more than $75, regardless of the type or amount of 9insulin needed. AB50-ASA2-AA11,23,1910(c) Application for patient assistance program. 1. An individual may apply to 11participate in a patient assistance program by filing an application with the 12manufacturer that established the patient assistance program, the individual’s 13health care practitioner if the practitioner participates in the patient assistance 14program, or a navigator included on the list under sub. (8) (c). A health care 15practitioner or navigator shall immediately submit the application to the 16manufacturer. Upon receipt of an application, the manufacturer shall determine 17the individual’s eligibility under par. (b) and, except as provided in subd. 2., notify 18the individual of the determination no later than 10 days after receipt of the 19application. AB50-ASA2-AA11,24,2202. If necessary to determine the individual’s eligibility under par. (b), the 21manufacturer may request additional information from an individual who has filed 22an application under subd. 1. no later than 5 days after receipt of the application. 23Upon receipt of the additional information, the manufacturer shall determine the
1individual’s eligibility under par. (b) and notify the individual of the determination 2no later than 3 days after receipt of the requested information. AB50-ASA2-AA11,24,833. Except as provided in subd. 5., if the manufacturer determines under subd. 41. or 2. that the individual is eligible for the patient assistance program, the 5manufacturer shall provide the individual with a statement of eligibility. The 6statement of eligibility shall be valid for 12 months and may be renewed upon a 7determination by the manufacturer that the individual continues to meet the 8eligibility requirements under par. (b). AB50-ASA2-AA11,24,1994. If the manufacturer determines under subd. 1. or 2. that the individual is 10not eligible for the patient assistance program, the manufacturer shall provide the 11reason for the determination in the notification under subd. 1. or 2. The individual 12may appeal the determination by filing an appeal with the commissioner that shall 13include all of the information provided to the manufacturer under subds. 1. and 2. 14The commissioner shall establish procedures for deciding appeals under this 15subdivision. The commissioner shall issue a decision no later than 10 days after the 16appeal is filed, and the commissioner’s decision shall be final. If the commissioner 17determines that the individual meets the eligibility requirements under par. (b), the 18manufacturer shall provide the individual with the statement of eligibility 19described in subd. 3. AB50-ASA2-AA11,25,5205. In the case of an individual who has prescription drug coverage through an 21individual or group health plan, if the manufacturer determines under subd. 1. or 2. 22that the individual is eligible for the patient assistance program but also 23determines that the individual’s insulin needs are better addressed through the use
1of the manufacturer’s copayment assistance program rather than the patient 2assistance program, the manufacturer shall inform the individual of the 3determination and provide the individual with the necessary coupons to submit to 4a pharmacy. The individual may not be required to pay more than the copayment 5amount specified in par. (d) 2. AB50-ASA2-AA11,25,126(d) Provision of insulin under a patient assistance program. 1. Upon receipt 7from an individual of the eligibility statement described in par. (c) 3. and a valid 8insulin prescription, a pharmacy shall submit an order containing the name of the 9insulin and daily dosage amount to the manufacturer. The pharmacy shall include 10with the order the pharmacy’s name, shipping address, office telephone number, 11fax number, email address, and contact name, as well as any days or times when 12deliveries are not accepted by the pharmacy. AB50-ASA2-AA11,25,21132. Upon receipt of an order meeting the requirements under subd. 1., the 14manufacturer shall send the pharmacy a 90-day supply of insulin, or lesser amount 15if requested in the order, at no charge to the individual or pharmacy. The pharmacy 16shall dispense the insulin to the individual associated with the order. The insulin 17shall be dispensed at no charge to the individual, except that the pharmacy may 18collect a copayment from the individual to cover the pharmacy’s costs for processing 19and dispensing in an amount not to exceed $50 for each 90-day supply of insulin. 20The pharmacy may not seek reimbursement from the manufacturer or a 3rd-party 21payer. AB50-ASA2-AA11,26,2223. The pharmacy may submit a reorder to the manufacturer if the individual’s
1eligibility statement described in par. (c) 3. has not expired. The reorder shall be 2treated as an order for purposes of subd. 2. AB50-ASA2-AA11,26,534. Notwithstanding subds. 2. and 3., a manufacturer may send the insulin 4directly to the individual if the manufacturer provides a mail-order service option, 5in which case the pharmacy may not collect a copayment from the individual. AB50-ASA2-AA11,26,86(4) Exceptions. (a) This section does not apply to a manufacturer that shows 7to the commissioner’s satisfaction that the manufacturer’s annual gross revenue 8from insulin sales in this state does not exceed $2,000,000. AB50-ASA2-AA11,26,139(b) A manufacturer may not be required to make an insulin product available 10under sub. (2) or (3) if the wholesale acquisition cost of the insulin product does not 11exceed $8, as adjusted annually based on the U.S. consumer price index for all 12urban consumers, U.S. city average, per milliliter or the applicable national council 13for prescription drug programs’ plan billing unit. AB50-ASA2-AA11,26,1614(5) Confidentiality. All medical information solicited or obtained by any 15person under this section shall be subject to the applicable provisions of state law 16relating to confidentiality of medical information, including s. 610.70. AB50-ASA2-AA11,26,2217(6) Reimbursement prohibition. No person, including a manufacturer, 18pharmacy, pharmacist, or 3rd-party administrator, as part of participating in an 19urgent need safety net program or patient assistance program may request or seek, 20or cause another person to request or seek, any reimbursement or other 21compensation for which payment may be made in whole or in part under a federal 22health care program, as defined in 42 USC 1320a-7b (f). AB50-ASA2-AA11,27,223(7) Reports. (a) Annually, no later than March 1, each manufacturer shall
1report to the commissioner all of the following information for the previous calendar 2year: AB50-ASA2-AA11,27,431. The number of individuals who received insulin under the manufacturer’s 4urgent need safety net program. AB50-ASA2-AA11,27,752. The number of individuals who sought assistance under the 6manufacturer’s patient assistance program and the number of individuals who 7were determined to be ineligible under sub. (3) (c) 4. AB50-ASA2-AA11,27,983. The wholesale acquisition cost of the insulin provided by the manufacturer 9through the urgent need safety net program and patient assistance program. AB50-ASA2-AA11,27,1310(b) Annually, no later than April 1, the commissioner shall submit to the 11governor and the chief clerk of each house of the legislature, for distribution to the 12legislature under s. 13.172 (2), a report on the urgent need safety net programs and 13patient assistance programs that includes all of the following: AB50-ASA2-AA11,27,14141. The information provided to the commissioner under par. (a). AB50-ASA2-AA11,27,16152. The penalties assessed under sub. (9) during the previous calendar year, 16including the name of the manufacturer and amount of the penalty. AB50-ASA2-AA11,27,2117(8) Additional responsibilities of commissioner. (a) Application form. 18The commissioner shall make the application form described in sub. (2) (c) 1. a. 19available on the office’s website and shall make the form available to pharmacies 20and health care providers who prescribe or dispense insulin, hospital emergency 21departments, urgent care clinics, and community health clinics. AB50-ASA2-AA11,28,222(b) Public outreach. 1. The commissioner shall conduct public outreach to
1create awareness of the urgent need safety net programs and patient assistance 2programs. AB50-ASA2-AA11,28,432. The commissioner shall develop and make available on the office’s website 4an information sheet that contains all of the following information: AB50-ASA2-AA11,28,65a. A description of how to access insulin through an urgent need safety net 6program. AB50-ASA2-AA11,28,87b. A description of how to access insulin through a patient assistance 8program. AB50-ASA2-AA11,28,109c. Information on how to contact a navigator for assistance in accessing 10insulin through an urgent need safety net program or patient assistance program. AB50-ASA2-AA11,28,1211d. Information on how to contact the commissioner if a manufacturer 12determines that an individual is not eligible for a patient assistance program. AB50-ASA2-AA11,28,1413e. A notification that an individual may contact the commissioner for more 14information or assistance in accessing ongoing affordable insulin options. AB50-ASA2-AA11,28,2115(c) Navigators. The commissioner shall develop a training program to provide 16navigators with information and the resources necessary to assist individuals in 17accessing appropriate long-term insulin options. The commissioner shall compile a 18list of navigators that have completed the training program and are available to 19assist individuals in accessing affordable insulin coverage options. The list shall be 20made available on the office’s website and to pharmacies and health care 21practitioners who dispense and prescribe insulin. AB50-ASA2-AA11,29,422(d) Satisfaction surveys. 1. The commissioner shall develop and conduct a 23satisfaction survey of individuals who have accessed insulin through urgent need
1safety net programs and patient assistance programs. The survey shall ask 2whether the individual is still in need of a long-term solution for affordable insulin 3and shall include questions about the individual’s satisfaction with all of the 4following, if applicable: AB50-ASA2-AA11,29,55a. Accessibility to urgent-need insulin. AB50-ASA2-AA11,29,76b. Adequacy of the information sheet and list of navigators received from the 7pharmacy. AB50-ASA2-AA11,29,88c. Helpfulness of a navigator. AB50-ASA2-AA11,29,109d. Ease of access in applying for a patient assistance program and receiving 10insulin from the pharmacy under the patient assistance program. AB50-ASA2-AA11,29,14112. The commissioner shall develop and conduct a satisfaction survey of 12pharmacies that have dispensed insulin through urgent need safety net programs 13and patient assistance programs. The survey shall include questions about the 14pharmacy’s satisfaction with all of the following, if applicable: AB50-ASA2-AA11,29,1615a. Timeliness of reimbursement from manufacturers for insulin dispensed by 16the pharmacy under urgent need safety net programs. AB50-ASA2-AA11,29,1717b. Ease in submitting insulin orders to manufacturers.
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