Amendment AA11-ASA2-AB50

AB50-ASA2-AA11,13,17 (b) A brand name drug or biologic that, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, has a wholesale acquisition cost that has increased by at least $3,000 during a 12-month period.

AB50-ASA2-AA11,13,20 (c) A biosimilar that has a launch wholesale acquisition cost that is not at least 15 percent lower than the referenced brand biologic at the time the biosimilar is launched.

AB50-ASA2-AA11,14,2 (d) A generic drug that has a wholesale acquisition cost, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, that meets all of the following conditions:

AB50-ASA2-AA11,14,8 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the federal food and drug administration, a supply lasting a patient for a period of fewer than 30 days based on the recommended dosage approved for labeling by the federal food and drug administration, or one unit of the drug if the labeling approved by the federal food and drug administration does not recommend a finite dosage.

AB50-ASA2-AA11,14,12 2. Increased by at least 200 percent during the preceding 12-month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the preceding 12 months.

AB50-ASA2-AA11,14,15 (e) Other prescription drug products, including drugs to address public health emergencies, that may create affordability challenges for the health care system and patients in this state.

AB50-ASA2-AA11,14,20 (2) Affordability review. (a) After identifying prescription drug products under sub. (1), the board shall determine whether to conduct an affordability review for each identified prescription drug product by seeking stakeholder input about the prescription drug product and considering the average patient cost share of the prescription drug product.

AB50-ASA2-AA11,15,3 (b) The information used to conduct an affordability review under par. (a) may include any document and research related to the manufacturer’s selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in this state, market competition and context, projected revenue, and the estimated value or cost-effectiveness of the prescription drug product.

AB50-ASA2-AA11,15,6 (c) The failure of a manufacturer to provide the board with information for an affordability review under par. (b) does not affect the authority of the board to conduct the review.

AB50-ASA2-AA11,15,14 (3) Affordability challenge. When conducting an affordability review of a prescription drug product under sub. (2), the board shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the federal food and drug administration or standard medical practice has led or will lead to an affordability challenge for the health care system in this state, including high out-of-pocket costs for patients. To the extent practicable, in determining whether a prescription drug product has led or will lead to an affordability challenge, the board shall consider all of the following factors:

AB50-ASA2-AA11,15,16 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

AB50-ASA2-AA11,15,20 (b) The average monetary price concession, discount, or rebate the manufacturer provides, or is expected to provide, to health plans in this state as reported by manufacturers and health plans, expressed as a percentage of the wholesale acquisition cost for the prescription drug product under review.

AB50-ASA2-AA11,16,2 (c) The total amount of the price concessions, discounts, and rebates the manufacturer provides to each pharmacy benefit manager for the prescription drug product under review, as reported by the manufacturer and pharmacy benefit manager and expressed as a percentage of the wholesale acquisition cost.

AB50-ASA2-AA11,16,4 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

AB50-ASA2-AA11,16,7 (e) The average monetary concession, discount, or rebate the manufacturer provides or is expected to provide to health plan payors and pharmacy benefit managers in this state for therapeutic alternatives to the prescription drug product.

AB50-ASA2-AA11,16,10 (f) The costs to health plans based on patient access consistent with labeled indications by the federal food and drug administration and recognized standard medical practice.

AB50-ASA2-AA11,16,12 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

AB50-ASA2-AA11,16,14 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

AB50-ASA2-AA11,16,17 (i) The relative financial impacts to health, medical, or social services costs that can be quantified and compared to baseline effects of existing therapeutic alternatives to the prescription drug product.

AB50-ASA2-AA11,16,19 (j) The average patient copay or other cost sharing for the prescription drug product in this state.

AB50-ASA2-AA11,16,20 (k) Any information a manufacturer chooses to provide.

AB50-ASA2-AA11,16,21 (L) Any other factors as determined by the board by rule.

AB50-ASA2-AA11,17,2 (4) Upper payment limit. (a) If the board determines under sub. (3) that use of a prescription drug product has led or will lead to an affordability challenge, the board shall establish an upper payment limit for the prescription drug product after considering all of the following:

AB50-ASA2-AA11,17,3 1. The cost of administering the drug.

AB50-ASA2-AA11,17,4 2. The cost of delivering the drug to consumers.

AB50-ASA2-AA11,17,5 3. Other relevant administrative costs related to the drug.

AB50-ASA2-AA11,17,11 (b) For a prescription drug product identified in sub. (1) (b) or (d) 2., the board shall solicit information from the manufacturer regarding the price increase. To the extent that the price increase is not a result of the need for increased manufacturing capacity or other effort to improve patient access during a public health emergency, the board shall establish an upper payment limit under par. (a) that is equal to the cost to consumers prior to the price increase.

AB50-ASA2-AA11,17,15 (c) 1. The upper payment limit established under this subsection shall apply to all purchases and payor reimbursements of the prescription drug product dispensed or administered to individuals in this state in person, by mail, or by other means.

AB50-ASA2-AA11,18,3 2. Notwithstanding subd. 1., while state-sponsored and state-regulated health plans and health programs shall limit drug reimbursements and drug payment to no more than the upper payment limit established under this subsection, a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse more than the upper payment limit. A provider who dispenses and administers a prescription drug product in this state to an individual in this state may not bill a payor more than the upper payment limit to the patient regardless of whether a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above the upper payment limit.

AB50-ASA2-AA11,18,5 (5) Public inspection. Information submitted to the board under this section shall be open to public inspection only as provided under ss. 19.31 to 19.39.

AB50-ASA2-AA11,18,9 (6) No prohibition on marketing. Nothing in this section may be construed to prevent a manufacturer from marketing a prescription drug product approved by the federal food and drug administration while the prescription drug product is under review by the board.

AB50-ASA2-AA11,18,14 (7) Appeals. A person aggrieved by a decision of the board may request an appeal of the decision no later than 30 days after the board makes the determination. The board shall hear the appeal and make a final decision no later than 60 days after the appeal is requested. A person aggrieved by a final decision of the board may petition for judicial review in a court of competent jurisdiction.

AB50-ASA2-AA11,9 Section 9. 609.83 of the statutes is amended to read:

AB50-ASA2-AA11,18,18 609.83 Coverage of drugs and devices. Limited service health organizations, preferred provider plans, and defined network plans are subject to ss. 632.853, 632.861, and 632.895 (6) (b), (16t), and (16v).

AB50-ASA2-AA11,10 Section 10. 632.868 of the statutes is created to read:

AB50-ASA2-AA11,18,20 632.868 Insulin safety net programs. (1) Definitions. In this section:

AB50-ASA2-AA11,18,22 (a) “Manufacturer” means a person engaged in the manufacturing of insulin that is self-administered on an outpatient basis.

AB50-ASA2-AA11,18,23 (b) “Navigator” has the meaning given in s. 628.90 (3).

AB50-ASA2-AA11,19,2 (c) “Patient assistance program” means a program established by a manufacturer under sub. (3) (a).

AB50-ASA2-AA11,19,3 (d) “Pharmacy” means an entity licensed under s. 450.06 or 450.065.

AB50-ASA2-AA11,19,6 (e) “Urgent need of insulin” means having less than a 7-day supply of insulin readily available for use and needing insulin in order to avoid the likelihood of suffering a significant health consequence.

AB50-ASA2-AA11,19,8 (f) “Urgent need safety net program” means a program established by a manufacturer under sub. (2) (a).

AB50-ASA2-AA11,19,12 (2) Urgent need safety net program. (a) Establishment of program. No later than July 1, 2026, each manufacturer shall establish an urgent need safety net program to make insulin available in accordance with this subsection to individuals who meet the eligibility requirements under par. (b).

AB50-ASA2-AA11,19,14 (b) Eligible individual. An individual shall be eligible to receive insulin under an urgent need safety net program if all of the following conditions are met:

AB50-ASA2-AA11,19,15 1. The individual is in urgent need of insulin.

AB50-ASA2-AA11,19,16 2. The individual is a resident of this state.

AB50-ASA2-AA11,19,17 3. The individual is not receiving public assistance under ch. 49.

AB50-ASA2-AA11,19,22 4. The individual is not enrolled in prescription drug coverage through an individual or group health plan that limits the total cost sharing amount, including copayments, deductibles, and coinsurance, that an enrollee is required to pay for a 30-day supply of insulin to no more than $75, regardless of the type or amount of insulin prescribed.

AB50-ASA2-AA11,20,2 5. The individual has not received insulin under an urgent need safety net program within the previous 12 months, except as allowed under par. (d).

AB50-ASA2-AA11,20,6 (c) Provision of insulin under an urgent need safety net program. 1. In order to receive insulin under an urgent need safety net program, an individual who meets the eligibility requirements under par. (b) shall provide a pharmacy with all of the following:

AB50-ASA2-AA11,20,10 a. A completed application, on a form prescribed by the commissioner that shall include an attestation by the individual, or the individual’s parent or legal guardian if the individual is under the age of 18, that the individual meets all of the eligibility requirements under par. (b).

AB50-ASA2-AA11,20,11 b. A valid insulin prescription.

AB50-ASA2-AA11,20,14 c. A valid Wisconsin driver’s license or state identification card. If the individual is under the age of 18, the individual’s parent or legal guardian shall meet this requirement.

AB50-ASA2-AA11,20,22 2. Upon receipt of the information described in subd. 1. a. to c., the pharmacist shall dispense a 30-day supply of the prescribed insulin to the individual. The pharmacy shall also provide the individual with the information sheet described in sub. (8) (b) 2. and the list of navigators described in sub. (8) (c). The pharmacy may collect a copayment, not to exceed $35, from the individual to cover the pharmacy’s costs of processing and dispensing the insulin. The pharmacy shall notify the health care practitioner who issued the prescription no later than 72 hours after the insulin is dispensed.

AB50-ASA2-AA11,21,7 3. A pharmacy that dispenses insulin under subd. 2. may submit to the manufacturer, or the manufacturer’s vendor, a claim for payment that is in accordance with the national council for prescription drug programs’ standards for electronic claims processing, except that no claim may be submitted if the manufacturer agrees to send the pharmacy a replacement of the same insulin in the amount dispensed. If the pharmacy submits an electronic claim, the manufacturer or vendor shall reimburse the pharmacy in an amount that covers the pharmacy’s acquisition cost.

AB50-ASA2-AA11,21,9 4. A pharmacy that dispenses insulin under subd. 2. shall retain a copy of the application form described in subd. 1. a.

AB50-ASA2-AA11,21,16 (d) Eligibility of certain individuals. An individual who has applied for public assistance under ch. 49 but for whom a determination of eligibility has not been made or whose coverage has not become effective or an individual who has an appeal pending under sub. (3) (c) 4. may access insulin under this subsection if the individual is in urgent need of insulin. To access a 30-day supply of insulin, the individual shall attest to the pharmacy that the individual is described in this paragraph and comply with par. (c) 1.

AB50-ASA2-AA11,21,21 (3) Patient assistance program. (a) Establishment of program. No later than July 1, 2026, each manufacturer shall establish a patient assistance program to make insulin available in accordance with this subsection to individuals who meet the eligibility requirements under par. (b). Under the patient assistance program, the manufacturer shall do all of the following:

AB50-ASA2-AA11,22,2 1. Provide the commissioner with information regarding the patient assistance program, including contact information for individuals to call for assistance in accessing the patient assistance program.

AB50-ASA2-AA11,22,4 2. Provide a hotline for individuals to call or access between 8 a.m. and 10 p.m. on weekdays and between 10 a.m. and 6 p.m. on Saturdays.

AB50-ASA2-AA11,22,6 3. List the eligibility requirements under par. (b) on the manufacturer’s website.

AB50-ASA2-AA11,22,10 4. Maintain the privacy of all information received from an individual applying for or participating in the patient assistance program and not sell, share, or disseminate the information unless required under this section or authorized, in writing, by the individual.

AB50-ASA2-AA11,22,12 (b) Eligible individual. An individual shall be eligible to receive insulin under a patient assistance program if all of the following conditions are met:

AB50-ASA2-AA11,22,13 1. The individual is a resident of this state.

AB50-ASA2-AA11,22,16 2. The individual, or the individual’s parent or legal guardian if the individual is under the age of 18, has a valid Wisconsin driver’s license or state identification card.

AB50-ASA2-AA11,22,17 3. The individual has a valid insulin prescription.

AB50-ASA2-AA11,22,20 4. The family income of the individual does not exceed 400 percent of the poverty line as defined and revised annually under 42 USC 9902 (2) for a family the size of the individual’s family.

AB50-ASA2-AA11,22,21 5. The individual is not receiving public assistance under ch. 49.

AB50-ASA2-AA11,23,4 6. The individual is not eligible to receive health care through a federally funded program or receive prescription drug benefits through the U.S. department of veterans affairs, except that this subdivision does not apply to an individual who is enrolled in a policy under Part D of Medicare under 42 USC 1395w-101 et seq. if the individual has spent at least $1,000 on prescription drugs in the current calendar year.

AB50-ASA2-AA11,23,9 7. The individual is not enrolled in prescription drug coverage through an individual or group health plan that limits the total cost sharing amount, including copayments, deductibles, and coinsurance, that an enrollee is required to pay for a 30-day supply of insulin to no more than $75, regardless of the type or amount of insulin needed.

AB50-ASA2-AA11,23,19 (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 that established the patient assistance program, the individual’s health care practitioner if the practitioner participates in the patient assistance 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.

AB50-ASA2-AA11,24,2 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.

AB50-ASA2-AA11,24,8 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 under par. (b).

AB50-ASA2-AA11,24,19 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.

AB50-ASA2-AA11,25,5 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.

AB50-ASA2-AA11,25,12 (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, email address, and contact name, as well as any days or times when deliveries are not accepted by the pharmacy.

AB50-ASA2-AA11,25,21 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.

AB50-ASA2-AA11,26,2 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.

AB50-ASA2-AA11,26,5 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.

AB50-ASA2-AA11,26,8 (4) Exceptions. (a) This section does not apply to a manufacturer that 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.

AB50-ASA2-AA11,26,13 (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.

AB50-ASA2-AA11,26,16 (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.

AB50-ASA2-AA11,26,22 (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).

AB50-ASA2-AA11,27,2 (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:

AB50-ASA2-AA11,27,4 1. The number of individuals who received insulin under the manufacturer’s urgent need safety net program.

AB50-ASA2-AA11,27,7 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.

AB50-ASA2-AA11,27,9 3. The wholesale acquisition cost of the insulin provided by the manufacturer through the urgent need safety net program and patient assistance program.

AB50-ASA2-AA11,27,13 (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:

AB50-ASA2-AA11,27,14 1. The information provided to the commissioner under par. (a).