AB50-ASA2-AA16,60,8
1(3) Affordability challenge. When conducting an affordability review of a 2prescription drug product under sub. (2), the board shall determine whether use of 3the prescription drug product that is fully consistent with the labeling approved by 4the federal food and drug administration or standard medical practice has led or 5will lead to an affordability challenge for the health care system in this state, 6including high out-of-pocket costs for patients. To the extent practicable, in 7determining whether a prescription drug product has led or will lead to an 8affordability challenge, the board shall consider all of the following factors: AB50-ASA2-AA16,60,109(a) The wholesale acquisition cost for the prescription drug product sold in 10this state. AB50-ASA2-AA16,60,1411(b) The average monetary price concession, discount, or rebate the 12manufacturer provides, or is expected to provide, to health plans in this state as 13reported by manufacturers and health plans, expressed as a percentage of the 14wholesale acquisition cost for the prescription drug product under review. AB50-ASA2-AA16,60,1815(c) The total amount of the price concessions, discounts, and rebates the 16manufacturer provides to each pharmacy benefit manager for the prescription drug 17product under review, as reported by the manufacturer and pharmacy benefit 18manager and expressed as a percentage of the wholesale acquisition cost. AB50-ASA2-AA16,60,2019(d) The price at which therapeutic alternatives to the prescription drug 20product have been sold in this state. AB50-ASA2-AA16,60,2321(e) The average monetary concession, discount, or rebate the manufacturer 22provides or is expected to provide to health plan payors and pharmacy benefit 23managers in this state for therapeutic alternatives to the prescription drug product. AB50-ASA2-AA16,61,3
1(f) The costs to health plans based on patient access consistent with labeled 2indications by the federal food and drug administration and recognized standard 3medical practice. AB50-ASA2-AA16,61,54(g) The impact on patient access resulting from the cost of the prescription 5drug product relative to insurance benefit design. AB50-ASA2-AA16,61,76(h) The current or expected dollar value of drug-specific patient access 7programs that are supported by the manufacturer. AB50-ASA2-AA16,61,108(i) The relative financial impacts to health, medical, or social services costs 9that can be quantified and compared to baseline effects of existing therapeutic 10alternatives to the prescription drug product. AB50-ASA2-AA16,61,1211(j) The average patient copay or other cost sharing for the prescription drug 12product in this state. AB50-ASA2-AA16,61,1313(k) Any information a manufacturer chooses to provide. AB50-ASA2-AA16,61,1414(L) Any other factors as determined by the board by rule. AB50-ASA2-AA16,61,1815(4) Upper payment limit. (a) If the board determines under sub. (3) that use 16of a prescription drug product has led or will lead to an affordability challenge, the 17board shall establish an upper payment limit for the prescription drug product after 18considering all of the following: AB50-ASA2-AA16,61,19191. The cost of administering the drug. AB50-ASA2-AA16,61,20202. The cost of delivering the drug to consumers. AB50-ASA2-AA16,61,21213. Other relevant administrative costs related to the drug. AB50-ASA2-AA16,62,422(b) For a prescription drug product identified in sub. (1) (b) or (d) 2., the board 23shall solicit information from the manufacturer regarding the price increase. To
1the extent that the price increase is not a result of the need for increased 2manufacturing capacity or other effort to improve patient access during a public 3health emergency, the board shall establish an upper payment limit under par. (a) 4that is equal to the cost to consumers prior to the price increase. AB50-ASA2-AA16,62,85(c) 1. The upper payment limit established under this subsection shall apply 6to all purchases and payor reimbursements of the prescription drug product 7dispensed or administered to individuals in this state in person, by mail, or by other 8means. AB50-ASA2-AA16,62,1992. Notwithstanding subd. 1., while state-sponsored and state-regulated 10health plans and health programs shall limit drug reimbursements and drug 11payment to no more than the upper payment limit established under this 12subsection, a plan subject to the Employee Retirement Income Security Act of 1974 13or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse 14more than the upper payment limit. A provider who dispenses and administers a 15prescription drug product in this state to an individual in this state may not bill a 16payor more than the upper payment limit to the patient regardless of whether a 17plan subject to the Employee Retirement Income Security Act of 1974 or Part D of 18Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above 19the upper payment limit. AB50-ASA2-AA16,62,2120(5) Public inspection. Information submitted to the board under this 21section shall be open to public inspection only as provided under ss. 19.31 to 19.39. AB50-ASA2-AA16,63,222(6) No prohibition on marketing. Nothing in this section may be construed 23to prevent a manufacturer from marketing a prescription drug product approved by
1the federal food and drug administration while the prescription drug product is 2under review by the board. AB50-ASA2-AA16,63,73(7) Appeals. A person aggrieved by a decision of the board may request an 4appeal of the decision no later than 30 days after the board makes the 5determination. The board shall hear the appeal and make a final decision no later 6than 60 days after the appeal is requested. A person aggrieved by a final decision of 7the board may petition for judicial review in a court of competent jurisdiction. AB50-ASA2-AA16,63,159(1) Staggered terms for prescription drug affordability review board. 10Notwithstanding the length of terms specified for the members of the prescription 11drug affordability review board under s. 15.735 (1) (b) to (e), 2 of the initial 12members shall be appointed for terms expiring on May 1, 2027; 2 of the initial 13members shall be appointed for terms expiring on May 1, 2028; 2 of the initial 14members shall be appointed for terms expiring on May 1, 2029; and 2 of the initial 15members shall be appointed for terms expiring on May 1, 2030. AB50-ASA2-AA16,63,2017(1) Prescription drug affordability review board. The treatment of ss. 1815.07 (3) (bm) 7., 15.735, 601.78, 601.785, and 601.79 and subch. VI (title) of ch. 601 19and Section 9123 (1) of this act take effect on the first day of the 7th month 20beginning after publication.”. AB50-ASA2-AA16,64,2
1632.869 Reimbursement to federal drug pricing program 2participants. (1) In this section: AB50-ASA2-AA16,64,73(a) “Covered entity” means an entity described in 42 USC 256b (a) (4) (A), (D), 4(E), (J), or (N) that participates in the federal drug pricing program under 42 USC 5256b, a pharmacy of the entity, or a pharmacy contracted with the entity to 6dispense drugs purchased through the federal drug pricing program under 42 USC 7256b. AB50-ASA2-AA16,64,88(b) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c). AB50-ASA2-AA16,64,109(2) No person, including a pharmacy benefit manager or 3rd-party payer, may 10do any of the following: AB50-ASA2-AA16,64,1411(a) Reimburse a covered entity for a drug that is subject to an agreement 12under 42 USC 256b at a rate lower than that paid for the same drug to pharmacies 13that are not covered entities and have a similar prescription volume to that of the 14covered entity. AB50-ASA2-AA16,64,1715(b) Assess a covered entity any fee, charge back, or other adjustment on the 16basis of the covered entity’s participation in the federal drug pricing program under 1742 USC 256b. AB50-ASA2-AA16,64,2018(3) The commissioner may promulgate rules to implement this section and to 19establish minimum reimbursement rates for covered entities and any other entity 20described under 42 USC 256b (a) (4).”. AB50-ASA2-AA16,65,223601.31 (1) (nw) For issuing or renewing a license as a pharmacy services
1administrative organization under s. 632.864, an amount to be set by the 2commissioner by rule. AB50-ASA2-AA16,65,54632.864 Pharmacy services administrative organizations. (1) 5Definitions. In this section: AB50-ASA2-AA16,65,66(a) “Administrative service” means any of the following: AB50-ASA2-AA16,65,771. Assisting with claims. AB50-ASA2-AA16,65,882. Assisting with audits. AB50-ASA2-AA16,65,993. Providing centralized payment. AB50-ASA2-AA16,65,10104. Performing certification in a specialized care program. AB50-ASA2-AA16,65,11115. Providing compliance support. AB50-ASA2-AA16,65,12126. Setting flat fees for generic drugs. AB50-ASA2-AA16,65,13137. Assisting with store layout. AB50-ASA2-AA16,65,14148. Managing inventory. AB50-ASA2-AA16,65,15159. Providing marketing support. AB50-ASA2-AA16,65,171610. Providing management and analysis of payment and drug dispensing 17data. AB50-ASA2-AA16,65,181811. Providing resources for retail cash cards. AB50-ASA2-AA16,65,2119(b) “Independent pharmacy” means a pharmacy operating in this state that is 20licensed under s. 450.06 or 450.065 and is under common ownership with no more 21than 2 other pharmacies. AB50-ASA2-AA16,65,2222(c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c). AB50-ASA2-AA16,66,2
1(d) “Pharmacy services administrative organization” means an entity 2operating in this state that does all of the following: AB50-ASA2-AA16,66,431. Contracts with an independent pharmacy to conduct business with a 3rd-4party payer on the independent pharmacy’s behalf. AB50-ASA2-AA16,66,752. Provides at least one administrative service to an independent pharmacy 6and negotiates and enters into a contract with a 3rd-party payer or pharmacy 7benefit manager on behalf of the independent pharmacy. AB50-ASA2-AA16,66,108(e) “Third-party payer” means an entity, including a plan sponsor, health 9maintenance organization, or insurer, operating in this state that pays or insures 10health, medical, or prescription drug expenses on behalf of beneficiaries. AB50-ASA2-AA16,66,1711(2) Licensure. (a) Beginning on the first day of the 12th month beginning 12after the effective date of this paragraph .... [LRB inserts date], no person may 13operate as a pharmacy services administrative organization without being licensed 14by the commissioner as a pharmacy services administrative organization under this 15subsection. In order to obtain a license under this paragraph, the person shall 16apply to the commissioner in the form and manner prescribed by the commissioner. 17The application for licensure under this paragraph shall include all of the following: AB50-ASA2-AA16,66,19181. The name, address, telephone number, and federal employer identification 19number of the applicant. AB50-ASA2-AA16,66,21202. The name, business address, and telephone number of a contact person for 21the applicant. AB50-ASA2-AA16,66,22223. The fee under s. 601.31 (1) (nw). AB50-ASA2-AA16,66,23234. Evidence of financial responsibility of at least $1,000,000. AB50-ASA2-AA16,67,1
15. Any other information required by the commissioner. AB50-ASA2-AA16,67,32(b) The term of a license issued under par. (a) shall be 2 years from the date of 3issuance. AB50-ASA2-AA16,67,84(c) A license issued under par. (a) may be renewed. Renewal applications shall 5be submitted to the commissioner on a form provided by the commissioner and shall 6include all the items described in par. (a) 1. to 5. A renewal application under this 7paragraph may not be submitted more than 90 days prior to the end of the term of 8the license being renewed. AB50-ASA2-AA16,67,129(3) Disclosure to the commissioner. (a) A pharmacy services 10administrative organization licensed under sub. (2) shall disclose to the 11commissioner the extent of any ownership or control of the pharmacy services 12administrative organization by an entity that does any of the following: AB50-ASA2-AA16,67,13131. Provides pharmacy services. AB50-ASA2-AA16,67,14142. Provides prescription drug or device services. AB50-ASA2-AA16,67,16153. Manufactures, sells, or distributes prescription drugs, biologicals, or 16medical devices. AB50-ASA2-AA16,67,1917(b) A pharmacy services administrative organization licensed under sub. (2) 18shall notify the commissioner in writing within 5 days of any material change in its 19ownership or control relating to an entity described in par. (a). AB50-ASA2-AA16,67,2120(4) Rules. The commissioner may promulgate rules to implement this 21section.”. AB50-ASA2-AA16,68,2
1601.31 (1) (nv) For issuing or renewing a license as a pharmaceutical 2representative under s. 632.863, an amount to be set by the commissioner by rule. AB50-ASA2-AA16,68,54632.863 Pharmaceutical representatives. (1) Definitions. In this 5section: AB50-ASA2-AA16,68,86(a) “Health care professional” means a physician or other health care 7practitioner who is licensed to provide health care services or to prescribe 8pharmaceutical or biologic products. AB50-ASA2-AA16,68,109(b) “Pharmaceutical” means a medication that may legally be dispensed only 10with a valid prescription from a health care professional. AB50-ASA2-AA16,68,1311(c) “Pharmaceutical representative” means an individual who markets or 12promotes pharmaceuticals to health care professionals on behalf of a 13pharmaceutical manufacturer for compensation. AB50-ASA2-AA16,68,2114(2) Licensure. Beginning on the first day of the 12th month beginning after 15the effective date of this subsection .... [LRB inserts date], no individual may act as 16a pharmaceutical representative in this state without being licensed by the 17commissioner as a pharmaceutical representative under this subsection. In order 18to obtain a license under this subsection, the individual shall apply to the 19commissioner in the form and manner prescribed by the commissioner and shall 20pay the fee under s. 601.31 (1) (nv). The term of a license issued under this 21subsection is one year, and the license is renewable. AB50-ASA2-AA16,69,222(3) Display of license. A pharmaceutical representative licensed under sub.
1(2) shall display the pharmaceutical representative’s license during each visit with 2a health care professional. AB50-ASA2-AA16,69,63(4) Enforcement. (a) Any individual who violates this section or any rules 4promulgated under this section shall be fined not less than $1,000 nor more than 5$3,000 for each offense. Each day of continued violation constitutes a separate 6offense. AB50-ASA2-AA16,69,117(b) The commissioner may suspend or revoke the license of a pharmaceutical 8representative who violates this section or any rules promulgated under this 9section. A suspended or revoked license under this paragraph may not be 10reinstated until the pharmaceutical representative remedies all violations related 11to the suspension or revocation and pays all assessed penalties and fees. AB50-ASA2-AA16,69,1412(5) Rules. The commissioner shall promulgate rules to implement this 13section, including rules that require pharmaceutical representatives to complete 14continuing educational coursework as a condition of licensure.”. AB50-ASA2-AA16,69,1917601.31 (1) (mv) For initial issuance or renewal of a license as a pharmacy 18benefit management broker or consultant under s. 628.495, amounts set by the 19commissioner by rule.
/2025/related/amendments/ab50/aa16_asa2_ab50
true
amends
/2025/related/amendments/ab50/aa16_asa2_ab50/9423-3/_4
amends/2025/REG/AB50-ASA2-AA16,64,2
amends/2025/REG/AB50-ASA2-AA16,64,2
section
true