Amendment AA16-ASA2-AB50

AB50-ASA2-AA16,59,9 (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-AA16,59,14 (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-AA16,59,20 (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-AA16,59,23 (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-AA16,60,8 (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-AA16,60,10 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

AB50-ASA2-AA16,60,14 (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-AA16,60,18 (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-AA16,60,20 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

AB50-ASA2-AA16,60,23 (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-AA16,61,3 (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-AA16,61,5 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

AB50-ASA2-AA16,61,7 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

AB50-ASA2-AA16,61,10 (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-AA16,61,12 (j) The average patient copay or other cost sharing for the prescription drug product in this state.

AB50-ASA2-AA16,61,13 (k) Any information a manufacturer chooses to provide.

AB50-ASA2-AA16,61,14 (L) Any other factors as determined by the board by rule.

AB50-ASA2-AA16,61,18 (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-AA16,61,19 1. The cost of administering the drug.

AB50-ASA2-AA16,61,20 2. The cost of delivering the drug to consumers.

AB50-ASA2-AA16,61,21 3. Other relevant administrative costs related to the drug.

AB50-ASA2-AA16,62,4 (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-AA16,62,8 (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-AA16,62,19 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-AA16,62,21 (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-AA16,63,2 (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-AA16,63,7 (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-AA16,9123 Section 9123. Nonstatutory provisions; Insurance.

AB50-ASA2-AA16,63,15 (1) Staggered terms for prescription drug affordability review board. Notwithstanding the length of terms specified for the members of the prescription drug affordability review board under s. 15.735 (1) (b) to (e), 2 of the initial members shall be appointed for terms expiring on May 1, 2027; 2 of the initial members shall be appointed for terms expiring on May 1, 2028; 2 of the initial members shall be appointed for terms expiring on May 1, 2029; and 2 of the initial members shall be appointed for terms expiring on May 1, 2030.

AB50-ASA2-AA16,9423 Section 9423. Effective dates; Insurance.

AB50-ASA2-AA16,63,20 (1) Prescription drug affordability review board. The treatment of ss. 15.07 (3) (bm) 7., 15.735, 601.78, 601.785, and 601.79 and subch. VI (title) of ch. 601 and Section 9123 (1) of this act take effect on the first day of the 7th month beginning after publication.”.

AB50-ASA2-AA16,63,21 22. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,63,22 “Section 71. 632.869 of the statutes is created to read:

AB50-ASA2-AA16,64,2 632.869 Reimbursement to federal drug pricing program participants. (1) In this section:

AB50-ASA2-AA16,64,7 (a) “Covered entity” means an entity described in 42 USC 256b (a) (4) (A), (D), (E), (J), or (N) that participates in the federal drug pricing program under 42 USC 256b, a pharmacy of the entity, or a pharmacy contracted with the entity to dispense drugs purchased through the federal drug pricing program under 42 USC 256b.

AB50-ASA2-AA16,64,8 (b) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50-ASA2-AA16,64,10 (2) No person, including a pharmacy benefit manager or 3rd-party payer, may do any of the following:

AB50-ASA2-AA16,64,14 (a) Reimburse a covered entity for a drug that is subject to an agreement under 42 USC 256b at a rate lower than that paid for the same drug to pharmacies that are not covered entities and have a similar prescription volume to that of the covered entity.

AB50-ASA2-AA16,64,17 (b) Assess a covered entity any fee, charge back, or other adjustment on the basis of the covered entity’s participation in the federal drug pricing program under 42 USC 256b.

AB50-ASA2-AA16,64,20 (3) The commissioner may promulgate rules to implement this section and to establish minimum reimbursement rates for covered entities and any other entity described under 42 USC 256b (a) (4).”.

AB50-ASA2-AA16,64,21 23. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,64,22 “Section 72. 601.31 (1) (nw) of the statutes is created to read:

AB50-ASA2-AA16,65,2 601.31 (1) (nw) For issuing or renewing a license as a pharmacy services administrative organization under s. 632.864, an amount to be set by the commissioner by rule.

AB50-ASA2-AA16,73 Section 73. 632.864 of the statutes is created to read:

AB50-ASA2-AA16,65,5 632.864 Pharmacy services administrative organizations. (1) Definitions. In this section:

AB50-ASA2-AA16,65,6 (a) “Administrative service” means any of the following:

AB50-ASA2-AA16,65,7 1. Assisting with claims.

AB50-ASA2-AA16,65,8 2. Assisting with audits.

AB50-ASA2-AA16,65,9 3. Providing centralized payment.

AB50-ASA2-AA16,65,10 4. Performing certification in a specialized care program.

AB50-ASA2-AA16,65,11 5. Providing compliance support.

AB50-ASA2-AA16,65,12 6. Setting flat fees for generic drugs.

AB50-ASA2-AA16,65,13 7. Assisting with store layout.

AB50-ASA2-AA16,65,14 8. Managing inventory.

AB50-ASA2-AA16,65,15 9. Providing marketing support.

AB50-ASA2-AA16,65,17 10. Providing management and analysis of payment and drug dispensing data.

AB50-ASA2-AA16,65,18 11. Providing resources for retail cash cards.

AB50-ASA2-AA16,65,21 (b) “Independent pharmacy” means a pharmacy operating in this state that is licensed under s. 450.06 or 450.065 and is under common ownership with no more than 2 other pharmacies.

AB50-ASA2-AA16,65,22 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50-ASA2-AA16,66,2 (d) “Pharmacy services administrative organization” means an entity operating in this state that does all of the following:

AB50-ASA2-AA16,66,4 1. Contracts with an independent pharmacy to conduct business with a 3rd- party payer on the independent pharmacy’s behalf.

AB50-ASA2-AA16,66,7 2. Provides at least one administrative service to an independent pharmacy and negotiates and enters into a contract with a 3rd-party payer or pharmacy benefit manager on behalf of the independent pharmacy.

AB50-ASA2-AA16,66,10 (e) “Third-party payer” means an entity, including a plan sponsor, health maintenance organization, or insurer, operating in this state that pays or insures health, medical, or prescription drug expenses on behalf of beneficiaries.

AB50-ASA2-AA16,66,17 (2) Licensure. (a) Beginning on the first day of the 12th month beginning after the effective date of this paragraph .... [LRB inserts date], no person may operate as a pharmacy services administrative organization without being licensed by the commissioner as a pharmacy services administrative organization under this subsection. In order to obtain a license under this paragraph, the person shall apply to the commissioner in the form and manner prescribed by the commissioner. The application for licensure under this paragraph shall include all of the following:

AB50-ASA2-AA16,66,19 1. The name, address, telephone number, and federal employer identification number of the applicant.

AB50-ASA2-AA16,66,21 2. The name, business address, and telephone number of a contact person for the applicant.

AB50-ASA2-AA16,66,22 3. The fee under s. 601.31 (1) (nw).

AB50-ASA2-AA16,66,23 4. Evidence of financial responsibility of at least $1,000,000.

AB50-ASA2-AA16,67,1 5. Any other information required by the commissioner.

AB50-ASA2-AA16,67,3 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

AB50-ASA2-AA16,67,8 (c) A license issued under par. (a) may be renewed. Renewal applications shall be submitted to the commissioner on a form provided by the commissioner and shall include all the items described in par. (a) 1. to 5. A renewal application under this paragraph may not be submitted more than 90 days prior to the end of the term of the license being renewed.

AB50-ASA2-AA16,67,12 (3) Disclosure to the commissioner. (a) A pharmacy services administrative organization licensed under sub. (2) shall disclose to the commissioner the extent of any ownership or control of the pharmacy services administrative organization by an entity that does any of the following:

AB50-ASA2-AA16,67,13 1. Provides pharmacy services.

AB50-ASA2-AA16,67,14 2. Provides prescription drug or device services.

AB50-ASA2-AA16,67,16 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

AB50-ASA2-AA16,67,19 (b) A pharmacy services administrative organization licensed under sub. (2) shall notify the commissioner in writing within 5 days of any material change in its ownership or control relating to an entity described in par. (a).

AB50-ASA2-AA16,67,21 (4) Rules. The commissioner may promulgate rules to implement this section.”.

AB50-ASA2-AA16,67,22 24. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,67,23 “Section 74. 601.31 (1) (nv) of the statutes is created to read:

AB50-ASA2-AA16,68,2 601.31 (1) (nv) For issuing or renewing a license as a pharmaceutical representative under s. 632.863, an amount to be set by the commissioner by rule.

AB50-ASA2-AA16,75 Section 75. 632.863 of the statutes is created to read:

AB50-ASA2-AA16,68,5 632.863 Pharmaceutical representatives. (1) Definitions. In this section:

AB50-ASA2-AA16,68,8 (a) “Health care professional” means a physician or other health care practitioner who is licensed to provide health care services or to prescribe pharmaceutical or biologic products.

AB50-ASA2-AA16,68,10 (b) “Pharmaceutical” means a medication that may legally be dispensed only with a valid prescription from a health care professional.

AB50-ASA2-AA16,68,13 (c) “Pharmaceutical representative” means an individual who markets or promotes pharmaceuticals to health care professionals on behalf of a pharmaceutical manufacturer for compensation.

AB50-ASA2-AA16,68,21 (2) Licensure. Beginning on the first day of the 12th month beginning after the effective date of this subsection .... [LRB inserts date], no individual may act as a pharmaceutical representative in this state without being licensed by the commissioner as a pharmaceutical representative under this subsection. In order to obtain a license under this subsection, the individual shall apply to the commissioner in the form and manner prescribed by the commissioner and shall pay the fee under s. 601.31 (1) (nv). The term of a license issued under this subsection is one year, and the license is renewable.

AB50-ASA2-AA16,69,2 (3) Display of license. A pharmaceutical representative licensed under sub. (2) shall display the pharmaceutical representative’s license during each visit with a health care professional.

AB50-ASA2-AA16,69,6 (4) Enforcement. (a) Any individual who violates this section or any rules promulgated under this section shall be fined not less than $1,000 nor more than $3,000 for each offense. Each day of continued violation constitutes a separate offense.

AB50-ASA2-AA16,69,11 (b) The commissioner may suspend or revoke the license of a pharmaceutical representative who violates this section or any rules promulgated under this section. A suspended or revoked license under this paragraph may not be reinstated until the pharmaceutical representative remedies all violations related to the suspension or revocation and pays all assessed penalties and fees.