SB45,1412,20 (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.

SB45,1412,23 (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.

SB45,1413,8 (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:

SB45,1413,10 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

SB45,1413,14 (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.

SB45,1413,18 (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.

SB45,1413,20 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

SB45,1413,23 (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.

SB45,1414,3 (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.

SB45,1414,5 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

SB45,1414,7 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

SB45,1414,10 (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.

SB45,1414,12 (j) The average patient copay or other cost sharing for the prescription drug product in this state.

SB45,1414,13 (k) Any information a manufacturer chooses to provide.

SB45,1414,14 (L) Any other factors as determined by the board by rule.

SB45,1414,18 (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:

SB45,1414,19 1. The cost of administering the drug.

SB45,1414,20 2. The cost of delivering the drug to consumers.

SB45,1414,21 3. Other relevant administrative costs related to the drug.

SB45,1415,4 (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.

SB45,1415,8 (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.

SB45,1415,19 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.

SB45,1415,21 (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.

SB45,1416,2 (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.

SB45,1416,7 (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.

SB45,2894 Section 2894. 601.83 (1) (a) of the statutes is amended to read:

SB45,1416,21 601.83 (1) (a) The commissioner shall administer a state-based reinsurance program known as the healthcare stability plan in accordance with the specific terms and conditions approved by the federal department of health and human services dated July 29, 2018. Before December 31, 2023, the commissioner may not request from the federal department of health and human services a modification, suspension, withdrawal, or termination of the waiver under 42 USC 18052 under which the healthcare stability plan under this subchapter operates unless legislation has been enacted specifically directing the modification, suspension, withdrawal, or termination. Before December 31, 2023, the commissioner may request renewal, without substantive change, of the waiver under 42 USC 18052 under which the health care stability plan operates in accordance with s. 20.940 (4) unless legislation has been enacted that is contrary to such a renewal request. The commissioner shall comply with applicable timing in and requirements of s. 20.940.

SB45,2895 Section 2895. 601.83 (1) (h) of the statutes is renumbered 601.83 (1) (h) (intro.) and amended to read:

SB45,1417,4 601.83 (1) (h) (intro.) In 2019 and in each subsequent year, the The commissioner may expend no more than $200,000,000 the following amounts from all revenue sources for the healthcare stability plan under this section, unless the joint committee on finance under s. 13.10 governor has increased this amount upon request by the commissioner.: