AB50-ASA2-AA16,51,135(b) For policies and plans that are affected by a collective bargaining 6agreement containing provisions inconsistent with these sections, the treatment of 7ss. 632.728, 632.746 (1) (a) and (b), (2) (a), (c), (d), and (e), (3) (a) and (d) 1., 2., and 83., (5), and (8) (a) (intro.), 632.748 (2), 632.76 (2) (a) and (ac) 1. and 2., 632.795 (4) 9(a), 632.895 (8) (d), (13m), (14) (a) 1. i., j., and k. to o., (b), (c), and (d) 3., (14m), (16m) 10(b), and (17) (b) 2. and (c), and 632.897 (11) (a) first applies to policy or plan years 11beginning on the effective date of this paragraph or on the day on which the 12collective bargaining agreement is entered into, extended, modified, or renewed, 13whichever is later. AB50-ASA2-AA16,51,2115(1) Coverage of individuals with preexisting conditions, essential 16health benefits, and preventive services. The treatment of ss. 632.728, 17632.746 (1) (a) and (b), (2) (a), (c), (d), and (e), (3) (a) and (d) 1., 2., and 3., (5), and (8) 18(a) (intro.), 632.748 (2), 632.76 (2) (a) and (ac) 1. and 2., 632.795 (4) (a), 632.895 (8) 19(d), (13m), (14) (a) 1. i., j., and k. to o., (b), (c), and (d) 3., (14m), (16m) (b), and (17) (b) 202. and (c), and 632.897 (11) (a) and Section 9323 (1) of this act take effect on the 21first day of the 4th month beginning after publication.”. AB50-ASA2-AA16,52,4
120.145 (1) (g) 5. All moneys received from the regulation of pharmacy benefit 2managers, pharmacy benefit management brokers, pharmacy benefit management 3consultants, pharmacy services administration organizations, and pharmaceutical 4representatives.”. AB50-ASA2-AA16,52,8715.07 (3) (bm) 7. The prescription drug affordability review board shall meet 8at least 4 times each year. AB50-ASA2-AA16,52,121015.735 Same; attached board. (1) There is created a prescription drug 11affordability review board attached to the office of the commissioner of insurance 12under s. 15.03. The board shall consist of the following members: AB50-ASA2-AA16,52,1313(a) The commissioner of insurance or his or her designee. AB50-ASA2-AA16,52,1714(b) Two members appointed for 4-year terms who represent the 15pharmaceutical drug industry, including pharmaceutical drug manufacturers and 16wholesalers. At least one of the members appointed under this paragraph shall be 17a licensed pharmacist. AB50-ASA2-AA16,52,1918(c) Two members appointed for 4-year terms who represent the health 19insurance industry, including insurers and pharmacy benefit managers. AB50-ASA2-AA16,52,2320(d) Two members appointed for 4-year terms who represent the health care 21industry, including hospitals, physicians, pharmacies, and pharmacists. At least 22one of the members appointed under this paragraph shall be a licensed 23practitioner. AB50-ASA2-AA16,53,2
1(e) Two members appointed for 4-year terms who represent the interests of 2the public. AB50-ASA2-AA16,53,53(2) A member appointed under sub. (1), except for a member appointed under 4sub. (1) (b), may not be an employee of, a board member of, or a consultant to a drug 5manufacturer or trade association for drug manufacturers. AB50-ASA2-AA16,53,106(3) Any conflict of interest, including any financial or personal association, 7that has the potential to bias or has the appearance of biasing an individual’s 8decision in matters related to the board or the conduct of the board’s activities shall 9be considered and disclosed when appointing that individual to the board under 10sub. (1). AB50-ASA2-AA16,6711Section 67. Subchapter VI (title) of chapter 601 [precedes 601.78] of the 12statutes is created to read: AB50-ASA2-AA16,53,1616AFFORDABILITY REVIEW BOARD AB50-ASA2-AA16,53,1818601.78 Definitions. In this subchapter: AB50-ASA2-AA16,53,2019(1) “Biologic” means a drug that is produced or distributed in accordance with 20a biologics license application approved under 21 CFR 601.20. AB50-ASA2-AA16,53,2221(2) “Biosimilar” means a drug that is produced or distributed in accordance 22with a biologics license application approved under 42 USC 262 (k) (3). AB50-ASA2-AA16,54,2
1(3) “Board” means the prescription drug affordability review board 2established under s. 15.735 (1). AB50-ASA2-AA16,54,53(4) “Brand name drug” means a drug that is produced or distributed in 4accordance with an original new drug application approved under 21 USC 355 (c), 5other than an authorized generic drug, as defined in 42 CFR 447.502. AB50-ASA2-AA16,54,96(5) “Financial benefit” includes an honorarium, fee, stock, the value of the 7stock holdings of a member of the board or any immediate family member of the 8member of the board, and any direct financial benefit deriving from the finding of a 9review conducted under s. 601.79. AB50-ASA2-AA16,54,1010(6) “Generic drug” means any of the following: AB50-ASA2-AA16,54,1211(a) A retail drug that is marketed or distributed in accordance with an 12abbreviated new drug application approved under 21 USC 355 (j). AB50-ASA2-AA16,54,1313(b) An authorized generic drug, as defined in 42 CFR 447.502. AB50-ASA2-AA16,54,1514(c) A drug that entered the market prior to 1962 and was not originally 15marketed under a new drug application. AB50-ASA2-AA16,54,1816(7) “Immediate family member” means a spouse, grandparent, parent, 17sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent, 18sibling, child, stepchild, or grandchild. AB50-ASA2-AA16,54,1919(8) “Manufacturer” means an entity that does all of the following: AB50-ASA2-AA16,54,2220(a) Engages in the manufacture of a prescription drug product or enters into 21a lease with another entity to market and distribute a prescription drug product 22under the entity’s own name. AB50-ASA2-AA16,55,2
1(b) Sets or changes the wholesale acquisition cost of the prescription drug 2product described in par. (a). AB50-ASA2-AA16,55,33(9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c). AB50-ASA2-AA16,55,54(10) “Prescription drug product” means a brand name drug, a generic drug, a 5biologic, or a biosimilar. AB50-ASA2-AA16,55,117601.785 Prescription drug affordability review board. (1) Mission. 8The purpose of the board is to protect state residents, the state, local governments, 9health plans, health care providers, pharmacies licensed in this state, and other 10stakeholders of the health care system in this state from the high costs of 11prescription drug products. AB50-ASA2-AA16,55,1212(2) Powers and duties. (a) The board shall do all of the following: AB50-ASA2-AA16,55,15131. Meet in open session at least 4 times per year to review prescription drug 14product pricing information in the manner described in subd. 2., except that the 15chairperson may cancel or postpone a meeting if there is no business to transact. AB50-ASA2-AA16,55,17162. To the extent practicable, access and assess pricing information for 17prescription drug products by doing all of the following: AB50-ASA2-AA16,55,2018a. Accessing and assessing information from other states by entering into 19memoranda of understanding with other states to which manufacturers report 20pricing information. AB50-ASA2-AA16,55,2121b. Assessing spending for specific prescription drug products in this state. AB50-ASA2-AA16,55,2222c. Accessing other available pricing information. AB50-ASA2-AA16,55,2323(b) The board may do any of the following: AB50-ASA2-AA16,56,1
11. Promulgate rules for the administration of this subchapter. AB50-ASA2-AA16,56,622. Enter into a contract with an independent 3rd party for any service 3necessary to carry out the powers and duties of the board. Unless written 4permission is granted by the board, any person with whom the board contracts may 5not release, publish, or otherwise use any information to which the person has 6access under the contract. AB50-ASA2-AA16,56,97(c) The board shall establish and maintain a website to provide public notices 8and make meeting materials available under sub. (3) (a) and to disclose conflicts of 9interest under sub. (4) (d). AB50-ASA2-AA16,56,1310(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide 11public notice of each board meeting at least 2 weeks prior to the meeting and shall 12make the materials for each meeting publicly available at least one week prior to 13the meeting. AB50-ASA2-AA16,56,1614(b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for 15public comment at each open meeting and shall provide the public with the 16opportunity to provide written comments on pending decisions of the board. AB50-ASA2-AA16,56,1917(c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board 18concerning proprietary data and information shall be conducted in closed session 19and shall in all respects remain confidential. AB50-ASA2-AA16,56,2120(d) The board may allow expert testimony at any meeting, including when the 21board meets in closed session. AB50-ASA2-AA16,57,222(4) Conflicts of interest. (a) A member of the board shall recuse himself 23or herself from a decision by the board relating to a prescription drug product if the
1member or an immediate family member of the member has received or could 2receive any of the following: AB50-ASA2-AA16,57,431. A direct financial benefit deriving from a determination, or a finding of a 4study or review, by the board relating to the prescription drug product. AB50-ASA2-AA16,57,752. A financial benefit in excess of $5,000 in a calendar year from any person 6who owns, manufactures, or provides a prescription drug product to be studied or 7reviewed by the board. AB50-ASA2-AA16,57,118(b) A conflict of interest under this subsection shall be disclosed by the board 9when hiring board staff, by the appointing authority when appointing members to 10the board, and by the board when a member of the board is recused from any 11decision relating to a review of a prescription drug product. AB50-ASA2-AA16,57,1512(c) A conflict of interest under this subsection shall be disclosed no later than 135 days after the conflict is identified, except that, if the conflict is identified within 145 days of an open meeting of the board, the conflict shall be disclosed prior to the 15meeting. AB50-ASA2-AA16,57,2016(d) The board shall disclose a conflict of interest under this subsection on the 17board’s website unless the chairperson of the board recuses the member from a 18final decision relating to a review of the prescription drug product. The disclosure 19shall include the type, nature, and magnitude of the interests of the member 20involved. AB50-ASA2-AA16,57,2321(e) A member of the board or a 3rd-party contractor may not accept any gift or 22donation of services or property that indicates a potential conflict of interest or has 23the appearance of biasing the work of the board. AB50-ASA2-AA16,58,32601.79 Drug cost affordability review. (1) Identification of drugs. 3The board shall identify prescription drug products that are any of the following: AB50-ASA2-AA16,58,74(a) A brand name drug or biologic that, as adjusted annually to reflect 5adjustments to the U.S. consumer price index for all urban consumers, U.S. city 6average, as determined by the U.S. department of labor, has a launch wholesale 7acquisition cost of at least $30,000 per year or course of treatment. AB50-ASA2-AA16,58,118(b) A brand name drug or biologic that, as adjusted annually to reflect 9adjustments to the U.S. consumer price index for all urban consumers, U.S. city 10average, as determined by the U.S. department of labor, has a wholesale acquisition 11cost that has increased by at least $3,000 during a 12-month period. AB50-ASA2-AA16,58,1412(c) A biosimilar that has a launch wholesale acquisition cost that is not at 13least 15 percent lower than the referenced brand biologic at the time the biosimilar 14is launched. AB50-ASA2-AA16,58,1815(d) A generic drug that has a wholesale acquisition cost, as adjusted annually 16to reflect adjustments to the U.S. consumer price index for all urban consumers, 17U.S. city average, as determined by the U.S. department of labor, that meets all of 18the following conditions: AB50-ASA2-AA16,59,2191. Is at least $100 for a supply lasting a patient for a period of 30 consecutive 20days based on the recommended dosage approved for labeling by the federal food 21and drug administration, a supply lasting a patient for a period of fewer than 30 22days based on the recommended dosage approved for labeling by the federal food
1and drug administration, or one unit of the drug if the labeling approved by the 2federal food and drug administration does not recommend a finite dosage. AB50-ASA2-AA16,59,632. Increased by at least 200 percent during the preceding 12-month period, as 4determined by the difference between the resulting wholesale acquisition cost and 5the average of the wholesale acquisition cost reported over the preceding 12 6months. AB50-ASA2-AA16,59,97(e) Other prescription drug products, including drugs to address public health 8emergencies, that may create affordability challenges for the health care system 9and patients in this state. AB50-ASA2-AA16,59,1410(2) Affordability review. (a) After identifying prescription drug products 11under sub. (1), the board shall determine whether to conduct an affordability 12review for each identified prescription drug product by seeking stakeholder input 13about the prescription drug product and considering the average patient cost share 14of the prescription drug product. AB50-ASA2-AA16,59,2015(b) The information used to conduct an affordability review under par. (a) may 16include any document and research related to the manufacturer’s selection of the 17introductory price or price increase of the prescription drug product, including life 18cycle management, net average price in this state, market competition and context, 19projected revenue, and the estimated value or cost-effectiveness of the prescription 20drug product. AB50-ASA2-AA16,59,2321(c) The failure of a manufacturer to provide the board with information for an 22affordability review under par. (b) does not affect the authority of the board to 23conduct the review. 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:
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