AB50,1403,1513(d) Develop and implement a registration process for health plans and health 14insurance policies, pharmacies, and health care providers interested in 15participating in the program. AB50,1403,1716(e) Create a publicly accessible source for listing prices of prescription drugs 17imported under the program. AB50,1403,2018(f) Create, publicize, and implement a method of communication to promptly 19answer questions from and address the needs of persons affected by the 20implementation of the program before the program is fully operational. AB50,1403,2221(g) Establish the audit functions under sub. (1) (n) with a timeline to complete 22each audit function every 2 years. AB50,1404,2
1(h) Conduct any other activities determined by the commissioner to be 2important to successful implementation of the program. AB50,1404,43(5) Report. By January 1 and July 1 of each year, the commissioner shall 4submit to the joint committee on finance a report including all of the following: AB50,1404,65(a) A list of prescription drugs included in the prescription drug importation 6program under this section. AB50,1404,97(b) The number of pharmacies, health care providers, and health plans and 8health insurance policies participating in the prescription drug importation 9program under this section. AB50,1404,1410(c) The estimated amount of savings to residents of this state, health plans 11and health insurance policies, and employers resulting from the implementation of 12the prescription drug importation program under this section reported from the 13date of the previous report under this subsection and from the date the program 14was fully operational. AB50,1404,1615(d) Findings of any audit functions under sub. (1) (n) completed since the date 16of the previous report under this subsection. AB50,1404,1817(6) Rule making. The commissioner may promulgate any rules necessary to 18implement this section. AB50,288919Section 2889. 601.59 of the statutes is created to read: AB50,1404,2020601.59 State-based exchange. (1) Definitions. In this section: AB50,1404,2121(a) “Exchange” has the meaning given in 45 CFR 155.20. AB50,1405,222(b) “State-based exchange on the federal platform” means an exchange that is
1described in and meets the requirements of 45 CFR 155.200 (f) and is approved by 2the federal secretary of health and human services under 45 CFR 155.106. AB50,1405,63(c) “State-based exchange without the federal platform” means an exchange, 4other than one described in 45 CFR 155.200 (f), that performs all the functions 5described in 45 CFR 155.200 (a) and is approved by the federal secretary of health 6and human services under 45 CFR 155.106. AB50,1405,137(2) Establishment and operation of state-based exchange. The 8commissioner shall establish and operate an exchange that at first is a state-based 9exchange on the federal platform and then subsequently transitions to a state-10based exchange without the federal platform. The commissioner shall develop 11procedures to address the transition from the state-based exchange on the federal 12platform to the state-based exchange without the federal platform, including the 13circumstances that shall be met in order for the transition to occur. AB50,1405,1614(3) Agreement with federal government. The commissioner may enter 15into any agreement with the federal government necessary to facilitate the 16implementation of this section. AB50,1405,2217(4) User fees. The commissioner shall impose a user fee, as authorized 18under 45 CFR 155.160 (b) (1), on each insurer that offers a health plan through the 19state-based exchange on the federal platform or the state-based exchange without 20the federal platform. The user fee shall be applied at one of the following rates on 21the total monthly premiums charged by an insurer for each policy under the plan for 22which enrollment is through the exchange: AB50,1406,2
1(a) For any plan year for which the commissioner operates a state-based 2exchange on the federal platform, the rate is 0.5 percent. AB50,1406,63(b) For the first 2 plan years for which the commissioner operates a state-4based exchange without the federal platform, the rate is equal to the user fee rate 5the federal department of health and human services specifies under 45 CFR 6156.50 (c) (1) for the federally facilitated exchanges for the applicable plan year. AB50,1406,97(c) Beginning with the 3rd plan year for which the commissioner operates a 8state-based exchange without the federal platform and for each plan year 9thereafter, the rate shall be set by the commissioner by rule. AB50,1406,1110(5) Rules. The commissioner may promulgate rules necessary to implement 11this section. AB50,289012Section 2890. Subchapter VI (title) of chapter 601 [precedes 601.78] of the 13statutes is created to read: AB50,1406,1414CHAPTER 601 AB50,1406,1515SUBCHAPTER VI AB50,1406,1616PRESCRIPTION DRUG AB50,1406,1717AFFORDABILITY REVIEW BOARD AB50,289118Section 2891. 601.78 of the statutes is created to read: AB50,1406,1919601.78 Definitions. In this subchapter: AB50,1406,2120(1) “Biologic” means a drug that is produced or distributed in accordance with 21a biologics license application approved under 21 CFR 601.20. AB50,1406,2322(2) “Biosimilar” means a drug that is produced or distributed in accordance 23with a biologics license application approved under 42 USC 262 (k) (3). AB50,1407,2
1(3) “Board” means the prescription drug affordability review board 2established under s. 15.735 (1). AB50,1407,53(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. AB50,1407,96(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. AB50,1407,1010(6) “Generic drug” means any of the following: AB50,1407,1211(a) A retail drug that is marketed or distributed in accordance with an 12abbreviated new drug application approved under 21 USC 355 (j). AB50,1407,1313(b) An authorized generic drug, as defined in 42 CFR 447.502. AB50,1407,1514(c) A drug that entered the market prior to 1962 and was not originally 15marketed under a new drug application. AB50,1407,1816(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. AB50,1407,1919(8) “Manufacturer” means an entity that does all of the following: AB50,1407,2220(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. AB50,1408,2
1(b) Sets or changes the wholesale acquisition cost of the prescription drug 2product described in par. (a). AB50,1408,33(9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c). AB50,1408,54(10) “Prescription drug product” means a brand name drug, a generic drug, a 5biologic, or a biosimilar. AB50,28926Section 2892. 601.785 of the statutes is created to read: AB50,1408,117601.785 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. AB50,1408,1212(2) Powers and duties. (a) The board shall do all of the following: AB50,1408,15131. 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. AB50,1408,17162. To the extent practicable, access and assess pricing information for 17prescription drug products by doing all of the following: AB50,1408,2018a. Accessing and assessing information from other states by entering into 19memoranda of understanding with other states to which manufacturers report 20pricing information. AB50,1408,2121b. Assessing spending for specific prescription drug products in this state. AB50,1408,2222c. Accessing other available pricing information. AB50,1408,2323(b) The board may do any of the following: AB50,1409,1
11. Promulgate rules for the administration of this subchapter. AB50,1409,622. 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. AB50,1409,97(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). AB50,1409,1310(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. AB50,1409,1614(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. AB50,1409,1917(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. AB50,1409,2120(d) The board may allow expert testimony at any meeting, including when the 21board meets in closed session. AB50,1410,222(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: AB50,1410,431. 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. AB50,1410,752. 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. AB50,1410,118(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. AB50,1410,1512(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. AB50,1410,2016(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. AB50,1410,2321(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. AB50,2893
1Section 2893. 601.79 of the statutes is created to read: AB50,1411,32601.79 Drug cost affordability review. (1) Identification of drugs. 3The board shall identify prescription drug products that are any of the following: AB50,1411,74(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. AB50,1411,118(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. AB50,1411,1412(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. AB50,1411,1815(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: AB50,1412,2191. 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. AB50,1412,632. 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. AB50,1412,97(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. AB50,1412,1410(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. AB50,1412,2015(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. AB50,1412,2321(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. AB50,1413,8
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: AB50,1413,109(a) The wholesale acquisition cost for the prescription drug product sold in 10this state. AB50,1413,1411(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. AB50,1413,1815(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. AB50,1413,2019(d) The price at which therapeutic alternatives to the prescription drug 20product have been sold in this state. AB50,1413,2321(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. AB50,1414,3
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. AB50,1414,54(g) The impact on patient access resulting from the cost of the prescription 5drug product relative to insurance benefit design. AB50,1414,76(h) The current or expected dollar value of drug-specific patient access 7programs that are supported by the manufacturer.
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