AB50-ASA2-AA8,136,431. Maintains a formulary and claims payment system with current 4information on prescription drugs imported under the program. AB50-ASA2-AA8,136,752. Bases cost-sharing amounts for participants or insureds under the plan or 6policy on no more than the actual acquisition cost of the prescription drug imported 7under the program that is dispensed to the participant or insured. AB50-ASA2-AA8,136,1083. Demonstrates to the commissioner or a state agency designated by the 9commissioner how premiums under the plan or policy are affected by savings on 10prescription drugs imported under the program. AB50-ASA2-AA8,136,1311(j) Any wholesale distributor importing prescription drugs under the program 12shall limit its profit margin to the amount established by the commissioner or a 13state agency designated by the commissioner. AB50-ASA2-AA8,136,1514(k) The program may not import any generic prescription drug that would 15violate federal patent laws on branded products in the United States. AB50-ASA2-AA8,136,2016(L) The program shall comply with tracking and tracing requirements of 21 17USC 360eee and 360eee-1, to the extent practical and feasible, before the 18prescription drug to be imported comes into the possession of this state’s wholesale 19distributor and fully after the prescription drug to be imported is in the possession 20of this state’s wholesale distributor. AB50-ASA2-AA8,136,2221(m) The program shall establish a fee or other mechanism to finance the 22program that does not jeopardize significant savings to residents of this state. AB50-ASA2-AA8,136,2323(n) The program shall have an audit function that ensures all of the following: AB50-ASA2-AA8,137,2
11. The commissioner has a sound methodology to determine the most cost-2effective prescription drugs to include in the program. AB50-ASA2-AA8,137,432. The commissioner has a process in place to select Canadian suppliers that 4are high quality, high performing, and in full compliance with Canadian laws. AB50-ASA2-AA8,137,653. Prescription drugs imported under the program are pure, unadulterated, 6potent, and safe. AB50-ASA2-AA8,137,774. The program is complying with the requirements of this subsection. AB50-ASA2-AA8,137,985. The program is adequately financed to support administrative functions of 9the program while generating significant cost savings to residents of this state. AB50-ASA2-AA8,137,11106. The program does not put residents of this state at a higher risk than if the 11program did not exist. AB50-ASA2-AA8,137,13127. The program provides and is projected to continue to provide substantial 13cost savings to residents of this state. AB50-ASA2-AA8,137,1614(2) Anticompetitive behavior. The commissioner, in consultation with the 15attorney general, shall identify the potential for and monitor anticompetitive 16behavior in industries affected by a prescription drug importation program. AB50-ASA2-AA8,138,317(3) Approval of program design; certification. No later than the first day 18of the 7th month beginning after the effective date of this subsection .... [LRB 19inserts date], the commissioner shall submit to the joint committee on finance a 20report that includes the design of the prescription drug importation program in 21accordance with this section. The commissioner may not submit the proposed 22program to the federal department of health and human services unless the joint 23committee on finance approves the proposed program. Within 14 days of the date of
1approval by the joint committee on finance of the proposed program, the 2commissioner shall submit to the federal department of health and human services 3a request for certification of the approved program. AB50-ASA2-AA8,138,114(4) Implementation of certified program. After the federal department of 5health and human services certifies the prescription drug importation program 6submitted under sub. (3), the commissioner shall begin implementation of the 7program, and the program shall be fully operational by 180 days after the date of 8certification by the federal department of health and human services. The 9commissioner shall do all of the following to implement the program to the extent 10the action is in accordance with other state laws and the certification by the federal 11department of health and human services: AB50-ASA2-AA8,138,1412(a) Become a licensed wholesale distributor, designate another state agency to 13become a licensed wholesale distributor, or contract with a licensed wholesale 14distributor. AB50-ASA2-AA8,138,1615(b) Contract with one or more Canadian suppliers that meet the criteria in 16sub. (1) (c) and (n). AB50-ASA2-AA8,138,1917(c) Create an outreach and marketing plan to communicate with and provide 18information to health plans and health insurance policies, employers, pharmacies, 19health care providers, and residents of this state on participating in the program. AB50-ASA2-AA8,138,2220(d) Develop and implement a registration process for health plans and health 21insurance policies, pharmacies, and health care providers interested in 22participating in the program. AB50-ASA2-AA8,139,2
1(e) Create a publicly accessible source for listing prices of prescription drugs 2imported under the program. AB50-ASA2-AA8,139,53(f) Create, publicize, and implement a method of communication to promptly 4answer questions from and address the needs of persons affected by the 5implementation of the program before the program is fully operational. AB50-ASA2-AA8,139,76(g) Establish the audit functions under sub. (1) (n) with a timeline to complete 7each audit function every 2 years. AB50-ASA2-AA8,139,98(h) Conduct any other activities determined by the commissioner to be 9important to successful implementation of the program. AB50-ASA2-AA8,139,1110(5) Report. By January 1 and July 1 of each year, the commissioner shall 11submit to the joint committee on finance a report including all of the following: AB50-ASA2-AA8,139,1312(a) A list of prescription drugs included in the prescription drug importation 13program under this section. AB50-ASA2-AA8,139,1614(b) The number of pharmacies, health care providers, and health plans and 15health insurance policies participating in the prescription drug importation 16program under this section. AB50-ASA2-AA8,139,2117(c) The estimated amount of savings to residents of this state, health plans 18and health insurance policies, and employers resulting from the implementation of 19the prescription drug importation program under this section reported from the 20date of the previous report under this subsection and from the date the program 21was fully operational. AB50-ASA2-AA8,139,2322(d) Findings of any audit functions under sub. (1) (n) completed since the date 23of the previous report under this subsection. AB50-ASA2-AA8,140,2
1(6) Rulemaking. The commissioner may promulgate any rules necessary to 2implement this section. AB50-ASA2-AA8,2673Section 267. Subchapter VI (title) of chapter 601 [precedes 601.78] of the 4statutes is created to read: AB50-ASA2-AA8,140,88AFFORDABILITY REVIEW BOARD AB50-ASA2-AA8,140,1010601.78 Definitions. In this subchapter: AB50-ASA2-AA8,140,1211(1) “Biologic” means a drug that is produced or distributed in accordance with 12a biologics license application approved under 21 CFR 601.20. AB50-ASA2-AA8,140,1413(2) “Biosimilar” means a drug that is produced or distributed in accordance 14with a biologics license application approved under 42 USC 262 (k) (3). AB50-ASA2-AA8,140,1615(3) “Board” means the prescription drug affordability review board 16established under s. 15.735 (1). AB50-ASA2-AA8,140,1917(4) “Brand name drug” means a drug that is produced or distributed in 18accordance with an original new drug application approved under 21 USC 355 (c), 19other than an authorized generic drug, as defined in 42 CFR 447.502. AB50-ASA2-AA8,140,2320(5) “Financial benefit” includes an honorarium, fee, stock, the value of the 21stock holdings of a member of the board or any immediate family member of the 22member of the board, and any direct financial benefit deriving from the finding of a 23review conducted under s. 601.79. AB50-ASA2-AA8,141,1
1(6) “Generic drug” means any of the following: AB50-ASA2-AA8,141,32(a) A retail drug that is marketed or distributed in accordance with an 3abbreviated new drug application approved under 21 USC 355 (j). AB50-ASA2-AA8,141,44(b) An authorized generic drug, as defined in 42 CFR 447.502. AB50-ASA2-AA8,141,65(c) A drug that entered the market prior to 1962 and was not originally 6marketed under a new drug application. AB50-ASA2-AA8,141,97(7) “Immediate family member” means a spouse, grandparent, parent, 8sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent, 9sibling, child, stepchild, or grandchild. AB50-ASA2-AA8,141,1010(8) “Manufacturer” means an entity that does all of the following: AB50-ASA2-AA8,141,1311(a) Engages in the manufacture of a prescription drug product or enters into 12a lease with another entity to market and distribute a prescription drug product 13under the entity’s own name. AB50-ASA2-AA8,141,1514(b) Sets or changes the wholesale acquisition cost of the prescription drug 15product described in par. (a). AB50-ASA2-AA8,141,1616(9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c). AB50-ASA2-AA8,141,1817(10) “Prescription drug product” means a brand name drug, a generic drug, a 18biologic, or a biosimilar. AB50-ASA2-AA8,142,220601.785 Prescription drug affordability review board. (1) Mission. 21The purpose of the board is to protect state residents, the state, local governments, 22health plans, health care providers, pharmacies licensed in this state, and other
1stakeholders of the health care system in this state from the high costs of 2prescription drug products. AB50-ASA2-AA8,142,33(2) Powers and duties. (a) The board shall do all of the following: AB50-ASA2-AA8,142,641. Meet in open session at least 4 times per year to review prescription drug 5product pricing information in the manner described in subd. 2., except that the 6chairperson may cancel or postpone a meeting if there is no business to transact. AB50-ASA2-AA8,142,872. To the extent practicable, access and assess pricing information for 8prescription drug products by doing all of the following: AB50-ASA2-AA8,142,119a. Accessing and assessing information from other states by entering into 10memoranda of understanding with other states to which manufacturers report 11pricing information. AB50-ASA2-AA8,142,1212b. Assessing spending for specific prescription drug products in this state. AB50-ASA2-AA8,142,1313c. Accessing other available pricing information. AB50-ASA2-AA8,142,1414(b) The board may do any of the following: AB50-ASA2-AA8,142,15151. Promulgate rules for the administration of this subchapter. AB50-ASA2-AA8,142,20162. Enter into a contract with an independent 3rd party for any service 17necessary to carry out the powers and duties of the board. Unless written 18permission is granted by the board, any person with whom the board contracts may 19not release, publish, or otherwise use any information to which the person has 20access under the contract. AB50-ASA2-AA8,142,2321(c) The board shall establish and maintain a website to provide public notices 22and make meeting materials available under sub. (3) (a) and to disclose conflicts of 23interest under sub. (4) (d). AB50-ASA2-AA8,143,4
1(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide 2public notice of each board meeting at least 2 weeks prior to the meeting and shall 3make the materials for each meeting publicly available at least one week prior to 4the meeting. AB50-ASA2-AA8,143,75(b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for 6public comment at each open meeting and shall provide the public with the 7opportunity to provide written comments on pending decisions of the board. AB50-ASA2-AA8,143,108(c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board 9concerning proprietary data and information shall be conducted in closed session 10and shall in all respects remain confidential. AB50-ASA2-AA8,143,1211(d) The board may allow expert testimony at any meeting, including when the 12board meets in closed session. AB50-ASA2-AA8,143,1613(4) Conflicts of interest. (a) A member of the board shall recuse himself 14or herself from a decision by the board relating to a prescription drug product if the 15member or an immediate family member of the member has received or could 16receive any of the following: AB50-ASA2-AA8,143,18171. A direct financial benefit deriving from a determination, or a finding of a 18study or review, by the board relating to the prescription drug product. AB50-ASA2-AA8,143,21192. A financial benefit in excess of $5,000 in a calendar year from any person 20who owns, manufactures, or provides a prescription drug product to be studied or 21reviewed by the board. AB50-ASA2-AA8,144,222(b) A conflict of interest under this subsection shall be disclosed by the board 23when hiring board staff, by the appointing authority when appointing members to
1the board, and by the board when a member of the board is recused from any 2decision relating to a review of a prescription drug product. AB50-ASA2-AA8,144,63(c) A conflict of interest under this subsection shall be disclosed no later than 45 days after the conflict is identified, except that, if the conflict is identified within 55 days of an open meeting of the board, the conflict shall be disclosed prior to the 6meeting. AB50-ASA2-AA8,144,117(d) The board shall disclose a conflict of interest under this subsection on the 8board’s website unless the chairperson of the board recuses the member from a 9final decision relating to a review of the prescription drug product. The disclosure 10shall include the type, nature, and magnitude of the interests of the member 11involved. AB50-ASA2-AA8,144,1412(e) A member of the board or a 3rd-party contractor may not accept any gift or 13donation of services or property that indicates a potential conflict of interest or has 14the appearance of biasing the work of the board. AB50-ASA2-AA8,144,1716601.79 Drug cost affordability review. (1) Identification of drugs. 17The board shall identify prescription drug products that are any of the following: AB50-ASA2-AA8,144,2118(a) A brand name drug or biologic that, as adjusted annually to reflect 19adjustments to the U.S. consumer price index for all urban consumers, U.S. city 20average, as determined by the U.S. department of labor, has a launch wholesale 21acquisition cost of at least $30,000 per year or course of treatment. AB50-ASA2-AA8,145,222(b) A brand name drug or biologic that, as adjusted annually to reflect 23adjustments to the U.S. consumer price index for all urban consumers, U.S. city
1average, as determined by the U.S. department of labor, has a wholesale acquisition 2cost that has increased by at least $3,000 during a 12-month period. AB50-ASA2-AA8,145,53(c) A biosimilar that has a launch wholesale acquisition cost that is not at 4least 15 percent lower than the referenced brand biologic at the time the biosimilar 5is launched. AB50-ASA2-AA8,145,96(d) A generic drug that has a wholesale acquisition cost, as adjusted annually 7to reflect adjustments to the U.S. consumer price index for all urban consumers, 8U.S. city average, as determined by the U.S. department of labor, that meets all of 9the following conditions: AB50-ASA2-AA8,145,15101. Is at least $100 for a supply lasting a patient for a period of 30 consecutive 11days based on the recommended dosage approved for labeling by the federal food 12and drug administration, a supply lasting a patient for a period of fewer than 30 13days based on the recommended dosage approved for labeling by the federal food 14and drug administration, or one unit of the drug if the labeling approved by the 15federal food and drug administration does not recommend a finite dosage. AB50-ASA2-AA8,145,19162. Increased by at least 200 percent during the preceding 12-month period, as 17determined by the difference between the resulting wholesale acquisition cost and 18the average of the wholesale acquisition cost reported over the preceding 12 19months. AB50-ASA2-AA8,145,2220(e) Other prescription drug products, including drugs to address public health 21emergencies, that may create affordability challenges for the health care system 22and patients in this state. AB50-ASA2-AA8,146,423(2) Affordability review. (a) After identifying prescription drug products
1under sub. (1), the board shall determine whether to conduct an affordability 2review for each identified prescription drug product by seeking stakeholder input 3about the prescription drug product and considering the average patient cost share 4of the prescription drug product. AB50-ASA2-AA8,146,105(b) The information used to conduct an affordability review under par. (a) may 6include any document and research related to the manufacturer’s selection of the 7introductory price or price increase of the prescription drug product, including life 8cycle management, net average price in this state, market competition and context, 9projected revenue, and the estimated value or cost-effectiveness of the prescription 10drug product. AB50-ASA2-AA8,146,1311(c) The failure of a manufacturer to provide the board with information for an 12affordability review under par. (b) does not affect the authority of the board to 13conduct the review.
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