AB50,1399,2221(d) The program shall have a process to sample the purity, chemical 22composition, and potency of imported prescription drugs. AB50,1400,223(e) The program shall import only those prescription drugs for which 24importation creates substantial savings for residents of this state and only those
1prescription drugs that are not brand-name drugs and that have fewer than 4 2competitor prescription drugs in the United States. AB50,1400,43(f) The commissioner shall ensure that prescription drugs imported under the 4program are not distributed, dispensed, or sold outside of this state. AB50,1400,55(g) The program shall ensure all of the following: AB50,1400,761. Participation by any pharmacy or health care provider in the program is 7voluntary. AB50,1400,982. Any pharmacy or health care provider participating in the program has the 9appropriate license or other credential in this state. AB50,1400,12103. Any pharmacy or health care provider participating in the program charges 11a consumer or health plan the actual acquisition cost of the imported prescription 12drug that is dispensed. AB50,1400,1613(h) The program shall ensure that a payment by a health plan or health 14insurance policy for a prescription drug imported under the program reimburses no 15more than the actual acquisition cost of the imported prescription drug that is 16dispensed. AB50,1400,1817(i) The program shall ensure that any health plan or health insurance policy 18participating in the program does all of the following: AB50,1400,20191. Maintains a formulary and claims payment system with current 20information on prescription drugs imported under the program. AB50,1400,23212. Bases cost-sharing amounts for participants or insureds under the plan or 22policy on no more than the actual acquisition cost of the prescription drug imported 23under the program that is dispensed to the participant or insured. AB50,1401,3
13. Demonstrates to the commissioner or a state agency designated by the 2commissioner how premiums under the plan or policy are affected by savings on 3prescription drugs imported under the program. AB50,1401,64(j) Any wholesale distributor importing prescription drugs under the program 5shall limit its profit margin to the amount established by the commissioner or a 6state agency designated by the commissioner. AB50,1401,87(k) The program may not import any generic prescription drug that would 8violate federal patent laws on branded products in the United States. AB50,1401,139(L) The program shall comply with tracking and tracing requirements of 21 10USC 360eee and 360eee-1, to the extent practical and feasible, before the 11prescription drug to be imported comes into the possession of this state’s wholesale 12distributor and fully after the prescription drug to be imported is in the possession 13of this state’s wholesale distributor. AB50,1401,1514(m) The program shall establish a fee or other mechanism to finance the 15program that does not jeopardize significant savings to residents of this state. AB50,1401,1616(n) The program shall have an audit function that ensures all of the following: AB50,1401,18171. The commissioner has a sound methodology to determine the most cost-18effective prescription drugs to include in the program. AB50,1401,20192. The commissioner has a process in place to select Canadian suppliers that 20are high quality, high performing, and in full compliance with Canadian laws. AB50,1401,22213. Prescription drugs imported under the program are pure, unadulterated, 22potent, and safe. AB50,1401,23234. The program is complying with the requirements of this subsection. AB50,1402,2
15. The program is adequately financed to support administrative functions of 2the program while generating significant cost savings to residents of this state. AB50,1402,436. The program does not put residents of this state at a higher risk than if the 4program did not exist. AB50,1402,657. The program provides and is projected to continue to provide substantial 6cost savings to residents of this state. AB50,1402,97(2) Anticompetitive behavior. The commissioner, in consultation with the 8attorney general, shall identify the potential for and monitor anticompetitive 9behavior in industries affected by a prescription drug importation program. AB50,1402,1910(3) Approval of program design; certification. No later than the first day 11of the 7th month beginning after the effective date of this subsection .... [LRB 12inserts date], the commissioner shall submit to the joint committee on finance a 13report that includes the design of the prescription drug importation program in 14accordance with this section. The commissioner may not submit the proposed 15program to the federal department of health and human services unless the joint 16committee on finance approves the proposed program. Within 14 days of the date of 17approval by the joint committee on finance of the proposed program, the 18commissioner shall submit to the federal department of health and human services 19a request for certification of the approved program. AB50,1403,420(4) Implementation of certified program. After the federal department of 21health and human services certifies the prescription drug importation program 22submitted under sub. (3), the commissioner shall begin implementation of the 23program, and the program shall be fully operational by 180 days after the date of
1certification by the federal department of health and human services. The 2commissioner shall do all of the following to implement the program to the extent 3the action is in accordance with other state laws and the certification by the federal 4department of health and human services: AB50,1403,75(a) Become a licensed wholesale distributor, designate another state agency to 6become a licensed wholesale distributor, or contract with a licensed wholesale 7distributor. AB50,1403,98(b) Contract with one or more Canadian suppliers that meet the criteria in 9sub. (1) (c) and (n). AB50,1403,1210(c) Create an outreach and marketing plan to communicate with and provide 11information to health plans and health insurance policies, employers, pharmacies, 12health care providers, and residents of this state on participating in the program. 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.
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