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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 entitys 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
17boards 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.
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