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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-AA8,140,66SUBCHAPTER VI
AB50-ASA2-AA8,140,77PRESCRIPTION DRUG
AB50-ASA2-AA8,140,88AFFORDABILITY REVIEW BOARD
AB50-ASA2-AA8,2689Section 268. 601.78 of the statutes is created to read:
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 entitys 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-AA8,26919Section 269. 601.785 of the statutes is created to read:
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
8boards 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-AA8,27015Section 270. 601.79 of the statutes is created to read:
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 manufacturers 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.
AB50-ASA2-AA8,146,2114(3) Affordability challenge. When conducting an affordability review of a
15prescription drug product under sub. (2), the board shall determine whether use of
16the prescription drug product that is fully consistent with the labeling approved by
17the federal food and drug administration or standard medical practice has led or
18will lead to an affordability challenge for the health care system in this state,
19including high out-of-pocket costs for patients. To the extent practicable, in
20determining whether a prescription drug product has led or will lead to an
21affordability challenge, the board shall consider all of the following factors:
AB50-ASA2-AA8,146,2322(a) The wholesale acquisition cost for the prescription drug product sold in
23this state.
AB50-ASA2-AA8,147,4
1(b) The average monetary price concession, discount, or rebate the
2manufacturer provides, or is expected to provide, to health plans in this state as
3reported by manufacturers and health plans, expressed as a percentage of the
4wholesale acquisition cost for the prescription drug product under review.
AB50-ASA2-AA8,147,85(c) The total amount of the price concessions, discounts, and rebates the
6manufacturer provides to each pharmacy benefit manager for the prescription drug
7product under review, as reported by the manufacturer and pharmacy benefit
8manager and expressed as a percentage of the wholesale acquisition cost.
AB50-ASA2-AA8,147,109(d) The price at which therapeutic alternatives to the prescription drug
10product have been sold in this state.
AB50-ASA2-AA8,147,1311(e) The average monetary concession, discount, or rebate the manufacturer
12provides or is expected to provide to health plan payors and pharmacy benefit
13managers in this state for therapeutic alternatives to the prescription drug product.
AB50-ASA2-AA8,147,1614(f) The costs to health plans based on patient access consistent with labeled
15indications by the federal food and drug administration and recognized standard
16medical practice.
AB50-ASA2-AA8,147,1817(g) The impact on patient access resulting from the cost of the prescription
18drug product relative to insurance benefit design.
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