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AB68-ASA2-AA2,53,2018 3. Demonstrates to the commissioner or a state agency designated by the
19commissioner how premiums under the policy or plan are affected by savings on
20prescription drugs imported under the program.
AB68-ASA2-AA2,53,2321 (j) Any wholesale distributor importing prescription drugs under the program
22under this section shall limit its profit margin to the amount established by the
23commissioner or a state agency designated by the commissioner.
AB68-ASA2-AA2,54,3
1(k) The prescription drug importation program under this section may not
2import any generic prescription drug that would violate federal patent laws on
3branded products in this country.
AB68-ASA2-AA2,54,84 (L) The prescription drug importation program under this section shall comply
5to the extent practical and feasible, before the prescription drug to be imported comes
6into the possession of the state's wholesale distributor and fully after the prescription
7drug to be imported is in the possession of the state's wholesale distributor, with
8tracking and tracing requirements of 21 USC 360eee to 360eee-1.
AB68-ASA2-AA2,54,119 (m) The prescription drug importation program under this section shall
10establish a fee or other mechanism to finance the program that does not jeopardize
11significant savings to residents of the state.
AB68-ASA2-AA2,54,1312 (n) The prescription drug importation program under this section shall have
13an audit function that ensures all of the following:
AB68-ASA2-AA2,54,1614 1. The commissioner has a sound methodology to determine the most
15cost-effective prescription drugs to include in the importation program under this
16section.
AB68-ASA2-AA2,54,1817 2. The commissioner has a process in place to select Canadian suppliers that
18are high quality, high performing, and in full compliance with Canadian laws.
AB68-ASA2-AA2,54,2019 3. Prescription drugs imported under the program are pure, unadulterated,
20potent, and safe.
AB68-ASA2-AA2,54,2221 4. The prescription drug importation program is complying with the
22requirements of this subsection.
AB68-ASA2-AA2,54,2523 5. The prescription drug importation program under this section is adequately
24financed to support administrative functions of the program while generating
25significant cost savings to residents of the state.
AB68-ASA2-AA2,55,2
16. The prescription drug importation program under this section does not put
2residents of the state at a higher risk than if the program did not exist.
AB68-ASA2-AA2,55,43 7. The prescription drug importation program under this section provides and
4is projected to continue to provide substantial cost savings to residents of the state.
AB68-ASA2-AA2,55,7 5(2) Anticompetitive behavior. The commissioner, in consultation with the
6attorney general, shall identify the potential for and monitor anticompetitive
7behavior in industries affected by a prescription drug importation program.
AB68-ASA2-AA2,55,18 8(3) Approval of program design; certification. No later than the first day of
9the 7th month beginning after the effective date of this subsection .... [LRB inserts
10date], the commissioner shall submit to the joint committee on finance a report that
11includes the design of the prescription drug importation program in accordance with
12this section. The commissioner may not submit the proposed prescription drug
13importation program to the federal department of health and human services unless
14the joint committee on finance approves the proposed prescription drug
15implementation program. Within 14 days of the date of approval by the joint
16committee on finance of the proposed prescription drug importation program, the
17commissioner shall submit to the federal department of health and human services
18a request for certification of the approved prescription drug importation program.
AB68-ASA2-AA2,56,2 19(4) Implementation of certified program. After the federal department of
20health and human services certifies the prescription drug importation program
21submitted under sub. (3), the commissioner shall begin implementation of the
22program, and the program shall be fully operational by 180 days after the date of
23certification by the federal department of health and human services. The
24commissioner shall do all of the following to implement the prescription drug

1importation program to the extent the action is in accordance with other state laws
2and the certification by the federal department of health and human services:
AB68-ASA2-AA2,56,53 (a) Become a licensed wholesale distributor, designate another state agency to
4become a licensed wholesale distributor, or contract with a licensed wholesale
5distributor.
AB68-ASA2-AA2,56,76 (b) Contract with one or more Canadian suppliers that meet the criteria in sub.
7(1) (c) and (n).
AB68-ASA2-AA2,56,118 (c) Create an outreach and marketing plan to communicate with and provide
9information to health plans and health insurance policies, employers, pharmacies,
10health care providers, and residents of the state on participating in the prescription
11drug importation program.
AB68-ASA2-AA2,56,1412 (d) Develop and implement a registration process for health plans and health
13insurance policies, pharmacies, and health care providers interested in participating
14in the prescription drug importation program.
AB68-ASA2-AA2,56,1615 (e) Create a publicly accessible source for listing prices of prescription drugs
16imported under the program.
AB68-ASA2-AA2,56,1917 (f) Create, publicize, and implement a method of communication to promptly
18answer questions from and address the needs of persons affected by the
19implementation of the program before the program is fully operational.
AB68-ASA2-AA2,56,2120 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete
21each audit function every 2 years.
AB68-ASA2-AA2,56,2422 (h) Conduct any other activities determined by the commissioner to be
23important to successful implementation of the prescription drug importation
24program under this section.
AB68-ASA2-AA2,57,2
1(5) Report. By January 1 and July 1 of each year, the commissioner shall
2submit to the joint committee on finance a report including all of the following:
AB68-ASA2-AA2,57,43 (a) A list of prescription drugs included in the importation program under this
4section.
AB68-ASA2-AA2,57,75 (b) The number of pharmacies, health care providers, and health plans and
6health insurance policies participating in the prescription drug importation program
7under this section.
AB68-ASA2-AA2,57,128 (c) The estimated amount of savings to residents of the state, health plans and
9health insurance policies, and employers resulting from the implementation of the
10prescription drug importation program under this section reported from the date of
11the previous report under this subsection and from the date the program was fully
12operational.
AB68-ASA2-AA2,57,1413 (d) Findings of any audit functions under sub. (1) (n) completed since the date
14of the previous report under this subsection.
AB68-ASA2-AA2,57,16 15(6) Rulemaking. The commissioner may promulgate any rules necessary to
16implement this section.
AB68-ASA2-AA2,411k 17Section 411k. 601.59 of the statutes is created to read:
AB68-ASA2-AA2,57,18 18601.59 State-based exchange. (1) Definitions. In this section:
AB68-ASA2-AA2,57,1919 (a) “Exchange” has the meaning given in 45 CFR 155.20.
AB68-ASA2-AA2,57,2220 (b) “State-based exchange on the federal platform” means an exchange that is
21described in and meets the requirements of 45 CFR 155.200 (f) and is approved by
22the federal secretary of health and human services under 45 CFR 155.106.
AB68-ASA2-AA2,58,223 (c) “State-based exchange without the federal platform” means an exchange,
24other than one described in 45 CFR 155.200 (f), that performs all the functions

1described in 45 CFR 155.200 (a) and is approved by the federal secretary of health
2and human services under 45 CFR 155.106.
AB68-ASA2-AA2,58,9 3(2) Establishment and operation of state-based exchange. The commissioner
4shall establish and operate an exchange that at first is a state-based exchange on
5the federal platform and then subsequently transitions to a state-based exchange
6without the federal platform. The commissioner shall develop procedures to address
7the transition from the state-based exchange on the federal platform to the
8state-based exchange without the federal platform, including the circumstances
9that shall be met in order for the transition to occur.
AB68-ASA2-AA2,58,12 10(3) Agreement with federal government. The commissioner may enter into
11any agreement with the federal government necessary to facilitate the
12implementation of this section.
AB68-ASA2-AA2,58,18 13(4) User fees. The commissioner shall impose a user fee, as authorized under
1445 CFR 155.160 (b) (1), on each insurer that offers a health plan through the
15state-based exchange on the federal platform or the state-based exchange without
16the federal platform. The user fee shall be applied at one of the following rates on
17the total monthly premiums charged by an insurer for each policy under the plan
18where enrollment is through the exchange:
AB68-ASA2-AA2,58,2019 (a) For any plan year for which the commissioner operates a state-based
20exchange on the federal platform, the rate is 0.5 percent.
AB68-ASA2-AA2,58,2221 (b) For the first 2 plan years for which the commissioner operates a state-based
22exchange without the federal platform, the rate is 3 percent.
AB68-ASA2-AA2,58,2523 (c) Beginning with the 3rd plan year for which the commissioner operates a
24state-based exchange without the federal platform, the rate shall be set by the
25commissioner by rule.
AB68-ASA2-AA2,59,2
1(5) Rules. The commissioner may promulgate rules necessary to implement
2this section.
AB68-ASA2-AA2,411n 3Section 411n. Subchapter VI (title) of chapter 601 [precedes 601.78] of the
4statutes is created to read:
AB68-ASA2-AA2,59,55 CHAPTER 601
AB68-ASA2-AA2,59,76 SUBCHAPTER VI
7 Prescription drug
AB68-ASA2-AA2,59,88 affordability review board
AB68-ASA2-AA2,59,9 9601.78 Definitions. In this subchapter:
AB68-ASA2-AA2,59,11 10(1) “Biologic” means a drug that is produced or distributed in accordance with
11a biologics license application approved under 21 CFR 601.20.
AB68-ASA2-AA2,59,13 12(2) “Biosimilar” means a drug that is produced or distributed in accordance
13with a biologics license application approved under 42 USC 262 (k) (3).
AB68-ASA2-AA2,59,15 14(3) “Board” means the prescription drug affordability review board established
15under s. 15.735 (1).
AB68-ASA2-AA2,59,18 16(4) “Brand name drug” means a drug that is produced or distributed in
17accordance with an original new drug application approved under 21 USC 355 (c),
18other than an authorized generic drug, as defined in 42 CFR 447.502.
AB68-ASA2-AA2,59,20 19(5) “Drug product” means a brand name drug, a generic drug, a biologic, a
20biosimilar, or an over-the-counter drug.
AB68-ASA2-AA2,59,24 21(6) “Financial benefit” includes an honoraria, fee, stock, the value of the stock
22holdings of a member of the board or any immediate family member, as defined in
23s. 97.605 (4) (a) 2., and any direct financial benefit deriving from the finding of a
24review conducted under s. 601.79.
AB68-ASA2-AA2,59,25 25(7) “Generic drug” means any of the following:
AB68-ASA2-AA2,60,2
1(a) A retail drug that is marketed or distributed in accordance with an
2abbreviated new drug application approved under 21 USC 355 (j).
AB68-ASA2-AA2,60,33(b) An authorized generic drug, as defined in 42 CFR 447.502.
AB68-ASA2-AA2,60,54 (c) A drug that entered the market prior to 1962 and was not originally
5marketed under a new drug application.
AB68-ASA2-AA2,60,6 6(8) “Manufacturer” means an entity that does all of the following:
AB68-ASA2-AA2,60,97 (a) Engages in the manufacture of a drug product or enters into a lease with
8another manufacturer to market and distribute a prescription drug product under
9the entity's own name.
AB68-ASA2-AA2,60,1110 (b) Sets or changes the wholesale acquisition cost of the drug product or
11prescription drug product described in par. (a).
AB68-ASA2-AA2,60,13 12(9) “Over-the-counter drug” means a drug intended for human use that does
13not require a prescription and meets the requirements of 21CFR parts 328 to 364.
AB68-ASA2-AA2,60,14 14(10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
AB68-ASA2-AA2,60,16 15(11) “Prescription drug product” means a brand name drug, a generic drug, a
16biologic, or a biosimilar.
AB68-ASA2-AA2,60,21 17601.785 Prescription drug affordability review board. (1) Mission. The
18purpose of the board is to protect state residents, the state, local governments, health
19plans, health care providers, pharmacies licensed in this state, and other
20stakeholders of the health care system in this state from the high costs of prescription
21drug products.
AB68-ASA2-AA2,60,22 22(2) Powers and duties. (a) The board shall do all of the following:
AB68-ASA2-AA2,60,2523 1. Meet in open session at least 4 times per year to review prescription drug
24product pricing information, except that the chair may cancel or postpone a meeting
25if there is no business to transact.
AB68-ASA2-AA2,61,2
12. To the extent practicable, access and assess pricing information for
2prescription drug products by doing all of the following:
AB68-ASA2-AA2,61,53 a. Accessing and assessing information from other states by entering into
4memoranda of understanding with other states to which manufacturers report
5pricing information.
AB68-ASA2-AA2,61,66 b. Assessing spending for specific prescription drug products in this state.
AB68-ASA2-AA2,61,77 c. Accessing other available pricing information.
AB68-ASA2-AA2,61,88 (b) The board may:
AB68-ASA2-AA2,61,99 1. Promulgate rules for the administration of this subchapter.
AB68-ASA2-AA2,61,1410 2. Enter into a contract with an independent 3rd party for any service
11necessary to carry out the powers and duties of the board. Unless written permission
12is granted by the board, any person with whom the board contracts may not release,
13publish, or otherwise use any information to which the person has access under the
14contract.
AB68-ASA2-AA2,61,18 15(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide
16public notice of each board meeting at least 2 weeks prior to the meeting and shall
17make the materials for each meeting publicly available at least one week prior to the
18meeting.
AB68-ASA2-AA2,61,2119 (b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for
20public comment at each open meeting and shall provide the public with the
21opportunity to provide written comments on pending decisions of the board.
AB68-ASA2-AA2,61,2422 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board
23concerning proprietary data and information shall be conducted in closed session
24and shall in all respects remain confidential.
AB68-ASA2-AA2,62,2
1(d) The board may allow expert testimony at any meeting, including when the
2board meets in closed session.
AB68-ASA2-AA2,62,6 3(4) Conflicts of interest. (a) A member of the board shall recuse himself or
4herself from a decision by the board relating to a prescription drug product if the
5member or an immediate family member, as defined in s. 97.605 (4) (a) 2., has
6received or could receive any of the following:
AB68-ASA2-AA2,62,87 1. A direct financial benefit deriving from a determination, or a finding of a
8study or review, by the board relating to the prescription drug product.
AB68-ASA2-AA2,62,119 2. A financial benefit in excess of $5,000 in a calendar year from any person who
10owns, manufactures, or provides a prescription drug product to be studied or
11reviewed by the board.
AB68-ASA2-AA2,62,1512 (b) A conflict of interest shall be disclosed by the board when hiring board staff,
13by the appointing authority when appointing members to the board, and by the board
14when a member of the board is recused from any final decision resulting from a
15review of a prescription drug product.
AB68-ASA2-AA2,62,1816 (c) A conflict of interest shall be disclosed no later than 5 days after the conflict
17is identified, except that, if the conflict is identified within 5 days of an open meeting
18of the board, the conflict shall be disclosed prior to the meeting.
AB68-ASA2-AA2,62,2319 (d) The board shall disclose a conflict of interest under this subsection on the
20board's Internet site unless the chair of the board recuses the member from a final
21decision resulting from a review of the prescription drug product. The disclosure
22shall include the type, nature, and magnitude of the interests of the member
23involved.
AB68-ASA2-AA2,63,3
1(e) A member of the board or a 3rd-party contractor may not accept any gift or
2donation of services or property that indicates a potential conflict of interest or has
3the appearance of biasing the work of the board.
AB68-ASA2-AA2,63,5 4601.79 Drug cost affordability review. (1) Identification of drugs. The
5board shall identify prescription drug products that are any of the following:
AB68-ASA2-AA2,63,106 (a) A brand name drug or biologic that, as adjusted annually to reflect
7adjustments to the U.S. consumer price index for all urban consumers, U.S. city
8average, as determined by the U.S. department of labor, has a launch wholesale
9acquisition cost of at least $30,000 per year or course of treatment or whose wholesale
10acquisition cost increased at least $3,000 during a 12–month period.
AB68-ASA2-AA2,63,1311 (b) A biosimilar drug that has a launch wholesale acquisition cost that is not
12at least 15 percent lower than the referenced brand biologic at the time the biosimilar
13is launched.
AB68-ASA2-AA2,63,1714 (c) A generic drug that has a wholesale acquisition cost, as adjusted annually
15to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
16city average, as determined by the U.S. department of labor, that meets all of the
17following conditions:
AB68-ASA2-AA2,63,2318 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
19days based on the recommended dosage approved for labeling by the U.S. food and
20drug administration, a supply lasting a patient for fewer than 30 days based on the
21recommended dosage approved for labeling by the federal food and drug
22administration, or one unit of the drug if the labeling approved by the federal food
23and drug administration does not recommend a finite dosage.
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