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AB68-SSA1,1319,1312 7. The prescription drug importation program under this section provides and
13is projected to continue to provide substantial cost savings to residents of the state.
AB68-SSA1,1319,16 14(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.
AB68-SSA1,1320,2 17(3) Approval of program design; certification. No later than the first day of
18the 7th month beginning after the effective date of this subsection .... [LRB inserts
19date], the commissioner shall submit to the joint committee on finance a report that
20includes the design of the prescription drug importation program in accordance with
21this section. The commissioner may not submit the proposed prescription drug
22importation program to the federal department of health and human services unless
23the joint committee on finance approves the proposed prescription drug
24implementation program. Within 14 days of the date of approval by the joint
25committee on finance of the proposed prescription drug importation program, the

1commissioner shall submit to the federal department of health and human services
2a request for certification of the approved prescription drug importation program.
AB68-SSA1,1320,10 3(4) Implementation of certified program. After the federal department of
4health and human services certifies the prescription drug importation program
5submitted under sub. (3), the commissioner shall begin implementation of the
6program, and the program shall be fully operational by 180 days after the date of
7certification by the federal department of health and human services. The
8commissioner shall do all of the following to implement the prescription drug
9importation program to the extent the action is in accordance with other state laws
10and the certification by the federal department of health and human services:
AB68-SSA1,1320,1311 (a) Become a licensed wholesale distributor, designate another state agency to
12become a licensed wholesale distributor, or contract with a licensed wholesale
13distributor.
AB68-SSA1,1320,1514 (b) Contract with one or more Canadian suppliers that meet the criteria in sub.
15(1) (c) and (n).
AB68-SSA1,1320,1916 (c) Create an outreach and marketing plan to communicate with and provide
17information to health plans and health insurance policies, employers, pharmacies,
18health care providers, and residents of the state on participating in the prescription
19drug importation program.
AB68-SSA1,1320,2220 (d) Develop and implement a registration process for health plans and health
21insurance policies, pharmacies, and health care providers interested in participating
22in the prescription drug importation program.
AB68-SSA1,1320,2423 (e) Create a publicly accessible source for listing prices of prescription drugs
24imported under the program.
AB68-SSA1,1321,3
1(f) Create, publicize, and implement a method of communication to promptly
2answer questions from and address the needs of persons affected by the
3implementation of the program before the program is fully operational.
AB68-SSA1,1321,54 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete
5each audit function every 2 years.
AB68-SSA1,1321,86 (h) Conduct any other activities determined by the commissioner to be
7important to successful implementation of the prescription drug importation
8program under this section.
AB68-SSA1,1321,10 9(5) Report. By January 1 and July 1 of each year, the commissioner shall
10submit to the joint committee on finance a report including all of the following:
AB68-SSA1,1321,1211 (a) A list of prescription drugs included in the importation program under this
12section.
AB68-SSA1,1321,1513 (b) The number of pharmacies, health care providers, and health plans and
14health insurance policies participating in the prescription drug importation program
15under this section.
AB68-SSA1,1321,2016 (c) The estimated amount of savings to residents of the state, health plans and
17health insurance policies, and employers resulting from the implementation of the
18prescription drug importation program under this section reported from the date of
19the previous report under this subsection and from the date the program was fully
20operational.
AB68-SSA1,1321,2221 (d) Findings of any audit functions under sub. (1) (n) completed since the date
22of the previous report under this subsection.
AB68-SSA1,1321,24 23(6) Rulemaking. The commissioner may promulgate any rules necessary to
24implement this section.
AB68-SSA1,2956 25Section 2956. 601.59 of the statutes is created to read:
AB68-SSA1,1322,1
1601.59 State-based exchange. (1) Definitions. In this section:
AB68-SSA1,1322,22 (a) “Exchange” has the meaning given in 45 CFR 155.20.
AB68-SSA1,1322,53 (b) “State-based exchange on the federal platform” means an exchange that is
4described in and meets the requirements of 45 CFR 155.200 (f) and is approved by
5the federal secretary of health and human services under 45 CFR 155.106.
AB68-SSA1,1322,96 (c) “State-based exchange without the federal platform” means an exchange,
7other than one described in 45 CFR 155.200 (f), that performs all the functions
8described in 45 CFR 155.200 (a) and is approved by the federal secretary of health
9and human services under 45 CFR 155.106.
AB68-SSA1,1322,16 10(2) Establishment and operation of state-based exchange. The commissioner
11shall establish and operate an exchange that at first is a state-based exchange on
12the federal platform and then subsequently transitions to a state-based exchange
13without the federal platform. The commissioner shall develop procedures to address
14the transition from the state-based exchange on the federal platform to the
15state-based exchange without the federal platform, including the circumstances
16that shall be met in order for the transition to occur.
AB68-SSA1,1322,19 17(3) Agreement with federal government. The commissioner may enter into
18any agreement with the federal government necessary to facilitate the
19implementation of this section.
AB68-SSA1,1322,25 20(4) User fees. The commissioner shall impose a user fee, as authorized under
2145 CFR 155.160 (b) (1), on each insurer that offers a health plan through the
22state-based exchange on the federal platform or the state-based exchange without
23the federal platform. The user fee shall be applied at one of the following rates on
24the total monthly premiums charged by an insurer for each policy under the plan
25where enrollment is through the exchange:
AB68-SSA1,1323,2
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.
AB68-SSA1,1323,43 (b) For the first 2 plan years for which the commissioner operates a state-based
4exchange without the federal platform, the rate is 3 percent.
AB68-SSA1,1323,75 (c) Beginning with the 3rd plan year for which the commissioner operates a
6state-based exchange without the federal platform, the rate shall be set by the
7commissioner by rule.
AB68-SSA1,1323,9 8(5) Rules. The commissioner may promulgate rules necessary to implement
9this section.
AB68-SSA1,2957 10Section 2957. Subchapter VI (title) of chapter 601 [precedes 601.78] of the
11statutes is created to read:
AB68-SSA1,1323,1212 CHAPTER 601
AB68-SSA1,1323,1413 SUBCHAPTER VI
14 Prescription drug
AB68-SSA1,1323,1515 affordability review board
AB68-SSA1,2958 16Section 2958. 601.78 of the statutes is created to read:
AB68-SSA1,1323,17 17601.78 Definitions. In this subchapter:
AB68-SSA1,1323,19 18(1) “Biologic” means a drug that is produced or distributed in accordance with
19a biologics license application approved under 21 CFR 601.20.
AB68-SSA1,1323,21 20(2) “Biosimilar” means a drug that is produced or distributed in accordance
21with a biologics license application approved under 42 USC 262 (k) (3).
AB68-SSA1,1323,23 22(3) “Board” means the prescription drug affordability review board established
23under s. 15.735 (1).
AB68-SSA1,1324,3
1(4) “Brand name drug” means a drug that is produced or distributed in
2accordance with an original new drug application approved under 21 USC 355 (c),
3other than an authorized generic drug, as defined in 42 CFR 447.502.
AB68-SSA1,1324,5 4(5) “Drug product” means a brand name drug, a generic drug, a biologic, a
5biosimilar, or an over-the-counter drug.
AB68-SSA1,1324,9 6(6) “Financial benefit” includes an honoraria, fee, stock, the value of the stock
7holdings of a member of the board or any immediate family member, as defined in
8s. 97.605 (4) (a) 2., and any direct financial benefit deriving from the finding of a
9review conducted under s. 601.79.
AB68-SSA1,1324,10 10(7) “Generic drug” means any of the following:
AB68-SSA1,1324,1211 (a) A retail drug that is marketed or distributed in accordance with an
12abbreviated new drug application approved under 21 USC 355 (j).
AB68-SSA1,1324,1313(b) An authorized generic drug, as defined in 42 CFR 447.502.
AB68-SSA1,1324,1514 (c) A drug that entered the market prior to 1962 and was not originally
15marketed under a new drug application.
AB68-SSA1,1324,16 16(8) “Manufacturer” means an entity that does all of the following:
AB68-SSA1,1324,1917 (a) Engages in the manufacture of a drug product or enters into a lease with
18another manufacturer to market and distribute a prescription drug product under
19the entity's own name.
AB68-SSA1,1324,2120 (b) Sets or changes the wholesale acquisition cost of the drug product or
21prescription drug product described in par. (a).
AB68-SSA1,1324,23 22(9) “Over-the-counter drug” means a drug intended for human use that does
23not require a prescription and meets the requirements of 21CFR parts 328 to 364.
AB68-SSA1,1324,24 24(10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
AB68-SSA1,1325,2
1(11) “Prescription drug product” means a brand name drug, a generic drug, a
2biologic, or a biosimilar.
AB68-SSA1,2959 3Section 2959. 601.785 of the statutes is created to read:
AB68-SSA1,1325,8 4601.785 Prescription drug affordability review board. (1) Mission. The
5purpose of the board is to protect state residents, the state, local governments, health
6plans, healthcare providers, pharmacies licensed in this state, and other
7stakeholders of the healthcare system in this state from the high costs of prescription
8drug products.
AB68-SSA1,1325,9 9(2) Powers and duties. (a) The board shall do all of the following:
AB68-SSA1,1325,1210 1. Meet in open session at least 4 times per year to review prescription drug
11product pricing information, except that the chair may cancel or postpone a meeting
12if there is no business to transact.
AB68-SSA1,1325,1413 2. To the extent practicable, access and assess pricing information for
14prescription drug products by doing all of the following:
AB68-SSA1,1325,1715 a. Accessing and assessing information from other states by entering into
16memoranda of understanding with other states to which manufacturers report
17pricing information.
AB68-SSA1,1325,1818 b. Assessing spending for specific prescription drug products in this state.
AB68-SSA1,1325,1919 c. Accessing other available pricing information.
AB68-SSA1,1325,2020 (b) The board may:
AB68-SSA1,1325,2121 1. Promulgate rules for the administration of this subchapter.
AB68-SSA1,1326,222 2. Enter into a contract with an independent 3rd party for any service
23necessary to carry out the powers and duties of the board. Unless written permission
24is granted by the board, any person with whom the board contracts may not release,

1publish, or otherwise use any information to which the person has access under the
2contract.
AB68-SSA1,1326,6 3(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide
4public notice of each board meeting at least 2 weeks prior to the meeting and shall
5make the materials for each meeting publicly available at least one week prior to the
6meeting.
AB68-SSA1,1326,97 (b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for
8public comment at each open meeting and shall provide the public with the
9opportunity to provide written comments on pending decisions of the board.
AB68-SSA1,1326,1210 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board
11concerning proprietary data and information shall be conducted in closed session
12and shall in all respects remain confidential.
AB68-SSA1,1326,1413 (d) The board may allow expert testimony at any meeting, including when the
14board meets in closed session.
AB68-SSA1,1326,18 15(4) Conflicts of interest. (a) A member of the board shall recuse himself or
16herself from a decision by the board relating to a prescription drug product if the
17member or an immediate family member, as defined in s. 97.605 (4) (a) 2., has
18received or could receive any of the following:
AB68-SSA1,1326,2019 1. A direct financial benefit deriving from a determination, or a finding of a
20study or review, by the board relating to the prescription drug product.
AB68-SSA1,1326,2321 2. A financial benefit in excess of $5,000 in a calendar year from any person who
22owns, manufactures, or provides a prescription drug product to be studied or
23reviewed by the board.
AB68-SSA1,1327,224 (b) A conflict of interest shall be disclosed by the board when hiring board staff,
25by the appointing authority when appointing members to the board, and by the board

1when a member of the board is recused from any final decision resulting from a
2review of a prescription drug product.
AB68-SSA1,1327,53 (c) A conflict of interest shall be disclosed no later than 5 days after the conflict
4is identified, except that, if the conflict is identified within 5 days of an open meeting
5of the board, the conflict shall be disclosed prior to the meeting.
AB68-SSA1,1327,106 (d) The board shall disclose a conflict of interest under this subsection on the
7board's Internet site unless the chair of the board recuses the member from a final
8decision resulting from a review of the prescription drug product. The disclosure
9shall include the type, nature, and magnitude of the interests of the member
10involved.
AB68-SSA1,1327,1311 (e) A member of the board or a 3rd party contractor may not accept any gift or
12donation of services or property that indicates a potential conflict of interest or has
13the appearance of biasing the work of the board.
AB68-SSA1,2960 14Section 2960. 601.79 of the statutes is created to read:
AB68-SSA1,1327,16 15601.79 Drug cost affordability review. (1) Identification of drugs. The
16board shall identify prescription drug products that are any of the following:
AB68-SSA1,1327,2117 (a) A brand name drug or biologic that, as adjusted annually to reflect
18adjustments to the U.S. consumer price index for all urban consumers, U.S. city
19average, as determined by the U.S. department of labor, has a launch wholesale
20acquisition cost of at least $30,000 per year or course of treatment or whose wholesale
21acquisition cost increased at least $3,000 during a 12–month period.
AB68-SSA1,1327,2422 (b) A biosimilar drug that has a launch wholesale acquisition cost that is not
23at least 15 percent lower than the referenced brand biologic at the time the biosimilar
24is launched.
AB68-SSA1,1328,4
1(c) A generic drug that has a wholesale acquisition cost, as adjusted annually
2to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
3city average, as determined by the U.S. department of labor, that meets all of the
4following conditions:
AB68-SSA1,1328,105 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
6days based on the recommended dosage approved for labeling by the U.S. food and
7drug administration, a supply lasting a patient for fewer than 30 days based on the
8recommended dosage approved for labeling by the federal food and drug
9administration, or one unit of the drug if the labeling approved by the federal food
10and drug administration does not recommend a finite dosage.
AB68-SSA1,1328,1311 2. Increased by at least 200 percent during the preceding 12–month period, as
12determined by the difference between the resulting wholesale acquisition cost and
13the average of the wholesale acquisition cost reported over the preceding 12 months.
AB68-SSA1,1328,1614 (d) Other prescription drug products, including drugs to address public health
15emergencies, that may create affordability challenges for the healthcare system and
16patients in this state.
AB68-SSA1,1328,21 17(2) Affordability review. (a) After identifying prescription drug products
18under sub. (1), the board shall determine whether to conduct an affordability review
19for each identified prescription drug product by seeking stakeholder input about the
20prescription drug product and considering the average patient cost share of the
21prescription drug product.
AB68-SSA1,1329,222 (b) The information to conduct an affordability review under par. (a) may
23include any document and research related to the manufacturer's selection of the
24introductory price or price increase of the prescription drug product, including life
25cycle management, net average price in this state, market competition and context,

1projected revenue, and the estimated value or cost–effectiveness of the prescription
2drug product.
AB68-SSA1,1329,43 (c) The failure of a manufacturer to provide the board with information for an
4affordability review does not affect the authority of the board to conduct the review.
AB68-SSA1,1329,12 5(3) Affordability challenge. When conducting an affordability review of a
6prescription drug product, the board shall determine whether use of the prescription
7drug product that is fully consistent with the labeling approved by the federal food
8and drug administration or standard medical practice has led or will lead to an
9affordability challenge for the healthcare system in this state, including high
10out–of–pocket costs for patients. To the extent practicable, in determining whether
11a prescription drug product has led or will lead to an affordability challenge, the
12board shall consider all of the following factors:
AB68-SSA1,1329,1413 (a) The wholesale acquisition cost for the prescription drug product sold in this
14state.
AB68-SSA1,1329,1815 (b) The average monetary price concession, discount, or rebate the
16manufacturer provides, or is expected to provide, to health plans in this state as
17reported by manufacturers and health plans, expressed as a percent of the wholesale
18acquisition cost for the prescription drug product under review.
AB68-SSA1,1329,2219 (c) The total amount of the price concessions, discounts, and rebates the
20manufacturer provides to each pharmacy benefit manager for the prescription drug
21product under review, as reported by the manufacturer and pharmacy benefit
22manager and expressed as a percent of the wholesale acquisition costs.
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