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AB68-SSA1,1315,2419 601.415 (14) Patient pharmacy benefits tool. (a) From the appropriation
20under s. 20.145 (1) (a), beginning in the 2022-23 fiscal year, the office shall award
21grants in a total amount of up to $500,000 each fiscal year to health care providers
22to develop and implement a tool for prescribers to disclose the cost of prescription
23drugs for patients. The tool must be usable by physicians and other prescribers to
24determine the cost of prescription drugs for their patients.
AB68-SSA1,1316,2
1(b) Any health care provider that receives a grant under par. (a) shall contribute
2matching funds equal to at least 50 percent of the grant amount awarded.
AB68-SSA1,2954 3Section 2954 . 601.46 (3) (b) of the statutes is amended to read:
AB68-SSA1,1316,64 601.46 (3) (b) A general review of the insurance business in this state, including
5a report on emerging regulatory problems, developments and trends , including
6trends related to prescription drugs
;
AB68-SSA1,2955 7Section 2955. 601.575 of the statutes is created to read:
AB68-SSA1,1316,13 8601.575 Prescription drug importation program. (1) Importation
9program requirements.
The commissioner, in consultation with persons interested
10in the sale and pricing of prescription drugs and appropriate officials and agencies
11of the federal government, shall design and implement a prescription drug
12importation program for the benefit of residents of this state, that generates savings
13for residents, and that satisfies all of the following:
AB68-SSA1,1316,1614 (a) The commissioner shall designate a state agency to become a licensed
15wholesale distributor or to contract with a licensed wholesale distributor and shall
16seek federal certification and approval to import prescription drugs.
AB68-SSA1,1316,1917 (b) The prescription drug importation program under this section shall comply
18with relevant requirements of 21 USC 384, including safety and cost savings
19requirements.
AB68-SSA1,1316,2220 (c) The prescription drug importation program under this section shall import
21prescription drugs from Canadian suppliers regulated under any appropriate
22Canadian or provincial laws.
AB68-SSA1,1316,2523 (d) The prescription drug importation program under this section shall have
24a process to sample the purity, chemical composition, and potency of imported
25prescription drugs.
AB68-SSA1,1317,4
1(e) The prescription drug importation program under this section shall import
2only those prescription drugs for which importation creates substantial savings for
3residents of the state and only those prescription drugs that are not brand-name
4drugs and that have fewer than 4 competitor prescription drugs in the United States.
AB68-SSA1,1317,75 (f) The commissioner shall ensure that prescription drugs imported under the
6program under this section are not distributed, dispensed, or sold outside of the
7state.
AB68-SSA1,1317,98 (g) The prescription drug importation program under this section shall ensure
9all of the following:
AB68-SSA1,1317,1110 1. Participation by any pharmacy or health care provider in the program is
11voluntary.
AB68-SSA1,1317,1312 2. Any pharmacy or health care provider participating in the program has the
13appropriate license or other credential in this state.
AB68-SSA1,1317,1614 3. Any pharmacy or health care provider participating in the program charges
15a consumer or health plan the actual acquisition cost of the imported prescription
16drug that is dispensed.
AB68-SSA1,1317,2017 (h) The prescription drug importation program under this section shall ensure
18that a payment by a health plan or health insurance policy for a prescription drug
19imported under the program reimburses no more than the actual acquisition cost of
20the imported prescription drug that is dispensed.
AB68-SSA1,1317,2321 (i) The prescription drug importation program under this section shall ensure
22that any health plan or health insurance policy participating in the program does all
23of the following:
AB68-SSA1,1317,2524 1. Maintains a formulary and claims payment system with current information
25on prescription drugs imported under the program.
AB68-SSA1,1318,3
12. Bases cost-sharing amounts for participants or insureds under the plan or
2policy on no more than the actual acquisition cost of the prescription drug imported
3under the program that is dispensed to the participant or insured.
AB68-SSA1,1318,64 3. Demonstrates to the commissioner or a state agency designated by the
5commissioner how premiums under the policy or plan are affected by savings on
6prescription drugs imported under the program.
AB68-SSA1,1318,97 (j) Any wholesale distributor importing prescription drugs under the program
8under this section shall limit its profit margin to the amount established by the
9commissioner or a state agency designated by the commissioner.
AB68-SSA1,1318,1210 (k) The prescription drug importation program under this section may not
11import any generic prescription drug that would violate federal patent laws on
12branded products in this country.
AB68-SSA1,1318,1713 (L) The prescription drug importation program under this section shall comply
14to the extent practical and feasible, before the prescription drug to be imported comes
15into the possession of the state's wholesale distributor and fully after the prescription
16drug to be imported is in the possession of the state's wholesale distributor, with
17tracking and tracing requirements of 21 USC 360eee to 360eee-1.
AB68-SSA1,1318,2018 (m) The prescription drug importation program under this section shall
19establish a fee or other mechanism to finance the program that does not jeopardize
20significant savings to residents of the state.
AB68-SSA1,1318,2221 (n) The prescription drug importation program under this section shall have
22an audit function that ensures all of the following:
AB68-SSA1,1318,2523 1. The commissioner has a sound methodology to determine the most
24cost-effective prescription drugs to include in the importation program under this
25section.
AB68-SSA1,1319,2
12. The commissioner has a process in place to select Canadian suppliers that
2are high quality, high performing, and in full compliance with Canadian laws.
AB68-SSA1,1319,43 3. Prescription drugs imported under the program are pure, unadulterated,
4potent, and safe.
AB68-SSA1,1319,65 4. The prescription drug importation program is complying with the
6requirements of this subsection.
AB68-SSA1,1319,97 5. The prescription drug importation program under this section is adequately
8financed to support administrative functions of the program while generating
9significant cost savings to residents of the state.
AB68-SSA1,1319,1110 6. The prescription drug importation program under this section does not put
11residents of the state at a higher risk than if the program did not exist.
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:
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