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SB45,1398,2016(d) The commissioner may, based on the findings of an audit under par. (a),
17order the insurer who is the subject of the audit to comply with a corrective action
18plan approved by the commissioner. The commissioner shall specify in any
19corrective action plan under this paragraph the deadline by which an insurer must
20be in compliance with the corrective action plan.
SB45,1398,2221(e) An insurer who is the subject of an audit under par. (a) shall provide a
22written response to any adverse findings of the audit.
SB45,1399,223(f) If an insurer fails to comply with a corrective action plan under par. (d) by

1the deadline specified by the commissioner, the commissioner may order the
2insurer to pay a forfeiture pursuant to s. 601.64 (3).
SB45,1399,63(7) Forfeitures. A violation of this section that results in a harmful delay in
4an insureds care or an adverse health outcome for an insured shall be subject to a
5civil forfeiture of $10,000 per occurrence, in addition to any other penalties provided
6in s. 601.64 (3) or other law.
SB45,28887Section 2888. 601.575 of the statutes is created to read:
SB45,1399,138601.575 Prescription drug importation program. (1) Importation
9program requirements. The commissioner, in consultation with persons
10interested in the sale and pricing of prescription drugs and appropriate officials
11and agencies of the federal government, shall design and implement a prescription
12drug importation program for the benefit of residents of this state, that generates
13savings for residents, and that satisfies all of the following:
SB45,1399,1614(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.
SB45,1399,1817(b) The program shall comply with relevant requirements of 21 USC 384,
18including safety and cost savings requirements.
SB45,1399,2019(c) The program shall import prescription drugs from Canadian suppliers
20regulated under any appropriate Canadian or provincial laws.
SB45,1399,2221(d) The program shall have a process to sample the purity, chemical
22composition, and potency of imported prescription drugs.
SB45,1400,223(e) The program shall import only those prescription drugs for which
24importation creates substantial savings for residents of this state and only those

1prescription drugs that are not brand-name drugs and that have fewer than 4
2competitor prescription drugs in the United States.
SB45,1400,43(f) The commissioner shall ensure that prescription drugs imported under the
4program are not distributed, dispensed, or sold outside of this state.
SB45,1400,55(g) The program shall ensure all of the following:
SB45,1400,761. Participation by any pharmacy or health care provider in the program is
7voluntary.
SB45,1400,982. Any pharmacy or health care provider participating in the program has the
9appropriate license or other credential in this state.
SB45,1400,12103. Any pharmacy or health care provider participating in the program charges
11a consumer or health plan the actual acquisition cost of the imported prescription
12drug that is dispensed.
SB45,1400,1613(h) The program shall ensure that a payment by a health plan or health
14insurance policy for a prescription drug imported under the program reimburses no
15more than the actual acquisition cost of the imported prescription drug that is
16dispensed.
SB45,1400,1817(i) The program shall ensure that any health plan or health insurance policy
18participating in the program does all of the following:
SB45,1400,20191. Maintains a formulary and claims payment system with current
20information on prescription drugs imported under the program.
SB45,1400,23212. Bases cost-sharing amounts for participants or insureds under the plan or
22policy on no more than the actual acquisition cost of the prescription drug imported
23under the program that is dispensed to the participant or insured.
SB45,1401,3
13. Demonstrates to the commissioner or a state agency designated by the
2commissioner how premiums under the plan or policy are affected by savings on
3prescription drugs imported under the program.
SB45,1401,64(j) Any wholesale distributor importing prescription drugs under the program
5shall limit its profit margin to the amount established by the commissioner or a
6state agency designated by the commissioner.
SB45,1401,87(k) The program may not import any generic prescription drug that would
8violate federal patent laws on branded products in the United States.
SB45,1401,139(L) The program shall comply with tracking and tracing requirements of 21
10USC 360eee and 360eee-1, to the extent practical and feasible, before the
11prescription drug to be imported comes into the possession of this states wholesale
12distributor and fully after the prescription drug to be imported is in the possession
13of this states wholesale distributor.
SB45,1401,1514(m) The program shall establish a fee or other mechanism to finance the
15program that does not jeopardize significant savings to residents of this state.
SB45,1401,1616(n) The program shall have an audit function that ensures all of the following:
SB45,1401,18171. The commissioner has a sound methodology to determine the most cost-
18effective prescription drugs to include in the program.
SB45,1401,20192. The commissioner has a process in place to select Canadian suppliers that
20are high quality, high performing, and in full compliance with Canadian laws.
SB45,1401,22213. Prescription drugs imported under the program are pure, unadulterated,
22potent, and safe.
SB45,1401,23234. The program is complying with the requirements of this subsection.
SB45,1402,2
15. The program is adequately financed to support administrative functions of
2the program while generating significant cost savings to residents of this state.
SB45,1402,436. The program does not put residents of this state at a higher risk than if the
4program did not exist.
SB45,1402,657. The program provides and is projected to continue to provide substantial
6cost savings to residents of this state.
SB45,1402,97(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.
SB45,1402,1910(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.
SB45,1403,420(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:
SB45,1403,75(a) Become a licensed wholesale distributor, designate another state agency to
6become a licensed wholesale distributor, or contract with a licensed wholesale
7distributor.
SB45,1403,98(b) Contract with one or more Canadian suppliers that meet the criteria in
9sub. (1) (c) and (n).
SB45,1403,1210(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.
SB45,1403,1513(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.
SB45,1403,1716(e) Create a publicly accessible source for listing prices of prescription drugs
17imported under the program.
SB45,1403,2018(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.
SB45,1403,2221(g) Establish the audit functions under sub. (1) (n) with a timeline to complete
22each audit function every 2 years.
SB45,1404,2
1(h) Conduct any other activities determined by the commissioner to be
2important to successful implementation of the program.
SB45,1404,43(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:
SB45,1404,65(a) A list of prescription drugs included in the prescription drug importation
6program under this section.
SB45,1404,97(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.
SB45,1404,1410(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.
SB45,1404,1615(d) Findings of any audit functions under sub. (1) (n) completed since the date
16of the previous report under this subsection.
SB45,1404,1817(6) Rule making. The commissioner may promulgate any rules necessary to
18implement this section.
SB45,288919Section 2889. 601.59 of the statutes is created to read:
SB45,1404,2020601.59 State-based exchange. (1) Definitions. In this section:
SB45,1404,2121(a) Exchange has the meaning given in 45 CFR 155.20.
SB45,1405,222(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.
SB45,1405,63(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.
SB45,1405,137(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.
SB45,1405,1614(3) Agreement with federal government. The commissioner may enter
15into any agreement with the federal government necessary to facilitate the
16implementation of this section.
SB45,1405,2217(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:
SB45,1406,2
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.
SB45,1406,63(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.
SB45,1406,97(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.
SB45,1406,1110(5) Rules. The commissioner may promulgate rules necessary to implement
11this section.
SB45,289012Section 2890. Subchapter VI (title) of chapter 601 [precedes 601.78] of the
13statutes is created to read:
SB45,1406,1414CHAPTER 601
SB45,1406,1515SUBCHAPTER VI
SB45,1406,1616PRESCRIPTION DRUG
SB45,1406,1717AFFORDABILITY REVIEW BOARD
SB45,289118Section 2891. 601.78 of the statutes is created to read:
SB45,1406,1919601.78 Definitions. In this subchapter:
SB45,1406,2120(1) Biologic means a drug that is produced or distributed in accordance with
21a biologics license application approved under 21 CFR 601.20.
SB45,1406,2322(2) Biosimilar means a drug that is produced or distributed in accordance
23with a biologics license application approved under 42 USC 262 (k) (3).
SB45,1407,2
1(3) Board means the prescription drug affordability review board
2established under s. 15.735 (1).
SB45,1407,53(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.
SB45,1407,96(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.
SB45,1407,1010(6) Generic drug means any of the following:
SB45,1407,1211(a) A retail drug that is marketed or distributed in accordance with an
12abbreviated new drug application approved under 21 USC 355 (j).
SB45,1407,1313(b) An authorized generic drug, as defined in 42 CFR 447.502.
SB45,1407,1514(c) A drug that entered the market prior to 1962 and was not originally
15marketed under a new drug application.
SB45,1407,1816(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.
SB45,1407,1919(8) Manufacturer means an entity that does all of the following:
SB45,1407,2220(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.
SB45,1408,2
1(b) Sets or changes the wholesale acquisition cost of the prescription drug
2product described in par. (a).
SB45,1408,33(9) Pharmacy benefit manager has the meaning given in s. 632.865 (1) (c).
SB45,1408,54(10) Prescription drug product means a brand name drug, a generic drug, a
5biologic, or a biosimilar.
SB45,28926Section 2892. 601.785 of the statutes is created to read:
SB45,1408,117601.785 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.
SB45,1408,1212(2) Powers and duties. (a) The board shall do all of the following:
SB45,1408,15131. 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.
SB45,1408,17162. To the extent practicable, access and assess pricing information for
17prescription drug products by doing all of the following:
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