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LRB-4350/1
TJD:klm
2021 - 2022 LEGISLATURE
September 2, 2021 - Introduced by Senators Roys, Erpenbach, Agard, Bewley,
Carpenter, Johnson, Larson, Pfaff and Ringhand, cosponsored by
Representatives Subeck, B. Meyers, Anderson, Cabral-Guevara, Cabrera,
Conley, Considine, Doyle, Emerson, Hebl, Hesselbein, Hong, Milroy, L.
Myers
, Neubauer, Ohnstad, S. Rodriguez, Shankland, Shelton, Sinicki,
Snodgrass, Spreitzer, Stubbs and Vruwink. Referred to Committee on
Government Operations, Legal Review and Consumer Protection.
SB539,1,2 1An Act to create 601.575 of the statutes; relating to: prescription drug
2importation program.
Analysis by the Legislative Reference Bureau
This bill requires the commissioner of insurance, in consultation with persons
interested in the sale and pricing of prescription drugs and federal officials and
agencies, to design and implement a prescription drug importation program for the
benefit of and that generates savings for Wisconsin residents. The bill establishes
requirements for the program, including all of the following: the commissioner must
designate a state agency to become or contract with a licensed wholesale distributor
and seek federal certification and approval to import prescription drugs; the
importation program must comply with certain federal regulations and import from
Canadian suppliers only prescription drugs that are not brand-name drugs, have
fewer than four competitor drugs in this country, and for which importation creates
substantial savings; the commissioner must ensure that prescription drugs
imported under the program are not distributed, dispensed, or sold outside of
Wisconsin; and the importation program must have an audit procedure to ensure the
program complies with certain requirements specified in the bill. Before submitting
the proposed implementation program to the federal government for certification,
the commissioner must submit the proposed importation program to JCF for its
approval.

For further information see the state fiscal estimate, which will be printed as
an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SB539,1 1Section 1. 601.575 of the statutes is created to read:
SB539,2,7 2601.575 Prescription drug importation program. (1) Importation
3program requirements.
The commissioner, in consultation with persons interested
4in the sale and pricing of prescription drugs and appropriate officials and agencies
5of the federal government, shall design and implement a prescription drug
6importation program for the benefit of residents of this state, that generates savings
7for residents, and that satisfies all of the following:
SB539,2,108 (a) The commissioner shall designate a state agency to become a licensed
9wholesale distributor or to contract with a licensed wholesale distributor and shall
10seek federal certification and approval to import prescription drugs.
SB539,2,1311 (b) The prescription drug importation program under this section shall comply
12with relevant requirements of 21 USC 384, including safety and cost savings
13requirements.
SB539,2,1614 (c) The prescription drug importation program under this section shall import
15prescription drugs from Canadian suppliers regulated under any appropriate
16Canadian or provincial laws.
SB539,2,1917 (d) The prescription drug importation program under this section shall have
18a process to sample the purity, chemical composition, and potency of imported
19prescription drugs.
SB539,3,220 (e) The prescription drug importation program under this section shall import
21only those prescription drugs for which importation creates substantial savings for

1residents of the state and only those prescription drugs that are not brand-name
2drugs and that have fewer than 4 competitor prescription drugs in the United States.
SB539,3,53 (f) The commissioner shall ensure that prescription drugs imported under the
4program under this section are not distributed, dispensed, or sold outside of the
5state.
SB539,3,76 (g) The prescription drug importation program under this section shall ensure
7all of the following:
SB539,3,98 1. Participation by any pharmacy or health care provider in the program is
9voluntary.
SB539,3,1110 2. Any pharmacy or health care provider participating in the program has the
11appropriate license or other credential in this state.
SB539,3,1412 3. Any pharmacy or health care provider participating in the program charges
13a consumer or health plan the actual acquisition cost of the imported prescription
14drug that is dispensed.
SB539,3,1815 (h) The prescription drug importation program under this section shall ensure
16that a payment by a health plan or health insurance policy for a prescription drug
17imported under the program reimburses no more than the actual acquisition cost of
18the imported prescription drug that is dispensed.
SB539,3,2119 (i) The prescription drug importation program under this section shall ensure
20that any health plan or health insurance policy participating in the program does all
21of the following:
SB539,3,2322 1. Maintains a formulary and claims payment system with current information
23on prescription drugs imported under the program.
SB539,4,3
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.
SB539,4,64 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.
SB539,4,97 (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.
SB539,4,1210 (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.
SB539,4,1713 (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.
SB539,4,2018 (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.
SB539,4,2221 (n) The prescription drug importation program under this section shall have
22an audit function that ensures all of the following:
SB539,4,2523 1. The commissioner has a sound methodology to determine the most
24cost-effective prescription drugs to include in the importation program under this
25section.
SB539,5,2
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.
SB539,5,43 3. Prescription drugs imported under the program are pure, unadulterated,
4potent, and safe.
SB539,5,65 4. The prescription drug importation program is complying with the
6requirements of this subsection.
SB539,5,97 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.
SB539,5,1110 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.
SB539,5,1312 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.
SB539,5,16 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.
SB539,6,2 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.
SB539,6,10 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:
SB539,6,1311 (a) Become a licensed wholesale distributor, designate another state agency to
12become a licensed wholesale distributor, or contract with a licensed wholesale
13distributor.
SB539,6,1514 (b) Contract with one or more Canadian suppliers that meet the criteria in sub.
15(1) (c) and (n).
SB539,6,1916 (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.
SB539,6,2220 (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.
SB539,6,2423 (e) Create a publicly accessible source for listing prices of prescription drugs
24imported under the program.
SB539,7,3
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.
SB539,7,54 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete
5each audit function every 2 years.
SB539,7,86 (h) Conduct any other activities determined by the commissioner to be
7important to successful implementation of the prescription drug importation
8program under this section.
SB539,7,10 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:
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