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(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.
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(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.
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(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.
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(n) The prescription drug importation program under this section shall have
22an audit function that ensures all of the following:
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1. The commissioner has a sound methodology to determine the most
24cost-effective prescription drugs to include in the importation program under this
25section.
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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.
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3. Prescription drugs imported under the program are pure, unadulterated,
4potent, and safe.
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4. The prescription drug importation program is complying with the
6requirements of this subsection.
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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.
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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.
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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.
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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.
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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.
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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:
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(a) Become a licensed wholesale distributor, designate another state agency to
12become a licensed wholesale distributor, or contract with a licensed wholesale
13distributor.
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(b) Contract with one or more Canadian suppliers that meet the criteria in sub.
15(1) (c) and (n).
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(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.
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(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.
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(e) Create a publicly accessible source for listing prices of prescription drugs
24imported under the program.
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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.
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(g) Establish the audit functions under sub. (1) (n) with a timeline to complete
5each audit function every 2 years.
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(h) Conduct any other activities determined by the commissioner to be
7important to successful implementation of the prescription drug importation
8program under this section.
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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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(a) A list of prescription drugs included in the importation program under this
12section.
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(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.
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(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.
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(d) Findings of any audit functions under sub. (1) (n) completed since the date
22of the previous report under this subsection.
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23(6) Rulemaking. The commissioner may promulgate any rules necessary to
24implement this section.
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25Section 9123.
Nonstatutory provisions; Insurance.
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1(1)
Prescription drug importation program. The commissioner of insurance
2shall submit the first report required under s. 601.575 (5) by the next January 1 or
3July 1, whichever is earliest, that is at least 180 days after the date the prescription
4drug importation program is fully operational under s. 601.575 (4). The
5commissioner of insurance shall include in the first 3 reports submitted under s.
6601.575 (5) information on the implementation of the audit functions under s.
7601.575 (1) (n).