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1(a) The department shall designate a state agency to become a licensed
2wholesale distributor or to contract with a licensed wholesale distributor and shall
3seek federal certification and approval to import prescription drugs.
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(b) The prescription drug importation program under this section shall comply
5with relevant requirements of
21 USC 384, including safety and cost savings
6requirements.
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(c) The prescription drug importation program under this section shall import
8prescription drugs from Canadian suppliers regulated under any appropriate
9Canadian or provincial laws.
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(d) The prescription drug importation program under this section shall have
11a process to sample the purity, chemical composition, and potency of imported
12prescription drugs.
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(e) The prescription drug importation program under this section shall import
14only those prescription drugs for which importation creates substantial savings for
15residents of the state and only those prescription drugs that are not brand-name
16drugs and that have fewer than 4 competitor prescription drugs in the United States.
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(f) The department shall ensure that prescription drugs imported under the
18program under this section are not distributed, dispensed, or sold outside of the
19state.
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(g) The prescription drug importation program under this section shall ensure
21all of the following:
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1. Participation by any pharmacy or health care provider in the program is
23voluntary.
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2. Any pharmacy or health care provider participating in the program has the
25appropriate license or other credential in this state.
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13. Any pharmacy or health care provider participating in the program charges
2a consumer or health plan the actual acquisition cost of the imported prescription
3drug that is dispensed.
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(h) The prescription drug importation program under this section shall ensure
5that a payment by a health plan or health insurance policy for a prescription drug
6imported under the program reimburses no more than the actual acquisition cost of
7the imported prescription drug that is dispensed.
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(i) The prescription drug importation program under this section shall ensure
9that any health plan or health insurance policy participating in the program does all
10of the following:
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1. Maintains a formulary and claims payment system with current information
12on prescription drugs imported under the program.
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2. Bases cost-sharing amounts for participants or insureds under the plan or
14policy on no more than the actual acquisition cost of the prescription drug imported
15under the program that is dispensed to the participant or insured.
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3. Demonstrates to the department or a state agency designated by the
17department how premiums under the policy or plan are affected by savings on
18prescription drugs imported under the program.
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(j) Any wholesale distributor importing prescription drugs under the program
20under this section shall limit its profit margin to the amount established by the
21department or a state agency designated by the department.
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(k) The prescription drug importation program under this section may not
23import any generic prescription drug that would violate federal patent laws on
24branded products in this country.
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1(L) The prescription drug importation program under this section shall comply
2to the extent practical and feasible before the prescription drug to be imported comes
3into possession of the state's wholesale distributor and fully after the prescription
4drug to be imported is in possession of the state's wholesale distributor with tracking
5and tracing requirements of
21 USC 360eee to
360eee-1.
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(m) The prescription drug importation program under this section shall
7establish a fee or other approach to finance the program that does not jeopardize
8significant savings to residents of the state.
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(n) The prescription drug importation program under this section shall have
10an audit function that ensures all of the following:
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1. The department has a sound methodology to determine the most
12cost-effective prescription drugs to include in the importation program under this
13section.
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2. The department has a process in place to select Canadian suppliers that are
15high quality, high performing, and in full compliance with Canadian laws.
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3. Prescription drugs imported under the program are pure, unadulterated,
17potent, and safe.
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4. The prescription drug importation program is complying with the
19requirements of this subsection.
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5. The prescription drug importation program under this section is adequately
21financed to support administrative functions of the program while generating
22significant cost savings to residents of the state.
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6. The prescription drug importation program under this section does not put
24residents of the state at a higher risk than if the program did not exist.
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17. The prescription drug importation program under this section provides and
2is projected to continue to provide substantial cost savings to residents of the state.
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3(2) Anticompetitive behavior. The department, in consultation with the
4attorney general, shall identify the potential for and monitor anticompetitive
5behavior in industries affected by a prescription drug importation program.
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6(3) Approval of program design; certification. No later than the first day of
7the 7th month beginning after the effective date of this subsection .... [LRB inserts
8date], the department shall submit to the joint committee on finance a report that
9includes the design of the prescription drug importation program in accordance with
10this section. The department may not submit the proposed prescription drug
11importation program to the federal department of health and human services unless
12the joint committee on finance approves the proposed prescription drug
13implementation program. Within 14 days of the date of approval by the joint
14committee on finance of the proposed prescription drug importation program, the
15department shall submit to the federal department of health and human services a
16request for certification of the approved prescription drug importation program.