SB45,1399,20 (c) The program shall import prescription drugs from Canadian suppliers regulated under any appropriate Canadian or provincial laws.

SB45,1399,22 (d) The program shall have a process to sample the purity, chemical composition, and potency of imported prescription drugs.

SB45,1400,2 (e) The program shall import only those prescription drugs for which importation creates substantial savings for residents of this state and only those prescription drugs that are not brand-name drugs and that have fewer than 4 competitor prescription drugs in the United States.

SB45,1400,4 (f) The commissioner shall ensure that prescription drugs imported under the program are not distributed, dispensed, or sold outside of this state.

SB45,1400,5 (g) The program shall ensure all of the following:

SB45,1400,7 1. Participation by any pharmacy or health care provider in the program is voluntary.

SB45,1400,9 2. Any pharmacy or health care provider participating in the program has the appropriate license or other credential in this state.

SB45,1400,12 3. Any pharmacy or health care provider participating in the program charges a consumer or health plan the actual acquisition cost of the imported prescription drug that is dispensed.

SB45,1400,16 (h) The program shall ensure that a payment by a health plan or health insurance policy for a prescription drug imported under the program reimburses no more than the actual acquisition cost of the imported prescription drug that is dispensed.

SB45,1400,18 (i) The program shall ensure that any health plan or health insurance policy participating in the program does all of the following:

SB45,1400,20 1. Maintains a formulary and claims payment system with current information on prescription drugs imported under the program.

SB45,1400,23 2. Bases cost-sharing amounts for participants or insureds under the plan or policy on no more than the actual acquisition cost of the prescription drug imported under the program that is dispensed to the participant or insured.

SB45,1401,3 3. Demonstrates to the commissioner or a state agency designated by the commissioner how premiums under the plan or policy are affected by savings on prescription drugs imported under the program.

SB45,1401,6 (j) Any wholesale distributor importing prescription drugs under the program shall limit its profit margin to the amount established by the commissioner or a state agency designated by the commissioner.

SB45,1401,8 (k) The program may not import any generic prescription drug that would violate federal patent laws on branded products in the United States.

SB45,1401,13 (L) The program shall comply with tracking and tracing requirements of 21 USC 360eee and 360eee-1, to the extent practical and feasible, before the prescription drug to be imported comes into the possession of this state’s wholesale distributor and fully after the prescription drug to be imported is in the possession of this state’s wholesale distributor.

SB45,1401,15 (m) The program shall establish a fee or other mechanism to finance the program that does not jeopardize significant savings to residents of this state.

SB45,1401,16 (n) The program shall have an audit function that ensures all of the following:

SB45,1401,18 1. The commissioner has a sound methodology to determine the most cost- effective prescription drugs to include in the program.

SB45,1401,20 2. The commissioner has a process in place to select Canadian suppliers that are high quality, high performing, and in full compliance with Canadian laws.

SB45,1401,22 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

SB45,1401,23 4. The program is complying with the requirements of this subsection.

SB45,1402,2 5. The program is adequately financed to support administrative functions of the program while generating significant cost savings to residents of this state.

SB45,1402,4 6. The program does not put residents of this state at a higher risk than if the program did not exist.

SB45,1402,6 7. The program provides and is projected to continue to provide substantial cost savings to residents of this state.

SB45,1402,9 (2) Anticompetitive behavior. The commissioner, in consultation with the attorney general, shall identify the potential for and monitor anticompetitive behavior in industries affected by a prescription drug importation program.

SB45,1402,19 (3) Approval of program design; certification. No later than the first day of the 7th month beginning after the effective date of this subsection .... [LRB inserts date], the commissioner shall submit to the joint committee on finance a report that includes the design of the prescription drug importation program in accordance with this section. The commissioner may not submit the proposed program to the federal department of health and human services unless the joint committee on finance approves the proposed program. Within 14 days of the date of approval by the joint committee on finance of the proposed program, the commissioner shall submit to the federal department of health and human services a request for certification of the approved program.

SB45,1403,4 (4) Implementation of certified program. After the federal department of health and human services certifies the prescription drug importation program submitted under sub. (3), the commissioner shall begin implementation of the program, and the program shall be fully operational by 180 days after the date of certification by the federal department of health and human services. The commissioner shall do all of the following to implement the program to the extent the action is in accordance with other state laws and the certification by the federal department of health and human services:

SB45,1403,7 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.