Amendment AA16-ASA2-AB50

AB50-ASA2-AA16,73,11 (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.

AB50-ASA2-AA16,73,13 (k) The program may not import any generic prescription drug that would violate federal patent laws on branded products in the United States.

AB50-ASA2-AA16,73,18 (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.

AB50-ASA2-AA16,73,20 (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.

AB50-ASA2-AA16,73,21 (n) The program shall have an audit function that ensures all of the following:

AB50-ASA2-AA16,73,23 1. The commissioner has a sound methodology to determine the most cost- effective prescription drugs to include in the program.

AB50-ASA2-AA16,74,2 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.

AB50-ASA2-AA16,74,4 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

AB50-ASA2-AA16,74,5 4. The program is complying with the requirements of this subsection.

AB50-ASA2-AA16,74,7 5. The program is adequately financed to support administrative functions of the program while generating significant cost savings to residents of this state.

AB50-ASA2-AA16,74,9 6. The program does not put residents of this state at a higher risk than if the program did not exist.

AB50-ASA2-AA16,74,11 7. The program provides and is projected to continue to provide substantial cost savings to residents of this state.

AB50-ASA2-AA16,74,14 (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.

AB50-ASA2-AA16,75,2 (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.

AB50-ASA2-AA16,75,10 (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:

AB50-ASA2-AA16,75,13 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.

AB50-ASA2-AA16,75,15 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c) and (n).

AB50-ASA2-AA16,75,18 (c) Create an outreach and marketing plan to communicate with and provide information to health plans and health insurance policies, employers, pharmacies, health care providers, and residents of this state on participating in the program.

AB50-ASA2-AA16,75,21 (d) Develop and implement a registration process for health plans and health insurance policies, pharmacies, and health care providers interested in participating in the program.

AB50-ASA2-AA16,75,23 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

AB50-ASA2-AA16,76,3 (f) Create, publicize, and implement a method of communication to promptly answer questions from and address the needs of persons affected by the implementation of the program before the program is fully operational.

AB50-ASA2-AA16,76,5 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

AB50-ASA2-AA16,76,7 (h) Conduct any other activities determined by the commissioner to be important to successful implementation of the program.

AB50-ASA2-AA16,76,9 (5) Report. By January 1 and July 1 of each year, the commissioner shall submit to the joint committee on finance a report including all of the following:

AB50-ASA2-AA16,76,11 (a) A list of prescription drugs included in the prescription drug importation program under this section.

AB50-ASA2-AA16,76,14 (b) The number of pharmacies, health care providers, and health plans and health insurance policies participating in the prescription drug importation program under this section.

AB50-ASA2-AA16,76,19 (c) The estimated amount of savings to residents of this state, health plans and health insurance policies, and employers resulting from the implementation of the prescription drug importation program under this section reported from the date of the previous report under this subsection and from the date the program was fully operational.

AB50-ASA2-AA16,76,21 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.

AB50-ASA2-AA16,76,23 (6) Rulemaking. The commissioner may promulgate any rules necessary to implement this section.

AB50-ASA2-AA16,9123 Section 9123. Nonstatutory provisions; Insurance.

AB50-ASA2-AA16,77,8 (1) Prescription drug importation program. The commissioner of insurance shall submit the first report required under s. 601.575 (5) by the next January 1 or July 1, whichever is earliest, that is at least 180 days after the date the prescription drug importation program is fully operational under s. 601.575 (4). The commissioner of insurance shall include in the first 3 reports submitted under s. 601.575 (5) information on the implementation of the audit functions under s. 601.575 (1) (n).”.

AB50-ASA2-AA16,77,9 (end)