AB50-ASA2-AA16,68,2114(2) Licensure. Beginning on the first day of the 12th month beginning after 15the effective date of this subsection .... [LRB inserts date], no individual may act as 16a pharmaceutical representative in this state without being licensed by the 17commissioner as a pharmaceutical representative under this subsection. In order 18to obtain a license under this subsection, the individual shall apply to the 19commissioner in the form and manner prescribed by the commissioner and shall 20pay the fee under s. 601.31 (1) (nv). The term of a license issued under this 21subsection is one year, and the license is renewable. AB50-ASA2-AA16,69,222(3) Display of license. A pharmaceutical representative licensed under sub.
1(2) shall display the pharmaceutical representative’s license during each visit with 2a health care professional. AB50-ASA2-AA16,69,63(4) Enforcement. (a) Any individual who violates this section or any rules 4promulgated under this section shall be fined not less than $1,000 nor more than 5$3,000 for each offense. Each day of continued violation constitutes a separate 6offense. AB50-ASA2-AA16,69,117(b) The commissioner may suspend or revoke the license of a pharmaceutical 8representative who violates this section or any rules promulgated under this 9section. A suspended or revoked license under this paragraph may not be 10reinstated until the pharmaceutical representative remedies all violations related 11to the suspension or revocation and pays all assessed penalties and fees. AB50-ASA2-AA16,69,1412(5) Rules. The commissioner shall promulgate rules to implement this 13section, including rules that require pharmaceutical representatives to complete 14continuing educational coursework as a condition of licensure.”. AB50-ASA2-AA16,69,1917601.31 (1) (mv) For initial issuance or renewal of a license as a pharmacy 18benefit management broker or consultant under s. 628.495, amounts set by the 19commissioner by rule. AB50-ASA2-AA16,69,2321628.495 Pharmacy benefit management broker and consultant 22licenses. (1) Definition. In this section, “pharmacy benefit manager” has the 23meaning given in s. 632.865 (1) (c). AB50-ASA2-AA16,70,5
1(2) License required. Beginning on the first day of the 12th month 2beginning after the effective date of this subsection .... [LRB inserts date], no 3individual may act as a pharmacy benefit management broker or consultant and no 4individual may act to procure the services of a pharmacy benefit manager on behalf 5of a client without being licensed by the commissioner under this section. AB50-ASA2-AA16,70,86(3) Rules. The commissioner may promulgate rules to establish criteria and 7procedures for initial licensure and renewal of licensure and to implement licensure 8under this section.”. AB50-ASA2-AA16,70,1411632.865 (2m) Fiduciary duty and disclosures to health benefit plan 12sponsors. (a) A pharmacy benefit manager owes a fiduciary duty to the health 13benefit plan sponsor to act according to the health benefit plan sponsor’s 14instructions and in the best interests of the health benefit plan sponsor. AB50-ASA2-AA16,70,1815(b) A pharmacy benefit manager shall annually provide, no later than the 16date and using the method prescribed by the commissioner by rule, the health 17benefit plan sponsor all of the following information from the previous calendar 18year: AB50-ASA2-AA16,70,20191. The indirect profit received by the pharmacy benefit manager from owning 20any interest in a pharmacy or service provider. AB50-ASA2-AA16,70,22212. Any payment made by the pharmacy benefit manager to a consultant or 22broker who works on behalf of the health benefit plan sponsor. AB50-ASA2-AA16,71,3233. From the amounts received from all drug manufacturers, the amounts
1retained by the pharmacy benefit manager, and not passed through to the health 2benefit plan sponsor, that are related to the health benefit plan sponsor’s claims or 3bona fide service fees. AB50-ASA2-AA16,71,844. The amounts, including pharmacy access and audit recovery fees, received 5from all pharmacies that are in the pharmacy benefit manager’s network or have a 6contract to be in the network and, from these amounts, the amount retained by the 7pharmacy benefit manager and not passed through to the health benefit plan 8sponsor.”. AB50-ASA2-AA16,71,1611601.575 Prescription drug importation program. (1) Importation 12program requirements. The commissioner, in consultation with persons 13interested in the sale and pricing of prescription drugs and appropriate officials 14and agencies of the federal government, shall design and implement a prescription 15drug importation program for the benefit of residents of this state, that generates 16savings for residents, and that satisfies all of the following: AB50-ASA2-AA16,71,1917(a) The commissioner shall designate a state agency to become a licensed 18wholesale distributor or to contract with a licensed wholesale distributor and shall 19seek federal certification and approval to import prescription drugs. AB50-ASA2-AA16,71,2120(b) The program shall comply with relevant requirements of 21 USC 384, 21including safety and cost savings requirements. AB50-ASA2-AA16,71,2322(c) The program shall import prescription drugs from Canadian suppliers 23regulated under any appropriate Canadian or provincial laws. AB50-ASA2-AA16,72,2
1(d) The program shall have a process to sample the purity, chemical 2composition, and potency of imported prescription drugs. AB50-ASA2-AA16,72,63(e) The program shall import only those prescription drugs for which 4importation creates substantial savings for residents of this state and only those 5prescription drugs that are not brand-name drugs and that have fewer than 4 6competitor prescription drugs in the United States. AB50-ASA2-AA16,72,87(f) The commissioner shall ensure that prescription drugs imported under the 8program are not distributed, dispensed, or sold outside of this state. AB50-ASA2-AA16,72,99(g) The program shall ensure all of the following: AB50-ASA2-AA16,72,11101. Participation by any pharmacy or health care provider in the program is 11voluntary. AB50-ASA2-AA16,72,13122. Any pharmacy or health care provider participating in the program has the 13appropriate license or other credential in this state. AB50-ASA2-AA16,72,16143. Any pharmacy or health care provider participating in the program charges 15a consumer or health plan the actual acquisition cost of the imported prescription 16drug that is dispensed. AB50-ASA2-AA16,72,2017(h) The program shall ensure that a payment by a health plan or health 18insurance policy for a prescription drug imported under the program reimburses no 19more than the actual acquisition cost of the imported prescription drug that is 20dispensed. AB50-ASA2-AA16,72,2221(i) The program shall ensure that any health plan or health insurance policy 22participating in the program does all of the following: AB50-ASA2-AA16,73,2
11. Maintains a formulary and claims payment system with current 2information on prescription drugs imported under the program. AB50-ASA2-AA16,73,532. Bases cost-sharing amounts for participants or insureds under the plan or 4policy on no more than the actual acquisition cost of the prescription drug imported 5under the program that is dispensed to the participant or insured. AB50-ASA2-AA16,73,863. Demonstrates to the commissioner or a state agency designated by the 7commissioner how premiums under the plan or policy are affected by savings on 8prescription drugs imported under the program. AB50-ASA2-AA16,73,119(j) Any wholesale distributor importing prescription drugs under the program 10shall limit its profit margin to the amount established by the commissioner or a 11state agency designated by the commissioner. AB50-ASA2-AA16,73,1312(k) The program may not import any generic prescription drug that would 13violate federal patent laws on branded products in the United States. AB50-ASA2-AA16,73,1814(L) The program shall comply with tracking and tracing requirements of 21 15USC 360eee and 360eee-1, to the extent practical and feasible, before the 16prescription drug to be imported comes into the possession of this state’s wholesale 17distributor and fully after the prescription drug to be imported is in the possession 18of this state’s wholesale distributor. AB50-ASA2-AA16,73,2019(m) The program shall establish a fee or other mechanism to finance the 20program that does not jeopardize significant savings to residents of this state. AB50-ASA2-AA16,73,2121(n) The program shall have an audit function that ensures all of the following: AB50-ASA2-AA16,73,23221. The commissioner has a sound methodology to determine the most cost-23effective prescription drugs to include in the program. AB50-ASA2-AA16,74,2
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. AB50-ASA2-AA16,74,433. Prescription drugs imported under the program are pure, unadulterated, 4potent, and safe. AB50-ASA2-AA16,74,554. The program is complying with the requirements of this subsection. AB50-ASA2-AA16,74,765. The program is adequately financed to support administrative functions of 7the program while generating significant cost savings to residents of this state. AB50-ASA2-AA16,74,986. The program does not put residents of this state at a higher risk than if the 9program did not exist. AB50-ASA2-AA16,74,11107. The program provides and is projected to continue to provide substantial 11cost savings to residents of this state. AB50-ASA2-AA16,74,1412(2) Anticompetitive behavior. The commissioner, in consultation with the 13attorney general, shall identify the potential for and monitor anticompetitive 14behavior in industries affected by a prescription drug importation program. AB50-ASA2-AA16,75,215(3) Approval of program design; certification. No later than the first day 16of the 7th month beginning after the effective date of this subsection .... [LRB 17inserts date], the commissioner shall submit to the joint committee on finance a 18report that includes the design of the prescription drug importation program in 19accordance with this section. The commissioner may not submit the proposed 20program to the federal department of health and human services unless the joint 21committee on finance approves the proposed program. Within 14 days of the date of 22approval by the joint committee on finance of the proposed program, the
1commissioner shall submit to the federal department of health and human services 2a request for certification of the approved program. AB50-ASA2-AA16,75,103(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 program to the extent 9the action is in accordance with other state laws and the certification by the federal 10department of health and human services: AB50-ASA2-AA16,75,1311(a) Become a licensed wholesale distributor, designate another state agency to 12become a licensed wholesale distributor, or contract with a licensed wholesale 13distributor. AB50-ASA2-AA16,75,1514(b) Contract with one or more Canadian suppliers that meet the criteria in 15sub. (1) (c) and (n). AB50-ASA2-AA16,75,1816(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 this state on participating in the program. AB50-ASA2-AA16,75,2119(d) Develop and implement a registration process for health plans and health 20insurance policies, pharmacies, and health care providers interested in 21participating in the program. AB50-ASA2-AA16,75,2322(e) Create a publicly accessible source for listing prices of prescription drugs 23imported under the program. AB50-ASA2-AA16,76,3
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. AB50-ASA2-AA16,76,54(g) Establish the audit functions under sub. (1) (n) with a timeline to complete 5each audit function every 2 years. AB50-ASA2-AA16,76,76(h) Conduct any other activities determined by the commissioner to be 7important to successful implementation of the program. AB50-ASA2-AA16,76,98(5) Report. By January 1 and July 1 of each year, the commissioner shall 9submit to the joint committee on finance a report including all of the following: AB50-ASA2-AA16,76,1110(a) A list of prescription drugs included in the prescription drug importation 11program under this section. AB50-ASA2-AA16,76,1412(b) The number of pharmacies, health care providers, and health plans and 13health insurance policies participating in the prescription drug importation 14program under this section. AB50-ASA2-AA16,76,1915(c) The estimated amount of savings to residents of this state, health plans 16and health insurance policies, and employers resulting from the implementation of 17the prescription drug importation program under this section reported from the 18date of the previous report under this subsection and from the date the program 19was fully operational. AB50-ASA2-AA16,76,2120(d) Findings of any audit functions under sub. (1) (n) completed since the date 21of the previous report under this subsection. AB50-ASA2-AA16,76,2322(6) Rulemaking. The commissioner may promulgate any rules necessary to 23implement this section. AB50-ASA2-AA16,77,82(1) Prescription drug importation program. The commissioner of 3insurance shall submit the first report required under s. 601.575 (5) by the next 4January 1 or July 1, whichever is earliest, that is at least 180 days after the date the 5prescription drug importation program is fully operational under s. 601.575 (4). 6The commissioner of insurance shall include in the first 3 reports submitted under 7s. 601.575 (5) information on the implementation of the audit functions under s. 8601.575 (1) (n).”.
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