Amendment AA16-ASA2-AB50

AB50-ASA2-AA16,68,21 (2) Licensure. Beginning on the first day of the 12th month beginning after the effective date of this subsection .... [LRB inserts date], no individual may act as a pharmaceutical representative in this state without being licensed by the commissioner as a pharmaceutical representative under this subsection. In order to obtain a license under this subsection, the individual shall apply to the commissioner in the form and manner prescribed by the commissioner and shall pay the fee under s. 601.31 (1) (nv). The term of a license issued under this subsection is one year, and the license is renewable.

AB50-ASA2-AA16,69,2 (3) Display of license. A pharmaceutical representative licensed under sub. (2) shall display the pharmaceutical representative’s license during each visit with a health care professional.

AB50-ASA2-AA16,69,6 (4) Enforcement. (a) Any individual who violates this section or any rules promulgated under this section shall be fined not less than $1,000 nor more than $3,000 for each offense. Each day of continued violation constitutes a separate offense.

AB50-ASA2-AA16,69,11 (b) The commissioner may suspend or revoke the license of a pharmaceutical representative who violates this section or any rules promulgated under this section. A suspended or revoked license under this paragraph may not be reinstated until the pharmaceutical representative remedies all violations related to the suspension or revocation and pays all assessed penalties and fees.

AB50-ASA2-AA16,69,14 (5) Rules. The commissioner shall promulgate rules to implement this section, including rules that require pharmaceutical representatives to complete continuing educational coursework as a condition of licensure.”.

AB50-ASA2-AA16,69,15 25. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,69,16 “Section 76. 601.31 (1) (mv) of the statutes is created to read:

AB50-ASA2-AA16,69,19 601.31 (1) (mv) For initial issuance or renewal of a license as a pharmacy benefit management broker or consultant under s. 628.495, amounts set by the commissioner by rule.

AB50-ASA2-AA16,77 Section 77. 628.495 of the statutes is created to read:

AB50-ASA2-AA16,69,23 628.495 Pharmacy benefit management broker and consultant licenses. (1) Definition. In this section, “pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50-ASA2-AA16,70,5 (2) License required. Beginning on the first day of the 12th month beginning after the effective date of this subsection .... [LRB inserts date], no individual may act as a pharmacy benefit management broker or consultant and no individual may act to procure the services of a pharmacy benefit manager on behalf of a client without being licensed by the commissioner under this section.

AB50-ASA2-AA16,70,8 (3) Rules. The commissioner may promulgate rules to establish criteria and procedures for initial licensure and renewal of licensure and to implement licensure under this section.”.

AB50-ASA2-AA16,70,9 26. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,70,10 “Section 78. 632.865 (2m) of the statutes is created to read:

AB50-ASA2-AA16,70,14 632.865 (2m) Fiduciary duty and disclosures to health benefit plan sponsors. (a) A pharmacy benefit manager owes a fiduciary duty to the health benefit plan sponsor to act according to the health benefit plan sponsor’s instructions and in the best interests of the health benefit plan sponsor.

AB50-ASA2-AA16,70,18 (b) A pharmacy benefit manager shall annually provide, no later than the date and using the method prescribed by the commissioner by rule, the health benefit plan sponsor all of the following information from the previous calendar year:

AB50-ASA2-AA16,70,20 1. The indirect profit received by the pharmacy benefit manager from owning any interest in a pharmacy or service provider.

AB50-ASA2-AA16,70,22 2. Any payment made by the pharmacy benefit manager to a consultant or broker who works on behalf of the health benefit plan sponsor.

AB50-ASA2-AA16,71,3 3. From the amounts received from all drug manufacturers, the amounts retained by the pharmacy benefit manager, and not passed through to the health benefit plan sponsor, that are related to the health benefit plan sponsor’s claims or bona fide service fees.

AB50-ASA2-AA16,71,8 4. The amounts, including pharmacy access and audit recovery fees, received from all pharmacies that are in the pharmacy benefit manager’s network or have a contract to be in the network and, from these amounts, the amount retained by the pharmacy benefit manager and not passed through to the health benefit plan sponsor.”.

AB50-ASA2-AA16,71,9 27. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,71,10 “Section 79. 601.575 of the statutes is created to read:

AB50-ASA2-AA16,71,16 601.575 Prescription drug importation program. (1) Importation program requirements. The commissioner, in consultation with persons interested in the sale and pricing of prescription drugs and appropriate officials and agencies of the federal government, shall design and implement a prescription drug importation program for the benefit of residents of this state, that generates savings for residents, and that satisfies all of the following:

AB50-ASA2-AA16,71,19 (a) The commissioner shall designate a state agency to become a licensed wholesale distributor or to contract with a licensed wholesale distributor and shall seek federal certification and approval to import prescription drugs.

AB50-ASA2-AA16,71,21 (b) The program shall comply with relevant requirements of 21 USC 384, including safety and cost savings requirements.

AB50-ASA2-AA16,71,23 (c) The program shall import prescription drugs from Canadian suppliers regulated under any appropriate Canadian or provincial laws.

AB50-ASA2-AA16,72,2 (d) The program shall have a process to sample the purity, chemical composition, and potency of imported prescription drugs.

AB50-ASA2-AA16,72,6 (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.

AB50-ASA2-AA16,72,8 (f) The commissioner shall ensure that prescription drugs imported under the program are not distributed, dispensed, or sold outside of this state.

AB50-ASA2-AA16,72,9 (g) The program shall ensure all of the following:

AB50-ASA2-AA16,72,11 1. Participation by any pharmacy or health care provider in the program is voluntary.

AB50-ASA2-AA16,72,13 2. Any pharmacy or health care provider participating in the program has the appropriate license or other credential in this state.

AB50-ASA2-AA16,72,16 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.

AB50-ASA2-AA16,72,20 (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.

AB50-ASA2-AA16,72,22 (i) The program shall ensure that any health plan or health insurance policy participating in the program does all of the following:

AB50-ASA2-AA16,73,2 1. Maintains a formulary and claims payment system with current information on prescription drugs imported under the program.

AB50-ASA2-AA16,73,5 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.

AB50-ASA2-AA16,73,8 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.

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)