Amendment AA8-ASA2-AB50

AB50-ASA2-AA8,135,10 (f) The commissioner shall ensure that prescription drugs imported under the program are not distributed, dispensed, or sold outside of this state.

AB50-ASA2-AA8,135,11 (g) The program shall ensure all of the following:

AB50-ASA2-AA8,135,13 1. Participation by any pharmacy or health care provider in the program is voluntary.

AB50-ASA2-AA8,135,15 2. Any pharmacy or health care provider participating in the program has the appropriate license or other credential in this state.

AB50-ASA2-AA8,135,18 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-AA8,135,22 (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-AA8,136,2 (i) The program shall ensure that any health plan or health insurance policy participating in the program does all of the following:

AB50-ASA2-AA8,136,4 1. Maintains a formulary and claims payment system with current information on prescription drugs imported under the program.

AB50-ASA2-AA8,136,7 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-AA8,136,10 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-AA8,136,13 (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-AA8,136,15 (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-AA8,136,20 (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-AA8,136,22 (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-AA8,136,23 (n) The program shall have an audit function that ensures all of the following:

AB50-ASA2-AA8,137,2 1. The commissioner has a sound methodology to determine the most cost- effective prescription drugs to include in the program.

AB50-ASA2-AA8,137,4 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-AA8,137,6 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

AB50-ASA2-AA8,137,7 4. The program is complying with the requirements of this subsection.

AB50-ASA2-AA8,137,9 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-AA8,137,11 6. The program does not put residents of this state at a higher risk than if the program did not exist.

AB50-ASA2-AA8,137,13 7. The program provides and is projected to continue to provide substantial cost savings to residents of this state.

AB50-ASA2-AA8,137,16 (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-AA8,138,3 (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-AA8,138,11 (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-AA8,138,14 (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-AA8,138,16 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c) and (n).

AB50-ASA2-AA8,138,19 (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-AA8,138,22 (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-AA8,139,2 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

AB50-ASA2-AA8,139,5 (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-AA8,139,7 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

AB50-ASA2-AA8,139,9 (h) Conduct any other activities determined by the commissioner to be important to successful implementation of the program.

AB50-ASA2-AA8,139,11 (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-AA8,139,13 (a) A list of prescription drugs included in the prescription drug importation program under this section.

AB50-ASA2-AA8,139,16 (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-AA8,139,21 (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-AA8,139,23 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.

AB50-ASA2-AA8,140,2 (6) Rulemaking. The commissioner may promulgate any rules necessary to implement this section.

AB50-ASA2-AA8,267 Section 267. Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

AB50-ASA2-AA8,140,5 CHAPTER 601

AB50-ASA2-AA8,140,6 SUBCHAPTER VI

AB50-ASA2-AA8,140,7 PRESCRIPTION DRUG

AB50-ASA2-AA8,140,8 AFFORDABILITY REVIEW BOARD

AB50-ASA2-AA8,268 Section 268. 601.78 of the statutes is created to read:

AB50-ASA2-AA8,140,10 601.78 Definitions. In this subchapter:

AB50-ASA2-AA8,140,12 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

AB50-ASA2-AA8,140,14 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

AB50-ASA2-AA8,140,16 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

AB50-ASA2-AA8,140,19 (4) “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 USC 355 (c), other than an authorized generic drug, as defined in 42 CFR 447.502.

AB50-ASA2-AA8,140,23 (5) “Financial benefit” includes an honorarium, fee, stock, the value of the stock holdings of a member of the board or any immediate family member of the member of the board, and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

AB50-ASA2-AA8,141,1 (6) “Generic drug” means any of the following:

AB50-ASA2-AA8,141,3 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

AB50-ASA2-AA8,141,4 (b) An authorized generic drug, as defined in 42 CFR 447.502.

AB50-ASA2-AA8,141,6 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

AB50-ASA2-AA8,141,9 (7) “Immediate family member” means a spouse, grandparent, parent, sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent, sibling, child, stepchild, or grandchild.

AB50-ASA2-AA8,141,10 (8) “Manufacturer” means an entity that does all of the following:

AB50-ASA2-AA8,141,13 (a) Engages in the manufacture of a prescription drug product or enters into a lease with another entity to market and distribute a prescription drug product under the entity’s own name.

AB50-ASA2-AA8,141,15 (b) Sets or changes the wholesale acquisition cost of the prescription drug product described in par. (a).

AB50-ASA2-AA8,141,16 (9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50-ASA2-AA8,141,18 (10) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB50-ASA2-AA8,269 Section 269. 601.785 of the statutes is created to read:

AB50-ASA2-AA8,142,2 601.785 Prescription drug affordability review board. (1) Mission. The purpose of the board is to protect state residents, the state, local governments, health plans, health care providers, pharmacies licensed in this state, and other stakeholders of the health care system in this state from the high costs of prescription drug products.

AB50-ASA2-AA8,142,3 (2) Powers and duties. (a) The board shall do all of the following:

AB50-ASA2-AA8,142,6 1. Meet in open session at least 4 times per year to review prescription drug product pricing information in the manner described in subd. 2., except that the chairperson may cancel or postpone a meeting if there is no business to transact.

AB50-ASA2-AA8,142,8 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

AB50-ASA2-AA8,142,11 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

AB50-ASA2-AA8,142,12 b. Assessing spending for specific prescription drug products in this state.

AB50-ASA2-AA8,142,13 c. Accessing other available pricing information.

AB50-ASA2-AA8,142,14 (b) The board may do any of the following:

AB50-ASA2-AA8,142,15 1. Promulgate rules for the administration of this subchapter.

AB50-ASA2-AA8,142,20 2. Enter into a contract with an independent 3rd party for any service necessary to carry out the powers and duties of the board. Unless written permission is granted by the board, any person with whom the board contracts may not release, publish, or otherwise use any information to which the person has access under the contract.

AB50-ASA2-AA8,142,23 (c) The board shall establish and maintain a website to provide public notices and make meeting materials available under sub. (3) (a) and to disclose conflicts of interest under sub. (4) (d).

AB50-ASA2-AA8,143,4 (3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide public notice of each board meeting at least 2 weeks prior to the meeting and shall make the materials for each meeting publicly available at least one week prior to the meeting.

AB50-ASA2-AA8,143,7 (b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for public comment at each open meeting and shall provide the public with the opportunity to provide written comments on pending decisions of the board.

AB50-ASA2-AA8,143,10 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board concerning proprietary data and information shall be conducted in closed session and shall in all respects remain confidential.

AB50-ASA2-AA8,143,12 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

AB50-ASA2-AA8,143,16 (4) Conflicts of interest. (a) A member of the board shall recuse himself or herself from a decision by the board relating to a prescription drug product if the member or an immediate family member of the member has received or could receive any of the following:

AB50-ASA2-AA8,143,18 1. A direct financial benefit deriving from a determination, or a finding of a study or review, by the board relating to the prescription drug product.

AB50-ASA2-AA8,143,21 2. A financial benefit in excess of $5,000 in a calendar year from any person who owns, manufactures, or provides a prescription drug product to be studied or reviewed by the board.

AB50-ASA2-AA8,144,2 (b) A conflict of interest under this subsection shall be disclosed by the board when hiring board staff, by the appointing authority when appointing members to the board, and by the board when a member of the board is recused from any decision relating to a review of a prescription drug product.

AB50-ASA2-AA8,144,6 (c) A conflict of interest under this subsection shall be disclosed no later than 5 days after the conflict is identified, except that, if the conflict is identified within 5 days of an open meeting of the board, the conflict shall be disclosed prior to the meeting.

AB50-ASA2-AA8,144,11 (d) The board shall disclose a conflict of interest under this subsection on the board’s website unless the chairperson of the board recuses the member from a final decision relating to a review of the prescription drug product. The disclosure shall include the type, nature, and magnitude of the interests of the member involved.

AB50-ASA2-AA8,144,14 (e) A member of the board or a 3rd-party contractor may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the board.

AB50-ASA2-AA8,270 Section 270. 601.79 of the statutes is created to read:

AB50-ASA2-AA8,144,17 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

AB50-ASA2-AA8,144,21 (a) A brand name drug or biologic that, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, has a launch wholesale acquisition cost of at least $30,000 per year or course of treatment.

AB50-ASA2-AA8,145,2 (b) A brand name drug or biologic that, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, has a wholesale acquisition cost that has increased by at least $3,000 during a 12-month period.

AB50-ASA2-AA8,145,5 (c) A biosimilar that has a launch wholesale acquisition cost that is not at least 15 percent lower than the referenced brand biologic at the time the biosimilar is launched.