Amendment AA2-ASA2-AB68

AB68-ASA2-AA2,53,20 3. Demonstrates to the commissioner or a state agency designated by the commissioner how premiums under the policy or plan are affected by savings on prescription drugs imported under the program.

AB68-ASA2-AA2,53,23 (j) Any wholesale distributor importing prescription drugs under the program under this section shall limit its profit margin to the amount established by the commissioner or a state agency designated by the commissioner.

AB68-ASA2-AA2,54,3 (k) The prescription drug importation program under this section may not import any generic prescription drug that would violate federal patent laws on branded products in this country.

AB68-ASA2-AA2,54,8 (L) The prescription drug importation program under this section shall comply to the extent practical and feasible, before the prescription drug to be imported comes into the possession of the state's wholesale distributor and fully after the prescription drug to be imported is in the possession of the state's wholesale distributor, with tracking and tracing requirements of 21 USC 360eee to 360eee-1.

AB68-ASA2-AA2,54,11 (m) The prescription drug importation program under this section shall establish a fee or other mechanism to finance the program that does not jeopardize significant savings to residents of the state.

AB68-ASA2-AA2,54,13 (n) The prescription drug importation program under this section shall have an audit function that ensures all of the following:

AB68-ASA2-AA2,54,16 1. The commissioner has a sound methodology to determine the most cost-effective prescription drugs to include in the importation program under this section.

AB68-ASA2-AA2,54,18 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.

AB68-ASA2-AA2,54,20 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

AB68-ASA2-AA2,54,22 4. The prescription drug importation program is complying with the requirements of this subsection.

AB68-ASA2-AA2,54,25 5. The prescription drug importation program under this section is adequately financed to support administrative functions of the program while generating significant cost savings to residents of the state.

AB68-ASA2-AA2,55,2 6. The prescription drug importation program under this section does not put residents of the state at a higher risk than if the program did not exist.

AB68-ASA2-AA2,55,4 7. The prescription drug importation program under this section provides and is projected to continue to provide substantial cost savings to residents of the state.

AB68-ASA2-AA2,55,7 (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.

AB68-ASA2-AA2,55,18 (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 prescription drug importation program to the federal department of health and human services unless the joint committee on finance approves the proposed prescription drug implementation program. Within 14 days of the date of approval by the joint committee on finance of the proposed prescription drug importation program, the commissioner shall submit to the federal department of health and human services a request for certification of the approved prescription drug importation program.

AB68-ASA2-AA2,56,2 (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 prescription drug importation 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:

AB68-ASA2-AA2,56,5 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.

AB68-ASA2-AA2,56,7 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c) and (n).

AB68-ASA2-AA2,56,11 (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 the state on participating in the prescription drug importation program.

AB68-ASA2-AA2,56,14 (d) Develop and implement a registration process for health plans and health insurance policies, pharmacies, and health care providers interested in participating in the prescription drug importation program.

AB68-ASA2-AA2,56,16 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

AB68-ASA2-AA2,56,19 (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.

AB68-ASA2-AA2,56,21 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

AB68-ASA2-AA2,56,24 (h) Conduct any other activities determined by the commissioner to be important to successful implementation of the prescription drug importation program under this section.

AB68-ASA2-AA2,57,2 (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:

AB68-ASA2-AA2,57,4 (a) A list of prescription drugs included in the importation program under this section.

AB68-ASA2-AA2,57,7 (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.

AB68-ASA2-AA2,57,12 (c) The estimated amount of savings to residents of the 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.

AB68-ASA2-AA2,57,14 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.

AB68-ASA2-AA2,57,16 (6) Rulemaking. The commissioner may promulgate any rules necessary to implement this section.

AB68-ASA2-AA2,411k Section 411k. 601.59 of the statutes is created to read:

AB68-ASA2-AA2,57,18 601.59 State-based exchange. (1) Definitions. In this section:

AB68-ASA2-AA2,57,19 (a) “Exchange” has the meaning given in 45 CFR 155.20.

AB68-ASA2-AA2,57,22 (b) “State-based exchange on the federal platform” means an exchange that is described in and meets the requirements of 45 CFR 155.200 (f) and is approved by the federal secretary of health and human services under 45 CFR 155.106.

AB68-ASA2-AA2,58,2 (c) “State-based exchange without the federal platform” means an exchange, other than one described in 45 CFR 155.200 (f), that performs all the functions described in 45 CFR 155.200 (a) and is approved by the federal secretary of health and human services under 45 CFR 155.106.

AB68-ASA2-AA2,58,9 (2) Establishment and operation of state-based exchange. The commissioner shall establish and operate an exchange that at first is a state-based exchange on the federal platform and then subsequently transitions to a state-based exchange without the federal platform. The commissioner shall develop procedures to address the transition from the state-based exchange on the federal platform to the state-based exchange without the federal platform, including the circumstances that shall be met in order for the transition to occur.

AB68-ASA2-AA2,58,12 (3) Agreement with federal government. The commissioner may enter into any agreement with the federal government necessary to facilitate the implementation of this section.

AB68-ASA2-AA2,58,18 (4) User fees. The commissioner shall impose a user fee, as authorized under 45 CFR 155.160 (b) (1), on each insurer that offers a health plan through the state-based exchange on the federal platform or the state-based exchange without the federal platform. The user fee shall be applied at one of the following rates on the total monthly premiums charged by an insurer for each policy under the plan where enrollment is through the exchange:

AB68-ASA2-AA2,58,20 (a) For any plan year for which the commissioner operates a state-based exchange on the federal platform, the rate is 0.5 percent.

AB68-ASA2-AA2,58,22 (b) For the first 2 plan years for which the commissioner operates a state-based exchange without the federal platform, the rate is 3 percent.

AB68-ASA2-AA2,58,25 (c) Beginning with the 3rd plan year for which the commissioner operates a state-based exchange without the federal platform, the rate shall be set by the commissioner by rule.

AB68-ASA2-AA2,59,2 (5) Rules. The commissioner may promulgate rules necessary to implement this section.

AB68-ASA2-AA2,411n Section 411n. Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

AB68-ASA2-AA2,59,5 CHAPTER 601

AB68-ASA2-AA2,59,7 SUBCHAPTER VI Prescription drug

AB68-ASA2-AA2,59,8 affordability review board

AB68-ASA2-AA2,59,9 601.78 Definitions. In this subchapter:

AB68-ASA2-AA2,59,11 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

AB68-ASA2-AA2,59,13 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

AB68-ASA2-AA2,59,15 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

AB68-ASA2-AA2,59,18 (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.

AB68-ASA2-AA2,59,20 (5) “Drug product” means a brand name drug, a generic drug, a biologic, a biosimilar, or an over-the-counter drug.

AB68-ASA2-AA2,59,24 (6) “Financial benefit” includes an honoraria, fee, stock, the value of the stock holdings of a member of the board or any immediate family member, as defined in s. 97.605 (4) (a) 2., and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

AB68-ASA2-AA2,59,25 (7) “Generic drug” means any of the following:

AB68-ASA2-AA2,60,2 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

AB68-ASA2-AA2,60,3 (b) An authorized generic drug, as defined in 42 CFR 447.502.

AB68-ASA2-AA2,60,5 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

AB68-ASA2-AA2,60,6 (8) “Manufacturer” means an entity that does all of the following:

AB68-ASA2-AA2,60,9 (a) Engages in the manufacture of a drug product or enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name.

AB68-ASA2-AA2,60,11 (b) Sets or changes the wholesale acquisition cost of the drug product or prescription drug product described in par. (a).

AB68-ASA2-AA2,60,13 (9) “Over-the-counter drug” means a drug intended for human use that does not require a prescription and meets the requirements of 21CFR parts 328 to 364.

AB68-ASA2-AA2,60,14 (10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68-ASA2-AA2,60,16 (11) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB68-ASA2-AA2,60,21 601.785 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.

AB68-ASA2-AA2,60,22 (2) Powers and duties. (a) The board shall do all of the following:

AB68-ASA2-AA2,60,25 1. Meet in open session at least 4 times per year to review prescription drug product pricing information, except that the chair may cancel or postpone a meeting if there is no business to transact.

AB68-ASA2-AA2,61,2 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

AB68-ASA2-AA2,61,5 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

AB68-ASA2-AA2,61,6 b. Assessing spending for specific prescription drug products in this state.

AB68-ASA2-AA2,61,7 c. Accessing other available pricing information.

AB68-ASA2-AA2,61,8 (b) The board may:

AB68-ASA2-AA2,61,9 1. Promulgate rules for the administration of this subchapter.

AB68-ASA2-AA2,61,14 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.

AB68-ASA2-AA2,61,18 (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.

AB68-ASA2-AA2,61,21 (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.

AB68-ASA2-AA2,61,24 (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.

AB68-ASA2-AA2,62,2 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

AB68-ASA2-AA2,62,6 (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, as defined in s. 97.605 (4) (a) 2., has received or could receive any of the following:

AB68-ASA2-AA2,62,8 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.

AB68-ASA2-AA2,62,11 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.

AB68-ASA2-AA2,62,15 (b) A conflict of interest 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 final decision resulting from a review of a prescription drug product.

AB68-ASA2-AA2,62,18 (c) A conflict of interest 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.

AB68-ASA2-AA2,62,23 (d) The board shall disclose a conflict of interest under this subsection on the board's Internet site unless the chair of the board recuses the member from a final decision resulting from a review of the prescription drug product. The disclosure shall include the type, nature, and magnitude of the interests of the member involved.

AB68-ASA2-AA2,63,3 (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.

AB68-ASA2-AA2,63,5 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

AB68-ASA2-AA2,63,10 (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 or whose wholesale acquisition cost increased at least $3,000 during a 12–month period.

AB68-ASA2-AA2,63,13 (b) A biosimilar drug 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.

AB68-ASA2-AA2,63,17 (c) A generic drug that has a wholesale acquisition cost, 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, that meets all of the following conditions:

AB68-ASA2-AA2,63,23 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the U.S. food and drug administration, a supply lasting a patient for fewer than 30 days based on the recommended dosage approved for labeling by the federal food and drug administration, or one unit of the drug if the labeling approved by the federal food and drug administration does not recommend a finite dosage.