SB50: Bill Text

SB50,16,7 (k) The program may not import any generic prescription drug that would violate federal patent laws on branded products in the United States.

SB50,16,12 (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.

SB50,16,14 (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.

SB50,16,15 (n) The program shall have an audit function that ensures all of the following:

SB50,16,17 1. The commissioner has a sound methodology to determine the most cost- effective prescription drugs to include in the program.

SB50,16,19 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.

SB50,16,21 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

SB50,16,22 4. The program is complying with the requirements of this subsection.

SB50,17,2 5. The program is adequately financed to support administrative functions of the program while generating significant cost savings to residents of this state.

SB50,17,4 6. The program does not put residents of this state at a higher risk than if the program did not exist.

SB50,17,6 7. The program provides and is projected to continue to provide substantial cost savings to residents of this state.

SB50,17,9 (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.

SB50,17,19 (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.

SB50,18,4 (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:

SB50,18,7 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.

SB50,18,9 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c) and (n).

SB50,18,12 (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.

SB50,18,15 (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.

SB50,18,17 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

SB50,18,20 (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.

SB50,18,22 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

SB50,19,2 (h) Conduct any other activities determined by the commissioner to be important to successful implementation of the program.

SB50,19,4 (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:

SB50,19,6 (a) A list of prescription drugs included in the prescription drug importation program under this section.

SB50,19,9 (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.

SB50,19,14 (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.

SB50,19,16 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.

SB50,19,18 (6) Rule making. The commissioner may promulgate any rules necessary to implement this section.

SB50,18 Section 18. Subchapter VI of chapter 601 [precedes 601.78] of the statutes is created to read:

SB50,19,21 CHAPTER 601

SB50,19,22 SUBCHAPTER VI

SB50,20,2 PRESCRIPTION DRUG AFFORDABILITY REVIEW BOARD

SB50,20,3 601.78 Definitions. In this subchapter:

SB50,20,5 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

SB50,20,7 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

SB50,20,9 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

SB50,20,12 (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.

SB50,20,14 (5) “Drug product” means a brand name drug, a generic drug, a biologic, a biosimilar, or an over-the-counter drug.

SB50,20,18 (6) “Financial benefit” includes an honorarium, a fee, a stock, the value of the stock holdings of a member of the board or any immediate family member, and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

SB50,20,19 (7) “Generic drug” means any of the following:

SB50,20,21 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

SB50,20,22 (b) An authorized generic drug, as defined in 42 CFR 447.502.

SB50,21,2 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

SB50,21,5 (8) “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.

SB50,21,6 (9) “Manufacturer” means an entity that does all of the following:

SB50,21,9 (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.

SB50,21,11 (b) Sets or changes the wholesale acquisition cost of the drug product or prescription drug product described in par. (a).

SB50,21,13 (10) “Over-the-counter drug” means a drug intended for human use that does not require a prescription and meets the requirements of 21 CFR parts 328 to 369.

SB50,21,14 (11) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

SB50,21,16 (12) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

SB50,21,21 601.785 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.

SB50,21,22 (2) Powers and duties. (a) The board shall do all of the following:

SB50,22,2 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.

SB50,22,4 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

SB50,22,7 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

SB50,22,8 b. Assessing spending for specific prescription drug products in this state.

SB50,22,9 c. Accessing other available pricing information.

SB50,22,10 (b) The board may do any of the following:

SB50,22,11 1. Promulgate rules for the administration of this subchapter.

SB50,22,16 2. Enter into a contract with an independent 3rd party for any service necessary to carry out the powers and duties of the board as described in this subsection. Unless written permission is granted by the board, a person with whom the board contracts may not release, publish, or otherwise use any information to which the person has access under the contract.

SB50,22,19 (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).

SB50,22,23 (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.

SB50,23,3 (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.

SB50,23,6 (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.

SB50,23,8 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

SB50,23,12 (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 has received or could receive any of the following:

SB50,23,14 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.

SB50,23,17 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.

SB50,23,21 (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.

SB50,24,2 (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.

SB50,24,6 (d) The board shall disclose a conflict of interest under this subsection on the board’s website unless the chair 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.

SB50,24,9 (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.

SB50,24,11 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

SB50,24,15 (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.

SB50,24,19 (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 at least $3,000 during a 12-month period.

SB50,24,22 (c) A biosimilar that has a launch wholesale acquisition cost that is not 15 percent or more lower than the referenced brand biologic at the time the biosimilar is launched.

SB50,25,3 (d) 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:

SB50,25,9 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 federal food and drug administration, a supply lasting a patient for a period of 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.

SB50,25,13 2. Increased by at least 200 percent during the preceding 12-month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the preceding 12 months.

SB50,25,16 (e) Other prescription drug products, including drugs to address public health emergencies, that may create affordability challenges for the health care system and patients in this state.

SB50,25,21 (2) Affordability review. (a) After identifying prescription drug products under sub. (1), the board shall determine whether to conduct an affordability review for each identified prescription drug product by seeking stakeholder input about the prescription drug product and considering the average patient cost share of the prescription drug product.

SB50,26,4 (b) The information used to conduct an affordability review under par. (a) may include any document and research related to the manufacturer’s selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in this state, market competition and context, projected revenue, and the estimated value or cost-effectiveness of the prescription drug product.

SB50,26,7 (c) The failure of a manufacturer to provide the board with information for an affordability review under par. (b) does not affect the authority of the board to conduct the review.

SB50,26,15 (3) Affordability challenge. When conducting an affordability review of a prescription drug product under sub. (2), the board shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the federal food and drug administration or standard medical practice has led or will lead to an affordability challenge for the health care system in this state, including high out-of-pocket costs for patients. To the extent practicable, in determining whether a prescription drug product has led or will lead to an affordability challenge, the board shall consider all of the following factors:

SB50,26,17 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

SB50,26,21 (b) The average monetary price concession, discount, or rebate the manufacturer provides, or is expected to provide, to health plans in this state as reported by manufacturers and health plans, expressed as a percentage of the wholesale acquisition cost for the prescription drug product under review.

SB50,27,2 (c) The total amount of the price concessions, discounts, and rebates the manufacturer provides to each pharmacy benefit manager for the prescription drug product under review, as reported by the manufacturer and pharmacy benefit manager and expressed as a percentage of the wholesale acquisition cost.

SB50,27,4 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

SB50,27,7 (e) The average monetary concession, discount, or rebate the manufacturer provides or is expected to provide to health plan payors and pharmacy benefit managers in this state for therapeutic alternatives to the prescription drug product.