AB544: Bill Text

AB544,3 Section 3 . Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

AB544,4,11 CHAPTER 601

AB544,4,13 SUBCHAPTER VI Prescription drug

AB544,4,14 affordability review board

AB544,4,15 601.78 Definitions. In this subchapter:

AB544,4,17 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

AB544,4,19 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

AB544,4,21 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

AB544,4,24 (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.

AB544,5,2 (5) “Drug product” means a brand name drug, a generic drug, a biologic, a biosimilar, or an over-the-counter drug.

AB544,5,6 (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.

AB544,5,7 (7) “Generic drug” means any of the following:

AB544,5,9 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

AB544,5,10 (b) An authorized generic drug, as defined in 42 CFR 447.502.

AB544,5,12 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

AB544,5,13 (8) “Manufacturer” means an entity that does all of the following:

AB544,5,16 (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.

AB544,5,18 (b) Sets or changes the wholesale acquisition cost of the drug product or prescription drug product described in par. (a).

AB544,5,20 (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.

AB544,5,21 (10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB544,5,23 (11) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB544,6,3 601.785 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.

AB544,6,4 (2) Powers and duties. (a) The board shall do all of the following:

AB544,6,7 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.

AB544,6,9 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

AB544,6,12 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

AB544,6,13 b. Assessing spending for specific prescription drug products in this state.

AB544,6,14 c. Accessing other available pricing information.

AB544,6,15 (b) The board may:

AB544,6,16 1. Promulgate rules for the administration of this subchapter.

AB544,6,21 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.

AB544,6,25 (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.

AB544,7,3 (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.

AB544,7,6 (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.

AB544,7,8 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

AB544,7,12 (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, as defined in s. 97.605 (4) (a) 2., has received or could receive any of the following:

AB544,7,14 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.

AB544,7,17 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.

AB544,7,21 (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.

AB544,7,24 (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.

AB544,8,5 (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.

AB544,8,8 (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.

AB544,8,10 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

AB544,8,15 (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 or whose wholesale acquisition cost increased at least $3,000 during a 12–month period.

AB544,8,18 (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.

AB544,8,22 (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:

AB544,9,3 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.

AB544,9,6 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.

AB544,9,9 (d) 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.

AB544,9,14 (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.

AB544,9,20 (b) The information 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.

AB544,9,22 (c) The failure of a manufacturer to provide the board with information for an affordability review does not affect the authority of the board to conduct the review.

AB544,9,25 (3) Affordability challenge. When conducting an affordability review of a prescription drug product, 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:

AB544,10,7 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

AB544,10,11 (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 percent of the wholesale acquisition cost for the prescription drug product under review.

AB544,10,15 (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 percent of the wholesale acquisition costs.

AB544,10,16 (d) The price at which therapeutic alternatives have been sold in this state.

AB544,10,19 (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.

AB544,10,22 (f) The costs to health plans based on patient access consistent with labeled indications by the federal food and drug administration and recognized standard medical practice.

AB544,10,24 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

AB544,11,2 (h) The current or expected dollar value of drug–specific patient access programs that are supported by the manufacturer.

AB544,11,5 (i) The relative financial impacts to health, medical, or social services costs that can be quantified and compared to baseline effects of existing therapeutic alternatives.

AB544,11,7 (j) The average patient copay or other cost sharing for the prescription drug product in the state.

AB544,11,8 (k) Any information a manufacturer chooses to provide.

AB544,11,9 (L) Any other factors as determined by the board by rule.

AB544,11,13 (4) Upper payment limit. (a) If the board determines under sub. (3) that use of a prescription drug product has led or will lead to an affordability challenge, the board shall establish an upper payment limit for the prescription drug product after considering all of the following:

AB544,11,14 1. The cost of administering the drug.

AB544,11,15 2. The cost of delivering the drug to consumers.

AB544,11,16 3. Other relevant administrative costs related to the drug.

AB544,11,22 (b) For a prescription drug product identified in sub. (1) (d), the board shall solicit information from the manufacturer regarding the price increase. To the extent that the price increase is not a result of the need for increased manufacturing capacity or other effort to improve patient access during a public health emergency, the board shall establish an upper payment limit under par. (a) that is equal to the cost to consumers prior to the price increase.

AB544,12,2 (c) 1. The upper payment limit established under this subsection shall apply to all purchases and payor reimbursements of the prescription drug product dispensed or administered to individuals in this state in person, by mail, or by other means.

AB544,12,13 2. Notwithstanding subd. 1., while state-sponsored and state-regulated health plans and health programs shall limit drug reimbursements and drug payment to no more than the upper payment limit established under this subsection, a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse more than the upper payment limit. A provider who dispenses and administers a prescription drug product in this state to an individual in this state may not bill a payor more than the upper payment limit to the patient regardless of whether a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above the upper payment limit.

AB544,12,15 (5) Public inspection. Information submitted to the board under this section shall be open to public inspection only as provided under ss. 19.31 to 19.39.

AB544,12,19 (6) No prohibition on marketing. Nothing in this section may be construed to prevent a manufacturer from marketing a prescription drug product approved by the federal food and drug administration while the prescription drug product is under review by the board.

AB544,12,24 (7) Appeals. A person aggrieved by a decision of the board may request an appeal of the decision no later than 30 days after the board makes the determination. The board shall hear the appeal and make a final decision no later than 60 days after the appeal is requested. A person aggrieved by a final decision of the board may petition for judicial review in a court of competent jurisdiction.

AB544,4 Section 4. Nonstatutory provisions.

AB544,13,6 (1) Staggered terms for board. Notwithstanding the length of terms specified for the members of the board under s. 15.735 (1) (b) to (e), 2 of the initial members shall be appointed for terms expiring on May 1, 2023; 2 of the initial members shall be appointed for terms expiring on May 1, 2024; 2 of the initial members shall be appointed for terms expiring on May 1, 2025; and 2 of the initial members shall be appointed for terms expiring on May 1, 2026.

AB544,5 Section 5. Effective date.

AB544,13,9 (1) This act takes effect on the first day of the 7th month after the day of publication.

AB544,13,10 (End)