Amendment SA4-SSA2-SB70

SB70-SSA2-SA4,174,1 201. Page 374, line 11: after that line insert:

SB70-SSA2-SA4,174,2 “ Section 210. 256.158 of the statutes is created to read:

SB70-SSA2-SA4,174,3 256.158 Epinephrine for ambulances. (1) In this section:

SB70-SSA2-SA4,174,5 (a) “Ambulance service provider” means an ambulance service provider that is a public agency, volunteer fire department, or nonprofit corporation.

SB70-SSA2-SA4,174,7 (b) “Draw-up epinephrine” means epinephrine that is administered intramuscularly using a needle and syringe and drawn up from a vial or ampule.

SB70-SSA2-SA4,174,9 (c) “Draw-up epinephrine kit” means a single-use vial or ampule of draw-up epinephrine and a syringe for administration to a patient.

SB70-SSA2-SA4,174,11 (d) “Epinephrine auto-injector" means a device for the automatic injection of epinephrine into the human body.

SB70-SSA2-SA4,174,22 (2) From the appropriation under s. 20.435 (1) (b), the department shall reimburse ambulance service providers for a set of 2 epinephrine auto-injectors or a set of 2 draw-up epinephrine kits for each ambulance operating in the state. On an ongoing basis, the department shall, upon request from an ambulance service provider, reimburse the ambulance service provider for a replacement set of 2 epinephrine auto-injectors or a set of 2 draw-up epinephrine kits. The department shall allow the ambulance service provider to choose between epinephrine auto-injectors and draw-up epinephrine kits. The department may not reimburse an ambulance service provider for epinephrine unless each ambulance for which the ambulance service provider is reimbursed is staffed with an emergency medical services practitioner who is qualified to administer the provided epinephrine.”.

SB70-SSA2-SA4,174,23 202. Page 374, line 11: after that line insert:

SB70-SSA2-SA4,174,24 “ Section 211. 20.145 (1) (g) 5. of the statutes is created to read:

SB70-SSA2-SA4,175,4 20.145 (1) (g) 5. All moneys received from the regulation of pharmacy benefit managers, pharmacy benefit management brokers, pharmacy benefit management consultants, pharmacy services administration organizations, and pharmaceutical representatives.”.

SB70-SSA2-SA4,175,5 203. Page 374, line 11: after that line insert:

SB70-SSA2-SA4,175,6 “ Section 212. 15.07 (3) (bm) 7. of the statutes is created to read:

SB70-SSA2-SA4,175,8 15.07 (3) (bm) 7. The prescription drug affordability review board shall meet at least 4 times each year.

SB70-SSA2-SA4,213 Section 213. 15.735 of the statutes is created to read:

SB70-SSA2-SA4,175,12 15.735 Same; attached board. (1) There is created a prescription drug affordability review board attached to the office of the commissioner of insurance under s. 15.03. The board shall consist of the following members:

SB70-SSA2-SA4,175,13 (a) The commissioner of insurance or his or her designee.

SB70-SSA2-SA4,175,17 (b) Two members appointed for 4-year terms who represent the pharmaceutical drug industry, including pharmaceutical drug manufacturers and wholesalers. At least one of the members appointed under this paragraph shall be a licensed pharmacist.

SB70-SSA2-SA4,175,19 (c) Two members appointed for 4-year terms who represent the health insurance industry, including insurers and pharmacy benefit managers.

SB70-SSA2-SA4,175,22 (d) Two members appointed for 4-year terms who represent the health care industry, including hospitals, physicians, pharmacies, and pharmacists. At least one of the members appointed under this paragraph shall be a licensed practitioner.

SB70-SSA2-SA4,175,24 (e) Two members appointed for 4-year terms who represent the interests of the public.

SB70-SSA2-SA4,176,3 (2) A member appointed under sub. (1), except for a member appointed under sub. (1) (b), may not be an employee of, a board member of, or a consultant to a drug manufacturer or trade association for drug manufacturers.

SB70-SSA2-SA4,176,8 (3) Any conflict of interest, including any financial or personal association, that has the potential to bias or has the appearance of biasing an individual's decision in matters related to the board or the conduct of the board's activities shall be considered and disclosed when appointing that individual to the board under sub. (1).

SB70-SSA2-SA4,214 Section 214. Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

SB70-SSA2-SA4,176,11 CHAPTER 601

SB70-SSA2-SA4,176,13 SUBCHAPTER VI Prescription drug

SB70-SSA2-SA4,176,14 affordability review board

SB70-SSA2-SA4,215 Section 215. 601.78 of the statutes is created to read:

SB70-SSA2-SA4,176,16 601.78 Definitions. In this subchapter:

SB70-SSA2-SA4,176,18 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

SB70-SSA2-SA4,176,20 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

SB70-SSA2-SA4,176,22 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

SB70-SSA2-SA4,176,25 (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.

SB70-SSA2-SA4,177,3 (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, and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

SB70-SSA2-SA4,177,4 (6) “Generic drug” means any of the following:

SB70-SSA2-SA4,177,6 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

SB70-SSA2-SA4,177,7 (b) An authorized generic drug, as defined in 42 CFR 447.502.

SB70-SSA2-SA4,177,9 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

SB70-SSA2-SA4,177,12 (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.

SB70-SSA2-SA4,177,13 (8) “Manufacturer” means an entity that does all of the following:

SB70-SSA2-SA4,177,16 (a) Engages in the manufacture of a prescription drug product or enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name.

SB70-SSA2-SA4,177,18 (b) Sets or changes the wholesale acquisition cost of the prescription drug product described in par. (a).

SB70-SSA2-SA4,177,19 (9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

SB70-SSA2-SA4,177,21 (10) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

SB70-SSA2-SA4,216 Section 216. 601.785 of the statutes is created to read:

SB70-SSA2-SA4,178,2 601.785 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.

SB70-SSA2-SA4,178,3 (2) Powers and duties. (a) The board shall do all of the following:

SB70-SSA2-SA4,178,6 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.

SB70-SSA2-SA4,178,8 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

SB70-SSA2-SA4,178,11 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

SB70-SSA2-SA4,178,12 b. Assessing spending for specific prescription drug products in this state.

SB70-SSA2-SA4,178,13 c. Accessing other available pricing information.

SB70-SSA2-SA4,178,14 (b) The board may do any of the following:

SB70-SSA2-SA4,178,15 1. Promulgate rules for the administration of this subchapter.

SB70-SSA2-SA4,178,20 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.

SB70-SSA2-SA4,178,23 (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).

SB70-SSA2-SA4,179,2 (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.

SB70-SSA2-SA4,179,5 (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.

SB70-SSA2-SA4,179,8 (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.

SB70-SSA2-SA4,179,10 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

SB70-SSA2-SA4,179,14 (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:

SB70-SSA2-SA4,179,16 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.

SB70-SSA2-SA4,179,19 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.

SB70-SSA2-SA4,179,23 (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.

SB70-SSA2-SA4,180,2 (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.

SB70-SSA2-SA4,180,6 (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.

SB70-SSA2-SA4,180,9 (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.

SB70-SSA2-SA4,217 Section 217. 601.79 of the statutes is created to read:

SB70-SSA2-SA4,180,12 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

SB70-SSA2-SA4,180,16 (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.

SB70-SSA2-SA4,180,20 (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.

SB70-SSA2-SA4,180,23 (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.

SB70-SSA2-SA4,181,2 (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:

SB70-SSA2-SA4,181,8 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.

SB70-SSA2-SA4,181,11 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.

SB70-SSA2-SA4,181,14 (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.

SB70-SSA2-SA4,181,19 (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.

SB70-SSA2-SA4,181,25 (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.

SB70-SSA2-SA4,182,3 (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.

SB70-SSA2-SA4,182,11 (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:

SB70-SSA2-SA4,182,13 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

SB70-SSA2-SA4,182,17 (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.

SB70-SSA2-SA4,182,21 (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 cost.

SB70-SSA2-SA4,182,23 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

SB70-SSA2-SA4,183,3 (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.

SB70-SSA2-SA4,183,6 (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.

SB70-SSA2-SA4,183,8 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

SB70-SSA2-SA4,183,10 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

SB70-SSA2-SA4,183,13 (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 to the prescription drug product.