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AB50,1405,137(2) Establishment and operation of state-based exchange. The
8commissioner shall establish and operate an exchange that at first is a state-based
9exchange on the federal platform and then subsequently transitions to a state-
10based exchange without the federal platform. The commissioner shall develop
11procedures to address the transition from the state-based exchange on the federal
12platform to the state-based exchange without the federal platform, including the
13circumstances that shall be met in order for the transition to occur.
AB50,1405,1614(3) Agreement with federal government. The commissioner may enter
15into any agreement with the federal government necessary to facilitate the
16implementation of this section.
AB50,1405,2217(4) User fees. The commissioner shall impose a user fee, as authorized
18under 45 CFR 155.160 (b) (1), on each insurer that offers a health plan through the
19state-based exchange on the federal platform or the state-based exchange without
20the federal platform. The user fee shall be applied at one of the following rates on
21the total monthly premiums charged by an insurer for each policy under the plan for
22which enrollment is through the exchange:
AB50,1406,2
1(a) For any plan year for which the commissioner operates a state-based
2exchange on the federal platform, the rate is 0.5 percent.
AB50,1406,63(b) For the first 2 plan years for which the commissioner operates a state-
4based exchange without the federal platform, the rate is equal to the user fee rate
5the federal department of health and human services specifies under 45 CFR
6156.50 (c) (1) for the federally facilitated exchanges for the applicable plan year.
AB50,1406,97(c) Beginning with the 3rd plan year for which the commissioner operates a
8state-based exchange without the federal platform and for each plan year
9thereafter, the rate shall be set by the commissioner by rule.
AB50,1406,1110(5) Rules. The commissioner may promulgate rules necessary to implement
11this section.
AB50,289012Section 2890. Subchapter VI (title) of chapter 601 [precedes 601.78] of the
13statutes is created to read:
AB50,1406,1414CHAPTER 601
AB50,1406,1515SUBCHAPTER VI
AB50,1406,1616PRESCRIPTION DRUG
AB50,1406,1717AFFORDABILITY REVIEW BOARD
AB50,289118Section 2891. 601.78 of the statutes is created to read:
AB50,1406,1919601.78 Definitions. In this subchapter:
AB50,1406,2120(1) Biologic means a drug that is produced or distributed in accordance with
21a biologics license application approved under 21 CFR 601.20.
AB50,1406,2322(2) Biosimilar means a drug that is produced or distributed in accordance
23with a biologics license application approved under 42 USC 262 (k) (3).
AB50,1407,2
1(3) Board means the prescription drug affordability review board
2established under s. 15.735 (1).
AB50,1407,53(4) Brand name drug means a drug that is produced or distributed in
4accordance with an original new drug application approved under 21 USC 355 (c),
5other than an authorized generic drug, as defined in 42 CFR 447.502.
AB50,1407,96(5) Financial benefit includes an honorarium, fee, stock, the value of the
7stock holdings of a member of the board or any immediate family member of the
8member of the board, and any direct financial benefit deriving from the finding of a
9review conducted under s. 601.79.
AB50,1407,1010(6) Generic drug means any of the following:
AB50,1407,1211(a) A retail drug that is marketed or distributed in accordance with an
12abbreviated new drug application approved under 21 USC 355 (j).
AB50,1407,1313(b) An authorized generic drug, as defined in 42 CFR 447.502.
AB50,1407,1514(c) A drug that entered the market prior to 1962 and was not originally
15marketed under a new drug application.
AB50,1407,1816(7) Immediate family member means a spouse, grandparent, parent,
17sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent,
18sibling, child, stepchild, or grandchild.
AB50,1407,1919(8) Manufacturer means an entity that does all of the following:
AB50,1407,2220(a) Engages in the manufacture of a prescription drug product or enters into
21a lease with another entity to market and distribute a prescription drug product
22under the entitys own name.
AB50,1408,2
1(b) Sets or changes the wholesale acquisition cost of the prescription drug
2product described in par. (a).
AB50,1408,33(9) Pharmacy benefit manager has the meaning given in s. 632.865 (1) (c).
AB50,1408,54(10) Prescription drug product means a brand name drug, a generic drug, a
5biologic, or a biosimilar.
AB50,28926Section 2892. 601.785 of the statutes is created to read:
AB50,1408,117601.785 Prescription drug affordability review board. (1) Mission.
8The purpose of the board is to protect state residents, the state, local governments,
9health plans, health care providers, pharmacies licensed in this state, and other
10stakeholders of the health care system in this state from the high costs of
11prescription drug products.
AB50,1408,1212(2) Powers and duties. (a) The board shall do all of the following:
AB50,1408,15131. Meet in open session at least 4 times per year to review prescription drug
14product pricing information in the manner described in subd. 2., except that the
15chairperson may cancel or postpone a meeting if there is no business to transact.
AB50,1408,17162. To the extent practicable, access and assess pricing information for
17prescription drug products by doing all of the following:
AB50,1408,2018a. Accessing and assessing information from other states by entering into
19memoranda of understanding with other states to which manufacturers report
20pricing information.
AB50,1408,2121b. Assessing spending for specific prescription drug products in this state.
AB50,1408,2222c. Accessing other available pricing information.
AB50,1408,2323(b) The board may do any of the following:
AB50,1409,1
11. Promulgate rules for the administration of this subchapter.
AB50,1409,622. Enter into a contract with an independent 3rd party for any service
3necessary to carry out the powers and duties of the board. Unless written
4permission is granted by the board, any person with whom the board contracts may
5not release, publish, or otherwise use any information to which the person has
6access under the contract.
AB50,1409,97(c) The board shall establish and maintain a website to provide public notices
8and make meeting materials available under sub. (3) (a) and to disclose conflicts of
9interest under sub. (4) (d).
AB50,1409,1310(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide
11public notice of each board meeting at least 2 weeks prior to the meeting and shall
12make the materials for each meeting publicly available at least one week prior to
13the meeting.
AB50,1409,1614(b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for
15public comment at each open meeting and shall provide the public with the
16opportunity to provide written comments on pending decisions of the board.
AB50,1409,1917(c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board
18concerning proprietary data and information shall be conducted in closed session
19and shall in all respects remain confidential.
AB50,1409,2120(d) The board may allow expert testimony at any meeting, including when the
21board meets in closed session.
AB50,1410,222(4) Conflicts of interest. (a) A member of the board shall recuse himself
23or herself from a decision by the board relating to a prescription drug product if the

1member or an immediate family member of the member has received or could
2receive any of the following:
AB50,1410,431. A direct financial benefit deriving from a determination, or a finding of a
4study or review, by the board relating to the prescription drug product.
AB50,1410,752. A financial benefit in excess of $5,000 in a calendar year from any person
6who owns, manufactures, or provides a prescription drug product to be studied or
7reviewed by the board.
AB50,1410,118(b) A conflict of interest under this subsection shall be disclosed by the board
9when hiring board staff, by the appointing authority when appointing members to
10the board, and by the board when a member of the board is recused from any
11decision relating to a review of a prescription drug product.
AB50,1410,1512(c) A conflict of interest under this subsection shall be disclosed no later than
135 days after the conflict is identified, except that, if the conflict is identified within
145 days of an open meeting of the board, the conflict shall be disclosed prior to the
15meeting.
AB50,1410,2016(d) The board shall disclose a conflict of interest under this subsection on the
17boards website unless the chairperson of the board recuses the member from a
18final decision relating to a review of the prescription drug product. The disclosure
19shall include the type, nature, and magnitude of the interests of the member
20involved.
AB50,1410,2321(e) A member of the board or a 3rd-party contractor may not accept any gift or
22donation of services or property that indicates a potential conflict of interest or has
23the appearance of biasing the work of the board.
AB50,2893
1Section 2893. 601.79 of the statutes is created to read:
AB50,1411,32601.79 Drug cost affordability review. (1) Identification of drugs.
3The board shall identify prescription drug products that are any of the following:
AB50,1411,74(a) A brand name drug or biologic that, as adjusted annually to reflect
5adjustments to the U.S. consumer price index for all urban consumers, U.S. city
6average, as determined by the U.S. department of labor, has a launch wholesale
7acquisition cost of at least $30,000 per year or course of treatment.
AB50,1411,118(b) A brand name drug or biologic that, as adjusted annually to reflect
9adjustments to the U.S. consumer price index for all urban consumers, U.S. city
10average, as determined by the U.S. department of labor, has a wholesale acquisition
11cost that has increased by at least $3,000 during a 12-month period.
AB50,1411,1412(c) A biosimilar that has a launch wholesale acquisition cost that is not at
13least 15 percent lower than the referenced brand biologic at the time the biosimilar
14is launched.
AB50,1411,1815(d) A generic drug that has a wholesale acquisition cost, as adjusted annually
16to reflect adjustments to the U.S. consumer price index for all urban consumers,
17U.S. city average, as determined by the U.S. department of labor, that meets all of
18the following conditions:
AB50,1412,2191. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
20days based on the recommended dosage approved for labeling by the federal food
21and drug administration, a supply lasting a patient for a period of fewer than 30
22days based on the recommended dosage approved for labeling by the federal food

1and drug administration, or one unit of the drug if the labeling approved by the
2federal food and drug administration does not recommend a finite dosage.
AB50,1412,632. Increased by at least 200 percent during the preceding 12-month period, as
4determined by the difference between the resulting wholesale acquisition cost and
5the average of the wholesale acquisition cost reported over the preceding 12
6months.
AB50,1412,97(e) Other prescription drug products, including drugs to address public health
8emergencies, that may create affordability challenges for the health care system
9and patients in this state.
AB50,1412,1410(2) Affordability review. (a) After identifying prescription drug products
11under sub. (1), the board shall determine whether to conduct an affordability
12review for each identified prescription drug product by seeking stakeholder input
13about the prescription drug product and considering the average patient cost share
14of the prescription drug product.
AB50,1412,2015(b) The information used to conduct an affordability review under par. (a) may
16include any document and research related to the manufacturers selection of the
17introductory price or price increase of the prescription drug product, including life
18cycle management, net average price in this state, market competition and context,
19projected revenue, and the estimated value or cost-effectiveness of the prescription
20drug product.
AB50,1412,2321(c) The failure of a manufacturer to provide the board with information for an
22affordability review under par. (b) does not affect the authority of the board to
23conduct the review.
AB50,1413,8
1(3) Affordability challenge. When conducting an affordability review of a
2prescription drug product under sub. (2), the board shall determine whether use of
3the prescription drug product that is fully consistent with the labeling approved by
4the federal food and drug administration or standard medical practice has led or
5will lead to an affordability challenge for the health care system in this state,
6including high out-of-pocket costs for patients. To the extent practicable, in
7determining whether a prescription drug product has led or will lead to an
8affordability challenge, the board shall consider all of the following factors:
AB50,1413,109(a) The wholesale acquisition cost for the prescription drug product sold in
10this state.
AB50,1413,1411(b) The average monetary price concession, discount, or rebate the
12manufacturer provides, or is expected to provide, to health plans in this state as
13reported by manufacturers and health plans, expressed as a percentage of the
14wholesale acquisition cost for the prescription drug product under review.
AB50,1413,1815(c) The total amount of the price concessions, discounts, and rebates the
16manufacturer provides to each pharmacy benefit manager for the prescription drug
17product under review, as reported by the manufacturer and pharmacy benefit
18manager and expressed as a percentage of the wholesale acquisition cost.
AB50,1413,2019(d) The price at which therapeutic alternatives to the prescription drug
20product have been sold in this state.
AB50,1413,2321(e) The average monetary concession, discount, or rebate the manufacturer
22provides or is expected to provide to health plan payors and pharmacy benefit
23managers in this state for therapeutic alternatives to the prescription drug product.
AB50,1414,3
1(f) The costs to health plans based on patient access consistent with labeled
2indications by the federal food and drug administration and recognized standard
3medical practice.
AB50,1414,54(g) The impact on patient access resulting from the cost of the prescription
5drug product relative to insurance benefit design.
AB50,1414,76(h) The current or expected dollar value of drug-specific patient access
7programs that are supported by the manufacturer.
AB50,1414,108(i) The relative financial impacts to health, medical, or social services costs
9that can be quantified and compared to baseline effects of existing therapeutic
10alternatives to the prescription drug product.
AB50,1414,1211(j) The average patient copay or other cost sharing for the prescription drug
12product in this state.
AB50,1414,1313(k) Any information a manufacturer chooses to provide.
AB50,1414,1414(L) Any other factors as determined by the board by rule.
AB50,1414,1815(4) Upper payment limit. (a) If the board determines under sub. (3) that use
16of a prescription drug product has led or will lead to an affordability challenge, the
17board shall establish an upper payment limit for the prescription drug product after
18considering all of the following:
AB50,1414,19191. The cost of administering the drug.
AB50,1414,20202. The cost of delivering the drug to consumers.
AB50,1414,21213. Other relevant administrative costs related to the drug.
AB50,1415,422(b) For a prescription drug product identified in sub. (1) (b) or (d) 2., the board
23shall solicit information from the manufacturer regarding the price increase. To

1the extent that the price increase is not a result of the need for increased
2manufacturing capacity or other effort to improve patient access during a public
3health emergency, the board shall establish an upper payment limit under par. (a)
4that is equal to the cost to consumers prior to the price increase.
AB50,1415,85(c) 1. The upper payment limit established under this subsection shall apply
6to all purchases and payor reimbursements of the prescription drug product
7dispensed or administered to individuals in this state in person, by mail, or by other
8means.
AB50,1415,1992. Notwithstanding subd. 1., while state-sponsored and state-regulated
10health plans and health programs shall limit drug reimbursements and drug
11payment to no more than the upper payment limit established under this
12subsection, a plan subject to the Employee Retirement Income Security Act of 1974
13or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse
14more than the upper payment limit. A provider who dispenses and administers a
15prescription drug product in this state to an individual in this state may not bill a
16payor more than the upper payment limit to the patient regardless of whether a
17plan subject to the Employee Retirement Income Security Act of 1974 or Part D of
18Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above
19the upper payment limit.
AB50,1415,2120(5) Public inspection. Information submitted to the board under this
21section shall be open to public inspection only as provided under ss. 19.31 to 19.39.
AB50,1416,222(6) No prohibition on marketing. Nothing in this section may be construed
23to prevent a manufacturer from marketing a prescription drug product approved by

1the federal food and drug administration while the prescription drug product is
2under review by the board.
AB50,1416,73(7) Appeals. A person aggrieved by a decision of the board may request an
4appeal of the decision no later than 30 days after the board makes the
5determination. The board shall hear the appeal and make a final decision no later
6than 60 days after the appeal is requested. A person aggrieved by a final decision of
7the board may petition for judicial review in a court of competent jurisdiction.
AB50,28948Section 2894. 601.83 (1) (a) of the statutes is amended to read:
AB50,1416,219601.83 (1) (a) The commissioner shall administer a state-based reinsurance
10program known as the healthcare stability plan in accordance with the specific
11terms and conditions approved by the federal department of health and human
12services dated July 29, 2018. Before December 31, 2023, the commissioner may not
13request from the federal department of health and human services a modification,
14suspension, withdrawal, or termination of the waiver under 42 USC 18052 under
15which the healthcare stability plan under this subchapter operates unless
16legislation has been enacted specifically directing the modification, suspension,
17withdrawal, or termination. Before December 31, 2023, the commissioner may
18request renewal, without substantive change, of the waiver under 42 USC 18052
19under which the health care stability plan operates in accordance with s. 20.940 (4)
20unless legislation has been enacted that is contrary to such a renewal request. The
21commissioner shall comply with applicable timing in and requirements of s. 20.940.
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