SB70,1560,5 23(4) Implementation of certified program. After the federal department of
24health and human services certifies the prescription drug importation program
25submitted under sub. (3), the commissioner shall begin implementation of the

1program, and the program shall be fully operational by 180 days after the date of
2certification by the federal department of health and human services. The
3commissioner shall do all of the following to implement the program to the extent the
4action is in accordance with other state laws and the certification by the federal
5department of health and human services:
SB70,1560,86 (a) Become a licensed wholesale distributor, designate another state agency to
7become a licensed wholesale distributor, or contract with a licensed wholesale
8distributor.
SB70,1560,109 (b) Contract with one or more Canadian suppliers that meet the criteria in sub.
10(1) (c) and (n).
SB70,1560,1311 (c) Create an outreach and marketing plan to communicate with and provide
12information to health plans and health insurance policies, employers, pharmacies,
13health care providers, and residents of this state on participating in the program.
SB70,1560,1614 (d) Develop and implement a registration process for health plans and health
15insurance policies, pharmacies, and health care providers interested in participating
16in the program.
SB70,1560,1817 (e) Create a publicly accessible source for listing prices of prescription drugs
18imported under the program.
SB70,1560,2119 (f) Create, publicize, and implement a method of communication to promptly
20answer questions from and address the needs of persons affected by the
21implementation of the program before the program is fully operational.
SB70,1560,2322 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete
23each audit function every 2 years.
SB70,1560,2524 (h) Conduct any other activities determined by the commissioner to be
25important to successful implementation of the program.
SB70,1561,2
1(5) Report. By January 1 and July 1 of each year, the commissioner shall
2submit to the joint committee on finance a report including all of the following:
SB70,1561,43 (a) A list of prescription drugs included in the prescription drug importation
4program under this section.
SB70,1561,75 (b) The number of pharmacies, health care providers, and health plans and
6health insurance policies participating in the prescription drug importation program
7under this section.
SB70,1561,128 (c) The estimated amount of savings to residents of this state, health plans and
9health insurance policies, and employers resulting from the implementation of the
10prescription drug importation program under this section reported from the date of
11the previous report under this subsection and from the date the program was fully
12operational.
SB70,1561,1413 (d) Findings of any audit functions under sub. (1) (n) completed since the date
14of the previous report under this subsection.
SB70,1561,16 15(6) Rulemaking. The commissioner may promulgate any rules necessary to
16implement this section.
SB70,3041 17Section 3041. 601.59 of the statutes is created to read:
SB70,1561,18 18601.59 State-based exchange. (1) Definitions. In this section:
SB70,1561,1919 (a) “Exchange” has the meaning given in 45 CFR 155.20.
SB70,1561,2220 (b) “State-based exchange on the federal platform” means an exchange that is
21described in and meets the requirements of 45 CFR 155.200 (f) and is approved by
22the federal secretary of health and human services under 45 CFR 155.106.
SB70,1562,223 (c) “State-based exchange without the federal platform” means an exchange,
24other than one described in 45 CFR 155.200 (f), that performs all the functions

1described in 45 CFR 155.200 (a) and is approved by the federal secretary of health
2and human services under 45 CFR 155.106.
SB70,1562,9 3(2) Establishment and operation of state-based exchange. The commissioner
4shall establish and operate an exchange that at first is a state-based exchange on
5the federal platform and then subsequently transitions to a state-based exchange
6without the federal platform. The commissioner shall develop procedures to address
7the transition from the state-based exchange on the federal platform to the
8state-based exchange without the federal platform, including the circumstances
9that shall be met in order for the transition to occur.
SB70,1562,12 10(3) Agreement with federal government. The commissioner may enter into
11any agreement with the federal government necessary to facilitate the
12implementation of this section.
SB70,1562,18 13(4) User fees. The commissioner shall impose a user fee, as authorized under
1445 CFR 155.160 (b) (1), on each insurer that offers a health plan through the
15state-based exchange on the federal platform or the state-based exchange without
16the federal platform. The user fee shall be applied at one of the following rates on
17the total monthly premiums charged by an insurer for each policy under the plan for
18which enrollment is through the exchange:
SB70,1562,2019 (a) For any plan year for which the commissioner operates a state-based
20exchange on the federal platform, the rate is 0.5 percent.
SB70,1562,2421 (b) For the first 2 plan years for which the commissioner operates a state-based
22exchange without the federal platform, the rate is equal to the user fee rate the
23federal department of health and human services specifies under 45 CFR 156.50 (c)
24(1) for the federally facilitated exchanges for the applicable plan year.
SB70,1563,3
1(c) Beginning with the 3rd plan year for which the commissioner operates a
2state-based exchange without the federal platform and for each plan year thereafter,
3the rate shall be set by the commissioner by rule.
SB70,1563,5 4(5) Rules. The commissioner may promulgate rules necessary to implement
5this section.
SB70,3042 6Section 3042 . Subchapter VI (title) of chapter 601 [precedes 601.78] of the
7statutes is created to read:
SB70,1563,88 CHAPTER 601
SB70,1563,109 SUBCHAPTER VI
10 Prescription drug
SB70,1563,1111 affordability review board
SB70,3043 12Section 3043. 601.78 of the statutes is created to read:
SB70,1563,13 13601.78 Definitions. In this subchapter:
SB70,1563,15 14(1) “Biologic” means a drug that is produced or distributed in accordance with
15a biologics license application approved under 21 CFR 601.20.
SB70,1563,17 16(2) “Biosimilar” means a drug that is produced or distributed in accordance
17with a biologics license application approved under 42 USC 262 (k) (3).
SB70,1563,19 18(3) “Board” means the prescription drug affordability review board established
19under s. 15.735 (1).
SB70,1563,22 20(4) “Brand name drug” means a drug that is produced or distributed in
21accordance with an original new drug application approved under 21 USC 355 (c),
22other than an authorized generic drug, as defined in 42 CFR 447.502.
SB70,1563,25 23(5) “Financial benefit” includes an honorarium, fee, stock, the value of the stock
24holdings of a member of the board or any immediate family member, and any direct
25financial benefit deriving from the finding of a review conducted under s. 601.79.
SB70,1564,1
1(6) “Generic drug” means any of the following:
SB70,1564,32 (a) A retail drug that is marketed or distributed in accordance with an
3abbreviated new drug application approved under 21 USC 355 (j).
SB70,1564,44(b) An authorized generic drug, as defined in 42 CFR 447.502.
SB70,1564,65 (c) A drug that entered the market prior to 1962 and was not originally
6marketed under a new drug application.
SB70,1564,9 7(7) “Immediate family member” means a spouse, grandparent, parent, sibling,
8child, stepchild, or grandchild or the spouse of a grandparent, parent, sibling, child,
9stepchild, or grandchild.
SB70,1564,10 10(8) “Manufacturer” means an entity that does all of the following:
SB70,1564,1311 (a) Engages in the manufacture of a prescription drug product or enters into
12a lease with another manufacturer to market and distribute a prescription drug
13product under the entity's own name.
SB70,1564,1514 (b) Sets or changes the wholesale acquisition cost of the prescription drug
15product described in par. (a).
SB70,1564,16 16(9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
SB70,1564,18 17(10) “Prescription drug product” means a brand name drug, a generic drug, a
18biologic, or a biosimilar.
SB70,3044 19Section 3044. 601.785 of the statutes is created to read:
SB70,1564,24 20601.785 Prescription drug affordability review board. (1) Mission. The
21purpose of the board is to protect state residents, the state, local governments, health
22plans, health care providers, pharmacies licensed in this state, and other
23stakeholders of the health care system in this state from the high costs of prescription
24drug products.
SB70,1564,25 25(2) Powers and duties. (a) The board shall do all of the following:
SB70,1565,3
11. Meet in open session at least 4 times per year to review prescription drug
2product pricing information, except that the chair may cancel or postpone a meeting
3if there is no business to transact.
SB70,1565,54 2. To the extent practicable, access and assess pricing information for
5prescription drug products by doing all of the following:
SB70,1565,86 a. Accessing and assessing information from other states by entering into
7memoranda of understanding with other states to which manufacturers report
8pricing information.
SB70,1565,99 b. Assessing spending for specific prescription drug products in this state.
SB70,1565,1010 c. Accessing other available pricing information.
SB70,1565,1111 (b) The board may do any of the following:
SB70,1565,1212 1. Promulgate rules for the administration of this subchapter.
SB70,1565,1713 2. Enter into a contract with an independent 3rd party for any service
14necessary to carry out the powers and duties of the board. Unless written permission
15is granted by the board, any person with whom the board contracts may not release,
16publish, or otherwise use any information to which the person has access under the
17contract.
SB70,1565,2018 (c) The board shall establish and maintain a website to provide public notices
19and make meeting materials available under sub. (3) (a) and to disclose conflicts of
20interest under sub. (4) (d).
SB70,1565,24 21(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide
22public notice of each board meeting at least 2 weeks prior to the meeting and shall
23make the materials for each meeting publicly available at least one week prior to the
24meeting.
SB70,1566,3
1(b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for
2public comment at each open meeting and shall provide the public with the
3opportunity to provide written comments on pending decisions of the board.
SB70,1566,64 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board
5concerning proprietary data and information shall be conducted in closed session
6and shall in all respects remain confidential.
SB70,1566,87 (d) The board may allow expert testimony at any meeting, including when the
8board meets in closed session.
SB70,1566,12 9(4) Conflicts of interest. (a) A member of the board shall recuse himself or
10herself from a decision by the board relating to a prescription drug product if the
11member or an immediate family member has received or could receive any of the
12following:
SB70,1566,1413 1. A direct financial benefit deriving from a determination, or a finding of a
14study or review, by the board relating to the prescription drug product.
SB70,1566,1715 2. A financial benefit in excess of $5,000 in a calendar year from any person who
16owns, manufactures, or provides a prescription drug product to be studied or
17reviewed by the board.
SB70,1566,2118 (b) A conflict of interest under this subsection shall be disclosed by the board
19when hiring board staff, by the appointing authority when appointing members to
20the board, and by the board when a member of the board is recused from any decision
21relating to a review of a prescription drug product.
SB70,1566,2522 (c) A conflict of interest under this subsection shall be disclosed no later than
235 days after the conflict is identified, except that, if the conflict is identified within
245 days of an open meeting of the board, the conflict shall be disclosed prior to the
25meeting.
SB70,1567,4
1(d) The board shall disclose a conflict of interest under this subsection on the
2board's website unless the chair of the board recuses the member from a final
3decision relating to a review of the prescription drug product. The disclosure shall
4include the type, nature, and magnitude of the interests of the member involved.
SB70,1567,75 (e) A member of the board or a 3rd-party contractor may not accept any gift or
6donation of services or property that indicates a potential conflict of interest or has
7the appearance of biasing the work of the board.
SB70,3045 8Section 3045. 601.79 of the statutes is created to read:
SB70,1567,10 9601.79 Drug cost affordability review. (1) Identification of drugs. The
10board shall identify prescription drug products that are any of the following:
SB70,1567,1411 (a) A brand name drug or biologic that, as adjusted annually to reflect
12adjustments to the U.S. consumer price index for all urban consumers, U.S. city
13average, as determined by the U.S. department of labor, has a launch wholesale
14acquisition cost of at least $30,000 per year or course of treatment.
SB70,1567,1815 (b) A brand name drug or biologic that, as adjusted annually to reflect
16adjustments to the U.S. consumer price index for all urban consumers, U.S. city
17average, as determined by the U.S. department of labor, has a wholesale acquisition
18cost that has increased at least $3,000 during a 12-month period.
SB70,1567,2119 (c) A biosimilar that has a launch wholesale acquisition cost that is not at least
2015 percent lower than the referenced brand biologic at the time the biosimilar is
21launched.
SB70,1567,2522 (d) A generic drug that has a wholesale acquisition cost, as adjusted annually
23to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
24city average, as determined by the U.S. department of labor, that meets all of the
25following conditions:
SB70,1568,6
11. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
2days based on the recommended dosage approved for labeling by the federal food and
3drug administration, a supply lasting a patient for a period of fewer than 30 days
4based on the recommended dosage approved for labeling by the federal food and drug
5administration, or one unit of the drug if the labeling approved by the federal food
6and drug administration does not recommend a finite dosage.
SB70,1568,97 2. Increased by at least 200 percent during the preceding 12-month period, as
8determined by the difference between the resulting wholesale acquisition cost and
9the average of the wholesale acquisition cost reported over the preceding 12 months.
SB70,1568,1210 (e) Other prescription drug products, including drugs to address public health
11emergencies, that may create affordability challenges for the health care system and
12patients in this state.
SB70,1568,17 13(2) Affordability review. (a) After identifying prescription drug products
14under sub. (1), the board shall determine whether to conduct an affordability review
15for each identified prescription drug product by seeking stakeholder input about the
16prescription drug product and considering the average patient cost share of the
17prescription drug product.
SB70,1568,2318 (b) The information used to conduct an affordability review under par. (a) may
19include any document and research related to the manufacturer's selection of the
20introductory price or price increase of the prescription drug product, including life
21cycle management, net average price in this state, market competition and context,
22projected revenue, and the estimated value or cost-effectiveness of the prescription
23drug product.
SB70,1569,3
1(c) The failure of a manufacturer to provide the board with information for an
2affordability review under par. (b) does not affect the authority of the board to
3conduct the review.
SB70,1569,11 4(3) Affordability challenge. When conducting an affordability review of a
5prescription drug product under sub. (2), the board shall determine whether use of
6the prescription drug product that is fully consistent with the labeling approved by
7the federal food and drug administration or standard medical practice has led or will
8lead to an affordability challenge for the health care system in this state, including
9high out-of-pocket costs for patients. To the extent practicable, in determining
10whether a prescription drug product has led or will lead to an affordability challenge,
11the board shall consider all of the following factors:
SB70,1569,1312 (a) The wholesale acquisition cost for the prescription drug product sold in this
13state.
SB70,1569,1714 (b) The average monetary price concession, discount, or rebate the
15manufacturer provides, or is expected to provide, to health plans in this state as
16reported by manufacturers and health plans, expressed as a percent of the wholesale
17acquisition cost for the prescription drug product under review.
SB70,1569,2118 (c) The total amount of the price concessions, discounts, and rebates the
19manufacturer provides to each pharmacy benefit manager for the prescription drug
20product under review, as reported by the manufacturer and pharmacy benefit
21manager and expressed as a percent of the wholesale acquisition cost.
SB70,1569,2322 (d) The price at which therapeutic alternatives to the prescription drug product
23have been sold in this state.
SB70,1570,3
1(e) The average monetary concession, discount, or rebate the manufacturer
2provides or is expected to provide to health plan payors and pharmacy benefit
3managers in this state for therapeutic alternatives to the prescription drug product.
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