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4601.785 Prescription drug affordability review board. (1) Mission. The
5purpose of the board is to protect state residents, the state, local governments, health
6plans, health care providers, pharmacies licensed in this state, and other
7stakeholders of the health care system in this state from the high costs of prescription
8drug products.
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9(2) Powers and duties. (a) The board shall do all of the following:
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1. Meet in open session at least 4 times per year to review prescription drug
11product pricing information, except that the chair may cancel or postpone a meeting
12if there is no business to transact.
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2. To the extent practicable, access and assess pricing information for
14prescription drug products by doing all of the following:
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a. Accessing and assessing information from other states by entering into
16memoranda of understanding with other states to which manufacturers report
17pricing information.
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b. Assessing spending for specific prescription drug products in this state.
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c. Accessing other available pricing information.
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(b) The board may do any of the following:
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1. Promulgate rules for the administration of this subchapter.
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2. Enter into a contract with an independent 3rd party for any service
23necessary to carry out the powers and duties of the board. Unless written permission
24is granted by the board, any person with whom the board contracts may not release,
1publish, or otherwise use any information to which the person has access under the
2contract.
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(c) The board shall establish and maintain a website to provide public notices
4and make meeting materials available under sub. (3) (a) and to disclose conflicts of
5interest under sub. (4) (d).
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6(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide
7public notice of each board meeting at least 2 weeks prior to the meeting and shall
8make the materials for each meeting publicly available at least one week prior to the
9meeting.
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(b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for
11public comment at each open meeting and shall provide the public with the
12opportunity to provide written comments on pending decisions of the board.
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(c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board
14concerning proprietary data and information shall be conducted in closed session
15and shall in all respects remain confidential.
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(d) The board may allow expert testimony at any meeting, including when the
17board meets in closed session.
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18(4) Conflicts of interest. (a) A member of the board shall recuse himself or
19herself from a decision by the board relating to a prescription drug product if the
20member or an immediate family member has received or could receive any of the
21following:
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1. A direct financial benefit deriving from a determination, or a finding of a
23study or review, by the board relating to the prescription drug product.
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12. A financial benefit in excess of $5,000 in a calendar year from any person who
2owns, manufactures, or provides a prescription drug product to be studied or
3reviewed by the board.
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(b) A conflict of interest under this subsection shall be disclosed by the board
5when hiring board staff, by the appointing authority when appointing members to
6the board, and by the board when a member of the board is recused from any decision
7relating to a review of a prescription drug product.
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(c) A conflict of interest under this subsection shall be disclosed no later than
95 days after the conflict is identified, except that, if the conflict is identified within
105 days of an open meeting of the board, the conflict shall be disclosed prior to the
11meeting.
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(d) The board shall disclose a conflict of interest under this subsection on the
13board's website unless the chair of the board recuses the member from a final
14decision relating to a review of the prescription drug product. The disclosure shall
15include the type, nature, and magnitude of the interests of the member involved.
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(e) A member of the board or a 3rd-party contractor may not accept any gift or
17donation of services or property that indicates a potential conflict of interest or has
18the appearance of biasing the work of the board.
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19Section
83. 601.79 of the statutes is created to read:
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20601.79 Drug cost affordability review. (1) Identification of drugs. The
21board shall identify prescription drug products that are any of the following:
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(a) A brand name drug or biologic that, as adjusted annually to reflect
23adjustments to the U.S. consumer price index for all urban consumers, U.S. city
24average, as determined by the U.S. department of labor, has a launch wholesale
25acquisition cost of at least $30,000 per year or course of treatment.
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1(b) A brand name drug or biologic that, as adjusted annually to reflect
2adjustments to the U.S. consumer price index for all urban consumers, U.S. city
3average, as determined by the U.S. department of labor, has a wholesale acquisition
4cost that has increased at least $3,000 during a 12-month period.
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(c) A biosimilar that has a launch wholesale acquisition cost that is not at least
615 percent lower than the referenced brand biologic at the time the biosimilar is
7launched.
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(d) A generic drug that has a wholesale acquisition cost, as adjusted annually
9to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
10city average, as determined by the U.S. department of labor, that meets all of the
11following conditions:
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1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
13days based on the recommended dosage approved for labeling by the federal food and
14drug administration, a supply lasting a patient for a period of fewer than 30 days
15based on the recommended dosage approved for labeling by the federal food and drug
16administration, or one unit of the drug if the labeling approved by the federal food
17and drug administration does not recommend a finite dosage.
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2. Increased by at least 200 percent during the preceding 12-month period, as
19determined by the difference between the resulting wholesale acquisition cost and
20the average of the wholesale acquisition cost reported over the preceding 12 months.
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(e) Other prescription drug products, including drugs to address public health
22emergencies, that may create affordability challenges for the health care system and
23patients in this state.
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24(2) Affordability review. (a) After identifying prescription drug products
25under sub. (1), the board shall determine whether to conduct an affordability review
1for each identified prescription drug product by seeking stakeholder input about the
2prescription drug product and considering the average patient cost share of the
3prescription drug product.
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(b) The information used to conduct an affordability review under par. (a) may
5include any document and research related to the manufacturer's selection of the
6introductory price or price increase of the prescription drug product, including life
7cycle management, net average price in this state, market competition and context,
8projected revenue, and the estimated value or cost-effectiveness of the prescription
9drug product.
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(c)
The failure of a manufacturer to provide the board with information for an
11affordability review under par. (b) does not affect the authority of the board to
12conduct the review.
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13(3) Affordability challenge. When conducting an affordability review of a
14prescription drug product under sub. (2), the board shall determine whether use of
15the prescription drug product that is fully consistent with the labeling approved by
16the federal food and drug administration or standard medical practice has led or will
17lead to an affordability challenge for the health care system in this state, including
18high out-of-pocket costs for patients. To the extent practicable, in determining
19whether a prescription drug product has led or will lead to an affordability challenge,
20the board shall consider all of the following factors:
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(a) The wholesale acquisition cost for the prescription drug product sold in this
22state.
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(b) The average monetary price concession, discount, or rebate the
24manufacturer provides, or is expected to provide, to health plans in this state as
1reported by manufacturers and health plans, expressed as a percent of the wholesale
2acquisition cost for the prescription drug product under review.
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(c) The total amount of the price concessions, discounts, and rebates the
4manufacturer provides to each pharmacy benefit manager for the prescription drug
5product under review, as reported by the manufacturer and pharmacy benefit
6manager and expressed as a percent of the wholesale acquisition cost.
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(d) The price at which therapeutic alternatives to the prescription drug product
8have been sold in this state.
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(e) The average monetary concession, discount, or rebate the manufacturer
10provides or is expected to provide to health plan payors and pharmacy benefit
11managers in this state for therapeutic alternatives to the prescription drug product.
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(f) The costs to health plans based on patient access consistent with labeled
13indications by the federal food and drug administration and recognized standard
14medical practice.
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(g) The impact on patient access resulting from the cost of the prescription drug
16product relative to insurance benefit design.
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(h) The current or expected dollar value of drug-specific patient access
18programs that are supported by the manufacturer.
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(i) The relative financial impacts to health, medical, or social services costs that
20can be quantified and compared to baseline effects of existing therapeutic
21alternatives to the prescription drug product.
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(j) The average patient copay or other cost sharing for the prescription drug
23product in this state.
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(k) Any information a manufacturer chooses to provide.
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(L) Any other factors as determined by the board by rule.
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1(4) Upper payment limit. (a) If the board determines under sub. (3) that use
2of a prescription drug product has led or will lead to an affordability challenge, the
3board shall establish an upper payment limit for the prescription drug product after
4considering all of the following:
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1. The cost of administering the drug.
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2. The cost of delivering the drug to consumers.
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3. Other relevant administrative costs related to the drug.
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(b)
For a prescription drug product identified in sub. (1) (b) or (d) 2., the board
9shall solicit information from the manufacturer regarding the price increase. To the
10extent that the price increase is not a result of the need for increased manufacturing
11capacity or other effort to improve patient access during a public health emergency,
12the board shall establish an upper payment limit under par. (a) that is equal to the
13cost to consumers prior to the price increase.
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(c) 1. The upper payment limit established under this subsection shall apply
15to all purchases and payor reimbursements of the prescription drug product
16dispensed or administered to individuals in this state in person, by mail, or by other
17means.
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2. Notwithstanding subd. 1., while state-sponsored and state-regulated
19health plans and health programs shall limit drug reimbursements and drug
20payment to no more than the upper payment limit established under this subsection,
21a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of
22Medicare under
42 USC 1395w-101 et seq. may choose to reimburse more than the
23upper payment limit. A provider who dispenses and administers a prescription drug
24product in this state to an individual in this state may not bill a payor more than the
25upper payment limit to the patient regardless of whether a plan subject to the
1Employee Retirement Income Security Act of 1974 or Part D of Medicare under
42
2USC 1395w-101 et seq. chooses to reimburse the provider above the upper payment
3limit.
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4(5) Public inspection. Information submitted to the board under this section
5shall be open to public inspection only as provided under ss. 19.31 to 19.39.
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6(6) No prohibition on marketing. Nothing in this section may be construed to
7prevent a manufacturer from marketing a prescription drug product approved by the
8federal food and drug administration while the prescription drug product is under
9review by the board.
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10(7) Appeals. A person aggrieved by a decision of the board may request an
11appeal of the decision no later than 30 days after the board makes the determination.
12The board shall hear the appeal and make a final decision no later than 60 days after
13the appeal is requested. A person aggrieved by a final decision of the board may
14petition for judicial review
in a court of competent jurisdiction.
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15Section 9123.
Nonstatutory provisions; Insurance.
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(1u)
Staggered terms for board. Notwithstanding the length of terms
17specified for the members of the board under s. 15.735 (1) (b) to (e), 2 of the initial
18members shall be appointed for terms expiring on May 1, 2025; 2 of the initial
19members shall be appointed for terms expiring on May 1, 2026; 2 of the initial
20members shall be appointed for terms expiring on May 1, 2027; and 2 of the initial
21members shall be appointed for terms expiring on May 1, 2028.
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(1v)
Prescription drug affordability review board. The treatment of ss. 15.07
24(3) (bm) 7., 15.735, 601.78, 601.785, and 601.79 and subch. VI (title) of ch. 601 and
1Section 9123 (1u) of this act take effect on the first day of the 7th month beginning
2after publication.”.
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4“
Section
84. 20.005 (3) (schedule) of the statutes: at the appropriate place,
5insert the following amounts for the purposes indicated:
-
See PDF for table ![PDF](https://docs.legis.wisconsin.gov/assets/image/file_acrobat.gif)
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6Section
85. 20.435 (5) (ch) of the statutes is created to read:
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20.435
(5) (ch)
Suicide and crisis lifeline grants. The amounts in the schedule
8for grants under s. 46.533.
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9Section
86. 46.533 of the statutes is created to read:
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1046.533 Suicide and crisis lifeline; grants. (1) In this section, “national
11crisis hotline” means the telephone or text access number “988,” or its successor, that
12is maintained under the federally administered program under
42 USC 290bb-36c.
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13(2) From the appropriation under s. 20.435 (5) (ch), the department shall award
14grants to organizations that provide crisis intervention services and crisis care
15coordination to individuals who contact the national crisis hotline from anywhere
16within this state.”.
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18“
Section
87. 49.79 (9) (f) of the statutes is repealed.”.
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20“
Section
88. 46.48 (36) of the statutes is created to read:
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146.48
(36) Amyotrophic lateral sclerosis. From the appropriation under s.
220.435 (1) (b), the department shall award $250,000 in each fiscal year as a grant to
3an organization that supports and provides services to individuals with amyotrophic
4lateral sclerosis for the purposes of assisting individuals diagnosed with
5amyotrophic lateral sclerosis and their families with the costs of respite care and
6costs associated with amyotrophic lateral sclerosis that are not covered by
7insurance.”.
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9“
Section 9119.
Nonstatutory provisions; Health Services.
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(1)
Low-value care analysis grant. From the appropriation under s. 20.435 (1)
11(b), in the 2023-24 and 2024-25 fiscal years, the department of health services shall
12award a grant in an amount not to exceed $900,000 in each fiscal year to an
13organization for the purpose of conducting a data analysis of claims under the
14medical assistance program administered by the department of health services and
15claims under health care coverage plans offered by the state under s. 40.51 (6) to
16identify low-value care. The recipient of the grant under this subsection shall report
17the organization's findings, including any recommendations for providing effective
18and efficient care, to the department of health services and the department of
19employee trust funds. The department of health services and the department of
20employee trust funds shall distribute the findings reported under this subsection to
21health care providers that provide services covered by the medical assistance
22program or a health care coverage plan and to health maintenance organizations and
23insurance companies that provide health insurance to state employees.”.
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3Section
90. 20.435 (1) (ex) of the statutes is created to read:
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20.435
(1) (ex)
Maternal and infant mortality prevention and response. The
5amounts in the schedule for the prevention of and response to maternal and infant
6mortality under s. 253.143.
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7Section
91. 253.143 of the statutes is created to read:
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8253.143 Maternal and infant mortality prevention and response. From
9the appropriation under s. 20.435 (1) (ex), the department shall do all of the
10following:
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11(1) Annually award grants to community organizations whose goal is the
12prevention of maternal and infant mortality.
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13(2) Annually award grants to support the expansion of fetal and infant
14mortality review and maternal mortality review teams statewide and expand
15technical assistance and support for existing fetal and infant mortality review and
16child death review teams.
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17(3) Provide funding and technical assistance to community-based
18organizations aimed at preventing infant morality.
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1(4) Provide funding for grief and bereavement programming for those impacted
2by infant loss.
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3Section 9119.
Nonstatutory provisions; Health Services.
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4(1) Maternal and infant mortality prevention and response. The authorized
5FTE positions for the department of health services are increased by 2.0 FTE
6positions, to be funded from the appropriation under s. 20.435 (1) (ex), for the purpose
7of administering the maternal and infant mortality prevention and response
8program.”.